Inducing desirable temperature effects on body tissue

• US 10,213,252 B2
• Filed: 02/24/2012
• Issued: 02/26/2019
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix
• Inventors: Stone, Corbett W., Hoey, Michael F., Gustus, Rolfe Tyson, Perry, Mike, Blanck, Arthur G., Kunstmanas, Linas R.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Good, Samantha
• Application Number:
  US13/385,540
• Publication Number:
  US 20120157986A1
• Time in Patent Office: 2,559 Days
• Field of Search: 606 41, 607119
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe

Abstract

Methods and systems are disclosed for treating diseased tissue by gentle heating. The method induces vasodilation on tissue disposed about an lumen having both healthy tissue and diseased tissue. The method includes coupling a probe surface to the luminal tissue at a target location and transmitting desired quantities of tissue remodeling energy from the coupled probe into each of a plurality of discrete remodeling zones in the luminal tissue so that the tissue remodeling energy heats the plurality of remodeling zones, the remodeling energy being configured to avoid muscular contraction and inhibit both acute and long-term occlusion of the lumen.

Claims

1. A system for remodeling tissue disposed about a blood vessel, the system comprising:

an endovascular catheter having an energy delivery portion adapted to be coupled with a target tissue, wherein the catheter includes a balloon, wherein the energy delivery portion comprises a plurality of electrodes disposed about the balloon of the catheter so as to define a plurality of remodeling zones in the target tissue when the balloon is in contact with a blood vessel wall disposed adjacent to the target tissue; and

an energy source coupleable with the catheter, the energy source being configured to deliver a controlled quantity of energy to each of the plurality of electrodes in response to an input such that the controlled quantity of energy heats at least some of the plurality of remodeling zones of the target tissue so as to remodel the target tissue and inhibit thermal damage of collateral healthy tissues;

wherein the plurality of remodeling zones includes a first remodeling zone and a second remodeling zone disposed adjacent to the first remodeling zone and wherein the plurality of electrodes comprise a plurality of bipolar electrode pairs spaced around an axis of the balloon so that the plurality of remodeling zones defined by the bipolar electrode pairs are laterally separated from each other so as to form gaps between the first remodeling zone and the second remodeling zone;

wherein the energy source includes a processor, wherein the processor is designed to determine a frequency or range of frequencies at which a first impedance of the target tissue is equal to or greater than a second impedance of the collateral healthy tissue; and

wherein the processor is configured to deliver the controlled quantity of energy delivered to the plurality of electrodes at the frequency or range of frequencies.

2. The system of claim 1, wherein the energy source is configured to energize more than one of the plurality of bipolar electrode pairs so as to eliminate the gaps between the first remodeling zone and the second remodeling zone.

3. The system of claim 2, wherein the bipolar electrode pairs are arranged on the balloon so that, in combination, the bipolar electrode pairs are adapted to define the plurality of remodeling zones such that the plurality of remodeling zones substantially circumscribe the blood vessel wall.

4. The system of claim 1, wherein the plurality of electrodes are mounted on a surface of the balloon and arranged in an array.

5. The system of claim 1, wherein the controlled quantity of energy includes bipolar RF energy configured for application through healthy tissue within the plurality of remodeling zones.

6. The system of claim 1, wherein the energy source is configured to control heating the plurality of remodeling zones with the tissue remodeling energy to heat the tissue to between 47 and 99°

C.

7. The system of claim 1, wherein the energy source is configured to deliver 4 and 15 Joules to the plurality of electrodes.

8. The system of claim 1, wherein the energy source is configured to deliver 0.5 to 5 Watts to the plurality of electrodes for 0.1 to 180 seconds.

9. The system of claim 1, wherein the plurality of electrodes include a first bipolar electrode and a second bipolar electrode positioned adjacent to the first bipolar electrode, and wherein the first bipolar electrode and the second bipolar electrode are spaced apart so as to create an energy path through healthy tissue to deliver heat to remodel the target tissue.

10. The system of claim 1, wherein the energy source is configured to deliver the tissue remodeling energy in the form of pulses.

11. The system of claim 1, wherein the energy source is configured to deliver the quantity of energy according to a duty cycle so as to reduce overheating of healthy tissues and allow for a controlled dosing rate of the remodeling energy to the target tissue.

12. The system of claim 1, wherein the energy source is configured to deliver the tissue remodeling energy so as to provide a desired tissue temperature in the remodeling zones.

13. A system for remodeling tissue disposed about a blood vessel, the system comprising:

a catheter balloon having a plurality of electrode pairs disposed about the catheter balloon so that the balloon is adapted to couple with a wall of the blood vessel to define a plurality of laterally separated remodeling zones in a target tissue when the balloon is expanded within the blood vessel;

an energy source coupled with the plurality of electrode pairs and configured to energize the plurality of electrode pairs with a desired tissue remodeling energy to heat each of the plurality of laterally separated remodeling zones so as to remodel the target tissue while avoiding thermal damage of the blood vessel;

wherein the plurality of remodeling zones includes a first remodeling zone and a second remodeling zone disposed adjacent to the first remodeling zone and wherein the plurality of electrodes comprise a plurality of bipolar electrode pairs spaced around an axis of the balloon so that the plurality of remodeling zones defined by the bipolar electrode pairs are laterally separated from each other so as to form gaps between the first remodeling zone and the second remodeling zone; and

wherein the energy source includes a processor, wherein the processor is designed to determine a frequency or range of frequencies at which a first impedance of the target tissue is equal to or greater than a second impedance of the collateral healthy tissue, wherein the processor is configured to deliver a quantity of energy delivered to the plurality of electrode pairs at or below the frequency or range of frequencies.