ENDOMETRIAL ABLATION DEVICES AND SYSTEMS

• US 20100114089A1
• Filed: 10/26/2009
• Published: 05/06/2010
• Est. Priority Date: 10/21/2008
• Status: Active Grant

• Current Assignee: Hermes Innovations, LLC
• Original Assignee: Hermes Innovations, LLC
• Inventors: Truckai, Csaba, Toth, Akos
• Granted Patent: US 8,500,732 B2
• Time in Patent Office: Days
• 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 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation

Abstract

Systems and methods for endometrial ablation. The systems include a handle and elongated introducer sleeve extending to an expandable working end having a fluid-tight interior chamber. A thin dielectric wall surrounds at least a portion of the interior chamber and has an external surface for contacting endometrial tissue. The thin dielectric wall surrounds a collapsible-expandable frame and receives an electrically non-conductive gas. First and second polarity electrodes are exposed to the interior and exterior of the chamber, respectively. A radiofrequency power source operatively connects to the electrode arrangement to apply a radiofrequency voltage across the first and second electrodes, wherein the voltage is sufficient to initiate ionization of the neutral gas into a conductive plasma within the interior chamber, and to capacitively couple the current in the plasma across the thin dielectric wall to ablate endometrial tissue engaged by the external surface of the dielectric structure.

Claims

1. A system for endometrial ablation comprising:

a thin dielectric wall at least partially surrounding an interior chamber and having

a shape for positioning in a uterine cavity;

a gas source configured to deliver a non-conductive gas into the interior chamber;

a first polarity electrode exposed to the interior chamber;

a second polarity electrode external to the interior chamber for contacting patient tissue; and

a radiofrequency energy source coupled to the first and second polarity electrodes for providing a voltage sufficient to convert the non-conductive gas to a plasma and to capacitively couple current across the dielectric wall to endometrial tissue.

2. The system of claim 1, wherein the dielectric wall has a triangular configuration for contacting endometrial tissue about the uterine cavity.

3. The system of claim 1, wherein the dielectric wall comprises a distensible material.

4. The system of claim 1, wherein the dielectric wall comprises a non-distensible material.

5. The system of claim 1, wherein the dielectric wall comprises a silicone.

6. The system of claim 1, wherein the dielectric wall has a thickness in the range from 0.005 inches to 0.020 inches.

7. The system of claim 1, wherein the dielectric wall is capable of contracted and expanded shapes.

8. The system of claim 1, further comprising a support structure in the interior chamber capable of contracted and expanded shapes.

9. The system of claim 8, wherein the support structure comprises spring elements to bias the dielectric wall toward an expanded shape.

10. The system of claim 8, wherein the first polarity electrode comprises at least a portion of the support structure.

11. The system of claim 8, further comprising an elongated introducer connected to the dielectric wall and support structure.

12. The system of claim 10, wherein the second polarity electrode is carried by the introducer.

13. The system of claim 10, wherein the second polarity electrode is carried on an exterior surface of the dielectric wall.

14. The system of claim 10, further comprising at least two lumens in the introducer communicating with the interior chamber for providing a gas inflow from the gas source and a gas outflow out of the interior chamber, respectively.

15. The system of claim 14, wherein the gas source comprises a remote gas source coupled to one of the two lumens in the introducer for providing the gas inflow into the interior chamber.

16. The system of claim 15, further comprising a controller operatively coupled to the gas source for controlling gas inflow.

17. The system of claim 14, wherein the gas source comprises a gas source coupled to one of the two lumens in the introducer for providing a gas inflow into the interior chamber.

18. The system of claim 17, further comprising a controller operatively coupled to the vacuum source for controlling gas outflow.

19. The system of claim 1, wherein the interior chamber has a volume in the range from 1 ml to 10 ml.

20. The system of claim 1, wherein the radiofrequency energy source is configured to deliver in the range from 500V to 2500V.

21. An endometrial ablation device comprising:

an elongated introducer having a handle end and a working end;

an expandable dielectric wall carried at the working end, defining an interior chamber, and configured, when expanded, to contact endometrial tissue;

a gas source for flowing a neutral gas into the interior chamber; and

first and second polarity electrodes disposed internal and external to the interior chamber, respectively;

wherein, when the dielectric wall is expanded to contact endometrial tissue, application of a radiofrequency voltage across the first and second polarity electrodes when a neutral gas is within the interior chamber causes a plasma to form and capacitively couple current across the dielectric wall to ablate endometrial tissue.

22. The endometrial ablation device of claim 21, wherein the first polarity electrode comprises a portion of a support structure for supporting the dielectric wall in an expanded shape.

23. The endometrial ablation device of claim 21, wherein the second polarity electrode comprises an exterior surface portion of the dielectric wall.

24. The endometrial ablation device of claim 21, wherein the second polarity electrode comprises a portion of the introducer.

25. The endometrial ablation device of claim 21, wherein the gas source is configured to circulate gas through the interior chamber.

26. The endometrial ablation device of claim 21, wherein the gas source is configured to provide a flow of neutral gas into the interior chamber.

27. The endometrial ablation device of claim 26, wherein the a flow rate of the neutral gas into the interior chamber is within the range from 0.05 ml/sec to 50 ml/sec.

28. The endometrial ablation device of claim 21, wherein the gas source is configured to permit the flow of at least one of the neutral gas and the plasma out of the interior chamber.

29. The endometrial ablation device of claim 21, further comprising an expandable frame for expanding the dielectric wall.

30. The endometrial ablation device of claim 29, wherein the frame supports the dielectric wall.

31. The endometrial ablation device of claim 29, wherein the expandable frame comprises the first polarity electrode.

32. The endometrial ablation device of claim 29, wherein the second polarity electrode is carried on an exterior surface of the dielectric wall.

33. The endometrial ablation device of claim 21, wherein the dielectric wall has a triangular configuration for contacting endometrial tissue about the uterine cavity.

34. The endometrial ablation device of claim 21, wherein the dielectric wall comprises a distensible material.

35. The endometrial ablation device of claim 21, wherein the dielectric wall comprises a non-distensible material.

36. The endometrial ablation device of claim 21, wherein the dielectric wall comprises a silicone.

37. The endometrial ablation device of claim 21, wherein the dielectric wall has a thickness in the range from 0.005 inches to 0.020 inches.

38. The endometrial ablation device of claim 21, wherein the dielectric wall is capable of contracted and expanded shapes.

39. The endometrial ablation device of claim 21, further comprising an expandable member mounted to the introducer for sealing the cervical canal of the patient.

40. The endometrial ablation device of claim 39, wherein the expandable member comprises a balloon.