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

• US 9,186,211 B2
• Filed: 01/25/2013
• Issued: 11/17/2015
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Mathur, Prabodh
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/750,879
• Publication Number:
  US 20130165926A1
• Time in Patent Office: 1,026 Days
• Field of Search: 606 20- 52
• 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 medical device may include a catheter shaft. An expandable member may be coupled to the catheter shaft. A plurality of flexible electrode assemblies may be coupled to the expandable member. A control unit may be coupled to the electrode assemblies. The control unit may be configured to energize the electrode assemblies for approximately 10 seconds to less than approximately 1 minute.

Claims

1. A medical device for renal nerve ablation, comprising:

a catheter shaft;

an expandable member coupled to the catheter shaft;

a plurality of flexible electrode assemblies coupled to the expandable member, wherein each flexible electrode assembly of the plurality of flexible electrode assemblies comprises a proximal electrode pad, a distal electrode pad circumferentially offset from the proximal electrode pad, and an intermediate tail disposed between the proximal electrode pad and the distal electrode pad and at least some of the distal electrode pads are axially offset;

a control unit coupled to the electrode assemblies, wherein the control unit is designed to delivery radiofrequency (RF) energy to the electrode assemblies in order to ablate renal nerves; and

wherein the control unit is configured to energize the electrode assemblies for in a range of 10 seconds to 1 minute.

2. The medical device of claim 1, wherein the expandable member includes an expandable balloon.

3. The medical device of claim 1, wherein the control unit is configured to energize the electrode assemblies for in the range of 10-30 seconds.

4. The medical device of claim 1, wherein the control unit is configured to energize the electrode assemblies for 30 seconds.

5. The medical device of claim 1, wherein the control unit is configured to energize the electrode assemblies so that a treatment zone is defined adjacent to each of the electrode assemblies, wherein the control unit is configured to energize the electrode assemblies to heat each of the treatment zones, and wherein the control unit is configured to energize the electrode assemblies to heat each of the treatment zones to a temperature in a range of 55-75°

C.

6. The medical device of claim 5, wherein the control unit is configured to energize the electrode assemblies to heat each of the treatment zones to a temperature of 68°

C.

7. The medical device of claim 1, wherein the control unit is configured to energize the electrode assemblies within a range of 0.25-5 Watts average power.

8. The medical device of claim 7, wherein the control unit is configured to energize the electrode assemblies to 5 Watts average power.

9. The medical device of claim 1, wherein at least some of the electrode assemblies include a pair of adjacent bipolar electrodes.

10. The medical device of claim 1, wherein at least some of the electrode assemblies include a monopolar electrode.

11. The medical device of claim 1, wherein at least some of the electrode assemblies include a thermal sensor.

12. The medical device of claim 11, wherein the thermal sensor is positioned between a bottom surface of one of the electrode assemblies and an outer surface of the expandable member.

13. The medical device of claim 1, wherein the electrode assemblies are configured to deliver energy to a renal artery to reduce the concentration of norepinephrine adjacent to the renal artery by approximately 50% or more.

14. A medical device, comprising:

a catheter shaft;

an expandable balloon coupled to the catheter shaft;

a plurality of flexible electrode assemblies coupled to the balloon, wherein each flexible electrode assembly of the plurality of flexible electrode assemblies comprises a proximal electrode pad, a distal electrode pad circumferentially offset from the proximal electrode pad, and an intermediate tail disposed between the proximal electrode pad and the distal electrode pad and at least some of the distal electrode pads are axially offset;

a control unit coupled to the electrode assemblies, wherein the control unit is designed to delivery radiofrequency (RF) energy to the electrode assemblies in order to modulate sympathetic nerve function; and

wherein the control unit is configured to energize the electrode assemblies within a range of 0.25-5 Watts average power for in a range of 10-30 seconds.

15. The medical device of claim 14, wherein the control unit is configured to energize the electrode assemblies to 5 Watts average power.

16. A method for treating hypertension, the method comprising:

advancing a medical device through a blood vessel to a position within a renal artery, the medical device, comprising;

a catheter shaft,

an expandable member coupled to the catheter shaft,

a plurality of flexible electrode assemblies coupled to the expandable member, wherein each flexible electrode assembly of the plurality of flexible electrode assemblies comprises a proximal electrode pad, a distal electrode pad circumferentially offset from the proximal electrode pad, and an intermediate tail disposed between the proximal electrode pad and the distal electrode pad and at least some of the distal electrode pads are axially offset, and

a control unit coupled to the electrode assemblies, wherein the control unit is designed to delivery radiofrequency (RF) energy to the flexible electrode assemblies in order to modulate sympathetic nerve function;

advancing the medical device through a blood vessel to a position within a renal artery;

energizing the electrode assemblies for in a range of 10 seconds to 1 minute with the control unit.

17. The method of claim 16, wherein energizing the electrode assemblies for in the range of 10 seconds to 1 minute with the control unit includes heating a target tissue to a temperature in a range of 55-75°

C.

18. The method of claim 16, wherein energizing the electrode assemblies for in the range of 10 seconds to 1 minute with the control unit includes heating a target tissue to a temperature of 68°

C.

19. The method of claim 16, wherein energizing the electrode assemblies for in the range of 10 seconds to 1 minute with the control unit includes delivering energy to the renal artery to reduce the concentration of norepinephrine adjacent to the renal artery by approximately 50% or more.