# US 11,027,115 B2 · Systems and methods for electroporation

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- Number: US 11,027,115 B2
- Document ID: US11027115B2
- Status: Granted
- Kind: B2
- Application number: 16/805,017
- Filed: 2020-02-28
- Published: 2020-06-25
- Granted: 2021-06-08
- Earliest claimed: 2017-10-23
- Assignees: Mayo Foundation for Medical Education and Research
- Applicants: Mayo Foundation for Medical Education and Research
- Inventors: Samuel J. Asirvatham; Paul A. Friedman
- Web page: https://patentgrep.com/patent/US11027115B2

## CPC

- A61N 1/0416: {Anode and cathode}
- A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation}
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61N 1/0412: {Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs}
- A61N 1/36117: {for treating hypertension}
- A61N 1/36135: {using physiological parameters}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00613: {Irreversible electroporation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36185: {Selection of the electrode configuration}
- 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)

## Abstract

This document describes methods and materials for improving treatment of hypertension. For example, this document describes methods and devices for electroporation of nerves in the renal area to treat hypertension.

## Claims

### Claim 1

A system for providing electroporation, the system comprising:
a first electrode and a second electrode configured to be placed in a renal area of a patient;
a sensor; and
a pulse generator coupled to the first electrode, the second electrode, and the sensor, the pulse generator comprising:
a memory that is capable of storing computer executable instructions; and
a processor that is configured to facilitate execution of the executable instructions stored in the memory, wherein the instructions cause the processor to:
generate, via the pulse generator, a stimulation electrical current to cause stimulation between the first electrode and the second electrode for the renal area;
detect, via the sensor, a change in blood pressure of the patient resulting from the stimulation electrical current; and
in response to detecting the change in blood pressure of the patient, generate an electroporation electrical current to cause reversible or irreversible electroporation between the first electrode and the second electrode for the renal area.

### Claim 2 (depends on 1)

The system of claim 1, wherein the renal area comprises at least one of a renal vein, a renal artery, and a renal pelvis.

### Claim 3 (depends on 1)

The system of claim 1, wherein the instructions further cause the processor to change an electrode configuration when no change in blood pressure of the patient is detected.

### Claim 4 (depends on 3)

The system of claim 3, wherein the changing the electrode configuration comprises at least one of changing a location of the first electrode or the second electrode, changing a polarity of the first electrode or the second electrode, and changing a parameter for the stimulation electrical current.

### Claim 5 (depends on 1)

The system of claim 1, wherein the instructions further cause the processor to:
generate, via the pulse generator, a second stimulation electrical current; and
detect, via the sensor, a physiological response to the second stimulation electrical current.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a third electrode configured to be located outside of the renal area.

### Claim 7 (depends on 6)

The system of claim 6, wherein the instructions further cause the processor to:
change both the first electrode and the second electrode to an anode or a cathode;
change the third electrode to the other of the anode or the cathode;
generate, via the pulse generator, a second stimulation electrical current; and
detect, via the sensor, a physiological response to the second stimulation electrical current.

### Claim 8 (depends on 7)

The system of claim 7, wherein the instructions further cause the processor to generate a second electroporation electrical current in response to detecting the physiological response to the second stimulation electrical current.

### Claim 9 (depends on 1)

The system of claim 1, wherein the first and second electrodes are configured to be placed near sites of autonomic nervous tissue in the renal area of the patient.

### Claim 10 (depends on 9)

The system of claim 9, wherein the first and second electrodes are configured to permit electric field distribution over nerves adjacent the patient's inferior vena cava, descending aorta, or ureters.

### Claim 11 (depends on 1)

The system of claim 1, wherein the electroporation electric current is configured to be delivered in pulses with a pulse width in nanoseconds.

### Claim 12 (depends on 5)

The system of claim 5, wherein the physiological response is a change in at least one of heart rate, blood pressure, transcutaneous impedance, and neural traffic in a peripheral nerve.

### Claim 13

A method of providing electroporation, the method comprising:
placing a first electrode and a second electrode in a renal area of a patient;
generating, via a pulse generator, a stimulation electrical current to cause stimulation between the first electrode and the second electrode for the renal area;
detecting, via a sensor, a change in blood pressure of the patient resulting from the stimulation electrical current; and
in response to detecting the change in blood pressure of the patient, generating an electroporation electrical current to cause reversible or irreversible electroporation between the first electrode and the second electrode for the renal area.

### Claim 14 (depends on 13)

The method of claim 13, wherein the renal area comprises at least one of a renal vein, a renal artery, and a renal pelvis.

### Claim 15 (depends on 13)

The method of claim 13, further comprising:
changing an electrode configuration when no change in blood pressure of the patient is detected.

### Claim 16 (depends on 15)

The method of claim 15 wherein the changing further comprises changing at least one of:
a location of the first electrode or the second electrode,
a polarity of the first electrode or the second electrode, and
a parameter for the stimulation electrical current.

### Claim 17 (depends on 13)

The method of claim 13, further comprising:
generating a second stimulation electrical current to cause stimulation between the first electrode and the second electrode; and
detecting a physiological response to the second stimulation electrical current.

### Claim 18 (depends on 13)

The method of claim 13, further comprising placing a third electrode outside the renal area.

### Claim 19 (depends on 18)

The method of claim 18, further comprising:
changing both the first electrode and the second electrode to an anode or a cathode;
changing the third electrode to the other of the anode or the cathode;
generating, via the pulse generator, a second stimulation electrical current; and
detecting a physiological response to the second stimulation electrical current.

### Claim 20 (depends on 19)

The method of claim 19, further comprising generating a second electroporation electrical current in response to detecting the physiological response to the second stimulation electrical current.