Methods for therapeutic renal neuromodulation

• US 9,636,174 B2
• Filed: 03/03/2016
• Issued: 05/02/2017
• 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, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark, Gifford, III, Hanson
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/059,332
• Publication Number:
  US 20160250460A1
• Time in Patent Office: 425 Days
• Field of Search: 604500, 6048901-8911, 60428801, 607 2, 607 44, 607 96, 607 98, 607133, 601 2
• 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 hypertensive human patient, the method comprising:

intravascularly delivering a renal denervation catheter having one or more needles and one or more electrodes through an abdominal aorta of the patient to a renal blood vessel of the patient and proximate to renal nerves;

delivering an infusate and an electrode extravascularly via the one or more needles;

delivering electrical energy via the one or more electrodes to attenuate or block neural signaling along the renal nerves; and

removing the renal denervation catheter from the patient after delivering the infusate to conclude the procedure.

2. The method of claim 1 wherein delivering the electrical energy to attenuate or block neural signaling along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

3. The method of claim 1 wherein the renal denervation catheter comprises an expandable element at a distal region of the catheter, and wherein the method further comprises:

transforming the expandable element from a low-profile delivery configuration to an expanded treatment configuration within the renal blood vessel after intravascularly delivering the catheter to the renal artery of the patient and before delivering the infusate.

4. The method of claim 3 wherein transforming the expandable element from the low-profile delivery configuration to the expanded treatment configuration centers the renal denervation catheter within the renal blood vessel.

5. The method of claim 1 wherein the renal denervation catheter further comprises a plurality of ports with needles extendable therefrom, and wherein each needle houses an electrode, and wherein the method further comprises:

advancing the individual needles from the corresponding needle ports away from the catheter and piercing a vessel wall of the patient such that at least a tip of each needle is positioned extravascularly before delivering the infusate.

6. The method of claim 5 wherein advancing the individual needles comprises advancing the needles simultaneously.

7. The method of claim 1 wherein delivering the infusate via the one or more needles comprises delivering the infusate to tissue external to the renal blood vessel of the patient and adjacent to the renal nerves.

8. The method of claim 1 wherein delivering the electrical enemy to attenuate or block neural signaling along the renal nerves comprises systemically reducing sympathetic tone in the patient.

9. The method of claim 1 wherein delivering the electrical energy to attenuate or block neural signaling along the renal nerves comprises reducing afferent and/or efferent renal neural activity.

10. The method of claim 1 wherein delivering an infusate comprises delivering a drug.

11. The method of claim 1 wherein delivering an infusate comprises delivering saline.

12. The method of claim 1 wherein delivering an infusate comprises delivering a gas, solid or liquid.

13. The method of claim 1 wherein delivering an infusate comprises delivering a heated or chilled fluid.

14. The method of claim 1 wherein delivering electrical energy to attenuate or block neural signaling along the renal nerves comprises delivering the electrical energy to ablate the renal nerves.

15. The method of claim 1 wherein intravascularly delivering a renal denervation catheter through an abdominal aorta of the patient to a renal blood vessel comprises delivering the renal denervation catheter to the renal blood vessel via a guidewire.