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

• US 10,512,504 B2
• Filed: 11/29/2017
• Issued: 12/24/2019
• 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): Manuel, George
• Application Number:
  US15/825,436
• Publication Number:
  US 20180085162A1
• Time in Patent Office: 755 Days
• 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 method, comprising:

intravascularly delivering a catheter over a guide wire to a treatment site within a renal artery of a human patient, wherein the catheter comprises—

an elongated shaft; and

a treatment assembly at a distal region of the shaft, the treatment assembly comprising a support structure composed, at least in part, of multifilar stranded nitinol wire;

transforming the treatment assembly from a delivery state to an expanded state by proximally withdrawing the guide wire, wherein, in the expanded state, the support structure has a radially expanded, generally helical configuration shaped and sized to contact the wall of the renal artery and to allow blood to flow through the vessel; and

delivering electrical energy from one or more electrodes of the treatment assembly to renal nerves along the renal artery of the patient, thereby at least partially attenuating neural traffic to and/or from a kidney of the patient.

2. The method of claim 1 wherein delivering electrical energy from one or more electrodes of the treatment assembly comprises selectively delivering radio frequency (RF) energy in a bipolar fashion between the electrodes of the multi-electrode array.

3. The method of claim 1 wherein delivering electrical energy from one or more electrodes of the treatment assembly comprises delivering radio frequency (RF) energy in a monopolar fashion between a selected electrode and an external ground pad attached to skin of the patient.

4. The method of claim 1, further comprising monitoring a parameter of the one or more electrodes and/or tissue proximate to the renal nerves within the patient during therapy.

5. The method of claim 4 wherein monitoring a parameter comprises monitoring temperature and/or impedance.

6. The method of claim 4, further comprising controlling the delivery of electrical energy from one or more electrodes to the renal nerves in response to the monitored parameter.

7. The method of claim 1 wherein delivering electrical energy from one or more electrodes of the treatment assembly to renal nerves of the patient comprises thermally altering one or more renal nerves of the patient.

8. The method of claim 1 wherein delivering electrical energy from one or more electrodes of the treatment assembly to renal nerves of the patient comprises ablating one or more renal nerves of the patient.

9. The method of claim 1 wherein at least partially attenuating neural traffic to and/or from a kidney of the patient results in a therapeutically beneficial reduction in blood pressure of the patient.

10. The method of claim 1 wherein transforming the treatment assembly from a delivery state to an expanded state by proximally withdrawing the guide wire comprises partially withdrawing the guide wire from the treatment assembly such that at least a portion of the guide wire remains in the treatment assembly after the treatment assembly transforms to the expanded state.

11. The method of claim 1 wherein transforming the treatment assembly from a delivery state to an expanded state by proximally withdrawing the guide wire comprises completely withdrawing the guide wire from the treatment assembly such that a distalmost end of the guide wire is withdrawn to a point proximal of the treatment assembly.

12. A catheter, comprising:

an elongated shaft;

a treatment assembly at a distal portion of the elongated shaft and sized and shaped to be located at a target treatment site within a renal artery of a human patient, the therapeutic assembly having a support structure including (a) a control member comprising a pre-formed helical shape, and (b) a plurality of electrodes carried by the support structure, wherein the support structure is composed, at least in part, of multifilar stranded nitinol wire; and

a radio-frequency identification (RFID) tag configured to store data related to catheter identification information and/or catheter usage information,

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

wherein axial movement of the guide wire relative to the treatment assembly transforms the support structure between (a) a low-profile delivery state and (b) an expanded state tending to assume the pre-formed helical shape of the control member.

13. The catheter of claim 12 wherein the plurality of electrodes comprises a series of band electrodes.

14. The catheter of claim 13 wherein at least one of the band electrodes comprises tapered end portions, and wherein the tapered end portions are configured to provide an obtuse angle between an outer surface of the support structure and an outer surface of the at least one band electrode.

15. The catheter of claim 12 wherein the plurality of electrodes comprises four electrodes carried by the helical structure.

16. The catheter of claim 12 wherein the catheter identification information includes at least one of a unique identifier, a lot number, a customer number, and a model number.

17. The catheter of claim 12 wherein the catheter usage information comrpises whether the catheter has been previously electrically coupled to an energy source and/or the number of times the catheter has been previously electrically coupled to an energy source.

18. The catheter of claim 12 wherein the RFID tag is configured to limit use of the catheter to a specific number of times.

19. The catheter of claim 12 wherein the RFID tag is housed within or otherwise attached to a connector portion of a cable extending from a proximal portion of the catheter.

20. The catheter of claim 12 wherein the RFID tag is positioned along a cable extending from a proximal portion of the catheter.