Methods for bilateral renal neuromodulation via catheter apparatuses having expandable baskets

• US 9,138,281 B2
• Filed: 09/23/2013
• Issued: 09/22/2015
• 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, Hanson III, Deem, Mark, Sutton, Douglas, Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/034,434
• Publication Number:
  US 20140172054A1
• Time in Patent Office: 729 Days
• Field of Search: 604/891.1, 604/21
• US Class Current: 1/1
• 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 catheter-based renal neuromodulation of a human patient with a diagnosed condition comprising at least one of heart failure, hypertension, acute myocardial infarction, impaired renal function or chronic renal failure, the method comprising:

positioning a first catheter having a first therapeutic element in a low profile delivery configuration within a first renal blood vessel of the patient and proximate to neural fibers innervating a first kidney of the patient,

wherein the first therapeutic element comprises a first expandable basket sized and shaped for the first renal blood vessel, and wherein the first expandable basket comprises a plurality of first electrodes arranged thereon,

transforming the first therapeutic element from the delivery configuration to a treatment configuration such that the first electrodes on the first expandable basket are in contact with an inner wall of the first renal blood vessel;

inhibiting neural communication along the neural fibers innervating the first kidney via radio frequency (RF) energy from the first electrodes;

positioning a second catheter having a second therapeutic element in a low profile delivery configuration within a second renal blood vessel of the patient and proximate to neural fibers innervating a second kidney of the patient,

wherein the second therapeutic element comprises a second expandable basket sized and shaped for the second renal blood vessel, and wherein the second basket comprises a plurality of second electrodes arranged thereon;

transforming the second therapeutic element from the delivery configuration to a treatment configuration such that the plurality of second electrodes on the second expandable basket are in contact with an inner wall of the second renal blood vessel; and

inhibiting neural communication along the neural fibers innervating the second kidney via RF energy from the second electrodes wherein inhibiting neural communication along the neural fibers innervating the first and second kidney significantly improves a measureable physiological parameter corresponding to the diagnosed condition of the patient.

2. The method of claim 1 wherein the first renal blood vessel has a different diameter than the second renal blood vessel, and wherein, in the treatment configuration, the first basket has a different size than the second basket in the treatment configuration.

3. The method of claim 1 wherein the first renal blood vessel has the same or approximately the same diameter as the second renal blood vessel, and wherein, in the treatment configuration, the first basket is the same size as the second basket in the treatment configuration.

4. The method of claim 1, 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.

5. The method of claim 1 wherein positioning the first catheter within the first renal blood vessel of the patient and positioning the second catheter within the second renal blood vessel of the patient occur simultaneously.

6. The method of claim 1 wherein:

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

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

7. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises ablating the neural fibers innervating the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises ablating the neural fibers innervating the second kidney.

8. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises denervating the first kidney of the patient; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises denervating the second kidney of the patient.

9. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises denervating the first kidney of the patient; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises denervating the second kidney of the patient.

10. The method of claim 1 wherein:

inhibiting neural communication along the neural fibers innervating the first kidney comprises reducing renal sympathetic nerve activity of the first kidney; and

inhibiting neural communication along the neural fibers innervating the second kidney comprises reducing renal sympathetic nerve activity of the second kidney.

11. The method of claim 1 wherein:

inhibiting neural communication via RF energy from the first electrodes comprises selectively energizing two or more first electrodes along the first expandable basket to produce a first treatment zone along the first renal blood vessel; and

inhibiting neural communication via RF energy from the second electrodes comprises selectively energizing two or more second electrodes along the second expandable basket to produce a second treatment zone along the second renal blood vessel.

12. The method of claim 1 wherein the first electrodes comprise first bipolar RF electrodes, and wherein the second electrodes comprise second bipolar RF electrodes.

13. The method of claim 1 wherein the first electrodes and second electrodes comprise monopolar electrodes, and wherein

inhibiting neural communication via RF energy from the first electrodes comprises delivering RF energy in a monopolar fashion between the first electrodes and a ground electrode such that the resulting energy field attenuates neural communication along the neural fibers innervating the first kidney;

and

inhibiting neural communication via RF energy from the second electrodes comprises delivering RF energy in a monopolar fashion between the second electrodes and the ground electrode such that the resulting energy field attenuates neural communication along the neural fibers innervating the second kidney.

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

intravascularly positioning a first catheter having an expandable distal first basket within a first renal artery of the patient;

at least partially ablating nerves along the first renal artery via electric energy from first radio frequency (RF) electrodes carried by the first basket;

intravascularly positioning a second catheter having an expandable distal second basket within a second renal artery of the patient, wherein the second basket is different from the first basket; and

at least partially ablating nerves along the second renal artery via electric energy from second RF electrodes carried by the second basket wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery results in a therapeutically beneficial reduction in blood pressure in the patient.

15. The method of claim 14 wherein:

all or a subset of the plurality of first RF electrodes are dynamically assignable and configured for monopolar use in conjunction with a separate external patient ground; and

all or a subset of the plurality of second RF electrodes are dynamically assignable and configured for monopolar use in conjunction with the separate external patient ground.

16. The method of claim 14 wherein at least partially ablating the nerves along the first renal artery and the nerves along the second renal artery further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

17. The method of claim 14, further comprising:

monitoring contact between the first RF electrodes and a wall of the first renal artery; and

monitoring contact between the second RF electrodes and a wall of the second renal artery.

18. The method of claim 17 wherein monitoring contact between the first and second bipolar RF electrodes and the walls of the first and second renal arteries, respectitvely, comprises monitoring impedance and/or temperature.

19. The method of claim 17, further comprising adjusting a treatment parameter in repsonse to the monitoring.