Methods for catheter-based renal neuromodulation

• US 10,194,979 B1
• Filed: 03/13/2015
• Issued: 02/05/2019
• Est. Priority Date: 03/28/2014
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Brar, Sandeep S., Liu, Minglei, Negoita, Manuela
• Primary Examiner(s): Hupczey, Jr., Ronald
• Application Number:
  US14/656,885
• Time in Patent Office: 1,425 Days
• Field of Search: None
• 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 2018/00029 open
• 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Methods for treating preventing or decreasing the likelihood of a human patient developing hypertension and associated systems and methods are disclosed herein. One aspect of the present technology, for example, is directed to methods for therapeutic renal neuromodulation that partially inhibit sympathetic neural activity in renal nerves proximate a renal blood vessel of a human patient. This reduction in sympathetic neural activity is expected to therapeutically treat one or more conditions associated with hypertension or prehypertension of the patient. Renal sympathetic nerve activity can be modulated, for example, using an intravascularly positioned catheter carrying a neuromodulation assembly, e.g., a neuromodulation assembly configured to use electrically-induced, thermally-induced, and/or chemically-induced approaches to modulate the renal nerves.

Claims

1. In a resistant hypertensive human patient having a baseline office blood pressure of at least 160 mm Hg and on an aldosterone antagonist, a method of treating hypertension, comprising:

intravascularly placing an energy delivery element in a renal artery of the patient; and

modulating a renal nerve along the renal artery by delivering energy from the energy delivery element to a plurality of treatment locations along a wall of the renal artery;

whereby the patient achieves a decrease in office blood pressure of (a) not less than 14 mm Hg and (b) at least 7 mm Hg more than a resistant hypertensive control group patient,

wherein the control group patient has an average baseline office blood pressure of at least 160 mm Hg, is younger than 68 years of age, takes at least two or more anti-hypertensive medications at maximally tolerated doses in addition to an aldosterone antagonist, and underwent a sham procedure instead of the modulation treatment.

2. The method of claim 1 wherein the treatment locations are arranged in a helical pattern along the renal artery such that the helical pattern includes at least one treatment location in each of an inferior, anterior, superior and posterior position around the wall of the renal artery.

3. The method of claim 1 wherein delivering energy from the energy delivery element comprises delivering RF energy to the wall of the renal artery at the plurality of treatment locations.

4. The method of claim 1 wherein the energy delivery element comprises a single-electrode device, and wherein delivering energy from the energy delivery element comprises:

positioning the single-electrode at a treatment site;

delivering energy to the treatment site via the single-electrode;

moving the single-electrode proximally to a subsequent treatment site and rotating the single-electrode 45°

;

delivering energy to the subsequent treatment site via the single-electrode; and

repeating the moving and delivering energy acts at additional treatment sites.

5. The method of claim 1 wherein the patient is on a maximum tolerable dosage of one or more antihypertensive medications.

6. The method of claim 1 wherein the patient is less than 65 years of age.

7. The method of claim 1 wherein the patient achieves the decrease in office blood pressure by six months after modulation of the renal nerve.

8. In a resistant hypertensive human patient having a baseline office blood pressure of at least 160 mm Hg and on a maximum tolerable dosage of a plurality of antihypertensive medications, one of which is an aldosterone antagonist, a method of treating hypertension, comprising:

intravascularly placing an energy delivery element in a renal artery and adjacent to renal nerves of the patient; and

ablating the renal nerves via energy from the energy delivery element at a plurality of treatment locations along the renal artery, wherein the treatment locations are spaced apart from each other by not less than 5 mm and arranged in a helical pattern around a wall of the renal artery at 45°

intervals from neighboring treatment locations,

whereby ablating the renal nerves at the plurality of treatment locations causes a drop in office blood pressure of (a) not less than 14 mm Hg and (b) at least 7 mm Hg more than a resistant hypertensive control group patient,

wherein the control group patient has an average baseline office blood pressure of at least 160 mm Hg, is younger than 68 years of age, takes at least two or more anti-hypertensive medications at maximally tolerated doses in addition to an aldosterone antagonist, and underwent a sham procedure instead of the ablation treatment.

9. The method of claim 8 wherein the energy delivery element comprises a basket or a balloon and a plurality of electrodes carried by the basket or the balloon, and wherein ablating the plurality of locations comprises:

positioning the basket or the balloon at a distal portion of the renal artery;

delivering electrical energy through each of the electrodes at the distal portion of the renal artery;

moving the basket or the balloon proximally within the renal artery to a more proximal portion of the renal artery; and

delivering electrical energy to each of the electrodes at the more proximal portion of the renal artery.

10. The method of claim 8 wherein the energy delivery element comprises a single tip electrode, and wherein ablating the plurality of locations comprises:

positioning the electrode at a treatment site;

delivering RF energy to the treatment site via the electrode;

moving the electrode proximally to a subsequent treatment site and rotating the electrode 45°

;

delivering RF energy to the subsequent treatment site via the electrode; and

repeating the moving and delivering RF energy acts at additional treatment sites.

11. The method of claim 8 wherein:

the energy delivery element comprises a plurality of electrodes arranged along an elongated member, wherein the elongated member is (a) configured to be contained in a catheter in a low-profile, delivery configuration and (b) tending to have a helical shape in a deployed configuration;

intravascularly placing the energy delivery element in the renal artery comprises moving the elongated member into the deployed configuration such that the electrodes arranged along an elongated member in the helical shape are in apposition with an inner wall of the renal artery and such that the helical pattern includes at least one treatment location in each of an inferior, anterior, superior and posterior position around the wall; and

ablating the renal nerves via energy from the energy delivery element comprises delivering electrical energy via the plurality of electrodes.

12. The method of claim 8, further comprising receiving a generator feedback message regarding ablation at a treatment location, and wherein the method further comprises repeating ablation at the identified treatment location associated with the feedback message.

13. The method of claim 8 wherein the patient is less than 65 years of age.

14. The method of claim 8 wherein the antihypertensive medications further include one or more medications selected from the group consisting of angiotensin-converting-enzyme inhibitors, angiotensin receptor blockers, alpha-adrenergic blockers, beta blockers, calcium channel blockers, centrally-acting sympatholytics, diuretics, direct-acting renin inhibitors and direct-acting vasodilators.

15. The method of claim 8 wherein the renal artery has a diameter of at least 4 mm.

16. The method of claim 8 wherein the number of treatment locations is at least 8.

17. The method of claim 8 wherein the patient achieves the drop in office blood pressure by six months after ablation of the renal nerves.

18. In a resistant hypertensive human patient having a baseline office blood pressure of at least 160 mm Hg, a method of reducing a nocturnal systolic blood pressure comprising:

intravascularly placing an energy delivery element within a renal artery and adjacent to renal nerves of the patient; and

ablating the renal nerves via energy from the energy delivery element at a plurality of treatment locations along the renal artery,

wherein the treatment locations are spaced apart from each other by not less than 5 mm and arranged in a helical pattern around a wall of the renal artery at 45°

intervals from neighboring treatment locations,

whereby ablating the renal nerves causes a decrease in ambulatory nocturnal blood pressure of at least 4 mm Hg more than a resistant hypertensive control group patient,

wherein the control group patient has an average baseline office blood pressure of at least about 160 mm Hg, is younger than 68 years of age, takes at least two or more anti-hypertensive medications at maximally tolerated doses in addition to an aldosterone antagonist, and underwent a sham procedure instead of the ablation treatment.

19. The method of claim 18 wherein ablating the renal nerves causes a decrease in ambulatory peak nocturnal blood pressure of at least 5 mm Hg more than the control group patient.

20. The method of claim 18 wherein ablating the renal nerves further causes a decrease in ambulatory average morning blood pressure of at least 4 mm Hg more than the control group patient.