# US 10,945,788 B2 · Methods for treating depression in patients via renal neuromodulation

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- Number: US 10,945,788 B2
- Document ID: US10945788B2
- Status: Granted
- Kind: B2
- Application number: 16/026,369
- Filed: 2018-07-03
- Published: 2019-01-10
- Granted: 2021-03-16
- Earliest claimed: 2017-07-05
- Assignees: Medtronic Ardian Luxembourg S.a.r.l.
- Applicants: Medtronic Ardian Luxembourg S.a.r.l.
- Inventors: Marcia Gallagher; Douglas Hettrick
- Web page: https://patentgrep.com/patent/US10945788B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/082: {Probes or electrodes therefor}
- A61N 1/36096: {Mood disorders, e.g. depression, anxiety or panic disorder}
- A61N 7/022: {intracavitary}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 2018/0022: {Balloons}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00666: {using a threshold value}
- A61B 2018/00714: {Temperature}
- A61B 2018/00761: {Duration}
- A61B 2018/00791: {Temperature}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods for treating depression and for reducing a risk associated with developing depression in patients via therapeutic renal neuromodulation and associated systems are disclosed herein. Sympathetic nerve activity can contribute to several cellular and physiological conditions associated with depression as well as an increased risk of developing depression. One aspect of the present technology is directed to methods for improving a patient's calculated risk score corresponding to a depression status in the patient. Other aspects are directed to reducing a likelihood of developing depression in patients presenting one or more depression risk factors. Renal sympathetic nerve activity can be attenuated to improve a patient's depression status or risk of developing depression. The attenuation can be achieved, for example, using an intravascularly positioned catheter carrying a therapeutic assembly configured to use, e.g., electrically-induced, thermally-induced, and/or chemically-induced approaches to modulate the renal sympathetic nerve.

## Claims

### Claim 1

In a normotensive patient diagnosed with depression, a method comprising:
intravascularly positioning a neuromodulation assembly within a renal blood vessel of the patient and adjacent to a renal nerve of the patient; and
at least partially inhibiting sympathetic neural activity in the renal nerve of the patient via the neuromodulation assembly, wherein at least partially inhibiting sympathetic neural activity includes improving one or more depression-related symptoms in the patient as reported on a depression inventory scale and results in a therapeutically beneficial improvement in a measurable parameter associated with the depression of the patient including one or more of:
improving a sleep pattern of the patient;
improving a sleep quality of the patient;
increasing a heart rate variability of the patient;
increasing baroreceptor sensitivity in the patient;
reducing a plasma cortisol level in the patient;
reducing a level of glucocorticoid resistance in the patient; and
reducing a level of an inflammatory biomarker in the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein improving the one or more depression-related symptoms in the patient includes reducing a level of depression-related symptoms or a number of depression-related symptoms.

### Claim 3 (depends on 1)

The method of claim 1 wherein improving the one or more depression-related symptoms in the patient includes reducing a number of depression-related symptoms in the patient by at least about 5%, at least about 10%, at least about 20% or at least about 40% within about three months to about 12 months after at least partially inhibiting sympathetic neural activity in the patient by delivering energy to the renal nerve.

### Claim 4 (depends on 1)

The method of claim 1 wherein the patient is between the ages of 18 and 45, between the ages of 18 and 30, between the ages of 20 and 40, or between the ages of 20 and 35.

### Claim 5 (depends on 1)

The method of claim 1 wherein at least partially inhibiting sympathetic neural activity in the patient further comprises reducing an incidence of stroke or cardiovascular disease in the patient.

### Claim 6 (depends on 1)

The method of claim 1 wherein the patient has a history of cardiovascular disease or stroke, and wherein at least partially inhibiting sympathetic neural activity in the patient further comprises reducing an incidence of a future cardiovascular event or stroke.

### Claim 7 (depends on 1)

The method of claim 1 wherein a post-neuromodulation condition of the parameter associated with depression is improved compared to a baseline condition of the parameter.

### Claim 8 (depends on 7)

The method of claim 7 wherein the baseline condition and the post neuromodulation condition are determined using the depression inventory scale.
