Methods and apparatuses for remodeling tissue of or adjacent to a body passage

• US 9,174,050 B2
• Filed: 12/21/2012
• Issued: 11/03/2015
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Mathur, Prabodh, Nassif, Rabih, Dandler, Andres, Lee, Henry H.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/725,872
• Publication Number:
  US 20130165923A1
• Time in Patent Office: 1,047 Days
• Field of Search: 606/41, 606/47, 606/48, 606/49, 606/50
• US Class Current: 1/1
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

Medical devices and methods for making and using the same are disclosed. An example device may include a catheter extending along a longitudinal axis. A balloon may be coupled to an end of the catheter. The balloon having a plurality of cylindrical treatment zones extending along the longitudinal axis in an expanded state. A plurality of electrode assemblies may be coupled to the balloon. Each electrode assembly may include a distal electrode pad and a proximal electrode pad.

Claims

1. A device, comprising:

a catheter extending along a longitudinal axis;

a balloon coupled to an end of the catheter, the balloon having a plurality of cylindrical treatment zones extending along the longitudinal axis in an expanded state; and

a plurality of electrode assemblies coupled to the balloon, each electrode assembly comprising a distal electrode pad, a proximal electrode pad and an intermediate tail that extends between the distal electrode pad and the proximal electrode pad such that;

the distal electrode pad is longitudinally separated from the proximal electrode pad by the intermediate tail, each electrode assembly comprising a bipolar electrode pair, the distal electrode pad and proximal electrode pad being circumferentially offset from one another in the expanded state of the balloon,

wherein the plurality of electrode pads are each longitudinally arranged such that each cylindrical treatment zone includes at least one of the distal and proximal electrode pads of at least one of the plurality of electrode assemblies,

wherein the intermediate tail of each electrode assembly extends in the longitudinal direction such that the distal electrode pad and proximal electrode pad of any particular electrode assembly occupy non-adjacent treatment zones on the balloon.

2. The device of claim 1, wherein the balloon has four cylindrical treatment zones, and two electrode assemblies are coupled to the balloon such that each zone includes one distal electrode pad or one proximal electrode pad.

3. The device of claim 1, wherein the balloon has four cylindrical treatment zones, and three electrode assemblies are coupled to the balloon such that each of two non-adjacent cylindrical treatment zones includes two distal electrode pads or two proximal electrode pads and each of the other two non-adjacent cylindrical treatment zones includes one distal electrode pad or one proximal electrode pad.

4. The device of claim 3, wherein one particular cylindrical treatment zone includes one proximal electrode pad of one electrode assembly and two intermediate tails of the two other electrode assemblies.

5. The device of claim 3, wherein one particular cylindrical treatment zone includes two distal electrode pads of two different electrode assemblies and one intermediate tail of the remaining electrode assembly.

6. The device of claim 1, wherein the balloon has four cylindrical treatment zones, and four electrode assemblies are coupled to the balloon such that each of two non-adjacent cylindrical treatment zones includes two distal electrode pads or two proximal electrode pads and each of the other two non-adjacent cylindrical treatment zones includes one distal electrode pad or one proximal electrode pad.

7. The device of claim 6, wherein two distal electrode pads of two different electrode assemblies occupy a particular cylindrical treatment zone, with each of these two proximal electrode pads being circumferentially separated by the intermediate tail of one of the other two other electrode assemblies.

8. The device of claim 6, wherein two proximal electrode pads of two different electrode assemblies occupy a particular cylindrical treatment zone, with each of these two proximal electrode pads being circumferentially separated by the intermediate tail of one of the other two other electrode assemblies.

9. The device of claim 1, wherein each electrode pad includes a ground electrode and an active electrode.

10. The device of claim 1, wherein each electrode pad includes a heat sensing device.

11. The device of claim 1, wherein each electrode assembly further comprises a proximal tail extending from the proximal electrode pad.

12. The device of claim 1, wherein, for each electrode assembly, the intermediate tail comprises an intermediate ground line, intermediate active electrode line, and intermediate heat sensor line, and the proximal tail comprises the intermediate active electrode line, intermediate heat sensor line, a proximal ground line, proximal active electrode line, and proximal heat sensing line.

13. The device of claim 12, wherein the intermediate ground line is extended on an axis shared with the proximal ground line.

14. The device of claim 13, wherein a distal ground electrode of the distal electrode pad and a proximal ground electrode of the proximal electrode pad both extend along the axis shared with the intermediate and proximal ground lines, such that the distal ground electrode, intermediate ground line, proximal ground electrode, and proximal ground line all extend along on the axis.

15. A method for treating a patient having high blood pressure, the method comprising:

inserting a device into the renal artery, the device comprising;

a catheter extending along a longitudinal axis;

a balloon having an unexpanded state and an expanded state, and coupled to an end of the catheter, the balloon having a plurality of cylindrical treatment zones extending along the longitudinal axis in the expanded state; and

a plurality of electrode pad assemblies mounted to the balloon, each electrode pad assembly comprising a substrate supporting a first distal electrode pad and second proximal electrode pad and an intermediate tail that extends between the distal electrode pad and the proximal electrode pad such that the distal electrode pad is longitudinally separated from the proximal electrode pad by the intermediate tail, with each electrode pad having a pair of elongate bipolar electrodes, the distal electrode pad and the proximal electrode pad being circumferentially offset from one another in the expanded state of the balloon, wherein the plurality of electrode pad assemblies are each longitudinally arranged such that each cylindrical treatment zone includes at least one of the distal and proximal electrode pads of at least one of the plurality of electrode assemblies, wherein the intermediate tail of each electrode pad assembly extends in the longitudinal direction such that the distal electrode pad and proximal electrode pad of any particular electrode assembly occupy non-adjacent treatment zones on the balloon;

expanding the balloon in the renal artery so as to electrically couple the electrodes with a wall of the renal artery; and

driving bipolar energy between the electrodes of each bipolar pair so as to therapeutically alter nerves surrounding the renal artery such that the high blood pressure of the patient is mitigated.

16. The method of claim 15, wherein each electrode pad assembly includes a temperature sensor disposed between the electrodes of the pair, wherein the expanding of the balloon thermally couples the temperature sensors with the wall of the renal artery, and further comprising directing the energy to the bipolar pairs in response to a temperature signal from the temperature sensor so as to heat the wall approximately evenly.

17. The method of claim 15, wherein the electrode pad assemblies are arranged on the balloon so that at least some of the electrode pads are longitudinally separated from a circumferentially adjacent electrode pad, and further comprising advancing the balloon into the renal artery by flexing the balloon between the longitudinally separated electrode pads.