Methods for renal neuromodulation

• US 9,474,563 B2
• Filed: 04/16/2014
• Issued: 10/25/2016
• 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:
  US14/254,205
• Publication Number:
  US 20150080481A1
• Time in Patent Office: 923 Days
• Field of Search: 604/500, 6048901-8911, 604/288.01, 607/2, 607/44, 607/96, 607/98, 607/133, 601/2
• US Class Current: 1/1
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 18/1492 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: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• 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 treating contrast nephropathy, 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 hypertension, the method comprising:

directing a neuromodulatory energy to a post-ganglionic renal nerve innervating a kidney of a human patient,

wherein directing the neuromodulatory energy to the post-ganglionic renal nerve comprises modulating the post-ganglionic renal nerve without completely physically severing the post-ganglionic renal nerve, and

wherein directing the neuromodulatory energy to the post-ganglionic renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises modulating the renal nerve via an electric field.

3. The method of claim 2, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve via an electric field further comprises exposing the post-ganglionic renal nerve to a pulsed electric field.

4. The method of claim 2, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve via an electric field further comprises exposing the post-ganglionic renal nerve to a stimulation electric field.

5. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises at least partially denervating the kidney.

6. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises inducing an effect in the post-ganglionic renal nerve chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

7. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises thermally modulating the post-ganglionic renal nerve.

8. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises modulating the post-ganglionic renal nerve with high frequency ultrasound.

9. The method of claim 1, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises modulating the post-ganglionic renal nerve via ultrasound energy.

10. A method for treating hypertension, the method comprising:

directing a neuromodulatory energy via an intravascularly delivered catheter to a post-ganglionic renal nerve innervating a kidney of a patient, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve reduces neural signaling to and from the kidney of the patient; and

removing the catheter from the patient after modulating the post-ganglionic renal nerve,

wherein directing the neuromodulatory energy to the post-ganglionic renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

11. The method of claim 10, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises modulating the post-ganglionic renal nerve via an electric field.

12. The method of claim 11, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve via an electric field further comprises exposing the post-ganglionic renal nerve to a pulsed electric field.

13. The method of claim 11, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve via an electric field further comprises exposing the post-ganglionic renal nerve to a stimulation electric field.

14. The method of claim 10, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises at least partially denervating the kidney.

15. The method of claim 10, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises inducing an effect in the post-ganglionic renal nerve chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

16. The method of claim 10, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises thermally modulating the post-ganglionic renal nerve.

17. The method of claim 10, wherein directing the neuromodulatory energy to the post-ganglionic renal nerve further comprises modulating the post-ganglionic renal nerve with high frequency ultrasound.

18. A method for treating hypertension, the method comprising:

directing one or more neuromodulatory agents or drugs to a post-ganglionic renal nerve innervating a kidney of a human patient,

wherein directing the one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve comprises modulating the post-ganglionic renal nerve without completely physically severing the post-ganglionic renal nerve, and

wherein directing the one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

19. The method of claim 18, wherein directing one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve further comprises at least partially denervating the kidney.

20. The method of claim 18, wherein directing one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve further comprises inducing an effect in the post-ganglionic renal nerve chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.

21. A method for treating hypertension, the method comprising:

directing one or more neuromodulatory agents or drugs via an intravascularly delivered catheter to a post-ganglionic renal nerve innervating a kidney of a patient,

wherein directing the one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve reduces neural signaling to and from the kidney of the patient; and

removing the catheter from the patient after directing the one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve,

wherein directing the one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

22. The method of claim 21, wherein directing one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve further comprises at least partially denervating the kidney.

23. The method of claim 21, wherein directing one or more neuromodulatory agents or drugs to the post-ganglionic renal nerve further comprises inducing an effect in the post-ganglionic renal nerve chosen from the group consisting of irreversible electroporation, electrofusion, necrosis, apoptosis, gene expression alteration, cytokine up-regulation alteration, and combinations thereof.