# US 10,441,356 B2 · Methods for renal neuromodulation via neuromodulatory agents

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- Number: US 10,441,356 B2
- Document ID: US10441356B2
- Status: Granted
- Kind: B2
- Application number: 15/478,113
- Filed: 2017-04-03
- Published: 2017-07-20
- Granted: 2019-10-15
- Earliest claimed: 2002-04-08
- Assignees: Medtronic Ardian Luxembourg S.a.r.l.
- Applicants: Denise Zarins; Andrew Wu; Hanson Gifford, III; Mark Deem; Mark Gelfand; Howard R. Levin
- Inventors: Denise Zarins; Andrew Wu; Hanson Gifford, III; Mark Deem; Mark Gelfand; Howard R. Levin
- Web page: https://patentgrep.com/patent/US10441356B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61M 5/14276: {specially adapted for implantation}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61N 1/28: Apparatus for applying thermoelectric currents
- A61N 1/32: alternating or intermittent currents {(applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02)}
- A61N 1/326: {for promoting growth of cells, e.g. bone cells}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36117: {for treating hypertension}
- A61N 1/403: {for thermotherapy, e.g. hyperthermia}
- A61N 5/045: {specially adapted for treatment inside the body}
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00505: {Urinary tract}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- A61M 2210/1082: Kidney
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- A61N 2007/003: {Destruction of nerve tissue}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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)

## Abstract

Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

## Claims

### Claim 1

A method for treating a hypertensive human patient, the method comprising:
intravascularly delivering a renal denervation catheter having one or more needles through an abdominal aorta of the patient to a renal artery of the patient and proximate to renal nerves;
delivering a neuromodulatory agent via the one or more needles to attenuate or block neural signaling along the renal nerves; and
removing the renal denervation catheter from the patient after delivering the neuromodulatory agent to conclude the procedure.

### Claim 2 (depends on 1)

The method of claim 1 wherein delivering the neuromodulatory agent to attenuate or block neural signaling along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 3 (depends on 1)

The method of claim 1 wherein the renal denervation catheter comprises an expandable element at a distal region of the catheter, and wherein the method further comprises:
transforming the expandable element from a low-profile delivery configuration to an expanded treatment configuration within the renal artery after intravascularly delivering the catheter to the renal artery of the patient and before delivering the neuromodulatory agent.

### Claim 4 (depends on 3)

The method of claim 3 wherein transforming the expandable element from the low-profile delivery configuration to the expanded treatment configuration centers the renal denervation catheter within the renal artery.

### Claim 5 (depends on 1)

The method of claim 1 wherein the renal denervation catheter further comprises a plurality of needle lumens, and wherein each needle lumen houses one of the plurality of needles, and wherein the method further comprises:
advancing the individual needles from the corresponding needle lumens away from the catheter and piercing a vessel wall of the patient such that at least a tip of each needle is positioned extravascularly before delivering the neuromodulatory agent.

### Claim 6 (depends on 5)

The method of claim 5 wherein advancing the individual needles comprises advancing the needles simultaneously.

### Claim 7 (depends on 1)

The method of claim 1 wherein delivering the neuromodulatory agent via the one or more needles comprises delivering the neuromodulatory agent to tissue external to the renal artery of the patient and in contact with or adjacent to the renal nerves.

### Claim 8 (depends on 1)

The method of claim 1 wherein delivering the neuromodulatory agent to attenuate or block neural signaling along the renal nerves comprises systemically reducing sympathetic tone in the patient.

### Claim 9 (depends on 1)

The method of claim 1 wherein delivering the neuromodulatory agent to attenuate or block neural signaling along the renal nerves comprises reducing afferent and/or efferent renal neural activity.

### Claim 10 (depends on 1)

The method of claim 1 wherein delivering a neuromodulatory agent comprises delivering alcohol.

### Claim 11 (depends on 1)

The method of claim 1 wherein delivering a neuromodulatory agent comprises delivering phenol.

### Claim 12 (depends on 1)

The method of claim 1 wherein delivering a neuromodulatory agent comprises delivering a neurotoxin.

### Claim 13 (depends on 1)

The method of claim 1 wherein delivering a neuromodulatory agent comprises delivering botulinum toxin.

### Claim 14 (depends on 1)

The method of claim 1 wherein delivering a neuromodulatory agent to attenuate or block neural signaling along the renal nerves comprises delivering the neuromodulatory agent to ablate the renal nerves.

### Claim 15 (depends on 1)

The method of claim 1 wherein intravascularly delivering a renal denervation catheter through an abdominal aorta of the patient to a renal artery comprises delivering the renal denervation catheter to the renal artery via a guidewire.