METHODS AND APPARATUS FOR MULTI-VESSEL RENAL NEUROMODULATION

• US 20110178570A1
• Filed: 12/13/2010
• Published: 07/21/2011
• Est. Priority Date: 10/05/2004
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Demarais, Denise
• Granted Patent: US 8,433,423 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• 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 method for multi-vessel renal neuromodulation of a patient, the method comprising:

placing a first electrode in a first vessel of a patient in proximity to a neural fiber that contributes to a function of a kidney of the patient;

placing a second electrode in a second vessel of the patient, wherein the second vessel is a different vessel than the first vessel; and

passing electrical current through the first electrode and the second electrode to modulate the function of the neural fiber.

2. The method of claim 1 wherein passing electrical current through the first and second electrodes comprises creating an electric field between the first and second electrodes.

3. The method of claim 1 wherein passing electrical current through the first and second electrodes comprises creating a first electric field between the first electrode and a remote electrode and a second electric field between the second electrode and the remote electrode.

4. The method of claim 3 wherein the first and second electric fields are created simultaneously.

5. The method of claim 3 wherein the first and second electric field are created sequentially.

6. The method of claim 1 wherein passing electrical current through the first and second electrodes comprises creating a first electric field between the first electrode and a first remote electrode in the first vessel and a second electric field between the second electrode and a second remote electrode in the second vessel.

7. The method of claim 6 wherein the first and second electric fields are created simultaneously.

8. The method of claim 6 wherein the first and second electric fields are created sequentially.

9. The method of claim 1, wherein passing electrical current further comprises passing pulsed electrical current.

10. The method of claim 1, wherein modulating the function of the neural fiber further comprises at least partially denervating the kidney.

11. The method of claim 1, wherein modulating the function of the neural fiber further comprises inducing an effect in the neural fiber chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

12. The method of claim 1, wherein modulating the function of the neural fiber further comprises thermally modulating the function of the neural fiber.

13. The method of claim 1, wherein modulating the function of the neural fiber further comprises, on average during passage of the electrical current, modulating the function of the neural fiber substantially athermally.

14. The method of claim 1, wherein modulating the function of the neural fiber further comprises treating a medical condition afflicting the patient.

15. The method of claim 14, wherein treating the medical condition afflicting the patient further comprises treating a medical condition chosen from the group consisting of heart failure, hypertension, myocardial infarction, renal disease, contrast nephropathy and combinations thereof.

16. The method of claim 1, wherein placing the first electrode in the first vessel further comprises placing the first electrode in a first vessel of a renal vasculature of the patient.

17. The method of claim 16, wherein placing the second electrode in the second vessel further comprises placing the second electrode in a second vessel of the renal vasculature of the patient, the second vessel being a different vessel of the renal vasculature than the first vessel.

18. The method of claim 17, wherein placing the second electrode in the second vessel of the renal vasculature of the patient further comprises placing the second electrode in a second vessel branching of the renal vasculature.

19. The method of claim 1, wherein placing the first electrode in the first vessel and the second electrode in the second vessel further comprises placing the first electrode and the second electrode in different vessels of the patient chosen from the group consisting of a renal artery, renal artery branchings, a renal vein, renal vein branchings, an inferior vena cava, an abdominal aorta, renal vasculature, venous vasculature, arterial vasculature, and combinations thereof.

20. The method of claim 1 further comprising altering impedance in the first vessel or the second vessel before passage of the electrical current.

21. The method of claim 20, wherein altering impedance further comprises temporarily altering blood flow within the first vessel or the second vessel.

22. The method of claim 1, wherein passing the electrical current further comprises preferentially aligning the electrical current with a longitudinal dimension of the neural fiber.

23. The method of claim 22, wherein aligning the electrical current further comprises placing the first electrode and placing the second electrode such that the first electrode and the second electrode are spaced apart from one another about a lengthwise dimension of the neural fiber.

24. The method of claim 1 further comprising monitoring a change in a renal catecholamine spillover in response to the passage of the electrical current.

25. A method for a renal neuromodulation of a patient, the method comprising:

placing a first electrode within a first vessel of a patient at least substantially proximate to a neural fiber that contributes to a function of a kidney of the patient;

placing a second electrode within a second vessel of the patient, wherein the second vessel is a different vessel than the first vessel; and

delivering an electric field between the first electrode and the second electrode such that the resulting electric field is generally aligned with a longitudinal axis of a renal artery associated with the kidney, thereby modulating the function of the neural fiber.

26. The method of claim 25, wherein placing the first electrode within the first vessel and the second electrode within the second vessel further comprises placing the first electrode and the second electrode in different vessels of the patient chosen from the group consisting of the renal artery, renal artery branchings, a renal vein, renal vein branchings, an inferior vena cava, an abdominal aorta, renal vasculature, venous vasculature, arterial vasculature, and combinations thereof.

27. The method of claim 25 further comprising monitoring a change in a renal catecholamine spillover in response to the delivery of the electric field.

28. Apparatus for performing renal neuromodulation of a patient, the apparatus comprising:

a pulsed electric field generator;

a first element configured for placement within a first vessel of the patient, the first element comprising a first electrode electrically coupled to the pulsed electric field generator; and

a second element configured for placement within a second vessel of the patient that is different than the first vessel, the second element comprising a second electrode electrically coupled to the pulsed electric field generator,

wherein the apparatus is configured for delivery of a pulsed electric field between the first electrode and the second electrode to modulate a neural fiber that contributes to renal function while the first device is located within the first vessel and the second device is located within the second vessel.

29. The apparatus of claim 28, wherein the first element or the second element comprises a positioning element.

30. The apparatus of claim 29, wherein the positioning element is configured to alter impedance within a vessel of the patient.

31. The apparatus of claim 28, wherein the apparatus is configured for monopolar delivery of the pulsed electric field between the first electrode or the second electrode and a ground pad positioned external to the patient.

32. The method of claim 28, wherein the apparatus comprises an element for monitoring alteration of a renal catecholamine spillover in response to delivery of the pulsed electric field.