Apparatus and method for treatment of in-stent restenosis

• US 9,713,730 B2
• Filed: 10/04/2012
• Issued: 07/25/2017
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Mazor, Meital, Perez, Dolores, Mathur, Prabodh
• Primary Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US13/644,367
• Publication Number:
  US 20130282084A1
• Time in Patent Office: 1,755 Days
• Field of Search: 606 41, 606 42, 607113
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61N 2005/0602 for treatment of blood vessels
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body

Abstract

A catheter and catheter system can use energy tailored for remodeling and/or removal of target material proximate to a body lumen, often of stenotic material or tissue in the luminal wall 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 the luminal wall when the structure expands. Feedback using one or parameters of voltage, current, power, temperature, impedance magnitude, impedance phase angle, and frequency may be used to selectively control the delivery of energy.

Claims

1. A system for delivering energy-based treatment for in-stent restenosis and other stenosis of the vasculature, the system comprising:

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

a radially expandable structure near the distal end of the catheter body;

a plurality of electrodes positioned on the radially expandable structure so as to engage tissue upon expansion of the radially expandable structure, wherein the plurality of electrodes are included in one or more flex circuits, wherein the one or more flex circuits further comprise a temperature sensing structure mounted thereon adjacent to at least one of the electrodes;

a power source coupled with the electrodes such that when an electrode engages tissue an electrical circuit comprising the power source, the electrode, and the engaged tissue is defined; and

,

a processor coupled with the power source and the temperature sensing structure, the processor configured to verify the presence of the electrical circuit, to selectively energize the engaged electrodes, and to control the delivery of energy by regulating one or more parameters of the electrical circuit based on monitoring feedback from the electrical circuit and the temperature sensing structure such that energy delivered to a tissue treatment zone heats tissue therein to a surface temperature of about 55°

C. to about 75°

C. while tissue collateral to the treatment zone 1 mm from the surface and deeper is heated to less than about 45°

C., thereby inducing a tissue response that remodels stenosis and avoids a subsequently occluding tissue response caused by thermal damage,

wherein the processor is configured to monitor and modify energy delivery to at least one of the plurality of electrodes by the power source in response to a change in at least one of frequency range, impedance magnitude, impedance phase angle, temperature, power, voltage, and current, the change being associated with proximity to a metallic implanted structure.

2. The system of claim 1, wherein the plurality of electrodes are distributed about the circumference of the expandable structure so as to form an electrode array, the electrodes having an elongate shape oriented to be substantially parallel to the catheter axis upon expansion of the expandable structure.

3. The system of claim 1, wherein the expandable structure comprises a balloon.

4. The system of claim 3, wherein the one or more flex circuits include a monopolar electrode or a bipolar electrode pair.

5. The system of claim 3, wherein the balloon inflation pressure is about 10 atmospheres or less.

6. The system of claim 1, wherein the electrodes include a radiopaque material.

7. The system of claim 1, wherein the processor is configured to monitor and modify energy delivery to at least one of the plurality of electrodes by the power source in response to a change in at least one of frequency range, impedance magnitude, impedance phase angle, temperature, power, voltage, and current, the change being associated with heating of tissue.

8. The system of claim 7, wherein the processor halts energy delivery to said at least one of the plurality of electrodes while optionally continuing to energize and regulate energy delivery to another electrode.

9. The system of claim 1, wherein the expanded diameter of the expandable structure is about 2 mm to about 10 mm.

10. The system of claim 1, wherein the processor is configured to characterize tissue in the treatment zone using a tissue signature profile curve, within a frequency range, of impedance magnitude and phase angles of the circuit.

11. The system of claim 10, wherein the processor is configured to characterize tissue by comparing the tissue signature profile curve to at least one other tissue signature profile curve, by selectively energizing at least one of the plurality of electrodes, so as identify at least one of tissue to be treated and an implanted structure.

12. The system of claim 11, wherein the processor is configured to selectively energize said at least one of the plurality of electrodes, and by using at least one of a relative slope of the tissue signature profile curves and an offset between the tissue signature profiles, characterize the tissue to be treated.

13. The system of claim 11, wherein energy delivery may be selected by the processor based on a determination of a composition of the implanted structure according to an impedance measurement.

14. The system of claim 10, wherein the processor is configured to localize and characterize a plurality of materials about the vasculature, and to selectively treat different characterized materials by applying different remodeling energy treatments to selected electrodes.

15. The system of claim 1, wherein the processor selectively energizes at least one of the plurality of electrodes by modulating one or more of power, duty cycle, current, and voltage based on at least one of the one or more parameters of the electrical circuit.

16. The system of claim 1, wherein the electrodes are energized in a sequence.

17. The system of claim 16, wherein a first group of electrodes is energized in a sequence so as to define a first pattern of treatment zones, and wherein a second group of electrodes is energized in a sequence so as to define a second pattern of treatment zones, so as to minimize the gap between the first and second pattern of treatment zones.

18. The system of claim 1, wherein at least one of the plurality of electrodes is energized with a power of 0.5 Watts to 20 Watts for 0.5 seconds to 180 seconds.

19. The system of claim 1, wherein the expandable structure may be expanded and collapsed so as to allow for repositioning of the catheter along a portion of the vasculature.

20. The system of claim 1, wherein the power source includes a radiofrequency generator.

21. A catheter for delivering energy-based treatment for in-stent restenosis and other stenosis of the vasculature, the system comprising:

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

a radially expandable structure near the distal end of the catheter body;

a plurality of electrodes positioned on the radially expandable structure so as to engage tissue at an electrode position upon expansion of the radially expandable structure, the tissue in proximity to engaged electrodes defining a tissue treatment zone, wherein the electrodes are positioned on a flex circuit; and

a temperature sensing structure mounted on the flex circuit adjacent at least one of said plurality of electrodes, the temperature sensing structure being electrically coupled to a processor so as to comprise a means of feedback for control by a power source by sensing temperature in proximity to at least one electrode, wherein the processor is configured to deliver energy to a tissue treatment zone to heat tissue therein to a surface temperature of about 55°

C. to about 75°

C. while tissue collateral to the treatment zone 1 mm from the surface and deeper is heated to less than about 45°

C., thereby inducing a tissue response that remodels stenosis and avoids a subsequently occluding tissue response caused by thermal damage,

wherein the processor is configured to monitor and modify energy delivery to at least one of the plurality of electrodes by the power source in response to a change in at least one of frequency range, impedance magnitude, impedance phase angle, temperature, power, voltage, and current, the change being associated with proximity to a metallic implanted structure.

22. The catheter of claim 21, wherein the plurality of electrodes are distributed about the circumference of the expandable structure so as to form an electrode array, the electrodes having an elongate shape oriented to be substantially parallel to the catheter axis upon expansion of the expandable structure.

23. The catheter of claim 21, wherein the expandable structure comprises a balloon.

24. The catheter of claim 23, wherein the circuit includes a monopolar electrode or a bipolar electrode pair.

25. The catheter of claim 23, wherein the balloon inflation pressure is about 10 atmospheres or less.

26. The catheter of claim 21, wherein the electrodes are comprised of a radiopaque material.

27. The catheter of claim 21, wherein the expanded diameter of the expandable structure is about 2 mm to about 10 mm.

28. The catheter of claim 21, wherein the expandable structure may be expanded and collapsed so as to allow for repositioning of the catheter along a portion of the vasculature.

29. A system for delivering energy-based treatment for in-stent restenosis and other stenosis of the vasculature, the system comprising:

an elongate flexible catheter body having a proximal end, a distal end, and a longitudinal axis extending therebetween;

a radially expandable structure disposed on the catheter body near the distal end thereof;

a plurality of electrodes positioned on the radially expandable structure so as to engage a tissue upon expansion of the radially expandable structure, the tissue in proximity to engaged electrodes defining a tissue treatment zone, wherein the plurality of electrodes are included in one or more flex circuits, wherein the one or more flex circuits further comprise a temperature sensing structure mounted thereon adjacent to at least one of the electrodes;

a power source coupled with the electrodes such that when an electrode of the plurality engages the tissue, an electrical circuit comprising the power source, the engaged electrode, and the tissue engaged by the electrode can be defined; and

a processor coupled with the power source and the temperature sensing structure, the processor configured to control the delivery of energy by regulating one or more parameters of the electrical circuit based on monitoring feedback acquired from the electrical circuit and the temperature sensing structure such that the controlled delivery of energy heats the tissue to be treated to a surface temperature of about 55°

C. to about 75°

C. while a collateral tissue adjacent the treatment zone 1 mm from the surface and deeper is heated to less than about 45°

C. thereby inducing a tissue response that remodels stenosis and avoids a subsequently occluding tissue response caused by thermal damage,

wherein the processor is configured to monitor and modify energy delivery to at least one of the plurality of electrodes by the power source in response to a change in at least one of frequency range, impedance magnitude, impedance phase angle, temperature, power, voltage, and current, the change being associated with proximity to a metallic implanted structure.