Systems and methods for endometrial ablation

• US 8,529,562 B2
• Filed: 11/13/2009
• Issued: 09/10/2013
• Est. Priority Date: 11/13/2009
• Status: Active Grant

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: Minerva Surgical, Inc.
• Inventors: Toth, Akos, Hundertmark, Ronald, Vissy, Laszlo
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): SCOTT, AMANDA L
• Application Number:
  US12/618,257
• Publication Number:
  US 20110118719A1
• Time in Patent Office: 1,397 Days
• Field of Search: 606 32- 41
• US Class Current: 606/33
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00583 Coblation, i.e. ablation using a cold plasma
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes

Abstract

Methods, systems and devices for endometrial ablation. In accordance with a method, a working end of an RF ablation device is positioned in a patient uterus to contact endometrial tissue, the working end comprising a dielectric wall capable of non-expanded and expanded shapes. An indicator mechanism is operatively coupled to the wall and configured to indicate non-expanded and expanded shapes of the wall. An expandable member, such as a balloon, is provided that expands to close the cervical canal during ablation.

Claims

1. A system for treating uterine tissue, comprising:

an expandable wall having an exterior RF energy delivery surface and defining a fluid-tight interior chamber for positioning in a uterine cavity;

a first polarity electrode carried inside the fluid-tight chamber;

a second polarity electrode carried on the exterior RF delivery surface of the expandable wall;

an RF source connected to the first and second electrodes and configured to deliver current across the wall and into the uterine tissue; and

an expandable member separate from the expandable wall, said expandable member being disposed adjacent the energy delivery surface and configured for positioning in and expanding in a cervical canal.

2. The system of claim 1, wherein the expandable member comprises an inflatable balloon.

3. The system of claim 2, wherein the balloon has a compliant wall.

4. The system of claim 2, wherein the balloon has a non-complaint wall.

5. The system of claim 2, wherein the balloon has a longitudinal axis, and further comprising at least one longitudinal constraining element for constraining an expanded shape of the balloon.

6. The system of claim 2, wherein the balloon is elongated, and further comprising a constraining element extending a substantial length of the balloon in an expanded shape.

7. The system of claim 2, wherein the balloon is earned concentrically around a portion of a support member carrying the RF energy delivery surface, and further comprising a constraint in the balloon for maintaining the balloon when expanded in use in a symmetric configuration around the support member.

8. The system of claim 2, wherein the balloon has a longitudinal axis, and further comprising at least two longitudinal inflation chambers.

9. The system of claim 8, wherein the at least two longitudinal inflation chambers are separately expandable.

10. The system of claim 2, further comprising a manually operable inflation source in fluid communication with an inflation chamber of the balloon.

11. The system of claim 2, further comprising a controller operated inflation source in fluid communication with an inflation chamber of the balloon.

12. The system of claim 2, further comprising an indicator mechanism for indicating a leak in the balloon.

13. The system of claim 12, wherein the indicator mechanism comprises at least one of a pressure sensor and a flow sensor.

14. The system of claim 12, wherein the indicator mechanism is coupled to a controller and a leak in the balloon disables the RF source to prevent the delivery of RF current to the energy delivery surface.

15. The system of claim 1, wherein the expandable member comprises a mechanically expandable structure.

16. The system of claim 1, wherein the energy delivery surface comprises a wall surrounding an interior chamber.

17. The system of claim 16, wherein the wall comprises at least partly a dielectric.

18. The system of claim 16, wherein the wall comprises an electrode.

19. The system of claim 16, wherein the interior chamber is fluid-tight.

20. A method of treating uterine tissue, comprising:

expanding an expandable wall having an exterior RF energy delivery surface and defining a fluid-tight interior chamber within a patient'"'"'s uterine cavity;

expanding an expandable member in the patient'"'"'s cervical canal; and

activating an RF source connected to a first polarity electrode carried inside the fluid-tight chamber and a second polarity electrode carried on the exterior RF delivery surface of the expandable wall to deliver current across the surface and into the endometrial tissue to ablate said endometrial tissue.

21. The method of claim 20, wherein expanding the expandable wall having the RF energy delivery surface comprises expanding a frame supporting the wall.

22. The method of claim 20, wherein expanding the expandable member comprises inflating the member.

23. The method of claim 20, wherein expanding the expandable member comprises inflating and circulating a fluid through the member.

24. The method of claim 20, further including monitoring the expanded condition of the expandable member.

25. The method of claim 24, wherein monitoring comprises sensing pressure of a fluid within the expandable member.

26. The method of claim 24, wherein monitoring comprises sensing a flow of a fluid within the expandable member.

27. The method of claim 24, further comprising disabling an electrosurgical energy source operatively coupled to the RF energy delivery surface if monitoring detects a leak in the expandable member.