Methods for therapeutic renal neuromodulation

• US 9,308,044 B2
• Filed: 11/20/2014
• Issued: 04/12/2016
• 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:
  US14/549,229
• Publication Number:
  US 20150080873A1
• Time in Patent Office: 509 Days
• Field of Search: 607/2, 607 40- 41, 607/44, 607/96, 607/98, 607/133
• US Class Current: 1/1
• 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

Abstract

Methods and apparatus are provided for treating hypertension, 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 for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

positioning an energy element within a renal artery of the patient and proximate post-ganglionic neural fibers innervating a kidney of the patient; and

at least partially ablating the neural fibers of the patient via the energy element,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

2. A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:

positioning a thermal element within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

at least partially ablating the neural fibers of the patient via the thermal element,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

3. The method of claim 2 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

4. A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:

intravascularly positioning a nerve modulation device within a renal artery of the patient and in vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

reducing neural communication to and from the kidney by at least partially ablating the neural fibers of the patient via energy from the nerve modulation device,

wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient.

5. The method of claim 4 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises heating afferent and efferent renal nerves of the patient with radiofrequency (RF) energy delivered via the nerve modulation device.

6. The method of claim 5 wherein heating afferent and efferent renal nerves of the patient with RF energy comprises delivering RF energy to the renal nerves in a monopolar fashion.

7. The method of claim 5 wherein heating afferent and efferent renal nerves of the patient with RF energy comprises delivering RF energy to the renal nerves in a bipolar fashion.

8. The method of claim 4 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises irreversibly ablating the neural fibers.

9. The method of claim 4 wherein reducing neural communication to and from the kidney by at least partially ablating the neural fibers comprises reducing afferent neural traffic from the kidney.

10. A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:

positioning a thermal element within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

at least partially ablating the neural fibers of the patient via energy from the thermal element,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

11. The method of claim 10 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

12. A method for catheter-based renal denervation, the method comprising:

intravascularly positioning a catheter having an electrode within a renal artery of a human patient;

ablating nerves that innervate a kidney of the patient via radio frequency (RF) energy from the electrode,

wherein ablating the nerves results in a therapeutically beneficial reduction in central sympathetic overactivity in the patient; and

removing the catheter from the patient after ablating the nerves.

13. The method of claim 12 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

14. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprises intravascularly positioning an expandable basket carrying a plurality of electrodes within the renal artery of the patient.

15. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprises intravascularly positioning an expandable balloon carrying a plurality of electrodes within the renal artery of the patient.

16. The method of claim 12 wherein intravascularly positioning a catheter having an electrode within a renal artery comprising positioning the catheter and electrode at a first location within the renal artery, and ablating nerves that innervate the kidney comprises a first ablation procedure, and wherein the method further comprises:

positioning the catheter and electrode at a second, different location within the renal artery after the first ablation procedure; and

ablating nerves that innervate the kidney via RF energy from the electrode in a second ablation procedure.