# US 12,465,762 B2 · Method and device for pelvic floor tissue treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,465,762 B2 - Document ID: US12465762B2 - Status: Granted - Kind: B2 - Application number: 18/438,711 - Filed: 2024-02-12 - Published: 2024-07-04 - Granted: 2025-11-11 - Earliest claimed: 2017-04-04 - Assignees: BTL Healthcare Technologies A.S. - Applicants: BTL Healthcare Technologies A.S. - Inventors: Tomás Schwarz; Lucia Jelinkova; Jan Milichovsky - Web page: https://patentgrep.com/patent/US12465762B2 ## CPC - A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61B 18/1815: {using microwaves} - A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals} - A61N 2/002: {in combination with another treatment} - A61N 2/004: {specially adapted for a specific therapy} - A61N 5/0603: {for treatment of body cavities} - A61B 2018/00505: {Urinary tract} - A61B 2018/00559: {Female reproductive organs} - A61B 2018/00577: {Ablation} - A61B 2018/00702: {Power or energy} - A61B 2018/00791: {Temperature} - A61B 2018/00875: {Resistance or impedance} - A61B 2018/143: {multiple needles} - A61N 1/0512: {Anal electrodes} - A61N 1/0524: {Vaginal electrodes} - A61N 1/06: for high-frequency therapy - A61N 5/022: {Apparatus adapted for a specific treatment} - A61N 7/02: Localised ultrasound hyperthermia - A61N 2005/0611: {Vagina} - A61N 2007/0043: {intra-cavitary} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A method for a genital tissue treatment comprises providing a device including a central control unit, an energy generator and an internal applicator, wherein the internal applicator is detachable and includes at least one ring-shaped circular energy delivery element encircling or around the internal applicator, with the at least one circular energy delivery element, inserting the internal applicator into vagina and into or onto the genital tissue, transferring radiofrequency energy into the genital tissue, heating the genital tissue and, wherein the applicator includes at least one temperature sensor in communication with the central control unit or the energy generator and providing a feedback during treatment, wherein the feedback includes changing output of at least one energy delivery element. ## Claims ### Claim 1 A method for treating a female genital tissue comprising: providing an applicator comprising an external part and an internal part, the internal part being detachably coupleable to the external part; assembling the applicator comprising the external part and the internal part; wherein the applicator comprises a plurality of ring-shaped circular energy delivery elements around or encircling the internal part; wherein each of the plurality of ring-shaped circular energy delivery elements has a radius in a range of 0.5 cm to 12 cm and a width in a range of 1 mm to 50 mm; wherein the plurality of ring-shaped circular energy delivery elements is spaced apart from each other by a distance in a range of 0.01 mm to 20 mm; wherein the plurality of ring-shaped circular energy delivery elements is configured to apply a radiofrequency energy; inserting the internal part into the female genital tissue; maintaining the internal part inside the female genital tissue without additional movement of the internal part during the treatment; activating the plurality of ring-shaped circular energy delivery elements via a control unit, sequentially or in partial overlap, in order to simulate movement with the internal applicator; and applying the radiofrequency energy to the female genital tissue, thereby causing heating of the female genital tissue. ### Claim 2 (depends on 1) The method of claim 1, further comprising providing an energy generator configured to generate the radiofrequency energy with a frequency in a range of 350 kHz to 100 MHz and an output power up to 200 W; providing a user interface configured to provide initial set-up of the treatment to a user; automatically controlling the energy generator by the control unit according to the initial set-up; wherein the energy generator is coupled to the applicator; and wherein the plurality of ring-shaped circular energy delivery elements comprises a first ring-shaped circular energy delivery element, a second ring-shaped circular energy delivery element and a third ring-shaped circular energy delivery element; and wherein each of the first, second, and third ring-shaped circular energy delivery elements comprises an electrode. ### Claim 3 (depends on 2) The method of claim 2, further comprising activating the second ring-shaped circular energy delivery element after activation and deactivation of the first ring-shaped circular energy delivery element; and activating the third ring-shaped circular energy delivery element after the activation and deactivation of the second ring-shaped circular energy delivery element. ### Claim 4 (depends on 2) The method of claim 2, further comprising activating the second ring-shaped circular energy delivery element while the first ring-shaped circular energy delivery element is still active; and activating the third ring-shaped circular energy delivery element while the second ring-shaped circular energy delivery element is still active. ### Claim 5 (depends on 2) The method of claim 2, further comprising activating the second ring-shaped circular energy delivery element after activation and deactivation of the first ring-shaped circular energy delivery element; and activating the third ring-shaped circular energy delivery element while the second ring-shaped circular energy delivery element is still active. ### Claim 6 (depends on 1) The method of claim 1, wherein the internal part further comprises a widened proximal part configured to decrease pressure inside the female genital tissue, therefore holding the internal part inside the female genital tissue. ### Claim 7 (depends on 1) The method of claim 1, further comprising attaching a spacing object to the internal part to provide indirect contact of the internal part with the female genital tissue, allowing the internal part to be reusable after the treatment. ### Claim 8 A method for a female genital tissue treatment comprising: providing an applicator comprising an external part and an internal part, the internal part being detachably coupleable to the external part; assembling the applicator comprising the external part and the internal part; wherein the applicator comprises a plurality of ring-shaped circular energy delivery elements around or encircling the internal part; wherein each of the plurality of ring-shaped circular energy delivery elements has a radius in a range of 0.5 cm to 12 cm and a width in a range of 1 mm to 50 mm; wherein the plurality of ring-shaped circular energy delivery elements is spaced apart from each other by a distance in a range of 0.01 mm to 20 mm; wherein the plurality of ring-shaped circular energy delivery elements is configured to apply an electric energy different from radiofrequency energy; inserting the internal part into the female genital tissue; maintaining the internal part inside the female genital tissue without additional movement of the internal part during the treatment; activating the plurality of ring-shaped circular energy delivery elements via a control unit, sequentially or in partial overlap, in order to simulate movement with the internal part; and applying the electric energy to the female genital tissue, thereby causing a stimulation of muscles of the female genital tissue. ### Claim 9 (depends on 8) The method of claim 8, wherein the plurality of ring-shaped circular energy delivery elements comprises bipolar electrodes. ### Claim 10 (depends on 9) The method of claim 9, further comprising applying the electric energy with the bipolar electrodes in pulses with a repetition in a range of 0.01 Hz to 100 Hz with an output current in a range of 0.01 mA to 180 mA and output voltage in a range of 0.001 V to 250 V; and wherein the stimulation of muscles of the female genital tissue comprises a muscle contraction. ### Claim 11 (depends on 9) The method of claim 9, wherein the internal part has a phallic shape comprising at least one curve having a radius of curvature in a range of 135 mm to 450 mm; and wherein the bipolar electrodes have a radius in a range of 0.5 cm to 12 cm. ### Claim 12 (depends on 9) The method of claim 9, wherein the bipolar electrodes comprise a first pair of bipolar electrodes, a second pair of bipolar electrodes being different from the first pair of bipolar electrodes, and a third pair of bipolar electrodes being different from the first pair of bipolar electrodes and the second pair of bipolar electrodes; activating and deactivating the first, second and third pairs of bipolar electrodes sequentially in a forward direction to simulate movement with the internal part; and activating and deactivating the first, second and third pair of bipolar electrodes sequentially in a backward direction to simulate movement with the internal part; wherein the forward direction comprises: activating and deactivating the first pair of bipolar electrodes; activating and deactivating the second pair of bipolar electrodes after activation and deactivation of the first pair of bipolar electrodes; and activating and deactivating the third pair of bipolar electrodes after activation and deactivation of the second pair of bipolar electrodes; and wherein the backward direction comprises: activating and deactivating the third pair of bipolar electrodes; activating and deactivating the second pair of bipolar electrodes after activation and deactivation of the third pair of bipolar electrodes; and activating and deactivating the first pair of bipolar electrodes after activation and deactivation of the second pair of bipolar electrodes. ### Claim 13 (depends on 9) The method of claim 9, wherein the bipolar electrodes comprise a first electrode, a second electrode, a third electrode, and a fourth electrode, the method further comprising the step of activating and deactivating the bipolar electrodes sequentially in a forward direction to simulate movement with the internal part; wherein the forward direction comprises: activating and deactivating the first electrode and the second electrode; activating and deactivating the second electrode and the third electrode after activation and deactivation of the first electrode and the second electrode; activating and deactivating the third electrode and the fourth electrode after activation and deactivation of the second electrode and the third electrode. ### Claim 14 (depends on 9) The method of claim 9, further comprising activating the bipolar electrodes for an active time interval in a range of 0.01 second to 20 seconds.