Methods and apparatus for bilateral renal neuromodulation

Patent metadata

Field	Value
Publication number	US-10850091-B2
Application number	US-201816211142-A
Country	US
Kind code	B2
Filing date	Dec 5, 2018
Priority date	Apr 8, 2002
Publication date	Dec 1, 2020
Grant date	Dec 1, 2020

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.

First claim

The invention claimed is:

1. A method, comprising:
positioning a first expandable element of a first catheter within a first renal artery of a hypertensive human patient and adjacent to first neural fibers innervating a first kidney of the patient;
transforming the first expandable element from a reduced profile configuration to an, expanded configuration;
delivering first ultrasound energy from the first catheter to the first neural fibers, wherein the first ultrasound energy is sufficient to at least partially ablate the first neural fibers;
positioning a second expandable element of a second catheter within a second renal artery of the patient and adjacent to second neural fibers innervating a second kidney of the patient;
transforming the second expandable element from a reduced profile configuration to an expanded configuration; and
delivering second ultrasound energy from the second catheter to the second neural fibers, wherein the second ultrasound energy is sufficient to at least partially ablate the second neural fibers,
wherein at least partially ablating the first neural fibers and the second neural fibers results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein at least partially ablating the first neural fibers and the second neural fibers results further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

3. The method of claim 1 , further comprising transforming the first expandable element from the expanded configuration to the reduced profile configuration and removing the first catheter from the patient before positioning the second catheter within the second renal artery of the patient.

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

5. The method of claim 1 wherein:
positioning a first expandable element of a first catheter within a first renal artery of a hypertensive human patient comprises intravascularly delivering the first expandable element of the first catheter over a first guidewire to the first renal artery; and
positioning a second expandable element of a second catheter within a second renal artery of the patient comprises intravascularly delivering the second expandable element of the second catheter over a second guidewire to the second renal artery.

6. The method of claim 1 wherein the first ultrasound energy is different from the second ultrasound energy.

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

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

9. The method of claim 1 wherein positioning a first expandable element of a first catheter within a first renal artery and positioning a second expandable element of a second catheter within a second renal artery occurs simultaneously.

10. The method of claim 1 wherein positioning a first expandable element of a first catheter within a first renal artery and positioning a second expandable element of a second catheter within a second renal artery occur sequentially.

11. The method of claim 1 wherein:
delivering first ultrasound energy from the first catheter to the first neural fibers further comprises reducing renal sympathetic nerve activity of the first kidney; and
delivering second ultrasound energy from the second catheter to the second neural fibers further comprises reducing renal sympathetic nerve activity of the second kidney.

12. The method of claim 1 wherein, in the expanded configurations, the first expandable element occludes blood flow in the first renal artery and the second expandable element occludes blood flow in the second renal artery.

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

14. Me method of claim 13 wherein monitoring a parameter comprises monitoring temperature of target tissue.

15. The method of claim 13 , further comprising altering first and/or second ultrasound energy delivery in response to the monitored parameter.

16. The method of claim 13 , further comprising adjusting a treatment parameter in response to the monitoring.

Assignees

• Medtronic Ardian Luxembourg

Inventors

• Zarins Denise
• Gifford Iii Hanson
• Deem Mark
• Sutton Douglas
• Levin Howard R
• Gelfand Mark

Classifications

• A61B2018/00434

  Neural system · CPC title

• A61M2210/1082

  Kidney · CPC title

• A61B2018/00511

  Kidney · CPC title

• A61N1/36007

  of urogenital or gastrointestinal organs, e.g. for incontinence control · CPC title

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title