Methods for therapeutic renal neuromodulation

• US 9,895,195 B2
• Filed: 03/22/2017
• Issued: 02/20/2018
• 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: Zarins, Denise, Gifford, III, Hanson, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/466,594
• Publication Number:
  US 20170245926A1
• Time in Patent Office: 335 Days
• 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 intravascularly-induced renal neuromodulation, the method comprising:

intravascularly delivering a catheter comprising a shaft and an electrode disposed along the shaft, wherein delivering the catheter includes positioning the electrode at a treatment site within a renal blood vessel of a hypertensive human patient,

wherein, when positioned at the treatment site, the electrode is held spaced apart from a wall of the renal blood vessel; and

delivering an electric field via the electrode to induce renal neuromodulation,

wherein inducing renal neuromodulation results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein the catheter further comprises an expandable element, and wherein the method further comprises:

expanding the expandable element into contact with the wall of the renal blood vessel to center the electrode within the blood vessel and hold the electrode spaced apart from the wall before delivering the electric field.

3. The method of claim 2 wherein the expandable element comprises a balloon.

4. The method of claim 3, further comprising occluding blood flow in the renal blood vessel with the balloon.

5. The method of claim 2 wherein expanding the expandable element into contact with the wall of the renal blood vessel further comprises locally increasing impedance within the renal blood vessel via the expandable element.

6. The method of claim 5 wherein the electrode is a first electrode proximal to and external of the expandable element, and wherein the catheter further comprises a second electrode disposed along the shaft distal to and external of the expandable element, and wherein locally increasing impedance further comprises directing the electric field across the wall of the renal blood vessel between the first and second electrodes.

7. The method of claim 1 wherein the electrode is a first electrode, and wherein the catheter further comprises a second electrode disposed along the shaft and spaced apart from the first electrode, and wherein delivering an electric field to induce renal neuromodulation comprises delivering a bipolar electric field between the first and second electrodes.

8. The method of claim 7 wherein delivering an electric field to induce renal neuromodulation comprises thermally inhibiting neural communication along neural fibers innervating a kidney of the patient.

9. The method of claim 7 wherein delivering an electric field to induce renal neuromodulation comprises ablating neural fibers innervating a kidney of the patient via the electric field.

10. The method of claim 7 wherein delivering an electric field to induce renal neuromodulation comprises partially ablating neural fibers innervating a kidney of the patient via the electric field.

11. The method of claim 7 wherein delivering an electric field to induce renal neuromodulation comprises at least partially denervating a kidney of the patient.

12. The method of claim 1 wherein positioning the electrode at a treatment site within a renal blood vessel of a hypertensive human patient comprises positioning the catheter within a renal artery of the patient.

13. The method of claim 1 wherein intravascularly delivering a catheter comprises intravascularly delivering the catheter to the renal blood vessel over a guidewire.

14. The method of claim 1 wherein intravascularly delivering a catheter comprises intravascularly delivering the catheter to the renal blood vessel within a guide catheter.

15. The method of claim 1, further comprising removing the catheter from the patient after therapy.

16. The method of claim 1, further comprising monitoring a parameter of target tissue and/or non-target tissue within the patient before and during energy delivery.

17. The method of claim 16 wherein monitoring a parameter comprises monitoring temperature of target tissue, and wherein the method further comprises maintaining the target tissue at a desired temperature during energy delivery.

18. The method of claim 16, further comprising altering energy delivery in response to the monitored parameter.

19. A method for catheter-based renal denervation of a hypertensive human patient, the method comprising:

transluminally positioning a renal denervation catheter within a renal artery of the patient and adjacent to renal nerves of the patient, wherein the catheter includes an expandable element and a pair of electrodes disposed along a shaft of the catheter and external of the expandable element;

inflating the expandable element within the renal artery of the patient such that the pair of electrodes are centered within the renal blood vessel; and

after inflating the expandable element, at least partially ablating the renal nerves of the patient via energy delivery from the pair of electrodes,

wherein at least partially ablating the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

20. The method of claim 19, further comprising monitoring temperature of target tissue within the patient before and during energy delivery from the pair of electrodes, and wherein the method further comprises altering energy delivery to the neural fibers via the bipolar electrodes throughout therapy to maintain the target tissue at a predetermined temperature.

21. The method of claim 19 wherein at least partially ablating the renal nerves of the patient via energy delivery from the pair of electrodes comprises at least partially ablating the renal nerves via radio frequency (RF) electrical energy from the pair of electrodes.