Systems and methods for electrosurgical myocardial revascularization

• US 5,873,855 A
• Filed: 11/22/1996
• Issued: 02/23/1999
• Est. Priority Date: 01/07/1992
• 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.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/753,227
• Time in Patent Office: 823 Days
• Field of Search: 604/113, 604/114, 604/22, 604/41, 606/27-32, 606/35, 606/38, 606/41, 128/401, 128/402
• US Class Current: 604/114
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/149 bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• 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 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00097 one of the thermometric elements being an electrode or the heating element
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00119 : with metal oxide nitride
• CPC Class Codes: A61B 2018/0016 : Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00178 : Electrical connectors
• CPC Class Codes: A61B 2018/00196 : reciprocating lengthwise
• CPC Class Codes: A61B 2018/00327 : Ear, nose or throat
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00505 : Urinary tract
• 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 2018/00601 : Cutting
• CPC Class Codes: A61B 2018/00642 : with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/0066 : without feedback, i.e. open loop control
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00726 : Duty cycle
• CPC Class Codes: A61B 2018/00738 : Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 : Current
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/00886 : Duration
• CPC Class Codes: A61B 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/1213 : creating an arc
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1246 : characterised by the output polarity
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1273 : including multiple generators in one device
• CPC Class Codes: A61B 2018/1407 : Loop
• 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 2018/1497 : Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2018/162 : located on the probe body
• CPC Class Codes: A61B 2018/165 : Multiple indifferent electrodes
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0158 : with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

A method for transmyocardial revascularization of the heart of a patient includes positioning an active electrode surface in close proximity to a target site on the wall of a patient'"'"'s heart, and applying high frequency voltage between the active voltage surface and a return electrode to ablate tissue at the heart wall. The high frequency voltage ablates, i.e. volumetrically removes the heart tissue, and the electrode surface is axially translated into the space vacated by the removed tissue to bore a channel through the heart tissue. The active electrode surface may be introduced into the thoracic cavity and placed adjacent the epicardium to form an inward channel toward the ventricular cavity, or it may be delivered into the ventricular cavity of the heart and positioned adjacent the endocardium to form a channel extending outward towards the epicardium. In either case, the channels formed through the myocardium promote direct communication between blood within the ventricular cavity and that of existing myocardial vasculature to increase blood flow to the heart tissue.

Claims

1. A method of revascularizing a portion of a patient'"'"'s myocardium comprising:

positioning an active electrode surface in close proximity to a target site on a wall of the patient'"'"'s heart; and

applying high frequency voltage between the active electrode surface and a return electrode to remove tissue at the heart wall and to form a revascularizing channel through at least a portion of the heart wall, the revascularizing channel extending from a surface of the heart wall into the myocardium to restore blood flow to a portion of the myocardium.

2. The method of claim 1 further comprising axially translating the active electrode surface through a portion of the heart wall to form the revascularizing channel.

3. The method of claim 1 further comprising:

introducing at least a distal end of an electrosurgical catheter into the ventricle of the heart; and

positioning the distal end of the catheter in close proximity to the endocardium.

4. The method of claim 1 further comprising:

introducing at least a distal end of an electrosurgical probe through an opening in the patient'"'"'s chest cavity; and

positioning the distal end of the probe in close proximity to the epicardium.

5. The method of claim 4 wherein the probe is introduced through an intercostal penetration in the patient.

6. The method of claim 1 wherein the voltage is applied continuously between the active and return electrodes.

7. The method of claim 1 wherein the voltage is applied in pulses to correspond to a beating of the patient'"'"'s heart.

8. The method of claim 1 further comprising an electrode array including a plurality of electrically isolated electrode terminals.

9. The method of claim 8 further including independently controlling current flow from at least two of the electrode terminals based on impedance between the electrode terminal and the return electrode.

10. The method of claim 8 wherein the electrode terminals are embedded in an insulating matrix to electrically isolate each terminal, the insulating matrix comprising an inorganic material.

11. The method of claim 8 wherein the return electrode is proximally recessed from the active electrode terminals.

12. The method of claim 8 wherein the return electrode and the active electrode terminals are disposed on a distal surface of an electrosurgical probe.

13. The method of claim 1 wherein the active electrode surface comprises a single electrode at or near a distal end of an electrosurgical probe.

14. The method of claim 1 further comprising forming a revascularizing channel with a lateral dimension of about 1.5 to 3.0 mm.

15. The method of claim 1 further comprising positioning a radially expandable lumenal prosthesis in the revascularizing channel to maintain patency of the channel.

16. The method of claim 1 wherein the channel formed by the active electrode surface is curved.

17. The method of claim 16 wherein the channel formed by the active electrode surface has first and second openings on one side of the heart wall, and a substantially U-shape therebetween.

18. The method of claim 1 further comprising controlling the depth of the revascularizing channel.

19. The method of claim 18 further comprising visually marking the target site on the heart wall.

20. The method of claim 18 further comprising determining a thickness of the heart wall at the target site.

21. The method of claim 20 wherein the determining step comprises measuring tissue impedance beyond the distal end of the active electrode surface.

22. The method of claim 18 further comprising setting a predetermined distance through the heart wall at the target site and interrupting the flow of voltage to the active electrode surface when said active electrode surface has advanced the predetermined distance to control the depth of the channel.

23. The method of claim 1 further comprising the step of determining when the active electrode surface has substantially penetrated through the heart wall.

24. The method of claim 23 further comprising terminating the high frequency voltage before the active electrode surface pierces an opposite wall surface of the heart wall.

25. The method of claim 1 wherein the return electrode is a dispersive pad in contact with an external body surface of the patient.

26. The method of claim 1 further comprising positioning the active electrode surface within electrically conducting fluid.

27. The method of claim 26 further comprising positioning the return electrode within the electrically conducting fluid to generate a current flow path between the active electrode surface and the return electrode.

28. The method of claim 26 wherein the electrically conductive fluid comprises isotonic saline.

52. The method of claims 1 and 29 wherein the revascularizing channel extends at least 1.0 mm and terminates within the myocardium.

53. The method of claims 1 and 29 wherein the revascularizing channel extends completely through the heart wall.

56. The method of claims 1 and 29 wherein the return electrode is located on an external surface of the patient'"'"'s body.

57. The method of claims 1 and 29 wherein the return electrode and the electrode terminal are both located on the electrosurgical probe.

29. A method of transmyocardial revascularization of the heart of a patient comprising:

positioning a distal end of an instrument in close proximity to a target site on a wall of the patient'"'"'s heart; and

applying energy to the heart wall to remove tissue at the heart wall while axially translating the distal end of the instrument through at least a portion of the space vacated by the removed tissue to form a revascularizing channel through the heart wall, the revascularizing channel extending from a surface of the heart wall into the myocardium to restore blood flow to a portion of the myocardium.

30. The method of claim 29 wherein the instrument is axially translated through at least a portion of the heart wall at a substantially constant rate.

31. The method of claim 29 further comprising means for automatically translating the instrument through a substantial portion of the heart wall.

32. An electrosurgical device for transmyocardial revascularization of a patient'"'"'s heart tissue, the device comprising:

an instrument shaft having proximal and distal end portions, the distal end portion being sized for delivery through a small revascularizing channel in the patient'"'"'s heart;

an electrode terminal disposed on the distal end portion;

a return electrode;

a high frequency power supply for applying a voltage difference between the return electrode and the electrode terminal, the voltage difference being sufficient to form a revascularizing channel through at least a portion of the heart wall, the revascularizing channel extending from a surface of the heart wall into the myocardium to restore blood flow to a portion of the myocardium; and

a connector disposed near the proximal end portion of the shaft for electrically coupling the electrode terminal to the high frequency voltage source.

33. The device of claim 32 wherein the shaft is a catheter shaft configured for endoluminal delivery into the patient'"'"'ventricular cavity.

34. The device of claim 32 wherein the shaft is a probe shaft configured for intercostal delivery into the thoracic cavity.

35. The device of claim 32 further comprising an electrode array disposed at or near the distal end of the shaft and including a plurality of electrically isolated electrode terminals, wherein current flow from at least two of the electrode terminals is independently controlled based on impedance between the electrode terminal and the return electrode.

36. The device of claim 35 wherein the electrode terminals are embedded in an insulating matrix to electrically isolate each terminal, the insulating matrix comprising an inorganic material.

37. The device of claim 35 further comprising an array of return electrodes on a distal surface of the shaft and having an opposite polarity from the electrode terminals.

38. The device of claim 35 wherein the distal end of the shaft has a conical surface, the electrode terminals extending axially from the conical surface.

39. The device of claim 35 further comprising a plurality of impedance monitors coupled to the electrode terminals for determining impedance between each individual electrode terminal and the return electrode.

40. The device of claim 32 wherein the maximum lateral dimension of the distal end portion of the shaft is less than about 1.0 mm.

41. The device of claim 32 wherein the maximum lateral dimension of the distal end portion of the shaft is less than about 2.0 mm.

42. The device of claim 32 further comprising a guide catheter having a flexible steerable shaft for delivering the instrument through a percutaneous penetration into the ventricular cavity.

43. The device of claim 32 wherein the return electrode is disposed on the probe and proximally recessed from the electrode terminal.

44. The device of claim 32 wherein the return electrode and the electrode terminal are disposed on a distal surface of the shaft.

45. The device of claim 32 further comprising a fluid lumen within the shaft for delivering an electrically conducting fluid to the electrode terminal, wherein the fluid lumen is fluidly coupled to the return electrode and the electrode terminal.

46. The device of claim 32 further comprising a suction lumen within the shaft for removing gaseous products of ablation from the target site.

54. The device of claims 32 and 47 wherein the revascularizing channel extends at least 1.0 mm and terminates within the myocardium.

55. The device of claims 32 and 47 wherein the revascularizing channel extends completely through the heart wall.

47. An electrosurgical device for transmyocardial revascularization of a patient'"'"'s heart tissue, the device comprising:

an instrument shaft having a proximal and distal end portions, the distal end portion being sized for delivery through a small revascularizing channel in the patient'"'"'s heart, wherein the maximum lateral dimension of the distal end portion is about 2 mm;

an electrode terminal disposed on the distal end portion;

a fluid delivery element having an opening adjacent the electrode terminal for delivering electrically conductive fluid between the electrode terminal and the patient'"'"'s heart tissue; and

a connector disposed near the proximal end portion of the shaft for electrically coupling the electrodes terminal to a high frequency voltage source to remove tissue at the heart wall and to form a revascularizing channel through at least a portion of the heart wall, the revascularizing channel extending from a surface of the heart wall into the myocardium to restore blood flow to a portion of the myocardium.

48. The device of claim 47 wherein the shaft is a catheter shaft configured for endoluminal delivery into the patient'"'"'s ventricular cavity.

49. The device of claim 47 wherein the shaft is a probe shaft configured for delivery into the thoracic cavity.

50. The device of claim 47 further comprising an electrode array disposed at the distal end of the shaft and including a plurality of electrically isolated electrode terminals.

51. The device of claim 47 further comprising a return electrode on the shaft spaced proximally from the electrode terminal.