Precision electrode movement control for renal nerve ablation

• US 9,358,365 B2
• Filed: 07/30/2011
• Issued: 06/07/2016
• Est. Priority Date: 07/30/2010
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Smith, Scott, Richardson, Leonard B., Jenson, Mark L.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Kim, Eunhwa
• Application Number:
  US13/194,920
• Publication Number:
  US 20120029513A1
• Time in Patent Office: 1,774 Days
• Field of Search: 606/41
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter is configured to access a renal artery. A lumen of the catheter'"'"'s shaft is dimensioned to receive a flexible actuation member which extends between the shaft'"'"'s proximal and distal ends. The actuation member is moveable within the lumen and subject to elastic deformation, friction, and/or whip along its length. A flexible support member is coupled to a distal end of the actuation member and extendible beyond a distal tip of the shaft. An RF ablation electrode at a distal end of the support member is configured to ablated perivascular renal nerve tissue. A position converter at the distal end of the shaft is configured to convert movement of the actuation member into one or both of controlled rotational and axial movement of the support member and electrode to one of a multiplicity of stable circumferential positions substantially free of elastic deformation, friction, and/or whip impacting actuation member movement.

Claims

1. An apparatus, comprising:

a catheter comprising a flexible shaft having a proximal end, a distal end, a length, and a lumen extending between the proximal and distal ends, the length of the flexible shaft sufficient to access a patient'"'"'s renal artery relative to a percutaneous access location;

a flexible actuation member provided within the lumen and extending between the proximal and distal ends of the shaft, the flexible actuation member moveable within the lumen of the flexible shaft and subject to one or more of elastic deformation, friction, and whip along its length during movement within the flexible shaft'"'"'s lumen;

a flexible support member coupled to a distal end of the flexible actuation member and extendible beyond a distal tip of the flexible shaft and into a lumen of the renal artery;

an electrode provided at a distal end of the flexible support member and configured to contact an inner wall of the renal artery and deliver high frequency AC energy sufficient to ablate perivascular renal nerve tissue proximate the electrode, the flexible support member configured to urge the electrode into contact with the inner wall of the renal artery; and

a position converter provided at the distal end of the flexible shaft and coupled to the distal end of the flexible actuation member and a proximal end of the flexible support member, the position converter configured to convert movement of the flexible actuation member into at least controlled rotational movement of the flexible support member and the electrode to one of a plurality of stable circumferential positions substantially free of the one or more of elastic deformation, friction, and whip impacting the flexible actuation member movement;

wherein the position converter is configured to convert movement of the actuation member into controller axial movement of the flexible support member and the electrode to one of a plurality of stable axial positions.

2. The apparatus of claim 1, wherein:

the position converter is disposed within the lumen of the flexible shaft;

the flexible actuation member and the flexible support member define a continuous member; and

the continuous member is movable within the position converter.

3. The apparatus of claim 1, wherein:

the position converter is disposed within the lumen of the flexible shaft; and

the flexible actuation member and the flexible support member define separate members each having a proximal end and a distal end.

4. The apparatus of claim 1, wherein the position converter comprises a ratcheting arrangement configured to convert axial movement of the flexible actuation member into controlled rotational movement of the flexible support member and the electrode to one of the plurality of stable circumferential positions.

5. The apparatus of claim 1, wherein the position converter comprises a ratcheting arrangement configured to convert axial movement of the flexible actuation member into controlled axial and rotational movement of the flexible support member and the electrode to one of a plurality of stable circumferential and axial positions.

6. The apparatus of claim 4, wherein the ratcheting arrangement comprises a spring-loaded rotating ratcheting element having a proximal end coupled to the distal end of the flexible actuation member and a distal end coupled to the proximal end of the flexible support member, the spring-loaded rotating ratcheting element configured to rotate the flexible support member and the electrode to one of a plurality of stable circumferential positions in response to an actuation force applied to the proximal end of the flexible actuation member.

7. The apparatus of claim 4, wherein the ratcheting arrangement comprises:

a control member having a proximal end, a distal end, and a length extending along the length of the flexible shaft;

a spring-loaded rotating ratcheting element having a proximal end coupled to the distal end of the control member and a distal end coupled to the proximal end of the flexible support member;

a plurality of circumferentially spaced keyways having opposing end locations each of which defines a predetermined stable axial and circumferential position; and

a key component provided at a distal end of the flexible support member and having a shape configured to be received by each of the plurality of circumferentially spaced keyways;

wherein the rotating ratcheting element rotatably aligns the key component of the flexible support member with one of the plurality of circumferentially spaced keyways and the aligned flexible support member is axially displaced along said one of the plurality of circumferentially spaced keyways to one of the stable axial and circumferential position in response to each application of an actuation force to the proximal end of the control member.

8. The apparatus of claim 1, wherein the position converter comprises a magnetic indexing arrangement configured to magnetically urge the flexible support member and the electrode to one of the plurality of stable circumferential positions.

9. The apparatus of claim 1, wherein the position converter comprises a magnetic indexing arrangement configured to magnetically urge the flexible support member and the electrode to one of the plurality of stable circumferential positions and one of a plurality of stable axial positions.

10. The apparatus of claim 8, wherein the magnetic indexing arrangement comprises:

a magnet arrangement provided at the distal end of the flexible shaft; and

a magnet arrangement provided on the flexible actuation member, the magnet arrangements of the flexible shaft and the flexible actuation member magnetically interacting to urge the flexible support member and the electrode to rotate to one of the plurality of stable circumferential positions in response to an actuation force applied to the proximal end of the flexible actuation member.

11. The apparatus of claim 8, wherein the magnetic indexing arrangement comprises:

a plurality of magnets provided at discrete circumferential and axial locations at the distal end of the shaft; and

a plurality of magnets provided on the flexible actuation member at discrete axial locations of the flexible actuation member, the magnets of the flexible shaft and the flexible actuation member magnetically interacting to urge the flexible support member and the electrode to rotate to one of the plurality of stable circumferential positions in response to an actuation force applied to the proximal end of the flexible actuation member.

12. The apparatus of claim 8, wherein the distal end of the flexible shaft comprises a pre-formed spiral shape, and the magnetic indexing arrangement comprises:

a plurality of magnets provided at discrete circumferential and axial locations along the spiral shaped distal end of the flexible shaft; and

a plurality of magnets provided on the flexible actuation member at discrete axial locations of the flexible actuation member, the magnets of the flexible shaft and the flexible actuation member magnetically interacting to urge the flexible support member and the electrode to rotate to one of the plurality of stable circumferential positions along the spiral shaped distal end of the flexible shaft in response to an actuation force applied to the proximal end of the flexible actuation member.

13. The apparatus of claim 1, wherein the position converter comprises a geometric keyed orientation mechanism configured to guide a key component of the flexible actuation member into and along a keyway arrangement that limits the movement of the flexible support member and the electrode to one of the plurality of stable circumferential positions.

14. The apparatus of claim 1, wherein the position converter comprises a geometric keyed orientation mechanism configured to guide a key component of the flexible actuation member into and along a keyway arrangement that limits the rotational movement of the flexible support member and the electrode to one of the plurality of stable circumferential positions and limits the axial movement of the flexible support member and the electrode to one of a plurality of stable axial positions.

15. The apparatus of claim 13, wherein the keyway arrangement comprises a plurality of spaced-apart keyways each comprising a tapered entrance configured to guide the key component into alignment with each of the plurality of spaced-apart keyways.

16. The apparatus of claim 13, wherein the keyway arrangement comprises a plurality of circumferentially spaced-apart keyways, with alternate keyways of the keyway arrangement having differing lengths.

17. The apparatus of claim 13, wherein the keyway arrangement comprises a plurality of circumferentially and axially spaced-apart keyways.

18. The apparatus of claim 13, wherein the keyway arrangement comprises a plurality of spaced-apart keyways, the plurality of spaced-apart keyways having one of an elliptical, square, rectangular, and triangular cross-section.