SELECTABLE ECCENTRIC REMODELING AND/OR ABLATION

• US 20130274658A1
• Filed: 03/15/2013
• Published: 10/17/2013
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: STONE, CORBETT W., STEINKE, THOMAS A., ROSS, STEPHEN O., KELLEHER, BRIAN S., MICHEL, RAPHAEL M., KOENIG, DONALD H.
• Granted Patent: US 10,188,457 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• 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 2018/0041 Removal of thrombosis
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/373 using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

A catheter and catheter system for treatment of a blood vessel of a patient include an elongate flexible catheter body with a radially expandable structure. A plurality of electrodes or other electrosurgical energy delivery surfaces can radially engage material to be treated when the structure expands. A material detector near the distal end of the catheter body may measure circumferential material distribution, and a power source selectively energizes the electrodes to eccentrically treat of a body lumen.

Claims

1. An apparatus for renal neuromodulation, the apparatus comprising:

a catheter configured for intravascular placement within a renal blood vessel of a human patient;

an expandable balloon at a distal portion of the catheter, wherein the expandable balloon is configured to vary between a delivery configuration and a deployed configuration sized to fit within the renal blood vessel;

a first electrode having a first pair of bipolar contacts attached to the expandable balloon; and

a second electrode having a second pair of bipolar contacts attached to the expandable balloon,

wherein the first electrode and the second electrode are spaced apart lengthwise and angularly offset from one another when the expandable balloon is in the deployed configuration,

wherein each of the first electrode and the second electrode is configured to deliver thermal energy to less than a full circumference of the renal blood vessel of the patient.

2. The apparatus of claim 1 wherein:

the first electrode is configured to deliver thermal energy to create a first non-continuous, circumferential treatment zone along a lengthwise segment of the renal blood vessel; and

the second electrode is configured to deliver thermal energy to create a second non-continuous, circumferential treatment zone along the lengthwise segment of the renal blood vessel,

wherein the first circumferential treatment zone and the second circumferential treatment zone are formed in separate normal radial planes and are not continuous completely around the circumference of the renal blood vessel.

3. The apparatus of claim 2 wherein the first electrode and the second electrode are configured to respectively create the first circumferential treatment zone and second circumferential treatment zone in sequence.

4. The apparatus of claim 2 wherein the first electrode and the second electrode are configured to respectively create the first circumferential treatment zone and second circumferential treatment zone concurrently.

5. The apparatus of claim 1 wherein the first electrode and the second electrode are parts of a flex circuit on a surface of the expandable balloon.

6. The apparatus of claim 5 wherein the flex circuit terminates proximally to a distal end portion of the balloon.

7. The apparatus of claim 1 wherein the expandable balloon is configured to bring the first electrode and the second electrode into contact with an inner wall of the renal blood vessel when the expandable balloon is in the deployed configuration.

8. The apparatus of claim 1 wherein the expandable balloon is configured to block fluid flow within the renal blood vessel during energy delivery.

9. The apparatus of claim 1 wherein the expandable balloon is configured to not block fluid flow within the renal blood vessel during energy delivery.

10. The apparatus of claim 1, further comprising:

a third electrode having a third pair of bipolar contacts attached to the expandable balloon; and

a fourth electrode having a fourth pair of bipolar contacts attached to the expandable balloon,

wherein the third and fourth electrodes are spaced apart lengthwise and angularly offset from each other and from the first and second electrodes when the expandable balloon is in the deployed configuration,

wherein each of the electrodes are configured to deliver thermal energy to a less than a full circumference of the renal blood vessel of the patient.

11. The apparatus of claim 1 wherein the first electrode further comprises at least one sensor configured to monitor a parameter of the apparatus or of tissue within the patient.

12. The apparatus of claim 11, further comprising a feedback control system configured to alter treatment in response to the monitored parameter.

13. The apparatus of claim 1 wherein the first and second electrodes are configured to deliver thermal energy sufficient to modulate neural activity in neural fibers within a wall of, or in proximity to, the renal blood vessel.

14. The apparatus of claim 1 wherein the first and second electrodes are configured to deliver thermal energy sufficient to ablate neural fibers within a wall of, or in proximity to, the renal blood vessel.

15. The apparatus of claim 1 wherein the catheter is configured for infusion of one or more agents into the renal blood vessel before, during, or after energy delivery.

16. The apparatus of claim 1, further comprising an electric field generator external to the patient and electrically coupled to the first and second electrodes.

17. An apparatus for treating a patient, the apparatus comprising:

a catheter configured for intravascular placement within a blood vessel of a human patient;

an expandable balloon at a distal portion of the catheter, wherein the expandable balloon is configured to vary between a delivery configuration and a deployed configuration sized to fit within the blood vessel;

a first electrode having a first pair of bipolar contacts attached to the expandable balloon; and

a second electrode having a second pair of bipolar contacts attached to the expandable balloon,

wherein the first electrode and the second electrode are spaced apart lengthwise and angularly offset from one another when the expandable balloon is in the deployed configuration,

wherein each of the first electrode and the second electrode is configured to deliver thermal energy to less than a full circumference of the blood vessel of the patient.

18. The apparatus of claim 17 wherein:

the first electrode is configured to deliver thermal energy to create a first non-continuous, circumferential treatment zone along a lengthwise segment of the blood vessel; and

the second electrode is configured to deliver thermal energy to create a second non-continuous, circumferential treatment zone along the lengthwise segment of the blood vessel,

wherein the first circumferential treatment zone and the second circumferential treatment zone are formed in separate normal radial planes and are not continuous completely around the circumference of the blood vessel.

19. The apparatus of claim 18 wherein the first electrode and the second electrode are configured to respectively create the first circumferential treatment zone and second circumferential treatment zone in sequence.

20. The apparatus of claim 18 wherein the first electrode and the second electrode are configured to respectively create the first circumferential treatment zone and second circumferential treatment zone concurrently.

21. The apparatus of claim 17 wherein the first electrode and the second electrode are parts of a flex circuit on a surface of the expandable balloon.

22. The apparatus of claim 21 wherein the flex circuit terminates proximally to a distal end portion of the balloon.

23. The apparatus of claim 17 wherein the expandable balloon is configured to bring the first electrode and the second electrode into contact with an inner wall of the blood vessel when the expandable balloon is in the deployed configuration.

24. The apparatus of claim 17 wherein the expandable balloon is configured to block fluid flow within the blood vessel during energy delivery.

25. The apparatus of claim 17 wherein the expandable balloon is configured to not block fluid flow within the blood vessel during energy delivery.

26. The apparatus of claim 17, further comprising:

a third electrode having a third pair of bipolar contacts attached to the expandable balloon; and

a fourth electrode having a fourth pair of bipolar contacts attached to the expandable balloon,

wherein the third and fourth electrodes are spaced apart lengthwise and angularly offset from each other and from the first and second electrodes when the expandable balloon is in the deployed configuration,

wherein each of the electrodes are configured to deliver thermal energy to a less than a full circumference of the blood vessel of the patient.

27. The apparatus of claim 17 wherein the first electrode further comprises at least one sensor configured to monitor a parameter of the apparatus or of tissue within the patient.

28. The apparatus of claim 27, further comprising a feedback control system configured to alter treatment in response to the monitored parameter.

29. The apparatus of claim 17 wherein the first and second electrodes are configured to deliver thermal energy sufficient to modulate neural activity in neural fibers within a wall of, or in proximity to, the blood vessel.

30. The apparatus of claim 17 wherein the first and second electrodes are configured to deliver thermal energy sufficient to ablate neural fibers within a wall of, or in proximity to, the blood vessel.

31. The apparatus of claim 17 wherein the catheter is configured for infusion of one or more agents into the blood vessel before, during, or after energy delivery.

32. The apparatus of claim 17, further comprising an electric field generator external to the patient and electrically coupled to the first and second electrodes.