# US 11,896,823 B2 · Method and device for pelvic floor tissue treatment

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- Number: US 11,896,823 B2
- Document ID: US11896823B2
- Status: Granted
- Kind: B2
- Application number: 16/052,369
- Filed: 2018-08-01
- Published: 2018-12-06
- Granted: 2024-02-13
- Earliest claimed: 2017-04-04
- Assignees: BTL Healthcare Technologies A.S.
- Applicants: BTL Medical Technologies S.R.O.
- Inventors: Tomá{hacek over (s)} Schwarz; Lucia Jelinkova; Jan Milichovsky
- Web page: https://patentgrep.com/patent/US11896823B2

## 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

In methods and devices for treating a body canal or cavity, an internal applicator has an insertable part or section for insertion into the body canal or cavity (e.g. vagina or anal canal) and non-insertable part which may be detachable from a handle or second part of the device. The insertable part may include a plurality of energy delivery elements, optionally spaced apart in an array. During treatment the insertable part is positioned into or onto the body canal or cavity. The treatment may then proceed without additional movement of the insertable part. The energy delivery elements may be activated in predetermined order.

## Claims

### Claim 1

A method for a female genital tissue treatment comprising:
providing an internal applicator including an insertable part and a non-insertable part;
assembling the insertable part with first and second detachable parts along a length of the insertable part, wherein the first detachable part includes a first ring-shaped circular radiofrequency electrode encircling or around the first detachable part and the second detachable part includes a second ring-shaped circular radiofrequency electrode encircling or around the second detachable part;
with the first and second ring-shaped circular radiofrequency electrodes having a length in a range of 0.1 mm to 100 mm and a radius in a range of 0.2 cm to 20 cm;
wherein the non-insertable part, the first and second detachable parts and centers of the first and second ring-shaped circular radiofrequency electrodes are configured to be on the same longitudinal axis;
wherein the first and second ring-shaped circular radiofrequency electrodes are perpendicular to the longitudinal axis; and
wherein the first and the second ring-shaped circular radiofrequency electrodes are spaced apart from each other by a distance in a range of 0.01 mm to 20 mm;
inserting the insertable part having a length in a range of 0.75 cm to 20 cm at east partially into a vagina;
transferring a radiofrequency energy into the genital tissue of the vagina with the first and second ring-shaped circular radiofrequency electrodes;
wherein the radiofrequency energy is in a range of 350 kHz to 100 MHz with an output up to 450 W providing an energy flux in a range 0.001 W/cm2 to 1500 W/cm2; and
heating an epithelium of the vagina.

### Claim 2 (depends on 1)

The method of claim 1, wherein the first and second ring-shaped circular radiofrequency electrodes cover 2% to 100% of the surface of the insertable part.

### Claim 3 (depends on 1)

The method of claim 1, wherein the insertable part is positioned between a labia minora and a cervix.

### Claim 4 (depends on 1)

The method of claim 1, further including generating the radiofrequency energy by the first ring-shaped circular radiofrequency electrode for a first active time interval and generating the radiofrequency energy by the second ring-shaped circular radiofrequency electrode for a second active time interval,
wherein the second active time interval is in a range of 0.05 seconds to 60 seconds, and wherein the second active time interval begins after a beginning of the first active time interval.

### Claim 5 (depends on 4)

The method of claim 4, wherein the second active time interval begins during the first active time interval.

### Claim 6 (depends on 4)

The method of claim 4, wherein the second active time interval is at east 5 percent longer than the first active time interval or vice versa.

### Claim 7

A method for a female genital tissue treatment comprising:
providing an internal applicator including an insertable part and a non-insertable part;
wherein the insertable part includes a first ring-shaped circular electrode and a second electrode;
wherein the first ring-shaped circular electrode is configured to provide a radiofrequency energy and the second electrode is configured to provide an electric energy different from the radiofrequency energy;
with the first ring-shaped circular electrode and the second electrode having a length in a range of 0.1 mm to 100 mm and a radius in a range of 0.2 cm to 20 cm;
wherein the non-insertable part and a center of at least one of the first ring-shaped circular electrode or the second electrode are configured to be on a same longitudinal axis;
wherein the first ring-shaped circular electrode and the second electrode are perpendicular to the longitudinal axis; and
wherein the first ring-shaped circular electrode and the second electrode are spaced apart from each other by a distance in a range of 001 mm to 20 mm;
inserting the insertable part having a length in a range of 0.75 cm to 20 cm at least partially into a vagina;
transferring the radiofrequency energy into the genital tissue of the vagina with the first ring-shaped circular electrode to heat an epithelium of the vagina to a temperature in a range of 35° C. to 48° C.;
wherein the radiofrequency energy is in a range of 350 kHz to 100 MHz with an output up to 450 W providing an energy flux in a range 0.001 W/cm2 to 1500 W/cm2; and
transferring the electric energy into the genital tissue of the vagina with the second electrode to cause muscle stimulation b the electric energy;
wherein the electric energy is applied in pulses in a range of 0.05 Hz to 85 Hz.

### Claim 8 (depends on 7)

The method of claim 7,
further including applying the radiofrequency energy and the electric energy simultaneously.

### Claim 9 (depends on 7)

The method of claim 7,
further including applying the radiofrequency energy and the electric energy in at least partial overlap.

### Claim 10 (depends on 7)

The method of claim 7,
wherein the insertable part comprises at least one sensor configured to communicate with a control unit.

### Claim 11 (depends on 10)

The method of claim 10,
wherein the at least one sensor is a temperature sensor.

### Claim 12 (depends on 7)

The method of claim 7,
wherein the muscle stimulation caused by applying the electric energy is a muscle contraction.

### Claim 13 (depends on 7)

The method of claim 7, wherein the temperature of heating the epithelium of the vagina with the radiofrequency energy is in the range of 40.5° C. to 43.5° C.

### Claim 14

A method for a female genital tissue treatment comprising:
providing an internal applicator including an insertable part and a non-insertable part;
wherein the insertable part includes a first energy delivery element and a second energy delivery element configured for treatment of a vaginal tissue;
wherein the first energy delivery element is a first ring-shaped circular electrode;
wherein the first ring-shaped circular electrode is configured to provide a radiofrequency energy and the second energy delivery element is configured to provide an electric energy different from the radiofrequency energy;
with the first ring-shaped circular electrode having a length in a range of 0.1 mm to 100 mm and a radius in a range of 0.2 cm to 20 cm;
wherein the non-insertable part and a center of at least one of the first ring-shaped circular electrode or the second energy delivery element are configured to be on a same longitudinal axis;
wherein the first ring-shaped circular electrode and the second energy delivery element are perpendicular to the longitudinal axis; and
wherein the first ring-shaped circular electrode and the second energy delivery element are spaced apart from each other by a distance in a range of 0.01 mm to 20 mm;
inserting the insertable part having a length in a range of 0.75 cm to 20 cm at least partially into a vagina;
transferring the radiofrequency energy into the genital tissue of the vagina with the first ring-shaped circular electrode to heat an epithelium of the vagina;
wherein the radiofrequency energy is in a range of 350 kHz to 100 MHz with an output up to 450 W providing an energy flux in a range 0.001 W/cm2 to 1500 W/cm2; and
transferring the electric energy into the genital tissue of the vagina with the second electrode;
wherein the electric energy is configured to provide a nonthermal effect.

### Claim 15 (depends on 14)

The method of claim 14, wherein the second energy delivery element is a second ring-shaped circular electrode.

### Claim 16 (depends on 14)

The method of claim 14, wherein the temperature of heating the epithelium of the vagina with the radiofrequency energy is in a range of 40.5° C. to 43.5° C.

### Claim 17 (depends on 14)

The method of claim 14, further providing maintaining a stability of vaginal laxity.

### Claim 18 (depends on 14)

The method of claim 14, further comprising delivering the energy to a patient in a self-operated manner without continuous supervision or manual action of an operator.

### Claim 19 (depends on 14)

The method of claim 14, wherein the first energy delivery element or the second energy delivery element is divided into segments.

### Claim 20 (depends on 14)

The method of claim 14, wherein the nonthermal effect is one of muscle stimulation, analgesic effect, contraction of muscles and/or myorelaxation effect.