Tuned RF energy and electrical tissue characterization for selective treatment of target tissues

• US 8,939,970 B2
• Filed: 02/29/2012
• Issued: 01/27/2015
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Stone, Corbett W., Hoey, Michael F., Steinke, Tom A., Michel, Raphael M., Blanck, Arthur G., Truesdale, Marlene Kay, Herscher, Bret
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US13/408,135
• Publication Number:
  US 20120157989A1
• Time in Patent Office: 1,063 Days
• Field of Search: 606/33, 606/41, 606 47- 50, 607101-102, 607/122, 600/439
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/00106 ultrasonic
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00869 Phase
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2068 using pointers, e.g. pointers having reference marks for determining coordinates of body points
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

A catheter and catheter system can use energy tailored for remodeling and/or removal of target material along a body lumen, often of atherosclerotic material of a blood vessel of a patient. An elongate flexible catheter body with a radially expandable structure may have a plurality of electrodes or other electrosurgical energy delivery surfaces to radially engage atherosclerotic material when the structure expands. An atherosclerotic material detector system may measure and/or characterize the atherosclerotic material and its location, optionally using impedance monitoring.

Claims

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 catheter body;

a plurality of flex circuits, each of the flex circuits including a polymer substrate attached to an outer surface of the radially expandable structure;

one or more pairs of bipolar electrodes coupled to each of the flex circuits and being 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 configured 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,

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 plurality of flex circuits are mounted to the radially expandable structure.

3. The catheter system of claim 2 wherein the radially expandable structure comprises a balloon.

4. The catheter system of claim 3, wherein the balloon is configured for use with balloon inflation pressures of less than 10 atm.

5. The catheter system of claim 1, wherein the one or more pairs of bipolar electrodes define a circumferentially distributed electrode array.

6. The catheter system of claim 5 wherein the power source is configured to deliver the controlled remodeling energy by sequentially energizing selected subsets of the electrode array.

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

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

9. The catheter system of claim 8, including a controller configured for selectively energizing the one or more pairs of bipolar electrodes.

10. The catheter system of claim 9 further wherein the processor is configured to determine electrode selection using an electrode temperature input to provide the controlled electrical remodeling energy.

11. The catheter system of claim 8, wherein a controller is configured to control delivery of the 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.

13. The catheter system of claim 8, wherein the processor is configured to deliver the remodeling energy in pulses of energy.

14. The catheter system of claim 8, wherein the processor is configured to monitor a characteristic of a circuit formed along the blood vessel using selected electrodes of the one or more pairs of bipolar electrodes.

15. The catheter system of claim 14, wherein the processor is configured to modify a remodeling energy delivered with the one or more pairs of bipolar electrodes in response to the monitored characteristic of the circuit.

16. The catheter system of claim 14, wherein the processor is configured to halt delivery of the remodeling energy in response to the monitored characteristic of the circuit.

17. The catheter system of claim 14, wherein the characteristic comprises impedance magnitude of the circuit.

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

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

C.