Apparatuses for Renal Neuromodulation and Associated Systems and Methods

• US 20140018723A1
• Filed: 06/28/2013
• Published: 01/16/2014
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Deem, Mark E., Gifford, Hanson III, Zarins, Denise, Sutton, Douglas, Thai, Erik, Gelfand, Mark, Levin, Howard R.
• Granted Patent: US 8,852,163 B2
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00071 Electrical conductivity
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• 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 2018/00505 Urinary tract
• 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 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• 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 1/18 : Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/205 : for promoting a biological process
• CPC Class Codes: A61N 1/326 : for promoting growth of cells, e.g. bone cells
• 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 1/36057 : adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36103 : Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• 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 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00
• 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 renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

Claims

1-28. -28. (canceled)

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

intravascularly positioning a catheter within a renal artery of a human patient and proximate to renal nerves of the patient; and

delivering a neuromodulatory agent via the catheter to tissue external to the renal artery and in contact with or adjacent to the renal nerves, wherein the neuromodulatory agent reduces neural traffic along the renal nerves to and/or from a kidney of the patient,

wherein reducing the neural traffic results in a therapeutically beneficial reduction in blood pressure of the patient.

30. The method of claim 29 wherein delivering a neuromodulatory agent via the catheter comprises delivering a neurotoxin.

31. The method of claim 29 wherein delivering a neuromodulatory agent via the catheter comprises delivering botulinum toxin.

32. The method of claim 29 wherein delivering a neuromodulatory agent via the catheter comprises delivering phenol.

33. The method of claim 29 wherein delivering a neuromodulatory agent via the catheter comprises delivering alcohol.

34. The method of claim 29 wherein reducing neural traffic along the renal nerves via the neuromodulatory agent comprises blocking afferent and/or efferent renal nerve activity.

35. The method of claim 29 wherein the catheter comprises an infusion needle at a distal portion of the catheter, and wherein the method further comprises:

passing the infusion needle through a wall of the renal artery to position at least a portion of the infusion needle at an extravascular location in contact with or adjacent to the renal nerves, and

wherein delivering a neuromodulatory agent comprises delivering the neuromodulatory agent via the infusion needle and ablating at least a portion of the renal nerves of the patient.

36. The method of claim 35 wherein the distal portion of the catheter comprises a side port, and wherein intravascularly positioning the catheter within the renal artery comprises positioning the catheter with the infusion needle positioned for delivery via the side port through at least a portion of the wall of the renal artery.

37. The method of claim 35 wherein the distal portion of the catheter further comprises an expandable positioning element, and wherein intravascularly positioning the catheter within the renal artery comprises locating the catheter within the renal artery via the expandable positioning element before passing the infusion needle through the wall of the renal artery.

38. The method of claim 37 wherein the expandable positioning element comprises an inflatable balloon.

39. The method of claim 29 wherein intravascularly positioning the catheter within the renal artery of the patient comprises delivering the catheter to the renal artery via a guidewire.

40. The method of claim 29, further comprising intravascularly removing the catheter from the patient after delivering the neuromodulatory agent.