Electrosurgical systems and methods for the removal of pacemaker leads

• US 6,183,469 B1
• Filed: 01/02/1998
• Issued: 02/06/2001
• Est. Priority Date: 08/27/1997
• Status: Expired due to Term

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Inventors: Eggers, Philip E., Thapliyal, Hira V., Baker, Michael A., Olsen, Phillip M., Williams, Katherine M.
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US09/002,315
• Time in Patent Office: 1,131 Days
• Field of Search: 606/41, 606/45, 606/48, 606/108, 607/122, 607/126, 607/128, 604/22, 604/35
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00422 Angioplasty
• 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 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/1213 creating an arc
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/1273 including multiple generators in one device
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 2218/008 : for smoke evacuation

Abstract

The present invention is directed to systems, methods and apparatus for removing implanted objects from a patient'"'"'s body, particularly implanted endocardial or epicardial pacemaker leads and transvenous defibrillation leads from a patient'"'"'s heart. In one aspect of the invention, an electrosurgical catheter is advanced to a position within the thoracic cavity adjacent a portion of a pacemaker lead that is affixed to heart tissue. Preferably, the catheter is advanced over the pacemaker lead, i.e., using the pacemaker lead as a guidewire, to facilitate this positioning step. Once the distal end of the catheter reaches a blockage, or a portion of the lead that is attached to fibrous scar tissue, a high frequency voltage difference is applied between one or more electrode terminal(s) at the distal end of the catheter and one or more return electrode(s) to remove the scar tissue around the lead. The catheter is then advanced further along the lead until it reaches another blockage caused by fibrous scar tissue, and the process is continued until the catheter reaches the distal tip of the lead in the myocardium. At this point, the distal tip may be severed from the rest of the lead, or pulled out of the myocardial tissue in a conventional manner. The scar tissue around the pacemaker lead is precisely ablated before removing the lead, which minimizes or eliminates the risks associated with mechanical traction and countertraction, such as disruption of the heart wall, lead breakage with subsequent migration and the like.

Claims

1. An apparatus for removing a pacemaker lead attached to heart tissue within a patient'"'"'s body comprising:

a shaft having a proximal end, a distal end, a distal opening and an inner lumen in communication with the distal opening, the distal opening and the inner lumen being sized to accommodate the pacemaker lead;

an electrode terminal on the shaft adjacent the distal opening;

an electrically insulating support member at the distal end of the shaft supporting the electrode terminal, the support member comprising an inorganic material selected from the group comprising ceramic, glass or combinations thereof; and

a connector extending from the electrode terminal to the proximal end of the shaft for coupling the electrode terminal to a source of high frequency electrical energy.

2. The apparatus of claim 1 wherein the inner lumen extends from the distal opening to the proximal end of the shaft.

3. The apparatus of claim 1 further comprising a hole in the shaft spaced proximally from the distal opening and sized to accommodate the pacemaker lead, the inner lumen extending from the distal opening to the hole.

4. The apparatus of claim 3 wherein the hole is spaced about 0.1 to about 10 cm from the distal opening of the shaft.

5. The apparatus of claim 1 further comprising a return electrode on the shaft spaced from the electrode terminal.

6. The apparatus of claim 1 further comprising a plurality of electrically isolated electrode terminals circumferentially spaced around the distal opening of the shaft.

7. The method of claims 1 wherein the electrically insulating support member has a distal opening aligned with the distal opening of the shaft, and a proximal opening spaced from the distal opening and sized to accommodate the pacemaker lead, wherein the inner lumen couples the proximal and distal openings.

8. The apparatus of claim 1 further comprising a plurality of electrically isolated electrode assemblies extending distally from the distal end of the shaft and circumferentially spaced around the distal opening, each of the electrode assemblies comprising an active electrode, an electrically insulating support member coupled to the active electrode and a return electrode positioned proximal to the active electrode and the support member.

9. The apparatus of claim 1 wherein the electrically insulating support member comprises a distal tissue treatment surface, and the electrode terminal is substantially flush with the tissue treatment surface.

10. The apparatus of claim 1 wherein the electrically insulating support member comprises a distal tissue treatment surface, and the electrode terminal extends from the tissue treatment surface by a distance of less than 3 mm.

11. The apparatus of claim 1 further comprising one or more suction lumens within the shaft, each having a distal opening at the distal end of the shaft, and a proximal end adapted for coupling to a vacuum source.

12. The apparatus of claim 1 further comprising at least one fluid lumen within the shaft having a distal opening at the distal end of the shaft, and a proximal end adapted for coupling to a source of electrically conductive fluid for delivering electrically conductive fluid to a region around the electrode terminal.

13. The apparatus of claim 12 wherein the fluid lumen is positioned so as to deliver electrically conductive fluid past a return electrode and the electrode terminal to generate a current flow path therebetween.

14. The apparatus of claim 12 wherein the fluid lumen extends through the electrode terminal.

15. The apparatus of claim 1 wherein the electrode terminal has a flattened distal end.

16. The apparatus of claim 1 wherein the electrode terminal extends from the distal end of the shaft about 0.05 to 5 mm.

17. The apparatus of claim 1 wherein the shaft has a length of about 50 to 80 cm.

18. The apparatus of claim 1 wherein the inner lumen of the shaft has a diameter of about 0.5 to about 10 mm.

19. A method for removing a pacemaker lead attached to heart tissue within a patient'"'"'s body comprising:

positioning a plurality of electrically isolated electrode terminals adjacent a portion of the pacemaker lead attached to the heart tissue;

applying high frequency voltage to the electrically isolated electrode terminals and at least one return electrode in the presence of electrically conductive fluid such that an electrical current flows from each of the electrode terminals, through the electrically conductive fluid, and to the return electrode, the high frequency voltage being sufficient to detach said portion of the pacemaker lead from the heart tissue; and

independently controlling current flow from at least two of the electrode terminals based on impedance between each of the electrode terminals and the return electrode.

20. The method of claim 19 further comprising advancing a distal portion of a catheter body over the pacemaker lead to position the electrode terminals in close proximity with the tissue attached to the lead.

21. The method of claim 20 wherein the electrode terminals are positioned at a distal portion of the catheter body, the method further comprising rotating at least the distal portion of the catheter body during the applying step.

22. The method of claim 20 wherein the catheter body has an inner lumen sized to accommodate the pacemaker lead, the method further comprising advancing the catheter body over the length of the pacemaker lead to position the electrode terminals adjacent the heart tissue attached to the lead.

23. The method of claim 19 further comprising applying a sufficient high frequency voltage difference between one or more of the electrode terminals and the return electrode to ablate a portion of the heart tissue attached to the pacemaker lead and further advancing the electrode terminals along the pacemaker lead as the heart tissue releases the lead.

24. The method of claim 19 wherein the return electrode is proximal to the electrode terminals such that the electrical current flows from the electrode terminals in a proximal direction to the return electrode away from the tissue.

25. The method of claim 19 further comprising aspirating a region around the electrode terminals.

26. The method of claim 19 wherein the high frequency voltage is sufficient to vaporize the fluid in a thin layer between at least a portion of the electrode terminals and the heart tissue.

27. The method of claim 26 further comprising accelerating charged particles from the vaporized fluid to the heart tissue to cause dissociation of the molecular bonds within the heart tissue.

28. The method of claim 19 further comprising directing an electrically conductive fluid through a fluid lumen in a catheter body to the electrode terminals to generate a current flow path between the electrodes terminal and the return electrode.

29. The method of claim 19 wherein the pacemaker lead includes a distal tip embedded within heart tissue, the method further comprising removing the distal tip of the pacemaker lead from the heart tissue by applying sufficient high frequency voltage to one or more of the electrode terminals to remove at least a portion of the tissue surrounding the tip.

30. The method of claim 29 further comprising deflecting the electrode terminals radially outward to accommodate an enlarged distal tip of the pacemaker lead.

31. The method of claim 29 wherein the distal tip of the pacemaker lead includes one or more tines extending radially outward from the lead, the method further comprising severing the tines. catheter body over the length of the pacemaker lead to position the electrode terminal adjacent the heart tissue attached to the lead.

32. The method of claim 19 wherein the electrode terminals are located on a distal portion of a catheter body having an inner lumen, a distal hole and an opening in the catheter body proximal to the distal hole, the method further comprising advancing the distal portion of the catheter body over the length of the pacemaker lead such that the lead extends through the distal hole, the inner lumen and the proximal opening.

33. A method for removing a pacemaker lead attached to heart tissue within a patient'"'"'s body comprising:

positioning an electrode terminal adjacent a portion of the pacemaker lead attached to the heart tissue, wherein the pacemaker lead includes a distal tip embedded within the heart tissue and having one or more tines extending radially outward from the lead;

applying a first high frequency voltage to the electrode terminal to detach said portion of the pacemaker lead from the heart tissue; and

removing the distal tip of the pacemaker lead from the heart tissue by applying a second high frequency voltage to the electrode terminal to remove at least a portion of the tissue surrounding the tip and sever the tines.

34. The method of claim 33 further comprising advancing a distal portion of a catheter body over the pacemaker lead to position the electrode terminal in close proximity with the tissue attached to the lead.

35. The method of claim 34 further comprising aspirating a region around the electrode terminal.

36. The method of claim 34 wherein the first and second high frequency voltages are sufficient to vaporize an electrically conductive fluid in a thin layer between at least a portion of the electrode terminal and the heart tissue.

37. The method of claim 36 further comprising accelerating charged particles from the vaporized fluid to the heart tissue to cause dissociation of the molecular bonds within the heart tissue.

38. The method of claim 34 wherein the catheter body has an inner lumen sized to accommodate the pacemaker lead, the method further comprising advancing the catheter body over the length of the pacemaker lead to position the electrode terminal adjacent the heart tissue attached to the lead.

39. The method of claim 34 wherein the electrode terminal is located on a distal portion of a catheter body having an inner lumen, a distal hole and an opening in the catheter body proximal to the distal hole, the method further comprising advancing the distal portion of the catheter body over the length of the pacemaker lead such that the lead extends through the distal hole, the inner lumen and the proximal opening.

40. The method of claim 33 wherein the first high frequency voltage is sufficient to to ablate a portion of the heart tissue attached to the pacemaker lead, the method further comprising further advancing the electrode terminal along the pacemaker lead as the heart tissue releases the lead.

41. The method of claim 33 wherein the first and second high frequency voltages are applied between the electrode terminal and a return electrode, and wherein the return electrode is proximal to the electrode terminal such that an electrical current flows from the electrode terminal in a proximal direction to the return electrode away from the tissue.

42. The method of claim 33 wherein the electrode terminal is positioned at a distal portion of a catheter body, the method further comprising rotating at least the distal portion of the catheter body during the applying step.

43. The method of claim 33 further comprising directing an electrically conductive fluid through a fluid lumen in a catheter body to the electrode terminal to generate a current flow path between the electrode terminal and a return electrode.