Granted Patent B2

US 12,336,752 · App. 17/729,981 · Granted Jun 24, 2025

Inventors: Corbett W. Stone (San Diego, CA); Michael F. Hoey (Shoreview, MN); Thomas A. Steinke (Hollywood, FL); Raphael M. Michel (Palo Alto, CA); Arthur G. Blanck (Ramona, CA); Marlene Kay Truesdale (Green Bay, WI); Bret Herscher (Cupertino, CA)

Assignee: Boston Scientific Scimed, Inc.

A61B18/1492A61B18/1206A61M5/14A61M25/10A61B2017/00106A61B2018/0016A61B2018/00214A61B2018/0022A61B2018/00267A61B2018/00702A61B2018/00869A61B2018/00875A61B2034/105A61B2034/2068A61B2090/3735

Abstract

Claims (40)

1. A catheter system for remodeling of a target tissue adjacent a blood vessel of a patient, the catheter system comprising:

an elongate flexible catheter body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure coupled to the elongate flexible catheter body; one or more pairs of bipolar electrodes engageable with a vessel wall of the blood vessel;

a power source electrically coupled to the one or more pairs of bipolar electrodes, the power source configured to energize the one or more pairs of bipolar electrodes with a controlled electrical remodeling energy that heats the target tissue so as to remodel the target tissue without thermally damaging a collateral tissue; and

a processor programmed to determine the controlled electrical remodeling energy by monitoring a characteristic of a circuit comprising the one or more pairs of bipolar electrodes engaged against the vessel wall, the target tissue, and the collateral tissue, the processor programmed to select a phase angle of the controlled electrical remodeling energy to compensate for a measured phase angle of the circuit;

wherein the controlled electrical remodeling energy is such that energizing the circuit heats the target tissue to a target tissue treatment temperature so as to remodel the target tissue and heats the collateral tissue to a collateral tissue temperature that is lower than the target tissue treatment temperature.

2. The catheter system of claim 1 , wherein the one or more pairs of bipolar electrodes define a circumferentially distributed electrode array and wherein the power source is configured to deliver the controlled electrical remodeling energy by sequentially energizing selected subsets of the circumferentially distributed electrode array.

3. The catheter system of claim 1 , wherein the one or more pairs of bipolar electrodes define a circumferential array having axially offset electrodes.

4. The catheter system of claim 1 , wherein the power source comprises an RF generator.

5. The catheter system of claim 4 , including a controller configured for selectively energizing the one or more pairs of bipolar electrodes.

6. The catheter system of claim 5 , wherein the processor is configured to determine electrode selection using an electrode temperature input to provide the controlled electrical remodeling energy.

7. The catheter system of claim 4 , wherein a controller is configured to control delivery of the controlled electrical remodeling energy with the one or more pairs of bipolar electrodes so as to heat the target tissue to a temperature between about 50° C. and 95° C.

8. The catheter of system 4 , wherein the processor is further configured to deliver the controlled electrical remodeling energy so as to limit heating of an adventitial layer of the blood vessel to no more than 63° C.

9. The catheter system of claim 4 , wherein the processor is configured to deliver the controlled electrical remodeling energy in pulses of energy.

10. The catheter system of claim 4 , wherein the processor is configured to monitor the characteristics of the circuit formed along the blood vessel using selected electrodes of the one or more pairs of bipolar electrodes.

11. The catheter system of claim 1 , wherein the processor is configured to modify the controlled electrical remodeling energy delivered with the one or more pairs of bipolar electrodes in response to the monitored characteristic of the circuit.

12. The catheter system of claim 1 , wherein the processor is configured to halt delivery of the controlled electrical remodeling energy in response to the monitored characteristic of the circuit.

13. The catheter system of claim 1 , wherein the characteristics of the circuit comprises an impedance magnitude of the circuit.

14. The catheter system of claim 1 , wherein the processor is configured to characterize the target tissue by monitoring the characteristic of the circuit.

15. A catheter system for remodeling of a target tissue adjacent a body lumen of a patient, the catheter system comprising:

an elongate flexible catheter body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure coupled to the elongate flexible catheter body;

one or more pairs of bipolar electrodes configured to engage a surrounding lumen wall upon expansion of the radially expandable structure;

a power source comprising an RF generator electrically coupled to the one or more pairs of bipolar electrodes, the power source configured to energize the one or more pairs of bipolar electrodes with a controlled electrical remodeling energy that heats the target tissue so as to remodel the target tissue without thermally damaging a collateral tissue;

a controller configured for selectively energizing the one or more pairs of bipolar electrodes; and

a processor programmed to determine the controlled electrical remodeling energy by monitoring a characteristic of a circuit comprising selected electrodes of the one or more pairs of bipolar electrodes engaged against the lumen wall, the target tissue, and the collateral tissue, the processor programmed to select a phase angle of the controlled electrical remodeling energy to compensate for a measured phase angle of the circuit;

wherein the controlled electrical remodeling energy is such that energizing the circuit heats the target tissue to a target tissue treatment temperature so as to remodel the target tissue and heats the collateral tissue to a collateral tissue temperature that is lower than the target tissue treatment temperature.

16. The catheter system of claim 15 , wherein the processor is configured to modify the controlled electrical remodeling energy delivered with the one or more pairs of bipolar electrodes in response to the monitored characteristic of the circuit.

17. The catheter system of claim 15 , wherein the processor is configured to halt delivery of the controlled electrical remodeling energy in response to the monitored characteristic of the circuit.

18. The catheter system of claim 15 , wherein the characteristics of the circuit comprises an impedance magnitude of the circuit.

19. The catheter system of claim 15 , wherein the processor is configured to characterize the target tissue by monitoring the characteristic of the circuit.

20. A catheter system for remodeling of a target tissue adjacent a body lumen of a patient, the catheter system comprising:

an elongate flexible catheter body having a proximal end and a distal end with an axis therebetween;

a radially expandable structure coupled to the elongate flexible catheter body;

one or more pairs of bipolar electrodes configured to engage a surrounding wall of the body lumen upon expansion of the radially expandable structure;

a power source comprising an RF generator electrically coupled to the one or more pairs of bipolar electrodes, the power source configured to energize the one or more pairs of bipolar electrodes with a controlled electrical remodeling energy that heats the target tissue so as to remodel the target tissue without thermally damaging a collateral tissue;

a controller configured for selectively energizing the one or more pairs of bipolar electrodes; and

a processor programmed to determine the controlled electrical remodeling energy by monitoring a characteristic of a circuit comprising selected electrodes of the one or more pairs of bipolar electrodes engaged against the wall of the body lumen, the target tissue, and the collateral tissue, the processor programmed to select a phase angle of the controlled electrical remodeling energy to compensate for a measured phase angle of the circuit;

wherein the characteristic comprises an impedance of the circuit measured at a plurality of frequencies, and

wherein the controlled electrical remodeling energy is such that energizing the circuit heats the target tissue to a target tissue treatment temperature so as to remodel the target tissue and heats the collateral tissue to a collateral tissue temperature that is lower than the target tissue treatment temperature.

Continuity (6)

References Cited (400)