Catheter apparatuses having multi-electrode arrays for renal neuromodulation and associated systems and methods

• US 8,998,894 B2
• Filed: 10/25/2011
• Issued: 04/07/2015
• Est. Priority Date: 10/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Mauch, Kevin, Chang, William, Goshgarian, Justin, Rivera, Leonila, Rothman, Martin
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/281,361
• Publication Number:
  US 20120116383A1
• Time in Patent Office: 1,260 Days
• Field of Search: 606/33, 606/41
• US Class Current: 606/41
• 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 2018/00023 closed, i.e. without wound contact by the fluid
• 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 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0133 Tip steering devices
• 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

Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function or of vascular structures that feed or perfuse the neural fibers.

Claims

1. A catheter apparatus, comprising:

an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured for intravascular delivery to a renal artery of a human patient;

a tubular control member slidably received within the distal portion of the shaft and extending distally therefrom along a central axis;

a treatment section affixed to and extending distally of the distal portion of the elongated shaft and spirally disposed about the control member; and

a plurality of energy delivery elements carried by the treatment section and including at least a first energy delivery element and a second energy delivery element axially and radially spaced apart from one another about the central axis,

wherein the tubular control member defines a central lumen configured to receive a guide wire, and wherein the control member further comprises an opening proximally adjacent to the treatment section and adapted for exit of the guide wire,

wherein the control member is operably couple to a distal region of the spiral treatment section, and wherein

distal movement of the control member places the spiral treatment section in a low-profile delivery configuration; and

proximal movement of the control member places the spiral treatment section in an expanded treatment configuration.

2. The catheter apparatus of claim 1 wherein at least one of the control member or the treatment section comprises a shape memory material.

3. The catheter apparatus of claim 1, further comprising a retractable sheath at least partially surrounding at least one of the control member or the treatment section when the treatment section is in the delivery configuration.

4. The catheter apparatus of claim 1 wherein the distal portion of the elongated shaft, the treatment section, and the energy delivery elements are sized and configured for intravascular delivery into the renal artery via a 6 French or smaller guide catheter.

8. The catheter apparatus of claim 1 wherein the control member comprises a push-pull member extending axially within the elongated shaft.

9. The catheter apparatus of claim 8 wherein the push-pull member has a tapered or angled distal end.

10. The catheter apparatus of claim 9 wherein the control member opening is an oblique opening adjacent the push-pull member distal end.

11. The catheter apparatus of claim 1 wherein the elongate shaft further comprises an opening alignable with the control member opening to provide for exit of the guidewire through both the control member opening and the shaft opening.

5. A catheter apparatus for treatment of a human patient via renal denervation, the catheter apparatus comprising:

an elongated shaft having a proximal portion and a distal portion; and

a control member protruding from the distal portion of the elongated shaft and extending proximally into the shaft, wherein the support structure defines a guide wire lumen configured to receive a guide wire; and

a treatment assembly including

a support structure wrapped about a distal region of the control member; and

a plurality of energy delivery elements carried by the support structure,

wherein a distal end of the support structure terminates along an outer surface of a distal end portion of the control member and is affixed thereto;

wherein

the control member further comprises a rapid exchange port proximally adjacent to the treatment assembly and adapted for exit of the guide wire;

distal movement of the control member relative to the elongated shaft places the treatment assembly in a delivery configuration; and

proximal movement of the control member relative to the elongated shaft places the treatment assembly in a deployed helical configuration.

6. The catheter apparatus of claim 5 wherein the distal portion of the elongated shaft, the treatment assembly, and the energy delivery elements are sized and configured for intravascular delivery into a renal artery of the patient via a 6 French or smaller guide catheter.

7. The catheter apparatus of claim 5, further comprising a retractable sheath at least partially surrounding at least one of the treatment assembly or the control member when the treatment assembly is in the delivery configuration.