Methods for therapeutic renal neuromodulation

• US 9,439,726 B2
• Filed: 03/14/2016
• Issued: 09/13/2016
• 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:
  US15/069,830
• Publication Number:
  US 20160192985A1
• Time in Patent Office: 183 Days
• 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 2018/00351 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 reversible electroporation A61N1/327
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• 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
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 2007/025 : interstitial
• 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
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

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 a nerve modulation device within renal vasculature of the patient and in the 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 the nerve modulation device,

wherein the kidney continues to secrete renin in the patient after reducing neural communication with the nerve modulation device,

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

2. The method of claim 1 wherein positioning a nerve modulation device within renal vasculature comprises positioning the nerve modulation device within a renal artery of the patient.

3. The method of claim 1 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 RF energy delivered via the nerve modulation device.

4. A method for treating a human patient with diagnosed hypertension, the method comprising:

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

directing a neuromodulatory energy from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient,

wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device.

5. The method of claim 4 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient.

6. A method for treatment of a human patient via renal denervation, the method comprising:

positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing a neuromodulatory energy from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

7. The method of claim 6 wherein the neuromodulatory energy comprises RF energy.

8. A method for catheter-based renal neuromodulation, the method comprising:

positioning a catheter having a therapeutic element within a renal artery of a human patient;

directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and

removing the catheter from the patient after the attenuation of neural traffic to and/or from the kidney.

9. The method of claim 8 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery.

10. The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve.

11. The method of claim 9 wherein directing the neuromodulatory energy from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve.

12. The method of claim 8 wherein the neuromodulatory energy comprises RF energy.

13. The method of claim 8 wherein:

positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and

wherein directing a neuromodulatory energy from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

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

delivering an energy element to an intravascular location within a renal artery of the patient and adjacent to post-ganglionic neural fibers innervating a kidney of the patient; and

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

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

15. A method for treating a human patient with diagnosed hypertension, the method comprising:

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

directing one or more neuromodulatory agents or drugs from the nerve modulation device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney significantly improves a measureable physiological parameter associated with the hypertension of the patient,

wherein the kidney continues to secrete renin in the patient after the reduction in neural communication with the nerve modulation device.

16. The method of claim 15 wherein positioning a nerve modulation device within a renal blood vessel of the patient comprises positioning the nerve modulation device within a renal artery of the patient.

17. A method for treatment of a human patient via renal denervation, the method comprising:

positioning a renal denervation catheter having a treatment device within a renal artery of the patient and in the vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and

directing one or more neuromodulatory agents or drugs from the treatment device to the post-ganglionic neural fibers to reduce neural communication to and from the kidney,

wherein the reduction in neural communication to and from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

18. A method for catheter-based renal neuromodulation, the method comprising:

positioning a catheter having a therapeutic element within a renal artery of a human patient;

directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate neural traffic to and/or from a kidney of the patient, wherein the attenuation of neural traffic therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient; and

removing the catheter from the patient after attenuating neural traffic to and/or from the kidney.

19. The method of claim 18 wherein the post-ganglionic neural fiber comprises a renal nerve adjacent the renal artery.

20. The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises partially ablating the renal nerve.

21. The method of claim 19 wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to the post-ganglionic neural fiber comprises ablating the renal nerve.

22. The method of claim 18 wherein:

positioning a catheter having a therapeutic element within a renal artery of a human patient comprises positioning the catheter in a patient diagnosed with hypertension; and

wherein directing one or more neuromodulatory agents or drugs from the therapeutic element to a post-ganglionic neural fiber to attenuate the neural traffic to and/or from the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.