Methods and apparatus for multi-vessel renal neuromodulation

• US 9,108,040 B2
• Filed: 06/26/2014
• Issued: 08/18/2015
• 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:
  US14/316,052
• Publication Number:
  US 20150025603A1
• Time in Patent Office: 418 Days
• Field of Search: 607 2- 3, 607/44, 607/62, 607117-118, 604/891.1
• 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 2018/0022 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 reversible electroporation A61N1/327
• 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 treatment method for selectively affecting renal nerves proximate renal vasculature of a human patient, the method comprising:

positioning a first electrode within a first part of the renal vasculature, wherein the first part of the renal vasculature is located within a renal artery or a first vessel branching from the renal artery;

positioning a second electrode within a second part of the renal vasculature, wherein the second part of the renal vasculature is located within the renal artery or the first vessel branching from the renal artery or a second, different vessel branching from the renal artery, and wherein the first and second parts of the renal vasculature are in different locations and are both connected to the same kidney of the human patient;

delivering an electric field between the first and second electrodes, wherein at least a portion of the electric field defines a treatment zone between the first and second electrodes; and

selectively modulating, via the electric field, a function of renal nerves passing through the treatment zone.

2. The method of claim 1 wherein intensity of the electric field within the treatment zone has a magnitude sufficient to thermally modulate the function of the renal nerves passing through the treatment zone, and further wherein intensity of the electric field outside the treatment zone is insufficient to damage non-target tissue.

3. The method of claim 1 wherein the electric field comprises a pulsed electric field.

4. The method of claim 1, further comprising, during the selectively modulating step, monitoring a parameter of the first electrode, the second electrode, and or tissue proximate the renal nerves passing through the treatment zone.

5. The method of claim 4, further comprising altering delivery of the electric field in response to the monitored parameter.

6. The method of claim 4, further comprising adjusting the treatment of the patient in response to the monitored parameter.

7. The method of claim 1 wherein the electric field does not substantially affect arterial smooth muscle cells within or adjacent to the treatment zone.

8. The method of claim 1 wherein the first and second parts of the renal vasculature are located within the renal artery of the patient with the first part spaced apart from the second part along a lengthwise dimension of the renal artery, and further wherein the electric field is aligned with the lengthwise dimension of the renal artery.

9. A method for performing renal neuromodulation in a human patient, the method comprising:

delivering a first bipolar electric field between a first pair electrodes positioned within a first renal blood vessel of the patient, wherein the first bipolar electric field is at least partially aligned with a lengthwise dimension of the first renal blood vessel;

delivering a second bipolar electric field between a second pair of electrodes positioned within a second renal blood vessel of the patient, wherein the second bipolar electric field at least partially overlaps the first bipolar electric field to create an overlap zone; and

selectively modulating, via the first and second bipolar fields, a function of one or more renal nerves passing through the overlap zone.

10. The method of claim 9 wherein the first renal blood vessel comprises a renal artery of the patient and the second renal blood vessel comprises a vessel branching from the renal artery.

11. The method of claim 9 wherein the first renal blood vessel comprises a first vessel branching from a renal artery of the patient and the second renal blood vessel comprises a second, different vessel branching from the renal artery.

12. The method of claim 9 wherein the first renal blood vessel comprises a renal artery of the patient and the second renal blood vessel comprises a renal vein of the patient, and wherein the overlap zone includes renal nerves extending lengthwise along the renal artery and between the renal artery and the renal vein.

13. The method of claim 12 wherein intensities of the first and second bipolar electric fields outside the overlap zone are insufficient to modulate renal nerves or damage non-target tissue.

14. The method of claim 9 wherein the second bipolar electric field is at least partially aligned with a lengthwise dimension of the second renal blood vessel.

15. The method of claim 9 wherein selectively modulating a function of one or more renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

16. The method of claim 9 wherein selectively modulating a function of one or more renal nerves at least partially denervates a kidney of the patient.