Multi-electrode catheter assemblies for renal neuromodulation and associated systems and methods

• US 9,138,292 B2
• Filed: 10/09/2014
• Issued: 09/22/2015
• Est. Priority Date: 05/11/2012
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Chang, William W., Goshgarian, Justin, Mauch, Kevin Michael, Rivera, Leonila, Shin, Sukyoung, Tran, Don H.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/511,078
• Publication Number:
  US 20150025527A1
• Time in Patent Office: 348 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/00059 Material properties
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• 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 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves

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 spiral/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., spiral/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.

Claims

1. A renal neuromodulation system for treatment of a human patient, the system comprising:

an energy source including a radio-frequency identification (RFID) evaluation module;

a catheter, including—

a handle assembly configured to operably couple to the energy source;

a radio-frequency identification (RFID) tag configured to communicate with the RFID evaluation module;

an elongate tubular shaft having a proximal portion coupled to the handle assembly and a distal portion;

a therapeutic assembly disposed at the distal portion of the elongated shaft and adapted to be located at a target location within a renal artery of a human patient, the therapeutic assembly including a support structure comprising—

a control member comprising a pre-formed helical shape; and

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

wherein the elongated tubular shaft and the therapeutic assembly together define therethrough a guide wire lumen configured to slidably receive a medical guide wire, and

wherein axial movement of the guide wire relative to the therapeutic assembly transforms the support structure between (a) a low-profile delivery configuration and (b) a deployed configuration tending to assume the pre-formed helical shape of the control member; and

a cable configured to operably couple the energy source and the catheter, wherein the RFID tag is positioned along the cable.

2. The system of claim 1 wherein the RFID tag is configured to store data related to catheter identification information and/or catheter usage information.

3. The system of claim 2 wherein the catheter identification information includes at least one of a unique identifier, a lot number, a customer number, and a model number.

4. The system of claim 2 wherein the catheter usage information includes at least one of whether the catheter has been previously electrically coupled to an energy source, and the number of times the catheter has been previously electrically coupled to an energy source.

5. The system of claim 2 wherein the evaluation module is configured to use stored data from the RFID tag to limit use of the catheter to a specific number of times.

6. The system of claim 1 wherein the RFID tag is configured to store data related to catheter identification information, and wherein the RFID evaluation module includes processing circuitry and a memory storing instructions that, when executed by the processing circuitry, cause the evaluation module to—

communicate with the RFID tag;

process the identification information; and

based on the identification information, validate the catheter.

7. The system of claim 1 wherein the RFID tag is configured to store data related to catheter identification information, and wherein the RFID evaluation module includes processing circuitry and a memory storing instructions that, when executed by the processing circuitry, cause the evaluation module to—

communicate with the RFID tag;

process the identification information; and

based on the identification information, adjust an operating parameter of the energy source.

8. The system of claim 1 wherein the RFID tag is configured to store data related to catheter usage information, and wherein the RFID evaluation module includes processing circuitry and a memory storing instructions that, when executed by the processing circuitry, cause the evaluation module to—

communicate with the RFID tag;

process the usage information; and

based on the usage information, enable energy delivery to the catheter from the energy source.

9. The system of claim 1 wherein the RFID evaluation module is configured to detect a counterfeit catheter apparatus and, when a counterfeit is detected, disable energy delivery from the energy source to the counterfeit catheter apparatus.

10. The system of claim 1 wherein the RFID evaluation module is configured to wirelessly communicate with the RFID tag.