Nerve ablation devices and related methods of use

• US 10,265,122 B2
• Filed: 02/13/2014
• Issued: 04/23/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Wang, Huisun, Cao, Hong
• Primary Examiner(s): Kim, Eun Hwa
• Application Number:
  US14/180,257
• Publication Number:
  US 20140276752A1
• Time in Patent Office: 1,895 Days
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00279 deployable
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

An ablation device is provided for forming one or more lesions on a wall of an artery, such as a renal artery. The device can include an elongate shaft having a proximal end and a distal end. The device may also include a handle disposed at the proximal end, a distal tip including an electrode disposed at the distal end, and one or a plurality of independently expandable splines proximate the distal end.

Claims

1. An ablation device for performing nerve ablation in a vessel wall, comprising:

an elongate shaft having a proximal end region and a distal end region;

a handle disposed adjacent to the proximal end region;

a distal tip including a single electrode, which is the only electrode in the ablation device, disposed at a distal end of the elongate shaft; and

a plurality of expandable splines adjacent to the distal end region and positioned proximal to the single electrode;

wherein each of the plurality of expandable splines is independently actuatable between a first contracted position and a second expanded position that extends radially outward to a variable distance from the outer surface of the elongate shaft; and

wherein the ablation device is configured such that independent actuation of each of the plurality of expandable splines to the second expanded position against a wall of a vessel biases the single electrode in a direction that is generally radially opposite to the actuated spline.

2. The ablation device of claim 1, wherein in the first contracted position, each of the plurality of expandable splines is flush with or contained within an outer surface of the elongate shaft.

3. The ablation device of claim 1, wherein in the second expanded position, the plurality of expandable splines form an arcuate shape.

4. The ablation device of claim 1, wherein the plurality of expandable splines includes at least four expandable splines.

5. The ablation device of claim 1, wherein each of the plurality of expandable splines is oriented generally equidistant about a central longitudinal axis of the elongate shaft.

6. The ablation device of claim 1, wherein each of the plurality of expandable splines includes an insulative covering.

7. The ablation device of claim 1, wherein the handle includes a plurality of control elements configured to actuate the plurality of expandable splines.

8. The ablation device of claim 1, wherein a distal end of each of the plurality of expandable splines is attached to the distal end of the elongate shaft and a proximal end of each of the plurality of expandable splines is attached to a control element.

9. The ablation device of claim 1, further including a temperature sensor disposed within the distal tip.

12. A method of performing nerve ablation, comprising:

inserting the ablation device of claim 1 into a vessel;

deploying one or more of the plurality of splines to the second expanded position such that the single electrode is brought into contact with a wall of the vessel at a first location;

applying RF energy at the first location through the single electrode;

retracting the one or more deployed splines to the first contracted position;

moving the elongate shaft to a second location;

deploying one or more of the plurality of splines to the second expanded position such that the single electrode is brought into contact with a wall of the vessel at the second location;

applying RF energy at the second location through the single electrode;

retracting the one or more deployed splines to the first contracted position; and

withdrawing the ablation device from the vessel.

13. The method of claim 12, wherein the plurality of splines includes at least four splines.

14. The method of claim 12, wherein before withdrawing the ablation device, the method further includes:

moving the elongate shaft to a third location;

deploying one or more of the plurality of splines to the second expanded position such that the single electrode is brought into contact with a wall of the vessel at the third location;

applying RF energy at the third location through the single electrode;

retracting the one or more deployed splines to the first contracted position;

moving the elongate shaft to a forth location;

deploying one or more of the plurality of splines to the second expanded position such that the single electrode is brought into contact with a wall of the vessel at the fourth location;

applying RF energy at the forth location through the single electrode; and

retracting the one or more deployed splines to the first contracted position.

15. The method of claim 12, wherein deploying one or more of the plurality of splines to the second expanded position biases the single electrode toward the wall of the vessel in a direction generally opposite the direction that the one or more splines are deployed.

10. An ablation device for performing nerve ablation in a vessel wall comprising:

an elongate shaft having a proximal end region and a distal end region;

a handle disposed adjacent to the proximal end region;

a distal tip including a single electrode, which is the only electrode in the ablation device, disposed at a distal end of the elongate shaft; and

a plurality of splines adjacent to the distal end region and positioned proximal to the single electrode, wherein each one of the plurality of splines is independently actuatable between a first contracted position, and a second expanded position that extends radially outward to a variable distance from the outer surface of the elongate shaft;

wherein the plurality of splines includes at least three independently actuatable splines; and

wherein the ablation device is configured such that independent actuation of each of the plurality of splines to the second radially expanded position against a wall of a vessel biases the single electrode in a direction that is generally radially opposite to the actuated spline.

11. The ablation device of claim 10, wherein the handle includes a plurality of control elements each configured to independently actuate one of the plurality of splines.

16. An ablation device for performing nerve ablation in a vessel wall, comprising:

an elongate shaft having a proximal end region and a distal end region;

a handle disposed adjacent to the proximal end region;

a distal tip including a single electrode, which is the only electrode in the ablation device, disposed at a distal end of the elongate shaft, the single electrode extending circumferentially around the distal end of the elongate shaft; and

a plurality of expandable splines adjacent to the distal end region and positioned proximal to the single electrode;

wherein each of the plurality of expandable splines is independently actuatable between a first contracted position, and a second expanded position that extends radially outward to a variable distance from the outer surface of the elongate shaft;

wherein the ablation device is configured such that independent actuation of each of the plurality of expandable splines to the second radially expanded position against a wall of a vessel biases the single electrode in a direction that is generally radially opposite to the actuated spline;

wherein in the first delivery position, each of the plurality of expandable splines is contained within a slot in an outer surface of the elongate shaft;

wherein in the second expanded position, the plurality of expandable splines form an arcuate shape; and

wherein the plurality of expandable splines includes at least three expandable splines.

17. The ablation device of claim 16, wherein each of the plurality of expandable splines comprises an insulative covering.

18. The ablation device of claim 16, wherein each of the plurality of expandable splines is formed from a polymer.

19. The ablation device of claim 16, wherein an axial cross-section of each of the plurality of expandable splines is rectangular, circular or ovoid.

20. The ablation device of claim 16, wherein the handle includes a plurality of control elements configured to actuate the plurality of expandable splines.