CN118382481A - Device for cosmetic treatment of biological structures by means of radio frequency and magnetic energy - Google Patents

Device for cosmetic treatment of biological structures by means of radio frequency and magnetic energy Download PDF

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Publication number
CN118382481A
CN118382481A CN202280071798.1A CN202280071798A CN118382481A CN 118382481 A CN118382481 A CN 118382481A CN 202280071798 A CN202280071798 A CN 202280071798A CN 118382481 A CN118382481 A CN 118382481A
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China
Prior art keywords
applicator
magnetic field
electrode
treatment
field generating
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CN202280071798.1A
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Chinese (zh)
Inventor
朗·弗兰蒂斯科
施瓦兹·托马斯
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Bitler Medical Solutions Co ltd
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Bitler Medical Solutions Co ltd
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Priority claimed from PCT/IB2022/059794 external-priority patent/WO2023062563A1/en
Publication of CN118382481A publication Critical patent/CN118382481A/en
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Abstract

The present invention provides an apparatus that excites muscle contraction by a time-varying magnetic field to provide magnetic therapy and heats biological structures to provide radio frequency therapy. The device may provide pressure therapy. The device includes an applicator having an RF electrode and a magnetic field generating device. The device also includes a main unit, a human-machine interface, and a control unit. The control unit adjusts the signal supplied to the RF electrode and forms an RF circuit, and also adjusts the signal supplied to the magnetic field generating device and forms a magnetic circuit electrically insulated from the RF circuit. The RF circuit may include a power source and a power amplifier and the magnetic circuit may include an energy storage device to power the magnetic field generating device with the circuit.

Description

Device for cosmetic treatment of biological structures by means of radio frequency and magnetic energy
Cross Reference to Related Applications
The present application claims priority from U.S. patent application Ser. No. 17/500,612, filed on day 10, month 13 of 2021, and U.S. patent application Ser. No. 63/316,758, filed on day 3, month 4 of 2022. The entire contents of each of these applications are incorporated herein by reference.
Background
Cosmetic medicine includes all treatments that result in enhanced visual appearance according to patient criteria. The patient wishes to minimize all imperfections, including for example undesired body fat of a specific body part, improve body shape, and eliminate the effects of natural ageing. The patient needs a rapid non-invasive procedure that provides satisfactory results with minimal health risks.
The most common methods for non-invasive cosmetic applications are based on the application of mechanical waves (such as ultrasound or shock wave therapy) or electromagnetic waves (such as radio frequency therapy or light therapy including laser therapy). The effect of mechanical waves on the wave tissue is based on cavitation, vibration and/or thermally induced effects. The effect of electromagnetic wave application is based on the heat generation of biological structures.
Mechanical treatment with mechanical waves and/or pressure may be used for the treatment of cellulite or adipocytes. However, such mechanical treatments have several drawbacks, such as the risk of panniculitis, destruction of non-target tissue, and/or non-uniform results.
Thermal treatment, including heating, is suitable for use in patients for enhancing the visual effects of the skin and body, such as by increasing collagen and/or elastin production, smoothing the skin, reducing cellulite, and/or eliminating adipocytes. However, thermal treatment has some drawbacks, such as the risk of overheating the patient, or even causing thermal damage to undesirable biological structures. The risk of adiposities and/or non-uniform results can be a very common side effect of existing heat treatments. In addition, insufficient blood flow and/or lymphatic flow during and/or after treatment may lead to post-treatment fatty inflammation and other health complications. Furthermore, the treatment may be uncomfortable and accompanied by a pain sensation.
Muscle stimulation of time-varying magnetic fields provides a number of benefits over known methods for treating biological structures and allows for non-invasive stimulation of muscles located beneath other muscles. In addition, the time-varying magnetic field may be used to provide muscle stimulation to cause muscle contraction by electrical stimulation of thick layers of adipose tissue to provide muscle contraction to deliver electrical current from the electrodes through the adipose tissue to the nerve and/or neuromuscular plates associated with the muscle. Adipose tissue has a higher resistivity than muscle tissue and the delivery of electrical current from the electrode through the insulating adipose tissue to the muscle tissue is less efficient. Targeting of current to the exact muscle can be imprecise and muscle stimulation is very difficult, nearly impossible. Furthermore, for thicker adipose tissue, the current delivered by electrical therapy must be high, and such high amounts of current that are propagated and dissipated over long distances are very uncomfortable for the patient. On the other hand, the time-varying magnetic field induces currents in the muscles, neuromuscular plates and/or nerves, so targeting and muscle stimulation by the time-varying magnetic field is easier, more accurate, more comfortable and more efficient. The time-varying magnetic field also allows for comfortable stimulation, or a large number of muscles and/or muscle groups and applicators may be in direct contact with the patient's body, which non-direct contact may also improve the hygienic condition of the treatment and other treatment parameters.
A combination of Radio Frequency (RF) therapy, which provides heating of patient soft tissue, and magnetic therapy, which provides stimulation of patient muscle tissue, may have a significant synergistic effect. Combination therapy may provide improved therapeutic effects, which may lead to a shortened treatment cycle, increased patient comfort during treatment; it may be possible to combine different therapeutic effects with synergistic effects, improve patient safety as described further herein below, etc.
For optimal synergy, it is preferable to target the magnetic therapy providing muscle stimulation and the RF therapy to one body part (e.g., the same body part), wherein at least one RF electrode providing the RF therapy should be flat and/or should be in response to the patient's skin to ensure uniform heating of the patient's soft tissue. To target RF therapy and magnetic therapy to the same body part, it is necessary to position the magnetic field generating device and the RF electrode in close proximity to each other, e.g. the magnetic field generating device and the RF electrode at least partially overlap. However, placing the RF electrode and the magnetic field generating device in close proximity is problematic because the time-varying magnetic field generated by the magnetic field generating device may induce undesirable physical effects, such as eddy currents, skin effects, and/or other physical effects in the RF electrode. Undesired physical effects may cause significant energy losses, inefficiency of such device arrangements and heating of the RF electrodes, effects of device functions such as incorrect tuning of the device, inaccurate targeting of the generated energy, degradation of the generated magnetic field, electromagnetic field, and so forth. The RF electrode may be affected by the magnetic field generating device and vice versa.
The devices and methods described herein present a solution for providing RF and magnetic therapy with maximum synergistic effect, and also preserve the safety and efficiency of the delivered magnetic and RF (electromagnetic) fields.
Disclosure of Invention
The present disclosure provides therapeutic devices and methods for providing one or more therapeutic effects to at least one biological structure of at least one body part. The treatment device provides unique opportunities for how to shape the human or animal body, improve visual appearance, restore muscle function, increase muscle strength, change (e.g., increase) muscle volume, change (e.g., increase) muscle tone, cause hypertrophy of muscle fibers, cause hyperplasia of muscle fibers, reduce the number and volume of fat cells and adipose tissue, eliminate cellulite, and the like. The treatment apparatus and method may utilize the use of Radio Frequency (RF) therapy and magnetic therapy to cause heating of at least one target biological structure within a body part and to cause muscle stimulation, including muscle contraction, of nearby or the same body part. The treatment device may use the RF electrodes as a treatment energy source to generate RF energy (which may be referred to as an RF field) to provide RF treatment and the magnetic field generating device as a treatment energy source to generate a time-varying magnetic field to provide magnetic treatment.
The therapeutic effects provided by the therapeutic devices and methods may include muscle stimulation, where the muscle stimulation may include muscle contraction, e.g., super-maximal muscle contraction. Therapeutic effects may include heating a body part. The treatment apparatus and method may provide a combination of therapeutic effects, such as muscle stimulation and heating of a body part. The treatment apparatus and method may provide muscle contraction and heating at the same time or at different times during treatment. The treatment apparatus and method may provide muscle contraction and heating of body adipose tissue at the same time or at different times during treatment. Furthermore, the treatment apparatus and method may provide muscle contraction and heating of adipose tissue of the same body part at the same time or at different times during treatment. Furthermore, the treatment apparatus and method may provide muscle contraction and heating of the same muscle at the same time or at different times during treatment. Furthermore, the treatment apparatus and method may provide muscle contraction and heating of the same muscle of the same body part at the same time or at different times during treatment.
Furthermore, the treatment apparatus and method may provide muscle contraction and heating of the body skin at the same time or at different times during treatment. Furthermore, the treatment apparatus and method may provide muscle contraction and heating of the skin of the same body part at the same time or at different times during treatment.
To enhance the efficiency and safety of the treatment, to minimize energy losses and unwanted physical effects induced in at least one radio frequency electrode and/or the magnetic field generating device, the device may utilize one or more segmented radio frequency electrodes, where segmented radio frequency electrode means a radio frequency electrode having, for example, one or more apertures, cutouts and/or protrusions to minimize the effects of nearby time-varying magnetic fields generated by the magnetic field generating device. The aperture may be an opening in the body of the radiofrequency electrode. The cutout may be an opening in the body of the radiofrequency electrode along the boundary of the radiofrequency electrode. The opening in the body of the radiofrequency electrode may be defined by a view from the ground projection, which shows the radiofrequency electrode from above. The apertures, cutouts, and/or raised outer regions may be filled with air, dielectric, and/or other electrically insulating material. The apertures, cutouts, and/or protrusions of the radiofrequency electrode may minimize eddy current induction in the radiofrequency electrode, minimize energy loss, and inhibit overheating of the therapeutic device. In addition, the apertures, cutouts, and/or protrusions may minimize the impact of magnetic therapy on the RF therapy generated. The RF electrode is designed to allow the same applicator to include a magnetic field generating device and an RF electrode that at least partially overlap, according to the terrestrial projection of the applicator, while allowing RF therapy and magnetic therapy to be targeted to the same site of the patient's body with the parameters described herein. The combination of the rf electrode and the magnetic field generating device in one applicator may enhance treatment targeting and achieve positive treatment results with minimal negative impact as described above.
In addition, the mutual insulation of the at least one RF circuit and the at least one magnet circuit prevents interactions between electrical and/or electromagnetic signals.
The combination of the magnetic field generating device and the energy storage device allows to generate a magnetic field having a certain strength (which may be a magnetic flux density) which induces a muscle contraction. The energy storage device may be used to store electrical energy, allowing the accumulation of an electric field having a voltage in the range of 500V to 15 kV. The energy storage device may provide stored electrical energy to the magnetic field generating device in pulses of several microseconds to several milliseconds.
The treatment method allows heating at least one body part, which also induces muscle contraction that minimizes muscle and/or ligament injury (such as tearing or inflammation). When the patient considers the treatment uncomfortable, the heating of the skin, contracted muscles, positively contracted muscles, relaxed muscles, adipose tissue, and/or adjacent biological structures of the treated body part may shift.
Thus, heating may allow a higher amount of electromagnetic energy (e.g., RF and/or magnetic fields) to be delivered to the patient's body to provide more muscle work through muscle contraction and subsequent relaxation. Another benefit of using RF therapy and magnetic therapy at the same site is that muscle work (e.g., provided by repeated muscle contraction and relaxation) accelerates blood and lymphatic flow at the targeted site and thus improves the dissipation of thermal energy created by RF therapy. The application of RF therapy and magnetic therapy also improves the uniformity of heating of the biological structure, which prevents the formation of hot spots, edge effects, and/or other adverse effects. Therapeutic approaches that cause muscle stimulation and heating of the same body part can lead to excessive acidification of the extracellular matrix, which leads to apoptosis or necrosis of adipose tissue. RF treatment may provide selective heating of adipose tissue that results in at least one of: apoptosis, necrosis, volume reduction, and cellulite elimination of adipocytes.
A therapeutic device is capable of providing muscle contraction and/or heating to a body part of a patient. Muscle contraction may be provided by magnetic therapy and heating may be provided by radio frequency therapy.
A therapeutic device that provides muscle contraction and/or heating may include at least one magnetic field generating device and/or at least one radio frequency electrode.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and optionally a radio frequency electrode having a plurality of openings.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and optionally a radio frequency electrode having a plurality of incisions.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and optionally a radio frequency electrode having a plurality of protrusions.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and optionally a radio frequency electrode, wherein the radio frequency electrode may be located between the magnetic field generating device and the body part of the patient. The radio frequency electrode may be arranged to overlap the magnetic field generating device according to a ground projection of the applicator comprising the magnetic field generating device and the radio frequency electrode.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and optionally a radio frequency electrode, wherein the radio frequency electrode comprises at least one layer of a substrate covered by at least one conductive layer.
A therapy device for providing magnetic therapy and radio frequency therapy to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, a plurality of radio frequency electrodes, and an optional impedance element.
A treatment device that provides magnetic and radio frequency treatment to a body part of a patient may include an energy storage device, a magnetic field generating device, a switching device, and/or a radio frequency electrode comprising metal foam.
A therapeutic device for providing muscle contraction and/or heating to a body part of a patient may include an applicator with a temperature sensor. The positioning of the temperature sensor and/or the wire connection between the temperature sensor and the rest of the treatment device may be designed to minimize the impact of the operation of the applicator. The location of the temperature sensor may include the temperature sensor being present in a protrusion of the applicator. The design of the wire connection may include materials and/or thicknesses thereof as further disclosed herein.
A therapeutic device for providing magnetic and radio frequency therapy to a body part of a patient may comprise a main unit and an applicator comprising at least one magnetic field generating device and at least one radio frequency electrode. The applicator may be connected to the main unit by a connection accessory comprising male and/or female contacts. One or more contacts of the connection accessory may be used to communicate signals to and from at least one magnetic field generating device, at least one radio frequency electrode, or a temperature sensor. Furthermore, as described herein, one or more contacts of the attachment accessory can be used to identify the type of applicator, to deliver a cooling fluid, to provide a safety circuit, or to control the durability of the applicator.
In some aspects, a device for providing magnetic therapy and radio frequency therapy to a patient is provided, the device comprising a magnetic field generating device and a radio frequency electrode, wherein the magnetic field generating device provides muscle contraction, and wherein the radio frequency electrode provides heating of patient tissue.
In some aspects, a device is provided for providing magnetic therapy, radio frequency therapy, and pressure therapy to a patient, the device comprising a magnetic field generating device, one or more radio frequency electrodes, and a pressure outlet, wherein the magnetic field generating device provides muscle contraction, wherein the one or more radio frequency electrodes provide heating of patient tissue, and wherein the pressure therapy provides mechanical pulses.
In some aspects, an apparatus is provided for providing magnetic therapy, radio frequency therapy, and pressure therapy to a patient, the apparatus comprising an applicator, a magnetic field generating device, one or more radio frequency electrodes, and a pressure outlet, wherein the magnetic field generating device provides muscle contraction, wherein the one or more radio frequency electrodes provide heating of patient tissue, wherein the pressure therapy provides mechanical pulses, and wherein the applicator comprises the magnetic field generating device, the one or more radio frequency electrodes, and the pressure outlet.
In some aspects, an applicator is provided that may have more than one portion for applying a treatment. In some aspects, the applicator may include first and second portions that are movable relative to one another. In some aspects, the first and second applicator portions may be defined by first and second planes, and the applicator portions may be positioned such that the planes are not parallel to one another. As described herein, treatment may be performed in a similar manner as an applicator configured with a single portion. In some cases, treatment may be provided by multiple applicator portions lying in more than one plane, which may be beneficial for body parts or body part portions that include curves or other irregular shapes (e.g., flanks, latissimus, lumbar regions, shoulders, or knees). In some cases, treatment of body parts that are more difficult to reach or effectively treated with a single-part applicator may improve treatment by using a multi-part applicator.
In some aspects, the treatment device provides magnetic therapy, massage, and radio frequency therapy. In some aspects, the treatment device includes an applicator that provides magnetic therapy, massage, and radio frequency therapy.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy, pressure therapy, and radio frequency therapy to a body part of a patient, the apparatus comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.1 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a radio frequency electrode configured to generate a radio frequency field to heat tissue in a body part of a patient; and a pressure outlet configured to provide pressure therapy to skin in a body part of the patient.
In some embodiments, there is provided a therapeutic apparatus for providing magnetic therapy, massage and radio frequency therapy to a body part of a patient, the apparatus comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.1 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a radio frequency electrode configured to generate a radio frequency field to heat tissue in a body part of a patient; and a pressure outlet configured to provide a massage to skin in a body part of the patient.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy, pressure therapy, and radio frequency therapy to a body part of a patient, the apparatus comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.1 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; and a radio frequency electrode configured to generate a radio frequency field to heat tissue in a body part of a patient; a pressure outlet configured to provide pressure therapy including pressure pulses to skin in a body part of a patient.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy, vibration and radio frequency therapy to a body part of a patient, the apparatus comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.1 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; and an RF electrode configured to generate a radio frequency field to heat tissue in a body part of a patient; a pressure outlet configured to provide vibrations to skin in a body part of a patient.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a first part including a first magnetic field generating device; a second part including a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a movement structure configured to provide free movement of the first portion, wherein the movement structure comprises a gear and/or a joint.
A moving structure may include a joint, a gear, a rotor, a cam, or a combination thereof.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a first part including a first magnetic field generating device; a second part including a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a moving structure configured to provide free movement of the first portion, wherein the moving structure comprises a gear train comprising two gears.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a first part including a first magnetic field generating device; a second part including a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a moving structure configured to provide free movement of the first and second portions, wherein the moving structure comprises a gear train comprising two gears.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy and pressure therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; a pressure outlet; a positioning mechanism configured to provide movement of the magnetic field generating device within the applicator, and wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700Hz, and wherein the pressure outlet is configured to provide pressure therapy comprising pressure pulses to tissue in a body part of the patient.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy and pressure therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a magnetic field generating device configured to provide a time-varying magnetic field to a body part of a patient such that muscles of the body part of the patient contract; a pressure outlet; a positioning mechanism configured to provide movement of the pressure outlet within the applicator, and wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700Hz, and wherein the pressure outlet is configured to provide pressure therapy comprising pressure pulses to tissue in a body part of the patient.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: a first applicator comprising a first magnetic field generating device; an applicator comprising a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a movement structure configured to provide free movement of the first and second applicators, wherein the movement structure comprises a gear train comprising two gears.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: a first applicator comprising a first magnetic field generating device; an applicator comprising a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; wherein the movement structure is configured to provide movement between the first applicator and the movement structure at an angle in the range of 10 ° to 175 °.
In some aspects, there is provided a therapeutic apparatus for providing magnetic therapy to a body part of a patient, the apparatus comprising: an applicator, comprising: a first part including a first magnetic field generating device; a second part including a second magnetic field generating device; wherein the first magnetic field generating device and the second magnetic field generating device are configured to provide a time-varying magnetic field to a body part of the patient such that muscles of the body part of the patient contract; wherein the time-varying magnetic field has a magnetic flux density in the range of 0.5 tesla to 7 tesla and a repetition rate in the range of 0.1Hz to 700 Hz; a movement structure configured to provide free movement of the first portion and the second portion, wherein the movement structure is configured to provide movement between the first portion and the movement structure at an angle in the range of 10 ° to 175 °.
Drawings
The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present disclosure and, together with the description, further serve to explain the principles of the disclosure and to enable a person skilled in the pertinent art to make and use the disclosure.
Fig. 1a to 1e show exemplary schematic views of a therapeutic device.
Fig. 1f shows exemplary individual components of a therapeutic apparatus.
Fig. 2 shows an exemplary communication diagram between components of a treatment device, such as an applicator, a remote control, an additional treatment device, and a communication device.
Fig. 3 shows an exemplary communication diagram between a server and components of a treatment device, such as an applicator, a remote control, and an additional treatment device.
Fig. 4 shows an exemplary communication diagram between the communication medium of the treatment device, the therapy generator, and the host unit.
Fig. 5 illustrates communication between a communication medium of a treatment device and a therapy generator.
Fig. 6 shows different views of an exemplary main unit of the treatment apparatus.
FIG. 7 illustrates an exemplary human-machine interface (HMI).
Fig. 8 a-8 e show components of an exemplary applicator from an external view.
Fig. 9a shows an exemplary magnetic field generating device from a ground projection of the applicator.
Fig. 9b shows the thickness of an exemplary magnetic field generating device.
Fig. 10a to 10u show possible positions of an exemplary RF electrode with respect to an exemplary magnetic field generating device.
Fig. 11 a-11 i show cross-sectional views of the location of an exemplary RF electrode positioned relative to an exemplary magnetic field generating device.
Fig. 12 shows a terrestrial projection of an applicator comprising RF electrodes and a magnetic field generating device that partially overlap according to the terrestrial projection of the applicator.
Fig. 13 a-13 b illustrate an exemplary RF electrode having an orifice.
Fig. 13c shows an exemplary RF electrode with apertures, protrusions and cutouts.
Fig. 13d shows an exemplary RF electrode with an aperture and a slit.
Fig. 13e shows an exemplary RF electrode with protrusions.
Fig. 14a to 14e show bipolar RF electrodes with parallel pairs of projections.
Fig. 15 a-15 c illustrate bipolar RF electrode pairs with protrusions, wherein a first RF electrode at least partially surrounds a second RF electrode of the RF electrode pair.
Fig. 16 shows an exemplary protrusion intersecting a magnetic field line, wherein the difference is higher than 0.1T.
Fig. 17 shows an exemplary schematic of a magnet circuit.
Fig. 18a shows an exemplary schematic of the electrical components of the treatment device.
Fig. 18b shows an exemplary schematic of the RF circuit.
Fig. 18c to 18i show exemplary schematic diagrams of electrical elements of the treatment device.
Fig. 19a shows an exemplary composition of a magnetic field comprising pulses or pulse rates.
Fig. 19b shows an exemplary composition of a radio frequency field comprising pulses or pulse rates.
Fig. 20 shows a trapezoidal envelope.
Fig. 21 shows different types of muscle stimulation.
Fig. 22 shows a support matrix for attaching the applicator and/or additional treatment device to the patient's body.
Fig. 23 shows a cross-section of a first side portion of an exemplary curved applicator.
Fig. 24 shows an exemplary symmetry element SYM.
Fig. 25a shows an exploded view of the applicator element.
Fig. 25b-f show cross-sections of exemplary applicators.
Fig. 26 shows an exemplary spatial arrangement of components within a main unit of a treatment apparatus.
Fig. 27a to 27d show examples of synchronous application of magnetic fields.
Fig. 27e shows an example of independent application of magnetic fields.
Fig. 28 shows an exemplary increasing envelope of the magnetic field.
Fig. 29 shows an exemplary reduced envelope of the magnetic field.
Fig. 30 shows an exemplary rectangular envelope of a magnetic field.
Fig. 31 shows an exemplary combined envelope of magnetic fields.
Fig. 32 shows an exemplary combined envelope of magnetic fields.
Fig. 33 shows an exemplary triangular envelope of a magnetic field.
Fig. 34 shows an exemplary trapezoidal envelope of a magnetic field.
Fig. 35 shows an exemplary trapezoidal envelope of the magnetic field.
Fig. 36 shows an exemplary trapezoidal envelope of a magnetic field.
Fig. 37 shows an exemplary step envelope of the magnetic field.
Fig. 38 shows an exemplary step envelope of the magnetic field.
Fig. 39 shows an exemplary trapezoidal envelope of a magnetic field.
Fig. 40 shows an example of an envelope of a magnetic field, including modulation in the repetition rate domain.
Fig. 41 shows an exemplary trapezoidal envelope formed by a sequence of magnetic fields.
Fig. 42 shows an exemplary combined envelope of magnetic fields.
Fig. 43 shows an exemplary combined envelope of magnetic fields.
Fig. 44 shows two exemplary envelopes as examples of inter-envelope periods.
Fig. 45a shows a front perspective view of the main unit of the treatment device according to one embodiment.
Fig. 45b shows a rear perspective view of the main unit of the treatment device shown in fig. 45 a.
Fig. 46 shows a top view of the main unit of the treatment device shown in fig. 45 a.
Fig. 47 shows a left side view of the main unit of the treatment device shown in fig. 45 a.
Fig. 48 shows a bottom view of the main unit of the treatment device shown in fig. 45 a.
Fig. 49 shows a rear view of the main unit of the treatment apparatus shown in fig. 45 a.
Fig. 50 shows a front view of the main unit of the treatment apparatus shown in fig. 45 a.
Fig. 51 shows a right side view of the main unit of the treatment device shown in fig. 45 a.
Fig. 52a shows the connection accessory between the applicator and the main unit.
Fig. 52b shows an applicator connector.
Fig. 52 c-52 d show the connection accessory between the applicator connector and the tube connector in the connected and disconnected positions.
Fig. 53 a-53 c illustrate exemplary RF electrodes according to some aspects of the invention.
Fig. 54 a-54 f illustrate an exemplary applicator including an RF electrode that includes a substrate.
Fig. 54g shows an RF electrode including a suture.
Fig. 54 h-54 j illustrate an exemplary applicator comprising a plurality of RF electrodes.
Fig. 54 k-54 o illustrate exemplary locations of multiple RF electrodes within and/or on an applicator.
Fig. 54p shows an exemplary applicator comprising a plurality of RF electrodes.
Fig. 55a to 55b show impedance elements.
Fig. 56a to 56e show exemplary schematic diagrams of electrical elements for mechanical treatment.
Fig. 56f shows an exemplary schematic of the electrical components of the treatment device.
Fig. 57 a-57 g illustrate an exemplary applicator including a pressure outlet.
Fig. 58 a-58 b illustrate an exemplary applicator including a pressure outlet and an edge.
FIG. 59 illustrates an exemplary applicator including a plurality of pressure outlets.
Fig. 60 a-60 e illustrate an exemplary applicator including an ultrasonic transducer.
Fig. 61 a-61 t illustrate ground projections of an exemplary applicator.
Fig. 61 u-61 x show cross-sectional front views of exemplary applicators.
Fig. 62a shows a side cross-sectional view of an exemplary applicator.
Fig. 62b shows a side cross-sectional view of an exemplary applicator.
Fig. 62c shows a ground projection of the position of an exemplary RF electrode relative to an exemplary magnetic field generating device within an exemplary applicator.
Fig. 62d shows a ground projection of the position of an exemplary RF electrode relative to an exemplary magnetic field generating device within an exemplary applicator.
Fig. 62e shows a side cross-sectional view of an exemplary applicator.
Fig. 62f and 62g illustrate an exemplary applicator.
Fig. 63 shows an exploded view of the applicator element.
Fig. 64 shows a cross-sectional view of an exemplary magnetic field generating device.
Fig. 65 illustrates the exemplary magnetic field generating device shown in fig. 64.
Fig. 66a shows a top view of an exemplary magnetic field generating device.
Fig. 66b illustrates a bottom view of the exemplary magnetic field generating device shown in fig. 66 a.
Fig. 66c shows an isometric view of the example magnetic field generating device of fig. 66a and 66 b.
Fig. 67 illustrates an exemplary magnetic field generating device.
Fig. 68 shows an exemplary schematic of the electrical components of the treatment apparatus.
Fig. 69 a-69 d illustrate side cross-sectional views of an exemplary applicator.
Fig. 70 a-70 e illustrate front cross-sectional views of exemplary applicators.
Fig. 70 f-70 l illustrate side cross-sectional views of an exemplary applicator.
Fig. 70 j-70 n illustrate front cross-sectional views of exemplary applicators.
Fig. 70 m-70 r illustrate side cross-sectional views of an exemplary applicator.
Detailed Description
The present therapeutic devices and methods used provide novel physiotherapy and/or cosmetic treatments through a combination of RF treatment and treatment providing muscle stimulation intended to achieve various therapeutic effects (such as rejuvenation, healing) and/or remodeling at least a portion of at least one biological structure of patient tissue of at least one body part.
The biological structure may be any tissue in the human and/or animal body that may have an equivalent function, structure and/or composition. The biological structure may include or may be at least a portion of any type of tissue, such as: connective tissue (e.g., tendons, ligaments, collagen, elastic fibers), adipose tissue (e.g., adipocytes and/or visceral adipocytes of subcutaneous adipose tissue), bone, dermis, and/or other tissue, such as at least one neuron, neuromuscular plate (neuromuscular junction), muscle cell, at least a portion of one or more individual muscles, muscle group, muscle fiber, volume of extracellular matrix, endocrine glands, neural tissue (e.g., peripheral neural tissue, neurons, glia, neuromuscular plate), and/or a portion of a joint or junction. For the purposes of the present application, a biological structure may be referred to as a target biological structure.
The therapeutic effect provided to at least a portion of the at least one target biological structure may include muscle contraction (including excessive contraction and/or tonic contraction, muscle twitches, muscle relaxation, and heating of the biological structure). Muscle contraction and heating may be provided simultaneously. In addition, therapeutic effects may include, for example, remodeling of biological structures, reduction of the number and/or volume of adipocytes by apoptosis and/or necrosis, muscle strengthening, muscle volume augmentation, induction of muscle fiber hypertrophy, muscle fiber hyperplasia, recovery of muscle function, proliferation and/or differentiation of body cells into muscle cells, improvement of muscle shape, improvement of muscle endurance, muscle lines, muscle relaxation, reduction of muscle volume, reorganization of collagen fibers, neocollagen production, elastogenesis, collagen treatment, improvement of blood and lymphatic flow, acceleration of at least a portion of at least one target biological structure, and/or other functions or benefits. More than one therapeutic effect may be provided during treatment of a body part by a treatment device, and various therapeutic effects may be combined.
The therapeutic effect provided to the target biological structure may result in body shaping, improved body contour, body conditioning, muscle shaping, body shaping, breast lifting, buttock rounding, and/or buttock tightening. In addition, providing a therapeutic effect may result in body rejuvenation such as reduced wrinkles, skin rejuvenation, skin tightening, uniformity of skin color, reduction of sagging flesh, lip enhancement, cellulite elimination, stretch mark reduction, and/or scar elimination. The therapeutic effect may also cause acceleration of the healing process, antirheumatic effects, and/or other physical therapies and therapeutic effects.
The treatment apparatus and method may be used in hospitals, beauty clinics, fitness centers, and/or in the patient's home.
The treatment devices and methods may be used for physiotherapy treatments, including treatment of pain, atrophy and/or rehabilitation after stroke. Other physiotherapy treatments may include treatment of achilles tendinitis, ankle joint deformity, tibial anterior syndrome, hand joint inflammation, joint disease, bursitis, carpal tunnel syndrome, neck pain, back pain, epicondylitis, facial nerve paralysis, herpes labialis, hip joint disease, impact syndrome/frozen shoulder, knee joint disease, knee joint deformity, lumbosacral pain, nerve repair, onychomycosis, osgdong-Shi Late syndrome, pain relief, painful shoulder, patellar tendinitis, plantar fasciitis/calcaneal spur, tarsal tunnel syndrome, tendinopathy, and/or tenosynovitis.
The treatment devices and methods can be used to treat pelvic floor tissue, including urinary incontinence, fecal incontinence, bladder dysfunction, sexual dysfunction, erectile dysfunction, fertility problems, pelvic pain, vulvar pain, dysmenorrhea, menopausal disorders, and/or postmenopausal disorders.
The treatment devices and methods can prevent and/or treat lifestyle disorders including atherosclerosis, hypertension, heart attack risk, stroke risk, abnormal glucose tolerance in pregnancy, and/or diabetes. The term "diabetes" may include type 1 diabetes, type 2 diabetes, protein deficiency pancreatic diabetes, malnutrition-related diabetes, fibrolithiasis pancreatic diabetes, and/or gestational diabetes. Using the treatment device and providing muscle stimulation (e.g., muscle contraction) and/or heating to the patient's body may prevent glucose tolerance or insulin reduction. Using the treatment device and providing muscle stimulation (e.g., muscle contraction) and/or heating to the patient's body may result in increased release of insulin and/or glycogen. Use of the therapeutic device can balance blood glucose levels by varying the concentration of glucose in the blood. The use of the therapeutic device can balance triglyceride blood levels by varying the concentration of triglycerides in the blood. Use of the therapeutic device can balance cholesterol blood levels by altering the concentration of cholesterol in the blood. The change in concentration may be achieved by muscle contraction and/or exercise provided by heating the patient's body. The use of the device may improve glucose metabolism and/or improve glucose transport into the cell. Improving glucose transport into cells can reduce the glucose concentration in the blood. This effect can improve insulin secretion.
The treatment apparatus and method may be used to improve athletic performance by selectively treating the correct muscle group. In addition, the treatment apparatus and method may be used for athlete recovery after exercise and/or injury. In addition, the treatment apparatus and method may be used to regenerate at least one muscle after exercise and/or injury. Furthermore, the treatment apparatus and method may be used to exercise muscles and other parts of the patient's body. For such treatment, the device may be used not only in hospitals or beauty clinics, but also in gymnasiums and/or at home.
The treatment device may provide one or more types of therapeutic energy, where the therapeutic energy may include a magnetic field (also referred to as magnetic energy) and an RF field (also referred to as RF energy) and/or a magnetic field (also referred to as magnetic energy). The magnetic field is provided during magnetic treatment. The RF field provided during RF treatment may include an electrical component of the RF field and a magnetic component of the RF field. The electrical component of the RF field may be referred to as one or more RF waves. The RF electrode may generate an RF field, an RF wave, and/or other components of the RF field. The RF electrode may be an element that generates an RF field, RF waves, and/or other components of the RF field that cause heating of biological structures and/or body parts.
The magnetic field and/or RF field may be characterized by an intensity. In the case of a magnetic field, the strength may include the magnetic flux density or the magnitude of the magnetic flux density. In the case of an RF field, the intensity may include the energy flux density of the RF field or RF wave.
The body part may comprise at least a portion of a patient's body including at least muscles or muscle groups covered by other soft tissue structures (e.g., adipose tissue, skin, etc.). The body part may be treated by a treatment device. The body part may be a body part such as buttocks, saddles, lumbar excrescence, abdomen, hips, legs, lower legs, thighs, arms, trunk, shoulders, knees, neck, limbs, breast fat, face or chin, forehead, back, lower back, chest, sides, pelvic floor, and/or any other tissue. For purposes of this description, the term "body part" and the term "body part" may be interchangeable.
Skin tissue consists of three basic elements: epidermis, dermis and hypodermis (so-called subcutaneous tissue). The outer layer of the skin and also the most thin layer is the epidermis. The dermis is composed of collagen, elastic tissue and reticular fibers. The hypodermis is the lowest layer of the skin and includes the root of hair follicles, lymphatic vessels, collagen tissue, nerves, and fat, which forms Subcutaneous White Adipose Tissue (SWAT). Adipose tissue may refer to at least one lipid-rich cell, e.g., an adipocyte, such as a lipoblast. Adipocytes form leaflets, which are defined by connective tissue, fibrous septa (tunica media).
Another portion of adipose tissue, so-called visceral adipose tissue, is located in the abdominal cavity and forms Visceral White Adipose Tissue (VWAT) located between the parietal and visceral peritoneum, immediately below the muscle fibers of the adjacent subcutaneous layer.
The muscle may include at least a portion of a muscle fiber, an intact muscle, a muscle group, a neuromuscular plate, a peripheral nerve, and/or a nerve innervating at least one muscle.
Deep muscle may refer to muscle covered at least partially by superficial muscle and/or muscle covered by a thick layer of other tissue, such as adipose tissue, wherein the thickness of the cover layer may be at least 4cm, 5cm, 7 cm, 10 cm, up to 15cm thick.
The individual muscles may be abdominal muscles, including rectus abdominis, oblique abdominis, transverse abdominis, and/or quadriceps. The individual muscles may be those of the buttocks, including the gluteus maximus, gluteus medius, and/or gluteus parus. The individual muscles may be those of the lower limb, including quadriceps, sartorius, gracilis, biceps femoris, adductor longus/short, tibialis anterior, extensor longus, triceps femoris/lateral, soleus, longus, flexor longus, extensor digitorum brevis, abductor thumb, adductor thumb, abductor little finger and/or interplanar muscles. The ligament may be a cooper ligament of the breast.
One example may be the application of a therapeutic device and method to the abdomen of a patient that may provide (or where treatment may ultimately result in) therapeutic effects such as reduced numbers and volumes of adipocytes, muscle strengthening, fat elimination, reorganization of collagen fibers, acceleration of new collagen production and elastic tissue production, muscle strengthening, muscle function and muscle endurance, and improvement of muscle shape. These therapeutic effects can lead to reduced circumference of the abdominal region, elimination of abdominal drooping and/or compaction of the abdominal region, reduced cellulite, reduced scarring, and improved body posture (through strengthening of abdominal muscles, body contours, body appearance, and patient health).
One other example may be the application of a therapeutic device and method to a body part including the buttocks, which may provide (or where treatment may ultimately result in) therapeutic effects such as reduced number and volume of adipocytes, reorganization of collagen fibers, acceleration of new collagen production and elastic tissue production, muscle strengthening, muscle conditioning, and muscle shaping. These therapeutic effects may result in reduced waist or hip circumference, elevated hip, rounded hip, tight hip and/or reduced cellulite.
Another example may be the application of a treatment device and method to a body part including the thigh, which treatment device and method may provide (or where treatment may be ultimately obtained) a reduction in the number and volume of adipocytes, muscle strengthening, muscle shaping, and muscle conditioning. Application of the therapeutic devices and methods to body parts including the thigh can result in reduced circumference of the thigh, elimination of abdominal drooping, and reduced cellulite.
Yet another example may be the application of a treatment device and method to a body part including an arm, which treatment device and method may provide (or where treatment may be ultimately obtained) a reduction in the number and volume of adipocytes, muscle strengthening, muscle shaping, and muscle conditioning. Application of the treatment devices and methods to body parts including arms may result in reduced circumference of the abdomen, elimination of abdominal drooping, and reduced cellulite.
The one or more therapeutic effects provided to the one or more target biological structures may be based on selectively targeting RF fields to the one or more biological structures and providing heating and applying magnetic fields that cause muscle stimulation (including muscle contraction). RF treatment may cause selective heating of one or more biological structures, polarization of the extracellular matrix, and/or changes in cell membrane potential of the patient's body. The magnetic field may be a time-varying magnetic field or a static magnetic field. When a time-varying magnetic field is used, the magnetic treatment may be referred to as time-varying magnetic treatment. Magnetic therapy may cause muscle contraction, muscle relaxation, cell membrane polarization, eddy current induction, and/or other therapeutic effects that are caused by generating a time-varying magnetic field in at least a portion of one or more target biological structures. The time-varying magnetic field may induce an electrical current in the biological structure. This induced current may cause muscle contraction. Muscle contraction may be repetitive. Muscle contractions provided by the magnetic field may include excessive contractions, tonic contractions, and/or incomplete tonic contractions. In addition, the magnetic field may provide muscle twitches.
The therapeutic effects provided by using the therapeutic device and by applying the magnetic therapy and the RF therapy may be combined. For example, a reduction in the number and volume of adipocytes during actual treatment or during the time following treatment (e.g., three or six months) may be achieved along with muscle strengthening, muscle shaping, and/or muscle conditioning. Furthermore, the effects provided by the use of the treatment device and by the application of magnetic and RF treatments may be cumulative. For example, muscle conditioning may be achieved by a combined reduction in the number and volume of adipocytes, which may be achieved along with muscle strengthening.
The therapeutic approach may provide a therapeutic effect to at least one of the target biological structures by RF fields in combination with thermal therapy provided by the applied magnetic therapy. Therapeutic effects on the target biological structure may be provided by heating at least one biological structure and inducing at least partial muscle contraction or muscle contraction of the muscle by magnetic therapy.
The treatment method may allow heating of the body part, wherein muscle contraction is induced by a magnetic field. Heating may minimize muscle damage and/or ligament damage (including tears or inflammation). Heating of the positively contracting muscles and/or adjacent biological structures may also shift the threshold for uncomfortable treatment. Thus, heating caused by the RF field may allow a higher amount of magnetic energy to be delivered to the patient's biological structure for more muscle work. Heating of the muscle and/or adjacent biological structures may also improve the quality and/or level of muscle contraction. Due to the heating provided by the RF field, more muscle fibers and/or longer portions of muscle fibers may be able to contract during the magnetic treatment. Heating may also improve the permeability of the muscle stimulation generated by the magnetic therapy. Furthermore, the patient's uncomfortable heating threshold may also shift higher when at least part of the muscle contraction or muscle contraction is repeatedly induced. Such shifting of the threshold may allow more RF energy to be delivered to the patient's body.
Repeating muscle contraction and subsequent muscle relaxation in combination with heating may inhibit the uncomfortable feeling caused by muscle stimulation (e.g., muscle contraction). Muscle stimulation in combination with heating may provide better regeneration after treatment and/or better prevention of panniculitis and other tissue damage.
Repeating muscle contraction and subsequent muscle relaxation (according to preliminary testing) in combination with RF heating may have a positive effect on treating and/or inhibiting symptoms of diabetes. The repeated muscle contraction induced by the provided magnetic field and the heating of the biological structure by the RF field may also improve the effect of the diabetic symptoms or may also positively influence the outcome of the diabetic symptom medication. Successful treatment of diabetic symptoms can be caused by deep penetration of high amounts of radio frequency energy into the abdominal region of the patient. Such penetration may be caused by the simultaneous application of magnetic therapy, which may cause suppression of patient discomfort associated with high RF energy flux density and increased temperature in the tissue. In addition, magnetic therapy can cause polarization and depolarization of patient tissue, which can also increase RF energy penetration into the patient's body. RF treatment and/or magnetic treatment may affect glucose metabolism or may help to lose weight, which may inhibit symptoms of diabetes. It is believed that weight loss and exercise in patients with diabetic symptoms may help to suppress diabetic symptoms.
The application of RF therapy by RF fields and magnetic therapy by magnetic fields can also positively affect proliferation and differentiation of body cells into muscle cells. Tests have shown that magnetic treatments comprising time periods (e.g., pulses or sequences as defined below) of different duration, repetition rate and magnetic flux density can provide the stimulus required to initiate proliferation and differentiation of the body cells.
Tests have also shown that a therapeutic method of providing a magnetic field comprising at least two or at least three consecutive periods (e.g., pulses, bursts or sequences as defined below) of different duration, repetition rate and magnetic flux density can provide muscle impulses. Thus, the regeneration process leading to proliferation and differentiation of the body cells can be initiated and further accelerated by the delivered RF field. Proliferation and differentiation of somatic cells can result in muscle enhancement, restoration of muscle function, increase of muscle volume, and improvement of muscle shape, posture or muscle tone.
The method of applying at least part of the muscle stimulation or muscle contraction and heat to the same body part may result in excessive acidification of the extracellular matrix. Excessive acidification can lead to apoptosis of adipose tissue, and acceleration of weight loss and body volume loss. Excessive acidification may be caused by the release of fatty acids to the extracellular matrix, which may be caused by the work of contracted high-intensity muscles. The contracted high-intensity muscle work may be provided by a number of repeated muscle contractions induced by the application of time-varying magnetic fields generated by the described magnetic field generating device and therapeutic device.
The therapeutic effect of RF treatment may be enhanced by magnetic treatment, such as by reducing or eliminating the risk of fatty inflammation or local skin inflammation, as any aggregation of the treated lipoblast cells may be prevented by improved metabolism. The improved blood and/or lymphatic flow may help to eliminate lipoblast. The elimination of adipocytes can also be facilitated by a larger number of cells that phagocytose the adipocytes. The synergistic effect of magnetic therapy and Radio Frequency (RF) therapy significantly improves metabolism. Thus, the likelihood of adverse events occurring is limited and the therapeutic results induced by the apparatus and method are achieved in a shorter period of time.
The treatment apparatus and treatment method may provide treatment of the same patient body part, wherein the magnetic treatment and the RF treatment may target at least a portion of one or more biological structures. One or more volumes of patient body tissue affected by the targeted RF and/or magnetic therapy may be in close proximity. The volume of at least a portion of at least one or more affected biological structures of a patient's body tissue may be defined as an affected tissue volume, wherein the therapeutic effect provided by the therapeutic apparatus and/or therapeutic method described above occurs. The therapeutic effect may be caused by repeated muscle contraction (e.g., provided by magnetic therapy), changes in tissue temperature (e.g., provided by RF therapy), and/or by at least partial polarization and acceleration of molecules in the patient's tissue. The change in tissue temperature may include, for example, an increase in tissue temperature of at least 3 ℃ or 4 ℃ or 5 ℃ or 6 ℃ or 7 ℃ or 10 ℃ with reference to normal tissue temperature. Furthermore, the change in tissue temperature may comprise an increase or decrease in tissue temperature in the range of 1 ℃ to 50 ℃ or 2 ℃ to 30 ℃ or 2 ℃ to 25 ℃ compared to untreated tissue located in the same or different body part. The altered tissue temperature may be interpreted as a change in temperature of any volume or any portion of biological tissue.
The proximity of the tissue volume affected by the at least one RF treatment and/or the at least one magnetic treatment has the meaning of the distance between the two affected tissue volumes. At least two adjacent affected tissue volumes may have at least partial overlap, where 2% to 15% or 5% to 30% or 2% to 100% or 30% to 60% or 80% to 100% or 40% to 85% of the smaller affected tissue volume may overlap the larger affected tissue volume. In addition, the distance between the affected tissue volumes may be in the range of 0.01cm to 10cm, or in the range of 0.01cm to 5cm, 0.01cm to 3cm, or 0.01cm to 1 cm. Or the overlap of the ranges described above may be applied to two or more affected tissue volumes having equal volumes without any distinction between smaller or larger tissue volumes.
Fig. 1a to 1e show exemplary schematic diagrams of a therapeutic device. These schematic diagrams may only be applicable to the main unit and the applicator. The treatment device may include an input interface 103, a control system 104, a power supply 105, a power network 106, one or more treatment clusters 107, and one or more treatment energy sources 108.
A plurality of therapeutic energy sources 108 may be coupled to or in communication with at least one therapeutic cluster 107. The control system 104 may be coupled to and in communication with each treatment cluster.
The illustrated components of the treatment apparatus of fig. 1a to 1e may be electrical elements of an electrical circuit. In addition, one or more of the illustrated components of the schematic diagrams of fig. 1 a-1 e may include multiple independent electrical elements. The electrical components may generate, communicate, modify, receive, or transmit electromagnetic signals (e.g., electrical signals) between individual electrical components. The electromagnetic signal may be characterized by a current, a voltage, a phase, a frequency, an envelope, a current value, a signal amplitude, and/or combinations thereof. When the electromagnetic signals reach the therapeutic energy sources, the respective therapeutic energy sources may generate therapeutic energy and/or fields.
The input interface 103 may receive input from a user. The input interface may include a human-machine interface (HMI). The HMI may include one or more displays, such as a Liquid Crystal Display (LCD), a Light Emitting Diode (LED) display, an Organic LED (OLED) display, which may also include a touch screen display. The HMI may include one or more control elements for adjusting or controlling the treatment device. The control element may be at least one button, lever, dial, switch, knob, sliding control, pointer, touchpad, and/or keypad. The input interface may be communicatively coupled to a control system, a power network.
The user may be an operator (e.g., doctor, technician, nurse) or the patient himself; however, the treatment device may be operated by the patient only. In most cases, the treatment device may be operated by a properly trained user. In most cases, the user may be any individual affecting the treatment parameters prior to or during treatment, except for the patient.
The control system 104 may include a host unit or one or more control units. The control system may be an integral part of the input interface 103. The control system 104 may be controlled via the input interface 103. The control system may include one or more control elements for adjusting or controlling any component or electrical element of the treatment device. The host unit is part of the treatment device (e.g., the applicator and/or the main unit) or an electrical element of a circuit that can be selected by the user and/or the treatment device to provide master-slave communications including high priority instructions to other components of the treatment device. For example, the host unit may be a control unit or portion of an input interface that provides high priority instructions to other portions of the treatment device. The treatment apparatus may comprise a series of master-slave communications. For example, the treatment cluster 107 may include a control unit that provides instructions to the electrical components of the treatment device 107; while the control unit of the treatment cluster 107 is subordinate to the host unit. The control system 104 may be coupled to, or in communication with, the input interface 103, one or more power sources 105, the power network 106, and/or one or more treatment clusters in which treatment devices are present. The control system 104 may include one or more processors (e.g., microprocessors) or Process Control Blocks (PCBs).
The power supply 105 may provide electrical energy, including electrical signals, to one or more clusters of instructions. The power supply may include a module that converts an AC voltage to a DC voltage.
The power network 106 may represent a plug. The power network may represent a connection to the grid. However, the power network may represent a battery for operation of the treatment device without the need for a power grid. The power network may provide electrical energy required for operation to the entire treatment device and/or components thereof. As shown in the exemplary schematic diagrams of fig. 1 a-1 e, the power network provides electrical energy to the input interface 103, the control system 104, and the power source 105.
The treatment clusters 107 may include one or more electrical elements associated with the generation of respective treatment energies. For example, a treatment cluster (referred to as HIFEM) for magnetic treatment may include, for example, energy storage elements and switching devices. For another example, a treatment cluster of RF treatment (referred to as an RF cluster) may include, for example, a power amplifier and/or a filter.
The therapeutic energy source 108 may include a particular source of therapeutic energy. In the case of magnetic therapy, the therapeutic energy source of the magnetic field may be a magnetic field generating device, such as a magnetic coil. In the case of RF therapy, the therapeutic energy source of RF energy (including RF waves) may be an RF electrode.
The treatment device may include one or more treatment circuits. A therapy circuit may include a power source, an electrical component of a therapy cluster, and a corresponding therapeutic energy source. In the case of magnetic therapy, the magnetic circuit may include a power supply, HIFEM clusters, and a magnetic field-generating device. In the case of RF therapy, the RF circuitry may include a power supply, an RF cluster, and a magnetic field generating device. The RF circuitry may include a power supply, an RF cluster, and at least one RF electrode. Electromagnetic signals generated and/or transmitted within a therapy circuit for RF therapy (also referred to as RF circuitry) may be referred to as RF signals. Wires connecting the respective electrical elements of one treatment cluster may also be included in the respective clusters. Each of the treatment clusters of fig. 1 a-1 e described in detail below may be any of HIFEM, RF, or a combination.
One or more of the therapy circuits and/or components thereof may be individually controlled or regulated by any portion of the control system 104. For example, the speed of operation of the HIFEM cluster of one therapy circuit may be individually adjusted when the HIFEM cluster of another therapy circuit is operated. In some aspects, the amount of energy flux density delivered by operating the RF electrode of one therapy circuit may be set independently of the operation of the RF electrode of another therapy circuit.
Fig. 1a shows an exemplary schematic of a treatment device comprising an input interface 103, a control system 104, a power supply 105, a power network 106, two treatment clusters (comprising treatment cluster a 107a, treatment cluster B107B), a treatment energy source a 108a and a treatment energy source B108B. In such cases, the treatment device may include two treatment circuits. One therapy circuit may include a power supply 105, a therapy cluster a 107a, and a therapy energy source a 108a. Another therapy circuit may include a power supply 105, a therapy cluster B107B, and/or a therapy energy source B108B. Treatment clusters 107a and 107b can communicate with each other.
Fig. 1B shows an exemplary schematic of a treatment device comprising an input interface 103, a control system 104, two power sources (comprising power source a 105a and power source B105B), a power network 106, two treatment clusters (comprising treatment cluster a 107a and treatment cluster B107B), a treatment energy source a 108a and a treatment energy source B108B. In such cases, the treatment device may include two treatment circuits. One therapy circuit may include a power source 105a, a therapy cluster a 107a, and/or a therapy energy source a 108a. Another therapy circuit may include a power source B105B, a cluster of therapy devices B107B, and/or a source of therapeutic energy B108B. Treatment clusters 107a and 107b can communicate with each other.
Fig. 1c shows an exemplary schematic of a treatment device comprising an input interface 103, a control system 104, a power supply 105, a power network 106, two treatment clusters (comprising treatment cluster a 107a and treatment cluster B107B) and one treatment energy source 108. In such cases, the treatment device may include two treatment circuits. One therapy circuit may include a power source 105, a therapy cluster a 107a, and/or a therapeutic energy source 108. Another therapy circuit may include a power supply 105, a therapy cluster B107B, and/or a therapy energy source 108. Treatment clusters 107a and 107b can communicate with each other. The illustrated schematic may include a magnetic field generating device that provides both RF therapy and magnetic therapy.
Fig. 1d shows an exemplary schematic of a treatment device comprising an input interface 103, a control system 104, a power supply 105, a power network 106, four treatment clusters (including treatment cluster a1107a, treatment cluster a2107aa, treatment cluster B1107B, treatment cluster B2107 bb) and four treatment energy sources (including treatment energy source a1108a, treatment energy source a2108aa, treatment energy source B1108B, and treatment energy source B2108 bb). In such a case, the treatment apparatus may include four treatment circuits. The first therapy circuit may include a power source 105, a therapy cluster a1107a, and/or a therapy energy source 108a. The second therapy circuit may include a power source 105, a therapy cluster a2107aa, and/or a therapy energy source a2108aa. The third therapy circuit may include the power supply 105, the therapy cluster B1107B, and/or the therapy energy source B1108B. The fourth therapy circuit may include a power supply 105, a therapy cluster B2107bb, and/or a therapy energy source B2108bb. The therapeutic energy sources of the first therapeutic circuit and the second therapeutic circuit may be located in one applicator and the therapeutic energy sources of the third therapeutic circuit and the fourth therapeutic circuit may be located in another applicator.
Fig. 1e shows another schematic diagram of a treatment device comprising an input interface 103, a control system 104, two power sources (comprising power source a 105a and power source B105B), a power network 106, four treatment clusters (treatment cluster a1107a, treatment cluster a2107aa, treatment cluster B1107B, treatment cluster B2107 bb) and four treatment energy sources (comprising treatment energy source a1108a, treatment energy source a2108aa, treatment energy source B1108B and treatment energy source B2108 bb). In such a case, the treatment apparatus may include four treatment circuits. The first therapy circuit may include a power source a 105a, a therapy cluster a1107a, and/or a therapy energy source 108a. The second therapy circuit may include a power source a 105a, a therapy cluster a2107aa, and/or a therapy energy source a2108aa. The third therapy circuit may include a power source B105B, a therapy cluster B1107B, and/or a therapy energy source B1108B. The fourth therapy circuit may include a power source B105B, a therapy cluster B2107bb, and/or a therapy energy source B2108bb. The therapeutic energy sources of the first therapeutic circuit and the second therapeutic circuit may be located in one applicator and the therapeutic energy sources of the third therapeutic circuit and the fourth therapeutic circuit may be located in another applicator.
Fig. 1f shows the individual components of the treatment device, including a main unit 11, a remote control 13, an add-on or add-on treatment device 14 and/or a communication device 15, the main unit 11 being connected or coupled to at least one applicator 12. The additional treatment device may be at the same stand alone level as the entire treatment device.
The treatment device may comprise a remote control 13. The remote control 13 may comprise an uncomfortable button for safety purposes, so that the user can press the uncomfortable button when the patient feels any discomfort during the treatment. When the discomfort button is pressed, the remote control 13 may send a signal to the main unit and stop the treatment. In addition, the remote control 13 may inform the user through a human-machine interface (HMI). To stop treatment during periods of discomfort, the operation of the discomfort button may overrule instructions of the host unit. Or the discomfort button may be coupled to or may be part of the main unit 11.
The main unit 11 may be coupled or connected to one or more additional treatment devices 14, and the additional treatment devices 14 may be powered by the main unit 11. However, the treatment device comprising the main unit 11 may be paired with one or more additional treatment devices 14 by software. In addition, one or more additional treatment devices 14 may also be powered by their own energy source or sources. The communication device 15, the additional treatment device 14, the remote control 13 and the at least one applicator 12 may each be in communication with the main unit 11. Communication may include sending and/or receiving information. Communication may be provided by wire and/or wirelessly, such as through an internet network, a local network, RF waves, acoustic waves, optical waves, 3G, 4G, 5G, GSM, HUB switches, LTE networks, GSM networks, bluetooth, and/or other communication methods or protocols.
The additional treatment device 14 may be any device capable of providing at least one type of therapeutic energy (e.g., RF fields, magnetic fields, ultrasound waves, light, time-varying mechanical pressure, shock waves, or electrical current) to the patient's body to cause a therapeutic effect of at least one target biological structure. The additional treatment device 14 may include at least one electrical element that generates therapeutic energy for at least one treatment, such as a magnet, radio frequency, light, ultrasound, heating, cooling, massaging, plasma, and/or electrotherapy. The additional treatment device 14 may be capable of providing at least one treatment without instructions from the main unit 11. The additional treatment device 14 may be in communication with the main unit 11, the communication device 15, and/or other additional treatment devices 14. The additional treatment device 14 may be any other device of the same or other company, where the device may be capable of providing a particular type or types of therapeutic energy. The additional treatment device 14 may be an extension of the treatment device, wherein the additional treatment device 14 may provide treatment energy through parameters defined by the HMI of the main unit 11.
The communication device 15 may be connected to the main unit 11 by wire and/or wirelessly. The communication device 15 may be a computer (such as a notebook or desktop) or a mobile electronic device (such as a smartphone) or an electronic tablet. The communication device may send and/or receive information related to the therapeutic function of the therapeutic device and/or other information. The additional treatment device 14 and/or the communication device 15 may communicate directly with the main unit 11 or indirectly with the main unit 11 through one or more additional pieces or communication devices. To provide communication, the communication device may include a receiver, a transmitter, and a control unit to process transmitted and/or received information.
The information sent to and/or received from the separate components of the treatment device may include communication data between the communication device 15 and the main unit 11, communication data between the applicator 12 and the main unit 11, communication data between the additional treatment device 14 and the main unit 11, and/or communication data between the remote control 13 and the main unit 11. The transmitted and/or received information may be stored in a black box, cloud storage space, and/or other storage device. The black box may be part of the main unit 11 or any other part of the treatment device. The other storage device may be a USB, other memory device, and/or a communication device with internal memory. At least a portion of the transmitted and/or received information may also be displayed through the HMI. The transmitted and/or received information may be displayed, evaluated and/or changed by the user automatically through the HMI and/or by the control system. One type of transmitted and/or received information may be a predetermined value or current value or selection of one or more treatment parameters or patient information. The patient information may include, for example, the sex of the patient, the age and/or size of the patient.
The transmitted and/or received information may also inform external institutions, such as support centers, e.g., service and/or sales departments, which are also a subset of the communication devices. The transmitted and/or received information for the external institution may include information regarding the condition of the treatment device, the history of one or more provided treatments, the operating history of the treatment device, software update information, wear information, durability of the RF electrode, durability of the magnetic field generating device, treatment warnings, treatment credit/billing information, such as quantitative information of paid treatments or credits, and/or other operational and usage information.
One possible type of transmitted and/or received information may be the identification of the connection of one or more applicators 12, remote controls 13, additional treatment devices 14 and/or communication devices 15. Based on this information, the treatment device may manually or automatically identify the type of additional treatment device 14 and/or applicator 12 that is connected. Automatic identification may be provided by the control system. Based on information about the connection of one or more applicators 12, the connection of the additional treatment device 14 and/or the communication device 15, the treatment device may provide an implementation of an HMI that may show notification of possible optimizations about the connection of the applicators and/or new treatment options. Possible optimizations of the new treatment options may include, for example, adjustment of at least one treatment parameter, implementation of additional treatment energy sources, parameter changes of the new treatment energy sources, and so forth. The treatment device (e.g., control system) may automatically adjust or provide adjusted treatment parameters based on the newly connected applicator 12 and/or additional treatment device 14. The identification of the connected applicator 12, additional treatment device 14, and/or communication device 15 may be based on a particular connector (e.g., a particular pin connector). In addition, connection identification may be provided by a specific physical characteristic (e.g. impedance of the connected components) or by a specific signal provided by the applicator or its connection component to the main unit 11. The connection between the individual components of the treatment device, such as the main unit 11, the applicator 12, the remote control 13, the additional treatment device 14 and/or the communication device 15, may be provided by means of wires and/or wirelessly (e.g. by means of RFID tags, RF, bluetooth and/or photo-electromagnetic pulses). The applicator 12 may be connected to the main unit 11 by wires to effectively energize. Or the applicators may be connected in a wireless manner to communicate with the main unit 11 and/or the communication device 15. The connected applicator 12, additional treatment device 14 and/or communication device 15 may be identified by software identification, a specific binary ID, manual identification of a component selected from a list implemented in the treatment device and/or by pairing the application.
The connector side in the main unit 11 may comprise a unit capable of reading and/or identifying information comprised by the connector side of the applicator and/or the connector side of the additional treatment device. Based on the read and/or identified information, the applicator and/or the additional treatment device may identify the main unit 11. The connector side of the main unit 11 may be used as a first side connector of the connection, wherein the connection of the applicator or the additional treatment device may be used as a second side connector of the connection. The transmission of information, the reception of information and/or the identification of the second side connector by the first side connector may be based on binary information received by conductive contact between the two connector sides, by optical reading and/or by identification provided by the first side connector. The optical identification may be based on, for example, a reading of a particular QR code, bar code, etc. of a particular applicator 12.
The first side connector located in the main unit 11 may comprise a unit capable of reading/identifying binary information implemented by the second side connector of the cable of the applicator 12 and/or the additional treatment device 14. The implemented information in the second side connector may be stored in the SD card. Based on such implemented information, any component of the treatment device may be identified by the main unit 11.
Communication between the individual components of the treatment device, including, for example, the main unit 11, the remote control, the one or more applicators, the one or more additional treatment devices, and/or the communication device, may be based on peer-to-peer (referred to as P2P) and/or master-slave communication. During P2P communication, the individual components of the treatment device have the same priority of their commands and/or can communicate directly with each other. P2P communication may be used during initial identification of the connected individual components of the treatment device. P2P communication may be used between some components of the treatment device during treatment, such as between communication devices.
The master-slave communication may be used between the individual components of the treatment device for at least a short time before and/or during each treatment of the individual patient. During master-slave communication, one component of the treatment device may provide the command with the highest priority. The individual components of the treatment device (e.g., the main unit 11) may provide the command with the highest priority and are referred to as the host unit. The treatment device may include at least one master-slave communication between separate electrical elements, such as a power source and/or one or more control voltages, wherein the one or more control elements act as a master.
The host unit may be selected by the user before, after and/or during treatment. The user may select the host unit based on the available individual components or electrical elements of the treatment device. Thus, the user may select the main unit 11, the applicator 12, the remote control 13, the additional treatment device 14 or the communication device 15 as the host unit. The host unit may be a control unit, e.g. in the main unit 11, optionally present in a separate part of the treatment device. The user may select the host unit to facilitate adjustment of the treatment parameters. The user may also select the communication device 15 as the host unit, wherein the communication device selected as the host device may provide control of more than one treatment device. The host unit 11 may comprise a control unit as host unit that monitors and evaluates at least one parameter of the treatment, such as patient temperature, voltage on the individual elements of the treatment device, etc.; the at least one parameter allows providing a safe treatment even with a connection therebetween. In addition, the host unit may be a separate electrical component outside of the human interface. The host unit may be controlled by a user through a human-machine interface.
Or the host unit may be automatically selected based on a predetermined priority value of the connection components of the treatment device. The selected host unit may remain unchanged and selected components of the treatment device may act as host units throughout the treatment period. However, the selection of the host unit may be changed during treatment based on the user's command priority and/or selection. The host unit may also be determined according to a manufacturing configuration, or depending on a factory reset. For example, the remote control 13 may provide the command with the highest priority to stop the treatment when the patient feels uncomfortable and the treatment will stop irrespective of the independent components of the treatment device set as the host unit and the setting parameters of the treatment.
Fig. 2 to 5 show some possible master-slave communication schemes that may be used for communication between the main unit 11 and one or more applicators 12, remote controls 13, additional treatment devices 14 and/or communication devices 15. According to fig. 2, one or more therapy generators (therapy generator) 201 generate modified electrical signals to provide signals to a therapeutic energy source, such as an RF electrode and/or a magnetic field generating device. The therapy generator 201 may comprise at least two components of the electrical component group or groups of electrical components of the therapy device and/or the electrical circuitry present in the main unit. The electrical component set may include a control unit, a power source, a coaxial cable system, one or more switches, one or more energy storage devices, one or more pin diodes, one or more LC circuits, one or more LRC circuits, one or more power amplifiers, and/or other components of the therapeutic device that actively modify the electrical signal in a controlled manner. The therapy generator may provide modification of the electrical signal in a controlled manner.
Modifying the electrical signal in a controlled manner may include providing and/or controlling impedance adjustments of the provided RF therapy, for example, based on impedance matches measured across patient tissue and/or RF electrodes. An actively modified electrical signal may be interpreted such that the electrical signal may have different parameters, such as frequency, symmetry, amplitude, voltage, phase, intensity, etc. Parameters of the electrical signal may be based on the requirements of the treatment, including patient type, treatment parameters. Furthermore, parameters of the electrical signal may be modified based on feedback information, such as measured standing wave rate of the RF energy, tissue temperature, temperature of the RF electrode, temperature inside the applicator, temperature of the surface of the applicator, current and voltage of individual elements of the treatment device, and so forth.
The schematic diagram of fig. 2 shows a security 203, the security 203 preventing any unauthorized intrusion into the treatment device communication and protecting personal user data and/or accounts. The security 203 may protect the treatment device from computer viruses, unauthorized access, and/or may protect communications between individual components of the treatment device from reading or alteration by unauthorized media or individuals. The security 203 may provide encoding of information for communication and/or anti-virus services that prevent intrusion of unwanted binary codes into the treatment device and/or communication. The security 203 may correct errors generated during communication. The security 203 may prevent unauthorized/undesired external devices from being connected to the treatment device.
The security 203 in fig. 2 may be located between the host unit 202 and the communication interface 204 in the communication diagram. The security 203 may also be part of the subscriber unit 208, the service portion 207, and/or the sales portion 206. The security 203 may also be located between the communication interface 204 and the communication medium 205, the therapy generator 201, and/or may be part of them.
The communication interface 204 may include hardware and/or software components that allow for converting electrical, electromagnetic, infrared, and/or other signals into a readable form to allow communication between at least two components of the treatment device and/or other communication sides or mediums. Communication interface 204 may provide for communication and/or encoding of information and/or data. The communication interface 204 may be, for example, a modem or a GSM module that provides communication between the treatment device and an online network or server. The communication interface 204 may be part of the host unit 202, the therapy generator 201, and/or other parts of the therapy device.
Communication medium 205 may be a medium that communicates communication data. The communication medium 205 may be used for communication between the treatment device and the user 208, the service part 207 and/or the sales part 206. The communication medium 205 may be wire, SD card, flash memory, coaxial wire, any conductive connection, a server, in principle some kind of network, such as RF waves, acoustic waves, optical waves, GSM, 3G, 4G, 5G, HUB switch, bluetooth, wi-Fi, and/or other medium that may include one or more servers.
The communication data/information may be redirected to a separate component of the treatment device and/or may be redirected to a separate user or service, such as user 208, service 207, and/or sales department 206. The communication data/information may be redirected through the host unit 202, the communication medium 205, and/or the therapy generator 201. For example, the server may filter the data of the user 208 and may filter other communications that are to be redirected to the service 207, control unit, and/or other components of the treatment device.
The element in FIG. 2 referred to as "user 208" may be a representation of the HMI controlled by the user. Or the element referred to as "user 208" in fig. 2 may be a representation of other communication devices (personal computers, laptops, mobile phones, tablet lights) controlled by the user, wherein the communication devices may send information to and/or receive information from at least a portion of the treatment device. The information provided over the present communication channel may be the type of treatment regimen, information regarding the treatment effect, actual and/or predetermined values of one or more treatment parameters, feedback information, selection of a treated body part, behavioral advice before and after treatment, and/or other information. At least a portion of the information may be sent to a user controlling the treatment device and may also be sent to the patient, such as through a software application for a mobile phone, tablet or laptop.
The service 207 in fig. 2 may represent a service department that has authorized access to information about the treatment device. The service 207 may be a service of a company that provides or manufactures the treatment device, wherein communication between the service of the company and the user may be provided through an HMI, a communication device, and/or automatically through a preprogrammed software interface. The information provided through the present communication channel may include wear of the individual electrical components of the treatment device, durability of any RF electrodes and/or magnetic field generating device, failure of individual electrical components, possible software optimization and/or implementation of the device, thereby providing an application for connecting another additional treatment device or the like. Optimization and/or implementation of the treatment device may include, for example, remote access to treatment device software and/or correction of errors.
The sales department 206 in fig. 2 may be a sales department that has authorized access to the treatment device information. The sales department 206 can inform the user of the type of accessory that can be added to the treatment device. Additionally, sales department 206 may facilitate sales of plug-in modules and/or may facilitate sales of accessories for the treatment device. In addition, sales department 206 may provide offers related to billing and rental systems. The information exchanged to or from sales portion 206 via communication may be, for example, the number of treatments, the time of the treatments, and/or the type of treatments applied, information about the applicator, and so forth.
The treatment device may include a black box for storing data regarding treatment history, operation history, communication between individual components of the treatment device, data derived from or regarding billing and leasing systems, operational errors, and/or other information. The data may be accessible to sales department 206, service department 207, and/or user 208 via a communication medium (e.g., a storage cloud and/or server). The treatment device may include a billing and leasing system to manage costs related to using the treatment device and/or corresponding additional treatment devices. The billing and lease system may send such information to the provider to prepare a billing invoice. The data of the black box may be downloaded by an authenticated authorized person, such as a service technician, accountant, and/or other person having administrator access. Verification of authorized individuals may be provided by a particular key, password, number of digits of software code, and/or by a particular interconnect cable.
The billing and rental system can be based on the points subtracted from the user account. The score may be predefined by the provider of the treatment device, for example the manufacturer of the treatment device. The points may be charged during treatment device runtime and/or may be charged to an online account associated with one or more treatment devices of the user and/or provider. The integral may be subtracted depending on the selected treatment regimen or body part. The integral value of the individual one or more treatments and/or treatment phases may be displayed to the user before the treatment begins, during the treatment, and/or after the treatment. If the credit for the user account is exhausted, the treatment device may not allow any further treatment until the credit is charged. The credits may be used as currency for independent treatments, where different treatments may cost different amounts of credits based on the type of treatment, the duration of the treatment, the number of applicators used, and/or other factors. The points may also be used to rent or purchase individual components of the treatment device, the complete treatment device, hardware or software extensions of the treatment device, and/or other consumables and spare parts that are subordinate to the treatment device. The interface in which the integration system may be rechargeable may be part of the treatment device, HMI, and/or may be accessible online through a website interface.
One or more software extensions (e.g., software applications) may be associated with the treatment device and treatment method. The one or more software extensions may be downloaded to any communication device, such as a smart phone, tablet, computer, and/or other electronic device. The software extensions may communicate with the main unit and/or other components of the treatment device. A communication device with the software extensions installed may be used to display or adjust one or more treatment parameters or information associated with the treatment. Such information that may display treatment parameters and be associated with the treatment may include, for example, a time schedule of the treatment, measured dimensions of the treated body part before and/or after the independent treatment, a schematic illustration of the applied burst or sequence, a remaining time of the treatment, a heart rate of the patient, a temperature of the patient's body (e.g., a temperature of a body surface), a type of treatment provided, a type of treatment regimen provided, a comparison of patient body parameters to previous treatments (e.g., a percentage of body fat), and/or an actual treatment effect of the treatment (e.g., muscle contraction or muscle relaxation). The software extensions may also be provided to the patient to inform them of the schedule of treatment, the progress of the mapping between independent treatments, the percentage of treatment results compared to others, and/or behavioral advice before and/or after treatment. Behavior suggestions may include, for example, the following suggestions: the amount of water a patient should drink during a day, advice on how much water a patient should drink during the day, how the patient's diet should be, the type and number of exercises a patient should provide before and/or after treatment, and/or other information that may improve the outcome of the treatment.
The communication between the individual elements of the communication diagram, such as the therapy generator 201, the host unit 202, the security portion 203, the communication interface 204, the communication medium 205, the user 208, the service portion 207, and/or the sales portion 206, may be bi-directional or multi-directional.
The connections between the user 208, the service portion 207, the sales portion 206, the communication medium 205, and/or the connection between the therapy generator 201 and the host unit 202 may be secured by the security portion 203 to provide secure communications and eliminate errors. The security 203 may be located between the host unit 202 and the communication interface 204 and/or between the communication medium 205 and the communication interface 204.
As shown in fig. 3, another option for remote access communication between the user 208, the service portion 207 and/or the sales portion 206 and the treatment device may be provided by the server 301. The server 301 may include a security portion 203. The security portion 203 may enable independent access to the user 208, the service portion 207, and/or the sales portion 206.
As shown in fig. 4, the communication medium 205 may be in communication with one or more therapy generators 201. One or more therapy generators 201 may be in communication with a host unit 202. The information of the communication medium 205 may be verified by the security 203 before the therapy generator 201 sends the information to the host unit 202.
Fig. 5 shows a schematic communication diagram between a communication medium 205 and one or more therapy generators 201A-201D. The therapy generator A201A may be in communication with at least one or more therapy generators 201B-201D. The other therapy generator B201B may also be in communication with one or more therapy generators 201a,201c,201 d. Therapy generator C201C may not communicate directly with therapy generator a 201A and may communicate through therapy generator B201B. The guard 203 may be in a communication pathway between the various therapy generators 201A-201D and/or between the therapy generator 201A and the communication medium 205.
Fig. 6 shows the main unit 11 of the treatment device. The main unit 11 may include an HMI 61, a ventilator grill 62, at least one applicator holder 63a and 63b, at least one equipment control 64, applicator connectors 65a and 65b, at least one main power input 66, a curved cover 67 of the main unit 11, wheels 68, a main unit cover opening 69, a main unit handle 70, and/or an identification area 71. The primary power input 66 may provide coupling or connection to a power grid or power network.
The ventilator grill 62 of the treatment device may be designed as a single piece and/or may be split into multiple ventilator grills 62 to provide heat dissipation. The ventilator grill 62 may face the person operating the main unit 11, face the ground and are not visible, and/or the ventilator grill 62 may be on the side of the main unit 11. The ground-facing position of the ventilator grid may be used to minimize disturbing noise of the patient, as the cooling process of the main unit 11 and/or the electrical components, such as powered by electrical energy, may generate noise. The surface area of all ventilator grids 62 on the surface of the main unit 11 may be in the range of 100cm 2 to 15000cm 2, or 200cm 2 to 1000cm 2, or 300cm 2 to 800cm 2.
Manipulation of the main unit 11 may be provided by a swivel wheel 68 on the bottom of the main unit 11 and/or by a main unit handle 70. The identification area 71 of the company providing the treatment device may be located below the main unit handle 70 and/or may be located anywhere on the curved cover 67 and HMI 61.
As shown in fig. 6, the front side of the main unit 11 facing the patient may be designed as a curved cover 67 of the main unit. Depending on the ground projection of the main unit 11, the front side of the main unit 11 facing the patient may not have a right angle. The front side of the main unit 11 facing the patient may be designed to cover one, two or more pieces of the inner side of the main unit 11. Having a curved side-facing main unit 11 may improve the handling of the main unit 11 itself in the vicinity of the patient support, wherein the risk of collision of the main unit 11 with the respective sensitive body parts (e.g. fingers) of the patient is minimized. The facing side of the main unit 11 may also include a main unit cover opening 69. The main unit cover opening 69 may include a thermal camera for monitoring the temperature of the patient or target body part; a camera may be included for monitoring the position of one or more applicators, movement of the patient, and the like. The main unit cover opening 69 may be represented by an opening in the curved cover 67 of the main unit. The main unit cover opening 69 may include one or more connectors for connecting additional treatment devices. In addition, the main unit cover opening 69 may include one or more sensors (such as cameras, infrared sensors) to scan patient movement, heating of the body part being treated, and/or biological structures. Based on information from such sensors, the actual and/or predetermined values of one or more treatment parameters may be optimized as the patient moves, the skin surface reaches a temperature threshold limit, a determination of a treated body part or the like. The front side of the main unit 11 may also include one or more applicator connectors 65a and/or 65b.
Fig. 52a shows a connection attachment 521 between the main unit and the applicator. One applicator may be connected to the main unit by a connection attachment 521, wherein the connection attachment 521 may comprise at least one applicator connector 65 and at least one tube connector 522. One applicator may be disconnected from the main unit and replaced by another applicator. The applicator may be connected to the main unit by a connecting tube including a tube connector 522, which may be connected to an applicator connector (e.g., applicator connector 65) located on the main unit. The tube connector 522 may be a plug and the applicator connector 65 may be a socket, or vice versa. The tube connector 522 may be an integral part of the connecting tube. The tube connector 522 and/or the applicator connector 65 may include male contacts (e.g., pins) and/or female contacts. In one example, the tube connector 522 may include female and/or male contacts.
Fig. 52b shows an applicator connector 65 having a variety of contacts. In fig. 52b, a colored circle within another circle represents a contact including a pin. One or more contacts in the tube connector 522 and/or the applicator connector 65 may be used to transmit electrical signals for radio frequency therapy and/or magnetic therapy. For example, two or four pairs of male and female contacts may be used to transmit electrical signals for radio frequency therapy. Multiple pins (e.g., two or four pins) of the contacts 525 of the applicator connector 65 may be used to transmit electrical signals for RF therapy. In some aspects, two pairs of male and female contacts may be used to transmit electrical signals for magnetic therapy. A pair of contacts 523 and a pair of contacts 527 of the applicator connector 65 may be used to transmit electrical signals for magnetic therapy. The pair of contacts 523 may be used to transmit electrical signals in the form of high power pulses from a main unit (e.g., from an energy storage device) to a magnetic field generating device of an applicator. The pair of contacts 527 may be used to transmit electrical signals from the magnetic field generating device back to the main unit (e.g., to the energy storage device).
Further, one or more contacts in the tube connector 522 and/or the applicator connector 65 may be used to transmit electrical signals to or from other electronic components of the applicator, where such electronic components may include fans (in the case of air cooling), computer memory, feedback sensors (e.g., temperature sensors), or human-machine interfaces on the applicator or connection tube. The signals from the electronic components may be multiplexed, i.e. transmitted through one wire or a set of conductive wires arranged in a protective shield. The plurality of pins of the contacts 526 of the applicator connector 65 may be used to transmit electrical signals to or from other electronic components present in the applicator.
Furthermore, one or more contacts in the tube connector and/or the applicator connector may be used as a safety circuit. For example, the connection between the contacts of the applicator connector 65 and the tube connector 522 may provide information about the secure connection of the tube and/or applicator to the main unit. When the wire in the tube connector 522 encounters a selected pin of the applicator connector 65, the control unit may be notified to close the safety circuit by a change in resistance of the selected pin.
Or the safety circuit may be represented by a safety circuit, the operation of which is shown in fig. 52 c-d. Fig. 52c shows an applicator connector 65 with a pin 551 and a safety wire 552 of the main unit. The tube connector 522 includes a safety wire 553 of the tube connector 522 and a socket 554 for receiving the pin 551. Conductive pin 551 represents the open end of safety wire 552 and socket 554 represents the open end of safety wire 553. Fig. 52d shows the connection attachment of the applicator connector 65 and the tube connector 522, wherein the pins 551 are connected to the socket 554. By this connection, the safety wires 552 and 553 are connected to each other. The created safety circuit may include a safety wire 552, a safety wire 553, a pin 551, and a socket 554. The control unit may be informed of the connection of the applicator to the main unit by closing and/or electrically activating the safety circuit. Or a pin for closing the safety circuit may be located on the pipe connector and the safety wire 553 may be located in the main unit. When the connector is not connected and the safety circuit is not closed, the control unit may not allow the treatment to be started and/or the therapeutic energy source to be used. With respect to fig. 52b, multiple pins of the contacts 526 of the applicator connector 65 may be used to close the safety circuit.
Furthermore, a connection accessory comprising a tube connector and/or an applicator connector (e.g. a hose) may be used for transferring the cooling liquid between the applicator and the main unit. In this case, the connection accessory may include a fluid coupler. With respect to fig. 52b, a plurality of fluid couplers 528 of the applicator connector 65 may be used to transport the cooling fluid.
Further, one or more contacts in the tube connector 522 may be used to control the unit and/or the main unit identify the applicator. For example, one or more contacts in the tube connector 522 may be connected to an electrical element (e.g., an identification resistor or RFID element) that may be of one type and/or provide a resistance value assigned to a particular type of applicator. By this identification, the main unit and/or the control unit can identify the type of applicator connected to the applicator connector 65 and then allow treatment. The different applicators may include applicators for different body parts, e.g., applicators for the patient's arms, buttocks, or abdomen, and other body parts, and/or applicators having different components, e.g., applicators having one or more magnetic field generating devices, one or more RF electrodes, or a combination thereof. If the connected applicator is not identified, the main unit or the control unit may not allow treatment. Furthermore, depending on the type of applicator identified, the main unit or control unit may only allow certain treatment protocols based on the type of applicator identified.
Further, one or more contacts in the tube connector 522 may be used to track the overall use of the applicator. The applicator may include computer memory (e.g., RAM, ROM PROM, EPROM, or memory) that stores a preset maximum number of operating minutes or a preset maximum number of magnetic pulses that the applicator can use for application. The control unit and/or the main unit may set or identify the maximum number of operating minutes or magnetic pulses depending on the type of applicator. The information transmitted from the applicator to the main unit via the connector may include the number of working minutes or magnetic pulses used. When the number of working minutes or pulses used reaches or equals a preset maximum number stored in the applicator, the human-machine interface may display a message and/or the control unit may prevent further treatment of the applicator. Or the control unit may subtract the number of operating minutes or the number of magnetic pulses from a preset number stored in the memory of the applicator. When the number of working minutes or pulses counted by the main unit (e.g., the control unit) reaches or equals zero, the human-machine interface may display a message and/or the control unit may prevent further treatment of the applicator. With respect to fig. 52b, the plurality of contacts 529 of the applicator connector 65 can be used to track the overall use of the applicator.
The connection of the tube connector 522 to the applicator connector 65 (providing the connection of the applicator to the main unit) may be secured or locked by a locking mechanism (e.g., a bayonet closure) as well as other removable or temporary connections. The connection of the tube connector to the applicator connector may be secured by at least one locking mechanism, for example, a locking element connected to a spring. The locking element may comprise plastic connected to the spring element, wherein the applicator connector and the tube connector may each comprise one locking mechanism.
As shown in fig. 6, patient-facing applicator connectors 65a and 65b may be closer to the patient's body than applicators connected to the side facing the operator (e.g., doctor or technician). Accordingly, the length of the connection tube 814 connecting the applicator with the main unit 11 can be minimized. Manipulation of the applicator and/or applicators connected by the shorter connecting tube 814 may be easier than the applicators connected by the longer connecting tube 814.
The front side of the main unit 11 may not have corners and/or angles and may include at least partially elliptical and/or circular curvature. The curvature may have a radius of curvature in the range of 20cm to 150cm,30cm to 100cm,30cm to 70cm, or 40cm to 60 cm. The angle of curvature of the front side of the main unit 11 may be in the range of 30 ° to 200 °, or 50 ° to 180 °, or 90 ° to 180 °. The angle of curvature may be defined in the same principle as the angle 30 defining the section 26 of fig. 23, as discussed in further detail below.
The device may also include a remote control for use by the patient and/or operator to signal discomfort during treatment. The remote control may comprise at least one button in communication with the main unit 11, for example by a wired or wireless connection. During treatment, the remote control may be located near the patient. The patient can hold the button in his hand and press it whenever any discomfort arises. By pressing a button on the remote control due to discomfort, the patient may stop the treatment and may stop applying magnetic fields and/or radio frequency energy.
The main unit may include a slot for receiving a card (e.g., an SD card). The card may include a counter for operating minutes. After inserting the SD card into the slot, the device can identify the number of minutes of operation. The device may only allow for the number of operating minutes identified by the treatment.
The card may also be used to calibrate the device and/or applicator. The device may provide calibration of the applicator, wherein the calibration may comprise calibration data of the applicator temperature, cooling of the RF electrode, cooling of the magnetic field generating device or calibration of the temperature sensor. After calibration, the device may save the calibration data to the card. Calibration may be performed by a service and/or by a user during manufacturing.
The main unit 11 may include one or more applicator holders, such as 63a and 63b. Or one or more applicator holders may be coupled to the main unit 11. Each applicator holder 63a and 63b may have a specific design for a different type of applicator. Applicator holders 63a and 63b may each hold a single applicator 12a or 12b. Each applicator holder 63a, 63b may have several functions. For example, applicator holders 63a and 63b may be used for preheating or precooling at least a portion of the applicator. In addition, applicator holders 63a and 63b may include another HMI and may be used to display information regarding the selected treatment, actual values and/or predetermined values of one or more treatment parameters. In addition, applicator holders 63a and/or 63b may provide an indication of whether the applicator is ready for use. Further, the applicator holders 63a and/or 63b may indicate a current value temperature of at least a portion of the applicator. The indication may be provided by a color flash or vibration. Applicator holders 63a and/or 63b may be used to set one or more treatment parameters and/or actual and/or predetermined values of the applicator parameters, such as the temperature of the portion of the applicator that contacts the patient.
The main unit 11 may include device controls 64 for switching the main unit 11 on and off, manual setting of power input parameters, and/or other functions. The applicator connectors 65a and 65b may be used for the transmission of electrical and/or electromagnetic signals from the main unit 11 and the applicators. Applicator connectors 65a and 65b may be used to connect one or more applicators (via connection tube 814), communication devices, additional treatment devices, and/or memory storage devices; such as a USB, SSD disk, diagnostic device, and/or other memory storage devices known in the art. An applicator connector 65 (e.g., 65a and/or 65 b) for connecting one, two or more applicators may be located in the main unit 11 or on a side of the main unit 11. The length of the coaxial cable may be related to the frequency of the transmitted electrical signal. To provide easier handling of one or more applicators 12a and/or 12b, the connection length from the main unit 11 to e.g. the applicator 12a (and thus the connection tube 814) should be as long as possible. However, the length of the at least one coaxial cable between the electrical elements of the main unit 11 may be related to the frequency of the transmitted electrical signal (e.g., RF signal) that is sent to at least one therapeutic energy source (e.g., RF electrode to provide RF energy). Thus, the length of at least one coaxial cable inside the main unit (e.g., between the power source and the applicator connector 65a and/or 65 b) may be as short as possible. The length of the coaxial cable located in the main unit 11 may be in the range of 3cm to 40cm, or 7cm to 30cm, or 10cm to 20 cm. To optimize the manipulation of one or more applicators 12a or 12b connected to the main unit 11, the applicator connectors 65a and 65b may be located on the curved front side of the main unit 11.
HMI 61 may include a touch screen display that shows actual and/or predetermined values of one or more treatment parameters. The touch screen may provide options to select the displayed treatment parameters and/or to adjust these parameters. The HMI 61 may be divided into two display sections 61a and a selection section 61b. The display section 61a may display actual and/or predetermined values of one or more treatment parameters, and other information of the user. The selection section 61b of the HMI 61 may be used for selection of treatment parameters and/or other adjustments of the treatment. The HMI may be included in or coupled to, or may be part of, one or more applicators 12, the main unit 11, the additional treatment device 14, and/or other one or more communication devices 15.
HMI may be included in the main unit 11. The HMI may be fixed to the main unit 11 in a horizontal orientation, or the HMI 61 may be oriented or tilted between 0 ° and 90 ° with respect to the ground or other horizontal support surface. The angle between the plane of the HMI 61 and the ground may be adjusted by at least one joint or may be rotated about at least one cartesian coordinate. The HMI 61 may be in the form of a detachable HMI (e.g., a tablet). The HMI 61 may be telescopically and/or rotationally adjustable according to one, two or three cartesian coordinates by a holder that may adjust the distance of the HMI 61 from the main unit 11 and/or the orientation of the HMI 61 relative to the main unit 11 and the user. The holder may comprise at least one, two or three realized joint members.
One HMI 61 may be used for more than one type of treatment device provided by the provider. The HMI software interface may be part of the main unit software or part of the software included in one or more additional treatment devices and/or communication devices. The software interface may be downloaded and/or implemented by connecting a communication device, an add-on therapy device, a flash memory device, by remotely connecting a sales department, a service department, and/or the internet.
Fig. 26 shows an exemplary layout of the inside of the main unit 11. The interior of the main unit 11 may include a plurality of electrical element control systems, one or more control RF circuits, magnetic circuits, and/or other elements as required for proper functioning of the treatment device. The position of the individual elements in the main unit 11 can be described by means of cartesian coordinates, with a zero value at the bottom edge of the front side facing the patient. The main unit 11 may include one or more struts 74. At least two of the struts 74 may form an X-shape that may be secured at its ends to other vertical struts 74 to form the configuration of the main unit 11. The main unit 11 may include at least one cooling system 78, the cooling system 78 being configured to cool electrical components, such as one or more control units, PCBs, power supplies, switches, energy storage devices, and/or other electrical components of the treatment device. The cooling system 78 may be used to provide and/or cool a cooling fluid provided to the applicator. SYM element 79 may be located in the upper third of the Z-coordinate and in the first third of the X-coordinate, independent of the Y-coordinate. The function of the SYM is explained below. The primary element 11 may also include one or more housings 72 formed of aluminum or other metallic material. The one or more housings 72 may provide electrical, electromagnetic and/or radiation insulation (the latter being merely insulation) of one or more interior portions of the main unit 11 from other portions of the main unit 11. For example, at least a portion of RF circuitry 73 may be located in one of the housings at the rear third of the X and Z coordinates. The power supply 75 (powering at least a portion of the RF circuitry and/or the magnetic circuitry) may be located at the rear third of the X-coordinate and at the front third of the Z-coordinate. The energy storage device 76 may be at least partially insulated from the one or more RF circuits. When multiple magnetic circuits are used, the multiple magnetic circuits may be at least partially insulated from each other. To ensure the short length of the coaxial cable leading from the energy storage device 76 to the applicator connector 65 as described earlier, the elements (energy storage device 76 and applicator connector 65, e.g., 65 a) may both be located in the same half of the X and Z coordinates, such as in the first half of the X and Z coordinates. Other electrical components of the magnetic circuit, represented by box 77, may be located in the first half of the X-coordinate and two-thirds of the Z-coordinate.
Fig. 7 illustrates an exemplary display interface 700 of the HMI 61. The HMI 61 may display one or more applicator symbols 701. The one or more applicator symbols 701 and their colors may represent the available or connected applicators, the connection treatments, the number and/or the type of additional treatment devices (connected to the main unit 11 and/or participating in the treatment). The list 702 may be redirected to a page or a different display layout, where the list of treatment protocols may be recorded or adjusted. The list 702 of treatment protocols may include one or more predetermined values of at least one or more treatment parameters (e.g., magnetic field strength, RF field strength, magnetic pulse strength, pulse duration, burst duration, composition of individual bursts, duty cycle, envelope shape, treatment time, composition of treatment components, threshold temperature of biological structures during treatment, and/or other parameters). The list of treatment parameters may include one or more conservation treatment regimens optimized for the individual patient or body part. After selecting the treatment regimen, the treatment parameters may be additionally optimized by the user. In addition, the treatment parameters may be adjusted by selecting additional patient parameters, such as patient size (e.g., lean, slim, average body weight, overweight, or obese), or patient BMI, sex, age group (e.g., under 30 years old, 30 to 39 years old, 40 to 49 years old, 50 to 59 years old, 60 years old, and above). In addition, the treatment parameters may be additionally optimized by selecting only a portion of the treatment regimen.
The HMI 61 may include one or more sliders that may have some functionality. For example, the slider 703 may be used as a navigator for selecting an interface page being used, such as a list 702, a treatment icon 704, or a record 707. In addition, the slider 703 may be used to indicate the length of time remaining until the end of the treatment.
Treatment icon 704 may represent the interface shown in fig. 7. Timer 705 may represent a duration of treatment, a remaining time of treatment, and/or an elapsed time of treatment. The "scheme 1" icon 706 may illustrate the type and number of schemes selected and/or currently applied and/or ready to be applied. The "record" 707 may be redirected to another page of the interface with a history of records of the treatment, information about the patient being treated, information about billing and lease systems, information about billing information, and/or an integrated cost of the treatment. "record" 707 may display how much credit remains on the credit account, how much credit is spent, the duration of use of the treatment device, and/or other billing information. The icon shown by the symbol "set" 708 may redirect the user to settings of the treatment device, including, for example, settings of the melody and/or intensity of the sound produced by the device and/or the brightness of the display. The sound produced by the treatment device and/or the brightness of the display may be different before and/or during treatment. The "setup" 708 interface may also allow for changing the date, time, language, type and/or parameters of connection between the main unit and the applicator, additional treatment devices, and/or communication devices. The "setup" 708 interface may include icons for initiating calibration and functional scanning of the treatment device and its connected portions. The "settings" 708 interface may provide software information, software history and/or software implementation, buttons for contacting the service and/or sending error schemes, type of operation mode (e.g., "basic" or "expert" with allowed additional settings for the treatment device), possibility to recharge the treatment credits, return to factory settings, and/or other settings.
As shown, the intensity indicator 709 may be in the form of a percentage, number, power, and/or other format. The intensity indicator 709 may be positioned adjacent to an icon that may adjust the intensity of the therapeutic energy source. The intensity indicator 709 may be located below, above, and/or in the icon (e.g., as a number in the intensity bar 710), and/or may be another visualization that may adjust the intensity of the therapeutic energy source. Each intensity bar 710 that identifies one therapeutic energy source of supplied energy (e.g., RF field or magnetic field) may have its own intensity signature 709. The treatment device may include a plurality of applicators 714, e.g., a first applicator a and a second applicator B may be connected to a main unit of the treatment device. Thus, applicators A and B may be applied to different muscles in the same muscle group or to pairs of muscles such as left and right buttocks, left and right sides of the abdomen, left and right thigh, and other pairs or cooperating muscles. The number of connected applicators and/or additional treatment devices providing treatment energy may be lower or higher than two.
As shown in fig. 7, each applicator may provide magnetic therapy 718 (left HMI portion labeled HIFEM A and HIFEM B for purposes of fig. 7 and shown as an exemplary interface human-machine interface) and/or RF therapy 712 (right HMI portion labeled RF a and RF B for purposes of fig. 7 and shown as an exemplary HMI).
The strength of each RF field and/or magnetic field may be independently adjusted, for example, by an independent magnetic strength roller 719 and/or by a strength bar 710 to roller the RF strength roller 711. One or more of the rollers or intensity bars may be moved alone or may be moved with another roller or intensity bar to adjust multiple magnetic fields together, multiple RF fields, and/or multiple RF fields and magnetic fields provided by one applicator together. In addition, one or more of the rollers or intensity bars may be controlled individually or may be moved with another roller or intensity bar to adjust multiple magnetic fields together, multiple RF fields, and/or multiple RF fields and magnetic fields provided by both applicators together. One or more intensity bars 710 may be distinguished by color and may be adjusted by intensity scrollers 719 or 711 and/or by intensity buttons 720. The intensity button 720 may change (e.g., increase or decrease) the RF field and/or magnetic field intensity by a fixed increment, such as 1% or 2% or 5% or 10% of the maximum possible field intensity, or in the range of 1% to 10%, or in the range of 1% to 5%. The strength of the magnetic field and/or the RF field may be individually adjustable for each therapeutic energy source. Additionally, the strength of the magnetic field and/or RF field may be adjusted by the selection and/or connection of one or more applicators, additional therapeutic devices, and/or therapeutic energy sources.
The operation of one or more RF electrodes and/or magnetic field generating devices may be synchronized and controlled by one, two or more intensity scrollers 719 and/or intensity buttons 720. Treatment may be initiated by a button initiation 713, which button initiation 713 may be automatically (e.g., after initiation of treatment) changed to a button suspension. During treatment, treatment may be restarted and/or stopped by button stop 716. The interface may also show an indicator of uncomfortable buttons 717; when the treatment is uncomfortable, the uncomfortable button 717 may be activated by the patient via a remote control. When the discomfort button 717 is activated, the treatment may be automatically and immediately interrupted (e.g., paused or stopped). When the discomfort button 717 is activated, the treatment device may provide human perceptible signals, including audible alarms (including audible signals). Furthermore, the human perceptible signal may include a visual alert including, for example, a flashing color. Based on patient discomfort, the user may adjust, for example, treatment parameters or treatment protocols, attachment or coupling of the applicator. The interface may also include a software power switch 715 to turn the treatment device on or off.
As shown in fig. 7, the HMI may include two intensity bars (e.g., 710) for RF therapy and two intensity bars for magnetic therapy. In addition, the HMI may include two intensity scrollers (e.g., 711) for RF therapy and two intensity bars (e.g., 719) for magnetic therapy. Further, the HMI may include four intensity buttons for RF therapy and four intensity buttons for magnetic therapy (e.g., 720). One intensity scroller, one intensity bar, and/or two intensity buttons may be provided for one treatment circuit. Thus, fig. 7 may show an HMI of a treatment apparatus comprising two treatment circuits for RF treatment and two treatment circuits for magnetic treatment.
The treatment device may include one or more applicators. The treatment device may comprise two, three, four, five or more applicators. Each applicator may include at least one, two, or more different therapeutic energy sources, such as one or more RF electrodes to provide RF therapy and one or more magnetic field generating devices to provide magnetic therapy. For example, the first applicator may comprise one RF electrode and one magnetic field generating device, while the second applicator may comprise another RF electrode and another magnetic field generating device. The RF electrode may not contact the patient's skin. The RF electrode may be placed inside the applicator together with the magnetic field generating means. An applicator may be coupled to the main unit by a connecting tube. The connection tubes of the different applicators may be interconnected or separated for each applicator. Or multiple applicators may be coupled to the main unit through a common connection tube. At least one treatment parameter of at least one applicator may be varied independently of the other one or more applicators and/or additional treatment devices.
One or more applicators, additional treatment devices, and/or communication devices may mechanically connect the main units through one or more wires and/or through a fluid conduit. One or more wires and/or fluid conduits may be positioned and guided through the connecting tube. One or more wires coupled between the main unit and the applicator may be used for the transfer of electrical signals (representing, for example, RF signals) to RF electrodes located in the applicator to generate RF energy. One or more wires may be used to provide current to a magnetic field generating device located in the applicator to generate pulses of magnetic field. The same wire and/or a different wire coupling the applicator and the main unit 11 may be used for communication between the main unit 11 and the applicator 12 and/or for collecting feedback information. The feedback application may include measured signal parameters and/or impedance characteristics of the wire, for example, before and/or during treatment. The fluid conduit between the main unit 11 and the applicator 12 may direct liquid, oil, water, steam, gas, and/or other temperature regulated cooling fluids.
The one or more applicators may be coupled to the patient's body and/or body part by one or more straps, one or more bands, or by creating a vacuum under the applicators. In addition, the applicator may be coupled to the body part by a support matrix or by an adhesive layer that is located on at least a portion of the applicator surface and contacts the patient's body or clothing. The applicator may be coupled to a body part of a patient by pushing the applicator to the body part or clothing via an adjustable mechanical positioning arm; wherein the applicator is detachably coupled to a positioning arm that includes at least one, two or more joints. The strips may be at least partially elastic and may form a closed loop, such as by hook and loop fasteners (by Velcro); snaps, studs, and/or other fastening mechanisms may be used to adjust the length. The band may be coupled to a body part and may include a fastening mechanism for coupling the applicator to the band and/or the skin or clothing of the patient. Such fastening mechanism may be, for example, a dimpled strip for an applicator. Coupling the applicator to the body part may include attaching or positioning the applicator adjacent to or in contact with the body part. Or the applicator may not contact the body part. The one or more applicators may be coupled to the body part prior to or during the application of one or more types of therapy (e.g., RF therapy or magnetic therapy). In addition, the applicator may be coupled to the body part, skin or clothing by a cover of soft material that may be folded around the applicator and/or around a portion of the body part. Furthermore, the applicator may be covered with a soft material cover providing other coupling points for attaching the strap, folding the soft material, or any other coupling options described herein.
The strap may be a length adjustable strap, which may be at least partially flexible. One or more straps may couple or secure and/or attach one, two or more applicators to the patient's body or body part. The ribbon may be coupled to one applicator 800, or one ribbon may couple two or more applicators to the patient's body. When multiple applicators (e.g., two, three, or more) are used, one applicator may be coupled to a body part of the patient's body by one strap and another applicator may be coupled to the body part by a different strap. Or multiple applicators (e.g., two, three, or more) may be coupled to a body part of a patient via one and the same strap. At least one applicator coupled by the band may be statically fixed relative to the patient's body for at least a portion of the treatment. At least one applicator coupled to the patient's body by the webbing may be manually or automatically repositioned one or more times by the operator during treatment to ensure optimal treatment effect and therapeutic comfort for the patient.
Coupling the applicator and/or the additional treatment device to the patient's body may include placing the applicator adjacent to the patient's body and/or body part. In the case of proximal coupling, the shortest distance between the applicator and the patient's skin may be in the range of 0.01cm to 10cm, or 0.01cm to 5cm, or 0.01cm to 2cm, or 0.01cm to 1cm, or 0.01cm to 5mm, or 0.01cm to 2 mm. However, the applicator may also be placed in direct contact with the patient's skin. In the case of direct contact, there may be a meaningless distance between the application of the treatment and the patient's skin. In the case of proximal or direct contact, the intervening material may be located between the applicator and the patient's skin or clothing or body part. The intervening material may be an air gap, a wadding, a support matrix, a portion of a belt, a fabric, other garment, a gel, a liquid absorbent material, or a metal.
Fig. 22 illustrates an exemplary attachment of the applicator and/or additional treatment device 21 to the patient's body using a support matrix 22. As shown in fig. 22, the support matrix 22 may be shaped as a grid and/or a scaffold. The grid and/or the support are at least partially flexible and attached to the patient's body. The support matrix may be used to couple the applicator and/or additional treatment device 21 to a defined location, referred to as an applicator site 24, near the patient's body by fastening members 23. The support matrix may be a polymer scaffold-like substrate of fig. 22, such as a fabric/polymer sheet or the like. The fastening means may be one or more elements, such as locking mechanisms, hinges, bayonet-like systems, velcro, for fastening the applicator and/or the additional treatment device 21.
As shown in fig. 25a, the applicator 800 may include one or more components defining a housing of the applicator, which may be connected to the main unit by a connecting tube 814. In addition, the applicator may include one or more components hidden within the applicator that further define the function and functionality of the applicator. The housing of the applicator may include various components such as a handle cover 512, a handle 514, a top cover 516, a second side portion 802, the second side portion 802 forming a bottom cover 517 of the applicator. Handle cover 512 may include indicia 813 and/or HMI 508 for use, for example, in displaying and/or adjusting actual and/or predetermined values of one or more treatment parameters. The handle 514 may be used for manipulation of the applicator 800 and/or for coupling the applicator 800 to a body part of a patient. The cap 516 may define an interior of the applicator. The cap 516 may include an air opening 504, the air opening 504 allowing air to flow to or from the interior of the applicator to cool electrical components located within the interior of the applicator. The electrical components located inside the interior of the applicator may include, for example, RF electrodes, magnetic field generating devices, and/or temperature sensors 510. The RF electrode may be located on the substrate 113 a. The RF electrode may be located on a side of the substrate 113a closer to the patient. The second side portion 802 forms a bottom cap of the applicator. The bottom cover 517 may be positioned closer to the patient than the top cover 516 of the applicator 800. Accordingly, the RF electrode may be positioned between the substrate 113a and the bottom cover 517. The second side portion 802 may include one or more protruding shapes, grooves, etc. Power, energy, one or more electromagnetic signals, and/or cooling fluid may be delivered to the applicator via connection tube 814. Further, cooling of one or more electrically powered elements in the applicator (e.g., the magnetic field generating device 900 and/or the substrate 113a having at least one RF electrode) may be provided by a fan 524, the fan 524 being secured to the top cover 516 and/or the second side portion 802. The RF electrode pad 113a can include a temperature sensor 510, the temperature sensor 510 configured to determine a temperature of the applicator, at least a portion of the bottom cover 517, the body part, and/or the patient's biological structure. The RF electrode on the substrate may be connected to the mating element 136, and the mating element 136 reconnects to the coaxial cable. Mating member 136 is further described with reference to fig. 24. Fig. 25 also shows a frame 506, the frame 506 being operable to secure the magnetic field generating device to the top cover 516 and/or the second side portion 802. The frame 506 may be configured to eliminate noise and vibration during magnetic therapy. The magnetic field generating device 900 may be housed within the housing of the applicator 800. Further, the RF electrode may be housed within the housing of the applicator 800. Further, a plurality of RF electrodes may be housed within the housing of applicator 800. By housing the magnetic field generating device 900 within the housing of the applicator 800, the magnetic field generating device 900 may not be in contact with the patient's body. Furthermore, by housing the RF electrode within the housing of the applicator 800, the RF electrode may not be in contact with the patient's body. Further, by housing the magnetic field generating device 900 and the RF electrode within the housing of the applicator 800, the magnetic field generating device 900 and the RF electrode may not be in contact with the patient's body.
The fan 524 may be an axial fan or a radial fan. The applicator may include one, two, or more fans configured to provide cooling of the magnetic field generating device 900 and/or the RF electrode. Cooling may be provided by drawing fluid into or pushing fluid out of the fan. As shown in fig. 25b, when two fans are located within the applicator 800, the first fan 524a may be configured to provide cooling to the upper side 251a of the magnetic field generating device 900 and the second fan 524b may be configured to provide cooling to the lower side 251b of the magnetic field generating device 900. The first gap 252a between the upper side of the magnetic field generating device and the top cover 516 may be in the range of 0.1mm to 80mm or 0.1mm to 50mm or 0.5mm to 25mm or 1mm to 10 mm. The second gap 252b between the lower side of the magnetic field generating device and the bottom cover 517 may be in the range of 0.1mm to 75mm or 0.1mm to 50 mm. The gap between the magnetic field generating device and the housing (top cover 516 and/or bottom cover 517) may have a size of about 4mm, which is optimal for maintaining a sufficient fluid flow rate between the magnetic field generating device and the housing, and thus, when the first gap and the second gap have about the same size, the fluid flow rate on both sides of the magnetic field generating device may be about the same. In this case, the term "about" should be interpreted as being within 5% of the stated value.
The operation of one or more fans may be monitored by sensors (e.g., pressure sensors, temperature sensors, current sensors, and/or flow sensors). One or more fans and/or sensors may be connected to the control unit and/or the control system. Further, the sensor may detect one or more parameters of the fluid being processed by the fan. Further, a sensor (e.g., a temperature sensor) may measure the temperature of the magnetic field generating device and/or its vicinity. The inputs and/or outputs of one or more fans may be monitored and their operation may be controlled by a control system. For example, the control system may increase the output of the fan when the sensor detects a low speed of fluid flow. For another example, the control system may increase the output of the fan when the temperature sensor measures that the temperature of the magnetic field generating device and/or its vicinity is above a safe value. In yet another example, when a sensor measures a failure of one fan, the control system may increase the output of the remaining fans, or the control system may stop the operation of the device and treatment.
The design of the applicator may include a first gap that is larger than a second gap. In this design, air may flow through the first gap at a different velocity than in the second gap. For adequate cooling, it may be beneficial to have the same or similar fluid flow rates near both sides of the magnetic field generating device. Thus, when the applicator has two different gaps, the applicator may include one or more barriers. The barrier may direct fluid flow closer to the magnetic field generating device, induce eddy currents and/or provide turbulent fluid flow. In some aspects, the barrier may be formed of plastic. In some aspects, the barrier may have the form of a rib. The barrier may be part of the lid (e.g., top lid 516 or bottom lid 517). The barrier may be perpendicular to the direction of the airflow. The distance between the edge of the barrier and the magnetic field generating device may be in the range of 1mm to 10mm or 1mm to 8 mm. The height of the barrier may be in the range 1mm to 100mm or 2mm to 50 mm. As shown in fig. 25c, an exemplary applicator 800 that does not include the rf electrode 101 includes three barriers 518 on the sides of the top cover 516. The distance between the barrier edge and the magnetic device is depicted as 519. As shown in fig. 25d, the exemplary applicator 800 includes three barriers on the bottom cover 517 side and three barriers on the top cover 516 side. Fig. 25e shows an exemplary applicator comprising a barrier, a magnetic field generating device 900 and a radio frequency electrode 101, positioned close to a body part 541. In this configuration, the barrier may be positioned near the upper side of the magnetic field generating device 900. In fig. 25f, the bottom view of the top cap 516 shows the barrier 518a positioned perpendicular to the fluid flow direction and the barrier 518b positioned along the fluid flow direction. The barrier 518b may facilitate directing fluid to the vertical barrier 518a.
The applicator may be designed as exemplarily shown in fig. 8a to 8 d. As shown in fig. 8 a-8 d, the applicator 800 may be used for treatment of a body part.
One or more RF electrodes in the applicator 800 may be located between the magnetic field generating device and the patient's body part. The RF electrode may be shaped to at least partially match the curvature of the first side portion 801, the second side portion 802, and/or the curvature of the patient's body part. The magnetic field generating device may at least partially match the curvature of the first side portion 801, the second side portion 802, and/or the curvature of the patient's body part. The RF electrode and/or the magnetic field generating device may be curved to focus and/or provide better targeting of RF therapy and/or magnetic therapy. The first side portion 801 may be configured to maintain the position of the limb within the first side portion 801 during treatment. The first side portion 801 may provide stable position and/or balance of the body part being treated. The position of the patient's limb may be maintained in the first side portion 801 even though the limb is movable by muscle contraction. Lateral movement and/or rotation of the limb may be limited due to the first side portion 801 and/or the band 817 in such a way: the limb may be in a stable position. Rotational movement relative to the applicator 800 may be limited by coupling the applicator 800 to a body part (at least part of the body limb being treated) via a strap. Furthermore, when a portion of the arm is treated by magnetic and/or RF therapy, at least a portion of the limb may also be attached to the patient's torso to minimize movement of the limb.
The second side portion 802 may be located on an opposite side of the applicator 800 relative to the first side portion 801. The second side portion 802 may be generally planar, or the second side portion 802 may be at least partially concave and/or convex. Applicator 800 may be coupled to the patient by a positioning mechanism, such as a band 817, as shown in fig. 8a and 8 b.
Fig. 8a depicts an applicator comprising a positioning mechanism that can be secured in a recess 803 at a first end 804 of the first side portion 801 and in a recess 806 at a second end 805 of the first side portion 801. The positioning mechanism (such as a belt or strip) may be fastened or its length may be adjusted by a clamp 807. The clamp 807 is movable in a clockwise or counter-clockwise direction about a pin 808. The clamp 807 may be biased by a spring. Or the clamp 807 may be locked by a suitable locking mechanism or by any other movement constraint. The clamp 807 may include fasteners 809 on the underside of the clamp 807 for securing the correct length of the positioning mechanism. The fasteners 809 may be hook and loop fasteners, velcro fasteners, pin type fasteners, and other mechanical fasteners. Coupling the applicator 800 to the patient's body as described above may be used primarily when the patient's body part is attached to the first side portion 801 of the applicator 800. The RF electrode and/or the magnetic field generating device may be shaped to at least partially match the curvature of the first side portion 801. The RF electrode and/or the magnetic field generating device may be curved to focus and/or provide better targeting of RF therapy and/or magnetic therapy.
Fig. 8b and 8c illustrate an applicator that includes a positioning mechanism that may be directed perpendicularly to the curvature of the first side portion 801 and/or perpendicularly to the axis 810 of the applicator. The positioning mechanism may be positioned or guided by the concave surface 815 of the handle 812. Further, a positioning mechanism (e.g., a strap) may be positioned or guided below the handle 812 and above the magnetic field generating device. Further, a positioning mechanism (e.g., a strap) may be positioned on the handle 812 by, for example, a clip. The band 817 may also be directed through and/or over the applicator 800 in any direction to hold the applicator 800 to the patient's skin. Coupling the applicator 800 to the patient's body as described above may be used primarily when the patient's body part is attached to the second side portion 802 of the applicator 800. The RF electrode and/or the magnetic field generating device may be shaped to at least partially match the first side portion 801. The RF electrode and/or the magnetic field generating device may be flat or curved to focus and/or provide better targeting of RF therapy and/or magnetic therapy.
Fig. 8b shows a top view of the applicator 800. Applicator 800 may include indicia 813, indicia 813 corresponding to the position of the magnetic field generating device within applicator 800. Indicia 813 may be located above the center of the magnetic field generating device. Indicia 813 can allow a user to easily and comfortably position applicator 800. Recesses in the surface of applicator 800 may be used as indicia 813. Or indicia 813 may be different surface variations of a portion of the applicator cover such as different colors, different roughness, pressure of one or more light sources (e.g., light emitting diodes LEDs), specific curvature of the housing of the applicator, identification of manufacturing or distribution companies, etc. The housing of the applicator may comprise at least two colors. The first color may be on the applicator housing above the magnetic field generating device to allow for proper positioning of the applicator, and the remainder of the applicator may have a second color that is different than the first color. Color may be interpreted as a coating that reflects and/or absorbs light of a particular wavelength. Similar to indicia 813, the applicator may include a second indicia to show the location of at least one RF electrode.
As shown in fig. 8b and 8c, the applicator may include an outlet 811. The outlet 811 may allow for circulation of air in the applicator 800 and heat dissipation of heat generated by at least one or more magnetic field generating devices and/or RF electrodes located in the applicator and supplied with energy through one or more wires inside the connecting tube 814. The connection tube 813 may further include a fluid conduit that may provide or direct cooling fluid from the main unit 11 to the applicator 800.
Applicator 800 may also include one or more temperature sensors 816, for example, as shown in fig. 8 c. The temperature sensor 816 may protrude from the housing of the applicator 800, such as, for example, from a surface of the second side portion 802 and/or from the first side portion 801. The temperature sensor 816 may protrude from the housing of the applicator 800 to create a higher pressure through the applicator 800 for a portion of the body part being treated and to provide a better measurement of the temperature of the biological structure, body part, and/or patient's body.
Fig. 8e illustrates an exemplary placement of temperature sensor 816 within applicator 800. The temperature sensor 816 may be located in a protruding portion 821 of the applicator. The protruding portion 821 of the applicator 800 may protrude from the surface of the applicator that is in contact with the patient such that the protruding portion 821 with the temperature sensor is pressed into the patient's skin and closer to the surface of the patient than other electrical elements of the applicator.
The second side portion 802 and/or the first side portion 801 may be heated and/or cooled. The second side portion 802 and/or the first side portion 801 may be heated (e.g., at the beginning of treatment) to reach the treatment temperature faster. The treatment temperature may include the temperature of the body part and/or biological structure increased by the application of RF waves, which may be adapted to apply a magnetic field. Cooling or heating of portions of the applicator may be used to maintain a constant temperature on the patient's skin. In addition, cooling or heating of portions of the applicator may be used to achieve higher treatment temperatures of the patient's biological structure (0.5 cm deeper below the patient's skin). Cooling a portion of the applicator that contacts the patient (e.g., the second side portion 802 and/or the first side portion 801 of the applicator) may be used to minimize perspiration of the patient. The patient's skin may be cooled by a cooling fluid (e.g., air) that flows and/or is blown from the applicator and/or other components of the treatment device. Cooling of the patient's skin may be provided by heat dissipation between the cooled portion of the applicator contacting the patient's skin and the patient's skin. The cooling portion of the applicator may be cooled by a cooling fluid flowing in the applicator and/or by Peltier elements utilizing the Peltier (Peltier) effect.
Patient perspiration can be uncomfortable for the patient and adversely affect feedback information collection, can contact the applicator and the patient's skin, and/or can result in lower adhesion of the applicator to the patient's skin. To prevent perspiration of the patient's skin, cooling of the applicator contact area (e.g., first side portion 801 and/or second side portion 802) may be utilized. The second side portion 802 and/or the first side portion 801 may comprise a groove 819, which groove 819 may be supplied with a cooling fluid through the applicator slot 820, wherein a liquid and/or a gas (e.g., gas, oil, or water) may flow as shown in fig. 8 d. The first side portion or the second side portion of the applicator may include an applicator aperture or applicator slit 820, wherein air of the applicator 800 may be directed to remove heat, moisture, and/or perspiration from the patient's skin. Holes or slits may be present in the groove 819. The holes may be used to provide active substances to the patient. The contact portion of the applicator that contacts the body part may comprise a fluid absorbent material, such as a sponge, hydrophilic material, non-woven organic and/or polymeric textile; the fluid absorbent material may at least partially remove perspiration from the patient's skin and/or may improve conductivity between the patient and the applicator 800. The reduction of perspiration in the patient in at least a portion of the body part being treated may be provided by a reduction in sweat gland activity. The reduction of sweat gland activity may be provided by the application of a pulsed magnetic field, intense light, thermal shock, by the application of an active substance (such as ethylenediamine terephthalate) to the patient and/or to the patient, and/or by other mechanisms, the thermal shock being provided by periodic cooling of the patient's skin.
Fig. 23 illustrates an exemplary applicator that includes a concave surface. The applicator may be designed with a first side portion 801, the first side portion 801 being at least partially convex. The first side portion 801 may alternatively be V-shaped or U-shaped. The radius of curvature may correspond to the size of a patient's limb. The second side portion 802 may alternatively or additionally be at least partially convex.
The patient may lie in a supine position or sit on a patient support such as a bed, couch or chair. The patient's arm may be set on the first side portion 801 of the applicator 800. The first side portion 801 may be in direct contact with the patient and RF therapy may be applied in combination with magnetic therapy. Additionally, a strip or ribbon may be guided through the concave surface 815 to attach the applicator to the patient's body.
According to a vertical cross-section, the first side portion 801 may have an at least partly elliptical or circular shape, wherein according to the curvature 25 in fig. 23 may be defined as a part of an ellipse or circle that is adapted to the curvature of at least a part of the first side portion 801. A section in which the curvature of the first side portion 801 matches the adapted ellipse or circle may be referred to as section 26. Section 26 is defined as the angle 30 between line 28 and line 29. The lines 28 and 29 traverse the center of symmetry 27 and points 31 and 32, the points 31 and 33 being located in the section 26 having the longest distance, depending on the elliptical or circular adaptation of the curvature of the replication applicator 800. The center of symmetry 27 is the center of the adapted ellipse and/or the adapted circle. The angle 30 of the section 26 defining the first side portion 801 may be at least 5 °, or may be in the range of 10 ° to 270 °, 30 ° to 235 °, 45 ° to 180 °, or 60 ° to 135 °. The radius of curvature of at least a portion of the adapted circle for the first side portion 801 may be in the range of 50mm to 1250mm, or in the range of 10mm to 750mm, or in the range of 50mm to 500mm, or in the range of 60mm to 250 mm. The second side portion 802 may be curved over at least a portion of its surface, wherein the section 26 of the second side portion 802 may be at least 5 °, or in the range of 10 ° to 270 °, 30 ° to 235 °, 45 ° to 180 °, or 60 ° to 135 °. In addition, the radius of curvature of at least a portion of the adapted circle for the second side portion 802 may be in the range of 50mm to 1250mm, 10mm to 750mm, 50mm to 500mm, or 60mm to 250 mm.
One or more applicators and/or additional treatment devices may include tampons 32, for example, as shown in fig. 23. Tampons 32 may refer to a layer of material that is located between an applicator or RF electrode (located on the surface of the applicator) and a patient's body part or skin (including the epidermis or clothing of the patient's skin). Tamponade 32 may refer to a layer of material between the RF electrode (on the surface of the applicator) and the patient's body part or skin. Additionally, the tampons 32 may be separate components from the applicator 800. The tampons 32 may be attached to the first side portion 801 and/or the second side portion 802 of the applicator 800. The tampons 32 may be removed and detached from the applicator 800. The tampons 32 may be mechanically coupled to the first side portion 801 and/or the second side portion 802 of the applicator 800. The tamponade 32 is made of a solid flexible material and/or a combination of solid and flexible materials may be used as the tamponade. The tamponade 32 may include a fluid material, such as water, a gel, or a fluid solution that includes ceramic, metal, polymer, and/or other particles encapsulated in a flexible bladder made of a biocompatible material. The tamponade 32 may be parsed in that the thickness of the tamponade 32 as a layer between the RF electrode and the patient's skin may be different. In locations where the energy flux density of the RF treatment (including the RF field) is high enough to form uncomfortable thermal sites and/or non-uniform temperature distribution, the thickness of the tamponade 32 may be high. The tamponade 32 allows for more uniform biological structure heating and minimizes edge effects. The edge effects can also be minimized by the different dielectric properties of the tamponade in terms of tamponade volume and/or tamponade area. The tamponade 32 may have a greater thickness under at least a portion of the edge of the RF electrode. The thickness of the tamponade below at least a portion of the edge of the RF electrode may be greater than at least 5%, 10%, 15%, or 20% of the thickness of the tamponade 32 below at least a portion of the center of the RF electrode, with no gaps, cutouts, and/or protrusions being considered. The tamponade 32 may have a greater thickness under at least a portion of the bipolar RF electrodes and/or under at least a portion of the distance between at least two bipolar RF electrodes. The tamponade 32 may exceed the thickness of the tamponade 32 (where the distance between two closest points of two different bipolar RF electrodes is at least 5%, 10%, 15%, or 20% or more) by about at least 5%, 10%, 15%, or 20% at such locations. The tamponade 32 may also improve the delivery of therapeutic energy (e.g., magnetic and/or RF fields) into at least one biological structure and may minimize energy reflection by providing a gradual transition in dielectric properties between the applicator and two different interfaces of the biological structure. The tamponade 32 may be profiled or focused to the RF field and/or magnetic field to enhance the therapeutic effect and/or to provide deeper tissue penetration of the treatment.
The tampons 32 may also be a liquid absorbent material such as a foam material, a textile material, or a gel material to provide better environmental conductivity between the applicator and the patient's body. Better conductivity of the contact portion of the applicator may be used for better adjustment of the RF signal of the RF treatment applied to the patient's body and/or better collection of feedback information. The tamponade 32 may facilitate conductive contact between the RF electrode and the patient's skin or body part. Additionally, the tamponade 32 may be used as a non-conductive or dielectric material that modifies energy transfer to the patient's body, provides cooling of the patient's skin, removes perspiration from the patient's skin, and/or provides heating, such as capacitive heating of the patient's body. The fluid absorbent material used as the tamponade 32 may also provide better thermal conductivity and, therefore, the temperature of the biological structure and/or the applicator may be adjusted faster, easier, and more accurately. The tamponade 32 may also include additional RF electrodes to provide RF therapy.
As previously described, the treatment device may include one, two, three, four, six or more applicators and/or additional treatment devices for providing magnetic and/or RF treatment. Each applicator, additional treatment device, and/or therapeutic energy source (e.g., magnetic field generating device and/or RF electrode) may have its own treatment circuit for energy delivery, where each treatment circuit may be individually adjustable by a control system to provide each parameter of therapeutic energy. Each applicator, treatment device, or source of therapeutic energy may be adjustable and individually provide therapy; and/or two or more applicators, therapeutic energy sources, and/or additional therapeutic devices may be adjusted in an overall set, and may be adjusted simultaneously, synchronously, and/or may cooperate with each other.
When the treatment device comprises two or more applicators, they may be coupled to the contact or adjacent to different parts of the body. In one example, the first applicator may be coupled to the contact or near the left hip and the second applicator may be coupled to the contact or near the right hip. In some aspects, the first applicator may be coupled to the contact portion or near the left side of the abdominal region, and the second applicator may be coupled to the contact portion or near the right side of the abdominal region. In yet another example, the first applicator may be coupled to the contact portion or near the left thigh portion and the second applicator may be coupled to the contact portion or near the right thigh portion. In yet another example, the first applicator may be coupled to the contact portion or proximate to the left calf, and the second applicator may be coupled to the contact portion or proximate to the right calf. Multiple applicators may be beneficial for the treatment of cooperative muscles and/or paired muscles.
The one or more applicators and/or additional treatment devices may include a magnetic field generating device (e.g., a magnetic coil) that generates a magnetic field for magnetic treatment. The magnetic field generating device may generate RF fields for RF therapy. Essentially, the generated frequencies of the electromagnetic field have far different values. The magnetic field generating device may generate dominant magnetic field vectors for magnetic therapy during lower frequencies of the generated electromagnetic field. However, the magnetic field generating device may generate a dominant electromagnetic field vector for magnetic therapy during higher frequencies of the electromagnetic field, which may be used for RF therapy. The magnetic field generating device in the high frequency electromagnetic field domain may provide an RF field similar to that provided by the RF electrode. When one magnetic field generating device is available to provide both RF therapy and magnetic therapy, the difference between the frequencies generated for RF therapy and magnetic therapy may be in the range of 500kHz to 5GHz, or 500kHz to 2.5GHz, or 400kHz to 800kHz, or 2GHz to 2.5 GHz. In addition, when one magnetic field generating device is used to provide both RF therapy and magnetic therapy, the frequency for RF therapy may correspond to a frequency in the range of 100kHz to 3GHz, 400kHz to 900MHz, or 500kHz to 3 GHz.
The one or more applicators and/or additional treatment devices may include one or more RF electrodes and one or more magnetic field generating devices, wherein the RF electrodes have different characteristics, structures, and/or designs than the magnetic field generating devices. The one or more RF electrodes may not contact the surface of the patient. One or more RF electrodes may be located inside the applicator along with the magnetic field generating device. The RF electrode may operate as a monopolar electrode, a bipolar electrode, and/or a multipolar electrode. One or more RF electrodes may be used for capacitive, inductive or resistive heating of biological structures or body parts. Further, the inductive RF electrode may be coiled.
The applicator may comprise two bipolar RF electrodes. The bipolar electrodes may transfer an RF field between two bipolar RF electrodes located in at least one applicator. Bipolar electrodes may increase the safety and targeting of provided RF treatments compared to monopolar electrodes. The bipolar electrodes may provide an electromagnetic field through patient tissue that is located around and between the RF electrodes; wherein due to impedance matching it is possible to prevent the formation of electromagnetic standing waves in the patient tissue and to prevent unwanted thermal damage of non-targeted tissue. In addition, the distance between the bipolar electrodes affects the depth of RF wave penetration, which allows for enhanced targeting of RF therapy. The bipolar RF electrode comprises a positive RF electrode and a negative RF electrode, wherein the mutual polarity of the bipolar RF electrodes is changing, because the polarity of the RF signal is changing from a positive phase to a negative phase of the RF signal, which is given by the frequency of the RF signal and the generated RF wave. The bipolar RF electrodes are powered, for example, by wires 100a and 100b as shown in fig. 14a-14e, wires 100a and 100b being connected to the remaining elements of the RF circuit (e.g., power amplifiers and/or symmetrical elements).
The applicator may include one or more multipole RF electrodes, wherein each electrode is charged with a different charge (value and/or polarity, e.g., phase shift of the RF signal or RF signal).
The applicator may comprise a monopolar RF electrode or a plurality of monopolar electrodes. The monopolar electrode may transfer radiofrequency energy between the active electrode and the passive electrode, wherein the active electrode may be a component of the applicator and the passive electrode having a larger surface area may be located at least 5cm, 10cm or 20cm from the applicator. The ground electrode may be used as a passive electrode. The ground electrode may be on an opposite side of the patient's body to which the applicator is attached.
The magnetic treatment may be provided by a magnetic field generating device, which may be made of an electrically conductive material, such as a metal, including for example copper. The magnetic field generating device may be formed as coils of different sizes and shapes. The magnetic field generating device may be a coil of a plurality of windings, wherein one loop of the coil may comprise one or more wires. The individual loops of one or more wires may be insulated from other turns or loops of one or more wires. With respect to magnetic coils, each loop of wire may be referred to as a turn. In addition, individual wires in one turn or loop may be insulated from each other. The shape of the magnetic field generating device may be optimized with reference to the size and design of the applicator. The coil may be wound to match at least a portion of the shape of the applicator according to a ground projection of the applicator. The coil windings may be at least partially circular, elliptical, and/or may have any other shape that matches the shape of the applicator or portion thereof. Loops of windings may be stacked on top of each other, may be arranged side by side; or stacks of windings may be combined side by side and may be on top of other windings. The coil may be flat. The magnetic field generating device may comprise a magnetic coil and an impregnating material which may prevent wire movement during operation of the magnetic coil. The impregnating material may be an electrically insulating material that prevents the passage of electrical current between turns or loops. The impregnating material may be located on the surface and/or inside the magnetic coil. The impregnating material may include a resin (e.g., an epoxy resin).
Fig. 9 shows a ground projection of an exemplary circular planar magnetic field generating device 900. The magnetic field generating device may be circular, oval, rectangular or it may have other shapes. The magnetic field generating device may be planar. The magnetic field generating device may be curved, for example, to fit the applicator and/or body curve. The magnetic field generating device 900 is characterized by dimensions including an outer diameter D, an inner radius R, and an outer radius R. The magnetic field generating device 900 may also be characterized by areas A1 and A2. Region A2 may represent the winding region of the coil, while A1 may represent the core or the region without any core or winding.
Region A1 is associated with dimensions r and d. The area A1 may not include windings of the coil and may be filled with air, oil, polymer material. Region A1 may represent a magnetic core, wherein the magnetic core may be an air core. Or the core may be a magnetically permeable material with high field saturation, such as a solid core made of soft iron, iron alloy, laminated silicon steel, silicon alloy, vitreous metal, iron-cobalt alloy, iron-nickel alloy, powdered metal or ceramic, and/or other materials.
The area A2 is associated with the dimensions of the outer radius R and the outer diameter D.
The size of the inner radius R may be in the range of 1% to 90% of the size of the outer radius R, or in the range of 2% to 80%, or 3% to 60%, or 4% to 50%, or 8% to 30%, or 20% to 40%, or 30% to 50% of the outer radius R. The dimensions of the inner radius R and the outer radius R can be used to achieve a convenient shape of the generated magnetic field.
The outer diameter D of the magnetic device may be in the range of 30mm to 250mm, or 40mm to 150mm, or 50mm to 135mm, or 90mm to 125mm, and the size of the inner radius R may be in the range of 1% to 70%, or 1% to 50%, or 30% to 50%, or 5% to 25%, or 8% to 16% of the size of the outer radius R. For example, the outer radius R may be 50mm in size and the dimension R may be 5mm. The region A1 may be omitted and the magnetic field generating device may only include the region A2 having the coil windings.
As discussed, region A2 may include multiple windings. One winding may comprise one or more wires. The windings may be closely arranged and one winding may contact an adjacent winding to provide a magnetic field with a high magnetic flux density. Winding area A2 may range from 4cm 2 to 790cm 2、15cm2 to 600cm 2、45cm2 to 450cm 2 or 80cm 2 to 300cm 2、80cm2 to 150cm 2 or 80cm 2 to 130cm 2.
Or the windings may include gaps between the individual windings. The gap may be between 0.01% to 50, or 0.1% to 25, or 0.1% to 10, or 0.1% to 5, or 0.001% to 1% of the dimension R-R. Such a configuration may facilitate cooling and insulation of the individual windings of the magnetic field generating device. In addition, the shape of the generated magnetic field may be modified by such a configuration of the magnetic field generating device.
The wires of the coil windings may have different cross-sectional areas. The cross-sectional area of the winding wire may be larger at the center of the winding, wherein the coil winding radius is smaller. Such cross-sectional area of the wire may be 2% to 50%, 5% to 30% or 10% to 20% larger than the cross-sectional area of the same wire (measured on the outer winding turns of the magnetic field generating device), wherein the coil winding radius is larger. The cross-sectional area of the winding wire of the magnetic field generating device may be larger on the outer coil winding turns of the magnetic field generating device, wherein the coil winding radius is larger. Such cross-sectional area of the wire may be 2% to 50%, 5% to 30% or 10% to 20% larger than the cross-sectional area of the same wire (measured on the inner turns of the magnetic field generating device), wherein the coil winding radius is smaller.
The principles and parameters described above may be used to modify the shape of the provided magnetic field relative to the patient's body, provide more uniform and/or targeted muscle stimulation (e.g., muscle contraction), reduce the expansion of the magnetic field generating device during treatment, and/or increase the durability of the magnetic field generating device. The magnetic field generating device may stretch and shrink during generation of the time-varying magnetic field, and this may cause damage to the magnetic field generating device. The different cross-sectional areas of the conductive material used (e.g., wire, metal strips, or windings forming the magnetic field generating device) may minimize the damaging effects of expanding and contracting the magnetic field generating device.
As discussed above, the cross-sectional area of the conductive material used (e.g., wire, metal strips, and/or forming windings of the magnetic field generating device) may be varied between individual loops of the wire in the range of 2% to 50%, or 5% to 30%, or 10% to 20%, to improve the focus of the magnetic treatment provided, to increase the durability of the magnetic field generating device, to minimize heating of the magnetic field generating device, and so on.
In addition, the stack of wires and/or insulating and/or intumescent layers between the individual conductive windings of the magnetic field generating device may be non-constant and may vary based on the wire cross-sectional area, winding radius, shape required to provide the magnetic field and/or other parameters.
The thickness 901 of the magnetic field generating device 900 shown in fig. 9b may be in the range of 0.3cm to 6cm, or 0.5cm to 5cm, or 1cm to 3cm, depending on the side view of the applicator.
Depending on the ground projection of the applicator, the total surface area of the magnetic field generating device surface (i.e., area a1+a2) may be in the range of 5cm 2 to 800cm 2、10cm2 to 400cm 2、20cm2 to 300cm 2 or 50cm 2 to 150cm 2.
The ratio of the area A1 and the winding area A2 may be in the range of 0.001 to 0.8, or 0.02 to 0.5, or 0.1 to 0.3, depending on the ground projection of the applicator. Depending on the ground projection of the applicator, the ratio between the winding area A2 of the magnetic field generating device and the area of the RF electrode located in the same applicator may be in the range of 0.01 to 4, or 0.5 to 3, or 0.5 to 2, or 0.3 to 1, or 0.2 to 0.5, or 0.6 to 1.7, or 0.8 to 1.5, or 0.9 to 1.2.
Fig. 10a to 10g show the position of one or more radio frequency electrodes 101 relative to at least one magnetic field generating device 900 in the applicator 800. The location of the rf electrodes 101, 102 and/or the magnetic field generating device 900 can critically affect the efficiency and targeting of the therapeutic energy source. The RF electrode and the magnetic field generating device may be located within the applicator.
One or more rf electrodes 101, 102 may be located on the inside of the applicator 800 (as shown in fig. 10a3001, 10b, 10d, 10e, 10f, 10 g) and/or on the outside of the applicator 800 (as shown in fig. 10 c).
As shown in fig. 10a to 10e and 10g, the at least one RF electrode may at least partially overlap with the area A2 or A1 of the at least one magnetic field generating device according to the ground projection of the applicator. Such an arrangement may allow for optimal synergy of magnetic and RF treatments, may improve uniformity of tissue heating by RF treatment, may improve targeting of magnetic and RF treatments, and may also minimize health risks.
Fig. 10a shows a side view of an applicator comprising at least one RF electrode and a magnetic field generating device. The illustrated applicator may include at least one radio frequency electrode 101, and the radio frequency electrode 101 may be located below the magnetic field generating device 900 in the applicator 800. The rf electrode 101 may be positioned between the bottom cover 517 of the applicator 800 and the magnetic field generating device 900. Fig. 10b shows an upper view of the same type of applicator comprising an RF electrode and a magnetic field generating device. As shown in fig. 10a and 10b, at least one radio frequency electrode 101 may be extremely thin to reduce unwanted physical effects caused by time-varying magnetic fields. Fig. 10b shows that at least one radio frequency electrode 101 may almost completely overlap with the magnetic field generating device 900.
Fig. 10c shows another exemplary applicator comprising at least one RF electrode and a magnetic field generating device. According to fig. 10c, at least one radio frequency electrode 101 may be located outside the applicator 800, such as on or adjacent to an external surface of the applicator 800. The RF electrode outside the applicator is more insulating than the magnetic field generating device and/or other conductive elements of the applicator that radiate an electromagnetic field. The better insulation may reduce the influence of undesired physical effects induced by the at least one radio frequency electrode 101 by the radiated electromagnetic field and/or the time-varying magnetic field. As shown in fig. 10c, one or more radio frequency electrodes 101 located outside the applicator may also have better contact with the patient's body and thus may improve the operation of the tuned electrical components of the RF circuit. In addition, delivery of RF therapy to at least one patient target biological structure may be enhanced.
Fig. 10d shows another exemplary applicator comprising at least one RF electrode and a magnetic field generating device. At least one radio frequency electrode 101 may be located below the magnetic field generating device 900. The applicator 800 may also include at least one additional RF electrode 102 located above the magnetic field generating device 900, wherein both the RF electrode and the magnetic field generating device may be located in one applicator 800. The first side portion 801 (having at least one curved RF electrode 102 near or on its surface) may be used to treat curved body parts (e.g., at least a portion of a thigh, hip, neck, and/or arm). The second side portion 802 (having at least one flat radio frequency electrode 101 near or on its surface) may be used to treat a body part, where a flat or nearly flat side of the applicator would be more appropriate, such as the abdominal region or buttocks.
Fig. 10e shows a front view of an applicator 800 similar to fig. 10 d. Fig. 10e shows that the radiofrequency electrode 101 may actually be two electrodes 101a and 101b. The electrodes 101a and 101b may be bipolar electrodes. Thus, the applicator may comprise two bipolar electrodes 101a and 101b under the magnetic field generating device 900. When the applicator 800 includes two bipolar RF electrodes, the bipolar RF electrodes may be located between the bottom cover and the magnetic field generating device 900. Further, fig. 10e shows another RF electrode 102 located above the magnetic field generating device 900.
Fig. 10f shows another exemplary applicator 800, the applicator 800 comprising an RF electrode and a magnetic field generating device. The applicator may include one or more radio frequency electrodes 101; depending on the terrestrial projection of the applicator, the RF electrode may have minimal or no overlap with the at least one magnetic field generating device 900. The applicator may comprise two radio frequency electrodes 101, the radio frequency electrodes 101 having no or minimal overlap with the magnetic field generating device.
The at least one radio frequency electrode 101 may be located in the applicator 800 below the magnetic field generating device 900, e.g. as shown in fig. 10a, in the applicator below the applicator 800 as shown in fig. 10c, and/or the at least one radio frequency electrode 101 may be located at least partially in the vicinity of the magnetic field generating device 900, as shown in fig. 10 f. Furthermore, at least one RF electrode may be located above the applicator and/or above the magnetic field generating device. The RF electrode and/or applicator may be in contact with the patient.
Fig. 10g shows another exemplary applicator 800, the applicator 800 comprising an RF electrode and a magnetic field generating device. The applicator may comprise at least one radio frequency electrode 101, which radio frequency electrode 101 may be located above the magnetic field generating device 900. The magnetic field generating device 900 may be located between the bottom cover 517 of the applicator 800 and the rf electrode 101. The heating provided by the RF electrode located above the magnetic field generating device may also be provided to the magnetic field generating device itself.
Fig. 10h shows another exemplary applicator 800 having two magnetic field generating devices 900a and 900b, in particular, a first radio frequency electrode 101a, a first magnetic field generating device 900a, a second radio frequency electrode 101b and a second magnetic field generating device 900b, in one applicator. The first radio frequency electrode 101a may be located between the patient's body and the first magnetic field generating device 900a and the second radio frequency electrode 101b may be located between the patient's body and the second magnetic field generating device 900b. In addition, the first rf electrode 101a may be positioned between the bottom cover 517 and the first magnetic field generating device 900a, and the second rf electrode 101b may be positioned between the bottom cover 517 and the second magnetic field generating device 900b.
The magnetic field generating device and the one or more RF electrodes may be positioned differently with respect to tissue of the patient's body and/or body part. Further, the magnetic field generating device and the one or more RF electrodes may be positioned differently relative to the bottom cover of the applicator. As described above, the RF electrode may be a monopolar RF electrode, a bipolar RF electrode, or a multipolar RF electrode.
The RF electrode may be coated with a coating material that prevents spark discharge or plasma discharge to avoid pain in the patient. The coating material may comprise an electrically insulating material. The coating material may include a metal oxide (e.g., alumina) and/or a plastic material (e.g., an epoxy material). The coating may be located on a side of the RF electrode that is closer to the patient when the device is in use.
Fig. 10i shows a cross-sectional view of an exemplary applicator 800 comprising a Magnetic Field Generating Device (MFGD) 900 and an RF electrode (RFE) 101, wherein the radio frequency electrode 101 is positioned to cover and/or be located between the magnetic field generating device 900 and patient tissue 601. The rf electrode 101 is positioned between the magnetic field generating device 900 and the bottom cover 517 of the applicator 800.
Fig. 10j shows a cross-sectional view of another example applicator 800 including a magnetic field generating device 900 and a radio frequency electrode 101, wherein the magnetic field generating device 900 is positioned to cover and/or be positioned between the radio frequency electrode 101 and patient tissue 601. The magnetic field generating device 900 is located between the rf electrode 101 and the bottom cover 517 of the applicator 800.
Fig. 10k shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a radio frequency electrode 101, wherein the radio frequency electrode 101 is positioned close to the magnetic field generating device 900. The magnetic field generating device 900 may be in the vicinity of the radio frequency electrode 101. The radio frequency electrode 101 may be arranged in the same plane as the magnetic field generating device 900. The upper edge of the radio frequency electrode 101 may be located on the same horizontal plane as the upper edge of the magnetic field generating device 900. The radio frequency electrode 101 may be separated from the magnetic field generating device 900 by air, oil and/or a plastic material.
Fig. 10l shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a radio frequency electrode 101, wherein the radio frequency electrode 101 is not placed overlapping the magnetic field generating device 900. The upper edge of the radio frequency electrode 101 may be located on a different level than the upper edge of the magnetic field generating device 900. The upper edge of the rf electrode 101 may be located in a horizontal plane that is spaced a greater distance from the bottom cover 517 than the horizontal plane along which the upper edge of the magnetic field generating device 900 is located.
Fig. 10m shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a radio frequency electrode 101, wherein the radio frequency electrode 101 is not placed overlapping the magnetic field generating device 900. The upper edge of the radio frequency electrode 101 may be located on a different level than the upper edge of the magnetic field generating device 900. The upper edge of the rf electrode 101 may be located in a horizontal plane that is a shorter distance from the bottom cover 517 than the horizontal plane along which the upper edge of the magnetic field generating device 900 is located. The rf electrode 101 and/or its coating may be in contact with the bottom cover 517 of the applicator 800. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the rf electrode 101 and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
Fig. l0n shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a radio frequency electrode 101, wherein the radio frequency electrode 101 protrudes through a bottom cover 517. In this way, the radiofrequency electrode 101 and/or its coating may be in contact with the patient, and one or more conductive wires that power the radiofrequency electrode 101 may be located in the applicator 800. The RF electrode may be thin enough so that the bottom cover 517 and the RF electrode may be in contact with the tissue 601. The rf electrode 101 may be removable from the applicator 800 and replaceable. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the rf electrode 101 and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
Fig. 10o shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a radio frequency electrode 101, wherein the radio frequency electrode 101 is located below and/or attached to a bottom cover 517 of the applicator 800. The radio frequency electrode 101 may be in contact with the patient. One or more wires that power the rf electrode 101 may pass through holes in the bottom cover 517, for example. The RF electrode may be thin enough so that the bottom cover 517 and the RF electrode may be in contact with the tissue 601. The rf electrode 101 may be removable and/or replaceable from the applicator 800. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the rf electrode 101 and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
Fig. 10p shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar radio frequency electrodes 101a, 101 b. The pair of bipolar radiofrequency electrodes 101a, 101b may comprise a first radiofrequency electrode 101a and a second radiofrequency electrode 101b, wherein the pair of bipolar radiofrequency electrodes 101a, 101b are positioned to cover and/or be located between the magnetic field generating device 900 and the tissue 601 of the patient. In addition, the pair of bipolar radio frequency electrodes 101a, 101b are located between the magnetic field generating device 900 and the bottom cover 517 of the applicator 800.
Fig. 10q shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar RF electrodes 101a, 101b comprising a first RF electrode 101a and a second RF electrode 101b. The magnetic field generating device 900 is positioned to cover and/or be positioned between the pair of bipolar radio frequency electrodes 101a, 101b and the tissue 601 of the patient. Further, the magnetic field generating device 900 is located between the pair of bipolar radio frequency electrodes 101a, 101b and the bottom cover 517.
Fig. l0r shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar RF electrodes 101a, 101b comprising a first RF electrode 101a and a second RF electrode 101b. The pair of bipolar radio frequency electrodes 101a, 101b is positioned close to the magnetic field generating device 900. The upper edge of one or both of the radio frequency electrodes 101a, 101b may be located on the same horizontal plane as the upper edge of the magnetic field generating device 900.
Fig. 10s shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar RF electrodes 101a, 101b comprising a first RF electrode 101a and a second RF electrode 101b. The pair of bipolar radio frequency electrodes 101a, 101b is not positioned to cover the magnetic field generating device 900. The upper edges of the pair of bipolar radio frequency electrodes 101a, 101b may be located on a different level than the upper edge of the magnetic field generating device 900. The upper edges of the pair of bipolar radio frequency electrodes 101a, 101b may be located in a horizontal plane that is a shorter distance from the bottom cover 517 than the horizontal plane along which the upper edges of the magnetic field generating device 900 are located. The pair of bipolar radiofrequency electrodes 101a, 101b and/or electrode coating may be in contact with the bottom cover 517 of the applicator 800. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the RF electrode and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
Fig. 10t shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar RF electrodes 101a, 101b comprising a first RF electrode 101a and a second RF electrode 101b. The pair of bipolar rf electrodes 101a, 101b extend through the bottom cover 517 of the applicator 800. The pair of bipolar radiofrequency electrodes 101a, 101b and/or their coatings may be in contact with the tissue 601 of the patient. The RF electrode may be thin enough so that the bottom cover 517 and the RF electrode may be in contact with the tissue 601. The rf electrode 101 may be removable from the applicator 800 and replaceable. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the RF electrode and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
Fig. 10u shows a cross-sectional view of another exemplary applicator 800 comprising a magnetic field generating device 900 and a pair of bipolar RF electrodes 101a, 101b comprising a first RF electrode 101a and a second RF electrode 101b. The pair of bipolar radiofrequency electrodes 101a, 101b are positioned below and/or attached to the bottom cover 517 of the applicator 800. The pair of bipolar radiofrequency electrodes 101a, 101b may be in contact with tissue 601 of the patient. The RF electrode may be thin enough so that the bottom cover 517 and the RF electrode may be in contact with the tissue 601. The pair of bipolar radiofrequency electrodes 101a, 101b may be removable from the applicator 800 and replaceable. In addition, the magnetic field generating device 900 may be in contact with the bottom cover 517. For example, the RF electrode and/or the magnetic field generating device 900 may be adhered or fixed to the bottom cover 517.
As described herein, one or more RF electrodes may be located between the magnetic field generating device and the patient. Further, one or more RF electrodes may be located between the magnetic field generating device and the bottom cap of the applicator. Such an arrangement of the RF electrodes relative to the magnetic field generating device and/or the bottom cover may be advantageous for transferring the radio frequency field to the patient. When the one or more RF electrodes are positioned between the magnetic field generating device and the bottom cover of the applicator such that the one or more RF electrodes are disposed closer to the patient, the provided radio frequency waves are not absorbed by the magnetic field generating device to the same extent as when the RF electrodes are positioned above the magnetic field generating device. Further, by positioning one or more RF electrodes between and separate from the magnetic field generating device and the patient, the radio frequency field is not absorbed by the magnetic field generating device and may be provided to the patient. The one or more RF electrodes and the magnetic field generating device may be separated by air, plastic or dielectric material.
However, one or more RF electrodes may be in contact with the magnetic field generating device.
One or more RF electrodes located on one or more applicators 800 may be placed in contact with the patient. Additionally, one or more RF electrodes and/or applicators may be separated from the patient by an air gap, tamponade, dielectric material, insulating material, gel, and/or other material.
One or more radio frequency electrodes 101, 102 and/or magnetic field generating device 900 within an applicator may be separated from each other by an air gap, printed circuit board material, insulation, cooling fluid, and/or other materials. The distance between the conductive portion of the magnetic field generating device and the nearest RF electrode may be in the range of 0.1mm to 100mm, or 0.5mm to 50mm, or 1mm to 50mm, or 2mm to 30mm, or 0.5mm to 15mm, or 0.5mm to 5 mm. The spacing between the magnetic field generating device and the RF electrode may also be provided in the form of an insulating barrier separating the RF circuit from the magnetic circuit and preventing the further therapeutic circuit or the further therapeutic energy source from affecting the one therapeutic circuit or the therapeutic energy source. A magnetic field generating device positioned closer to the patient's body may be able to more effectively and more invasively stimulate the therapeutic effect and provide the therapeutic effect to at least a portion of the at least one target biological structure than a magnetic field generating device positioned at a greater distance from the patient's body.
The magnetic field generating device and/or the one or more RF electrodes included in or on the applicator may be cooled during treatment. Cooling of the magnetic field generating device and/or the one or more RF electrodes may be provided by peltier effect based elements and/or by the flow of a cooling fluid (such as air, water, oil and/or fluid) within or near the applicator. The cooling fluid may flow or be directed around the one or more magnetic field generating devices, the one or more RF electrodes, and may flow or be directed between the magnetic field generating devices and at least a portion of the at least one RF electrode. The cooling fluid may flow only on the top and/or bottom of the magnetic field generating device. The cooling fluid may be a fluid such as a gas, oil, water, and/or liquid. The cooling fluid may be delivered from the main unit to the applicator, wherein the cooling fluid may be tempered. The cooling fluid may be delivered to the applicator and may be delivered to the vicinity of the magnetic field generating device and/or the RF electrode. The cooling fluid may be delivered to the applicator through a connecting tube coupled to the main unit. The connecting tube may comprise a fluid conduit which may serve as a path for cooling fluid between the applicator and the main unit.
The main unit may comprise one or more cooling tanks, wherein the cooling fluid may be stored in the cooling tanks and/or cooled. Each cooling tank may include one or more pumps, one of which may provide a flow of cooling fluid to one of the applicators. Or one pump may provide a flow of cooling fluid to multiple applicators (e.g., two applicators). In addition, the main unit may comprise a cooling tank storing and/or cooling fluid for a respective applicator or applicators. For example, when the treatment apparatus comprises two applicators, the main unit may comprise one cooling tank providing cooling fluid to both applicators. In some aspects, when the treatment apparatus includes two applicators, the main unit may include two cooling tanks that provide cooling of the cooling fluid. Each cooling tank may provide cooling of the cooling fluid to a particular applicator either simultaneously or individually. The cooling tank or cooling conduit may comprise a temperature sensor for measuring the temperature of the cooling fluid.
The fluid conduit may be a plastic tube. The plastic tubing may be routed from the cooling tank to the applicator and then returned to the cooling tank. When the treatment apparatus comprises, for example, two applicators, the fluid conduit may lead from the cooling tank to one applicator and then back to the cooling tank, while the second fluid conduit may lead from the same or a different cooling tank to the second applicator and then back to the cooling tank. However, the fluid conduit may lead from the cooling tank to the first applicator, then to the second applicator and finally to the cooling tank.
When the RF electrode is located in the vicinity of the magnetic field generating device, the time-varying magnetic field generated by the magnetic field generating device may induce undesirable physical effects of the RF electrode. Undesirable physical effects induced by time-varying magnetic fields may include, for example, induction of eddy currents, overheating of the RF electrode, skin effects, and/or causing other electronic and/or electromagnetic effects, such as phase shifting of the RF electrode. Such undesirable physical effects may lead to treatment device failure, energy loss, reduced treatment effects, increased energy consumption, overheating of at least the applicator components (e.g., RF electrodes), collecting false feedback information, signal conditioning failure provided to the RF electrodes, and/or other undesirable effects. Furthermore, deleterious physical effects may be associated with the treatment itself, for example, with the effectiveness of the treatment. The RF electrode may block or limit the transmittance of the magnetic field through the RF electrode. When the magnetic field generated by the magnetic field generating device is prevented from being transmitted through the RF electrode, the effect of the magnetic field (e.g., muscle contraction) may not be achieved.
The present disclosure provides methods or designs of how to prevent and/or minimize one or more deleterious physical effects induced by magnetic fields in RF electrodes. The methods or designs described in the present application can prevent unwanted effects related to the transmittance of the magnetic field through the RF electrode. The same approach or design may help to minimize shielding of the RF electrode from the magnetic field. The RF electrode may overlap with the magnetic field generating device with minimal or no overlap, depending on the terrestrial projection of the applicator. In addition, the RF electrode may be specially designed as described below. In addition, the RF electrode may have a smaller thickness. The RF electrode may be made of a conductive material that reduces the induction of undesirable physical effects and heating of the RF electrode. Other possibilities are as follows. One or more RF electrodes that provide RF energy during treatment by the treatment devices described herein may use at least one, at least two, and/or a combination of all of these possibilities.
Depending on the terrestrial projection of the applicator, the RF electrode may overlap with the magnetic field generating device minimally or non-overlapping.
Fig. 11 shows an example in which the radio frequency electrode 101a may be located below, near and/or above the magnetic field generating device 900 and have no or minimal overlap with the magnetic field generating device 900 depending on the terrestrial projection of the applicator. As shown in fig. 11, the electrode 101a may be located outside the region A2.
Fig. 11b shows an example of a lateral cross-sectional view of the applicator 800, wherein the radio frequency electrode 101 is located in the vicinity of the magnetic field generating device 900. The radio frequency electrode 101 may be on the same level as the magnetic field generating device and without any overlap. The radio frequency electrode 101 may surround the magnetic field generating device 900. The radio frequency electrode 101 and the magnetic field generating device 900 may be separated from each other by a space 902, which may be filled with air and/or an insulating material (e.g. a plastic material). The distance between the radio frequency electrode 101 and the magnetic field generating device 900 may be in the range of 0.1mm to 10cm to ensure transmission of radio frequency waves. In the example shown in fig. 11b, the radio frequency electrode 101 may have the form of an open loop. Thus, the rf electrode 101 may have the form of a ring with a gap 904. In this example, the radio frequency electrode 101 may be a monopolar or monopolar RF electrode.
Fig. 11c shows another example of a lateral cross-sectional view of the applicator 800, wherein the radio frequency electrode 101 is located in the vicinity of the magnetic field generating device 900. The radio frequency electrode 101 may surround the magnetic field generating device 900. The radio frequency electrode 101 may be on the same horizontal plane as the magnetic field generating device 900 and without any overlap. The radio frequency electrode 101 and the magnetic field generating device 900 may be separated from each other by a space 902, which may be filled with air and/or an insulating material (e.g. a plastic material). In the example shown in fig. 11c, the radio frequency electrode 101 may have the form of a closed loop around the magnetic field generating device 900. In this example, the radio frequency electrode 101 may be a monopolar or monopolar RF electrode.
Fig. 11d shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises an active radio frequency electrode 101, a ground plate 120 and a magnetic field generating device 900. The ground plate 120 is separated from the active rf electrode 101 by air and/or an insulating material (e.g., a plastic material). The active radio frequency electrode 101 may be a monopolar RF electrode.
Fig. 11e shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises a plurality of radio frequency electrodes 101a, 101b and a magnetic field generating device 900. The radio frequency electrodes 101a, 101b may be bipolar RF electrodes surrounding the magnetic field generating device 900. The rf electrodes 101a, 101b may be in the form of two closed loops, two open loops, or one loop may be open and the other closed. The radio frequency electrodes 101a, 101b may be separated from each other and from the magnetic field generating device 900 by a space 902, the space 902 may be filled with air and/or an insulating material (e.g. a plastic material).
Fig. 11f shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises a plurality of radio frequency electrodes 101a, 101b and a magnetic field generating device 900. The first RF electrode 101a may be a positive RF electrode and the second RF electrode 101b may be a negative RF electrode. The mutual polarity of the RF electrodes varies with the frequency of the RF signal. The radio frequency electrodes 101a, 101b may not overlap the magnetic field generating device 900. Two radio frequency electrodes 101a, 101b are located in the vicinity of the magnetic field generating device 900. The two radio frequency electrodes 101a, 101b and the magnetic field generating device 900 may be separated from each other by air and/or an insulating material (e.g. a plastic material). The plurality of rf electrodes 101a, 101b may be controlled by a control system to transmit rf waves.
Fig. 11g shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises a plurality of radio frequency electrodes 101a, 101b, 101c, 101d and a magnetic field generating device 900. The radio frequency electrodes 101a-101d may be arranged on the same horizontal plane as the magnetic field generating device 900 and without any overlap. As illustrated in exemplary fig. 11g, one or more of the plurality of radio frequency electrodes 101a-101d are located in proximity to the magnetic field generating device 900. The plurality of radio frequency electrodes 101a-101d and the magnetic field generating device 900 may be separated from each other by air and/or an insulating material (e.g. a plastic material). Each of the plurality of radio frequency electrodes 101a-101d may be a monopolar RF electrode or a monopolar RF electrode. However, the RF electrodes 101a-101d may be operated in a multipole mode. Further, activation of the RF electrodes may be provided by one or more RF switches 545 that power one or more RF electrodes. One or more RF switches may be located in the applicator 800 and/or in the main unit.
Fig. 11h shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises a plurality of radio frequency electrodes 101a, 101b, 101aa, 101bb and a magnetic field generating device 900. Radiofrequency electrodes 101a and 101aa may be positive RF electrodes and radiofrequency electrodes 101b and 101bb may be negative RF electrodes. The mutual polarity of the RF electrodes varies with the frequency of the RF signal. Thus, there are two bipolar RF electrode pairs in the example of fig. 11 h. The activation of the RF electrode may be controlled by a control system, so that the transmission of RF waves may be affected by this control. For example, the first pair of radio frequency electrodes 101a, 101b may be active, while the second pair of radio frequency electrodes 101aa, 101bb may be inactive. In some aspects, the two pairs of RF electrodes may be activated by a predetermined sequence, wherein the second pair of RF electrodes 101a, 101b is deactivated when the first pair of RF electrodes 101a, 101b is active and the second pair is activated when the first pair is inactive. Further, activation of the RF electrodes may be provided by one or more RF switches 545 that power one or more RF electrodes. The RF switch 545 may be located in the applicator 800 and/or in the main unit. In addition, the signal to the RF electrode may be split or separated by a splitter.
Fig. 11i shows another example of a lateral cross-sectional view of an applicator 800, wherein the applicator 800 comprises a plurality of radio frequency electrodes 101a, 101b and a magnetic field generating device 900. The first RF electrode 101a may be a positive RF electrode and the remaining three RF electrodes 101b may be negative RF electrodes. The mutual polarity of the RF electrodes varies with the frequency of the RF signal. RF waves may be transmitted between the positive RF electrode 101a and one or more negative RF electrodes 101 b. In addition, since the mutual polarities of the RF electrodes are being changed, RF waves can be transmitted between the RF electrode 101b and the RF electrode 101 a. Further, activation of the RF electrodes may be provided by one or more RF switches 545 that power one or more RF electrodes. The RF switch 545 may be located in the applicator 800 and/or in the main unit.
With respect to fig. 11g, 11h and 1li, a plurality of RF electrodes may be controlled by a control system to transmit radio frequency waves. The control system may comprise a control unit, wherein the control unit may comprise a microprocessor. In one example, in fig. 11g, the pair of rf electrodes 101a and 101c may be active, while the rf electrodes 101b and 101d may be inactive. In some aspects, the RF electrodes may be activated by a predetermined sequence, wherein the RF electrode 101a is active, then deactivated, and the RF electrode 101b is activated. In some aspects related to fig. 11h, the first pair of bipolar radiofrequency electrodes 101a and 101b may be active, while the second pair of bipolar radiofrequency electrodes 101a and 101b is inactive. In another example related to fig. 11i, one, two or three negative radio frequency electrodes 101b may be active simultaneously, so RF waves may be transmitted between the positive radio frequency electrode 101a and each negative radio frequency electrode 101b. In yet another example, activation of the RF electrode may follow a clockwise or counter-clockwise direction. The at least two RF electrodes may be active simultaneously with the magnetic field generating device. Activation of the RF electrode may be provided by one or more RF switches 545 located in the applicator and/or the main unit. In addition, the signal to the RF electrode may be split or separated by a splitter.
One or more RF electrodes may be activated by one or more RF switches 545 (also referred to as 545a and/or 545 b), for example, as shown in fig. 11g, 11h, and 1li and elsewhere. The RF switch 545 may be located in the main unit and/or the applicator. Each RF electrode may be connected to one RF switch 545, or more than one RF electrode may be connected to one RF switch 545, where the RF switches may be connected to one or more electronic components of the RF circuit. The RF switch 545 may include an electrical element that provides a switchable connection of an output of an RF signal (e.g., any electrical element connected to a power supply of an RF therapy and/or power amplifier) to an input of the RF signal (e.g., an RF electrode). Further, activation or deactivation of one RF electrode may be controlled by more than one RF switch 545. The RF switch 545 may include relays, electronically controlled switches, voltage controlled switches, current controlled switches, mechanical switches, diodes, PIN diodes, piezoelectric switches, transistors, thyristors, and/or vacuum tubes, etc. The RF switch may be located in the circuit between the splitter and the one or more RF electrodes. The RF switch may have a drain-source capacitance in the range of 0.1 picofarads to 10 nanofarads, 0.1 picofarads to 1 nanofarads, or 1 picofarads to 990 picofarads.
Fig. 12 illustrates another example applicator that includes a magnetic field generating device and one or more RF electrodes. The applicator may comprise at least one magnetic field generating device and at least one RF electrode. Applicator 800 may include two radio frequency electrodes 101a and 101b separated by a gap 113. Depending on the terrestrial projection of the applicator, the two radio frequency electrodes 101a and/or 101b may at least partially overlap 112 with the winding area A2 and/or the area A1 of the magnetic field generating device 900. The partial overlap 112 is represented by the shaded area in fig. 12. When two elements are stacked, the upper element is stacked on a portion of the lower element. When the magnetic field generating device and the RF electrode overlap, the surface of the magnetic field generating device is superimposed over the surface area of the RF electrode. The ground projection may be represented by a picture of the applicator 800 taken from the bottom of the applicator by X-rays. Such partial overlap 112 may be in the range of 1% to 100%, or 1% to 99%, or 1% to 70%, or 5% to 50%, or 5% to 40%, or 10% to 30%, or 25% to 100%, or 10% to 100%, or 30% to 95%, or 40% to 100%, or 70% to 100%, or 80% to 95%, or 30% to 70% of one RF electrode area, depending on the terrestrial projection of the applicator. The overlap of two regions may refer to the ratio between the two different regions.
One or more temperature sensors 816a may be located between the bipolar rf electrodes 101a, 101b, as shown in fig. 12. When the applicator 800 includes two bipolar RF electrodes, the bipolar RF electrodes may be located between the bottom cover of the applicator 800 and the magnetic field generating device 900. Depending on the terrestrial projection of the applicator, one or more temperature sensors 816a may be at least partially surrounded by at least one radio frequency electrode 101a and 101b, as shown in fig. 12 with temperature sensor 816 a. The highest amount of RF energy may flow between bipolar electrodes 101a and 101 b. Thus, the body part or the part of the tissue to be treated between or directly below the bipolar electrodes may have the highest temperature and should be measured as a temperature reference for the actual temperature or the predetermined temperature. However, the temperature sensor may be placed inside the applicator or on the surface of the applicator.
The characteristic shape of the RF electrode may create a non-uniform temperature distribution of heat during treatment. It is useful to place the temperature sensor 816b in such a way that the temperature sensor is not surrounded by bipolar electrodes 101a,101b, so that the temperature sensor 816b is located between the RF bipolar temperature sensor 816b electrodes 101a,101 b. The temperature sensor may be placed inside the applicator or on the surface of the applicator. In addition, temperature sensor 816c may be located below the RF electrode. However, in some aspects, the temperature sensor may be located at a different location of the applicator than below the RF electrode. The material of the first side portion 801 and/or the second side portion 802 that covers at least a portion of the temperature sensor 816 (e.g., 816a, 816b, or 816 c) and contacts the patient's body may be made of the same material as the first side portion 801 and/or the second side portion 802. However, the material covering the first side portion 801 or the second side portion 802 of the temperature sensor 816 may be a different material than the rest of the first side portion 801 or the second side portion 802, such as a material having a higher thermal conductivity, for example, ceramic, titanium, aluminum, or other metallic material or alloy. The temperature sensor 816 may be a thermistor. In particular, the temperature sensor 816 may be a Negative Temperature Coefficient (NTC) thermistor. The temperature sensor 816 (e.g., 816a, 816b, or 816 c) may be secured or coupled to the first side portion 801 and/or the second side portion 802 by a thermally conductive material having good thermal conductivity, such as a layer of thermal epoxy. The wire connection between the temperature sensor 816 and the rest of the device (see, e.g., wire connection 822 in fig. 8 e) may be heated due to operation of the magnetic field generating device and/or the RF electrode, which is undesirable. The design of the wire connection 822 may prevent the operation of the magnetic field generating device and/or the RF electrode from affecting the readings provided by the temperature sensor, which is also undesirable. The wire connection 822 between the temperature sensor 816 and the rest of the treatment apparatus may be represented by one, two or more conductive wires having diameters in the range of 0.05mm to 3mm, or 0.01mm to 1mm, or 0.1mm to 0.5 mm. wire connections comprising conductive wires having the described diameters are advantageous because heat transfer between the wires and the temperature sensor 816 is minimized. The range of thermal conductivities of the wire connection 822 of the temperature sensor 816 is: 5 W.m -1·K-1 to 320 W.m -1·K-1, or 6 W.m -1·K-1 to 230 W.m -1·K-1, Or 6 W.m -1·K-1 to 160 W.m -1·K-1, or 20 W.m -1·K-1 to 110 W.m -1·K-1, Or 45 W.m -1·K-1 to 100 W.m -1·K-1, or 50 W.m -1·K-1 to 95 W.m -1·K-1. The material of the wire connection may be, for example: nickel, monel, platinum, osmium, niobium, potassium, steel, germanium, aluminum, cobalt, magnesium copper, and/or alloys thereof. At least a portion of the wire connection 822 connected to the temperature sensor 816 may be thermally insulated by a sheath or shield (such as by a rubber tubing). The temperature sensor 816 may be an optical temperature sensor, such as an infrared IR thermal sensor, which may be part of the applicator and/or the main unit. During treatment, the optical temperature sensor may be positioned in contact with the patient's skin, or may be in the range of 0.1cm to 3cm, or 0.2cm to 2cm, from the patient's skin. the optical temperature sensor may collect information from the patient's skin via an optical cable.
One or more RF electrodes positioned at least partially overlapping under the magnetic field generating device may provide a synergistic effect of magnetic therapy and RF therapy. The stronger or more intense treatment results may be provided by RF electrodes positioned under the magnetic field generating device with at least partial overlap. RF fields and magnetic fields generated from therapeutic energy sources in such configurations may target the same body part and/or target biological structure. This may result in better heating of the stimulated muscles and adjacent tissues, better suppression of discomfort caused by muscle stimulation (e.g., muscle contraction), better regeneration after treatment, and/or better prevention of excessive acidification and other tissue damage.
The RF electrode may include special designs as described below to minimize or eliminate undesirable physical effects.
In some aspects, undesirable physical effects induced by magnetic fields in the RF electrode (which is located near or at least partially overlapping with the magnetic field generating device) may be further minimized or eliminated using a segmented RF electrode. The segmented RF electrode may include slits, cutouts, and/or protrusions. The area of the slit and/or cutout may be formed by air, dielectric, and/or other electrically insulating material. The electrodes may include various protrusions. Another parameter by which the ground projection of multiple slits and/or cuts from such an electrode may be visually minimizing or eliminating the presence of undesirable physical effects may be the thickness of the RF electrode. If the conductive material of the RF electrode is thin and the regions of the RF electrode are at least partially separated by an insulator, the eddy current loops induced by the magnetic field may be minimal and because induction in such regions is minimized.
The RF electrode may include one or more slits or cuts that may segment the conductive region of the RF electrode and/or the perimeter of the RF electrode. Thus, in contrast to conventional electrodes, RF electrodes are segmented by interruption of the surface area (i.e., electrodes without gaps or cuts). Two or more slits or cuts of one RF electrode may be asymmetric. The one or more slits and cuts may have, for example, a rectangular or circular shape. The slit may be any hole and/or opening slit and/or cutout in the electrode area of the RF electrode, which may have a regular, irregular, symmetrical and/or asymmetrical shape, depending on the ground projection of the applicator. The slits and/or cuts may be filled with, for example, air, dielectric, and/or other electrically insulating material (e.g., dielectric material of a printed circuit board). When the RF electrode comprises two or more slits or incisions, the apertures or incisions may have the same point of symmetry and/or line of symmetry. The distance between two nearest points located on the boundary of two different slits and cuts of the RF electrode may be in the range of 0.1mm to 50mm, or 0.1mm to 15mm, or 0.1mm to 10mm, or 0.1mm to 8 mm. When the RF electrode at least partially overlaps the magnetic field generating device, the RF electrode may include a larger slit and cutout in a portion of the conductive surface that is closer to the center of the magnetic field generating device. An RF electrode comprising a plurality of openings (e.g. holes or cutouts) and/or protrusions may be located below the magnetic field generating device. An RF electrode comprising a plurality of openings (e.g. holes or incisions) and/or protrusions may be located between the magnetic field generating device and the patient.
Fig. 13a shows an exemplary RF electrode, wherein radio frequency electrode 101 includes an electrode region 119a and defines one or more slots 117 in the RF electrode's conductive region. Slit 117 may be an elongated slot having a rectangular shape. One slit 117 may be parallel to the other slits.
Fig. 13b shows another exemplary RF electrode, wherein radio frequency electrode 101 includes electrode region 119a and one or more slots 117a and 117b in the RF electrode's conductive region. Slit 117a is not parallel to slit 117b.
Fig. 13c shows another exemplary RF electrode, wherein RF electrode 101 includes electrode region 119a, and a combination of one or more slots 117 in the conductive region, cutouts 115 in the conductive region, and protrusions 114 of the RF electrode.
Fig. 13d shows another exemplary RF electrode, wherein the radio frequency electrode 101 comprises a combination of one or more slots 117 at the conductive region and a cutout 115 in the electrode region. The lines represent thin lines (e.g., single wires) of the electrode 1 spear 119a of the RF electrode. The RF electrode may be a mesh of conductive wires or a mesh of conductive wires. The protrusions 114 may define one or more cutouts 115 at the perimeter of the electrode. The distance D between the boundaries of the individual wires (e.g., wires or groups of wires) may be in the range of 0.01mm to 100mm, or 0.1mm to 50mm, or 0.1mm to 10 mm.
Fig. 13e shows another exemplary RF electrode including protrusions and cutouts. The rf electrode 101 has an electrode region 119a, a border length 119b, and a plurality of protrusions, shown as N #. The protrusions may define protrusion cutouts (e.g., cutouts 115, where the cutouts may be openings or gaps). The protrusions may define a cutout (e.g., cutout 115, where the cutout may be an opening or a gap). The rf electrode 101 may include at least two, three, or five protrusions 114 (e.g., 114a,114 b) or more. The protrusions 114 may be separated from each other by cutouts 115. Similarly, the rf electrode 101 may include one, two, three, or more raised cutouts. The first protrusions 114a and the second protrusions 114b of the plurality of protrusions may be arranged substantially parallel to each other. The projections 114 may be spaced apart at regular intervals and may be regularly arranged. The protrusions 114a,114b may be shaped as rods or pins having a substantially linear shape. The protrusions 114a and 114b may be made of a conductive material. The cutouts 115 may be filled with air, dielectric, or other electrically insulating material. The distance between the protrusions is such that: at least one circle 118a may be virtually inscribed in the cutout 115 and between the two projections 114a and 114 b. At least one circle 118a may have a diameter in the range of 0.001mm to 30mm, or 0.005mm to 15mm, or 0.01mm to 10mm, or 0.01mm to 8mm, or 0.01mm to 7mm, or 0.01mm to 5mm, or 0.01mm to 3mm, or 0.01mm to 2mm, wherein each circle may have at least one tangent point located on the first protrusion 114a and at least one tangent point located on the second protrusion 114 b. Each circle 118a may have a different tangent point. The cutout 115 may be symmetrical and/or asymmetrical along its length. The cutout 115 may form a constant distance between the protrusions 114a and 114 b. The distance between the protrusions 114a and 114b may be non-constant along the length of the protrusions. The minimum distance between the two nearest protrusions 114a,114b may increase as the protrusion length increases and/or decreases.
The projections 114 or cutouts 115 may have symmetrical, asymmetrical, irregular, and/or regular shapes. The size, shape, and/or symmetry of the individual projections 114 may be the same and/or different across the rf electrode 101. For example, each protrusion 114 may have the same shape, the same size, and/or symmetry.
The protrusion 114 is characterized by an imaginary inscribed circle 118b directly into the protrusion. The diameter of the imaginary inscribed circle 118b to the protrusion 114 ranges from: 0.001mm to 30mm, or 0.01mm to 15mm, or 0.2mm to 10mm, or 0.2mm to 7mm, or 0.1mm to 3m. The imaginary inscribed circle may not intersect the boundary of the inscribed protrusion. The magnetic flux density B measured over at least a portion of the RF electrode surface area may be in the range of 0.1T to 5T, or in the range of 0.2T to 4T, or in the range of 0.3T to 3T, or in the range of 0.5T to 5T, or in the range of 0.7T to 4T, or in the range of 1T to 3T. The magnetic flux density B measured over at least a portion of the RF electrode surface area may be measured during treatment. The RF electrode surface area may include the surface area of the conductive surface of the RF electrode.
The magnetic flux density B measured on at least one protrusion of the RF electrode may be in the range of 0.1T to 5T, or in the range of 0.2T to 4T, or in the range of 0.3T to 3T, or in the range of 0.5T to 5T, or in the range of 0.7T to 4T, or in the range of 1T to 3T. The magnetic flux density B measured in the at least one hole of the RF electrode surface area may be in the range of 0.1T to 5T, or in the range of 0.2T to 4T, or in the range of 0.3T to 3T, or in the range of 0.5T to 5T, or in the range of 0.7T to 4T, or in the range of 1T to 3T. The magnetic flux density B measured in the at least one cutout of the RF electrode surface area may be in the range of 0.1T to 5T, or in the range of 0.2T to 4T, or in the range of 0.3T to 3T, or in the range of 0.5T to 5T, or in the range of 0.7T to 4T, or in the range of 1T to 3T. The magnetic flux density measured in the slit and/or the hole may be measured by a fluxgate and/or its probe located in the center of the slit and/or the opening.
The number of protrusions N # comprised by one RF electrode means the highest possible number of conductive areas electrically insulated from each other, which may be formed between two parallel slices 111 traversing the surface of the RF electrode and/or may be formed by parallel slices 111. The distance between two parallel slices 111 may be in the range of 1mm to 50mm, or 2mm to 35mm, or 5mm to 20 mm. The number of protrusions N # may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 75.
Regardless of the parallel slices 111, the total number of projections in one RF electrode may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140.
Regardless of the parallel slices 111, the total number of slits or cuts in one RF electrode may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140.
The number of slits, cuts and/or protrusions in one RF electrode located under the coil comprising the core may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140.
In a region of size 2cm x 1cm, the number of individual projections included in one RF electrode may be in the range of 1 to 8000, or 2 to 8000, or 5 to 8000, or 3 to 5000, or 5 to 1000, or 5 to 500, or 10 to 500, or 5 to 220, or 10 to 100.
To provide a radio frequency field with a uniform output, the plurality of holes of the RF electrode may be divided into a first plurality of holes and a second plurality of holes. The first plurality of apertures may be located below and cover the magnetic field generating device and the second plurality of apertures may be located outside the coverage of the magnetic field generating device, i.e. not below the magnetic field generating device. The presence of the second plurality of holes and the surrounding electrode area of the RF electrode that are outside the coverage of the magnetic field generating device may prevent mechanical and/or electrical stress of the first plurality of holes and the surrounding electrode area of the RF electrode, which stress may result in a change of the RF field output. Furthermore, the presence of the second plurality of holes of the RF electrode and surrounding electrode areas that are outside the coverage of the generated magnetic field may improve the cooling of the RF electrode. The number of apertures of the first plurality of apertures may range from 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140. The number of holes of the second plurality of holes may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140.
Fig. 53a shows a radio frequency electrode 101 with a plurality of holes 117c, 117 d. The magnetic field generating device 531 covering the radio frequency electrode 101 is indicated by a dashed line. The first plurality of holes 117d may be located below the magnetic field generating device 531 and the holes 117c may be located outside the coverage of the magnetic field generating device 531.
To provide a radio frequency field with a uniform output, the plurality of cuts of the RF electrode may be divided into a first plurality of cuts and a second plurality of cuts. The first plurality of cutouts may be located below and cover the magnetic field generating device and the second plurality of cutouts may be located outside the coverage of the magnetic field generating device and thus not below the magnetic field generating device. The presence of the second plurality of cutouts of the RF electrode and the surrounding electrode area outside the coverage of the magnetic field generating device may prevent mechanical and/or electrical stress of the first plurality of cutouts of the RF electrode and the surrounding electrode area. Furthermore, the presence of the second plurality of cutouts of the RF electrode and surrounding electrode areas that are outside the coverage of the generated magnetic field may improve the cooling of the RF electrode. The number of the first plurality of cuts may range from 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140. The number of the second plurality of cuts may range from 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140. Fig. 53b shows a radiofrequency electrode 101 with cutouts 115a, 115 b. The magnetic field generating device 531 is indicated by a dashed line. The first plurality of cutouts 115b is located below the magnetic field generating device. The second plurality of cutouts 115a is located outside the coverage area of the magnetic field generating device.
In order to provide a radio frequency field with a uniform output, the plurality of protrusions of the RF electrode may be divided into a first plurality of protrusions and a second plurality of protrusions. The first plurality of protrusions may be located below and cover the magnetic field generating device and the second plurality of protrusions may be located outside the coverage of the magnetic field generating device, i.e. not below the magnetic field generating device. The presence of the second plurality of protrusions of the RF electrode that are located outside the coverage of the magnetic field generating device may prevent mechanical and/or electrical stress of the first plurality of protrusions of the RF electrode. Furthermore, the presence of a second plurality of protrusions of the RF electrode that are located outside the coverage of the generated magnetic field may improve the cooling of the RF electrode. The number of first plurality of protrusions may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140. The number of the second plurality of protrusions may be in the range of 5 to 1000, or 10 to 600, or 20 to 400, or 50 to 400, or 100 to 400, or 15 to 200, or 30 to 100, or 40 to 150, or 25 to 140. Fig. 53c shows a radio frequency electrode 101 with protrusions 114c, 114 d. The magnetic field generating device 531 is indicated by a dashed line. The first plurality of protrusions 114d are located below the magnetic field generating device 531. The second plurality of protrusions 114c are located outside the coverage of the magnetic field generating device 531.
During treatment, the magnetic flux density B and/or the magnitude of the magnetic flux density measured over at least a portion of the radiofrequency electrode 101 may be in the range of 0.1T to 5T, 0.2T to 4T, 0.3T to 3T, 0.7T to 5T, 1T to 4T, or 1.5T to 3T. The electrode may be defined by a bump density ρ p according to equation 1,
Equation 1:
Where n represents the number of protrusions intersecting the magnetic field lines of the magnetic flux density BT, and l cm represents the length of the intersecting magnetic field lines of the protrusions. The length l may be at least 1cm long and the magnetic field lines may have a magnetic flux density B [ T ] of at least 0.3T or 0.7T. In at least a portion of the RF electrode, the protrusion density according to the treatment device may be in the range of 0.3cm -1·T-1 to 72cm -1·T-1, or 0.4cm -1·T-1 to 10cm -1·T-1, or 0.4cm -1·T-1 to 7cm -1·T-1, or 0.5cm -1·T-1 to 6cm -1·T-1, or 0.8cm -1·T-1 to 5.2cm -1·T-1.
The protrusions may be wider (i.e., they may have a greater thickness), with a lower magnetic flux density; and may be thinner, with a higher magnetic flux density. In addition, the protrusion density ρ p may be higher, wherein the magnetic flux density is higher.
Depending on the terrestrial projection of the applicator, the electrode area of one or more RF electrodes in an applicator or an additional treatment device may be in the range of 1cm 2 to 2500cm 2, or 25cm 2 to 800cm 2, or 30cm 2 to 600cm 2, or 30cm 2 to 400cm 2, or 50cm 2 to 300cm 2, or 40cm 2 to 200cm 2.
The RF electrode may have a boundary ratio. The boundary ratio may be defined as the ratio between the perimeter and the area of the electrode. An example of a boundary ratio is shown in fig. 13e, where the perimeter may be described as a boundary length 119b and the area of the RF electrode is described by the electrode area 119a of the RF electrode according to the terrestrial projection of the applicator. Electrode area 119a is the area of the RF electrode without the wire supplying power to the RF electrode and without the sum of the circumferences of all slits and/or cuts. The boundary length 119b is the sum of the circumferences of the electrodes, and all circumferences of the orifices inscribed inside the electrodes, if any. The RF electrode boundary ratio may be between 10m -1 and 50000m -1, or between 50m -1 and 40000m -1, Or 150m -1 to 20000m -1, or 200m -1 to 10000m -1, Or 200m -1 to 4000m -1, or 300m -1 to 10000m -1, Or 300m -1 to 4000m -1, or 500m -1 to 4000m -1, or 10m -1 to 20000m -1, Or 20m -1 to 10000m -1, or 30m -1 to 5000m -1.
Depending on the ground projection of the applicator, the magnetic flux density B on at least a portion of the RF electrode surface therein may be in the range of 0.1T to 7T, or 0.3T to 5T, or 0.5T to 3T, or 0.5T to 7T, or in the range of 0.7T to 5T, or in the range of 1T to 4T, at least one RF electrode may have a position in the range of 10m -1 to 50000m -1, Or 50m -1 to 40000m -1, or 150m -1 to 20000m -1, Or 250m -1 to 10000m -1, or 200m -1 to 4000m -1, Or 300m -1 to 1000m -1, or 400m -1 to 4000m -1, or 400m -1 to 1200m -1, Or 500m -1 to 2000m -1, or 10m -1 to 20000m -1, or 20m -1 to 10000m -1, Or a boundary ratio in the range of 30m -1 to 5000m -1. As the magnetic flux density B increases over the RF electrode area, the boundary ratio may increase.
The ratio between the boundary ratio and the magnetic flux density B over the RF electrode surface area may be referred to as the charging rate. The charge rate may relate to a square surface area of the RF electrode of at least 1.5cm 2 and a magnetic flux density in the range of 0.1T to 7T, or 0.3T to 5T, or 0.5T to 3T, or 1T to 5T, or 1.2T to 5T. The rate of charge of at least a portion of the RF electrode may be in the range of 70m -1·T-1 to 30000m -1·T-1, or 100m -1·T-1 to 5000m -1·T-1, or 100m -1·T-1 to 2000m -1·T-1, or 120m -1·T-1 to 1200m -1·T-1, or 120m -1·T-1 to 600m -1·T-1, or 230m -1·T-1 to 600m -1·T-1. The square surface area of the RF electrode may include a surface area having a square shape.
Due to the higher boundary ratio and/or charging rate, the induced undesirable physical effects in the RF electrode may be lower because the RF electrode may include protrusions that are partially insulated from each other. The possible imaginary inscribed circles in the projections must also be smaller due to the higher boundary ratio and/or charging rate, and thus the loops of the induced eddy currents must be smaller. Thus, the induced eddy currents are smaller and the undesirable physical effects induced in the RF electrode are lower or minimal.
In one applicator and depending on its ground projection, the ratio between the area of one side of all RF electrodes (ground projection) and one side of all winding areas of all magnetic field generating devices (area A2 as shown in fig. 9 a) may be in the range of 0.1 to 15, or 0.5 to 8, or 0.5 to 4, or 0.5 to 2.
As shown in fig. 16, if one protrusion 114 intersects magnetic field lines B 1 and B 2, where the absolute value of |b 1 | is higher than the absolute value of |b 2 | and |b 1|-|B2 < |0.05t, The bulge can be divided into three areas by the lines of force B 1 and B 2. In other words, as shown in fig. 16, the protrusion 114 may be divided into three regions S 1、S2、S3 having the same length according to the magnetic field gradient direction, and S 1 is exposed to a magnetic flux density higher than S 3. Region S 1 may be placed in the highest magnetic flux density, S 2 may be placed in the medium magnetic flux density, and S 3 may be placed in the lowest magnetic flux density. The largest imaginary inscribed circle k 1 having the diameter d 1 inscribed in the region S 1 may have a smaller diameter than the largest inscribed circle k 2 having the diameter d 2 inscribed in the region S 3. The diameter d 2 may be 2% to 1500%, or 5% to 500%, or 10% to 300%, or 10% to 200%, or 10% to 100%, or 5% to 90%, or 20% to 70%, or 5% to 20% greater than the diameter d 1. In such cases, the protrusions are thinner and the magnetic flux density is higher, so that protrusions are formed that are at least partially cone-shaped. further, the protrusions may be thinner and the magnetic flux density higher.
The RF electrodes may have different sizes and shapes. The plurality of RF electrodes may include bipolar electrodes. The bipolar electrodes may be parallel electrodes (such as shown in fig. 14 a-14 e), or concentric electrodes (as shown in fig. 15 a-15 c). The same type of RF electrode 101 shown in fig. 14 a-14 e and 15 a-15 c may be used as RF electrode 102 and/or any other RF electrode or electrodes; the RF electrode 101 may be positioned proximate to the second side portion of the applicator and the RF electrode 102 positioned proximate to the first side portion.
The shape and arrangement of the RF electrodes of the at least one applicator may be based on the size, shape and symmetry of the body location (anatomy) to which the at least one applicator is attached. The positioning and different shapes of the RF electrodes are beneficial to avoid hot spot formation, providing as large a uniform heating of the treated body part as possible to avoid the need to move with one or more applicators.
Fig. 14a shows an example of symmetrical positioning of RF electrodes. Fig. 14b shows another example of symmetrical positioning of the RF electrode. Fig. 14c shows an example of yet another symmetrical positioning of the RF electrode. Fig. 14d shows a view of an applicator comprising symmetrical positioning of RF electrodes. Fig. 14e shows a side view of an applicator comprising an example of symmetrical positioning of RF electrodes.
According to the example of RF electrodes shown in fig. 14 a-14 e, the applicator may comprise at least one pair of parallel bipolar radiofrequency electrodes 101a and 101b separated by a gap 113. The RF electrodes are powered by wires 100a and 100 b. As shown in fig. 14a, 14b and 14d, the rf electrodes 101a, 101b may be symmetrical and may be mirror images. The shape of the individual RF electrodes 101a and 101b may be irregular or asymmetric, wherein at least 40%, 50%, 70%, 90% or 99% of the length and/or area of all protrusions in one RF electrode may be different. The anatomy and testing of the body may confirm that this type of RF electrode may provide the most comfortable and effective treatment of body parts, such as abdominal parts, buttocks, arms and/or thighs.
As shown in fig. 14c, the radio frequency electrodes 101a, 101b may be at least partially symmetrical according to at least one axis or point of symmetry (such as according to linear symmetry, point symmetry and rotational symmetry). For example, each electrode may be semi-circular or C-shaped. In addition, the gap 113 between the radio frequency electrodes 101a and 101b may be irregular and/or may be designed according to at least one symmetry axis, such as a linear symmetry axis with mirror symmetry. Thus, in the case when the electrodes 101a and 101b may be semicircular, the gap 113 may be circular. The use of such symmetric electrodes may be beneficial for treating body parts, where such symmetry may be necessary to emphasize the symmetry of the body part (e.g., buttocks or thigh).
The gap 113 between the rf electrodes 101a and 101b may include air, cooling fluid, oil, water, dielectric material, fluid, and/or any other electrical insulator, such as a substrate made of a composite material for printed board circuitry. The rf electrodes 101a and 101b may be formed from copper foil and/or layers deposited on such substrates. The gap 113 may affect the shape of the electromagnetic field (e.g., RF field) generated by the RF electrode, and the penetration depth of the electromagnetic field into the patient's body tissue. In addition, the distance between the at least two radio frequency electrodes 101a and 101b may form a gap 113, the gap 113 may have an at least partially circular, elliptical and/or parabolic shape, as shown in fig. 14 a. The gap 113 may have a regular shape for separating the RF electrodes at a constant distance, as shown in fig. 14 b.
The gap 113 between the radio frequency electrodes 101a and 101b may be designed to pass through the magnetic field generated by the magnetic field generating device by an amount in the range of 2% to 70% or 5% to 50% or 15% to 40%. The distance between the nearest portions of at least two different RF electrodes in one applicator may be in the range of 0.1cm to 25cm, or 0.2cm to 15cm, or 2cm to 10cm, or 2cm to 5 cm.
The gap 113 between the two RF electrodes may be designed in the plane of the RF bipolar electrode, wherein the gap 113 may at least partially overlap the position where the magnetic flux density generated by the magnetic field generating device has the largest absolute value. Gap 113 may be located at such a location to optimize therapeutic efficiency and minimize energy loss.
It should be noted that strong magnetic fields with high derivatives of the magnetic flux density dB/dt may induce undesirable physical effects even in RF electrodes with protrusions, slits and/or cuts. The gap 113 may be located or at a position where the absolute value of the magnetic flux density is maximum. As a result, the plurality of RF electrodes located around the gap 113 may be subsequently affected by a lower amount of magnetic flux density.
A plurality of RF electrodes (e.g., two radio frequency electrodes 101a and 101 b) may be located on the substrate 113a, as shown in fig. 14 d. The substrate 113a may serve as a filler for the gap 113 between the RF electrodes and between the one or more cutouts 115. As shown in fig. 14d and 25, the substrate 113a and one or more RF electrodes may be bent to a desired shape and/or radius to fit a body part of a patient. The rf electrode 101a or 101b may be bent along the lower cover 125 of the applicator 800, particularly along the bent portion 126 of the lower cover 125. As shown in fig. 14d, the substrate 113a may define a substrate gap 113b for at least one sensor, such as a temperature sensor. The substrate gap 113b may also allow for passage of one or more wires, cooling fluid, and/or a light therapeutic energy source (e.g., LED, laser diode) for implementing another therapeutic energy source, such as providing illumination or additional heating of biological structures and/or body parts.
Fig. 15a, 15b and 15c show two radiofrequency electrodes 101a and 101b, wherein at least one radiofrequency electrode 101a may at least partially surround the other radiofrequency electrode 101b. The radio frequency electrodes 101a and 101b may be separated by a gap 113, the gap 113 comprising, for example, a substrate 113a having the same insulating properties, as described above with respect to fig. 114a to 14 e. The rf electrode 101b may include holes 116 to minimize shielding of the magnetic field and to minimize induction of undesirable physical effects induced by the rf electrode 101b. The aperture 116 may be located in the plane of the RF electrode, wherein the magnetic flux density of the magnetic field generated by the magnetic field generating device reaches a maximum during treatment. The aperture 116 may be circular, or may have other shapes, such as oval, square, triangular, rectangular, or the like. The area of the aperture 116 may range from: 0.05cm 2 to 1000cm 2, or 0.05cm 2 to 100cm 2, or 3cm 2 to 71cm 2, or 3cm 2 to 40cm 2, or 3cm 2 to 20cm 2, or 3cm 2 to 15cm 2, or 0.5cm 2 to 2.5cm 2. The RF electrode may be fully or partially concentric.
Fig. 15a shows two radio frequency electrodes 101a and 101b, which may be non-circular, with at least one line and/or point symmetry, the electrodes 101a and 101b shown may not have a center of symmetry. The illustrated RF electrode 101a may include a hole 116 in its center with a magnetic flux density that is maximized to minimize induction of unwanted physical effects of the RF electrode through the magnetic field.
Fig. 15b shows two radio frequency electrodes 101a and 101b with rotational symmetry, which may have a circular shape. The rf electrodes 101a and 101b may have the same center of symmetry. The illustrated RF electrode 101a may include a hole 116 in its center with a magnetic flux density that is maximized to minimize induction of unwanted physical effects of the RF electrode through the magnetic field.
Fig. 15c shows two radio frequency electrodes 101a and 101b which may not have symmetry and which do not have a centre of symmetry.
To minimize or eliminate undesirable physical effects, the RF electrode may include a reduced thickness. The thickness of the RF electrode may be in the range of 0.01mm to 50mm, or 0.01mm to 10mm, or 0.01mm to 5mm, or 0.01mm to 3mm, or 0.01mm to 1mm, or 0.1mm to 1mm, or 0.005mm to 0.1mm, or 0.01mm to 0.2 mm.
The RF electrode may include one or more substrates covered by a conductive layer (e.g., a thin conductive layer). The thin conductive layer may be plated on the substrate, for example, by electroplating. The thickness of the conductive layer of the RF electrode may be in the range of 0.01mm to 50mm, or 0.01mm to 10mm, or 0.01mm to 5mm, or 0.01mm to 3mm, or 0.01mm to 1mm, or 0.1mm to 1mm, or 0.005mm to 0.1mm, or 0.01mm to 0.2 mm. One type of RF electrode may be designed by a similar method to that used to prepare Printed Circuit Boards (PCBs), where a thin conductive layer may be deposited as and/or on a substrate having insulating properties. However, the substrate may have dielectric properties or conductive properties. In other words, the RF electrode may comprise a conductive layer deposited on the substrate layer. The substrate material of the substrate layer forming the electrode may be rigid or flexible. The substrate may include one, two, or more conductive layers of material, such as copper, silver, nickel, aluminum, alloys of nickel and zinc, mu-metal, austenitic stainless steel, and/or other materials, to form an RF electrode. Furthermore, combinations of materials may be used for the conductive layer, for example, nickel-copper combinations.
The conductive layer may completely or partially cover the substrate layer. The substrate may be covered or plated with a conductive layer of the RF electrode on the side of the substrate facing the patient and/or the side of the substrate facing away from the patient. The thickness of the substrate material may be in the range of 0.01mm to 45mm, or 0.01mm to 10mm, or 0.01mm to 5mm, or 0.01mm to 3mm, or 0.01mm to 2mm, or 0.1mm to 2mm, or 0.5mm to 1.5mm, or 0.05mm to 1 mm. The substrate material may be a polymer, ceramic, copolymer sheet, phenolic resin layer, epoxy resin layer, fiberglass fabric, other woven fabric, polymeric fabric, and the like. The substrate may be at least partially flexible and/or rigid. Further, the substrate material may be a foam material including a plastic foam, a polyolefin foam, a polyurethane foam, or a carbon foam. The foam may add flexibility and protection to the conductive layer during vibrations that may occur during treatment. The substrate material may be a fabric. The substrate material may be a nanomaterial, for example, nanotubes or nanoparticles.
The conductive layer deposited on the substrate layer may comprise any design of cutouts, protrusions and/or holes, as shown in any of figures 13a, 13b, 13c, 13d, 13 e. Further, the conductive layer may not include any openings or protrusions. The conductive layer may comprise a sheet of conductive material. The conductive layer may be plated on the substrate layer. In addition, in the case of the optical fiber,
The conductive layers plated on both sides of the substrate layer may be connected by stitching one or more conductive wires (e.g., through the metal loading of the substrate layer) so that the conductive layer and the substrate layer may be considered an RF electrode. The conductive layer may be made of aluminum, copper, nickel, cobalt, manganese, zinc, iron, titanium, silver, brass, platinum, palladium, and/or other materials that may produce alloys, such as permalloy, electrical steel, ferritic steel, ferrite, stainless steel. The surface resistance Rs of the RF electrode may be in the range of 0.00005 Ω/cm 2 to 15 Ω/cm 2, or 0.0001 Ω/cm 2 to 10 Ω/cm 2, or 0.0002 Ω/cm 2 to 5 Ω/cm 2. The volume resistance Rv of the RF electrode may be in the range of 0.0001 Ω/mm 2 to 20 Ω/cm 2, or 0.0001 Ω/mm 2 to 10 Ω/mm 2, or 0.001 Ω/mm 2 to 8 Ω/mm 2.
Fig. 54a shows an applicator 800 comprising a magnetic field generating device 540 and a radio frequency electrode 101 located near a body part 541 of a patient. The rf electrode 101 may include a substrate 542 covered by a conductive layer 543. As shown in fig. 54a, a conductive layer 543 may be located between the substrate 542 and the body portion 541 of the patient. The conductive layer 543 may cover a side of the substrate 542 closer to the body portion 541 of the patient. By positioning the conductive layer 543 closer to the patient, by positioning the conductive layer 543 away from the magnetic field generating device 540, undesired physical effects may be prevented.
Fig. 54b shows an applicator 800 in which the radio frequency electrode 101 comprises a substrate 542 covered by a conductive layer 543 on the side close to the magnetic field generating device 540. Positioning the conductive layer 543 closer to the magnetic field generating device 540 may prevent stress provided to the substrate 542.
Fig. 54c shows an applicator 800 in which the radio frequency electrode 101 comprises a substrate 542 covered by conductive layers 543a and 543b on both sides of the substrate 542. Positioning the conductive layers on both sides of the substrate 542 may prevent stress provided to the substrate 542 and result in uniform fabrication of the RF electrode.
Fig. 54d shows an applicator 800 in which the radio frequency electrode 101 comprises a substrate 542 covered by a conductive layer 543 on the side close to the body region 541, wherein the conductive layer 543 may be applied as a discontinuous layer. The discontinuity of conductive layer 543 may include any examples including protrusions, cutouts, or holes. Similarly, the discontinuity of the conductive layer 543 may generate less eddy currents in the conductive layer 543 of the radio frequency electrode 101.
Fig. 54e shows an applicator 800 in which the radio frequency electrode 101 comprises a substrate 542 covered by conductive layers 543a and 543b on both sides of the substrate 542, wherein the conductive layer 543a may not be applied as a continuous layer. The conductive layer 543a may be discontinuously applied on the side of the substrate 542 near the magnetic field generating device 540. The discontinuity of conductive layer 543a can include any example including a bump, a cutout, or a hole. Similarly, the discontinuity of conductive layer 543a may generate less eddy currents in conductive layer 543a of rf electrode 101.
Fig. 54f shows an applicator 800 in which the radio frequency electrode 101 comprises a substrate 542 covered by conductive layers 543a and 543b on both sides of the substrate 542, wherein the conductive layer 543b may not be applied as a continuous layer. The layer 543b may be discontinuously applied on the side of the substrate 542 near the body region 541. The discontinuity of conductive layer 543b can include any example including a bump, a cutout, or a hole. Similarly, the discontinuity of the conductive layer 543b may generate less eddy currents in the conductive layer 543b of the radio frequency electrode 101.
Fig. 54g shows a radio frequency electrode 101 comprising a substrate 542 having portions 542a-c, wherein the substrate 542 is covered by conductive layers 543a and 543 b. The conductive layers 543a, 543b may be connected by stitching 544 through the substrate 542, wherein the stitching 544 may be made of a conductive or semiconductive material.
The RF electrode locations shown in fig. 54a-54g are merely exemplary. The one or more RF electrodes may be located above the magnetic field generating device or in the vicinity of the magnetic field generating device.
The RF electrode may be a system of thin conductive wires, flat strips, sheets, etc.
The RF electrode may be made of a conductive material that reduces unwanted physical effects of the RF electrode and induction of heating.
The RF electrode may be made of a specific conductive material that reduces the induction of undesirable physical effects in the RF electrode. Such materials may have a relative permeability in the range of 4 to 1000000, or 20 to 300000, or 200 to 250000, or 300 to 100000, or 300 to 18000, or 1000 to 8000. The material of the RF electrode may include carbon, aluminum, copper, nickel, cobalt, manganese, zinc, iron, titanium, silver, brass, platinum, palladium, etc., which may be formed into alloys such as multiple alloys, permalloy, electrical steel, ferritic steel, ferrite, stainless steel thereof. In addition, the RF electrode may be made of a fixed powder of mixed metal oxide and/or metal oxide (metal of M metal element) to minimize eddy currents and induction of heating of the RF electrode and also minimize energy loss of the time-varying magnetic field.
As described above, the RF electrode may include a conductive layer. The conductive layer may be deposited on the substrate, but the substrate is optional. The RF electrode may include only the conductive layer. One or more RF electrodes may be located in the same plane or in different planes. For example, two RF electrodes may be arranged on one horizontal plane and a third RF electrode may be arranged on a different horizontal plane, e.g. parallel. RF electrodes arranged in different planes may overlap each other. The RF electrodes may be separated by air or an insulating material (e.g., plastic). For example, the RF electrodes may be separated by plastic used in a Printed Circuit Board (PCB). The configuration, distance and coverage of the RF electrodes may provide different depths of penetration for the RF waves and thus different depths of heating for the patient's body (e.g., dermis and epidermis or epidermis only).
Fig. 54h shows a longitudinal cross-section of an applicator 800 with a magnetic field generating device 540 and radio frequency electrodes 101a-101 d. The radio frequency electrodes 101a, 101b are located in a first plane and the radio frequency electrodes 101c, 101d are located in a second plane different from the first plane. Both pairs of RF electrodes may be located between the magnetic field generating device 540 and the tissue 601 of the patient. In addition, two pairs of RF electrodes may be positioned between the magnetic field generating device 540 and the bottom cover 517 of the applicator 800.
Fig. 54i shows a schematic arrangement of four RF electrodes and related circuitry comprising two wires 100a and 100b providing RF signals. Although the wires 100a and 100b are shown as having a positive or negative polarity, their mutual polarity varies with the frequency of the RF signal. As the polarity of the wire changes, the mutual polarity of the RF electrodes connected to the wire also changes. The rf electrode 101a is directly connected to the wire 100a and the rf electrode 101b is directly connected to the wire 100b. When wires 100a and 100b are active, the two radio frequency electrodes 101a and 101b may establish a first bipolar electrode pair, which indicates that they are providing RF signals. The RF electrode 101d is connected to the wire 100a through the RF switch 545a, and the RF electrode 101c is connected to the wire 100b through the RF switch 545 b. The RF switches 545a, 545b may be turned off or off (as shown in fig. 54 i). When wires 100a and 100b are active and RF switches 545a, 545b are open, RF electrodes 101c and 101d are inactive. When wires 100a and 100b are active and RF switches 545a and 545b are closed, radio frequency electrodes 101c and 101d establish a second bipolar electrode pair. When both bipolar electrode pairs are active, the position of the RF switches 545a, 545b and the associated connection of the circuit results in one RF electrode (e.g., 101 a) being present over the opposite polarity RF electrode (e.g., 101 c). When both bipolar electrode pairs are active simultaneously, the second bipolar electrode pair may absorb at least a portion of the RF wave generated by the first bipolar electrode pair. However, the second bipolar electrode pair may also generate RF waves. Because the RF wave generated by the first bipolar electrode pair is partially absorbed by the second bipolar electrode pair, the RF wave generated by the first bipolar electrode pair may not penetrate the treated tissue to a deeper layer. However, the RF wave generated by the second bipolar electrode pair is closer to the patient and may be able to reach deeper layers of tissue. Thus, the illustrated schematic arrangement of four RF electrodes and associated circuitry is capable of simultaneously heating deep and shallow tissue layers during treatment. The deep tissue layer may include a subcutaneous tissue layer and/or a muscle layer, and the shallow tissue layer may include dermis and/or epidermis. Further, similar results may be achieved by turning off only one of the RF switches 545a or 545 b.
Fig. 54j shows another exemplary arrangement of four RF electrodes and related circuitry, including two wires 100a and 100b providing RF signals. Although the wires 100a and 100b are shown as having a positive or negative polarity, their mutual polarity varies with the frequency of the RF signal. As the polarity of the wires 100a, 100b changes, the mutual polarity of the RF electrodes connected to the wires also changes. The rf electrode 101a is directly connected to the wire 100a and the rf electrode 101b is directly connected to the wire 100b. When wires 100a and 100b are active, the two radio frequency electrodes 101a and 101b may establish a first bipolar electrode pair, which indicates that they are providing RF signals. The RF electrode 101c is connected to the wire 100a through the RF switch 545a, and the RF electrode 101d is connected to the wire 100b through the RF switch 545 b. The RF switches 545a, 545b may be turned off or off (as shown in fig. 54 j). When the wires 100a, 100b are active and the RF switches 545a, 545b are open, the radio frequency electrodes 101c, 101d are inactive. When the wires 100a, 100b are active and the RF switches 545a, 545b are closed, the radio frequency electrodes 101c, 101d establish a second bipolar electrode pair. When both bipolar electrode pairs are active simultaneously, the second bipolar electrode pair may absorb at least a portion of the RF wave generated by the first bipolar electrode pair. However, because one RF electrode is located below another RF electrode having the same polarity, the amount of absorbed RF waves may be lower than the example of fig. 54 i. In addition, as shown in fig. 54i, when two RF electrodes 101c, 101d are positioned closer to each other than RF electrodes 101a and 101b, a bipolar electrode pair comprising RF electrodes 101c, 101d may provide RF waves to heat one or more shallow tissue layers. Thus, when two bipolar electrode pairs are active simultaneously, the RF waves provided by the RF electrodes 101c, 101d may provide heating of one or more shallow tissue layers, and the RF waves provided by the RF electrodes 101a, 101b may provide heating of one or more deeper tissue layers of the same body part. It should be noted that the positions of a pair of RF electrodes providing heating of different tissue layers may be interchanged, i.e. when the RF electrodes 101a, 101b are closer to each other than the RF electrodes 101c, 101d, the RF waves provided by the RF electrodes 101a, 101b may provide heating of one or more shallow tissue layers and the RF waves provided by the RF electrodes 101c, 101d may provide heating of one or more deeper tissue layers of the same body part.
Fig. 54o shows a longitudinal cross-section of an applicator 800 with a magnetic field generating device 540 and radio frequency electrodes 101a-101 d. The RF electrodes lie in one plane. All RF electrodes may be located between the magnetic field generating device 540 and the tissue 601 of the patient. In addition, all RF electrodes may be located between the magnetic field generating device 540 and the bottom cover 517 of the applicator 800.
Fig. 54p shows another schematic arrangement of four RF electrodes and related circuitry, including two wires 100a and 100b providing RF signals. Although the wires 100a and 100b are shown as having a positive or negative polarity, their mutual polarity varies with the frequency of the RF signal. As the polarity of the wires 100a, 100b changes, the mutual polarity of the RF electrodes connected to the wires also changes. Wire 100a is connected to RF electrodes 101a and 101c through RF switch 545 a. Wire 100b is connected to RF electrodes 100b and 100d through RF switch 545 b. Depending on the configuration of the switches 545a and 545b, a bipolar pair may be established by the radio frequency electrodes 101a and 101b, 101a and 101d, 101c and 101b, and/or 101c and 101 d. This variation of creating a bipolar pair may be beneficial for treatment when the RF electrodes are positioned as shown in fig. 54 o. For example, when a bipolar pair is established by radio frequency electrodes 101a and 101b, the RF field may provide RF treatment and/or heating to one or more deeper tissue layers. Since the RF electrodes 101a and 101b are remote from each other, the RF field passes deeper between the electrodes. In some aspects, the distance between the radio frequency electrodes 101a and 101b may be in the range of 1cm to 100cm or 1.5cm to 50cm or 2cm to 40 cm. When the bipolar pair is established by the RF electrodes 101c and 101d, the RF field may provide RF treatment and/or heating to one or more shallow tissue layers. Since the RF electrodes 101c and 101d are positioned closer to each other, the RF field passes through the shallow tissue between the electrodes. In some aspects, the distance between the rf electrodes 101c and 101d may be in the range of 0.1 to 0.9 or 0.2 to 0.8 or 0.25 to 0.7 of the distance between the rf electrodes 101a and 101 b. In some aspects, the distance between the radio frequency electrodes 101c and 101d may be in the range of 0.1cm to 90cm or 1.5cm to 45cm or 2cm to 35 cm. When the bipolar pair is established by the radio frequency electrodes 101a and 101c, the RF field may provide RF therapy and/or heating at a region of the body part. Since the radio frequency electrodes 101a and 101c are positioned closer to each other and at one location of the applicator, the RF field passes between the electrodes through the shallow tissue and one region of the body part. In some aspects, the distance between the rf electrodes 101a and 101c may be in the range of 0.2 to 0.8 or 0.3 to 0.6 or 0.3 to 0.5 of the distance between the rf electrodes 101a and 101 b. In some aspects, the distance between the radio frequency electrodes 101a and 101c may be in the range of 0.1cm to 90cm or 2cm to 40cm or 2.5cm to 35 cm. When the bipolar pair is established by the RF electrodes 101d and 101b, the RF field may provide RF therapy and/or heating at a region of the body part. Since the radio frequency electrodes 101d and 101b are positioned closer to each other and at one location of the applicator, the RF field passes through shallow tissue and one region of the body part between the electrodes. In some aspects, the distance between the rf electrodes 101d and 101b may be in the range of 0.2 to 0.8 or 0.3 to 0.6 or 0.3 to 0.5 of the distance between the rf electrodes 101a and 101 b. In some aspects, the distance between the radio frequency electrodes 101d and 101b may be in the range of 1cm to 50cm or 2cm to 45cm or 2.5cm to 35 cm.
Fig. 54k shows another longitudinal cross-section of an applicator 800 with a magnetic field generating device 540 and radio frequency electrodes 101a-101 d. The radio frequency electrodes 101a, 101b are located in a first plane and the radio frequency electrodes 101c, 101d are located in a second plane different from the first plane. Both pairs of RF electrodes may be located between the magnetic field generating device 540 and the tissue 601 of the patient. However, only one pair of RF electrodes may be present. The following figures 54i-54k are views from below the applicator. 54i-54k may be considered as further examples of RF electrode positioning.
Fig. 54i shows the example of fig. 54i, wherein four radio frequency electrodes 101a-101d are RF electrodes with openings, e.g. cutouts and protrusions. As shown, the rf electrode 101c below the rf electrode 101a has at least one protrusion 114c below the rf electrode 101 a. The RF electrodes 101a and 101d may be connected by a circuit including an RF switch 545 a. When the RF switches 545a and 545b are open, the RF electrodes 101c and 101d are not powered and only the bipolar RF electrodes 101a and 101b that establish the first bipolar electrode pair are active. When the RF switches 545a and 545b are closed, the radio frequency electrodes 101c and 101d are powered and the second bipolar electrode pair is active with the first bipolar electrode pair. The advantage of such a connection of the RF electrode and the RF switch is described with respect to fig. 54 i.
Fig. 54m shows an example of fig. 54j, where four electrodes 101a-101d are RF electrodes with openings, e.g. cutouts and protrusions. As shown, the rf electrode 101c below the rf electrode 101a has at least one protrusion 114c below the rf electrode 101 a. The RF electrodes 101a and 101c may be connected by a circuit including an RF switch 545a, and the RF electrodes 101b and 101d may be connected by a circuit including an RF switch 545 b. The advantage of such a connection of the RF electrode is described with respect to fig. 54 j. When two RF electrodes 101c and 101d are positioned closer to each other than RF electrodes 101a and 101b, a bipolar electrode pair comprising RF electrodes 101c and 101d may provide RF waves that provide heating of one or more shallow tissue layers. In this case, one or more protrusions of the rf electrode 101c may be located between the protrusions of the rf electrode 101 d.
Fig. 54l and 54m are exemplary schematic diagrams of possible connections of RF switches to RF electrodes. Moreover, fig. 54l and 54m are exemplary schematic diagrams of possible connections of the wire to the RF electrode over the other two bipolar electrodes. Wire 100a and/or wire 100b may be connected to rf electrodes 101c and/or 101d located below rf electrodes 101a and 101 b. It is also possible to have only one pair of RF electrodes in one plane and another RF electrode in a different plane. Fig. 54n shows an example of such a different configuration of one bipolar pair and one RF electrode. The three radio frequency electrodes 101a, 101c, and 101d are RF electrodes with openings, such as cutouts and protrusions. As shown, the rf electrode 101c is disposed below the rf electrode 101a and has one or more protrusions 114c below the rf electrode 101 a. The rf electrode 101c is directly connected to the wire 100a, and the rf electrode 101d is directly connected to the wire 100b. The rf electrodes 101c and 101d establish a bipolar electrode pair. The RF electrode 101a is located above the RF electrode 101c and is connected to the wire 100b through the RF switch 545. When the RF switch 545 is turned off, the RF electrode 101a located above the RF electrode 101c becomes active and has an opposite polarity with respect to the RF electrode 101 c. The direction of the radio frequency wave traveling between the bipolar electrode pair (i.e., radio frequency electrodes 101c and 101 d) is changed by the presence of the active radio frequency electrode 101 a. As a result, RF waves may only reach a shallow depth of tissue. In this way, the radio frequency waves can provide different depths of heating to the patient's body.
When a pair of bipolar RF electrodes are housed within an applicator, the applicator may include a motion mechanism that may be configured to selectively adjust the distance between the RF electrodes to vary the depth of heating of the RF waves generated by the RF electrodes. For example, the movement mechanism may include a rotor or shaft configured to move a first RF electrode closer to (or farther from) a second RF electrode or to move both RF electrodes toward (or farther from) the center of the applicator.
By using the magnetic field generating device in combination with a plurality of RF electrodes and impedance elements, unwanted physical effects may be minimized or eliminated. The plurality of RF electrodes may be connected to at least one impedance element. As shown in fig. 55a, at least one RF electrode of the plurality of RF electrodes 556 and the impedance element 555 may be located below the magnetic field generating device 557 and at least partially cover the magnetic field generating device 557. At least one of the plurality of RF electrodes 556 and the impedance element 555 can be located between the magnetic field generating device 557 and the patient's body. Or as shown in fig. 55b, the impedance element 555 may be located at a position other than below the magnetic field generating device 557. The impedance element 555 may be part of an RF circuit. During operation of the magnetic field generating device 557 and/or the RF electrodes 556, the impedance element 555 can provide and/or propagate RF signals in the surface such that the RF signals can be transmitted to the plurality of RF electrodes 556. During simultaneous or sequential operation of the magnetic circuit, the impedance element 555 may be perceived by the field lines of the magnetic field as part of an open circuit. In this configuration, the impedance element does not significantly affect the transmissivity of the magnetic field. By using impedance elements, the RF electrode that is located below the magnetic field generating device 557 and/or at least partially covers the magnetic field generating device 557 may comprise an RF electrode without openings and/or protrusions.
The impedance element 555 may include one or more electrical elements. The impedance element 555 may be an impedance filter element. The impedance element 555 may be a low pass filter, a high pass filter, a band pass filter, or a band reject filter. Impedance element 555 may include a capacitor, for example, a film capacitor, an electrolytic capacitor, a ceramic capacitor, a polymer capacitor, a mica capacitor, a glass capacitor, a super capacitor, and/or a tantalum capacitor. The impedance element 555 may comprise a magnetic coil, which may have a smaller diameter than the magnetic field generating device for generating the magnetic field. The impedance element 555 may comprise a resistor. The impedance element 555 may be positioned on the applicator by surface mount technology. The impedance element 555 may be connected by wires to one or more RF electrodes 556 of a plurality of RF electrodes positioned to at least partially cover the magnetic field generating device 557. The impedance element 555 may be positioned in direct contact with one or more RF electrodes 556 of a plurality of RF electrodes positioned to at least partially cover the magnetic field generating device 557, such as by surface mount technology. The impedance element 555 may be a leadless element, so that the absence of leads may prevent the influence of the magnetic field generated by the magnetic field generating device.
By using RF electrodes made of metal foam, the undesirable physical effects associated with using a combination of magnetic fields and radio frequency waves can be minimized or eliminated. The metal foam may be a structure comprising a solid metal body having pores. The holes may be filled with a fluid, e.g. a gas. The presence of a plurality of pores within the metal foam may provide a discontinuity in the solid material for the presence of eddy currents generated by the magnetic field generating device. The metal may be aluminum, steel, zinc, tin, nickel, copper, silver, a high magnetic alloy, and/or other metals. In addition, alloys based on the above metals may be used. The pores in the metal foam may have a pore size in the range of 50 μm to 5,000 μm, or 200 μm to 4,000 μm, or 300 μm to 3,000 μm. Porosity is defined as the percentage of cells in the metal foam and may range from 10% to 99% or 25% to 99% or 50% to 99%.
By using an RF electrode that includes a fabric made of one or more conductive fibers, the undesirable physical effects associated with using a combination of magnetic fields and radio frequency waves can be minimized or eliminated. Such conductive fibers may be made from fibers comprising a metal, a metal alloy, a metal coated with an insulating material, a dielectric material coated with a metal, and/or an insulating material coated with a metal. Dielectric materials or insulating materials may provide higher mechanical stability. The metal may include silver, steel, nickel, gold, copper, aluminum, chromium, tungsten, and/or alloys thereof. The diameter of the fibers may be in the range of 0.1 μm to 2,000 μm, or 0.5 μm to 1000 μm, or 1 μm to 250 μm. The fabric warp density, defined as the number of fabric warp yarns per inch, may range from 30 warp yarns per inch to 250 warp yarns per inch, or from 35 warp yarns per inch to 230 warp yarns per inch, or from 40 warp yarns per inch to 220 warp yarns per inch. The weft yarn density, defined as the number of weft yarns per inch of the fabric, may range from 20 weft yarns per inch to 300 weft yarns per inch, or 30 weft yarns per inch to 275 weft yarns per inch, or 40 weft yarns per inch to 200 weft yarns per inch. The use of RF electrodes designed as fabrics may prevent undesired physical effects, as the fabrics may comprise openings and/or advantageous positioning of the at least one fiber.
The RF electrode may comprise a conductive polymer, for example in the form of a polymer salt. Such conductive polymers may include aromatic rings and/or at least one double bond. The conductive polymer may include nitrogen and/or sulfur atoms. For example, the conductive polymer may include polypyrrole (PPY), polythiophene (PT), poly 3, 4-ethylenedioxythiophene (PEDOT), poly p-phenylene sulfide (PPS), polyaniline (PANI), polyacetylene (PAC), and/or poly p-phenylene vinylene (PPV).
The one or more RF electrodes that provide RF energy during treatment by the described treatment apparatus may utilize at least one possibility, at least two possibilities, or a combination of these possibilities, as to how to minimize or eliminate the undesired physical effects induced by the magnetic field, as described above. In addition, one or more features of the possibilities may be used in the manufacture, design and operation of the treatment device.
In one example, a combination of the above designs may include the use of an RF electrode having a substrate plated on at least one side with a conductive layer made of a conductive material (e.g., copper and/or nickel), which may include a plurality of openings in the conductive region of the RF electrode.
In some aspects, the RF electrode may have a substrate with at least one side plated with a conductive layer, wherein the electrode region may not include any openings. The therapeutic device combining RF therapy with magnetic therapy may include one or more therapy circuits. The therapy circuit of the RF therapy may include a power source, RF electrodes, and/or all electrical elements described herein for the RF clusters. The therapy circuit for magnetic therapy may include a power source, a magnetic field generating device, all of the electrical elements described herein for magnetic clusters HIFEM. Multiple therapy circuits providing the same or different therapies may include a common power source. Or each therapy circuit may include its own power supply. The operation of all treatment circuits may be regulated by one host unit or one or more control units. The HMI, host voltage, and/or one or more control units may be used for selection, control, and/or adjustment of one or more treatment parameters for each applicator and/or each treatment energy source (e.g., RF electrode or magnetic field generating device). The treatment parameters may be individually selected, controlled and/or adjusted by the HMI, host unit and/or one or more control units of each applicator.
Furthermore, the RF electrode may comprise different RF electrode portions, wherein the transmission of RF signals to the RF electrode portions may be controlled by the control system. For example, the RF electrode may comprise two or more RF electrode portions. The temperature of each RF electrode portion may be detected by one or more temperature sensors in close proximity to or in contact with the RF electrode portion. One or more temperature sensors may be in communication with any portion of the control system. Based on this feedback, the control system can control and manipulate the delivery of RF signals to each RF electrode portion. As described in fig. 54i, 54j, 54l, 54m and/or 54n, the control and transmission of the RF signal to the RF electrode portions may be based on the same principle.
Fig. 17 shows exemplary electrical components of the magnetic circuit 400. The electrical signal passing through the magnetic circuit 400 may be converted into the form of one or more pulses of the electrical signal. The electrical pulses may be provided to a magnetic field generating device to generate pulses of a time-varying magnetic field. The individual electrical components of the magnetic circuit may be a Power Supply (PS), an Energy Storage Device (ESD), a Switch (SW), a Magnetic Field Generating Device (MFGD), and a Control Unit (CUM) of the magnetic circuit. The magnetic circuit may include a treatment cluster for magnetic treatment, referred to as HIFEM clusters. The HIFEM clusters may include, for example, ESD, SW, and/or cul. The control unit of the magnetic circuit CUM may be a component of the control system. The control unit of the magnetic cluster CUM and/or other electrical elements of the magnetic circuit can be slave mechanisms of the host unit. The HIFEM clusters, control systems, and/or CUMs can provide or control electrical energy storage in the ESD by controlling the amount of stored electrical energy. The HIFEM clusters, control systems, and/or the CUMs can provide modification of electrical signals, adjustment of parameters of electrical signals passed through the HIFEM clusters, safe operation of the circuits, and/or charging or recharging of the ESD. For example, the HIFEM cluster or control system may provide for adjustment of the magnetic flux density of the magnetic field provided by MFGD by adjustment of the voltage and/or current of the electrical pulses delivered to MFGD. The modification of the electrical signal may include distortion of the transmitted signal in the magnetic circuit; shape, amplitude and/or envelope distortion in the frequency domain; increased noise of the transmitted electrical signal, and/or other degradation of the transmitted original signal into the magnetic circuit. A cpu may control and/or operate one or more magnetic therapy circuits.
The energy storage device ESD may accumulate electrical energy, which may be provided to the magnetic field generating device in the form of an electrical signal of energy (e.g., in the form of high power pulses). The ESD may include one, two, three, or more capacitors. The ESD may also include one or more other electrical components, such as safety components, such as voltage sensors, high voltage indicators, and/or discharge resistors, as shown in fig. 18 a. The voltage sensor and the high voltage indicator may provide feedback information to the switch SW and/or to the control unit CUM. In a dangerous situation, a discharge resistor as part of the magnetic circuit may provide for the discharge of at least one capacitor. The discharge of one or more ESD may be controlled by the control unit CUM. The discharged electrical energy of the ESD may be delivered as high power pulses and/or pulses to at least a portion of the magnetic circuit, for example to the magnetic field generating device MFGD.
The capacitance of the energy storage device may be in the range of 5nF to 100mF, or in the range of 25nF to 50mF, or in the range of 100nF to 10mF, or in the range of 1 μf to 1mF, or in the range of 5 μf to 500 μf, or in the range of 10 μf to 180 μf, or in the range of 20 μf to 80 μf.
The energy storage device may be charged in a voltage range of 250V to 50kV, 700V to 5kV, 700V to 3kV, or 1kV to 1.8 kV.
The energy storage device may provide a current pulse discharge in the range of 100A to 5kA, 200A to 3kA, 400A to 3kA, or 700A to 2.5 kA. The current may correspond to a value of a peak magnetic flux density generated by the magnetic field generating device.
Furthermore, the energy storage device may provide a current pulse discharge in the range of 1000A to 10,000A or 2000A to 8000A or 2000A or 7500A.
By discharging the energy storage device, high power current pulses may be generated with energies in the range of 5J to 300J, 10J to 200J, or 30J to 150J.
The switch SW may include any switching device such as a diode, pin diode, MOSFET, JFET, IGBT, BJT, thyristor, and/or combinations thereof. The switch may include a modified pulse filter that provides the electrical signal. The pulse filter may suppress switching voltage ripple formed by the switch during ESD discharge.
The magnetic circuit may command the repeatedly on/off switch SW and ESD discharge the energy storage device to a magnetic field generating device, such as a coil, to generate a time-varying magnetic field.
The inductance of the magnetic field generating device may be at most 1H, or in the range of 1nH to 500mH, 1nH to 50mH, 50nH to 10mH, 500nH to 1mH, or in the range of 1 μh to 500 μh or in the range of 10 μh to 60 μh.
The magnetic field generating device may not emit any radiation (e.g., gamma radiation).
The magnetic circuit may comprise a series connection of a switch SW and a magnetic field generating device. The switch SW and the magnetic field generating device together may be connected in parallel with the energy storage device ESD. The energy storage device ESD may be charged by the power source PS. Thereafter, the energy storage device ESD may be discharged through the switch SW to the magnetic field generating device MFGD. During the second half period of the LC resonance, the polarity of the energy storage device ESD may be reversed compared to the power supply PS. Thus, there may be twice the voltage of the power supply. Thus, the power supply and all components to which the magnetic circuit is connected can be designed for high voltage loads, and a protection resistor can be placed between the power supply and the energy storage device.
The magnetic field generating device MFGD and the energy storage device ESD may be connected in series. The magnetic field generating device MFGD may be disposed in parallel with the switch SW. The energy storage device ESD may be charged by the magnetic field generating device. To provide the energy pulse to generate the magnetic pulse (or the pulse used to generate the magnetic pulse), a controlled short circuit of the power supply occurs through the switch SW. In this way, during the second half-cycle of the LC resonance associated with the known device, high voltage loads at the terminals of the power supply PS are avoided. During the second half period of the LC resonance, the voltage at the terminal of the power supply PS may have a voltage equal to the voltage drop of the switch SW.
The switch may be any kind of switching device. Depending on the type of switch, the load of the power supply may be reduced to several volts, for example 1 to 10 volts. Thus, there is no need to protect the power supply from high voltage loads, such as thousands of volts. Thus, the use of protection resistors and protection circuits may be reduced or eliminated.
Fig. 18b shows exemplary electrical components of RF circuit 480. The RF circuitry may provide adjustment and/or modification electromagnetic signals (electrical signals) to the RF electrode (RFE). The RF circuitry may include a Power Supply (PS), a treatment cluster for RF treatment (region labeled RF), a control unit for the RF Cluster (CURF), a Power Amplifier (PA), a splitter, a standing wave ratio for a combined power meter (SWR + power meter), a tuning element (tuning), a splitter, an insulator, a symmetric element (SYM), a pre-matcher, and an RF electrode (RFE). The treatment clusters of RF treatment may include, for example, a Control Unit (CURF) of the RF clusters, a Power Amplifier (PA), filters, standing wave ratio of combined power meters (SWR + power meters), and/or tuning elements (tuning). The control unit of the RF circuit CURF may be a component of the control system. The control unit of the RF circuit CURF and/or other electrical components of the RF circuit may be a slave to the host unit. One or more electrical components described as components of the RF circuit may be eliminated, some electrical components may be combined into one having similar functionality, and/or some electrical components may be added to improve the functionality of the circuit.
The power supply of the RF circuit may provide an electrical signal having a voltage in the range of 1V to 5kV, or 5V to 140V, or 10V to 120V, or 15V to 50V, or 20V to 50V. The power supply of the RF circuit and the power supply of the RF treatment may be the same. The power source for RF therapy may also be referred to as an adapter. The adapter may provide a voltage in the range of 5 to 100 volts, 10 to 80 volts, or 15 to 45 volts. For example, the adapter may provide a voltage of 24 volts. The adapter may include a filter.
CURF may control the operation of any electrical components of the RF circuit. CURF can adjust or modify parameters of the electrical signal delivered through the RF circuit. Parameters of the signal (e.g., voltage, phase, frequency, envelope, current value, signal amplitude, etc.) may be affected by the individual electrical components of the RF circuit, which may be controlled by CURF, the control system, and/or the electrical properties of the individual electrical components of the RF circuit. The electrical components affecting the signals of the RF circuit may be, for example, a Power Supply (PS), a Power Amplifier (PA), a filter, a swr+ power meter, a tuner, a splitter, an insulator, a symmetrical element (SYM) that changes the unbalanced signal to a balanced signal, a pre-matcher, and/or an RF electrode that generates RF waves. Modification of the electrical signal may include distortion of the transmitted signal in the RF circuit; shape, amplitude and/or envelope distortion in the frequency domain; increased noise of the transmitted electrical signal, and/or other degradation of the transmitted original signal into the RF circuitry. One CURF may control and/or operate one or more therapy circuits of the RF therapy.
The power amplifier PA may generate RF signals of corresponding frequencies for generating RF waves through the RF electrode. The power amplifier may be or include a unipolar transistor, a bipolar transistor, a MOSFET, a JFET LDMOS transistor, a field effect transistor, a gallium nitride field effect transistor, or a vacuum tube. The PA may be able to increase the amplitude of the provided signal and/or the modified signal as an electrical signal (e.g., RF signal). The power amplifier may generate an RF signal of a desired power and/or frequency. For example, the power amplifier may generate RF signals having frequencies in the range of 100kHz to 3GHz, 400kHz to 3GHz, or 400kHz to 10 MHz. For example, the power amplifier may generate RF signals having frequencies of 475kHz, 1MHz, 2MHz, 4MHz, 6MHz, 13.56MHz, 40.68MHz, 27.12MHz, or 2.45 GHz. The power amplifier may generate frequencies with deviations in the range of 1% to 10%.
The filters may include one or more filters that may suppress unwanted frequencies of the signal transmitted from the power amplifier. One or more filters may filter and provide treatment with a defined frequency band. Depending on the signal frequency domain, one or more filters may be used to filter electrical signals (such as electrical signals in an RF circuit) to allow only the desired frequency band to pass through. The filter may be capable of filtering out unsuitable signal frequencies based on internal software and/or hardware settings of the filter. The filter may operate in accordance with communication with one or more other electrical components (e.g., CURF). One or more filters may be located between the power supply of the RF signal PSRF and the RFE. However, the device may include additional filters located between various other electrical elements of the device.
The SWR + power meter may measure the output power of the RF energy and evaluate a plurality of impedance matches between the power amplifier and the applicator. The swr+ power meter may include a SWR meter that may measure a standing wave ratio in a wave transmission direction. The swr+ power meter may comprise a power meter that may measure the amplitude of such standing waves. The swr+ power meter may be in communication with CURF and/or tuning elements. Swr+ power meters can provide feedback information to prevent the formation of standing waves within the patient's body, to provide better signal conditioning through tuning elements, and to provide safer treatment and energy transfer to biological structures more efficiently in a more targeted manner. For example, the swr+ power meter may include a power divider that provides a portion of the power to the detector, thereby informing the control system of the parameters of the electrical signal transmitted.
The tuning element may provide an improvement in impedance matching. The tuning element may comprise, for example, a capacitor, LC and/or RLC circuit. The tuning element may provide controlled tuning of the capacity of RF circuitry, wherein the RF circuitry comprises individual electrical elements of the RF circuitry and further comprises currently treated tissue of the patient under the influence of the provided RF waves. Tuning of the RF circuitry may be provided before and/or during the therapeutic device. The tuning element may also be referred to as an adapter. The tuning element may comprise a coil and/or a relay, for example an electromagnetic relay.
The symmetrical element SYM may convert a signal from an unbalanced input to a balanced output. The SYM may be a balun and/or a balancer, including a twisted coaxial cable to balance signals between RF electrodes. The SYM element may be any type of balancer, including a coaxial balancer, a voltage balancer, and/or a current balancer. The SYM element may provide signal symmetry between the first and second bipolar RF electrodes, for example, by creating a lambda/2 phase shift of the RF signal directed through the coaxial cable to the first and second bipolar RF electrodes. The symmetrical element may be present in the applicator or in the main unit. The symmetrical element may also comprise a toroidal coil.
The splitter may split RF signals in the RF circuit that are delivered/delivered through the coaxial cable. The split signals may have the same phase of each split signal and/or the split signals may have a constant phase shift from each other. For example, the splitter may provide a first portion of the RF signal to the first RF electrode and a second portion of the RF signal to the second RF electrode of the bipolar electrode system. The splitter may be shared for one, two, or more independent RF circuits, or each RF circuit may have its own splitter. Further, the separator may provide a first portion of the RF signal to a first RF electrode of the bipolar RF electrode system and a second portion of the RF signal to a second RF electrode, wherein the first and second RF electrodes are housed in one applicator. Further, the separator may provide a first portion of the RF signal to a first RF electrode of the bipolar RF electrode system and a second portion of the RF signal to a second RF electrode, wherein the first RF electrode is housed within a first applicator and the second RF electrode is housed within a second applicator. In the case of a monopolar system, the separator may provide a first portion of the RF signal to a first active monopolar RF electrode and a second portion of the RF signal to a second active monopolar RF electrode, wherein the first and second RF electrodes are housed in one applicator. Further, the separator may provide a first portion of the RF signal to a first active monopolar RF electrode and a second portion of the RF signal to a second active monopolar RF electrode, wherein the first RF electrode is housed in a first applicator and the second RF electrode is housed in a second applicator.
The treatment apparatus may comprise one or more separators. One or more separators may be located within the main unit and/or the applicator. The splitter may include any component that splits a cable (e.g., a transmission line and/or a coaxial cable) carrying an RF signal into at least two cables (e.g., a transmission line and/or a coaxial cable). Further, a splitter may be any component that can split and/or divide power from one output into two or more outputs. In one example, the separator may include a partition portion made of plastic. The separator may comprise a control unit, which is part of the control system. The splitter may split and/or divide the power and/or RF signals equally between the two or more outputs. Furthermore, the splitter may split and/or divide the power and/or RF signals into two or more outputs not equally but at a ratio determined or controlled by the control system.
The insulator may be combined with the separator and/or may be located before and/or after the separator with respect to delivering the RF signal to the RF electrode. The insulator may be at least a portion of the RF circuit electrically isolated from the magnetic circuit. The insulator may be used to minimize the effect of the magnetic circuit on the RF circuitry.
The pre-matcher may be used in a device using coaxial cables. The pre-matcher may include a small coil, a condenser, and/or a resistor.
The RF electrodes (RFEs) (used as a therapeutic energy source) may include one or more unipolar RF electrodes, one or more monopolar RF electrodes, and/or one or more pairs of bipolar RF electrodes.
The power supply PS, power amplifier PA, filter, swr+ power meter, tuner, SYM, splitter, insulator and/or pre-matcher of the RF circuit may be at least partially and/or completely replaced by an HF generator that supplies a high frequency electrical signal to the rest of the circuit, including the RF electrodes.
Fig. 24 shows an example of the symmetrical element SYM. The input coaxial cable 130 provides an electrical signal (e.g., an RF signal) to the splitter 131, and the splitter 131 may split the RF signal into two branches. Separator 131 may also include an insulating element, such as at least one, two, three, or more serially connected capacitors, forming an insulating length in the range of 4mm to 100mm or 20mm to 50 mm. The SYM may be set up or represented by different lengths of coaxial cable leading or leading to the paired bipolar RF electrodes. The difference in length between coaxial cables 132 and 133 at location l 1 may be in the range of 0.4 to 0.6 or 0.46 to 0.55 λ, where λ may be the wavelength of the guided RF signal in coaxial cable 132 and/or coaxial cable 133. The length of the coaxial cable 132 may be in the range of 1cm to 5m, 5cm to 90cm, or 10cm to 50 cm. The length of the coaxial cable 132+135b may be in the range of λ/4±10% or ±5% or a positive integer multiple thereof. The length of the coaxial cable 133 may be in the range of 2m to 12m or 2.2m to 8 m. The length of coaxial cable 133 may be in the range of λ/2±10% or ±5% plus the length of cable 132. The length of the coaxial cable 133+135a may be in the range of 3λ/4±10% or ±5%. In summary, coaxial cable 132+135b is offset by λ/+ -10% or ±5% relative to coaxial cable 133+135a. The SYM of this portion may cause a 180 ° phase shift of the RF signal that is delivered to one of the radio frequency electrodes 101a and 101b. The rf electrodes 101a and 101b may be part of one applicator, or the rf electrode 101a may be part of a first applicator and the rf electrode 101b may be part of a second applicator. The connector 134 may be used to connect one or more applicators to the main unit. The connector 134 may be the applicator connector 65. The component l 2 may represent a connection tube of the applicator. The length of the coaxial cables 135a and 135b in the connection pipe may be in the range of 1m to 6m, or 1.1m to 4m, or lambda/4 + -10% or + -5%. Mating element 136 may be a conductive connection of conductive shielding portions of coaxial cables 135a and 135 b. Mating element 136 may have a surface area in the range of 0.5cm 2 to 100cm 2、1cm2 to 80cm 2 or 1.5cm 2 to 50cm 2. The mating element 136 may comprise a highly conductive material such as copper, silver, gold, nickel, or aluminum, wherein the impedance of the mating element 136 may be nearly zero. Capacitors, resistors, and/or inductors may be placed at mating element 136 or between the mating element and the electrode.
The RF circuitry and/or magnetic circuitry may be located at least partially in one or more applicators. The wire connection between the applicator, the additional treatment device and/or the main unit may also be considered as part of the RF circuit and/or the magnetic circuit element due to the impedance, resistivity and/or length of the wire connection. One or more of the electrical components of the magnetic circuit shown in fig. 17, the RF circuits shown in fig. 18b and 18a may be eliminated, stored in a different order, and/or two or more of the electrical components may form a single combined electrical component. The signal conditioning provided to the RF circuitry may be provided at least in part by or within a different circuit (e.g., magnetic circuitry, etc.) of the therapeutic device.
Fig. 18a shows an exemplary schematic 180 of the electrical components of the treatment device. The exemplary schematic includes two independent power supplies connected to a Power Network (PN), including a power supply for RF therapy (PSRF) and a power supply for magnetic therapy (PSM). The PSRF may provide electromagnetic signals to two independent treatment clusters RF a and/or RF B for RF treatment. The PSM may provide electromagnetic signals to one or more clusters HIFEM A and/or HIFEM B of magnetic treatments. The one or more power sources may also power other components of the treatment device, such as a human-machine interface (HMI) or a host unit, etc. Each magnetic circuit and/or RF circuit may have its own control unit (CUM a, CUM B and CURF A and CURF B). CURF A and CURF B may be control units for an RF therapy cluster for RF therapy a (RF a) and a therapy cluster for RF therapy B (RF B), respectively.
The control unit may comprise one or more PCBs or microprocessors. One or more control units may communicate with each other and/or with a host unit, which may be selected as the host unit for other control units in master-slave communication. The host unit may be a first or sole control unit in communication with the HMI. The host unit may control unit CUMA and CUM B. The host unit may be a control unit comprising one or more PCBs and/or microprocessors. The host unit or control unit a (CUMA) or control unit B (cumb) may be coupled to a human-machine interface. In addition, the host unit may be a human machine interface HMI, or may be coupled to a human machine interface HMI.
Fig. 18a shows two components of a treatment device, wherein a first component may provide RF treatment and a second component may provide magnetic treatment. The two components of the treatment device may be insulated from each other. The treatment device may include one or more electrical elements and/or components of the treatment device that are insulated from each other in a manner that shields the voltage, distance, and/or radiation barriers, as well as separate circuits. An example of an insulating member may be represented in fig. 18a by a dotted line. It is also possible that the individual electrical elements of the treatment device may be insulated from at least one component of the treatment device. Insulation of such components and/or electrical elements may be provided by high dielectric constant materials, by the distance of the individual components and/or electrical elements, by a system of capacitors or resistors. In addition, any shielding known from electronics, physics, by an aluminum box and/or by other means may be used.
RF therapy and/or magnetic therapy may be provided by at least one, two, three, four or more therapy circuits (which may be located in a main unit) and/or applicators, wherein one therapy circuit may comprise an RF cluster or a magnetic cluster. Each applicator a and B (APA and AP B) may include at least one electrical element of one, two or more therapy circuits. Each applicator may include at least one, two, or more different therapeutic energy sources, such as one or more RF electrodes to provide RF therapy and one or more magnetic field generating devices to provide magnetic therapy. As shown in fig. 18a, the treatment device may include a first applicator (APA) and a second applicator (AP B). The first applicator (APA) may include a first RF electrode (RFE a) of a first RF circuit and a first magnetic field generating device (MFGD A) of a first magnetic circuit. The second applicator (AP B) may include a second RF electrode (RFE B) of a second RF circuit and a second magnetic field generating device (MFGD B) of a second magnetic circuit. In different examples, the first applicator may include a first magnetic field generating device and a first pair of bipolar RF electrodes, and the second applicator may include a second magnetic field generating device and a second pair of bipolar RF electrodes. In some aspects, the first applicator may include a first magnetic field generating device, a second magnetic field generating device, and a first pair of bipolar RF electrodes, and the second applicator may include a third magnetic field generating device, a fourth magnetic field generating device, and a second pair of bipolar RF electrodes. The two applicators may be separately connected to the main unit and may be independently positioned in the vicinity of the body part prior to or during treatment, where they are coupled to the body part and contact the body part.
Fig. 18a also shows other independent components of the treatment device, such as a treatment cluster for RF treatment (RF a), a treatment cluster for RF treatment (RF B), a treatment cluster for magnetic treatment HIFEM A in a magnetic circuit, a treatment cluster for magnetic treatment HIFEM B, a power supply for RF treatment (PSRF), a power supply for magnetic treatment (PSM), an applicator a (APA), an applicator B (AP B). All components (except the applicator) may be located in the main unit. The splitter, symmetric element (SYMA), and symmetric element (SYM B) are shown as components of two RF circuits. The splitter shown in fig. 18a may be common to the RF circuitry. The power source for RF therapy (PSRF) may include a steady state power source of RF circuitry (SPSRF), an auxiliary power source of RF circuitry (APS RF), a power network filter PNFLT, and/or a Power Unit (PU). The individual electrical components may not be included in the PSRF with other electrical components. The power source for magnetic therapy (PSM) may include an auxiliary power source a (APS a), an auxiliary power source B (APS B), a steady state power source for magnetic circuits (SPSM), a Power Pump (PP), a plate power source a (bpsa), and/or a plate power source B (bpsb). The individual electrical components may not be included in the PSM with other electrical components. The therapy clusters HIFEMA of the magnetic circuit for magnetic therapy may include a control unit a (CUMA), an energy storage device a (ESD a), a switch a (SWA), a Safety Element (SE), and/or a Pulse Filter (PF). The therapy cluster HIFEM B for magnetic therapy of the magnetic circuit may include a control unit B (CUM B), an energy storage device B (ESD B), and/or a switch B (SW B). Although not shown in fig. 18a, the treatment cluster HIFEM B for magnetic treatment may also include a Pulse Filter (PF) and/or a Safety Element (SE). The individual electrical components may be insulated from each other. However, the individual electrical components and/or circuit elements may be combined and/or shared with other circuit elements. As an example, one control unit may be at least partially shared with two or more RF circuits and/or magnetic circuits, and one control unit may regulate power or a power network or power supply (providing power to the RF circuits and the magnetic circuits). Another example may be at least one auxiliary power supply and/or steady state power supply shared with at least two RF and/or magnetic circuits.
Fig. 18c shows another exemplary schematic 180 of an electrical component. In fig. 18c, both cables output from the splitter are symmetrical by means of a SYM element.
Fig. 18d shows another exemplary schematic 180 of an electrical component. In fig. 18d, the first cable output from the splitter is symmetrical by the SYM element and the second cable leads directly to the corresponding RF electrode. The SYM element may include different lengths of the cable to delay the electrical signal within the cable to achieve phase delay.
Fig. 18e shows another exemplary schematic 180 of an electrical component. In fig. 18e, two pairs of RF electrodes are powered by one RF cluster. Thus, two pairs of RF electrodes may be connected to one power amplifier. Similarly, when there is only one RF electrode in each applicator, both RF electrodes may be connected to one power amplifier. Fig. 18e shows two separators, one for each pair of RF electrodes. However, there may be only one splitter that splits or divides the signal into all four RF electrodes.
Fig. 18f shows another exemplary schematic 180 of an electrical component. As shown in fig. 18f, none of the cables output from the splitter are symmetrical by the SYM element. This configuration may be useful for monopolar configurations of RF electrodes when one or more of the RF electrodes within the applicator are monopolar and another ground plate is placed on the patient. Similarly, such a configuration may be useful for monopolar configurations of RF electrodes when one or more of the RF electrodes within the applicator are monopolar. However, the separator may be omitted and each RF electrode may be directly connected to its own therapy circuit (e.g., RF a). Each RF electrode may be connected to its own PSRF. The RF circuitry may not include all of the illustrated elements. For example, in the case of using a lower RF frequency, the swr+ power meter may be omitted.
Fig. 18g shows another exemplary schematic 180 of an electrical component. In fig. 18g, two pairs of RF electrodes are powered by one RF cluster. Thus, two pairs of RF electrodes may be connected to one power amplifier. Similarly, when there is only one RF electrode in each applicator, both RF electrodes may be connected to one power amplifier. Fig. 18g also shows two separators, one for each pair of RF electrodes. However, there may be only one splitter that splits or divides the signal into all four RF electrodes. Fig. 18g also shows select elements that may be present in the RF circuit. The selection element may be configured to provide RF signals to the first pair of RF electrodes or the second pair of RF electrodes so as to be activated at different times. The selection element may be configured to provide RF signals to the two pairs of RF electrodes at the same time or at different times during treatment via one or more separators.
Fig. 18h shows another exemplary schematic 180 of an electrical component. In fig. 18h, two pairs of RF electrodes within one applicator are powered by one RF cluster. Thus, two pairs of RF electrodes may be connected to one power amplifier. Similarly, when there is only one RF electrode in each applicator, both RF electrodes may be connected to one power amplifier. Fig. 18h also shows select elements that may be present in the RF circuit. The selection element may be configured to provide RF signals to one or more RF electrodes to activate at different times. Fig. 18h depicts a selection element without a divider. By including one or more selection elements according to this approach, the selection elements may provide RF signals to only one RF electrode. However, the selection element may provide RF signals to multiple RF electrodes of the same applicator and/or different applicators.
Fig. 18i shows another exemplary schematic 180 of an electrical component. In fig. 18h, two pairs of RF electrodes within one applicator are powered by one RF cluster. Thus, two pairs of RF electrodes may be connected to one power amplifier. Fig. 18i also shows two selection elements that may be present in the RF circuit. The first selection element may be configured to provide RF signals to one or more RF electrodes within the first applicator so as to be activated at different times. The second selection element may be configured to provide RF signals to one or more RF electrodes within the second applicator to activate at different times and/or at the same time. Fig. 18i includes two selection elements without a divider. By including two selection elements according to this scheme, each selection element may provide RF signals to only one or more RF electrodes of one applicator.
The selection elements shown in fig. 18g, 18h and 18i may be configured to select which RF electrode, RF electrodes or RF electrode pairs, or RF electrodes to transmit RF signals to. The one or more selection elements may be located in the main unit of the device and/or in the applicator. The selection element may comprise a pin diode, a relay, a multiplexer, a demultiplexer and/or a pair of multiplexers and demultiplexers. The selection element may comprise a multiple-input multiple-output switch. The multiplexer may comprise a multiple-input single-output switch. The demultiplexer may comprise a single-input multiple-output switch. The selection element may comprise an RF switch. Furthermore, the selection element may comprise a parallel connection of two or more pin diodes, relays, multiplexers, demultiplexers and/or pairs of multiplexers and demultiplexers. A parallel configuration may be useful when multiple electrodes need to be activated. With respect to the location of the selection element in the circuits shown in fig. 18g, 18h and 18i, this location is exemplary. It is possible to locate the selection element between any electrical elements of the RF clusters or the RF circuitry. Thus, the selection element may be located between the swr+ power meter and the tuner, between the power amplifier and the filter, or between the filter and the swr+ power meter.
As shown in fig. 18a, 18c, 18d and 18f, two treatment clusters (RFA and RF B) for RF treatment are shown connected to one RF treatment power supply. However, the device may include two RF treatment power sources, and each RF treatment power source may be shown connected to one RF electrode. Further, fig. 18c shows one splitter for a cable from one treatment cluster (e.g., RF a) and another splitter for a cable from another treatment cluster (e.g., RF B). As previously described, the splitter splits and/or divides the RF signal into two cables. The two cables from each separator are connected to two RF electrodes within one applicator. As shown, the two RF electrodes within one applicator are connected to two cables originating from one separator. However, it is possible to connect two electrodes within one applicator to two cables, wherein the first cable is from one separator and the second cable is from the other separator.
The therapy cluster HIFEMA for magnetic therapy may provide magnetic therapy independent of the therapy cluster HIFEM B for magnetic therapy. Or the treatment device may include only one treatment cluster HIFEM for magnetic treatment, or the treatment device may include two or more independent treatment clusters for magnetic treatment, wherein some treatment clusters HIFEM for magnetic treatment may share independent electrical elements, such as control units, energy storage devices, pulse filters, and the like.
As shown in fig. 18a, a treatment cluster HIFEM (e.g., HIFEMA) for magnetic treatment may include a control unit, such as CUMA. The control unit (e.g., CUM A) can control charging and/or discharging of the energy storage device (e.g., ESD A), process feedback information, and/or adjust parameters of the individual electrical components and/or treatment clusters HIFEM for magnetic treatment. Further, the control unit (e.g., CUMA) may control: adjust parameters or operations of the electrical components (e.g., BPS a of circuit component PSM, switch, PF, ESD a of treatment cluster HIFEMA for magnetic treatment), and/or process information of sensors in applicators APA and/or AP B. The control unit (e.g., CUMA) may also be in communication with other one or more magnetic and/or RF circuits, and/or include a host unit. The power supply PSM, the energy storage device ESD, and/or the switch SW may be at least partially regulated by a control unit of a magnetic circuit (e.g., CUMA). One or more individual electrical components of the control unit (e.g., CUMA) or the host unit and/or the circuit may be regulated by any other electrical component based on their intercommunication. The host unit may be able to adjust the treatment parameters of the magnetic treatment and/or the RF treatment based on feedback information provided from the sensors and/or based on communication with other control units (e.g., the host unit). One control unit CUM or CURF can individually adjust one or more circuits that provide magnetic and/or RF therapy. At least one control unit may utilize peer-to-peer communication and/or master-slave communication with other control units (e.g., CUMA may be a slave control unit of the host unit).
The treatment device may include one, two, three, or more ESDs, wherein each ESD may include one, two, three, or more capacitors. One ESD may provide energy to one, two, three, or more therapeutic energy sources, such as a magnetic field generating device that provides magnetic therapy. Each coil may be coupled to its own respective ESD or to more than one ESD. The ESD may include one or more other electrical elements, such as a safety element SE, such as a voltage sensor, a high voltage indicator, and/or a discharge resistor, as shown in fig. 18 a. The voltage sensor and the high voltage indicator may provide feedback information to the switch SW and/or the control unit, e.g. the CUM a. In a dangerous situation, a discharge resistor as a component of the SE may provide for the discharge of at least one capacitor. Discharge of one or more ESDs may be controlled by a control unit (e.g., cure a or cure B). The signal provided from the energy storage device ESD to the magnetic field generating device through the switch SW may be modified by a Pulse Filter (PF). The PF may be a component of the switch SW, and/or may be located between the switch SW and the magnetic field generating device (e.g., MFGD A). The PF may suppress a switching voltage ripple formed by the switch during discharge of the ESD. The proposed circuit can repeatedly turn on/off the switch SW and ESD discharge the energy storage device to the magnetic field generating device (e.g., MGFD A) to generate a time-varying magnetic field. As shown in fig. 18a, one or more electrical elements of the magnetic circuit and/or RF circuit may be omitted and/or combined into the other. For example, one or more separate electrical elements of the PSRF and/or PSM may be combined into one, but the independence of the separate circuits may be reduced. In addition, the electrical components, PF, SE, etc. may be individual electrical components. In addition, the independent therapy circuits (e.g., RF circuits) may be different from one another, as can be seen in fig. 18a and 18b, wherein electrical elements (such as filters, swr+ power meters, tuners, splitters, insulators, SYM, and/or pre-matchers) may be eliminated and/or combined into one. The elimination and/or combination of the individual electrical components may result in reduced efficiency of energy transfer to the patient's body (no tuning), higher energy loss (due to absence of SYM, pre-matcher and/or tuning), signal conditioning faults in the circuit, and incorrect feedback information (no SWR + power meter, separator and insulator); and/or without swr+ power meters, SYM, and/or tuning elements, the treatment device may be dangerous to the patient.
The control units CUM A and CUM B can act as slaves to the master unit, which can instruct both the control units CUMA and CUM B to discharge current to the respective magnetic field generating devices (e.g., MFGD A and MFGD B). Thus, the control of each control unit CUMA and CUM B is independent. Or CUM B can be a slave to CUMA, while CUM A itself can be a slave to the host unit. Thus, when the host unit instructs the CUM A to discharge current into a magnetic field generating device (e.g., MFGD A), the CUM A can instruct the CUM B to discharge current into another magnetic field generating device (e.g., MFGD B) located in a different applicator. In some aspects, additional control units may be located between the host unit and control units CUM A and CUM B, where such additional control units may provide timing of discharge, for example. By both methods, the pulses of the magnetic field may be applied simultaneously or simultaneously.
When the treatment device comprises more than one magnetic field generating device and the treatment method comprises using more than one magnetic field generating device (e.g. coils), each coil may be connected to a respective magnetic circuit. However, one coil may be connected to a plurality of magnetic circuits. In addition, a power supply PSM may be used for at least two magnetic field generating devices.
The power source (e.g., PSM and/or PSRF) may provide electrical energy to at least one of the RF circuitry, the magnetic circuitry, or at least one independent electrical element, and/or to another component of the treatment device, such as the host unit, HMI, an energy storage device (e.g., ESD a and/or ESD B), a control unit (e.g., CUMA and/or cut B), and/or a switch (e.g., SWA or SW B). The power supply may comprise one or more elements that convert the electrical energy of the power network connection PN, as shown in fig. 18 a. Some of the individual electrical components of the power supply, RF circuitry and/or magnetic circuitry may be configured as one common electrical component and need not be configured as separate electrical components as shown in fig. 18 a. Each RF and/or magnetic circuit may have its own power source and/or at least one electrical element of the power source that powers only one of the RF and/or magnetic circuits. Additionally, at least a portion of one power source may energize at least two different circuits before and/or during at least a portion of the treatment. The power source may include one or more portions that are shared with separate electrical circuits that may be at least partially electrically isolated from each other.
One or more electrical components of the power supply for RF therapy (e.g., steady State Power Supply (SPSM) of the magnetic circuit, auxiliary power supply APS a and/or APS B, power pump PP, board-mode power supply BPS a and/or bpsb) may provide electrical energy directly and/or indirectly to the RF circuit and/or to individual electrical components of the magnetic circuit. The directly supplied electrical energy is provided by a conductive connection between two electrical elements, wherein the other electrical elements of the circuit are not connected in series to the directly supplied electrical element. Insulation of the circuit and/or other electrical components (such as resistors, insulating capacitors, etc.) may not be considered electrical components. The indirectly powered electrical element may be powered by one or more other elements that provide electrical energy through any other element that may change a parameter of the provided electrical energy, such as a current value, frequency, phase, amplitude, etc.
The power supply PSM shown in more detail in fig. 18a may comprise a connection to a power network PN. The PN may provide filtering and/or other adjustment of the input electrical signal of the power network, such as frequency and current values. PN can also be used as an insulating element, which forms a barrier between the treatment device and the power network. The PN may include one or more of a capacitor, a resistor, and/or a filter that filters the signal returned from the treatment device. The PN may include a plug or a connection to a plug. The PN may be coupled to a plug or to a power grid. The PSM may include one or more steady state power supplies (e.g., steady state power supply SPSM of the magnetic circuit), auxiliary power supplies (e.g., APS a and/or APS B), one or more power pumps PP, and/or one or more plate-type power supplies (e.g., BPS a and/or BPS B). As shown in fig. 18a, the treatment device may comprise at least two electrically insulating magnetic and/or RF circuits, which may be controlled at least partly individually, e.g. the strength of the magnetic field generated by the magnetic field generating devices MFGD A and MFGD B connected to the treatment clusters HIFEMA and HIFEM B for magnetic treatment may be different. Under different power network conditions, a steady State Power Supply (SPSM) may provide a steady state output voltage. The steady state power supply SPSM can be connected to auxiliary power supplies (e.g., APS a and/or APS B). Two auxiliary power sources may be combined and form one electrical element. The steady state output voltage generated by the steady state power supply and/or auxiliary power supply may be in the range of 1V to 1000V, or 20V to 140V, or 50V to 700V, or 120V to 500V, or 240V to 450V.
The one or more auxiliary power supplies may power one or more control units of the independent circuit. The APS may also power one or more plate power BPS (e.g., BPS a and/or bpsb). The APS may also power the host unit HMI and/or other elements of the treatment device. Due to the APS, the at least one control unit and/or host unit may accurately, individually provide for the processing/adjustment of electrical signals in the RF and/or magnetic circuits, and/or the individual electrical components of the treatment device may also be protected from overload. A plate-type power supply (e.g., elements BPS a and/or bpsb) may be used as a source of electrical energy for at least one element of the magnetic circuit (e.g., energy storage devices ESD a and/or B). Or one or more elements of the power supply PSM may be combined and/or eliminated.
The power supply may be used as a high voltage generator that provides a voltage to the magnetic circuit and/or the RF circuit. The voltage provided by the power supply may be in the range 500V to 50kV, or 700V to 5kV, or 700V to 3kV, or 1kV to 1.8 kV. The power supply can deliver a sufficient amount of electrical energy to each circuit, such as to any electrical component (e.g., energy storage device ESD a) and magnetic field generating device (e.g., MFGD A). The magnetic field generating device may repeatedly generate a time-varying magnetic field with parameters sufficient to cause muscle contraction.
According to fig. 18a, the rf circuit has its own power supply PSRF, which may be at least partially different from PSM. The PSRF may include electrical components PNFLT, PNFLT that suppress electromagnetic radiation of the internal components of the PN and/or any components of the RF circuitry. Electrical element PNFLT may represent a power network filter. However PNFLT can also be a component of PN. The PSRF may include SPSRF that provides a steady state output voltage to an auxiliary power supply APS RF of the RF circuit, a control unit of the RF circuit, a power unit PU, and/or other electrical components utilizing a direct current source under different power network conditions. As further shown in fig. 18a, APS RF may include its own mechanism that converts ac to dc independently of SPSRF. APS RF may be capable of powering a control unit and/or a host unit of a treatment cluster RF a for RF treatment, while SPSRF may individually power a control unit of a treatment cluster RF B for RF treatment. The power unit PU of the RF circuit may power one or more RF circuits or at least one electrical element of the RF circuit, such as a power amplifier and/or other electrical elements of the treatment cluster RF a for RF treatment and/or the treatment cluster RF B for RF treatment, thereby forming and/or adjusting a high frequency signal.
At least one electrical element described as PSM, PSRF, APS, SPSM and/or SPSRF may be shared by at least one RF circuit and magnetic circuit.
The control unit CURF may act as a slave to the host unit that may instruct CURF to provide RF signals to the RF electrodes through the RF circuitry. In the case of two control units CURF, the control units each act as a slave to the host unit, which can instruct both control units CURF to provide RF signals to the respective RF electrodes. Thus, each control unit is independent from the control of possibly multiple CURF. Or the first CURF may be a slave to the second CURF and the first CURF itself may be a slave to the host unit. Thus, when the host unit instructs the first CURF to discharge current to the first RF electrode, the first CURF may instruct the second CURF to discharge current to the second RF electrode located in a different applicator. In some aspects, additional control units may be located between the host unit and the plurality of control units CURF, wherein such additional control units may provide timing of, for example, discharge. By both principles, the pulses of the RF field may be applied continuously or in a pulsed manner.
The treatment clusters HIFEMA and HIFEM B for magnetic treatments shown in fig. 17, 18a, and 18b may be controlled by one or more sliders or rollers associated with an HMI component, labeled HIFEM A and HIFEM B as shown in fig. 7. The user can control or adjust the speed of operation of one or more electrical elements of the treatment clusters HIFEM A and/or HIFEM B for magnetic treatment through an associated intensity scroller, intensity bar, and/or intensity slider shown on the human-machine interface HMI.
In addition, the treatment clusters RF a for RF treatment and RF B for RF treatment shown in fig. 17, 18a and 18B may be controlled by a slider, bar or intensity scroller associated with an HMI component labeled RF a and RF B712 shown in fig. 7. The user can control or adjust the operating speed of one or more electrical elements of the treatment clusters RF a and/or RF B for RF treatment by means of an associated intensity scroller, intensity bar and/or intensity slider shown on the human-machine interface HMI. In addition, by utilizing an associated intensity scroller, intensity bar, and/or intensity slider, a user can control or adjust the rate of transmission of electrical signals through or between treatment clusters RF a or RF B for RF treatment.
The treatment device may comprise two or more applicators, each of which may comprise one magnetic field generating device and one or two RF electrodes. The inductance of the first magnetic field generating device located in the first applicator may be equivalent to the inductance of the second magnetic field generating device located in the second applicator. In addition, the number of turns, winding area and/or non-winding area of the first magnetic field generating device in the first applicator may be equivalent to the number of turns, winding area and/or non-winding area of the second magnetic field generating device in the second applicator. The first magnetic field generating device in the first applicator may provide a magnetic field equivalent to the second magnetic field generating device in the second applicator. The equivalent magnetic fields provided by the plurality of magnetic field generating devices during the same or other treatment phases may have the same treatment parameters, such as the number of sequential pulses, the number of burst pulses, the same magnitude of the magnetic flux density of the pulses, the same envelope shape, etc. However, in an equivalent magnetic field, reasonable deviations in the magnitude of the magnetic flux seal, for example, can be tolerated. The amplitude deviation of the magnetic flux density or the average magnetic flux density as measured by a fluxgate or oscilloscope may be in the range of 0.1% to 10% or 0.1% to 5%.
Or the inductances of the magnetic field generating devices in the two applicators may be different. In addition, the magnetic fields provided by the plurality of magnetic field generating devices during the same or other treatment phases may have different treatment parameters.
When the treatment device has two or more applicators, each applicator may include one magnetic field generating device and one or two RF electrodes. The size or area of one RF electrode located in the first applicator may be equivalent to the other RF electrode locations in the second applicator. The first applicator and the second applicator may provide equivalent RF fields provided during the same or other treatment phases, wherein the equivalent RF fields may have the same treatment parameters, e.g., frequency, wavelength, phase, time period, power, and intensity of the RF fields. However, the first applicator and the second applicator may provide two RF fields during the same or different treatment periods, wherein the two RF fields may have different treatment parameters.
Or the area size of the RF electrodes in the two applicators may be different. In addition, the magnetic fields provided by the plurality of magnetic field generating devices during the same or other treatment phases may have different treatment parameters.
Fig. 19a shows an exemplary composition of a magnetic field (e.g., a time-varying magnetic field) provided by a magnetic field generating device. Fig. 19a shows an exemplary composition of the RF field. Fig. 19b shows an exemplary composition of an RF field applied in pulses, including pulses and pulse rates. Thus, in the description of fig. 19a and 19b in particular, the term "pulse" may refer to a "magnetic pulse" or an "RF pulse". Similarly, the term "pulse" may refer to a "magnetic pulse" or an "RF pulse. In addition, the term "sequence" may refer to a "magnetic sequence". The term "magnetic sequence" may include a sequence of magnetic pulses, wherein a sequence of magnetic pulses may be understood as a plurality of magnetic pulses, one pulse following the other pulse. Since the magnetic pulse may comprise one magnetic pulse, the term "magnetic sequence" may also comprise a sequence of magnetic pulses. The term "burst" may refer to a "magnetic burst".
As shown in fig. 19a or 19b, a pulse may refer to a period of applied therapeutic energy (e.g., a magnetic field) that has sufficient intensity to cause at least a portion of a therapeutic effect, such as at least a portion of a muscle contraction, a temperature change of a biological structure, and/or a nerve stimulation. The magnetic pulse may comprise a biphasic shape as shown in fig. 19 a. The magnetic pulse may include an amplitude of the magnetic flux density.
Magnetic pulses may refer to periods of time including passive periods of pulses and pulse rates. The magnetic pulse may refer to a period of one magnetic pulse and a passive period, i.e. a duration between two pulses from a rising/falling edge to a successive rising/falling edge. The passive duration of the pulse may include not applying therapeutic energy to the patient's body and/or applying therapeutic energy insufficient to cause at least a portion of the therapeutic effect due to insufficient therapeutic energy intensity (e.g., magnetic flux density) and/or frequency of therapeutic energy delivered. Such a period of time may be referred to as a pulse duration. As shown in fig. 19a, each pulse may comprise a two-phase shaped duration, referred to as a pulse duration. Or the pulses or pulse rate may be monophasic.
As further shown in fig. 19a or 19b, a plurality of pulses may form a sequence. A sequence may refer to a plurality of pulses, wherein a sequence may comprise at least two pulses, wherein the pulses follow each other. The sequence may last for a duration of time T 1 as shown in fig. 19a or fig. 19 b.
The magnetic sequence may comprise a plurality of magnetic pulses in the range of 2 magnetic pulses to 200000 magnetic pulses or 2 magnetic pulses to 150000 pulses or 2 magnetic pulses to 100000 magnetic pulses. The magnetic sequence may cause at least a partial muscle contraction or a muscle contraction, at least one incomplete tonic muscle contraction, at least one excessive contraction, or at least one complete tonic muscle contraction, one by one, a plurality of times. During the application of a sequence, the magnetic field may provide a muscle contraction followed by a muscle relaxation. During the application of one sequence, the muscle relaxation may be followed by another muscle contraction. During a sequence, the muscle work cycle (which may include muscle contraction followed by muscle relaxation) may be repeated at least two, three, four or more times.
An outbreak may refer to one sequence provided during time period T 1 and time period T 2, and time period T 2 may represent a time period when no therapeutic effect is elicited. The period T 2 may be a period of time that provides passive therapy in which therapeutic energy is not applied to the patient's body and/or the applied therapeutic energy is insufficient to cause a therapeutic effect. The period T 3 shown in fig. 19a or 19b may represent a sustained application of the burst.
The magnetic sequence of the time-varying magnetic field may then be a static magnetic field, and/or the magnetic sequence may then be a time-varying magnetic field of insufficient frequency and/or magnetic flux density to cause at least a portion of the muscle to contract or muscle to contract. For example, the burst may provide at least a partial muscle contraction at least once, followed by no muscle contraction. In some aspects, the burst provides at least one muscle contraction followed by no muscle contraction. The treatment may include a number of magnetic bursts in the range of 15 to 25000, or in the range of 40 to 10000, or in the range of 75 to 2500, or in the range of 150 to 1500, or in the range of 300 to 750, or at most 100000. The repetition rate of successive bursts may be incrementally increased/decreased in increments of 1Hz to 200Hz, or 2Hz to 20Hz, or 5Hz to 15Hz, or above 5 Hz. Or the magnitude of the magnetic flux density may change in successive bursts, such as increasing/decreasing incrementally by at least 1%, 2%, or 5% or more of the increment of the previous pulse frequency. During the application of a burst, the magnetic field may provide a muscle contraction followed by a muscle relaxation. During the application of the same burst, the muscle relaxation may be followed by another muscle contraction. During an explosion, the muscle work cycle (which may include muscle contraction followed by muscle relaxation) may be repeated at least two, three, four or more times.
In addition, the therapeutic duty cycle may be associated with the application of pulsed therapeutic energy of the magnetic field, as shown in fig. 19 a. The treatment duty cycle may refer to the ratio between the time of active treatment T 1 and the sum of the times of active and passive treatment during one period T 3.
An exemplary therapeutic duty cycle is shown in fig. 19a or 19 b. A duty cycle of 10% means that the active treatment T 1 lasts 2s and the passive treatment T 2 lasts 18s. In the present exemplary treatment, period T 3, which includes both active and passive treatments, lasts 20 seconds. The treatment duty cycle may be defined as the ratio between T 1 and T 3. The treatment duty cycle may be at 1:100 (it means 1%) to 24:25 (it means 96%), or 1:50 (it means 2%) to 4:6 (it means 67%), or 1:50 (it means 2%) to 1:2 (it means 50%), or 1:50 to 1:3 (it means 33%), or 1:50 (it means 2%) to 1:4 (it means 25%), or 1:20 (it means 5%) to 1:8 (it means 12.5%), or 1:100 (it means 1%) to 1:8 (it means 12.5%), or at least 1:4 (it means at least 25%).
An exemplary application of a burst repetition rate of 4Hz may be a time-varying magnetic field applied to the patient, with a repetition rate of 200Hz and a therapeutic duty cycle of 50% in sequences lasting 125ms, i.e., each sequence comprising 25 pulses. An alternative exemplary application of a burst repetition rate of 6 bursts per minute may be a time-varying magnetic field applied to the patient, with a repetition rate of 1Hz and a therapeutic duty cycle of 30% in sequences lasting 3s, i.e. each sequence comprising 3 pulses.
Fig. 19b may also show an exemplary composition of the order components provided by the RF electrode.
When the treatment device utilizes multiple applicators (e.g., two), each applicator may include a magnetic field generating device. Since each magnetic field generating device may provide a respective magnetic field, a plurality of applicators may provide different magnetic fields. In this case, the magnitudes of the magnetic flux densities of the magnetic pulses or pulse rates may be the same or different, as specified by the user through the HMI and/or by one or more control units.
The pulses of one magnetic field provided by one magnetic field generating device (e.g. a magnetic coil) may be generated and applied in synchronization with the pulses of the other magnetic field provided by the other magnetic field generating device. During a treatment phase with a treatment device comprising two magnetic field generating devices, pulses of one magnetic field provided by one magnetic field generating device may be generated in synchronization with pulses of a second magnetic field provided by a second magnetic field generating device. Synchronous generation may include simultaneous generation.
Synchronous generation of magnetic pulses may be provided by synchronous operation of a switch, an energy storage device, a magnetic field generating device, and/or other electrical elements of the plurality of magnetic therapy circuits. However, the synchronous operation of the electrical components of the magnetic therapy circuit may be commanded, adjusted or controlled by the user through the HMI, the host unit and/or the plurality of control units.
Fig. 27a shows simultaneous generation of magnetic pulses of two exemplary magnetic field generating devices of simultaneous type. The Magnetic Field Generating Device A (MFGDA) may generate a first magnetic field including a plurality of biphasic magnetic pulses 271a. The magnetic field generating device B (MFGD B) may generate a second magnetic field comprising a plurality of magnetic pulses 271B. The magnetic pulses of the two magnetic fields are generated during the pulse duration 272 of the magnetic pulse 271a of the first magnetic field. In addition, pulses of both magnetic fields are generated within the pulse duration 273 of the first magnetic field. The simultaneous generation of magnetic fields means that the magnetic pulses 271a of the first time-varying magnetic field are generated at the same time as the magnetic pulses 271b of the second time-varying magnetic field.
The synchronous generation of the magnetic fields may include generating a first pulse of the first time-varying magnetic field such that the first pulse lasts for a period of time from a beginning of the first pulse of the first time-varying magnetic field to a beginning of a next successive pulse of the first time-varying magnetic field; and generating, by the second magnetic field generating device, a second pulse of the second time-varying magnetic field such that the second pulse lasts from the beginning of the first pulse of the second time-varying magnetic field to the beginning of the next successive pulse of the second time-varying magnetic field. Synchronous generation of the magnetic field means that a first pulse of the second time-varying magnetic field is generated during a period of the first pulse.
Fig. 27b shows an example of synchronous generation of magnetic pulses. The Magnetic Field Generating Device A (MFGDA) may generate a first magnetic field including a plurality of biphasic magnetic pulses 271a. The magnetic field generating device B (MFGD B) may generate a second magnetic field comprising a plurality of magnetic pulses 271B. The magnetic pulse 271b of the second magnetic field may be generated during the pulse duration 273 of the pulse of the first magnetic field but outside the pulse duration 272 of the pulse of the first magnetic field.
Fig. 27c shows another example of synchronous generation of magnetic pulses. The Magnetic Field Generating Device A (MFGDA) may generate a first magnetic field including a plurality of biphasic magnetic pulses 271a. The magnetic field generating device B (MFGD B) may generate a second magnetic field comprising a plurality of magnetic pulses 271B. The magnetic pulse 271b of the second magnetic field may be generated during the pulse duration 273 of the pulse of the first magnetic field. In addition, the magnetic pulse 271b of the second magnetic field may be generated during the pulse duration 272 of the pulse of the first magnetic field. The beginning of the magnetic pulse 271b of the second magnetic field may be separated from the beginning of the pulse 271a of the first magnetic field by a period of time called pulse offset 274. The pulse offset may be in the range of 5 to 10ms, or 5 to 1000 mus, or 1 to 800 mus.
Fig. 27d shows yet another example of synchronous generation of magnetic pulses. The Magnetic Field Generating Device A (MFGDA) may generate a first magnetic field including a plurality of biphasic magnetic pulses 271a. The magnetic field generating device B (MFGD B) may generate a second magnetic field comprising a plurality of magnetic pulses 271B. The magnetic pulse 271b of the second magnetic field may be generated within the pulse duration 273 of the pulse of the first magnetic field. The magnetic pulse 271b of the second magnetic field may be generated outside the pulse duration 272 of the pulse of the first magnetic field. The beginning of the magnetic pulse 271b of the second magnetic field may be separated from the end of the magnetic pulse 271a of the first magnetic field by a period of time referred to as a pulse distance period 275. The pulse distance period may last in the range of 5 to 10ms, or 5 to 1000 mus, or 1 to 800 mus.
In addition to synchronous generation, the magnetic pulses of the plurality of magnetic fields may also be generated separately. The separate generation of the magnetic pulses of the magnetic field may include the generation of pulses of one magnetic field that are generated outside the pulse duration of another magnetic field.
Fig. 27e shows an example of separate generation of magnetic pulses. The magnetic field generating device a may generate a first magnetic field comprising a sequence of biphasic magnetic pulses 271a having a pulse duration 272 a. Each magnetic pulse 271a is a portion of a pulse having a pulse duration 273 a. The pulse duration 272a of the first magnetic field may be a fraction of the pulse duration 273a of the first magnetic field. The sequence of the first magnetic field may have a sequence duration 276a. The magnetic field generating device B may generate another magnetic field comprising another sequence of a plurality of magnetic pulses 271B having a pulse duration 272B. Each magnetic pulse 271b is a portion of a pulse having a pulse duration 273 b. The pulse duration 272b of the second magnetic field may be a fraction of the pulse duration 273b of the second magnetic field. The sequence of the second magnetic field may have a sequence duration 276b. The sequence with sequence duration 276a is generated by magnetic field generating device a at a different time than the sequence with sequence duration 276B is generated by magnetic field generating device B. The two sequences may be separated by an independent period 277, which independent period 277 may be in the range of 1ms to 30 s. During the independent period 277, the magnetic field generating device may be inactive, meaning that the energy storage device providing the current pulses may not store any energy.
All examples of synchronous or independent generation of magnetic pulses may be applied during one treatment phase. In addition, the pulse offset and/or pulse distance period may be calculated for any magnetic pulse 271B of a second or further magnetic field, which may be positioned according to any of the examples given by fig. 27B-27E. The pulse offset and/or pulse distance period may be measured and calculated from oscilloscope measurements. The synchronous generation of magnetic pulses may lead to and infer that magnetic pulses and/or sequences are generated by the synchronization of two or more magnetic field generating devices. Similarly, independent generation of magnetic pulses may result in and infer that magnetic pulses and/or sequences are generated by two or more magnetic field generating devices individually.
The adjustments or controls provided by the host unit and/or one or more control units may be used for the formation or shaping of the magnetic envelope or RF envelope. For example, the magnetic pulse or RF pulse may be modulated for the amplitude of each pulse or pulses to allow assembly of various envelopes. Similarly, the amplitude of the RF energy may be modulated with respect to amplitude to assemble various envelopes. The host unit and/or one or more control units may be configured to provide for the assembly of one or more envelopes described herein. The differentially shaped magnetic envelope and/or RF envelope (also referred to herein as the envelope) may be perceived differently by the patient. The envelope of the present application (or all envelopes shown in the figures) may be fitted to a curve by the amplitude of the magnetic flux density of the pulses, pulses or sequences and/or amplitudes of the power output of the RF pulses of the RF wave.
The envelope may be a magnetic envelope formed by magnetic pulses. The magnetic envelope formed by the pulses may comprise a plurality of pulses, for example at least two, three, four or more consecutive magnetic pulses. Successive magnetic pulses of such a magnetic envelope may follow each other. In the case of such an envelope, the envelope duration starts with the first pulse and ends with the last pulse of the plurality of pulses. The envelope may comprise a sequence of magnetic pulses. The envelope may be a fitted curve of the magnitude of the magnetic flux density through the pulse. Thus, the envelope formed by the magnetic pulses may define a sequence shape according to the magnetic flux density of the magnetic pulses, the repetition rate, and/or the modulation of the pulse duration. Thus, the envelope may be an RF envelope formed by the RF pulse and its envelope modulation, repetition rate or pulse duration of the RF pulse of the RF wave.
The envelope may be a magnetic envelope formed by magnetic pulses. The magnetic envelope formed by the pulses may include a plurality of pulses (e.g., at least two, three, four, or more consecutive magnetic pulses), wherein the pulses follow each other without any missing pulses. In such a case, the envelope duration may begin with the pulse of the first pulse and end with the passive duration of the last pulse of the plurality of pulses. Thus, the envelope formed by the magnetic pulses may define a sequence shape according to the modulation of the magnetic flux density, repetition rate, and/or pulse duration. The envelope may comprise a sequence of magnetic pulses. The sequence includes magnetic pulses in a pattern that is repeated at least twice during the protocol. The magnetic envelope may be a fitted curve of the magnitude of the magnetic flux density through the pulse.
The envelope may be a magnetic envelope formed from a magnetic sequence. The magnetic envelope formed from the sequences may include a plurality of sequences (e.g., at least two, three, four, or more consecutive magnetic sequences), wherein the sequences follow each other with a duration between the sequences. In such cases, the envelope duration may begin with a pulse of the first sequence and end with a passive duration of the plurality of pulses. Multiple sequences in an envelope may be separated by missing pulses including pulses. The number of missing pulses may be in the range of 1 to 20 or 1 to 10.
The envelope may be modulated for various offset values of the magnetic flux density. The offset value may be in the range of 0.01T to 1T, or 0.1T to 1T, or 0.2T to 0.9T. The offset value may correspond to a non-zero value of the magnetic flux density.
During one treatment phase, the treatment device may apply a variety of numbers of envelopes. Two or more envelopes of the magnetic field may be combined to form a possible resulting shape.
In the above described and examples, the envelope may start with a first pulse. Further, the envelope persists for the duration of the first corresponding pulse comprising the first pulse. In addition, the envelope may end with a passive duration of the last pulse, which may follow the first pulse. This option is shown in the following diagram showing an exemplary shape of the envelope of the magnetic pulse. As shown in the following figures, the envelope shape may be provided by modulation of the magnetic flux density. The shape of the RF envelope may be provided by modulation of the power of the RF wave or the amplitude of the pulses.
Fig. 28 is an exemplary illustration of an increased envelope 281 formed by magnetic pulses 282, where one magnetic pulse 282 is followed by a passive period of magnetic pulse. The magnitude of the magnetic flux density of successive pulses in the envelope is increased. The magnitude of the magnetic flux density of one pulse is higher than the magnitude of the magnetic flux density of the previous pulse. Similarly, the magnitude of the magnetic flux density of the second pulse is higher than the magnitude of the magnetic flux density of the first pulse. Increasing the amplitude may be used for muscle preparation. The envelope duration 283 of the envelope 281 is increased from the beginning of the first pulse to the end of the passive duration of the last pulse of the first pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the boost envelope 281.
Fig. 29 is an exemplary illustration of a reduced envelope 291 formed by a magnetic pulse 292. The magnitude of the magnetic flux density of successive pulses in the envelope is reduced. The magnitude of the magnetic flux density of one pulse is lower than the magnitude of the magnetic flux density of the previous pulse. Similarly, the magnitude of the magnetic flux density of the second pulse is lower than the magnitude of the magnetic flux density of the first pulse. The envelope duration 293 of the envelope 291 is reduced from the beginning of the first pulse to the end of the passive duration of the last pulse of the first pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the reduced envelope 291.
Fig. 30 is an exemplary illustration of a rectangular envelope 302 formed by magnetic pulses 303. The magnitude of the magnetic flux density of the pulses in the rectangular envelope may be constant. However, the amplitude of the magnetic flux density of successive pulses may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. The magnitude of the magnetic flux density of the first pulse may be equivalent to the magnitude of the magnetic flux density of the second pulse, wherein the second pulse follows the first pulse. The envelope duration 304 of the rectangular envelope 302 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. The rectangular envelope may be used for induction of muscle contractions or muscle twitches. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble rectangular envelope 302.
Fig. 31 is an exemplary illustration of a combined envelope 311, the combined envelope 311 can be virtually considered as a combination of an added envelope and a rectangular envelope. The combined envelope 311 includes magnetic pulses 312. The magnitude of the magnetic flux density of the pulses in the combined envelope may be increased in the range of 1% to 95% or 5% to 90% or 10% to 80% of the duration of the overall combined envelope. The amplitude of the magnetic flux density of successive pulses in the rectangular portion of the combined envelope may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. The envelope duration 313 of the combined envelope 311 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. The combination envelope as shown in fig. 31 may be used for muscle preparation and induction of muscle contractions or muscle twitches. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble envelope 311.
Fig. 32 is an exemplary illustration of a combined envelope 321, the combined envelope 321 can be virtually considered as a combination of a rectangular envelope and a reduced envelope. The combined envelope 321 includes magnetic pulses 322. The magnitude of the magnetic flux density of the pulses in the combined envelope may be reduced in the range of 1% to 95% or 5% to 90% or 10% to 80% of the duration of the overall combined envelope. The amplitude of the magnetic flux density of successive pulses in the rectangular portion of the combined envelope may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. The envelope duration 323 of the combined envelope 321 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. The combined envelope as shown in fig. 32 may be used for induction of muscle contractions or muscle twitches, and for successive ends of muscle stimulation. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the combined envelope 321.
Fig. 33 is an exemplary illustration of a triangular envelope 331, the triangular envelope 331 being understood as a combination of increasing envelopes immediately preceding decreasing envelopes. The triangular envelope 331 may include a magnetic pulse 332. The triangular shape of the envelope may be asymmetric. In addition, the flatness of one or more lines of the triangular shape may be interrupted by another type of envelope as described herein, such as a rectangular envelope. One triangle envelope may closely follow the other triangle envelope, or may be joined to the other triangle envelope. By combining two triangular envelopes, the resulting envelope may have a saw tooth shape. The envelope duration 333 of the triangular envelope 331 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the triangular envelope 331.
Fig. 34 is an exemplary illustration of a trapezoidal envelope 341. The trapezoidal envelope 341 may include a magnetic pulse 342. The trapezoidal envelope may include an increasing (rising) period T R, a holding period T H, and a decreasing (falling) period T F. During a larger period of time, the magnitude of the magnetic flux density of successive pulses is increased. In addition, during a greater period of time, the magnitude of the magnetic flux density of one pulse is higher than the magnitude of the magnetic flux density of the previous pulse. During the hold period, the amplitude of the magnetic flux density of successive pulses may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. During the decreasing time period, the amplitude of the magnetic flux density of the successive pulses is decreasing. In addition, during the decreasing period, the magnitude of the magnetic flux density of one pulse is lower than that of the previous pulse. The holding period may be interrupted by another holding period having a different predetermined value of the magnetic flux density. Envelope duration 343 of trapezoidal envelope 341 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the trapezoidal envelope 341.
The trapezoidal envelope may be perceived by the patient as being most comfortable for muscle tissue stimulation. The trapezoidal envelope honors the natural process of muscle contraction, i.e., muscle contraction may be time-varying. The intensity of natural muscle contraction increases, remains at its highest intensity and decreases. The trapezoidal envelope corresponds to natural muscle contraction, i.e. the strength of the muscle contraction may correspond to the magnetic flux density. The magnetic flux density increases, remains, and decreases during the duration of the trapezoidal envelope. The same shaped envelope may have an RF field formed by an RF pulse having a suitable amplitude.
The trapezoidal envelope may be interrupted at least once by one or more pulses, bursts and/or sequences that do not fit the shape of the trapezoidal envelope, but after this interruption the trapezoidal envelope may continue to exist.
In addition, the trapezoidal envelope may include multiple sequences, for example, two, three, four, or more sequences. In the case of a trapezoidal shape, the envelope may comprise three sequences. The first sequence may include pulses having an increased magnetic flux density. The magnetic flux density of one pulse may be higher than the magnetic flux density of a second pulse following the first pulse. The second sequence may include pulses having a constant magnetic flux density. However, the operation of the therapeutic device may not provide a strictly constant magnetic flux density to each pulse, and thus the magnetic flux density may oscillate in the range of 0.1% to 5%. The third sequence may include pulses having a reduced magnetic flux density. The magnetic flux density of one pulse may be lower than the magnetic flux density of a second pulse following the first pulse.
Further, the trapezoidal envelope may include multiple bursts, for example two, three, four, or more bursts. In the case of a trapezoidal shape, the envelope may include three bursts. The first burst may include pulses having an increased magnetic flux density. The magnetic flux density of one pulse may be higher than the magnetic flux density of a second pulse following the first pulse. The second burst may comprise pulses having a constant magnetic flux density. However, the operation of the therapeutic device may not provide a strictly constant magnetic flux density to each pulse, and thus the magnetic flux density may oscillate in the range of 0.1% to 5%. The third burst may include pulses having a reduced magnetic flux density. The magnetic flux density of one pulse may be lower than the magnetic flux density of a second pulse following the first pulse.
Fig. 20 shows another exemplary trapezoidal envelope. The vertical axis may represent magnetic flux density and the horizontal axis may represent time. The trapezoidal envelope may be a fitted curve of the magnitudes of the magnetic flux density of the applied pulses during the sequence, where T R is the period of time with an increase in magnetic flux density, referred to as an increase transient time, i.e., the magnitudes of the magnetic flux density may increase. T H is the period of time with the maximum magnetic flux density, i.e., the magnitude of the magnetic flux density may be constant. T F is a time period with reduced magnetic flux density, i.e., the magnitude of the magnetic flux density may be reduced. The sum of T R、TH and T F may be a trapezoidal envelope duration that may correspond to muscle contraction.
The trapezoidal envelope may reduce energy consumption. The trapezoidal shape may improve the cooling of the magnetic field generating device due to lower energy consumption. In addition, the resistive losses may be reduced due to the lower temperature of the magnetic field generating device. Different repetition rates may cause different types of muscle contractions. Each type of muscle contraction may consume a different amount of energy.
Fig. 35 is an exemplary illustration of a trapezoidal envelope 351, the trapezoidal envelope 351 including a larger time period T 1, a first reduced time period T 2, and a second reduced time period T 3. The trapezoidal envelope 351 includes magnetic pulses 352. The greater time period includes pulses having increasing magnitudes of magnetic flux density. The first and second reduced time periods include pulses having reduced magnitudes of magnetic flux density. In the illustrated example, the first reduction period follows a greater period of time and leads the second reduction period. The magnitude of the magnetic flux density of successive pulses is shown to decrease more sharply during the second decreasing time period. Or the magnitude of the magnetic flux density of successive pulses may decrease more sharply during the first decreasing period. The envelope duration 353 of the trapezoidal envelope 351 begins with the first pulse of the first pulse and ends with the passive duration of the last pulse. Thus, the envelope may be a magnetic envelope formed by the RF pulses. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the trapezoidal envelope 351.
Fig. 36 is an exemplary illustration of a trapezoidal envelope 361, the trapezoidal envelope 361 including a first greater time period, a second greater time period, and a reduced time period. Trapezoidal envelope 361 includes magnetic pulse 362. The first and second larger time periods include pulses having increasing magnitudes of magnetic flux density. The first and second larger time periods include pulses having increasing magnitudes of magnetic flux density. In the illustrated example, the second greater time period follows the first greater time period and leads the decrease time period. The magnitude of the magnetic flux density of successive pulses is shown to increase more sharply during a first, larger period of time. Or the magnitude of the magnetic flux density of successive pulses may increase more sharply during a second, larger period of time. Envelope duration 363 of trapezoidal envelope 361 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble trapezoidal envelope 361.
Fig. 37 is an exemplary illustration of a ladder envelope 371, the ladder envelope 371 including a first larger time period T 1, a first hold time period T 2, a second larger time period, a second hold time period, and a decrease time period. The step envelope 371 includes a magnetic pulse 372. During the first and second larger time periods, the magnitude of the magnetic flux density of successive pulses may increase. During the reduction period, the amplitude of the magnetic flux density of successive pulses may be reduced. During the holding period, the amplitude of the magnetic flux density of successive pulses may be constant, or may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. The envelope duration 373 of the step envelope 371 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble the step envelope 371.
Fig. 38 is an exemplary illustration of a staircase envelope 381, the staircase envelope 381 including a first larger time period T 1, a first hold time period T 2, a first decrease time period T 3, a second hold time period T 4, and a second decrease time period T 5. The staircase envelope 381 includes magnetic pulses 382. During a greater period of time, the magnitude of the magnetic flux density of successive pulses may increase. During the first and second reduction periods, the magnitude of the magnetic flux density of successive pulses may be reduced. During the holding period, the amplitude of the magnetic flux density of successive pulses may be constant, or may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. Envelope duration 383 of step envelope 381 begins with the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave may be modulated with respect to amplitude to assemble envelope 381.
Fig. 39 is an exemplary illustration of another type of trapezoidal envelope 391, the trapezoidal envelope 391 including magnetic pulses 392. The trapezoidal envelope may include a larger period T 1, a hold period T 2, and a decrease period T 3. During a larger period of time, the magnitude of the magnetic flux density of successive pulses is increased. In addition, during a greater period of time, the magnitude of the magnetic flux density of one pulse is higher than the magnitude of the magnetic flux density of the previous pulse. During the hold period, the amplitude of the magnetic flux density of successive pulses may oscillate around a predetermined value of the amplitude of the magnetic flux density in the range of 0.01% to 5%. During the decreasing time period, the amplitude of the magnetic flux density of the successive pulses is decreasing. In addition, during the decreasing period, the magnitude of the magnetic flux density of one pulse is lower than that of the previous pulse. The holding period may include another holding period T 4 having a different predetermined value of the magnetic flux density. The envelope duration 393 of the envelope 391 begins with the first pulse of the first pulse and ends with the passive duration of the last pulse. Similarly, the amplitude of the RF wave and/or RF pulse may be modulated with respect to amplitude to assemble envelope 391.
The envelope may include a combined modulation of the magnetic flux density and the repetition rate. Fig. 40 shows an exemplary illustration of a rectangular envelope 401 with a constant magnitude of magnetic flux density. The rectangular envelope 401 may include magnetic pulses 402. Time periods T RR2 and T RR3 show pulses having a higher repetition frequency than the rest of the magnetic pulses during the illustrated rectangular envelope T RR1. The illustrated time periods T RR2 and T RR3 may provide stronger muscle contraction than the rest of the illustrated rectangular envelope. However, all of the illustrated envelopes may include modulation of the repetition rate domain. The envelope duration 403 of the rectangular envelope 401 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Thus, the envelope may be a magnetic envelope formed by the RF pulses. The amplitude of which may also form an amplitude, known as the RF envelope. Similarly, the amplitude and/or repetition rate of the RF pulses may be modulated with respect to amplitude to assemble envelope 401.
As mentioned, the envelope may be formed by a magnetic sequence separated by one or more missing pulses. Fig. 41 shows an envelope formed by a magnetic sequence comprising magnetic pulses 412. As shown, the first sequence comprising a pulse sequence with increased magnetic flux density has a duration T 1. The second sequence comprising pulses with constant or oscillating magnetic flux density has a duration T 2. The third sequence comprising pulses with reduced magnetic flux density has a duration T 3. The envelope 411 comprising a plurality of sequences has a trapezoidal shape. The duration between durations T 1 and T 2 or durations T 2 and T 3 may represent a time gap in which a missing pulse, including a missing pulse, will be located. The envelope duration 413 of the envelope 411 starts from the first pulse of the first pulse to the end of the passive duration of the last pulse. Similarly, the amplitude of the RF wave or RF pulse may be modulated with respect to amplitude to assemble the envelope 411.
During treatment, the magnetic envelopes may be combined. Fig. 42 shows an example of a combination of magnetic envelopes. The increasing envelope 422 with increasing shape comprises a sequence of magnetic pulses 421. The boost envelope 422 may have a duration T E1. Rectangular envelope 423 includes a sequence of magnetic pulses 421. The rectangular envelope may have a duration T E2. The reduction envelope 424 comprises a sequence of magnetic pulses 421. The reduction envelope 424 may have a duration T E3. The resulting sub-period of the treatment regimen formed by the combination of the first, second and third envelopes may provide the same or similar therapeutic effect as the trapezoidal envelopes shown in, for example, fig. 34 and 20. The resulting sub-period of the treatment regimen has a duration 425 from the first pulse of the first pulse to the end of the passive duration of the last pulse of the treatment sub-period. Similarly, the amplitude of the RF wave and/or RF pulse may be modulated with respect to the amplitude to assemble a combination of envelopes.
Fig. 43 shows another example of a combination of magnetic envelopes in which the reduction period has a magnetic flux density different from that of a rectangular envelope. This example may show that a combination of magnetic envelopes may include envelopes having different magnetic flux densities. An increasing envelope 432 with increasing shape comprises a sequence of magnetic pulses 431. The increase envelope may have a duration T E1. Rectangular envelope 433 includes a sequence of magnetic pulses 431. The rectangular envelope may have a duration T E2. The reduced envelope includes a sequence of magnetic pulses 431. The reduced envelope 434 may have a duration T E3. The resulting sub-period of the treatment regimen formed by the combination of the first, second and third envelopes may provide the same or similar therapeutic effect as the trapezoidal envelopes shown in, for example, fig. 34 and 20. The resulting sub-period of the treatment regimen has a duration 435 ending from the first pulse of the first pulse to the passive duration of the last pulse of the treatment sub-period. Similarly, the amplitude of the RF wave and/or RF pulse may be modulated with respect to the amplitude to assemble a combination of envelopes.
Fig. 44 shows two exemplary envelopes of a magnetic field with an example of inter-envelope period, i.e. the period of time between the envelopes. The time period between envelopes may comprise the time of non-magnetic stimulation. However, the time period between envelopes may include magnetic pulses that provide insufficient or unidentifiable muscle stimulation (including, for example, muscle contraction and muscle relaxation). The magnetic pulses generated during the time periods between the envelopes may also form the envelopes. The magnetic pulses that provide insufficient or unidentifiable muscle stimulation may be generated by causing the energy storage device to discharge the magnetic field generating coils to discharge the stationary volume. The energy storage device may then be charged to a higher amount of current and/or voltage by the power supply to provide high power current pulses to the magnetic field generating device. A rectangular envelope 442 having a duration T 1 may include magnetic pulses 441. A trapezoidal envelope 444 having a duration T 2 may include magnetic pulses 441. The inter-envelope time period having duration T EP may include an envelope 443 (e.g., having a reduced shape), the envelope 443 being given by the magnetic flux density of the magnetic pulse 441 during the inter-envelope time period. Or the inter-envelope time period may comprise a single pulse providing muscle twitches. Thus, the envelope may be a magnetic envelope formed by the RF pulses. The amplitude of which may also form an amplitude, known as the RF envelope. The time period between RF envelopes may include a time without heating.
RF therapy (RF fields) may be generated by a therapeutic energy source (e.g., RF electrodes) in a continuous operation, a pulsed operation, or an operation comprising multiple cycles. Continuous operation is provided during continuous RF treatment. The pulsing operation is provided during pulsed RF therapy.
During continuous operation, the RF electrodes may generate RF fields for overall treatment or for a duration of treatment, as commanded by the host unit and one or more control units. The RF electrode may generate an RF wave having a sinusoidal shape. In other words, the RF electrode may generate a radio frequency waveform having a sinusoidal shape. Other shapes are also possible, such as saw tooth, triangle or square, depending on the amplitude of the RF wave.
Continuous RF therapy may have one of the following effects: due to the continuous heating of the patient's target biological structure, the highest synergistic effect of the provided magnetic treatment is employed, the highest effect of the polarization of the patient's target biological structure, to ensure deep magnetic field penetration into the patient's tissue and high effects of the generated magnetic field on the patient's tissue, such as promoting muscle contraction.
During pulsing generation, the RF electrode may generate RF fields for two or more therapeutically effective time periods, wherein the time periods may be separated by passive time periods. The active period of pulsed RF therapy may represent the period of time during which the RF electrode is active and generates an RF field. The effective period of time may be in the range of 1s to 15 minutes, or 30s to 10 minutes, or 5s to 900s, or 30s to 300s, or 60s to 360 s. The passive period of RF pulsed therapy may represent a period of time during which the RF electrode is inactive and does not generate an RF field. The passive period of time for the RF pulsed treatment may be in the range of 1s to 15 minutes, or 10s to 10 minutes, or 5s to 600s, or 5s to 300s, or 10s to 180 s. The pulsing generation and its parameters may be varied during treatment.
The user may select, control or adjust various treatment protocols of the treatment device via the control unit or host unit of the treatment device. In addition, the host unit and/or the control unit may select, control, or adjust a treatment regimen, body part, or another option selected by the user. Furthermore, the host unit and/or the control unit may select, control or adjust various treatment parameters of the treatment according to any of the sensors mentioned above.
The treatment protocol may include a selection of one or more treatment parameters and predetermined values thereof assigned to the respective protocol. Further, the treatment regimen may include various types of combination therapies of magnetic therapy and RF therapy.
Regarding the treatment parameters, a user may control or adjust various treatment parameters of the treatment device through a control system including a host unit or one or more control units of the treatment device. The host unit and/or the control unit may control or adjust the treatment parameters according to the treatment regimen, body part, or another option selected by the user. Furthermore, the host unit and/or the control unit may control or adjust various treatment parameters of the treatment based on feedback provided by any of the sensors described above. The host unit or one or more control units may provide for adjustment of magnetic field therapy parameters including magnetic flux density, amplitude of magnetic flux density, pulse duration, pulse repetition rate, sequence duration, number of pulses and/or pulses in a sequence, burst duration, composition of magnetic bursts, composition of magnetic sequence, number of envelopes, duty cycle, shape of envelopes, and/or maximum value of magnetic flux density derivative. The host unit or one or more control units may provide for adjustment of treatment parameters of the RF field including the frequency of the RF field, the duty cycle of the RF field, the strength of the RF field, the energy flux provided by the RF field, the power of the RF field, the power amplitude of the RF field, and/or the power amplitude of the RF wave, wherein the RF wave may refer to an electrical component of the RF field. The treatment parameters may be controlled or adjusted within the following ranges.
Furthermore, the treatment parameters may include, for example, treatment time, temperature of the magnetic field generating device, temperature of the RF electrode, temperature of the applicator, temperature of the cooling tank, selection of the targeted body part, number of applicators connected, temperature of the cooling fluid (as measured in the fluid conduit, connection tube, applicator or cooling tank by an appropriate temperature sensor), selected body part, and the like.
The composition of the different magnetic flux densities, pulse durations, sequences and/or bursts may have different effects on the muscle tissue. Part of the magnetic treatment may cause, for example, muscle training to increase muscle strength, muscle volume, muscle conditioning; and other parts of the magnetic treatment may cause muscle relaxation. The signal provided to the RF electrodes may be modulated with respect to the capacity of the circuit formed by the two bipolar RF electrodes and the patient's body, thereby preventing the formation of radio frequency standing waves in the applicator and/or patient, etc. Modulation of the radio frequency field may be provided in the frequency domain, the intensity domain, the pulse duration, and/or other parameters. The goal of independent radio frequency therapy, magnetic therapy, and/or combinations thereof is to achieve the most complex and/or effective treatment of the target biological structure. Modulation in the time domain may provide both active and passive stimulation periods. Passive cycling may occur when the RF therapy and/or magnetic therapy includes cycling without muscle stimulation and/or temperature changes or other therapeutic effects provided by the RF site of the target biological structure. During the passive period, no magnetic field and/or no RF field may be generated. Additionally, during the passive period, a magnetic field and an RF field may be generated, but the strength of the magnetic field and/or the RF field will be insufficient to provide a therapeutic effect of the at least one target biological structure.
The magnetic flux density of the magnetic field may be in the range of 0.1T to 7T, or in the range of 0.5T to 5T, or in the range of 0.5T to 4T, or in the range of 0.5T to 2T. Such definitions may include the magnitude of the magnetic flux density of the magnetic field. The illustrated range of magnetic flux densities may be used to cause muscle contraction. The magnetic flux density and/or the magnitude of the magnetic flux density may be measured by a flux meter or oscilloscope. The disclosed magnetic flux density range may be measured on the surface of the magnetic field generating device or on the surface of the applicator in contact with the patient.
The repetition rate may refer to the frequency of firing the magnetic pulses. The repetition rate may be derived from the duration of the magnetic pulse. The repetition rate of the magnetic pulses may be in the range of 0.1Hz to 700Hz, or 1Hz to 500Hz, or in the range of 1Hz to 300Hz, or 1Hz to 150 Hz. Since each magnetic pulse comprises one magnetic pulse, the repetition rate of the magnetic pulses is equivalent to the repetition rate of the magnetic pulses. The duration of the magnetic pulse may be in the range of 1 μs to 10ms, or 3 μs to 3ms, or 3 μs to 2ms, or 3 μs to 1ms, or 10 μs to 2000 μs, or 50 μs to 1000 μs, or 100 μs to 800 μs. The repetition rate of pulses can be measured from a record of oscilloscope measurements.
The sequence duration may be in the range of 1ms to 300s, or 1ms to 80s, or 2ms to 60s, or 4ms to 30s, or 8ms to 10s, or 25ms to 3 s. The time between two consecutive sequences may be in the range of 5ms to 100s, or 10ms to 50s, or 200ms to 25s, or 500ms to 10s, or 750ms to 5s, or 300ms to 20 s. The repetition rate can be measured from a record of oscilloscope measurements.
The burst duration may be in the range of 10ms to 100s, or 100ms to 15s, or 500ms to 7s, or 500ms to 5 s. The repetition rate of magnetic bursts may be in the range of 0.01Hz to 150Hz, or 0.02Hz to 100Hz, or in the range of 0.05Hz to 50Hz, or 0.05Hz to 10Hz, or 0.05Hz to 2 Hz. The repetition rate can be measured from a record of oscilloscope measurements.
Another parameter used to provide effective magnetic therapy and cause muscle contraction is the derivative of magnetic flux density defined by dB/dt, where: dB is the magnetic flux density derivative [ T ], and dt is the time derivative [ s ]. The derivative of the magnetic flux density is related to the magnetic field. The derivative of magnetic flux density may be defined as the amount of induced current in the tissue and thus it may be used as one of the key parameters to provide muscle contraction. The higher the derivative of magnetic flux density, the stronger the muscle contraction. The magnetic flux density derivative may be calculated according to the formula described above.
The maximum value of the magnetic flux density derivative may be at most 5MT/s, or in the range of 0.3 to 800kT/s, 0.5 to 400kT/s, 1 to 300kT/s, 1.5 to 250kT/s, 2 to 200kT/s, 2.5 to 150 kT/s.
The frequency of the RF field (e.g., RF waves) may be in the range of hundreds of kHz to tens of GHz, such as in the range of 100kHz to 3GHz, or 500kHz to 3GHz, 400kHz to 900MHz, or 500kHz to 900MHz, or about 13.56MHz, 40.68MHz, 27.12MHz, or 2.45GHz.
The energy flux provided by the RF field (e.g., RF waves) may be in the range of 0.001W/cm 2 to 1500W/cm 2, or 0.001W/cm 2 to 15W/cm 2, or 0.01W/cm 2 to 1000W/cm 2, or 0.01W/cm 2 to 5W/cm 2, or 0.08W/cm 2 to 1W/cm 2, or 0.1W/cm 2 to 0.7W/cm 2. The term "about" should be interpreted as being within 5% of the stated value.
The voltage of the electromagnetic signal provided by the power supply of the treatment circuit for RF treatment may be in the range of 1V to 5kV, or 5V to 140V, or 10V to 120V, or 15V to 50V, or 20V to 50V.
The power provided by the power source or adapter may be in the range of 100W to 1000W or 150W to 600W. The power provided by the power source or adapter may be 220W or 400W.
The temperature of the biological structure, the surface temperature of the treated body part, the temperature of the body part, the temperature inside the applicator, the temperature of the RF electrodes and/or the temperature of the magnetic field generating device may be measured by a temperature sensor 816 implemented in the applicator as shown in fig. 8 c. The temperature of the RF electrode and/or the magnetic field generating device may be maintained in the range of 38 to 150 ℃, 38 to 100 ℃, or 40 to 80 ℃,40 to 60 ℃, or 41 to 60 ℃, or 42 to 60 ℃. The surface temperature of the treated body part, the temperature in the treated body and/or biological structure may be increased to a temperature in the range of 38 ℃ to 60 ℃, or 40 ℃ to 52 ℃, or 41 ℃ to 50 ℃, or 41 ℃ to 48 ℃, or 42 ℃ to 45 ℃. The temperature values described above may be achieved during 5s to 600s, 10s to 300s, or 30s to 180s after the initiation of the RF treatment and/or the magnetic treatment. Thereafter, the temperature value may be maintained constant during the treatment, wherein the maximum temperature deviation is in the range of 5 ℃,3 ℃ or 2 ℃ or 1 ℃.
At the beginning of the treatment, the starting temperature in the skin and/or biological structures of the patient may be increased to a starting temperature in the range of 42 ℃ to 60 ℃, or 45 ℃ to 54 ℃, or 48 ℃ to 60 ℃, or 48 ℃ to 52 ℃, and/or to a temperature 3 ℃ or 5 ℃ or 8 ℃ higher than the temperature when the apoptotic process begins, but not exceeding 60 ℃. After 45s to 360s, or 60s to 300s, or 120s to 400s, or 300s to 500s, the strength of the RF field may be reduced and the temperature of the patient's skin and/or the temperature of the biological structure may be maintained at a temperature in the range of 41 ℃ to 50 ℃ or 42 ℃ to 48 ℃. According to another method of treatment, the temperature of the biological structure may be reduced and increased at least twice during treatment in the range of 2 ℃ to 10 ℃,2 ℃ to 8 ℃, or 3 ℃ to 6 ℃ while at least one applicator is attached to the same patient body part, such as the abdominal region, buttocks, arms, legs, and/or other body parts.
The temperature of the biological structure may be calculated from the mathematical model, the correlation function, and in combination with at least one or more measured characteristics. Such measured characteristics may include temperature of the patient's skin, capacitance between the RF electrodes, volt-ampere characteristics of the RF bipolar electrodes, and/or volt-ampere characteristics of electrical components connected to the RF electrodes.
The duration of treatment may be from 5 minutes to 120 minutes, or from 5 minutes to 60 minutes, or from 15 minutes to 40 minutes. One, two or three treatments of the same body part may be provided during a week. In addition, one pause between two consecutive treatments may be one week, two weeks, or three weeks.
The sum of the energy flux densities of the RF treatment and the magnetic treatment applied to the patient during treatment may be in the range of 0.03mW/mm 2 to 1.2W/mm 2, or in the range of 0.05mW/mm 2 to 0.9W/mm 2, or in the range of 0.01mW/mm 2 to 0.65W/mm 2. During simultaneous application of RF therapy and effective magnetic therapy, a portion of the energy flux density of the magnetic therapy may be in the range of 1% to 70%, 3% to 50%, 5% to 30%, or 1% to 20% of the treatment time.
The power output of the RF energy (i.e., RF field) provided by one RF electrode may be in the range of 0.005W to 350W, 0.1W to 200W, 0.1W to 150W, 1W to 100W, or 3W to 50W.
Fig. 21 shows different types of muscle contractions that may be provided by the treatment device and achieved by applying a magnetic field or a combination of magnetic and RF fields. Muscle contraction may differ in energy expenditure and muscle targeting, such as muscle strengthening, muscle volume increasing/decreasing, muscle durability, muscle relaxation, muscle warming, and/or other effects. The vertical axis may represent the strength of the muscle contraction and the horizontal axis may represent time. The arrows may represent magnetic pulses and/or impulses applied to the patient's muscles.
The low repetition rate of the time-varying magnetic field pulses (e.g., in the range of 1Hz to 15 Hz) can cause tics. The low repetition rate may be low enough to allow the treated muscles to relax completely. The energy expenditure of the treated muscle can be low due to the low repetition rate. However, a low repetition rate may cause an effective muscle relaxation between, for example, two contractions.
The intermediate repetition rate of the time-varying magnetic field pulses, which may be in the range of 15Hz to 29Hz, may cause incomplete tonic muscle contraction. Incomplete tonic muscle contraction may be defined by a repetition rate in the range of 10Hz to 30 Hz. The muscles may not relax completely. The muscles may partially relax. The muscle contraction strength may increase with the applied constant magnetic flux density.
The higher repetition rate of the time-varying magnetic field pulses may cause a fully tonic muscle contraction. The higher repetition rate may be, for example, in the range of 30Hz to 150Hz, or 30Hz to 90Hz, or 30Hz to 60 Hz. Full tonic muscle contraction may cause the strongest excess muscle contraction. Excessive muscle contraction may be stronger than the intended muscle contraction. The energy consumption may be higher. The strengthening effect can be improved. In addition, it is believed that the volume and/or number of adipocytes can be reduced at a repetition rate of at least 30 Hz.
Even higher repetition rates of time-varying magnetic field pulses above 90Hz may inhibit and/or prevent transmission of pain excitations of the nervous system and/or pain receptors at different levels. The higher repetition rate may be at least 100Hz, at least 120Hz, or at least 140Hz, or in the range of 100Hz to 230Hz, or 120Hz to 200Hz, or 140Hz to 180 Hz. Applying a time-varying magnetic field to the patient's muscles may cause a pain relief effect.
The high repetition rate of the time-varying magnetic field pulses (in the range of 120Hz to 300Hz, or 150Hz to 250Hz, or 180Hz to 350Hz, or higher than 200 Hz) can cause a muscle relaxing effect.
The mass of the muscle contraction caused by the time-varying magnetic field can be characterized by parameters such as the contractility of the muscle contraction, the muscle-tendon length, the relative shortening of the muscle, or the shortening rate of the muscle.
The contractile force of the muscle contractions may reach a contractile force of at least 0.1N/cm 2 and at most 250N/cm 2. The shrinkage force may be in the range of 0.5N/cm 2 to 200N/cm 2, or in the range of 1N/cm 2 to 150N/cm 2, or in the range of 2N/cm 2 to 100N/cm 2.
The muscle-tendon length may reach up to 65% of the remaining muscle-tendon length. The muscle-tendon length may be in the range of 1% to 65% of the remaining muscle-tendon length, or in the range of 3% to 55% of the remaining muscle-tendon length, or in the range of 5% to 50% of the remaining muscle-tendon length.
During muscle contraction of up to 60% of the resting muscle length, the muscle may shorten. Muscle shortening may be in the range of 1% to 50% of the resting muscle length, or in the range of 0.5% to 40% of the resting muscle length, or in the range of 1% to 25% of the resting muscle length.
The muscle may shorten at a rate of at most 10 cm/s. The muscle shortening speed may be in the range of 0.1cm/s to 7.5cm/s, or in the range of 0.2cm/s to 5cm/s, or in the range of 0.5cm/s to 3 cm/s.
A time-varying magnetic field may be applied to the patient to cause a muscle shaping effect through muscle contraction. The muscle may acquire increased tension and/or volume. The strength of the muscle may also increase.
Regarding the type of combined therapy of RF therapy and magnetic therapy, the therapy device may be configured to provide different therapeutic energies (e.g., RF fields and magnetic fields) for various periods of time during one therapy session. The user can control or adjust the treatment via the HMI. The HMI may be coupled to the host unit and/or one or more control units. In addition, the host unit and/or the control unit may control or adjust the application of different therapeutic energies depending on the treatment regimen, body part, or another option selected by the user. Furthermore, the host unit and/or the control unit may control or adjust the application of different therapeutic energies in accordance with feedback provided by any of the sensors described above. Thus, the host unit and/or one or more control units may control or adjust the treatment and the provision of treatment energy (e.g., RF treatment and magnetic treatment) at various periods of time during one treatment session. All of the illustrated application types of magnetic therapy and RF therapy may be provided by the therapeutic device.
One type of combined application of magnetic therapy and RF therapy may be simultaneous application. During simultaneous application, both magnetic therapy and RF therapy may be applied at the same time during the entire or most of the treatment phase. In one example, simultaneous application may be achieved by applying a magnetic field of one or more segments and applying a continuous RF field. In some aspects, pulsed magnetic therapy may be applied during continuous RF therapy. In yet another example, simultaneous application may be achieved by sequentially applying RF therapy and, for example, one or more long sequences of magnetic pulses. In such cases, the long sequence of magnetic pulses should include magnetic pulses having a repetition rate in the range of 1Hz to 15Hz or 1Hz to 10 Hz. When only one or two long magnetic sequences are used for the entire treatment phase, the sequence duration of such sequences may be in the range of 5s to 90 minutes, or 10s to 80 minutes, or 15 minutes to 45 minutes.
Muscle contraction caused by having simultaneous RF treatment or time-varying magnetic fields during which may include more affected muscle fibers. In addition, the targeted biological structure (e.g., muscle) may contract more at a lower magnetic flux density of the applied magnetic field than without simultaneous RF treatment.
Simultaneous application of RF therapy and magnetic therapy to the same body part may improve the dissipation of heat formed by RF therapy. This effect is based on an increased blood circulation in or near the treated body part. In addition, the induced muscle work may improve the homogeneity of the heating and dissipation of the heat induced and provided by the RF site.
Furthermore, applying both RF therapy and magnetic therapy simultaneously on the same body part may be used to treat blood limitations of muscles and/or body parts. In this example, the magnetic field may keep the body part and/or its surrounding area contracted and restrict blood flow into the body part. By heating, muscles with contracted blood flow can be better prepared for regeneration.
Another type of combined application of magnetic therapy and RF therapy may be a separate application. During separate applications, both magnetic therapy and RF therapy may be applied at different times during the treatment phase. RF therapy may be provided before, after, and/or between magnetic envelopes, bursts, sequences, pulses, and/or pulses of magnetic therapy.
The ratio between the time when the magnetic treatment is applied and the time when the RF treatment is applied may be in the range of 0.2% to 80%, or 2% to 60%, or 5% to 50%, or 20% to 60%. The time for the applied magnetic treatment for this calculation is the sum of all pulse durations during the treatment.
Another type of combined application of magnetic therapy and RF therapy may be dependent application. The application of one therapeutic energy may depend on the initiation of another therapeutic energy or one or more therapeutic parameters. The dependency application may be initiated or adjusted based on feedback from one or more sensors. For example, the initiation of the application of RF therapy may depend on the initiation of magnetic therapy, or the initiation of sequences, bursts, and/or envelopes. When the dissipation of heat provided by muscle work (including muscle contraction and/or relaxation) is not provided, the health risk of unwanted tissue damage caused by overheating may occur. In some aspects, the initiation of the application of the magnetic therapy may depend on the initiation, duration, or intensity of the RF therapy. The magnetic treatment may preferably be started after the biological structure is sufficiently heated. Providing magnetic therapy for at least partial muscle contraction or muscle contraction may improve blood or lymphatic flow, provide massage of adjacent tissue, and provide better redistribution of heat induced by RF therapy in the patient's body.
The apparatus and method may include a combination of magnetic fields and mechanical treatments. The apparatus and method may include different combinations of radio frequency therapy and mechanical therapy.
The apparatus and method may provide a combination of magnetic therapy, radio frequency therapy, and mechanical therapy. The apparatus and method may include applying a combination of magnetic therapy, radio frequency therapy, and mechanical therapy to the body part. The device may include an applicator configured to provide magnetic, radio frequency, and mechanical therapy to the body and/or body part. Furthermore, the treatment device may comprise a main unit housing electrical elements configured to provide magnetic, radio frequency and mechanical treatment to the body and/or body part.
The combined application of mechanical treatment with magnetic treatment and/or radio frequency treatment may prevent possible drawbacks of mechanical treatment alone, such as risk of panniculitis, non-target tissue destruction and/or uneven results by providing muscle contraction and/or heating.
The treatment device may include one or more applicators, wherein each applicator may include its own housing. An applicator may include one or more magnetic field generating devices, one or more RF electrodes, and/or one or more pressure outlets. An applicator may include one or more magnetic field generating devices, one or more RF electrodes, one or more pressure outlets, and/or one or more ultrasonic transducers. In one example, an applicator may include a magnetic field generating device, two RF electrodes, and a pressure outlet.
In some aspects, the mechanical treatment may include pressure treatment. The pressure treatment may include positive pressure treatment and/or negative pressure treatment of the body and/or body part. Positive pressure therapy may include applying a mechanical pulse (e.g., positive pressure pulse) having an intensity amplitude, wherein the mechanical pulse is applied to the tissue as a pulse of fluid from a compressor. Negative pressure therapy may include providing mechanical pulses (e.g., negative pressure pulses) by withdrawing fluid from adjacent areas of tissue through the action of a compressor. Mechanical treatment may also include shrinkage. More than one type of mechanical treatment may be applied simultaneously during the treatment. Mechanical treatment may include providing one or more mechanical pulses (e.g., pressure pulses) to the body and/or body part.
During treatment, the same body part receiving the magnetic treatment and/or the radio frequency treatment may be subjected to pressure treatment. Pressure therapy may be provided to any tissue within a body part, such as skin, epidermis, dermis, and/or subcutaneous tissue. For example, positive pressure therapy may be provided to the skin (including epidermis, dermis, and/or subcutaneous tissue). Pressure treatment may include massaging, kneading, and/or rubbing of tissue (e.g., skin). In addition, pressure treatment may include vibration of the tissue.
Positive pressure therapy and/or negative pressure therapy may be used to massage body parts, provide pressure waves, improve skin, and/or treat cellulite. Positive pressure therapy and/or negative pressure therapy may also destroy fat globules and/or fibrous septa. Positive pressure therapy may improve treatment by RF waves, as positive pressure therapy may improve uniformity of heating in and/or on the surface of the body part. Positive pressure therapy may include providing positive pressure pulses to the patient's body, a body part of the patient, the patient's skin, and/or the skin of the body part. Positive pressure therapy and/or negative pressure therapy may not heat the patient's body.
In addition, pressure therapy may provide cooling to tissue and/or body parts. When combined with magnetic therapy, pressure therapy (e.g., positive pressure therapy) may provide more comfortable muscle contraction, such that the patient feels the muscle contraction less intense.
The elements required to generate the pressure therapy may include a muffler, one or more filters, a compressor, one or more valves, a condensate separator, a pneumatic tank, and a coupling element, as described in more detail herein. It should be understood that not all components associated with pressure therapy are electrical components, as not all components must be electrically driven. For example, the muffler may not be electrically driven.
Fig. 56a shows an exemplary schematic 500 of the electrical component circuitry required to generate positive and/or negative pressure therapy. The circuit may include a compressor 561 and a pressure outlet 600. The pressure outlet 600 may be part of the applicator 800.
Fig. 56b shows an exemplary schematic 500 of the component circuitry required to generate positive pressure therapy. In this exemplary schematic, the circuit may include one or more of the following elements: a sound deadening filter 560, a compressor 561, a pressure relief valve 562, a check valve 563, a condensate separator 564, a fluid pressure tank 565, a sensor 566, a circuit relief valve 567, an application valve 568, a valve control unit 569, and a pressure outlet 600. The apply valve 568, valve control unit 569, and pressure outlet 600 may be part of the applicator 800. The silencing filter 560 and condensate separator 564 may be part of the compressor 561.
Fig. 56c shows another exemplary schematic 500 of the component circuitry required to generate positive pressure therapy. Fig. 56c is similar to the schematic 500 of fig. 56b, but with the check valve 563 after the condensate separator 564, i.e., downstream of the condensate separator 564.
Fig. 56d shows another exemplary schematic 500 of the component circuitry required to generate positive pressure therapy. Fig. 56d is similar to the schematic diagram 500 of fig. 56c, but omits the pressure relief valve 562. Such an architecture is possible, for example, when the compressor 561 comprises a brushless DC motor.
Fig. 56e shows an exemplary schematic 500 of the component circuitry required to generate negative pressure therapy. The circuit may include one or more applicators 800 including a valve control unit 569, an application valve 568, and a pressure outlet 600. In the case of negative pressure therapy, the pressure outlet 600 may provide negative pressure therapy by drawing fluid (e.g., air) possibly with the tissue to form a bulge on the tissue under the applicator 800. The direction of fluid in the compressor 561 is reversed compared to fig. 56b-56 d. The compressor 561 may include or may act as a vacuum pump to evacuate fluid from the pressure outlet 600. When the pressure outlet 600 discharges fluid from the pressure outlet 600, a negative pressure pulse is provided. As fluid is discharged into the device, the frequency of the negative pressure pulses may affect the internal components of the device. The fluid pressure tank 565 may act as a damper for frequency and/or negative pressure pulses within the device to protect the compressor 561. The fluid pressure tank 565 may also dampen the amplitude of negative pressure entering the device. The fluid pressure tank 565 may or may not be present.
The device may include circuitry or a combination of circuitry, including magnetic circuitry and a combination of RF circuitry and pressure therapy circuitry. For example, the device may include one or more separate exemplary circuits and/or electrical elements that provide positive pressure therapy as shown in any of figures 56a, 56b, 56c, and 56c and/or negative pressure therapy as shown in figure 56e, respectively, and circuits and/or electrical elements as shown in any of figures 17, 18a-18i, 54i-54j, and 54i-54 n. The circuitry including RF, magnetic therapy and pressure therapy circuitry and/or electrical components may be controlled by a control system control unit, which may include a microprocessor. The circuitry and/or electrical components in these figures may cooperate during the provision of the treatment, as commanded by the control system and/or one or more of the above-described suitable sensors.
Fig. 56f shows an exemplary schematic 180 of a combination of electrical component circuits for providing magnetic therapy, radio frequency therapy, and positive pressure therapy. The compressor is shown connected and powered by a power source for RF therapy. However, the compressor may be directly connected to and powered by the power grid. The component circuitry required for positive pressure therapy may be replaced by any of the circuitry shown in figures 56a-56 e.
Regarding schematic 500 of the component circuitry required to generate a pressure therapy, silencing filter 560 is configured to silence compressor 561 and/or remove undesirable particulates and/or solid particulates from the fluid compressed by compressor 561. The function of silencing filter 560 may be divided into two elements (e.g., a silencer and a fluid filter) that may also be present in the circuit for positive pressure therapy. The sound attenuating filter 560, the fluid filter, and/or the muffler may be components of the compressor 561.
The compressor 561 may include a fluid compressor. The compressor 561 may include elements that provide compressed fluid (e.g., air) to the applicator 800. Further, the direction of the fluid may be reversed, so that the compressor 561 may draw fluid from the applicator 800 and tissue may be drawn into the vicinity of the pressure outlet 600 and/or the applicator 800. The compressor 561 may include an air compressor that provides compressed air. The compressor 561 may include a pump and/or one or more pistons. For example, the compressor 561 may include a plurality of (e.g., two) pistons. The compressor 561 may be located in a main unit of the apparatus. The compressor 561 may be located at the bottom of the main unit due to vibration and water condensation associated with compressing fluid (e.g., air). The compressor 561 may compress fluid continuously or at predetermined intervals under the control of the control system. To prevent vibration, the compressor 561 may be located within the main unit and may be isolated by bushings (e.g., vibration isolators). For example, the compressor 561 may be isolated from the rest of the main unit by synthetic rubber and/or polyurethane. The compressor may include a motor, for example, a DC motor, an AC motor, or a brushless DC motor. The compressor may comprise its own control unit, which may be connected to and/or controlled by the control unit. The control of the compressor may be part of a control system. The flow rate of the compressor may be in the range of 2 to 300 liters per minute, or 4 to 200 liters per minute, or 5 to 150 liters per minute, wherein the flow rate is 6 bar. The power of the compressor may be in the range of 100W to 1500W, 150W to 1350W, or 200W to 1000W.
Pressure relief valve 562 may be configured to equalize fluid pressure in the electrical circuit. A pressure relief valve 562 located between the compressor 561 and the condensate separator 564 may be controlled by the control system in accordance with the pressure in the fluid pressure tank 565. The presence of pressure relief valve 562 in circuit 500 may also result in energy savings. When the compressor 561 supplies compressed fluid to the fluid pressure tank 565, the fluid pressure in the circuit portion between the compressor 561 and the fluid pressure tank 565 remains high. However, when the fluid pressure tank 565 includes fluid having sufficient pressure, the compressor 561 may be stopped or set to operate at low power. During operation of the compressor 561, the pressure relief valve 562 may reduce the fluid pressure in the circuit portion between the compressor 561 and the fluid pressure tank 565. When the compressor 561 is subsequently switched to high power operation, less energy may be required to compress the fluid in the portion of the circuit having the lower pressure.
The check valve 563 may allow fluid to flow in only one direction.
The condensate separator 564 may be configured for further filtering the fluid.
The condensate separator 564 may be configured to separate moisture derived from pressurizing the fluid and/or reducing the pressure in the circuit.
The fluid pressure tank 565 may be configured to store fluid and provide pressurized fluid to the circuit, e.g., in the direction of the pressure outlet 600. The fluid pressure tank 565 may be an air pressure tank configured to store air and provide pressurized air to the circuit, e.g., in the direction of the pressure outlet 600. The fluid pressure tank 565 is configured to be filled with compressed fluid by the compressor 561. The fluid pressure tank 565 may include a tank pressure sensor and a tank relief valve. When the fluid in the fluid pressure tank 565 has a pressure above a safe value, the tank pressure sensor may detect the pressure, provide information to the control system, and the control system may control the tank relief valve to open and reduce the pressure within the fluid pressure tank 565. The fluid pressure tank 565 may be configured to withstand fluid pressures in the range of 0.5 bar to 150 bar, 1 bar to 100 bar, or 1 bar to 80 bar.
The sensor 566 may communicate with and provide feedback to a control unit of the pressure therapy, which may be part of a control system and/or may include a microprocessor. The control unit of the pressure treatment may be controlled by the main unit. The sensor 566 may detect the pressure of the fluid, the duration of a mechanical pulse (e.g., a pressure pulse), the repetition rate of a pressure pulse, or the intensity of a pressure pulse.
The circuit relief valve 567 may be configured to equalize fluid pressure within the circuit. In the event of a power outage, a setting change, and/or a change in treatment regimen, the circuit relief valve 567 may open and reduce the fluid pressure within the circuit. The circuit relief valve 567 may include a regulator valve to prevent complete loss of circuit pressure.
As shown in fig. 56b-56e, the circuit may be split into multiple branches. Fig. 56b-56e show an example in which the circuit 500 is split into two branches leading to two applicators. In one example, the fluid pressure in the two branches may be the same or within a deviation range of 0.01% to 10%, 0.1% to 5%, or 0.1% to 3%. In some aspects, the fluid pressure in the first applicator 800 in the first branch may be different than the fluid pressure in the second applicator 800 in the second branch. Such a division may be provided by a dividing pressure element, for example a proportional valve controlled by a control system.
The apply valve 568 may be configured to control the pressurized fluid of the pressure outlet 600. The apply valve 568 may include or be adjacent to an applicator pressure sensor that measures the pressure of the fluid flowing to the pressure outlet 600, wherein the applicator pressure sensor may be located within the applicator and/or the connecting tube. The apply valve 568 may be configured to provide pressure therapy to the patient. The apply valve 568 may be configured to provide pressure therapy to a body part. An application valve 568 may be located in the applicator 800. In this configuration, when a pressure pulse is generated by opening the apply valve 568, the amplitude of the pressure pulse is sufficient to provide pressure therapy. In contrast, when the apply valve 568 is located in the main unit, the power loss of the pressure pulse can be significant. In addition, different parameters of the pressure therapy may be affected when the control system controls the operation of the application valve 568. For example, by controlling the opening speed of the application valve, the repetition rate of the pressure pulses may be affected. For another example, by controlling the duration of opening of the apply valve, the pulse duration of the pressure pulse may be affected. For another example, the amplitude of the pressure pulse may be affected by controlling the opening based on the pressure inside the applicator after the valve is applied.
The valve control unit 569 may be configured to control the apply valve 568. The valve control unit 569 may include a microprocessor. The valve control unit 569 may be in communication with, controlled by, and/or part of a control system. For example, the valve control unit 569 may be in communication with a main unit comprising a microprocessor, which may be located in the main unit of the device. The presence of an additional control unit (i.e., valve control unit 569) for pressure therapy within the applicator may control the pressure therapy faster with mechanical pulses without delay between communication from the main unit directly to the application valve 568. Furthermore, when the device uses multiple applicators (e.g., arm applicators or belly applicators), the additional control unit may store information needed to identify the applicators. When the applicator is connected to the main unit, the main unit and/or the control system may begin communicating with a control unit located within the applicator and verifying the type of applicator. Furthermore, a control unit located in the applicator may control and/or provide additional control of the operation of the one or more RF electrodes and/or the magnetic field generating device.
The apply valve 568, valve control unit 569, and pressure outlet 600 may be located in the applicator 800. As shown in fig. 56b, the apparatus may comprise two applicators 800, wherein each applicator 800 comprises one pressure outlet 600. However, the applicator 800 may include more than one pressure outlet 600, e.g., two or more. Further, one applicator 800 may include a number of application valves 568 and/or valve control units 569 corresponding to the number of pressure outlets 600. In some aspects, the applicator 800 may include only one valve control unit 569 and/or an application valve 568 having a plurality (e.g., two) of pressure outlets 600.
The pressure outlet 600 may include elements that provide positive pressure therapy or negative pressure therapy to the patient's body, body part skin, and/or patient's body skin. The pressure outlet 600 may include a cavity or aperture through which pressurized fluid flows into or out of the patient's body and/or body part. The pressure outlet 600 may be made of paramagnetic and/or diamagnetic materials. For example, the pressure outlet 600 may be made of a plastic material. The pressure outlet 600 may include a tube through which fluid is applied to or from tissue. The tube may comprise a tapered portion which tapers or narrows towards the opening of the pressure outlet so as to form an opening which is relatively small in diameter relative to the remainder of the tube. Or the tube may comprise an expansion portion widening towards the opening of the pressure outlet in order to form a relatively large diameter opening relative to the diameter of the rest of the tube. The tapered or expanded portion may be located on and/or within the bottom cap of the applicator. The expansion portion may create a cavity into which the tube enters. However, the expansion or taper may be part of the tube. The expansion portion may have a substantially circular shape on the bottom cover, wherein the circular shape of the expansion portion may have a diameter in the range of 1mm to 15cm, 2mm to 12cm, or 5mm to 10 cm. Furthermore, the expansion portion and/or the conical portion may be detachable and replaceable. The pressure outlet may comprise a fluid guiding element configured to allow changing the direction of fluid flow. Such fluid-directing elements may include solid elements (e.g., made of plastic) having a spiral curve shape.
The element providing positive or negative pressure within the pressure output may comprise a membrane. The membrane may vibrate in response to pressure pulses applied to the inside of the membrane, which is remote from the body part to be treated.
The pressure outlet may be configured to provide pressure therapy, including at least one of massage, pressure pulses, and/or vibration.
One or more pressure outlets 600 may be located at different locations on the applicator 800. For example, one or more pressure outlets 600 may be located in the center of the applicator 800. In some aspects, one or more pressure outlets 600 may be located in the center of the magnetic field generating device. In yet another example, one or more pressure outlets 600 may be located on a side of the applicator 800. In yet another example, one or more pressure outlets 600 may be located on a side of the magnetic field generating device and/or the RF electrode.
Fig. 57a shows a longitudinal cross-section of the applicator 800, wherein the pressure outlet 600 is located in the center of the applicator 800. The exemplary applicator 800 is shown with two magnetic field generating devices 900 and two radio frequency electrodes 101, wherein both radio frequency electrodes 101 are located between the magnetic field generating devices 900 and the tissue 601 of the patient. When the pressure outlet 600 is located at the center of the applicator, positive or negative pressure may be applied to the center of the same point on the body part where muscle contraction by magnetic therapy and heating by radio frequency therapy are provided.
Fig. 57b shows a cross-sectional view of the applicator 800, wherein the pressure outlet 600 is located in the center of the applicator 800. The exemplary applicator 800 is shown with two magnetic field generating devices 900 and two radio frequency electrodes 101. When the pressure outlet 600 is located in the center of the applicator and close to the magnetic field generating device 900, the pressure outlet 600 provides pressure therapy to the body part directly below the magnetic field generating device 900.
Fig. 57c shows a longitudinal cross-section of the applicator 800, wherein the pressure outlet 600 is located in the center of the magnetic field generating device 900. The exemplary applicator 800 is shown with one magnetic field generating device 900 and two radio frequency electrodes 101, wherein both radio frequency electrodes 101 are located between the magnetic field generating device 900 and the tissue 601 of the patient. The pressure outlet 600 may be surrounded by the magnetic field generating device 900 of the applicator 800. When the pressure outlet 600 is located in the center of the magnetic field generating device, the positive or negative pressure is as close as possible to the same point on the body part, at which point the muscle contraction by magnetic therapy and the heating by radio frequency therapy are provided.
Fig. 57d shows a lateral cross-sectional view of the applicator 800, wherein the pressure outlet 600 is located in the center of the magnetic field generating device 900. The exemplary applicator 800 is shown with one magnetic field generating device 900 and two radio frequency electrodes 101. The pressure outlet 600 may be located in the center of the gap 906 of the magnetic field generating device 900 where no windings of the magnetic field generating device 900 may be present. When the pressure outlet 600 is located at the center of the applicator, positive or negative pressure may be applied to the center of the same point on the body part where muscle contraction by magnetic therapy and heating by radio frequency therapy are provided.
Fig. 57e shows a lateral cross-section of the applicator 800, wherein the pressure outlet 600 is located at the side of the applicator 800. The exemplary applicator 800 is shown with one magnetic field generating device 900 and two radio frequency electrodes 101. When the pressure outlet 600 is located on the side of the applicator, the positive or negative pressure applied may provide additional cooling to the tissue from the side. Further, when the pressure outlet 600 is located at the side of the applicator 800, the pressure outlet 600 is not affected by the magnetic field generating device 900, but may be affected when the pressure outlet 600 is close to the magnetic field generating device 900.
Fig. 57f shows a lateral cross-section of the applicator 800, wherein the pressure outlet 600 is located at the side of the magnetic field generating device 900. The exemplary applicator 800 is shown with one magnetic field generating device 900 and two radio frequency electrodes 101. When the pressure outlet 600 is located at the side of the magnetic field generating device 900, the applied positive or negative pressure may provide different temperature receptions. As shown in fig. 57f, the RF electrode provides heating and the pressure outlets 600 at different locations provide pressure treatment.
Fig. 57g shows a transverse cross-section of the applicator 800 with the pressure outlet 600 located on the side of the rf electrode 101. The exemplary applicator 800 is shown with one magnetic field generating device 900 and two radio frequency electrodes 101. The positive or negative pressure applied may also provide different temperature receptions when the pressure outlet 600 is located on the side of the RF electrode. As shown in fig. 57g, the RF electrode provides heating and pressure outlets 600 located at different locations near the RF electrode provide pressure therapy.
The presence of one or more pressure outlets and the delivery of positive and/or negative pressure to the skin of the body part may affect the operation of the temperature sensor present on the applicator of the treatment device. Thus, the applicator may include an edge adjacent to and/or surrounding a pressure outlet opening on the surface of the applicator adjacent to the patient's body. The rim may at least partially surround the pressure outlet, or may surround the entire pressure outlet. The rim may also provide a recess for patient tissue, providing room for the application of mechanical pulses. When the edges provide grooves on the tissue surface, the mechanical pulses are felt more strongly by the patient being treated.
Fig. 58a shows a longitudinal cross-section of an exemplary applicator 800 comprising one magnetic field generating device 900, two radio frequency electrodes 101, a pressure outlet 600 and a temperature sensor 816. The applicator 800 also includes a rim 602 that is positioned adjacent to the pressure outlet 600 on the bottom cover 517 of the applicator 800 to prevent pressurized fluid from flowing in the direction of the bottom cover 517 portion of the applicator 800 below the temperature sensor 816.
Fig. 58b shows a bottom view of an applicator 800 having a pressure outlet 600 and an edge 602. Region 603 represents the surface of applicator 800 below temperature sensor 816. The edge 602 is positioned to prevent the flow of pressurized fluid from the pressure outlet 600 in the direction of the surface 603.
As previously described, and as further shown in the lateral cross-sectional view of the applicator 800 in fig. 59, the applicator 800 may have more than one pressure outlet 600 in the center of the magnetic field generating device 900. The control system may control the plurality of pressure outlets 600 to deliver pressurized fluid. For example, control may include delivering pressurized fluid from only one pressure outlet 600 of the plurality of pressure outlets 600. In some aspects, activation of the pressure outlet 600 may follow a clockwise or counter-clockwise pattern.
The repetition rate of the pressure pulses may be in the range of 0.1Hz to 2000Hz, 0.2Hz to 1000Hz, 0.25Hz to 500Hz, 0.3Hz to 250Hz, or 0.5Hz to 100 Hz. The positive and/or negative pressure of the fluid in the pressure outlet 600 may be in the range of 0.01 bar to 50 bar, 0.05 bar to 25 bar, 0.05 bar to 10 bar, or 0.05 bar to 6 bar, where 1 bar is equal to 100,000 pascals. The pressure within the electrical component circuitry required to generate the positive pressure treatment and/or the negative pressure treatment may be in the range of 0.01 bar to 80 bar, 0.05 bar to 50 bar, 0.05 bar to 25 bar, or 0.05 bar to 15 bar. The pressure within the circuit may be measured by a pressure sensor located within the circuit, for example, in a fluid pressure tank. The duration of the pressure pulse may be in the range of 0.1ms to 1000ms, 0.2ms to 250ms, or 1ms to 150 ms. The flow rate of the pressure pulses (also referred to as the amplitude of the pressure pulses) may be in the range of 0.1 to 200 liters/minute, 0.25 to 150 liters/minute, or 0.5 to 100 liters/minute, as measured in the pressure outlet in the plane of the bottom cap of the applicator. The pressure pulse may provide a pressure wave at a velocity of about 340 meters per second. All of these parameters may be controlled by the control system of the device, for example, using feedback from one or more of the sensors mentioned herein and/or by a human-machine interface (HMI) comprising a display. All of these parameters of the pressure therapy may be adjusted by the control unit and/or HMI during the therapy.
Mechanical treatment may include providing sonic and/or ultrasonic energy to the body and/or body part.
The ultrasonic energy may be generated by one or more ultrasonic sources. The ultrasonic source may comprise an ultrasonic transducer. The ultrasonic transducer may comprise a piezoelectric transducer and/or a capacitive transducer. One or more ultrasonic transducers may be located in the main unit and/or the applicator. The one or more ultrasound transducers may be connected to the grid through electrical elements present in the main unit of the device and/or the applicator.
Ultrasound therapy may be used to massage body parts, improve skin, and/or treat cellulite. Ultrasound therapy may also destroy fat globules and/or fibrous septa. Ultrasound may not heat the patient's body. Ultrasound therapy may also improve treatment by RF waves, as ultrasound therapy may improve the uniformity of heating in and/or on the surface of a body part. Ultrasound therapy may include applying ultrasound pulses to a patient's body, a body part of a patient, patient's skin, and/or body part skin. One or more ultrasonic transducers may be located between the bottom cap of the applicator and the magnetic field generating device. Furthermore, one or more ultrasound transducers may be located beside and/or above the magnetic field generating device. One or more ultrasound transducers may be located between the patient's body and the magnetic field generating device.
The plurality of ultrasonic transducers may be controlled by a control system to provide ultrasonic energy. Multiple ultrasonic transducers may provide ultrasonic energy at the same time or at different times. Furthermore, two or more ultrasonic transducers may be controlled to provide ultrasonic energy in such a way that one or more standing waves and/or resonances of ultrasonic energy may provide a change in the perception of ultrasonic energy.
Fig. 60a shows a lateral cross-sectional view of an exemplary applicator 800 comprising one magnetic field generating device 900 and a plurality of ultrasonic transducers 604. The ultrasonic transducer 604 may be located around the magnetic field generating device 900.
Fig. 60b shows a lateral cross-sectional view of another example applicator 800 including one magnetic field generating device 900 and a plurality of ultrasonic transducers 604, wherein the plurality of ultrasonic transducers 604 are located in and/or on a surface of a vibrating element 605 (e.g., a vibrating plate). When multiple ultrasound transducers 604 are active, the ultrasound energy may also generate vibrations, which are then transmitted to the patient's body and/or body part through the vibration element 605.
Fig. 60c shows a transverse cross-sectional view of another exemplary applicator 800 including a vibratory element 605. One or more ultrasonic transducers 604 are located in and/or on the surface of the vibrating element 605. The vibration element 605 or a portion of the vibration element 605 may be located between the bottom cover of the applicator 800 and the magnetic field generating device. Furthermore, the vibrating element 605 may be located beside and/or above the magnetic field generating device. The vibrating element 605 may be located between the patient's body and the magnetic field generating device.
With respect to the example shown in fig. 60b and 60c, one or more ultrasonic transducers 604 may be located near the vibrating element 605, but not within the vibrating element 605 and/or on the vibrating element 605.
The vibrating element may comprise a material having a different acoustic impedance than the rest of the applicator, for example, the housing of the applicator and/or the electrical elements of the applicator. Thus, the vibrating element may be affected to a greater extent by the one or more ultrasonic transducers than the rest of the applicator. The vibrating material may comprise a metal or plastic material.
Fig. 60d shows a transverse cross-sectional view of an exemplary applicator 800 comprising a plurality of ultrasonic transducers 604 and a reflective element 606. A reflective element 606 is shown connected to the ultrasound transducer 604. A reflective element 606 may be located within or on the surface of the applicator 800. The ultrasonic energy provided by the ultrasonic transducer 604 may be reflected by the reflective element 606 in one or more directions. The reflected ultrasonic energy and the non-reflected ultrasonic energy may be applied together to the patient.
Fig. 60e shows a cross-sectional view of an exemplary applicator 800 including a plurality of ultrasonic transducers 604 and a reflective element 606. The reflective element 606 is shown as having a pyramid shape, but may have a different shape. The reflective element may comprise a plastics material.
The ultrasonic energy may be in the range of 100Hz to 5GHz, 500Hz to 500MHz, or 800Hz to 100 MHz. The energy flux provided by the ultrasonic energy may be in the range of 0.001w.cm -2 to 500w.cm -2 or 0.005w.cm -2 to 350w.cm -2 or 0.05w.cm -2 to 250w.cm -2.
Mechanical treatment may include providing mechanical energy to the body and/or body part via mechanical elements. The mechanical element may comprise a roller. The mechanical element may comprise a pneumatic massager, for example, a shock wave generator. The mechanical element may be located within the applicator and/or on a surface of the applicator. The mechanical element may comprise a shrink band and/or a shrink sleeve band. The mechanical element may be part of a therapeutic device. The mechanical element may be an integral part of the applicator. However, the compression band and/or compression cuff may be separate portions that are added to or secured to the applicator during treatment. Where the mechanical element is a shrink band or a shrink sleeve band, the applicator of the device may still include a combination of magnetic therapy, radio frequency therapy, and mechanical therapy (e.g., pressure therapy, negative pressure therapy, and/or ultrasound therapy).
The mechanical element may provide shrinkage by its own weight and/or use. For example, a shrink band or shrink sleeve may provide pressure by securing it around the body. For another example, the retraction band or retraction cuff may provide pressure by securing one or more applicators to the body with the band. For another example, a strap for coupling the applicator to the body may provide mechanical treatment when suitably secured at high strength.
The mechanical element may provide mechanical treatment including contracting the body, a portion of a treated body part, and/or one or more body parts surrounding a treated body part, wherein the treatment area may include a body part that is subject to magnetic, radio frequency, and/or mechanical treatment.
The contraction provided by the mechanical element (e.g., a contraction band or a contraction cuff) may provide a blood flow restriction that may promote muscle growth provided by magnetic therapy during or after treatment. Furthermore, the restriction of blood flow may result in an enhanced heating effect provided by the radio frequency therapy during or after the treatment.
The mechanical element (e.g., a shrink band or shrink sleeve) may be positioned prior to and/or during magnetic, radio frequency, and/or mechanical treatment. The mechanical elements may be located in different parts of the body. Furthermore, the mechanical element may provide blood restriction at different parts of the body. For example, in the case of a therapeutic arm, the mechanical element may provide blood confinement at the upper portion of the arm about 5cm to 15cm below the shoulder joint. For another example, in the case of treating the thigh, the mechanical element may provide blood restriction at the natal level and/or about 5cm to 15cm below the natal. For another example, in the case of treating the lower leg, the mechanical element may provide blood restriction about 5cm to 15cm below the knee from below the popliteal fossa.
The constriction provided by the mechanical element (e.g., a constriction band or constriction cuff) may restrict blood flow in one or more arteries or veins. Furthermore, the contraction provided by the mechanical element may enhance the muscle growth of one or more muscles. For example, in the case of treating the arm, the mechanical element may restrict blood flow in the brachial artery and/or enhance muscle growth of the biceps brachii and/or triceps brachii. For another example, in the case of treating the thigh, the mechanical element may restrict blood flow in the femoral artery and/or enhance muscle growth of the femoral muscle, the popliteal muscle in the rear of the thigh, the quadriceps in the front of the thigh, and/or the adductor muscle inside the thigh. For another example, in the case of treating the calf, the mechanical element can restrict blood flow in the calf artery and/or enhance muscle growth of the triceps, soleus, and/or gastrocnemius muscles.
In some aspects, the apparatus may use a combination of magnetic treatment and mechanical treatment. In some aspects, the device may include electrical components configured to provide magnetic therapy and positive pressure therapy. In some aspects, the apparatus may include a main unit and one or more applicators. Furthermore, the applicator may be connected to the main unit by one or more connection tubes.
In some aspects, the device may be configured to apply magnetic and mechanical therapy to the same body part during one therapy. In some aspects, the device may be configured to apply magnetic therapy and mechanical therapy to different body parts during one therapy.
The device may be configured to apply magnetic pulses and mechanical pulses (e.g., positive pressure pulses). In some aspects, the apparatus may be configured to apply the magnetic pulse simultaneously with the mechanical pulse. In some aspects, the device may be configured to apply the magnetic pulse at a different time than the mechanical pulse,
Treatment combining mechanical and magnetic therapy may provide treatment of sexual dysfunction and/or rectal dysfunction. The magnetic therapy may be configured to provide muscle contraction to muscles within the body part. The mechanical treatment may be configured to massage tissue within the body part, stimulate nerves within the body part, stimulate muscles within the body part, increase blood flow within the body part, and/or increase angiogenesis within the body part.
A combination of mechanical and magnetic treatments may be applied to a body part including the perineum, buttocks and/or genitals.
Fig. 68 shows an exemplary schematic 181 of a circuit combination of electrical components for providing magnetic therapy and positive pressure therapy. In some aspects, the applicator may include an application valve, a pressure outlet, and a magnetic field generating device. In some aspects, the remaining electrical components may be located within the main unit and/or the connection tube.
The device may be configured to deliver positive pressure pulses to a patient's body (e.g., patient's skin). The positive pressure pulse may comprise an air delivery pulse. The device may include a temperature changing element configured to change the temperature of the air prior to delivery to the patient's body. The temperature change element may be a heater configured to heat air prior to delivery to the patient's body. The temperature change element may be a cooler configured to cool the air prior to delivery to the patient's body. In the case of heating, the heater may be configured to heat air to a temperature in the range of 20 ℃ to 50 ℃ or 1.5 ℃ to 30 ℃ or 2 ℃ to 25 ℃ above ambient temperature. Further, the heater may be configured to heat air to a range of 20 ℃ to 60 ℃ or 21 ℃ to 50 ℃ or 21 ℃ to 48 ℃. The temperature change element may be located within the fluid pressure tank and/or any other electrical element of the circuit for providing positive pressure therapy.
Fig. 69a-69d illustrate an exemplary device including an applicator that includes a patient support 830. The patient support 830 may be an applicator connectable to a main unit, or the patient support 830 may act as a main unit that also includes a control unit, HMI, a power grid, and/or a connection to a power grid. Furthermore, when the patient support 830 serves as a main unit, the patient support may include all electrical components for providing magnetic therapy and positive pressure. The patient support 830 may be a chair, a bed or a mattress.
Fig. 69a shows an exemplary device comprising a patient support 830, wherein the patient support 830 comprises a magnetic field generating device 900 and a pressure outlet 600. The pressure outlet 600 may be located within the patient support 830.
Fig. 69b shows an exemplary device comprising a patient support 830, wherein the patient support 830 comprises a magnetic field generating device 900 and a pressure outlet 600. The patient support 830 may also include a protrusion 831, the protrusion 831 including a pressure outlet 600. The projections 831 can be made of a flexible material, such as a polymer, plastic, and/or rubber. The protrusion 831 can be placed in a position where the patient is seated. The protrusion 831 may be configured to be positioned near and/or in contact with the patient's perineum.
Since the magnetic field generating device may be fixed in place in a large area of the patient support, the perception of treatment by the magnetic field may be different from treatment by a smaller applicator, such as shown in fig. 8 a. For example, due to the positive pressure pulse of the applied pressure therapy, the muscle contraction provided by the magnetic therapy may be perceived by the patient at a lower intensity than intended and/or in a different body part.
Fig. 69c shows an exemplary device comprising a patient support 830, wherein the patient support 830 comprises a magnetic field generating device 900, a pressure outlet 600 within a protrusion 831, and a positioning assembly 832 configured to provide movement to the pressure outlet 600, which is shown as moving sideways.
Fig. 69d shows an exemplary device comprising a patient support 830, wherein the patient support 830 comprises a magnetic field generating device 900, a pressure outlet 600 within a protrusion 831, and a positioning assembly 832, the positioning assembly 832 being configured to provide movement to the magnetic field generating device 800, the magnetic field generating device 800 being shown as moving sideways.
In some aspects, the positioning assembly may include one or more rails and a motor. The magnetic field generating device and/or the pressure outlet may be movable on a track. In one configuration, the magnetic field generating device may be moved along a line below the genitalia, perineum and interluteal fissure. The track may be made of a polymer to avoid the influence of the magnetic field on the metal track.
In some aspects, the positioning assembly may be one or more hydraulic pistons. The piston may comprise oil.
In some aspects, the positioning assembly may be one or more air pistons. The air piston may be controlled by a control system to operate in conjunction with a fan of the applicator. For example, a fan may provide air to operate a piston. In some aspects, the fan may exhaust air from the air piston.
In some aspects, a method of treatment of an exemplary device including a patient support may include positioning a patient to the patient support and providing magnetic therapy and/or pressure therapy. The patient may wear clothing during the treatment. The patient may be positioned such that the perineum is in contact with or in the vicinity of the pressure outlet.
In some aspects, a method of treatment of an exemplary device including a patient support and a protrusion may include positioning a patient to the patient support and providing magnetic therapy and/or pressure therapy. The patient may wear clothing during the treatment. The patient may be positioned such that the perineum is in contact with or in close proximity to the bulge comprising the pressure therapy. In some aspects, the protrusions may at least partially dip into the patient support when the patient sits on the positioning support.
In some aspects, a method of treatment of an exemplary device including a patient support, a boss, and a positioning assembly may include positioning a patient to the patient support and providing magnetic therapy and/or pressure therapy, the positioning assembly configured to provide movement to a pressure outlet. The patient may wear clothing during the treatment. The patient may be positioned such that the perineum is in contact with or in close proximity to the bulge comprising the pressure therapy. In some aspects, the protrusions may at least partially dip into the patient support when the patient is seated on the patient support. In some aspects, the position of the pressure outlet may be changed by a positioning assembly to keep the pressure outlet as close as possible to the perineum when the patient is seated on the patient support.
In some aspects, a method of treatment of an exemplary device including a patient support, a boss, and a positioning assembly may include positioning a patient to the patient support and providing magnetic therapy and/or pressure therapy, the positioning assembly configured to provide movement to a pressure outlet. The patient may wear clothing during the treatment. The patient may be positioned such that the perineum is in contact with or in close proximity to the bulge comprising the pressure therapy. In some aspects, the protrusions may at least partially dip into the patient support when the patient is seated on the patient support. In some aspects, the position of the magnetic field generating device may be changed by the positioning assembly via the HMI and/or the control unit when the patient is seated on the patient support.
A control system including a microprocessor may control the device to provide different treatment protocols.
The treatment regimen may be divided into two or more treatment phases. The number of treatment phases of one regimen may be in the range of 2 to 50, or 2 to 30, or 2 to 15.
Each treatment phase of the treatment regimen may include different treatment parameters and/or types of combined treatment of magnetic treatment and RF treatment, as described above. Further, one or more treatment phases of the treatment regimen may include predetermined treatment parameters for magnetic treatment, RF treatment, and/or mechanical treatment.
One treatment session may last for a session time, wherein the session time may be in the range of 10s to 30 minutes, or 15s to 25 minutes, or 20s to 20 minutes. Different phases may have different therapeutic effects in one or more therapeutic biological structures (e.g., muscle and adipose tissue). For example, one treatment session may provide high intensity muscle exercise, where muscle contraction is intense, and a large amount of such contraction is provided; wherein a higher repetition rate of magnetic pulses with high magnetic flux density can be used during one treatment phase. Another treatment phase may have a muscle relaxing effect, wherein a low and/or high repetition rate of the magnetic pulses may be used, and/or a lower magnetic flux density of the magnetic field may also be used.
The treatment regimen may include different settings of the power output of the RF treatment, such as commanded or controlled by control of the treatment device. One setting may be a constant power output, where the power output may be the same during a treatment regimen. Another setting may be the oscillating power output of the RF treatment. The power output of the RF treatment may oscillate around a predetermined value of power output in the range of 0.1% to 5% of the predetermined power output. Yet another setting may be a varying power output of the RF energy, wherein the power output of the RF treatment is varied during the treatment regimen. The change in power output of the RF treatment may be provided in one or more power output change steps, wherein one power output change step may comprise a change in the value of the power output of the RF treatment applied by the one or more RF electrodes. The change in power output of the RF treatment from one value to another during the power output change step may be in the range of 0.1W to 50W, or 0.1W to 30W, or 0.1W to 20W. The power output varying step may have a duration in the range of 0.1s to 10 minutes or 0.1s to 5 minutes.
With respect to variations in the power output of the RF energy, the power output of the RF energy may have different values during different time periods of the treatment regimen. Thus, the RF treatment may have a different value of power output during a first period of time followed by a power output varying step followed by a second period of time having a different value of power output of the RF treatment. The first period of time having one value of the power output of the RF treatment may be in the range of 1s to 15 minutes or 10s to 10 minutes. The second time period with another value of the power output of the RF treatment may be in the range of 1s to 45 minutes or 4s to 59 minutes or 5s to 35 minutes. For example, the RF treatment may have a power output value of about 20W during a first period of time and a power output value of about 10W during a second period of time.
The first exemplary treatment regimen may include two treatment phases. The first treatment phase may comprise envelopes of magnetic pulses, wherein the envelopes may comprise pulses having a repetition rate in the range of 1Hz to 10 Hz. The envelope of the first treatment phase may have a rectangular or trapezoidal shape. The duration of the first treatment phase may be 3 minutes to 15 minutes. The second treatment phase may comprise envelopes of the magnetic pulses, wherein these envelopes may comprise pulses having a repetition rate in the range of 15Hz to 45 Hz. The envelope of the second treatment phase may have a rectangular or trapezoidal shape. The duration of the first treatment phase may be 3 minutes to 15 minutes. The treatment phase may be repeated one by one. RF therapy may be applied continuously throughout the treatment regimen. RF treatment may include one or two power output variation steps.
The second exemplary treatment regimen may include three treatment phases. The first treatment phase may comprise envelopes of magnetic pulses, wherein the envelopes may comprise pulses having a repetition rate in the range of 5Hz to 50 Hz. The envelope of the first treatment phase may have a rectangular or trapezoidal shape. The duration of the first treatment phase may be 3 minutes to 15 minutes. The second treatment phase may comprise envelopes of the magnetic pulses, wherein these envelopes may comprise pulses having a repetition rate in the range of 15Hz to 45 Hz. The envelope of the second treatment phase may have a rectangular or trapezoidal shape. The duration of the first treatment phase may be 3 minutes to 15 minutes. The third treatment phase may comprise envelopes of the magnetic pulses, wherein these envelopes may comprise pulses having a repetition rate in the range of 10Hz to 40 Hz. The envelope of the third treatment stage may have a rectangular or trapezoidal shape. The duration of the third treatment phase may be 3 minutes to 15 minutes. The treatment phase may be repeated one by one. RF therapy may be applied continuously throughout the treatment regimen. RF treatment may include one or two power output variation steps. One power output change step may be initiated within 1 minute or 20 minutes after the beginning of the treatment regimen. In one example, one power output change step may be initiated within three minutes after the start of the treatment regimen.
The treatment regimen may include a combination of magnetic therapy, radio frequency therapy, and mechanical therapy. The treatment may be performed simultaneously or sequentially. The particular type of treatment selected may depend on a variety of factors, including the age of the patient and/or the body part being treated.
The treatment phases describing the magnetic treatment parameters mentioned below are part of a protocol called a magnetic treatment protocol, as they mainly discuss the parameters of the magnetic treatment. In general, the device may provide and/or control modulation of the duration of the magnetic pulses, the repetition rate of the magnetic pulses and/or the amplitude of the magnetic field density of the magnetic pulses, the number of magnetic pulses in the magnetic sequence, the duration of the magnetic sequence, the number of magnetic pulses in the magnetic burst, the duration of the magnetic burst, and/or the duration of the period of time that does not cause a therapeutic effect. Control of the modulation may be provided by a control system and/or a human-machine interface. An exemplary magnetic treatment regimen may include one or more treatment phases. The repetition rate of the magnetic pulses may be changed from a first value to a second value during any treatment phase.
One or more treatment phases may include magnetic pulses with a repetition frequency in the range of 5Hz to 150 Hz. The one or more treatment phases may include one or more sequences of magnetic pulses having magnetic flux density amplitudes forming one or more trapezoidal envelopes. The treatment phase may comprise a sequence of magnetic pulses having a repetition rate, wherein the magnetic pulses have a magnetic flux density amplitude forming a trapezoidal envelope, wherein the treatment phase may comprise one or more of such sequences. The trapezoidal envelope may include a greater period of time in the range of 0.1 seconds to 20 seconds, 0.15 seconds to 10 seconds, or 0.25 seconds to 8 seconds. The trapezoidal envelope may also include a hold time period in the range of 0.1 seconds to 25 seconds, 0.15 seconds to 15 seconds, or 0.25 seconds to 10 seconds. The trapezoidal envelope may also include a smaller period of time in the range of 0.1 seconds to 20 seconds, 0.15 seconds to 10 seconds, or 0.25 seconds to 8 seconds. The magnetic pulse sequence may be followed by a non-magnetic stimulation period in the range of 1 second to 60 seconds. The duration of the treatment phase may be in the range of 10 seconds to 5000 seconds.
A first exemplary treatment phase of the magnetic treatment regimen includes magnetic pulses with a repetition frequency of 21Hz to 40 Hz. Further, the first exemplary treatment phase includes one or more magnetic pulse sequences having magnetic flux density amplitudes to form one or more trapezoidal envelopes, wherein the trapezoidal envelopes include a larger time period of 0.25 seconds to 1.5 seconds, a hold time period of 2 seconds to 5 seconds, and a smaller time period of 0.5 seconds to 4 seconds.
A second exemplary treatment phase of the magnetic treatment regimen includes magnetic pulses with a repetition frequency of 1Hz to 20 Hz. Further, a second exemplary treatment phase includes one or more magnetic pulse sequences having magnetic flux density amplitudes to form one or more trapezoidal envelopes, wherein the trapezoidal envelopes include a greater period of time of 2 seconds to 8 seconds, a hold period of time of 1 second to 2 seconds, and a smaller period of time of 2 seconds to 8 seconds.
A third exemplary treatment phase of the magnetic treatment regimen includes magnetic pulses with a repetition frequency of 25Hz to 50 Hz. Further, a third exemplary treatment phase includes one or more magnetic pulse sequences having magnetic flux density amplitudes to form one or more rectangular envelopes.
The one or more magnetic treatment protocols may include one or more of the example treatment phases of the magnetic treatment protocol.
The following exemplary protocols are referred to as radio frequency treatment protocols, as these protocols primarily discuss parameters of radio frequency treatment. In general, the device may provide and/or control the duration of the radio frequency pulses, the repetition rate of the radio frequency pulses, and/or the modulation of the intensity amplitude (e.g., power output) of the radio frequency pulses. Control of the modulation may be provided by a control system and/or a human-machine interface. An exemplary radiofrequency treatment regimen may include one or more treatment phases.
One or more exemplary radio frequency treatment protocols (including radio frequency treatment) may be applied in a continuous manner over a treatment period without changing parameters set at the beginning of the treatment period.
One or more exemplary radio frequency treatment protocols (including radio frequency treatment) may be applied in a continuous manner throughout the treatment period while varying parameters set at the beginning of the treatment period.
One or more exemplary radio frequency treatment protocols may be applied at the same time or at different times as the magnetic treatment providing muscle contraction. Such a configuration may provide all of the benefits of the combination magnetic therapy and radio frequency therapy described in the present application.
The first exemplary radio frequency treatment regimen includes two treatment phases with different power outputs of the RF waves. The first treatment phase comprises RF waves having a power output in the range of 10W to 50W and the second treatment phase comprises RF waves having a power output in the range of 2W to 25W, wherein the first power output is different from the second power output. The duration of the first treatment phase may be in the range of 0.5 minutes to 15 minutes or 1 minute to 7 minutes. In one configuration applied to, for example, the abdomen, the first power output is in the range of 20W to 30W and the second power output is in the range of 15W to 30W. In another configuration applied to, for example, buttocks, the first power output is in the range of 15W to 30W and the second power output is in the range of 12W to 30W. In yet another configuration applied to, for example, the lower leg, the first power output is in the range of 10W to 30W and the second power output is in the range of 2W to 30W. In yet another configuration applied to, for example, an arm, the first power output is in the range of 10W to 30W and the second power output is in the range of 5W to 30W. In yet another configuration applied, for example, to the inside of the thigh, the first power output is in the range of 15W to 30W and the second power output is in the range of 5W to 30W. In yet another configuration applied to, for example, the abdomen, the first power output is in the range of 15W to 30W and the second power output is in the range of 12W to 30W. In yet another configuration applied to, for example, the rear thigh and/or the front thigh, the first power output is in the range of 10W to 30W and the second power output is in the range of 5W to 30W. In yet another configuration applied to, for example, the lateral thigh and/or the front thigh, the first power output is in the range of 15W to 30W and the second power output is in the range of 10W to 30W. The power output variation step may be located between two treatment phases. The first treatment stage may be used for heating enhancement to heat tissue (e.g., body part and/or biological structures) to a desired temperature, and the second treatment stage may be used to maintain the desired temperature for the remainder of the treatment. The desired temperature may be in the range of 38 ℃ to 60 ℃, or 40 ℃ to 52 ℃, or 41 ℃ to 50 ℃, or 41 ℃ to 48 ℃, or 42 ℃ to 45 ℃.
The second exemplary radio frequency treatment regimen includes three treatment phases with different power outputs of the RF waves. The first treatment phase comprises RF waves with a power output in the range of 10W to 35W, the second treatment phase comprises RF waves with a power output in the range of 2W to 18W, and the third treatment phase comprises RF waves with a power output in the range of 5W to 50W. The first power output is different from the second power output and the third power output is different from either of the first and second power outputs. The duration of the first treatment phase may be in the range of 0.5 minutes to 15 minutes or 1 minute to 7 minutes.
The following exemplary protocols are referred to as mechanical treatment protocols, as these protocols primarily discuss parameters of mechanical treatment. In general, the device may provide and/or control the duration of the mechanical pulses, the repetition rate of the mechanical pulses, and/or the modulation of the pressure amplitude (e.g., positive and/or negative) of the fluid in the pressure outlet. Control of the modulation may be provided by a control system and/or a human-machine interface. An exemplary mechanical treatment regimen may include one or more treatment phases.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied in a continuous manner during a treatment session without changing parameters set at the beginning of the treatment session.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied in a continuous manner during a treatment session while varying parameters set at the beginning of the treatment session.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied concurrently with magnetic treatment providing muscle contraction. This configuration may result in pain relief and/or skin massaging during muscle contraction to better withstand the muscle contraction.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied at a different time than magnetic treatment providing muscle contraction. Such mechanical treatment regimens may provide mechanical treatment (e.g., massage) to the body part and/or muscles in the absence of muscle contraction. This configuration may result in faster pain relief, muscle fatigue relief, and/or regeneration of the muscle between muscle contractions, and may help the muscle prepare for subsequent muscle contractions by reducing the concentration of lactic acid within the body part.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied concurrently with radio frequency treatment to provide heating to the body part. This configuration may improve the uniformity of heating within the body part.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may be applied at a different time than the radio frequency treatment provides heating of the body part. Such a configuration may result in regeneration and/or cooling of muscles and/or body parts.
One or more exemplary mechanical treatment protocols, including mechanical treatment (e.g., providing pressure pulses), may include at least one mechanical envelope created by the mechanical pulses. The mechanical pulse may be a pressure pulse. The mechanical envelope of the mechanical pulse may produce a trapezoidal envelope, a rectangular envelope, a triangular envelope, or a combination thereof. At least one mechanical envelope may be generated by varying the amplitude of the mechanical pulse. When the envelope is created by varying the amplitude of the mechanical pulses, the compressor may be operated at higher or lower power according to instructions from the control system. In another aspect, when the envelope is created by varying the amplitude of the mechanical pulses, the fluid pressure tank may provide different amounts of fluid to the circuit, store air, and provide pressurized air to the circuit, according to instructions from the control system. The mechanical envelope may be generated by varying the repetition rate of the mechanical pulses. When the envelope is created by varying the repetition rate of the mechanical pulses, the application valve can be opened and closed at different intervals, according to instructions from the control system. Such use of a mechanical envelope may result in relief of muscle fatigue and/or regeneration of muscle between muscle contractions, and may assist the muscle in preparation for subsequent muscle contractions by reducing the concentration of lactic acid within the body part. The first exemplary mechanical treatment regimen includes two treatment phases with different repetition rates of the pressure pulses. The first treatment phase comprises mechanical pulses having a repetition rate in the range of 1Hz to 10Hz and the second treatment phase comprises a repetition rate in the range of 5Hz to 25Hz, wherein the first repetition rate is different from the second repetition rate. In one configuration, the first repetition rate is 8Hz and the second treatment phase is 15Hz.
A second exemplary mechanical treatment regimen includes three treatment phases with a pressure pulse repetition rate. The first treatment phase comprises mechanical pulses with a repetition rate in the range of 1Hz to 10Hz, the second treatment phase comprises pressure pulses with a repetition rate in the range of 10Hz to 25Hz, and the third treatment phase comprises mechanical pulses with a repetition rate in the range of 5Hz to 15Hz, wherein one (e.g. the first) repetition rate is different from the (e.g. the second and third) other repetition rates. In one configuration, the first repetition rate is 8Hz, the second treatment phase is 12Hz, and the third repetition rate is 12Hz.
A third exemplary mechanical treatment regimen includes three treatment phases with a pressure pulse repetition rate. The first treatment phase comprises mechanical pulses with a repetition rate in the range of 1Hz to 10Hz, the second treatment phase comprises mechanical pulses with a repetition rate in the range of 10Hz to 25Hz, and the third treatment phase comprises mechanical pulses with a repetition rate in the range of 5Hz to 20Hz, wherein the first, second and third repetition rates are different. In one configuration, the first repetition frequency is 5Hz, the second treatment phase is 18Hz, and the third repetition frequency is 14Hz.
The duration of the mechanical pulses may vary during the treatment phase of any of three exemplary mechanical treatment protocols. The duration of the pressure pulse may be shorter when the repetition rate is higher, and longer when the repetition rate is lower. For example, when the repetition rate is in the range of 15Hz to 100Hz, the duration of the pressure pulse is in the range of 0.5ms to 15ms, and when the repetition rate is in the range of 0.1Hz to 14.9Hz, the duration of the pressure pulse is in the range of 15.1ms to 40 ms. Thus, exemplary treatment protocols may include combinations of any of the above-described magnetic, radio frequency, and mechanical treatment protocols. The duration of the pressure pulse may vary in the range of 0.5ms to 30ms or 0.5ms to 25 ms.
Fig. 45a, 45b and 46-51 show different views of the main unit 11 of the treatment device according to one embodiment.
As previously mentioned, the device may include one or more applicators. For example, the device may include two, four or more applicators. In some aspects, the applicator may include a magnetic field generating device and a radio frequency electrode. In some aspects, the applicator may include a magnetic field generating device and a pressure outlet. In some aspects, the applicator may include a magnetic field generating device, a pressure outlet, and one or more radio frequency electrodes. In some aspects, the applicator may include a magnetic field generating device and an ultrasonic transducer. In some aspects, the applicator may include a magnetic field generating device, a radio frequency electrode, and an ultrasonic transducer. In some aspects, the applicator may include a magnetic field generating device. In some aspects, the applicator may include a plurality of magnetic field generating devices.
The device may be configured to provide free movement of the magnetic field generating device, the RF electrode, the pressure outlet and/or the ultrasound transducer in at least one axis within the applicator. The applicator may comprise a plurality of portions, wherein each portion may be configured to move freely in at least one axis of motion.
The apparatus may include a movement structure configured to provide movement of an applicator, applicators, and/or applicator portions, as shown in fig. 61a-61 x. Each section may include its own housing including a top cover and a bottom cover. The portion of the applicator may be part of an applicator comprising at least one magnetic field generating device, radio frequency electrodes and/or pressure outlets. In some aspects, the portion may be connected to a connecting tube. In some aspects, the portion may be positioned independently of the other portions.
The moving structure may include a joint, a gear, a rotor, and/or a cam. The joint may be, for example, a swivel joint, a rotator, a buckling, a prismatic joint, a spherical joint, a joint, a turnbuckle, a bolt joint, a universal joint, a cotter pin, and/or a spherical joint. The gears may be spur gears, helical gears, double helical gears, bevel gears, spiral bevel gears, hypoid gears, crown gears, worm drives, gear trains, harmonic gears, cage gears, cycloidal gears, magnetic gears, and/or racks and pinions. The moving structure may include two gears in a gear train.
The moving structure may comprise a spacer and/or a moving connection. The spacer may comprise at least one gear and/or a joint. The mobile connection may comprise at least one gear and/or a joint. The mobile connector may be coupled to the spacer.
As described above, the moving structure may include a joint and/or a gear. However, the applicator portion and/or the applicator may be connected to the moving structure by a joint and/or a gear.
The moving structure may provide rotational, reciprocating, oscillating, and/or linear motion.
The moving structure may include a lock configured to hold the applicator and/or the applicator portion in a particular position and/or angle. The lock may be represented by a spring, a locking mechanism in a gear train, and/or a brake. The lock may be configured and/or controlled by the user and/or patient. The moving structure may include at least one friction element configured to provide locking in place. The moving structure may have a degree of rigidity so that the moving structure may maintain the position of the applicator and/or the applicator portion.
Fig. 61a shows an applicator 800 configured to provide free movement of the magnetic field generating device 900 and the radio frequency electrode 101. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may comprise the magnetic field generating device 900 and the second portion 833b may comprise the radio frequency electrode 101. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a can be coupled to a moving structure 834a that is configured to provide movement of the first portion 833 a. Further, the second portion 833b may be coupled to a moving structure 834b configured to provide movement of the second portion 833b.
Fig. 61b shows an applicator 800 configured to provide free movement of the magnetic field generating devices 900a and 900b. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and the second portion 833b may include a second magnetic field generating device 900b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a can be coupled to a moving structure 834a that is configured to provide movement of the first portion 833 a. Further, the second portion 833b may be coupled to a moving structure 834b configured to provide movement of the second portion 833b.
Fig. 61c shows an applicator 800 configured to provide free movement of a magnetic field generating device and a pair of RF electrodes. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and a pair of radio frequency electrodes 101a and 101b, and the second portion 833b may include a second magnetic field generating device 900b and a pair of radio frequency electrodes 101c and 101d. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a can be coupled to a moving structure 834a that is configured to provide movement of the first portion 833 a. Further, the second portion 833b may be coupled to a moving structure 834b configured to provide movement of the second portion 833b.
Fig. 61d shows an applicator 800 configured to provide free movement of a magnetic field generating device and a pair of RF electrodes. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a, a pair of rf electrodes 101a and 101b, and a pressure outlet 600a, and the second portion 833b may include a second magnetic field generating device 900b, a pair of rf electrodes 101c and 101d, and a pressure outlet 600b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a can be coupled to a moving structure 834a that is configured to provide movement of the first portion 833 a. Further, the second portion 833b may include a movement structure 834b configured to provide movement of the first portion 833b.
The device may be configured to provide free movement of the magnetic field generating device, the RF electrode, the pressure outlet and/or the ultrasound transducer in at least one axis within the applicator. The applicator may comprise a plurality of sections.
As shown in fig. 61e-61h, the applicator may include a movement structure configured to provide movement of the applicator and/or a portion of the applicator. Each section may include its own housing including a top cover and a bottom cover. The moving structure may comprise a spacer and/or at least one moving connection. The spacer and/or the mobile connector are configured to provide a connection between portions of the applicator.
Fig. 61e shows an applicator 800 configured to provide free movement of the magnetic field generating device and the RF electrode. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may comprise the magnetic field generating device 900 and the second portion 833b may comprise the radio frequency electrode 101. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61f shows an applicator 800 configured to provide free movement of the magnetic field generating devices 900a and 900b. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and the second portion 833b may include a second magnetic field generating device 900b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61g shows an applicator 800 configured to provide free movement of a magnetic field generating device and a pair of RF electrodes. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and a pair of radio frequency electrodes 101a and 101b, and the second portion 833b may include a second magnetic field generating device 900b and a pair of radio frequency electrodes 101c and 101d. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61h shows an applicator 800 configured to provide free movement of a magnetic field generating device and a pair of RF electrodes. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a, a pair of rf electrodes 101a and 101b, and a pressure outlet 600a, and the second portion 833b may include a second magnetic field generating device 900b, a pair of rf electrodes 101c and 101d, and a pressure outlet 600b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
The device may be configured to provide free movement of the two or more applicators on at least one axis.
The apparatus may include a plurality of applicators configured to be connectable to a moving structure, as shown in fig. 61i-61 l. The mobile structure may include a spacer and at least one mobile connector, wherein the spacer and the mobile connector are configured to provide a connection between the applicators.
Fig. 61i shows a first applicator 800a and a second applicator 800b connected to a moving structure 834. The applicator 800a may comprise a magnetic field generating device 900 and the second applicator 800b may comprise a radio frequency electrode 101. Each applicator may be connected to the main unit by a connecting tube 814.
Fig. 61j shows a first applicator 800a and a second applicator 800b connected to a moving structure 834. The applicator 800a may include a first magnetic field generating device 900a and the second applicator 800b may include a second magnetic field generating device 900b. Each applicator may be connected to the main unit by a connecting tube 814.
Fig. 61k shows a first applicator 800a and a second applicator 800b connected to a moving structure. The first applicator 800a may include a first magnetic field generating device 900a and a first pair of radio frequency electrodes 101a and 101b. The second applicator 800b may include a second magnetic field generating device 900b and a second pair of radio frequency electrodes 101a and 101b. Each applicator may be connected to the main unit by a connecting tube 814.
Fig. 61l shows a first applicator 800a and a second applicator 800b connected to a moving structure 834. The first applicator 800a may include a first magnetic field generating device 900a, a first pressure outlet 600a, and a first pair of radio frequency electrodes 101a and 101b. The second applicator 800b may include a second magnetic field generating device 900b, a second pressure outlet 600b, and a second pair of radio frequency electrodes 101a and 101b. Each applicator may be connected to the main unit by a connecting tube 814.
The moving structure may be coupled to at least one connection tube of the applicator and/or to connection tubes of a plurality of applicators.
Fig. 61m shows an applicator 800 configured to provide free movement of the magnetic field generating device and the RF electrode. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may comprise the magnetic field generating device 900 and the second portion 833b may comprise the radio frequency electrode 101. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The connecting tube 814 may be connected to a moving structure 834, which may be configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61n shows an applicator 800 configured to provide free movement of the magnetic field generating devices 900a and 900b. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and the second portion 833b may include a second magnetic field generating device 900b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b to the main unit. The connecting tube 814 may be connected to a moving structure 834, which may be configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61o shows an applicator 800 configured to provide free movement of a magnetic field generating device and a pair of RF electrodes. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and a pair of radio frequency electrodes 101a and 101b, and the second portion 833b may include a second magnetic field generating device 900b and a pair of radio frequency electrodes 101c and 101d. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The connecting tube 814 may be connected to a moving structure 834, which may be configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61p shows an applicator 800 configured to provide a magnetic field generating device and a pair of RF electrodes of the freely movable applicator 800. Applicator 800 may include a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a, a pair of rf electrodes 101a and 101b, and a pressure outlet 600a, and the second portion 833b may include a second magnetic field generating device 900b, a pair of rf electrodes 101c and 101d, and a pressure outlet 600b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The connecting tube 814 may be connected to a moving structure 834, which may be configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61q shows a first applicator 800a and a second applicator 800b. The applicator 800a may comprise a magnetic field generating device 900 and the second applicator 800b may comprise a radio frequency electrode 101. Each applicator may be connected to the main unit by a connecting tube 814. The connection tube 814 may be connected by a moving structure 834.
Fig. 61r shows a first applicator 800a and a second applicator 800b. The applicator 800a may include a first magnetic field generating device 900a and the second applicator 800b may include a second magnetic field generating device 900b. Each applicator may be connected to the main unit by a connecting tube 814. The connection tube 814 may be connected by a moving structure 834.
Fig. 61s shows a first applicator 800a and a second applicator 800b. The first applicator 800a may include a first magnetic field generating device 900a and a first pair of radio frequency electrodes 101a and 101b. The second applicator 800b may include a second magnetic field generating device 900b and a second pair of radio frequency electrodes 101a and 101b. Each applicator may be connected to the main unit by a connecting tube 814. The connection tube 814 may be connected by a moving structure 834.
Fig. 61t shows a first applicator 800a and a second applicator 800b. The first applicator 800a may include a first magnetic field generating device 900a, a first pressure outlet 600a, and a first pair of radio frequency electrodes 101a and 101b. The second applicator 800b may include a second magnetic field generating device 900b, a second pressure outlet 600b, and a second pair of radio frequency electrodes 101a and 101b. Each applicator may be connected to the main unit by a connecting tube 814. The connection tube 814 may be connected by a moving structure 834.
Fig. 61u shows a front cross-sectional view of an exemplary applicator 800. The first portion 833a and the second portion 833b may be connected to a moving structure 834. The moving structure 834 may include a joint 834c. While this configuration of one applicator is discussed, it should be understood that a similar configuration may be used for two independently movable applicators. For example, in the case of having two or more independently movable applicators, each applicator may be configured as shown in fig. 61 u.
Fig. 61v shows a front cross-sectional view of two exemplary applicators 800a and 800b connected to a moving structure. The first applicator 800a and the second applicator 800b may be connected to a moving structure 834, which may include at least one joint 834c.
Fig. 61w shows a front view of two exemplary applicators 800a and 800b connected to a moving structure represented by a spacer 834d and a moving link 834e. Applicators 800a and 800b are connected to a moving connection 834e by a joint 834 f. The moving connector 834d is connected to the spacer 834c by a joint 834 g.
Fig. 61x shows a front view of an exemplary applicator 800. The first portion 833a and the second portion 833b can be connected to a moving structure represented by joint 834f of the moving connector 834 e. The presence of additional joints 834g between the moving connector 834e and the spacer 834d can provide additional free movement of the moving structure itself.
As shown in fig. 61q-61x, the moving structure may be coupled to at least one connection tube.
Fig. 61q shows an applicator 800 comprising a first portion 833a and a second portion 833b. The first portion 833a may comprise a magnetic field generating device 900 and the second portion 833b may comprise a radio frequency applicator 101. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61r shows an applicator 800 comprising a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and the second portion 833b may include a second magnetic field generating device 900b. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61s shows an applicator 800 comprising a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a and a pair of radio frequency electrodes 101a and 101b. The second portion 833b may include a second magnetic field generating device 900b and a pair of radio frequency electrodes 101c and 101d. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61t shows an applicator 800 comprising a first portion 833a and a second portion 833b. The first portion 833a may include a first magnetic field generating device 900a, a first pressure outlet 600a, and a pair of radio frequency electrodes 101a and 101b. The second portion 833b may include a second magnetic field generating device 900b, a second outlet 600b, and a pair of radio frequency electrodes 101c and 101d. The connection tube 814 may be divided into two connection tube portions and connect the first portion 833a and the second portion 833b. The first portion 833a and the second portion 833b can be coupled to a moving structure 834 configured to provide movement of the first portion 833a and the second portion 833b.
Fig. 61u shows the first applicator 800a and the second applicator 800b connected to a moving structure that may be connected to a spacer 834c. The applicator 800a may comprise a magnetic field generating device 900 and the second applicator 800b may comprise a radio frequency electrode 101. Each applicator may include a connecting tube 814.
In some aspects, the movement structure may be configured to provide movement of one or more portions of the applicator in a selected direction. Fig. 70a-70r illustrate exemplary configurations of moving structures.
Fig. 70a shows an exemplary applicator 800 comprising a first portion 833a, a second portion 833b, and a moving structure. In some aspects, the first portion 833a includes a first magnetic field generating device 900a and the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in a Y-axis of a cartesian coordinate system, wherein the X-axis is directed towards the viewer. The position between the portion 833a and the moving connection 834 may be characterized by an angle 731. In some aspects, angle 731 may be in the range of 1 ° to 180 °, 10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °.
Fig. 70b illustrates an exemplary applicator 800 comprising a first portion 833a, a second portion 833b, and a moving structure. In some aspects, the first portion 833a includes a first magnetic field generating device 900a and the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in a Y-axis of a cartesian coordinate system, wherein the X-axis is directed towards the viewer. The position between the portion 833a and the moving connection 834 may be characterized by an angle 731. The first portion 833a is curved toward the moving link 834 e. In some aspects, angle 731 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70c shows an exemplary applicator 800 comprising a first portion 833a, a second portion 833b, and a moving structure. In some aspects, the first portion 833a includes a first magnetic field generating device 900a and the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in a Y-axis of a cartesian coordinate system, wherein the X-axis is directed towards the viewer. The position between the first portion 833a and the moving connector 834 can be characterized by an angle 731 a. The position between the second portion 833b and the moving connector 834 can be characterized by an angle 731b. In some aspects, angle 731a can be different from angle 731b. In some aspects, angles 731a and 731b are the same. Furthermore, the position of the portions relative to each other may be defined by angles 732a and 732b. The angle 732a may be defined by the bottom housing of the first portion 833a and the line 733. The angle 732b may be defined by the bottom housing of the first portion 833b and the line 733. A line 733 may be drawn between the centers of these portions. On the other hand, a line 733 may be drawn between the centers of the magnetic field generating devices 900a and 900b. In some aspects, angle 732a may be different than angle 732b. In some aspects, angles 732a and 732b are the same. In some aspects, angle 732a may be in the range of 1 ° to 180 °,10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °. In some aspects, the angle 732b may be in the range of 1 ° to 180 °,10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °. In some aspects, angle 731a can be in the range of 1 ° to 180 °,10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °. In some aspects, angle 731b can be in the range of 1 ° to 180 °,10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °.
Fig. 70d shows an exemplary applicator 800 comprising a first portion 833a, a second portion 833b, and a moving structure. In some aspects, the first portion 833a includes a first magnetic field generating device 900a and the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in a Y-axis of a cartesian coordinate system, wherein the X-axis is directed towards the viewer. The position of these portions relative to each other may be defined by angles 732a and 732 b. The angle 732a may be defined by the bottom housing of the first portion 833a and the line 733. The angle 732b may be defined by the bottom housing of the first portion 833b and the line 733. A line 733 may be drawn between the centers of these portions. On the other hand, a line 733 may be drawn between the centers of the magnetic field generating devices 900a and 900b. As shown in this figure, in some aspects, angles 732a and 732b are about 90 °. The moving structure is configured to position the bottom housings of the portions 833a and 833b against each other.
Fig. 70e shows an exemplary applicator 800 comprising a first portion 833a, a second portion 833b, and a moving structure. In some aspects, the first portion 833a includes a first magnetic field generating device 900a and the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in a Y-axis of a cartesian coordinate system, wherein the X-axis is directed towards the viewer. The movement of these parts may be provided by movement of parts of the moving structure. The position of the moving link 834e and spacer 834d can be defined by an angle 734. In some aspects, the angle 734 may be in the range of 1 ° to 180 °,10 ° to 175 °, 20 ° to 180 °, or 30 ° to 175 °.
Fig. 70f shows an exemplary applicator 800 from the side (as previously shown in fig. 70 a). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second portion 833b includes the second magnetic field generating device 900b, and the first portion is behind the second portion 833b as seen by a viewer in this fig. 70 f. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of a portion of the applicator in an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer.
Fig. 70g shows an exemplary applicator 800 from the side (as previously shown in fig. 70 a). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second portion 833b includes the second magnetic field generating device 900b, and the first portion is behind the second portion 833b as seen by a viewer in this fig. 70 g. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the portion of the applicator on an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer. The first portion 833b is shown positioned toward the mobile link 834 e. The position of the first portion 833b and the moving connector 834e can be defined by an angle 735. The angle may be defined between the top housing of the second portion 833b and the moving connector 834 e. In some aspects, angle 735 may be in the range of 1to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70h shows an exemplary applicator 800 from the side (as previously shown in fig. 70 a). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second portion 833b includes a second magnetic field generating device 900b. The first portion 833a is shown in fig. 70h with a dashed line behind the second portion 833 b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the portion of the applicator on an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer. The second portion 833b is shown positioned toward the mobile link 834e and the first portion 833a is shown in a different position. The position of the second portion 833b and the first portion 833a can be defined by an angle 736. The angle 736 may be defined between the bottom housing of the second portion 833b and the top housing of the first portion 833 a. In some aspects, angle 736 may be in the range of 1 ° to 180 °, 10 ° to 175 °, 20 ° to 180 °, or 30 ° to 175 °.
Fig. 70i shows an exemplary applicator 800 from the side (as in fig. 70 above). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second portion 833b includes a second magnetic field generating device 900b. In some aspects, each portion may further include at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure shown includes a spacer 834d, a moving connector 834e, and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the portion of the applicator on an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer. The movement of these parts may be provided by movement of parts of the moving structure. The position of the moving link 834e and spacer 834d can be defined by an angle 737. In some aspects, the angle 737 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
All examples of the various directions of movement shown in fig. 70a-70i may be combined.
The movement structure may be configured to provide movement of the plurality of applicators in a selected direction. Fig. 70j-70r illustrate exemplary configurations of movement.
Fig. 70j shows two exemplary applicators 800a and 800b, two connecting tubes 814a and 814b, and a moving structure. In some aspects, the first applicator 800a includes a first magnetic field generating device 900a and the second applicator 800b includes a second magnetic field generating device 900b. In some aspects, applicators 800a and 800b may also include at least one radiofrequency electrode and/or pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on a Y-axis of a cartesian coordinate system, wherein an X-axis is directed towards the viewer. The position between the applicator 800a and the mobile connector may be characterized by an angle 738. In some aspects, the angle 738 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70k shows two exemplary applicators, two connecting tubes 814a and 814b, and a moving structure. The first applicator 800a comprises a first magnetic field generating device 900a and the second applicator 800b comprises a second magnetic field generating device 900b. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on a Y-axis of a cartesian coordinate system, wherein an X-axis is directed towards the viewer. The position between the first applicator 800a and the mobile connector may be characterized by an angle 738. The first applicator 800a is bent toward the moving link 834 e. In some aspects, the angle 738 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 701 shows two applicators 800a and 800b, two connecting tubes 814a and 814b, and a moving structure. In some aspects, the first applicator 800a includes a first magnetic field generating device 900a and the second applicator 800b includes a second magnetic field generating device 900b. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on a Y-axis of a cartesian coordinate system, wherein an X-axis is directed towards the viewer. The position between the first applicator 800a and the mobile connector may be characterized by an angle 738 a. The position between the second applicator 800b and the mobile connector may be characterized by an angle 738b. In some aspects, angle 738a may be different than angle 738b. In some aspects, angles 738a and 738b are the same. Furthermore, the position of the applicators relative to each other may be defined by angles 739a and 739b. The angle 739a may be defined by the bottom shell of the first applicator 800a and the line 740. The angle 739b may be defined by the bottom shell of the first applicator 800b and the line 740. A line 740 may be drawn between the centers of the applicators. In another aspect, a line 740 may be drawn between the centers of the magnetic field generating devices 900a and 900b. In some aspects, angle 739a may be different than angle 739b. In some aspects, angles 739a and 739b are the same. The angles 739a and/or 739b may be in the range of 1 ° to 180 °,10 ° to 175 °, 20 ° to 180 °, or 30 ° to 175 °. The angles 738a and/or 738b may be in the range of 1 ° to 180 °,10 ° to 175 °, 20 ° to 180 °, or 30 ° to 175 °.
Fig. 70m shows two exemplary applicators, two connecting tubes 814a and 814b, and a moving structure. In some aspects, the first applicator 800a includes a first magnetic field generating device 900a and the second applicator 800b includes a second magnetic field generating device 900b. In some aspects, the applicator may further comprise at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator in a Y-axis of the cartesian system, wherein the X-axis is directed towards the viewer. The position of the applicators relative to each other may be defined by angles 739a and 739 b. The angle 739a may be defined by the bottom shell of the first applicator 800a and the line 740. The angle 739b may be defined by the bottom shell of the first applicator 800b and the line 740. A line 740 may be drawn between the centers of the applicators. In another aspect, a line 740 may be drawn between the centers of the magnetic field generating devices 900a and 900b. As shown in this figure, in some aspects, angles 739a and 739b are about 90 °. The moving structure is configured to position the bottom housings of the applicators 800a and 800b against each other.
Fig. 70n shows two exemplary applicators 800a and 800b, two connecting tubes 814a and 814b, and a moving structure. In some aspects, the first applicator 800a includes a first magnetic field generating device 900a and the second applicator 800b includes a second magnetic field generating device 900b. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the moving structure includes a spacer 834d, a moving connection 834e, joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on a Y-axis of a cartesian coordinate system, wherein an X-axis is directed towards the viewer. Movement of the applicator may be provided by movement of a component of the moving structure. The position of the moving link 834e and spacer 834d can be defined by an angle 741. In some aspects, angle 741 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70o shows two exemplary applicators 800a and 800b from the side (as in fig. 70j above). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second applicator 800b includes a second magnetic field generating device 900b, and the first applicator is positioned behind the second applicator 800b as seen by a viewer in this figure 70 o. In some aspects, the applicator may further comprise at least one radiofrequency electrode and/or a pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be reconfigured to provide movement of the applicator on an X-axis of a cartesian coordinate system, with a Y-axis pointing towards the viewer.
Fig. 70p shows two exemplary applicators 800a and 800b from the side (as in fig. 70j above). The second applicator 800b is shown on the Y-axis of the cartesian system, with the Y-axis pointing towards the viewer. In some aspects, the second applicator 800b includes a second magnetic field generating device 900b, and the first applicator is behind the second applicator 800b as seen by a viewer in this figure 70 p. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator in an X-axis of the cartesian system, wherein a Y-axis is directed towards the viewer. The first applicator 800b is shown positioned toward the mobile link 834 e. The position of the first applicator 800b and the moving link 834e can be defined by an angle 742. An angle 742 may be defined between the top housing of second applicator 800b and mobile connector 834 e. In some aspects, the angle 742 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70q shows two exemplary applicators 800a and 800b from the side (as in fig. 70j above). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second applicator 800b includes a second magnetic field generating device 900b. The first applicator 800a is shown in phantom behind the second applicator 800b in fig. 70 q. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the movement structure shown includes a movement connection 834e and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer. The second applicator 800b is shown positioned toward the mobile link 834e, and the first applicator 800 is shown in a different position. The position of the second applicator 800b and the first applicator 800a may be defined by an angle 743. An angle 743 may be defined between the bottom housing of the second applicator 800b and the top housing of the first applicator 800 a. In some aspects, the angle 743 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
Fig. 70r shows an exemplary applicator 800b from the side (as previously shown in fig. 70 j). The applicator is shown on the Y-axis of a cartesian coordinate system, with the Y-axis pointing towards the viewer. In some aspects, the second applicator 800b includes a second magnetic field generating device 900b. In some aspects, each applicator may further comprise at least one radiofrequency electrode and/or pressure outlet. In some aspects, the moving structure shown includes a spacer 834d, a moving connector 834e, and joints 834f and 834g. In some aspects, joints 834f and 834g include at least one gear. The movement structure may be configured to provide movement of the applicator on an X-axis of a cartesian coordinate system, wherein a Y-axis is directed towards the viewer. Movement of the applicator may be provided by movement of a component of the moving structure. The position of the moving link 834e and spacer 834d can be defined by an angle 744. In some aspects, the angle 744 may be in the range of 1 to 180 degrees, 10 to 175 degrees, 20 to 180 degrees, or 30 to 175 degrees.
All examples of the various directions of movement shown in fig. 70j-70r may be combined.
As noted above, the applicators described herein may have more than one portion for performing a treatment. In some aspects, the applicator may include first and second portions that are movable relative to one another. In some aspects, the first and second applicator portions may be defined by first and second planes, and the applicator portions may be positioned such that the planes are not parallel to one another. As described herein, treatment may be performed in a similar manner as an applicator configured with a single portion. In some cases, treatment may be provided by multiple applicator portions lying in more than one plane, which may be beneficial for body parts or body part portions that include curves or other irregular shapes (e.g., flanks, latissimus, lumbar regions, shoulders, or knees). In some cases, treatment of body parts that are more difficult to reach or effectively treated with a single-part applicator may improve treatment by using a multi-part applicator.
Thus, a treatment apparatus with a multi-part applicator and method of using the same may provide treatment for uneven, curved or irregularly shaped parts of a body part. In some aspects, examples of uneven, curved, or irregularly shaped body parts may include the legs, arms, shoulders, flanks (also known as latissimus dorsi or lumbar regions), buttocks, chest, or ankles of a person or animal being treated. The applicator and/or at least one component thereof may be curved, curled or located in multiple positions or multiple planes, for example, around a curved or irregularly shaped treatment body part. In some cases, such treatment may be substituted for treatment using an applicator having a single flat surface (e.g., as shown in fig. 25). As one example, in treating a patient's flank, the location of the magnetic field generating device within the multipart applicator, which may be located at multiple locations relative to the flank, provides a more targeted time-varying magnetic field that is sufficient to provide muscle contraction at the flank. By using an applicator configured to bend, curl, or lie in multiple positions or planes around a body part being treated, the magnetic field generating device can be located in advantageous positions and distances to provide a targeted time-varying magnetic field. Features described with reference to these aspects may be used with features described in other aspects described herein, and vice versa (e.g., fig. 1a through 60 e).
The device and/or applicator may provide a time-varying magnetic field to a body part of the patient, wherein the time-varying magnetic field may cause muscle contraction and/or a series of repetitive muscle contractions. The provided muscle contraction may enhance the visual appearance.
The device and/or applicator may provide radio frequency waves (via one or more radio frequency electrodes) to a body part of the patient, wherein the radio frequency waves may cause tissue to heat. Radio frequency waves provided within the ranges mentioned herein may cause heating of adipose tissue within the body part being treated, which may result in removal of adipose tissue and/or enhanced visual appearance.
An applicator that may treat an uneven, curved or irregularly shaped portion of a body part may include a housing, a first portion, a second portion, a moving structure (e.g., a joint), a connecting tube, and a tube connector. The first portion and/or the second portion may comprise one or more magnetic field generating devices. Further, the first portion and/or the second portion may comprise one or more radio frequency electrodes. The one or more magnetic field generating devices and the one or more radio frequency electrodes may be located within a housing of the applicator. The moving structure may ensure that the first portion is curved relative to the second portion. The applicator may be coupled to a body part. The applicator may be positioned in contact with a body part. Or the applicator may be adjacent to a body part. Furthermore, only a portion of the applicator may be in contact with the body part, while another portion may not be in contact with the body part. However, the applicator may not be in contact with the body part, but rather be located a few centimeters above the skin of the body part. Both parts may comprise a temperature sensor. Both parts may comprise protruding parts of the housing, for example, where the temperature sensor is located.
Fig. 62a shows a cross section of an exemplary applicator 610a that may treat uneven, curved or irregular portions of a body part. The applicator 610a may include a first portion 611 including a first magnetic field generating device 900a and a first radio frequency electrode 101a. In addition, the applicator 610a may further comprise a second portion 614 comprising a second magnetic field generating device 900b and a second radio frequency electrode 101b. In addition, the applicator 610a may include a displacement structure 615, a connecting tube 616, and a tube connector 617. The first portion 611 and the second portion 614 may be moved or positioned relative to each other at a moving structure 615. The moving structure 615 may have a degree of rigidity such that the moving structure 615 may maintain the position of the first portion 611 and the second portion 614. In some cases, the moving structure 615 may include a lock that locks the first portion 611 and the second portion 614 at a particular angle. The connection tube 616 may connect the applicator 610a to a main unit of the apparatus. The tubing connector 617 may connect the connection tubing to an applicator connector located on the main unit. The applicator is shown in an open position relative to the body part 618 (e.g., a flank).
Fig. 62b shows a cross-section of another exemplary applicator 610b that may treat uneven, curved or irregularly shaped portions of a body part. The applicator 610b may include a first portion 611 that includes the magnetic field generating device 900 and the first radio frequency electrode 101a. In addition, the applicator may further comprise a second portion 614 comprising a second radio frequency electrode 101b. In addition, the applicator 610b may include a moving structure 615, a connecting tube 616, and a tube connector 617. The first portion 611 and the second portion 614 may move relative to each other at a movement structure 615. The connection tube 616 may connect the applicator 610b to a main unit of the apparatus. The tubing connector 617 may connect the connection tubing to an applicator connector located on the main unit. Applicator 610b is shown in an open position relative to body part 618.
Fig. 62c shows a ground projection of the position of an exemplary RF electrode relative to an exemplary magnetic field generating device within an exemplary applicator 610 c. The applicator 610c may include a moving structure 615, a first portion 611, and a second portion 614. The first portion 611 may comprise a first magnetic field generating device 900a and two radio frequency electrodes 101a and 101aa, wherein the two radio frequency electrodes 101a and 101aa may overlap with the magnetic field generating device 900a when seen in a ground projection as shown in fig. 62 c. Furthermore, two radio frequency electrodes 101a and 101aa may be located between the magnetic field generating device 900a and the body part to be treated. The second portion 614 may comprise a magnetic field generating device 900b and two radio frequency electrodes 101b and 101bb, wherein the two radio frequency electrodes 101b and 101bb may overlap with the magnetic field generating device 900b when viewed in a ground projection as shown in fig. 62 c. Furthermore, two radio frequency electrodes 101b and 101bb may be located between the magnetic field generating device 900b and the body part being treated.
Fig. 62d shows a ground projection of the position of the exemplary RF electrode relative to the exemplary magnetic field generating device within the exemplary applicator 610 d. The applicator 610d may include a moving structure 615, a first portion 611, and a second portion 614. The first portion 611 may comprise the magnetic field generating device 900 and the two radio frequency electrodes 101a and 101aa, wherein the two radio frequency electrodes 101a and 101aa may overlap with the magnetic field generating device 900 when seen in a ground projection as shown in fig. 62 d. Furthermore, two radio frequency electrodes 101a and 101aa may be located between the magnetic field generating device 900 and the body part to be treated. The second portion 614 may include only two radio frequency electrodes 101b and 101bb. For example, when a magnetic field generating device of a new configuration as described below is used, such a configuration of an applicator having only one magnetic field generating device may be sufficient. Furthermore, the presence of only one magnetic field generating device may reduce the weight size and cooling requirements of the applicator.
Fig. 62e shows a cross section of an exemplary applicator 610e that may treat uneven or curved portions of a body part. The applicator 610e may include a first portion 611 that includes the first magnetic field generating device 900. In addition, the applicator 610e may include a second portion 614 that includes the second rf electrode 101. In addition, the applicator 610e may include a displacement structure 615, a connecting tube 616, and a tube connector 617. The first portion 611 and the second portion 614 may move relative to each other at a movement structure 615. The connection tube 616 may connect the applicator 610a to a main unit of the apparatus. The tubing connector 617 may connect the connection tubing to an applicator connector located on the main unit. The applicator is shown in an open position relative to the body part 618 (e.g., a flank).
The first portion of the applicators discussed herein may be positioned relative to the second portion of the respective applicators, e.g., so as to curve around an uneven, curved, or irregularly shaped portion of the body part. Positioning of the first and second portions through the moving structure may be useful in some cases to increase uniformity of treatment (e.g., uniformity of heating and/or muscle contraction). The position between the first portion and the second portion may be characterized by the angle as described below.
Fig. 62f shows an exemplary applicator 620 comprising a first portion 621, a second portion 622 and a moving structure 623. Fig. 62f shows a first imaginary line 627a between the center of the moving structure 629 and the side 628a of the first portion 621. In addition, fig. 62f shows a second imaginary line 627b between the center of the moving structure 629 and the side 628b of the second portion 622. The angle defined between the first and second imaginary lines 627a and 627b may be in the range of 1 ° to 180 °, 10 ° to 175 °,20 ° to 180 °, or 30 ° to 175 °. Reference numeral 624 shows the maximum angle between the parts. In one example, the maximum angle 624 may be 168 degrees.
Fig. 62g shows an exemplary applicator 620 comprising a first portion 621, a second portion 622, and a moving structure 623. Reference numeral 625 shows the minimum angle between these parts. In one example, the minimum angle 625 may be 38 degrees.
Fig. 62a and 62g illustrate that the first portion 621 and/or the second portion 622 may include one or more at least partially circular or oval concavity on its surface 630. The curvature may have a radius of curvature in the range of 20cm to 150cm, 30cm to 100cm, 30cm to 70cm, or 40cm to 60 cm. The radius of curvature may correspond to the size of a patient's limb or flank. The protruding portion 626a on the first portion 621 may include a first temperature sensor, and the protruding portion 626b on the second portion 622 may include a second temperature sensor.
Fig. 63 shows an exploded view of the applicator elements forming an exemplary applicator 620. The applicator may include a handle 631, a first part top cover 632, a moving structure member 633 including a hose with a holder, an applicator control unit 634, a blower 635, a magnetic field generating device 900, a frame 636, a first part RF electrode 101a, a first part bottom cover 639, a second part top cover 640, a second part RF electrode 101b, a second part bottom cover 641, a moving structure cover 642, and a screw cover 643.
The device may comprise a magnetic field generating device. An exemplary magnetic field generating device may be in the form of a magnetic coil comprising two windings separated by at least one coil frame portion. In some aspects, one winding may form one layer of the magnetic coil. In some aspects, the two winding portions may be part of one winding, wherein the first and second winding portions are separated by a coil former portion. Partial separation is understood to mean that the windings may have two surfaces separated by a coil former, but that portions of the windings may be connected by one or more electrically conductive wires or strips passing through the coil former. The one or more windings of the exemplary magnetic field generating device may include one or more insulated wires or metal strips. The two winding portions may be formed from the same set of conductive wires or strips. The magnetic field generating device may comprise litz wire with insulated wires.
Fig. 64 and 65 illustrate an exemplary magnetic field generating device 900 comprising a first winding 646 and a second winding 647 forming two layers separated by a coil former 645. The first winding 646 may be connected to the second winding 647. The first winding 646 and the second winding 647 may have a common core, e.g., an air core. The coil former 645 may be used to form a magnetic core. The coil frame 645 may define a magnetic core having concentric first portions (shown as 649a in fig. 66 a) and second portions (shown as 649b in fig. 66 b). The first winding 646 may be wound around the first portion 649a and the second winding 647 may be wound around the second portion 649 b. The first portion 649a and the second portion 649b may differ in size. The diameter 650b of the second portion 649b may be greater than the diameter 650a of the first portion 649 a. The first winding 646 may be wound around the first portion 649a and the second winding 647 may be wound around the second portion 649 b. As shown in fig. 64, a first portion of the core of the first winding 646 is of a different size than a second portion of the core of the second winding 647. The second portion of the magnetic core may be larger than the first portion of the magnetic core. Connectors 644 and 648 may be used to connect the magnetic field generating device 900 to other electrical components of the device, for example to an energy storage device or a switching device.
In one example, the larger second portion 649b of the magnetic core and the second winding 647 may be closer to the patient and/or body part than the first winding 646. In some aspects, the smaller first portion 649a of the magnetic core and the first winding 646 may be closer to the patient and/or body part than the second winding 647. In this way, the effective edges of the magnetic field generated may be blunter, making the patient more comfortable. Furthermore, by using a blunter magnetic field boundary, the muscles or nerves can be more easily targeted—in practice, the generated magnetic field can be configured to be wider, as the field lines of the magnetic field flow through the wider core, closer to the body during treatment. Thus, the sharper part of the field will be directed towards the opposite side of the patient's body and the body part being treated.
The diameter 650a of the first portion 649a of the magnetic core may be in the range of 1mm to 100mm or 10mm to 45 mm. The diameter 650b of the second portion 649b of the magnetic core may be in the range of 3mm to 150mm or 20mm to 60 mm. In one example, the diameter 650a of the first portion 649a of the magnetic core is 30mm and the diameter 650b of the second portion 649b of the magnetic core is 50mm.
The diameter ratio of the first portion 649a of the magnetic core to the second portion 649b of the magnetic core may be in the range of 0.001 to 15, or 0.05 to 8, or 0.05 to 3, or 0.3 to 0.8. In some aspects, the ratio of the diameters of the first portion 649a of the magnetic core and the second portion 649b of the magnetic core is about 0.6.
Fig. 66a shows a top view of an exemplary magnetic field generating device 900 showing the first winding 646, the first portion 649a of the magnetic core, and the diameter 650a of the first portion 649 a. The first portion 649a of the core is located within the coil frame 645.
Fig. 66b shows a bottom view of the example magnetic field generating device 900, illustrating the second winding 647, the second portion 649b of the magnetic core, and the diameter 650b of the second portion 649 b. The second portion 649b of the core is located within the coil frame 645. As described above, the second portion 649b of the magnetic core may be larger than the first portion 649a of the magnetic core. The coil frame 645 may further include screw holes 651 for connecting the magnetic field generating device 900 to the interior of the applicator.
Fig. 66c shows an isometric view of an exemplary magnetic field generating device 900, showing a second portion 649b of the magnetic core. In addition, fig. 66b and 66c show a connection 652 between the second winding 647 and the first winding 646 through one or more conductive wires, which may be from the same set of conductive wires or strips as the first winding 646 and the second winding 647. This connection 652, which may be located within the coil frame 645, the first portion 649a, and/or the second portion 649b, may ensure that electrical signals are transmitted from the first winding 646 to the second winding 647. Through this connection 652, the first winding 646 and the second winding 647 are part of one common winding.
The diameter of the first winding 646 may be the same as or different from the diameter of the second winding 647.
The first winding 646 may be wound on the coil frame 645 in one direction and the second winding 647 may be wound in the opposite direction, as shown in fig. 67. The direction may be clockwise or counterclockwise. The different winding directions on both sides of the magnetic field generating device 900 may allow for a first time varying magnetic field provided by the first winding 646 and a second time varying magnetic field provided by the second winding 647 to be combined (e.g., added). The combination (e.g., summation) of the first time-varying magnetic field and the second time-varying magnetic field may result in a change in shape of the generated time-varying magnetic field. The time-varying magnetic field generated may be wider than the time-varying magnetic field provided by the magnetic coils of only one layer of windings. The resulting wider time-varying magnetic field may be capable of stimulating at least one muscle of the body part, wherein the muscle cannot be stimulated by a coil of only one layer of windings.
Or the first winding 646 and the second winding 647 may be wound in the same direction.
The magnetic field generating device may be connected to at least one energy storage device, which may provide current pulses to the magnetic field generating device. During operation of the exemplary magnetic field generating device 900, current pulses may be provided to the first winding 646 by the connector 644. The current pulse flows through the wire of the first winding 646 wound in one direction and generates a pulse of the first time-varying magnetic field. Thereafter, the current pulse flows through one or more conductive wires within the coil form to the second winding 647. The current pulses generate pulses of the second time-varying magnetic field through the wire of the second winding 647 wound in the opposite direction.
The first winding 646 wound around the first portion 649a of the core provides a more concentrated time-varying magnetic field, while the second winding 647 wound around the second portion 649b of the core provides a less concentrated time-varying magnetic field. By combining (e.g., summing) two time-varying magnetic fields, the resulting time-varying magnetic field is more uniform and wider than using only one winding in one layer. By such homogenization, the exemplary magnetic field generating device 900 may provide more uniform and denser treatment.
In this configuration, the first and second time-varying magnetic fields combined to the generated time-varying magnetic field are generated by one current pulse. The time-varying magnetic field generated may combine the shape of the time-varying magnetic field, the shape of the magnetic field lines, and/or the magnetic flux densities of the first time-varying magnetic field and the second time-varying magnetic field. When the body part being treated includes areas of less available muscle, nerve or neuromuscular plates (e.g., the flank area), the time-varying magnetic field produced can still cause muscle contraction.
In some aspects, an applicator configured for treating a curved body part, including at least one of a patient's ventral, buttock, or shoulder, the applicator may comprise: a first part including a first magnetic field generating device; a second portion comprising a first RF electrode; a moving structure configured to provide bending of the first and second portions relative to each other; wherein the first magnetic field generating device is configured to provide a time-varying magnetic field to cause muscle contraction within the curved body part; wherein the first RF electrode is configured to provide heating to tissue within the curved body part; wherein the tissue may be adipose tissue.
A magnetic field generating device may include: a multilayer conductive wire winding; a coil former separating at least two layers of the multi-layer winding.
A magnetic field generating device may include: a multilayer conductive wire winding; a coil former separating at least two layers of the multi-layer winding; a connection between the multi-layer windings, wherein the connection comprises one or more conductive wires; wherein the multi-layer winding is formed from the same set of conductive wires; wherein the connected one or more conductive wires are formed from the same set of conductive wires.
All examples, portions of the descriptions and methods may be used alone or in any combination.
New systems and methods have been described. The present disclosure should be construed in the broadest sense and therefore various changes and substitutions can be made, of course, without departing from the spirit and scope of the present disclosure.
The following patent applications are incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 14/789,156, filed on 7.1.2015; U.S. patent application Ser. No. 14/789,658 filed on 7/1/2015; U.S. patent application Ser. No. 14/783,110, filed on 1 month 10 of 2015; U.S. patent application Ser. No. 14/926,365, filed on 10/29/2015; U.S. patent application Ser. No. 14/951,093, filed 11/24/2015; U.S. patent application Ser. No. 15/073,318, filed by day 2016, 3, 17; U.S. patent application Ser. No. 15/099,274, filed 4/14/2016; U.S. patent application Ser. No. 15/151,012, filed 5/10/2016; U.S. patent application Ser. No. 15/344,811, filed 11/7/2016; U.S. patent application Ser. No. 15/178,455, filed 6/9/2016; U.S. patent application Ser. No. 15/396,073, filed 12/30/2016; U.S. patent application Ser. No. 15/404,384, filed on 1 month 12 of 2017; U.S. provisional patent application Ser. No. 62/357,679, filed 7/1/2016; U.S. provisional patent application Ser. No. 62/440,905 filed 12/30/2016; U.S. provisional patent application Ser. No. 62/440,912, filed 12/30/2016; U.S. provisional patent application Ser. No. 62/440,922, filed 12/30/2016; U.S. provisional patent application Ser. No. 62/441,805 filed on 1/3/2017; U.S. provisional patent application Ser. No. 62/440,936 filed 12/30/2016; U.S. provisional patent application Ser. No. 62/440,940, filed 12/30/2016; U.S. patent application Ser. No. 15/446,951, filed 3/1/2017; U.S. patent application Ser. No. 15/473,390 filed on 29 th 3.2017; U.S. patent application Ser. No. 15/601,719 filed 5/22/2017; U.S. patent application Ser. No. 15/677,371 filed on 8/15/2017; U.S. patent application Ser. No. 15/860,443, filed on 1/2/2018; U.S. patent application Ser. No. 15/862,410, filed on 1/4/2018; U.S. patent application Ser. No. 15/954,783, filed on even date 17 at 4 in 2018; U.S. patent application Ser. No. 16/034,752, filed on 7/13/2018; U.S. patent application Ser. No. 16/034,793 filed on 7/13/2018; U.S. patent application Ser. No. 16/042,093 filed on 7/23/2018; U.S. patent application Ser. No. 16/196,798, filed 11/20/2018; U.S. patent application Ser. No. 16/196,837, filed 11/20/2018; U.S. patent application Ser. No. 16/218,735, filed on 13/12/2018; U.S. patent application Ser. No. 16/219,724, filed on 13/12/2018; U.S. provisional patent application Ser. No. 62/786,731, filed on day 31, 12, 2018; U.S. patent application Ser. No. 16/266,570, filed on 4/2/2019; U.S. patent application Ser. No. 16/266,494, filed 2/4/2019; U.S. patent application Ser. No. 16/294,034, filed 3/6/2019; U.S. patent application Ser. No. 16/560,790, filed on 4/9/2019; U.S. patent application Ser. No. 16/567,866, filed on 11/9/2019; U.S. patent application Ser. No. 16/664,524 filed on 10/25/2019; U.S. patent application Ser. No. 16/673,784, filed 11/4/2019; U.S. patent application Ser. No. 16/673,683, filed 11/4/2019; U.S. patent application Ser. No. 16/674,144, filed 11/5 in 2019; U.S. patent application Ser. No. 16/827,330, 23, 3/2020, and International patent application Ser. No. PCT/IB/2016/053930, 30, 6/2016.
Abbreviation list related to fig. 17, 18a, etc. (a/B) means that the corresponding elements of the list may be shown with corresponding letters. For example, an ESD (a/B) description shows an ESDA and/or an ESD B in at least one of the figures.
PS power supply
ESD (A/B) energy storage device
SW (A/B) switch
HIFEM (A/B) treatment clusters for magnetic treatment
MFGD (A/B) magnetic field generating device
Control unit of CUM (A/B) magnetic circuit
Auxiliary power supply for APS RF circuits
PU power unit
Stabilized power supply for SPSRF RF circuit
PNFLT power network filter
PSRF power supply for RF therapy
RF (A/B) therapy clusters for RF therapy
SYM (A/B) symmetrical element
AP (A/B) applicator
RFE (A/B) RF electrode
APS (A/B) auxiliary power supply
PSM power supply for magnetic therapy
BPS (A/B) plate type power supply
Stable power supply of SPSM magnetic circuit
PN power network
PF pulse filter
SE security element
PA power amplifier
Control unit of CURF RF circuit

Claims (4)

1. A treatment apparatus for providing pressure treatment and heating to a patient, the apparatus comprising:
an RF electrode configured to generate an RF field;
a magnetic field generating device configured to cause muscle contraction; and
A pressure outlet.
2. A method for treating a patient, the method comprising:
Providing pressure therapy;
Heating a body part of the patient;
Generating a magnetic field by a magnetic field generating device to cause muscle contraction;
generating a pressure through a pressure outlet; and
A radio frequency wave is generated and provided to the patient.
3. A therapeutic apparatus for providing magnetic therapy to a patient, the apparatus comprising:
an applicator comprising a first portion and a second portion; and
A movement structure configured to provide free movement of the first portion relative to the second portion.
4. A therapeutic apparatus for providing magnetic therapy to a patient, the apparatus comprising:
a first applicator and a second applicator; and
A movement structure configured to provide free movement of the first applicator relative to the second applicator.
CN202280071798.1A 2021-10-13 2022-10-12 Device for cosmetic treatment of biological structures by means of radio frequency and magnetic energy Pending CN118382481A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US17/500612 2021-10-13
US202263316758P 2022-03-04 2022-03-04
US63/316758 2022-03-04
PCT/IB2022/059794 WO2023062563A1 (en) 2021-10-13 2022-10-12 Devices for aesthetic treatment of biological structures by radiofrequency and magnetic energy

Publications (1)

Publication Number Publication Date
CN118382481A true CN118382481A (en) 2024-07-23

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Country Status (1)

Country Link
CN (1) CN118382481A (en)

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