Method and device for pelvic floor tissue treatment

• US 10,039,929 B1
• Filed: 04/04/2017
• Issued: 08/07/2018
• Est. Priority Date: 04/04/2017
• Status: Active Grant

• Current Assignee: BTL Healthcare Technologies As
• Original Assignee: BTL Holdings Limited
• Inventors: Schwarz, Toma{hacek over (s)}, Kosturiakova, Lucia, Milichovsky, Jan
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US15/478,943
• Time in Patent Office: 490 Days
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61N 2/004 specially adapted for a specific therapy
• CPC Class Codes: A61N 2005/0611 Vagina
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 5/0603 for treatment of body cavities
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and devices for pelvic floor tissue treatment involve positioning at least one applicator adjacent to the pelvic floor tissue and transferring energy into the tissue, causing a biological effect in the tissue. The applicator may have a detachable part which can be changed to better provide specific treatments. The detachable part may contain at least one energy delivery element providing one type of energy for use in providing the treatment.

Claims

1. A method for a genital tissue treatment comprising:

making an assembled applicator by attaching at least one detachable part to an applicator;

wherein the at least one detachable part includes at least one circular energy delivery element encircling or around the detachable part;

with the at least one circular energy delivery element having a width in a range of 0.1 mm to 100 mm and a radius in a range of 0.5 cm to 12 cm and covering 2% to 100% of the surface of the detachable part;

positioning the assembled applicator having a length in a range of 0.75 cm to 20 cm into or onto genital tissue;

transferring radiofrequency energy into the genital tissue;

wherein the radiofrequency energy is in a range of 350 kHz to 100 MHz with an output up to 450 W providing energy flux in a range of 0.001 W·

cm−

2 to 1500 W·

cm−

2; and

heating genital epithelium.

2. The method of claim 1 wherein the at least one detachable part further includes an energy delivery element delivering mechanical wave energy.

3. The method of claim 2 wherein the energy delivery element delivering mechanical wave energy provides ultrasound energy having an energy flux in the range of 0.001 W·

cm−

2 to 500 W·

cm−

2.

4. The method of claim 1 wherein the at least one detachable part is expandable.

5. The method of claim 1 wherein the applicator includes at least one impedance sensor in communication with a central control or an energy generator and providing feedback during treatment, wherein the feedback provides a human perceptible signal or deactivates the at least one energy delivery element.

6. The method of claim 1 wherein the applicator includes at least one impedance sensor in communication with a central control or an energy generator and providing feedback during treatment, wherein the feedback includes changing an output power or a temperature of the at least one energy delivery element.

7. The method of claim 1 wherein the applicator includes at least one temperature sensor in communication with a central control or an energy generator and providing feedback during treatment, wherein the feedback includes changing an output power or a temperature of the at least one energy delivery element.

8. The method of claim 1 wherein the heating of the genital epithelium is used for pain relief.

9. A method for a vaginal tissue treatment comprising:

making an assembled applicator by attaching at least one detachable part to an applicator;

with the applicator including at least one circular energy delivery element encircling or around the applicator;

with the at least one circular energy delivery element having a width in a range of 0.1 mm to 100 mm and a radius in a range of 0.5 cm to 12 cm;

positioning the assembled applicator having a length in a range of 0.75 cm to 20 cm into or onto vaginal tissue;

transferring radiofrequency energy into the vaginal tissue;

wherein the radiofrequency energy is in a range of 350 kHz to 100 MHz with an output up to 450 W providing energy flux in a range of 0.001 W·

cm−

2 to 1500 W·

cm−

2; and

heating vaginal epithelium tissue.

10. The method of claim 9 wherein the vaginal epithelium tissue is heated in a range of 34°

C. to 55°

C.

11. The method of claim 10 wherein the applicator includes at least one impedance sensor in communication with a central control or an energy generator and providing feedback during treatment, wherein the feedback includes activation or deactivation of the at least one energy delivery element.

12. The method of claim 11 wherein the applicator includes at least one temperature sensor in communication with the central control or the energy generator and providing the feedback during treatment, wherein the feedback includes changing output power or temperature of the at least one energy delivery element.

13. The method of claim 12 with the at least one energy delivery element covers 2% to 100% of a surface of the applicator.

14. The method of claim 13 wherein the applicator includes the at least one impedance sensor in communication with the central control or the energy generator and providing the feedback during treatment, wherein the feedback includes changing output power or temperature of the at least one energy delivery element.

15. The method of claim 14 wherein the heating of the vaginal tissue is used for blood flow enhancement.

16. The method of claim 15 wherein the applicator with the at least one detachable part further provides ultrasound energy having an energy flux in the range of 0.001 W·

cm−

2 to 500 W·

cm−

2 and providing the ultrasound energy to the vaginal tissue.

17. A method for a pelvic floor tissue treatment comprising:

making an assembled applicator by attaching at least one detachable part to an applicator;

with the assembled applicator including at least two energy delivery elements providing a first type of energy;

at least one of the energy delivery elements having a width in a range of 0.1 mm to 100 mm, with a distance between the at least two energy delivery elements in a range of 0.01 mm to 20 mm;

positioning the assembled applicator into or onto pelvic floor tissue;

transferring an energy into the pelvic floor tissue;

with a sum of energy flux from the energy delivery elements of the assembled applicator in a range of 0.0001 W·

cm−

2 to 2500 W·

cm−

2; and

causing a biological effect in the pelvic floor tissue.

18. The method of claim 17 with the assembled applicator having a length in a range of 0.75 cm to 20 cm.

19. The method of claim 18 wherein the applicator includes at least one sensor providing feedback during treatment, wherein the feedback includes a change of power output.

20. The method of claim 19 wherein the applicator includes at least one temperature sensor providing the feedback during treatment, wherein the feedback includes activation or deactivation of the at least one energy delivery element.

21. The method of claim 20 wherein the applicator includes at least one impedance sensor in communication with a central control or an energy generator and providing the feedback during treatment, wherein the feedback includes activation or deactivation of the at least one energy delivery element.

22. The method of claim 21 with the at least one energy delivery element covering 5% to 100% of the surface of the at least one detachable part.

23. The method of claim 22 where the first type of energy is radiofrequency energy, with one of the energy delivery elements providing a second type of energy;

wherein the second type of energy is mechanical wave energy, and application of the radiofrequency energy is simultaneously applied with application of the mechanical wave energy.

24. A method for a pelvic floor tissue treatment comprising:

making an assembled applicator by attaching at least one detachable part to an applicator;

with the assembled applicator including first and second energy delivery elements delivering a first type of energy and a second type of energy, respectively;

with at least one of the energy delivery elements comprising a circular energy delivery element having a width in the range of 0.1 mm to 100 mm and a radius in the range of 0.5 to 12 cm, and a distance between the first and second energy delivery elements in the range of 0.01 mm to 20 mm;

positioning the assembled applicator into or onto pelvic floor tissue;

transferring energy into the pelvic floor tissue;

with a sum of energy flux from the energy delivery elements of the assembled applicator in the range of 0.005 W·

cm−

2 to 1500 W·

cm−

2; and

causing a biological effect in the pelvic floor tissue.

25. The method of claim 24 wherein the tissue is heated to a range of 34°

C. to 55°

C.

26. The method of claim 25 with the at least one energy delivery element covering 2% to 100% of the surface of the at least one detachable part.

27. The method of claim 26 wherein the applicator includes at least one impedance sensor in communication with a central control or an energy generator and providing feedback during treatment, wherein the feedback includes activation or deactivation of the at least one energy delivery element.

28. The method of claim 27 wherein the applicator includes at least one temperature sensor in communication with the central control or the energy generator and providing the feedback during treatment, wherein the feedback includes changing frequency, output power or temperature of the at least one energy delivery element.

29. The method of claim 25 wherein the at least one detachable part is expandable.

30. The method of claim 28 where the first type of energy is radiofrequency energy and the second type of energy is mechanical wave energy, wherein application of the radiofrequency energy is simultaneous with application of the mechanical wave energy.