Methods and apparatus for advancing catheters through severely occluded body lumens

• US 5,419,767 A
• Filed: 08/24/1993
• Issued: 05/30/1995
• Est. Priority Date: 01/07/1992
• Status: Expired due to Term

• Current Assignee: ArthroCare Corporation (Smith & Nephew PLC)
• Original Assignee: Thapliyal and Eggers Partners
• Inventors: Eggers, Philip E., Thapliyal, Hira V.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/111,367
• Time in Patent Office: 644 Days
• Field of Search: 606/41, 606/31, 606/28, 606/194, 604/95, 604/20, 604/96-103, 604/113, 604/114, 604/264, 604/280-281, 128/341-344, 128/657, 128/772
• US Class Current: 604/114
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• 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 2017/00247 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00726 Duty cycle
• 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 2018/00886 : Duration
• CPC Class Codes: A61B 2018/1213 : creating an arc
• CPC Class Codes: A61B 2018/126 : bipolar
• 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 2090/378 : using ultrasound
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• 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 catheter system is provided that includes an electrode array near the distal end of the catheter. High frequency current is supplied between the electrodes of the array and a common electrode to cause heating of material lying between the electrodes. The catheter may include means for steering it through the lumen. In a preferred embodiment, the steering means includes a plurality of steering wires in contact with the catheter body. The steering wires may be formed of a shape-memory alloy. Wires of such an alloy may be made to contract when heated above a preselected transition temperature. The wires may be heated by the selective conduction of electrical current through them. Conduction of current through the steering wires is controlled based on the current flowing through the electrodes of the array. An inflatable balloon may be included proximal to the electrode array for dilating the vessel after the occlusion has been penetrated by the electrode array. The balloon may be shielded and protected behind a portion of the catheter having a diameter greater than the diameter of the uninflated balloon disposed about the catheter body. The catheter will include means for protecting the walls of the vessel from exposure to electrical current from the electrodes. This will commonly include switching means or other means for current control. The vessel wall may also be protected by setting the electrodes back some distance from the outer edge of the distal tip.

Claims

1. A catheter system comprising:

a catheter body having a proximal end and a distal end;

an electrode array disposed near the distal end of the catheter body, said array including a plurality of electrically isolated electrode terminals disposed over a contact surface;

means for applying a high frequency voltage between the electrode array and at least one common electrode, wherein current flow to each electrode terminal is selectively controllable; and

means for steering the catheter by changing the curvature of the catheter body between the proximal and distal ends in response to changes in current flow to electrode terminals in different regions of the electrode array.

2. The catheter system of claim 1, wherein the steering means comprises a plurality of steering wires disposed in the catheter body and connected to the distal end thereof, wherein the catheter body is steerable by selective contraction of at least one of the wires.

3. The catheter system of claim 2, wherein the steering wires are disposed within low-friction sleeves.

4. The catheter system of claim 2, wherein the steering means comprises at least four steering wires, one wire in each of four quadrants of the catheter body.

5. The catheter system of claim 2, wherein the steering wires are composed of a shape-memory alloy, and wherein the wires contract when heated above a predetermined transition temperature.

6. The catheter system of claim 2, wherein contraction of the steering wires is effected by the selective conduction of electrical current through the steering wires.

7. The catheter system of claim 6, further comprising means for selectively increasing current through each steering wire in response to a rise in current flow between the individual electrodes in the region of the array disposed opposite to the wire and the common electrode.

8. The catheter system of claim 1, wherein the catheter body includes regions of differing stiffness.

9. The catheter system of claim 8, wherein the catheter body includes at least three regions of differing stiffness, wherein the catheter body increases in stiffness from the distal to the proximal end.

10. The catheter system of claim 1, wherein the common electrode is selected from the group consisting of an electrode formed on the exterior surface of the catheter body, a guidewire, and a paired isolated electrode terminal.

11. A catheter comprising:

a catheter body having proximal and distal ends, a proximal region, and a distal tip, wherein the distal tip of the catheter body has a cross-sectional area greater than that of the proximal region whereby an annular protected region is formed proximally of the tip; and

a plurality of isolated electrode terminals formed over a distal surface of the distal tip of the catheter body.

12. The catheter of claim 11, wherein the structure is an angioplasty balloon and the combined diameter of the protected region and the balloon in its uninflated state is less than the diameter of the distal tip.

13. A catheter system comprising:

a catheter body having a proximal end, a distal end, and a forwardly disposed contact surface;

an electrode array disposed near the distal end of the catheter body, said array including a plurality of electrically isolated electrode terminals disposed over the contact surface; and

means for applying a high frequency voltage between the electrode array and a return electrode selected from the group consisting of a common electrode and a paired isolated electrode within the array, wherein current flow to each electrode terminal is selectively controllable, and wherein the diameter of the catheter body is greater in the vicinity of the contact surface than the diameter of the catheter body in a location proximal to the electrode array.

14. The catheter system of claim 13, further comprising:

an inflatable balloon disposed about the catheter body at a location proximal to the electrode array, wherein the diameter of the uninflated balloon disposed about the catheter body is less than the diameter of the catheter body in a location distal to the balloon.

15. The catheter system of claim 13, wherein the distal end of the catheter is formed to have a tapered forward surface and an outer perimeter, wherein the electrode array is formed over the tapered forward surface and the peripheral shank has the greater diameter.

16. A catheter system comprising:

a catheter body having a proximal end a distal end, and a distally exposed contact surface having an outer perimeter;

an electrode array disposed near the distal end of the catheter body, said array including a plurality of electrically isolated electrode terminals disposed over a portion of the contact surface; and

means for applying a high frequency voltage between the electrode array and a return electrode selected from the group consisting of a common electrode and a paired isolated electrode within the array, wherein current flow to each electrode is selectively controllable, and wherein the electrodes closest to the perimeter of the contact surface are laterally set back at some distance from the perimeter.

17. The catheter system of claim 16, wherein the electrodes have a circular cross-section and wherein the electrodes are set back a distance from the perimeter equal to or greater than one electrode diameter.

18. A method for advancing a catheter through a body lumen, the method comprising the steps of:

advancing the catheter into the lumen to engage a forwardly disposed contact surface against an atheromatous mass;

applying a high frequency voltage through an electrode array disposed over the contact surface;

changing the curvature of the catheter using steering wires disposed along the length of the catheter so that the electrode array remaining engaged against the atheromatous mass as the contact surface advances through the atheromatous mass in the body lumen.

19. The method of claim 18, wherein the step of controlling the curvature of the catheter is performed by selectively contracting one or more of the steering wires.

20. The method of claim 19, wherein the step of selectively contracting the steering wires is performed by selectively heating one or more of the steering wires.

21. The method of claim 19, wherein the step of selectively contracting the steering wires is performed by conducting electrical current selectively through one or more of the steering wires.

22. The method of claim 21, wherein the conduction of current through a steering wire is selectively increased in response to a rise in current flow to the individual electrodes in the region of the array opposite to the wire.

23. The method of claim 22, wherein current is supplied to the electrodes of the array through current supply wires in the catheter body, and wherein the step of conducting current through the steering wires includes sensing the current within the current supply wires and controlling the current in the steering wires based on the sensed current.

32. The catheter system of claim 21, wherein the catheter body includes at least three regions of differing stiffness, wherein the catheter body increases in stiffness from the distal to the proximal end.

24. A catheter system comprising:

a catheter body having a proximal end and a distal end;

an electrode array disposed near the distal end of the catheter body, said array including a plurality of electrically isolated electrode terminals disposed over a contact surface;

means for applying a high frequency voltage between the electrode array and a common electrode selected from the group consisting of an electrode formed on the exterior surface of the catheter body, a guidewire, and a paired isolated electrode terminal, wherein current flow to each electrode terminal is selectively controllable; and

means for steering the catheter by changing the curvature of the catheter body between the proximal and distal ends.

25. The catheter system of claim 24, wherein the steering means comprises a plurality of steering wires disposed in the catheter body and connected to the distal end thereof, wherein the catheter body is steerable by selective contraction of at least one of the wires.

26. The catheter system of claim 25, wherein the steering wires are disposed within low-friction sleeves.

27. The catheter system of claim 25, wherein the steering means comprises at least four steering wires, one wire in each of four quadrants of the catheter body.

28. The catheter system of claim 25, wherein the steering wires are composed of a shape-memory alloy, and wherein the wires contract when heated above a predetermined transition temperature.

29. The catheter system of claim 25, wherein contraction of the steering wires is effected by the selective conduction of electrical current through the steering wires.

30. The catheter system of claim 25, further comprising means for selectively increasing current through each steering wire in response to a rise in current flow between the individual electrodes in the region of the disposed opposite to the wire and the common electrode.

31. The catheter system of claim 24, wherein the catheter body includes regions of differing stiffness.

33. A catheter comprising:

a catheter body having proximal and distal ends, a proximal region, and a distal tip, wherein the distal tip of the catheter body has a cross-sectional area greater than that of the proximal region whereby an annular protected region is formed proximally of the tip;

a plurality of isolated electrode terminals formed over a distal surface of the distal tip catheter body; and

a balloon disposed within the annular protected region wherein the combined diameter of the protected region and the balloon in its uninflated state is less than the diameter of the distal tip.

34. A catheter system comprising:

a catheter body having a proximal end and a distal end;

an electrode array disposed near the distal end of the catheter body, said array including a plurality of electrically isolated electrode terminals disposed over a contact surface;

means for applying a high frequency voltage between the electrode array and a return electrode selected from the group consisting of a common electrode and a paired isolated electrode within the array, wherein current flow to each electrode terminal is selectively controllable, and wherein the diameter of the catheter body is greater in the vicinity of the electrode array than the diameter of the catheter body in a location proximal to the electrode array; and

an inflatable balloon disposed about the catheter body at a location proximal to the electrode array, wherein the diameter of the uninflated balloon disposed about the catheter body is less than the diameter of the catheter body in a location distal to the balloon.

35. The catheter system of claim 34, wherein the distal end of the catheter has a tapered forward surface and an outer perimeter, wherein the electrode array is formed over the tapered forward surface and the perimeter has a greater diameter than that of the proximal catheter body.