Methods and apparatus for renal neuromodulation

• US 9,675,413 B2
• Filed: 02/09/2016
• Issued: 06/13/2017
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Deem, Mark E., Zarins, Denise, Gifford, III, Hanson, Sutton, Douglas, Gelfand, Mark, Levin, Howard R., Thai, Erik
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/019,793
• Publication Number:
  US 20160220305A1
• Time in Patent Office: 490 Days
• 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. A method for treatment of a human patient diagnosed with hypertension, the method comprising:

intravascularly positioning a catheter in a reduced profile delivery configuration within a renal blood vessel and at least partially adjacent to renal nerves of the patient;

transforming a distal basket of the catheter from the delivery configuration to a treatment configuration, wherein, in the treatment configuration, the distal basket is expanded to place a plurality of electrodes arranged thereabout into contact with an inner wall of the renal blood vessel of the patient;

selectively energizing a first bipolar electrode pair carried by a first strut of the basket and delivering a first bipolar energy field to the renal nerves; and

selectively energizing a second bipolar electrode pair carried by a second, different strut of the basket and delivering a second bipolar energy field to the renal nerves,

wherein delivering the first and second bipolar energy fields modulates neural function of the renal nerves.

2. The method of claim 1 wherein modulating neural function of the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

3. The method of claim 1 wherein selectively energizing the first bipolar electrode pair and selectively energizing the second bipolar electrode pair occurs simultaneously.

4. The method of claim 1 wherein intravascularly positioning a catheter in a reduced profile delivery configuration within a renal blood vessel comprises delivering the catheter over a guidewire.

5. The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of the first and second bipolar energy fields.

6. The method of claim 5 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance.

7. The method of claim 5, further comprising altering delivery of at least one of the first and second bipolar energy fields in response to the monitored parameter.

8. The method of claim 1 wherein the catheter further comprises an insulating element carried by the basket.

9. The method of claim 8 wherein transforming the basket from the delivery configuration to a treatment configuration comprises blocking blood flow within the renal blood vessel via the insulating element.

10. The method of claim 8 wherein the insulating element comprises a balloon.

11. The method of claim 1 wherein delivering the first and second bipolar energy fields comprises thermally altering the renal nerves in a manner that reduces neural traffic to and from a kidney of the patient.

12. The method of claim 1 wherein delivering the first and second bipolar energy fields comprises ablating one or more renal nerves of the patient.

13. The method of claim 1 wherein delivering the first and second bipolar energy fields comprises partially ablating the renal nerves of the patient.

14. The method of claim 1 wherein delivering the first and second bipolar energy fields comprises at least partially blocking afferent and efferent neural traffic to and/or from a kidney of the patient.

15. A method for renal neuromodulation, the method comprising:

transluminally positioning an expandable basket of a renal denervation catheter at an intravascular location within a renal artery of a human patient and adjacent to neural fibers innervating a kidney of the patient;

transforming the expandable basket from a low-profile delivery configuration to an expanded treatment configuration,

wherein, in the treatment configuration, the basket is sized and shaped to place a first bipolar electrode pair carried by a first strut of the basket and a second bipolar electrode pair carried by a second, different strut of the basket in apposition with target tissue at or near the neural fibers; and

ablating the neural fibers innervating the kidney via radio frequency (RF) energy from the first and second bipolar electrode pairs.

16. The method of claim 15 wherein ablating the neural fibers innervating the kidney results in a therapeutically beneficial reduction in blood pressure of the patient.

17. The method of claim 15, further comprising monitoring a parameter of the renal denervation catheter and/or tissue within the patient before and during delivery of the RF energy.

18. The method of claim 17 wherein monitoring a parameter comprises monitoring temperature, power, and/or impedance, and wherein the method further comprises altering delivery of the RF energy in response to the monitored parameter.

19. The method of claim 15 wherein transluminally positioning an expandable basket of a renal denervation catheter at an intravascular location within a renal artery comprises delivering the catheter over a guidewire.

20. The method of claim 15 wherein transluminally positioning an expandable basket of a renal denervation catheter at an intravascular location within a renal artery comprises delivering the expandable basket within a guide sheath, and wherein the method further comprises at least partially withdrawing the guide sheath and transforming the expandable basket from the low-profile delivery configuration to the expanded treatment configuration before ablating the neural fibers.

21. The method of claim 15, further comprising removing the renal denervation catheter from the patient after ablating the neural fibers to conclude the procedure.

22. The method of claim 15 wherein ablating the neural fibers innervating the kidney comprises at least partially denervating the kidney of the patient.