# US 8,784,463 B2 · Methods for thermally-induced renal neuromodulation

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- Number: US 8,784,463 B2
- Document ID: US8784463B2
- Status: Granted
- Kind: B2
- Application number: 13/765,487
- Filed: 2013-02-12
- Published: 2013-06-20
- Granted: 2014-07-22
- Earliest claimed: 2002-04-08
- Assignees: Medtronic Ardian Luxembourg S.a.r.l.
- Applicants: Medtronic Ardian Luxembourg S.a.r.l.
- Inventors: Denise Zarins; Nicolas Zadno; Benjamin J. Clark; Erik Thai; Howard R. Levin; Mark Gelfand
- Web page: https://patentgrep.com/patent/US8784463B2

## CPC

- A61N 7/022: {intracavitary}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/12: by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61F 7/007: {characterised by electric heating}
- A61F 7/12: Devices for heating or cooling internal body cavities
- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61M 5/44: having means for cooling or heating the devices or media
- A61N 1/28: Apparatus for applying thermoelectric currents
- A61N 1/403: {for thermotherapy, e.g. hyperthermia}
- A61N 5/00: Radiation therapy (ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00)
- A61N 5/025: {Warming the body, e.g. hyperthermia treatment}
- A61N 5/045: {specially adapted for treatment inside the body}
- A61N 5/0603: {for treatment of body cavities}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 2018/0022: {Balloons}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- A61M 2210/1082: Kidney
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 2007/003: {Destruction of nerve tissue}
- A61N 2007/0078: {with multiple treatment transducers}
- 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)
- 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)}

## 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.

## Claims

### Claim 1

A method for thermally-induced renal neuromodulation of a human patient, the method comprising:
delivering a renal neuromodulation device to a vicinity of a neural fiber that contributes to renal function of the patient; and
thermally inducing modulation of a function of the neural fiber with the renal neuromodulation device such that the neural fiber is thermally altered.

### Claim 2 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises directly applying thermal energy to the neural fiber.

### Claim 3 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises indirectly applying thermal energy to the neural fiber.

### Claim 4 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal electric field to the neural fiber via at least one electrode.

### Claim 5 (depends on 4)

The method of claim 4 wherein:
delivering a renal neuromodulation device to a vicinity of the neural fiber further comprises intravascularly delivering the renal neuromodulation device; and
delivering a thermal electric field to the neural fiber via at least one electrode further comprises delivering the thermal electric field via at least one wall-contacting electrode.

### Claim 6 (depends on 1)

The method of claim 1, further comprising monitoring a parameter of (a) the neural fiber, (b) non-target tissue, and/or (c) the renal neuromodulation device during thermally-induced modulation of the function of the neural fiber.

### Claim 7 (depends on 6)

The method of claim 6, further comprising controlling the thermally-induced modulation in response to the monitored parameter.

### Claim 8 (depends on 1)

The method of claim 1, further comprising actively protecting non-target tissue during thermally-induced modulation of the function of the neural fiber.

### Claim 9 (depends on 8)

The method of claim 8 wherein actively protecting the non-target tissue further comprises reducing a degree of thermal damage induced in the non-target tissue.

### Claim 10 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering a thermal fluid to a vicinity of the neural fiber.

### Claim 11 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises exchanging heat with the neural fiber via a thermoelectric element.

### Claim 12 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering ultrasound to the neural fiber.

### Claim 13 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber further comprises delivering high intensity focused ultrasound to the neural fiber.

### Claim 14 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of the function of the neural fiber further comprises heating the neural fiber.

### Claim 15 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of the function of the neural fiber further comprises cooling the neural fiber.

### Claim 16 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber therapeutically treats a diagnosed condition or disease associated with cardio-renal function of the patient.

### Claim 17 (depends on 1)

The method of claim 1 wherein thermally inducing modulation of a function of the neural fiber results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 18 (depends on 1)

The method of claim 1, further comprising removing the renal neuromodulation device from the patient after thermally inducing modulation of the neural fiber.

### Claim 19

A method for thermally-induced renal neuromodulation of a human patient, the method comprising:
delivering a device proximate to a neural fiber that contributes to renal function of the patient; and
thermally inducing modulation of a function of the neural fiber with the device,
wherein thermally inducing modulation of a function of the neural fiber results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 20 (depends on 19)

The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises blocking neural traffic to and/or from a kidney of the patient.

### Claim 21 (depends on 19)

The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises ablating the neural fiber.

### Claim 22 (depends on 19)

The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises cooling the neural fiber.

### Claim 23 (depends on 19)

The method of claim 19 wherein thermally inducing modulation of a function of the neural fiber comprises at least partially denervating a kidney of the patient.

### Claim 24 (depends on 19)

The method of claim 19, further comprising removing the device from the patient after thermally inducing modulation of the neural fiber.
