Methods for bilateral renal neuromodulation

• US 9,456,869 B2
• Filed: 03/14/2016
• Issued: 10/04/2016
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Gifford, Hanson III, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/069,796
• Publication Number:
  US 20160192984A1
• Time in Patent Office: 204 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• 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: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• 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 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such 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, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Claims

1. A method of treating a disease of a human patient diagnosed with at least one of hypertension, heart failure, chronic kidney disease, and renal failure by bilateral renal neuromodulation, the method comprising:

directing a first neuromodulatory energy to a first post-ganglionic neural fiber that innervates a first kidney of the patient via an electric field that inhibits neural activity entering and exiting the first kidney; and

directing a second neuromodulatory energy to a second post-ganglionic neural fiber that innervates a second kidney of the patient via an electric field that inhibits neural activity entering and exiting the second kidney,

wherein directing the first and second neuromodulatory energies to the first and second post-ganglionic neural fibers significantly improves a measureable physiological parameter corresponding to the disease of the patient,

wherein at least one of the first kidney and second kidney continues to secrete renin in the patient after delivering the electric field.

2. The method of claim 1 wherein:

directing the first neuromoddulatory energy to the first post-ganglionic neural fiber that innervates the first kidney of the patient comprises ablating a left post-ganglionic neural fiber that contributes to left renal function; and

directing the second neuromodulatory energy to the second post-ganglionic neural fiber that innervates the second kidney of a patient comprises ablating a right post-ganglionic neural fiber that contributes to right renal function.

3. The method of claim 1 wherein:

directing the first neuromodulatory energy to the first post-ganglionic neural fiber that innervates the first kidney of a patient comprises partially ablating a left post-ganglionic neural fiber that contributes to left renal function; and

directing the second neuromodulatory energy to the second post-ganglionic neural fiber that innervates the second kidney of a patient comprises partially ablating a right post-ganglionic neural fiber that contributes to right renal function.

4. The method of claim 1 wherein the improvement in the measureable physiological parameter corresponding to the disease of the patient comprises a reduction in clinical symptoms of hypertension in the patient.

5. The method of claim 1 wherein the improvement in the measureable physiological parameter corresponding to the disease of the patient comprises a reduction in clinical symptoms of heart failure in the patient.

6. The method of claim 1 wherein the improvement in the measureable physiological parameter corresponding to the disease of the patient comprises a reduction in clinical symptoms of renal failure in the patient.

7. The method of claim 1 wherein the first neuromodulatory energy and the second neuromodulatory energy are the same.

8. A method for bilateral renal neuromodulation of a human patient with diagnosed hypertension, diagnosed heart failure, diagnosed chronic kidney disease, or diagnosed renal failure, the method comprising:

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney of the patient by directing a first neuromodulatory energy from a first neuromodulation element to the post-ganglionic renal nerves that contrinbute to function of the right kidney of the patient; and

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left lodmey of the patient by directing a second neuromodulatory energy from a second neuromodulation element to the post-ganglionic renal nerves that contribute to function of the left kidney of the patient,

wherein inhibiting neural activity along the post-ganglionic renal nerves that contribute to function of the right and left kidneys of the patient results in a therapeutically beneficial reduction in the clinical symptoms of hypertension, heart failure, chronic kidney disease, or renal failure in the patient,

wherein at least one of the right and left kidney continues to secrete rennin in the patient after inhibiting neural activity along the post-ganglionic renal nerves that contribute to the function thereof.

9. The method of claim 8 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to renal function of the right and left kidneys comprises ablating the post-ganglionic renal nerves.

10. The method of claim 8 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to renal function of the right and left kidneys further comprises partially ablating the post-ganglionic renal nerves.

11. The method of claim 8 wherein:

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney of the patient by drecting a first nouromodulatory enemy from a first neuromodulation element to the post-ganglionic renal nerves comprises delivering electrical energy to the post-ganglionic renal nerves that contribute to function of the right kidney via a first electrode carried by a first expandable element within a right renal artery of the patient; and

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient by directing a second neuromodulatory energy from a second neuromodulation element to the post-ganglionic renal nerves comprises delivering electrical energy to the post-ganglionic renal nerves that contribute to function of the left kidney via a second electrode carried by a second expandable element within a left renal artery of the patient.

12. The method of claim 11 wherein the first expandable element is a first balloon and the second expandable element is a second balloon.

13. The method of claim 11 wherein the first expandable element is a first basket and the second expandable element is a second basket.

14. The method of claim 11 wherein delivering electrical energy via the first electrode and the second electrode comprises delivering electrical energy in a monopolar fashion.

15. The method of claim 11 wherein:

delivering electrical energy to the po renal nerves that contribute to function of the right kidney via the first electrode comprises delivering energy in a bipolar fashion via the first electrode; and

delivering electrical energy to the post-ganglionic renal nerves that contribute to function of the left kidney via the second electrode comprises delivering energy in a bipolar fashion via the second electrode.

16. The method of claim 8 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney occurs before inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient.

17. The method of claim 8 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney occurs simultaneously with inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient.

18. The method of claim 8 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney occurs simultaneously with inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient.

19. The method of claim 8 wherein the first neuromodulatory energy and the second neuromodulatory energy are the same.

20. A method for bilateral renal denervation of a human patient diagnosed with hypertension, heart failure, chronic kidney disease, or renal failure, the method comprising:

reducing neural activity along nerves that innervate a first kidney of the patient via an intravascularly delivered first renal denervation catheter; and

reducing neural activity along nerves that innervate a second kidney of the patient via an intravascularly delivered second renal denervation catheter,

wherein reducing neural activity along the nerves that innervate the first and second kidneys of the patient results in a therapeutically beneficial reduction in central sympathetic overactivity in the patient,

wherein at least one of the first kidney and second kidney continues to secrete renin in the patient after reducing neural activity along the renal nerves that innervate the first kidney and second kidneys respectively.

21. The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

22. A method for bilateral renal neuromodulation of a human patient with diagnosed hypertension, diagnosed heart failure, diagnosed chronic kidney disease, or diagnosed renal failure, the method comprising:

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney of the patient by directing one or more neuromodulatory agents or drugs from a first neuromodulation element to the post-ganglionic renal nerves; and

inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient by directing one or more neuromodulatory agents or drugs from a second neuromodulation element to the post-ganglionic renal nerves,

wherein inhibiting neural activity along the post-ganglionic renal nerves that contribute to function of the right and left kidneys of the patient results in a therapeutically beneficial reduction in the clinical symptoms of hypertension in the patient,

wherein at least one of the right and left kidney continues to secrete renin in the patient after inhibiting neural activity along the post-ganglionic renal nerves that contribute to function of the right and left kidneys respectively.

23. The method of claim 22 wherein inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the right kidney occurs before inhibiting neural activity along post-ganglionic renal nerves that contribute to function of the left kidney of the patient.