Methods for catheter-based renal neuromodulation

• US 10,194,980 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:
  US14/656,892
• 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. A method for treating hypertension, the method comprising:

selecting a female human patient having a baseline blood pressure of at least 160 mm Hg;

intravascularly delivering an energy delivery element to a renal artery of the selected 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,

wherein the treatment locations are arranged in a helical pattern along the renal artery, and wherein the helical pattern includes at least one treatment location in each of the inferior, anterior, superior and posterior positions around the wall of the renal artery,

wherein the selected patient achieves a decrease in blood pressure of at least 6 mm Hg more than a resistant hypertensive, female control group patient, and

wherein the female control group patient having an average baseline blood pressure of at least 160 mm Hg, is younger than 68 years of age, takes three or more anti-hypertensive medications at maximally tolerated doses, and underwent a sham procedure instead of the modulation treatment.

2. The method of claim 1 whereby the selected patient achieves a decrease in office blood pressure of not less than 14 mm Hg.

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

4. The method of claim 1 wherein the number of treatment locations is at least 8.

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

6. A method for treating hypertension, the method comprising:

selecting a human patient having a baseline blood pressure of at least 160 mm Hg and on an aldosterone antagonist;

intravascularly positioning an energy delivery element within a renal artery of the selected patient; and

modulating a renal nerve along the renal artery via energy from the energy delivery element at a plurality of locations along a wall of the renal artery, wherein the selected patient achieves a decrease in blood pressure of at least 7 mm Hg more than a resistant hypertensive control group patient, and

wherein the control group patient has an average baseline blood pressure of at least 160 mm Hg, is younger than 68 years of age, is on an aldosterone antagonist, and underwent a sham procedure instead of the modulation treatment.

7. The method of claim 6 wherein the selected patient has a decrease in blood pressure of at least 4 mm Hg more than a comparable patient having a baseline office blood pressure of at least 160 mm Hg, and wherein the comparable patient is not taking an aldosterone antagonist, and wherein the comparable patient underwent method steps comprising:

intravascularly positioning an energy delivery element within a renal artery of the comparable patient; and

modulating a renal nerve along the renal artery of the comparable patient via energy from the energy delivery element at a plurality of treatment locations along a wall of the renal artery.

8. The method of claim 6 wherein the selected patient achieves a decrease in office blood pressure of not less than 14 mm Hg.

9. The method of claim 6 wherein the selected patient achieves a decrease in office blood pressure of not less than 20 mm Hg.

10. The method of claim 6 wherein the patient achieves the decrease in office blood pressure by six months after modulation of the renal nerve.

11. A method for treating hypertension, the method comprising:

selecting a human patient under 65 years of age and having a baseline blood pressure of at least 160 mm Hg;

intravascularly delivering an energy delivery element to a renal artery of the selected patient; and

modulating a renal nerve along the renal artery via energy from the energy delivery element at a plurality of treatment locations along a wall of the renal artery,

wherein the treatment locations are spaced apart from each other and arranged in a helical pattern about the wall of the renal artery, and wherein the helical pattern includes at least one treatment location in each of an inferior, anterior, superior and posterior position around the wall,

wherein the selected patient achieves a decrease in blood pressure of at least 5 mm Hg more than a resistant hypertensive control group patient, and

wherein the control group patient is under 65 years of age, has a baseline blood pressure of at least 160 mm Hg, takes one or more anti-hypertensive medication at maximally tolerated doses, and underwent a sham procedure instead of the modulation treatment.

12. The method of claim 11 wherein the selected patient achieves a decrease in office blood pressure of not less than 14 mm Hg.

13. The method of claim 11, further comprising receiving a generator feedback message regarding energy delivery at a particular treatment location, and wherein the method further comprises repeating energy delivery at the particular treatment location associated with the feedback message.

14. The method of claim 11 wherein modulating the renal nerve further causes a decrease in ambulatory peak nocturnal blood pressure of at least 5 mm Hg more than the control group patient.

15. The method of claim 11 wherein modulating the renal nerve further causes a decrease in ambulatory average morning blood pressure of at least 4 mm Hg more than the control group patient.