# US 8,145,317 B2 · Methods for renal neuromodulation

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- Number: US 8,145,317 B2
- Document ID: US8145317B2
- Status: Granted
- Kind: B2
- Application number: 11/368,577
- Filed: 2006-03-06
- Published: 2006-12-07
- Granted: 2012-03-27
- Earliest claimed: 2002-04-08
- Assignees: Ardian, Inc.
- Inventors: Denise Demarais; Hanson Gifford, III; Mark Deem; Douglas Sutton; Howard R. Levin; Mark Gelfand
- Web page: https://patentgrep.com/patent/US8145317B2

## CPC

- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61M 5/14276: {specially adapted for implantation}
- A61N 1/326: {for promoting growth of cells, e.g. bone cells}
- A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 2210/1082: Kidney
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36117: {for treating hypertension}
- A61N 1/3627: {for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy}
- 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)
- 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)}

## Abstract

Methods and apparatus are provided for treating hypertension, 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

### Claim 1

A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:
positioning a nerve modulation device in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and
reducing neural communication to and from the kidney by at least partially ablating the neural fibers of the patient via the nerve modulation device,
wherein the kidney continues to secrete renin in the patient after reducing neural communication with the nerve modulation device,
wherein reducing neural communication to and from the kidney results in improved cardio-renal function of the patient.

### Claim 2 (depends on 1)

The method of claim 1 wherein positioning a nerve modulation device in a vicinity of post-ganglionic neural fibers comprises positioning the nerve modulation device within a renal vasculature the patient.

### Claim 3 (depends on 2)

The method of claim 2 wherein positioning the nerve modulation device within a renal vasculature comprises positioning the nerve modulation device within a renal artery of the patient.

### Claim 4 (depends on 1)

The method of claim 1 wherein positioning the nerve modulation device in a vicinity of post-ganglionic neural fibers comprises percutaneously advancing the nerve modulation device within a renal blood vessel of the patient proximate to the renal nerve.

### Claim 5 (depends on 1)

The method of claim 1 wherein positioning a nerve modulation device comprises positioning a thermal transfer device in a vicinity of the post-ganglionic neural fibers of the patient.

### Claim 6 (depends on 5)

The method of claim 5 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises cooling afferent and efferent nerves of the patient via the thermal transfer device.

### Claim 7 (depends on 6)

The method of claim 6 wherein cooling afferent and efferent nerves of the patient comprises delivering a chilled fluid to a target region at least proximate to the afferent and efferent nerves.

### Claim 8 (depends on 6)

The method of claim 6 wherein positioning a thermal transfer device in a vicinity of the post-ganglionic neural fibers of the patient comprises positioning a Peltier device in a vicinity of the post-ganglionic neural fibers.

### Claim 9 (depends on 5)

The method of claim 5 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises heating afferent and efferent nerves of the patient via the thermal transfer device.

### Claim 10 (depends on 9)

The method of claim 9 wherein heating afferent and efferent nerves comprises heating the nerves with RF energy.

### Claim 11 (depends on 1)

The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises delivering an electric field via the nerve modulation device to afferent and efferent nerves of the patient.

### Claim 12 (depends on 1)

The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises delivering a chemical agent to afferent and efferent nerves proximate the nerve modulation device.

### Claim 13 (depends on 12)

The method of claim 12 wherein delivering a chemical agent comprises delivering alcohol.

### Claim 14 (depends on 12)

The method of claim 12 wherein delivering a chemical agent comprises delivering phenol.

### Claim 15 (depends on 1)

The method of claim 1 wherein reducing neural communication to and from the kidney by at least partially ablating a renal nerve comprises irreversibly ablating afferent and efferent nerves of the patient.

### Claim 16 (depends on 1)

The method of claim 1, further comprising removing the nerve modulation device from the patient after at least partially ablating the renal nerve.

### Claim 17

A method for treating a human patient with a diagnosed condition or disease associated with cardio-renal function, the method comprising:
positioning an energy element in a renal vasculature of the patient and in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and
at least partially ablating a renal nerve of the patient via the energy element,
wherein at least partially ablating the renal nerve results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 18 (depends on 17)

The method of claim 17 wherein positioning an energy element in a renal vasculature of the patient comprises positioning a thermal transfer device in the renal vasculature of the patient and in a vicinity of the neural fibers.

### Claim 19 (depends on 18)

The method of claim 18 wherein at least partially ablating a renal plexus of the patient comprises cooling afferent and efferent nerves of the patient via the thermal transfer device.

### Claim 20

A method for therapeutic renal denervation of a human patient having a diagnosed condition or disease associated with central sympathetic overactivity, the method comprising:
positioning a thermal element in a renal vasculature of the patient and in a vicinity of post-ganglionic neural fibers that innervate a kidney of the patient; and
at least partially ablating the neural fibers of the patient via the thermal element,
wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

### Claim 21 (depends on 20)

The method of claim 20 wherein positioning a thermal element in a renal vasculature of the patient comprises positioning a renal denervation catheter having an energy element in the renal vasculature of the patient.

### Claim 22 (depends on 21)

The method of claim 21 wherein positioning a renal denervation catheter having an energy element in the renal vasculature of the patient comprises positioning a renal denervation catheter having an electrode in the renal vasculature of the patient.

### Claim 23 (depends on 20)

The method of claim 20 wherein at least partially ablating the neural fibers of the patient via the thermal element comprises at least partially ablating the neural fibers via cold.

### Claim 24 (depends on 20)

The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of hypertension in the patient.

### Claim 25 (depends on 20)

The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of heart failure in the patient.

### Claim 26 (depends on 20)

The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of chronic renal failure in the patient.

### Claim 27 (depends on 20)

The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of impaired renal function in the patient.

### Claim 28 (depends on 20)

The method of claim 20 wherein the therapeutically beneficial reduction in central sympathetic overactivity comprises a reduction in clinical symptoms of acute myocardial infarction in the patient.
