Self-positioning electrode system and method for renal nerve modulation

• US 9,173,696 B2
• Filed: 09/17/2013
• Issued: 11/03/2015
• Est. Priority Date: 09/17/2012
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Petersen, Eric, Larsen, Steven R., Schauer, Travis J.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): FOWLER, DANIEL WAYNE
• Application Number:
  US14/029,090
• Publication Number:
  US 20140081261A1
• Time in Patent Office: 777 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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

Abstract

Systems for nerve and tissue modulation are disclosed. An example system may include an intravascular nerve modulation system including an elongated shaft having a proximal end region and a distal end region. The system may include an expandable frame having one or more electrodes positioned on or about the frame. An actuation assembly including a biasing element, a central shaft, and a piston may be configured to provide for controlled expansion of the expandable frame. The system may further include a control element for controlling the actuation assembly.

Claims

1. A system for nerve modulation, comprising:

an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween;

an expandable frame positioned adjacent the distal end of the elongate shaft, the expandable frame configured to shift between an expanded configuration and a collapsed configuration, the expandable frame comprising;

a proximal end and a distal end and a plurality of ribbons extending therebetween, at least one of the ribbons having an electrode positioned at a location radially inwards relative to the greatest radial extent of the expandable frame; and

an expansion mechanism comprising;

a biasing element positioned adjacent to the proximal end of the expandable frame;

a piston movably disposed within the lumen of the elongate shaft, the piston positioned proximal to the distal end of the elongate shaft;

a central shaft having a distal end attached to the distal end of the expandable frame and a proximal end attached to the piston; and

a control element extending proximally from a proximal end of the piston;

wherein the biasing element is disposed between the distal end of the elongate shaft and the piston.

2. The system for nerve modulation of claim 1, wherein a central region of each ribbon is stiffer than a proximal end region and a distal end region of each ribbon.

3. The system for nerve modulation of claim 1, wherein the biasing element is configured to move between a first compressed state and a second elongated state.

4. The system for nerve modulation of claim 3, wherein movement of the biasing element between the first compressed state and the second elongated state shifts the expandable frame between the collapsed configuration and the expanded configuration.

5. The system for nerve modulation of claim 1, wherein the biasing element is a spring.

6. The system for nerve modulation of claim 1, wherein the control element includes a hypotube.

7. The system for nerve modulation of claim 1, wherein the control element includes a pull wire.

8. The system for nerve modulation of claim 1, wherein the biasing element includes a shape memory material.

9. The system for nerve modulation of claim 1, wherein the control element is an electrical conductor.

10. A medical device assembly for nerve modulation, the assembly comprising:

an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween;

an expandable frame configured to shift between an expanded configuration and a collapsed configuration, the expandable frame having a proximal end and a distal end and one or more ribbons attached therebetween;

a biasing element disposed adjacent to the proximal end of the expandable frame;

a piston movably disposed within the lumen of the elongate shaft and positioned adjacent to a proximal end of the biasing element; and

a control element extending proximally from a proximal end of the piston;

wherein the biasing element is disposed between the distal end of the elongate shaft and the piston.

11. The medical device assembly of claim 10, wherein at least one of the one or more ribbons includes an electrode.

12. The medical device assembly of claim 10, wherein the biasing element is configured to move the expandable frame between the collapsed and the expanded configuration.

13. The medical device assembly of claim 10, wherein the control element is configured to exert a force on the piston that urges the piston distally.

14. The medical device assembly of claim 13, wherein when the force on the piston is released, the biasing element urges the piston proximally.

15. The medical device assembly of claim 10, wherein the biasing element includes a spring.

16. The medical device assembly of claim 10, wherein the control element includes a hypotube.

17. The medical device assembly of claim 10, wherein the control element includes a pull wire.

18. A method for modulating renal nerves, the method comprising:

advancing a system for nerve modulation within a renal blood vessel, the system for nerve modulation comprising;

an elongate shaft having a proximal end, a distal end, and a lumen disposed therebetween;

an expandable frame configured to shift between an expanded configuration and a collapsed configuration, the expandable frame having a proximal end and a distal end and a plurality of ribbons extending therebetween, at least one of the ribbons having an electrode positioned at a location radially inwards relative to the greatest radial extent of the expandable frame; and

an expansion mechanism comprising;

a biasing element positioned proximal to the proximal end of the expandable frame;

a piston movably disposed adjacent to a proximal end of the biasing element, wherein movement of the piston controls a length of the biasing element;

a central shaft having a distal end attached to the distal end of the expandable frame and a proximal end attached to the piston; and

a control element extending proximally from a proximal end of the piston;

wherein the expansion mechanism shifts the expandable frame between the expanded and the collapsed configuration; and

wherein the biasing element is disposed between the distal end of the elongate shaft and the piston;

maneuvering the elongate shaft to a desired location within the renal blood vessel;

expanding the expandable frame; and

ablating renal nerves perivascularly.