Methods and apparatus for multi-vessel renal neuromodulation

• US 9,950,161 B2
• Filed: 06/22/2016
• Issued: 04/24/2018
• Est. Priority Date: 10/05/2004
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/189,940
• Publication Number:
  US 20170021170A1
• Time in Patent Office: 671 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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 2018/00613 Irreversible electroporation
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0507 Electrodes for the digestive system
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/323 Interference currents, i.e. treatment by several currents summed in the body
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3605 : Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 : for treating hypertension

Abstract

Methods and apparatus are provided for multi-vessel neuromodulation, e.g., via a pulsed electric field. Such multi-vessel neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, the multi-vessel neuromodulation is applied to neural fibers that contribute to renal function. Such multi-vessel neuromodulation optionally may be performed bilaterally.

Claims

1. A renal neuromodulation apparatus for treating a human patient, the apparatus comprising:

an electric field generator external to the patient;

a catheter including a first electrode sized and shaped for intravascular placement within a first renal blood vessel of the patient, wherein the first electrode is electrically coupleable to the electric field generator; and

a second electrode carried by the catheter, wherein the second electrode is sized and shaped for intravascular placement within a second renal blood vessel of the patient different than the first renal blood vessel, and wherein the second electrode is electrically coupleable to the electric field generator,

wherein the electric field generator causes delivery of a non-pulsed thermal radiofrequency (RF) electric field between the first electrode and the second electrode to at least partially denervate a single kidney while the first electrode is located within the first renal blood vessel and the second electrode is located within the second renal blood vessel.

2. The renal neuromodulation apparatus of claim 1 wherein the catheter further comprises a positioning element adjacent the first electrode.

3. The renal neuromodulation apparatus of claim 2 wherein the positioning element is configured to alter impedance within the first renal blood vessel of the patient.

4. The renal neuromodulation apparatus of claim 2 wherein the positioning element is configured to occlude blood flow within the first renal blood vessel.

5. The renal neuromodulation apparatus of claim 2 wherein the positioning element is configured to temporarily alter blood flow within the first renal blood vessel without full occlusion.

6. The renal neuromodulation apparatus of claim 2 wherein the positioning element comprises an inflatable balloon.

7. The renal neuromodulation apparatus of claim 2 wherein the positioning element is an inflatable balloon having one or more third electrodes.

8. The renal neuromodulation apparatus of claim 2 wherein the positioning element comprises an expandable wire basket or cage.

9. The renal neuromodulation apparatus of claim 1, further comprising a guide catheter configured for intravascular placement in the renal blood vessel of the patient and for delivering the first and second electrodes therethrough.

10. The renal neuromodulation apparatus of claim 1 wherein the catheter further comprises a lumen with a side port such that the second electrode may be passed through the lumen and out of the side port for placement in the second renal blood vessel of the patient.

11. The renal neuromodulation apparatus of claim 1, further comprising a third electrode carried by the catheter and configured for intravascular placement within a third renal blood vessel of the patient different than the first and second renal blood vessels,

wherein the third electrode is electrically coupleable to the electric field generator external to the patient,

wherein the electric field generator causes delivery of an electric field between a desired pair of electrodes selected from among the first, second and third electrodes.

12. The renal neuromodulation apparatus of claim 1, further comprising an element for monitoring at least one physiological parameter.

13. The renal neuromodulation apparatus of claim 12 wherein the monitored physiological parameter comprises plasma renin levels, renal catecholamine spillover, urine catecholamines, and/or other neurohormones that are indicative of increased sympathetic nervous activity.

14. The renal neuromodulation apparatus of claim 1 wherein the energy from the electric field is sufficient to ablate a renal nerve innervating the single kidney.

15. The renal neuromodulation apparatus of claim 1 wherein the energy from the electric field is sufficient to partially ablate a renal nerve innervating the kidney.