Electrosurgical catheter and method for vascular applications

• US 4,682,596 A
• Filed: 05/22/1984
• Issued: 07/28/1987
• Est. Priority Date: 05/22/1984
• Status: Expired

• Current Assignee: Cordis Webster, Inc. (Johnson & Johnson)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Smith, Kevin W., Bales, Thomas O.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Hindenburg, Max F.
• Application Number:
  US06/612,879
• Time in Patent Office: 1,162 Days
• Field of Search: 128/4-8, 128/303.1, 128/303.13-303.18, 128/399-402, 128/783, 128/784, 128/786
• US Class Current: 606/39
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 2017/00247 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The method for resolving atherosclerotic plaque buildup and/or eroding unwanted tissue in a blood vessel includes the steps of: inserting an electrode in and along the lumen of a blood vessel; manually manipulating said electrode through the blood vessel; positioning said electrode proximate to atherosclerotic plaque buildup site or unwanted tissue site in the blood vessel; supplying a predetermined high-frequency, high-voltage electrical current to said electrode; maintaining said predetermined current for a predetermined time period; and sensing from time to time, the amount of plaque or unwanted tissue at the site.

The electrosurgical plaque-resolving or tissue-eroding device is adapted to be inserted within and along the lumen of a blood vessel and manipulated therethrough to a desired position where the device is operated to resolve atherosclerotic plaque buildup or erode tissue in the blood vessel according to the method to re-establish desired blood flow through the blood vessel or to remove tissue therefrom. The device comprises an elongate flexible hollow tubular body having a distal end and a proximal end. A hollow tip member is mounted at the distal end of the flexible hollow tubular body and an electrode is associated with the hollow tip member for resolving plaque or eroding tissue. A power supply circuit for supplying a high-frequency, high-voltage electrical current to the electrode is coupled to the electrode. A mechanism for sensing, from time to time, the amount of plaque or tissue at the site in the blood vessel is also provided with the device.

Claims

1. An electrosurgical plaque-resolving or tissue-eroding device having a distal end which is insertable within and along the lumen of a blood vessel and manipulated therethrough to a desired position without causing undue trauma where the device is operated to thermally resolve atherosclerotic plaque buildup or erode tissue in the blood vessel to re-establish desired blood flow through the blood vessel or to remove tissue therefrom, said device comprising:

an elongate flexible hollow tubular body having a distal end, a proximal end, and a diameter smaller than the diameter of the vessel into which said device is inserted;

first passage means within said tubular body for supplying a flushing fluid to the site where plaque or tissue is resolved or eroded;

second passage means within said tubular body for evacuating, such as by suction, debris at the site of resolving plaque or eroding tissue from the site;

a hollow tip member mounted at said distal end of said flexible hollow tubular body;

an electrode adjacent to and in operative association with said hollow tip member for resolving plaque or eroding tissue, said tip member being beveled or rounded at the distal end of said device;

means for supplying a high-frequency electrical current to said electrode for cutting tissue or coagulating body fluid; and

means for sensing, from time to time, the amount of plaque or tissue at the site in the blood vessel.

2. The device of claim 1 wherein said hollow tip member is said electrode.

3. The device of claim 2 wherein said hollow tip member is made of stainless steel.

4. The device of claim 2 wherein said electrode has the shape of a stove pipe hat having its top removed, with the brim shaped portion of said electrode being at the distal end of said device.

5. The device of claim 2 wherein said electrode is an unobstructed ring electrode positioned within said first passage means of the hollow tip member, a distal end of said ring electrode being flush with the end of said tip member.

6. The device of claim 2 wherein said electrode has the shape of a hollow mushroom including a head which is situated at the distal end of the device.

7. The device of claim 2 including an electrical insulator which has a high temperature melting point and which connects said tip member electrode to said tubular body.

8. The device of claim 7 including a ring electrode between said electrical insulator and said tubular body to form said device as a bipolar device.

9. The device of claim 7 wherein said insulator is made of a material selected from the group consisting of glass, ceramic, fluorocarbon polymers, polyimide polymers, and polyphenylene sulfide.

10. The device of claim 7 wherein said insulator has an inwardly stepped formation and said electrode is cup shaped, with a portion of its bottom removed, and is attached to a distal end of said electrical insulator with the cup walls surrounding said stepped formation.

11. The device of claim 1 wherein said electrode is covered with an ultra thin layer of insulation on the surface thereof which contacts the plaque or tissue buildup.

12. The device of claim 1 wherein said hollow tubular body is made of silicone rubber.

13. The device of claim 1 wherein said hollow tubular body is made of polyurethane.

14. The device of claim 1 wherein said hollow tubular body is made of polytetrafluoroethylene.

15. The device of claim 1 wherein said hollow tubular body is made of a polymeric substance capable of resisting softening during resolving.

16. The device of claim 1 wherein said hollow tip member is made of aluminum.

17. The device of claim 1 wherein said hollow tip member is made of tantalum.

18. The device of claim 1 wherein said hollow tip member is made of platinum.

19. The device of claim 1 wherein said high-voltage, high-frequency current supply means is capable of generating a pulsed current waveform having an intermittent group of pulses separated by periods of no current and being adapted for use in a coagulation mode of operation of said device.

20. The device of claim 19 wherein said pulsed current waveform has high voltage peaks and a low duty cycle.

21. The device of claim 1 wherein said high-voltage, high-frequency, current supply means is capable of generating a current waveform having a pure sine waveform.

22. The device of claim 1 wherein said high-voltage is several hundred volts.

23. The device of claim 1 wherein said high frequency is between 0.5 and 20 megahertz.

24. The device of claim 1 wherein said sensing means further includes radio-opaque dye and X-ray viewing means, said radio-opaque dye being injected into the blood vessel at the site and the X-ray image showing the amount of plaque remaining being displayed on said viewing means.

25. The device of claim 1 further including a third passage means for carrying at least one conductor.

26. The device of claim 25 wherein said passage means are arranged with their axes contained within the diameter of said tubular body.

27. The device of claim 21 wherein said passage means are arranged with their axes eccentric of the axis of said tubular body.

28. The device of claim 25 wherein said first passage means opens onto a cylindrical side wall surface of said tubular body at a location adjacent said tip member.

29. The device of claim 25 wherein said first passage means extends through said tip memeber and opens onto a front end surface of said tip member.

30. The device of claim 25 including a second electrode at the distal end of said tubular body.

31. The device of claim 30 wherein said tip member is made of a relatively high temperature resistance insulative material, said first electrode is mounted in said tip member and has an electrode surface on the distal end thereof, and said second electrode is a ring or sleeve electrode on said tubular body and located adjacent but rearwardly of said tip member.

32. The device of claim 30 wherein said tip member is made of a relatively high temperature resistance insulative material, and said first and second electrodes are semi-cylindrical in shape and are positioned with said tip member facing each other across the axis of said tip member.

33. The device of claim 30 including a fourth passage means for carrying a second wire conductor therein for connection to said second electrode.

34. The device of claim 25 including a trident structure at the proximal end of said tubular body, said trident structure having three legs each of which has a passageway communicating individually with a respective one of said passage means in said tubular body.

35. The device of claim 25 including a stiffening wire which extends through said first passageway for stiffening said tubular body.

36. The device of claim 1 including a collar at said distal end of said device, said collar having a bore therein and a countersunk formation in said bore, a front flat surface and an outer generally cylindrical surface said electrode being fully received within said countersunk formation having a bore therethrough which mates with and is flush with said bore of said collar, and having an annular front surface which is flush with said front surface of said collar, and said collar being beveled or rounded between the front surface and the outer surface.

37. The device of claim 1 wherein said sensing means includes means coupled to said electrode for measuring the impedance between said electrode through the plaque or tissue buildup and a current return path, the impedance measured being directly related to the amount of plaque or tissue buildup at the site.

38. The device of claim 37 wherein said impedance measuring means include means for supplying a low voltage DC current to said electrode for making the impedance measurement.

39. A cardiovascular thermal ablation device having a distal portion which is insertable into and along a lumen of a blood vessel to a desired position against an area of atherosclerotic plaque buildup or like obstruction within the lumen of the vessel without undue trauma, said device having means for thermally resolving the area of obstruction within the vessel and having means for removing resolved tissue from the area of thermal ablation, said device further comprising an elongate flexible hollow tubular body having a distal end and a proximal end;

a hollow tip member mounted at said distal end of said flexible hollow tubular body;

at least one electrode adjacent to and in operative association with said hollow tip member for resolving plaque or eroding tissue;

said tip member being beveled or rounded at said distal end of said device;

means for supplying electrical current to said electrode;

means for sensing, between periods of application of electrical current to said electrode, the amount of plaque or tissue remaining to obstruct the site in the blood vessel by measuring the impedance of the plaque of tissue;

means for supplying fluid to, or for supplying suction from, the site including at least one channel extending through said flexible hollow tubular body and tip member, and said device having at least one further channel, at least one wire conductor in said further channel extending proximally from said at least one electrode to said proximal end of said device and means for connecting said conductor to a source of electrical current.