# US 10,245,429 B2 · Methods and apparatus for renal neuromodulation

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- Number: US 10,245,429 B2
- Document ID: US10245429B2
- Status: Granted
- Kind: B2
- Application number: 15/946,919
- Filed: 2018-04-06
- Published: 2018-08-16
- Granted: 2019-04-02
- Earliest claimed: 2002-04-08
- Assignees: Medtronic Ardian Luxembourg S.a.r.l.
- Applicants: Medtronic Ardian Luxembourg S.a.r.l.
- Inventors: Mark E. Deem; Hanson Gifford, III; Denise Zarins; Douglas Sutton; Erik Thai; Mark Gelfand; Howard R. Levin
- Web page: https://patentgrep.com/patent/US10245429B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 18/1206: {Generators therefor}
- A61B 18/1233: {with circuits for assuring patient safety}
- A61B 18/18: by applying electromagnetic radiation, e.g. microwaves
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/18: Applying electric currents by contact electrodes
- A61N 1/205: {for promoting a biological process}
- A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/36103: {Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke}
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- A61N 1/36139: {with automatic adjustment}
- A61N 5/00: Radiation therapy (ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00)
- 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})
- A61B 2018/00071: {Electrical conductivity}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/0022: {Balloons}
- A61B 2018/00267: {having a basket shaped structure}
- 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 2018/00613: {Irreversible electroporation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2018/126: {bipolar}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61N 1/0412: {Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs}
- A61N 1/326: {for promoting growth of cells, e.g. bone cells}
- A61N 1/36117: {for treating hypertension}
- A61N 2007/0021: {Neural system treatment}
- A61N 2007/003: {Destruction of nerve tissue}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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 renal neuromodulation using a pulsed electric field to effectuate electroporation or electrofusion. It is expected that renal neuromodulation (e.g., denervation) may, among other things, reduce expansion of an acute myocardial infarction, reduce or prevent the onset of morphological changes that are affiliated with congestive heart failure, and/or be efficacious in the treatment of end stage renal disease. Embodiments of the present invention are configured for percutaneous intravascular delivery of pulsed electric fields to achieve such neuromodulation.

## Claims

### Claim 1

A method for catheter-based renal denervation of a hypertensive human patient, the method comprising:
intravascularly positioning a distal region of a catheter within a renal artery associated with a kidney of the patient; and
at least partially ablating target neural tissue innervating the kidney of the patient via ultrasound energy from the catheter, wherein the ultrasound energy is delivered via an ultrasound transducer carried by a shaft of the catheter,
wherein at least partially ablating the target neural tissue results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 2 (depends on 1)

The method of claim 1, further comprising removing the catheter from the patient after at least partially ablating the target neural tissue via the ultrasound energy to conclude the procedure.

### Claim 3 (depends on 1)

The method of claim 1 wherein at least partially ablating the target neural tissue innervating the kidney further results in a therapeutically beneficial reduction in central sympathetic overactivity of the patient.

### Claim 4 (depends on 1)

The method of claim 1 wherein the ultrasound energy is unfocused ultrasound energy.

### Claim 5 (depends on 1)

The method of claim 1 wherein the ultrasound energy is high frequency ultrasound energy.

### Claim 6 (depends on 1)

The method of claim 1 wherein intravascularly positioning a distal region of a catheter within a renal artery comprises intravascularly positioning the catheter over a guidewire.

### Claim 7 (depends on 1)

The method of claim 1, further comprising monitoring a parameter of the catheter and/or tissue within the patient before and during delivery of ultrasound energy.

### Claim 8 (depends on 7)

The method of claim 7, further comprising altering delivery of ultrasound energy in response to the monitored parameter.

### Claim 9 (depends on 1)

The method of claim 1 wherein the distal region of the catheter further comprises an expandable centering element, and wherein the method further comprises transforming the centering element between a low-profile delivery configuration and an expanded configuration after intravascularly positioning the distal region of the catheter within the renal artery and before delivering the ultrasound energy via the ultrasound transducer.

### Claim 10 (depends on 9)

The method of claim 9 wherein the expandable centering element comprises a balloon.

### Claim 11

A method, comprising:
intravascularly advancing an energy delivery element carried by a catheter within renal vasculature of a human patient and proximate to renal nerves of the patient; and
delivering unfocused ultrasound energy via the energy delivery element, wherein the ultrasound energy inhibits neural traffic along the renal nerves to and/or from a kidney of the patient,
wherein inhibiting the neural traffic along the renal nerves results in a therapeutically beneficial reduction in blood pressure of the patient.

### Claim 12 (depends on 11)

The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises blocking afferent and/or efferent renal nerve activity.

### Claim 13 (depends on 11)

The method of claim 11 wherein a distal portion of the catheter further comprises an expandable positioning element, and wherein intravascularly advancing an energy delivery element within renal vasculature of the patient comprises positioning the catheter within a renal artery of the patient via the expandable positioning element before delivering the unfocused ultrasound energy via the energy delivery element.

### Claim 14 (depends on 13)

The method of claim 13 wherein the expandable positioning element comprises an inflatable balloon.

### Claim 15 (depends on 11)

The method of claim 11, further comprising intravascularly removing the catheter and energy delivery element from the patient after delivering the unfocused ultrasound energy to conclude the procedure.

### Claim 16 (depends on 11)

The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises reducing renal sympathetic nerve activity of the kidney of the patient.

### Claim 17 (depends on 11)

The method of claim 11 wherein inhibiting neural traffic along the renal nerves via the ultrasound energy comprises denervating the kidney of the patient.