Methods and apparatus for bilateral renal neuromodulation

• US 10,179,235 B2
• Filed: 10/10/2017
• Issued: 01/15/2019
• 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, III, Hanson, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US15/729,326
• Publication Number:
  US 20180078758A1
• Time in Patent Office: 462 Days
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 2018/00267 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: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/327 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 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 bilateral renal neuromodulation, 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 treatment of a hypertensive human patient, the method comprising:

intravascularly positioning a catheter within a first renal artery associated with a first kidney of the patient;

ablating renal nerves along the first renal artery via first ultrasound energy from the catheter;

intravascularly positioning the catheter within a second renal artery associated with a second kidney of the patient; and

ablating renal nerves along the second renal artery via second ultrasound energy from the catheter,

wherein ablating renal nerves along the first renal artery and ablating renal nerves along the second renal artery results in a therapeutically beneficial reduction in blood pressure of the hypertensive patient.

2. The method of claim 1, further comprising removing the catheter from the patient after delivering the first and second ultrasound energy to conclude the procedure.

3. The method of claim 1 wherein the first ultrasound energy is the same as the second ultrasound energy.

4. The method of claim 1 wherein the first ultrasound energy and the second ultrasound energy are both high frequency ultrasound energy.

5. The method of claim 1 wherein ablating renal nerves along the first renal artery and ablating renal nerves along the second renal artery further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

6. A method for treating a hypertensive human patient, the method comprising:

intravascularly positioning a first catheter within a first renal blood vessel of the patient and adjacent to renal nerves innervating a first kidney of the patient;

delivering, via the first catheter, first ultrasound energy to the renal nerves disposed adjacent to the first renal blood vessel, wherein the first ultrasound energy attenuates neural traffic along the renal nerves innervating the first kidney;

intravascularly positioning a second catheter within a second renal blood vessel of the patient and adjacent to renal nerves innervating a second kidney of the patient;

delivering, via the second catheter, second ultrasound energy to the renal nerves disposed adjacent to the second renal blood vessel, wherein the second ultrasound energy attenuates neural traffic along the renal nerves innervating the second kidney, wherein attenuating neural traffic along the renal nerves innervating the first kidney and renal nerves innervating the second kidney results in a therapeutically beneficial improvement in one or more physiological conditions associated with hypertension of the patient.

7. The method of claim 6 wherein intravascularly positioning the first catheter within the first renal blood vessel of the patient and intravascularly positioning the second catheter within the second renal blood vessel of the patient occur simultaneously.

8. The method of claim 6 wherein:

intravascularly positioning a first catheter within a first renal blood vessel of the patient comprises intravascularly delivering the first catheter to the first renal blood vessel over a first guidewire; and

intravascularly positioning a second catheter within a second renal blood vessel of the patient comprises intravascularly delivering the second catheter to the second renal blood vessel over a second guidewire.

9. The method of claim 6, further comprising removing the first catheter from the first renal blood vessel of the patient before positioning the second catheter within the second renal blood vessel of the patient.

10. The method of claim 6 wherein:

attenuating neural traffic along the renal nerves innervating the first kidney comprises ablating the renal nerves innervating the first kidney; and

attenuating neural traffic along the renal nerves innervating the second kidney comprises ablating the renal nerves innervating the second kidney.

11. The method of claim 6 wherein:

attenuating neural traffic along the renal nerves innervating the first kidney comprises partially ablating the renal nerves innervating the first kidney; and

attenuating neural traffic along the renal nerves innervating the second kidney comprises partially ablating the renal nerves innervating the second kidney.

12. The method of claim 6 wherein:

attenuating neural traffic along the renal nerves innervating the first kidney comprises reducing renal sympathetic nerve activity of the first kidney; and

attenuating neural traffic along the renal nerves innervating the second kidney comprises reducing renal sympathetic nerve activity of the second kidney.

13. The method of claim 6 wherein attenuating neural traffic along the renal nerves innervating the first kidney and the renal nerves innervating the second kidney results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

14. The method of claim 6 wherein the first ultrasound energy is the same as the second ultrasound energy.

15. The method of claim 6 wherein the first ultrasound energy is high frequency ultrasound energy.

16. The method of claim 6 wherein intravascularly positioning the first catheter within the first renal blood vessel of the patient and intravascularly positioning the second catheter within the second renal blood vessel of the patient occur sequentially.