# US 2023/0054079 A1 · Pulse field ablation for the treatment of migraines

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- Number: US 2023/0054079 A1
- Document ID: US20230054079A1
- Status: Published application
- Kind: A1
- Application number: 17/892,509
- Filed: 2022-08-22
- Published: 2023-02-23
- Earliest claimed: 2021-08-23
- Inventors: Natraj Lakshmi
- Web page: https://patentgrep.com/patent/US20230054079A1

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1206: {Generators therefor}
- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61B 2017/0019: {Means for setting or varying the pulse width}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00321: {Head or parts thereof}
- A61B 2018/00327: {Ear, nose or throat}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00577: {Ablation}
- A61B 2018/00761: {Duration}
- A61B 2018/00767: {Voltage}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Described herein is a method of treating migraines using PFA ablation technology which includes advancing a pulse field ablation delivery member into a nasal cavity (both unilateral and bilateral) of a patient with the pulse field ablation member in a first collapsed configuration and contacting a surface of a nasal cavity tissue with the pulse field ablation delivery member without penetrating or piercing the nasal cavity tissue surface. The treatment further includes reconfiguring the pulse field ablation delivery member from the first collapsed configuration to an expanded configuration after introducing the pulse field ablation member into the desired position within the nasal cavity, and ablating a target treatment site with the pulse field ablation delivery member in order to treat or prevent at least one of the group of medical conditions, wherein the target treatment site includes at least one nasal nerve tissue or nasal blood vessel with or without contact.

## Claims

### Claim 1

A method for treating or preventing in a patient any one of a number of medical conditions in a group consisting of: a chronic daily headache, cluster headache, tension headache, migraine, or acute headache, the method comprising:
advancing a pulse field ablation delivery member into a nasal cavity (both unilateral and bilateral) of a patient with the pulse field ablation member in a first collapsed configuration;
contacting a surface of a nasal cavity tissue with the pulse field ablation delivery member without penetrating or piercing the nasal cavity tissue surface;
reconfiguring the pulse field ablation (PFA) delivery member from the first collapsed configuration to an expanded configuration after locating the pulse field ablation member proximate a target treatment site within the nasal cavity; and
ablating the target treatment site with the pulse field ablation delivery member to ablate tissue in the nasal cavity via a train of pulses having a predetermined time duration and amplitude level or voltage level, wherein the target treatment site includes at least one nasal nerve tissue or nasal blood vessel.

### Claim 2 (depends on 1)

The method of claim 1, wherein advancing the pulse field ablation delivery member into the nasal cavity includes further advancing the pulse field ablation delivery member into at least one of an inferior meatus, a middle meatus, or a superior meatus.

### Claim 3 (depends on 1)

The method of claim 1 wherein the nasal blood vessel is a sphenopalatine artery.

### Claim 4 (depends on 1)

The method of claim 1 wherein the nasal nerve tissue is a sphenopalatine ganglion (SPG), and wherein the sphenopalatine ganglion is ablated or pulsed through a perpendicular plate of a palatine bone within a superior meatus between a middle turbinate and an anterior face of a sphenoid sinus.

### Claim 5 (depends on 1)

The method of any one of claim 1, wherein the nasal nerve tissue is any one of a group consisting of:
a posterior nasal nerve or an accessory posterior nasal nerve;
a nerve branch originating from the sphenopalatine ganglion;
an autonomic nerve branch; and
a sensory nerve fiber.

### Claim 6 (depends on 1)

The method of any one of claim 1, wherein the nasal nerve tissue is a parasympathetic nerve fiber.

### Claim 7 (depends on 6)

The method of claim 6, wherein the parasympathetic nerve fiber is a postsynaptic parasympathetic nerve fibers emerging from a sphenopalatine ganglion.

### Claim 8 (depends on 1)

The method of claim 1, wherein advancing the pulse field ablation delivery member into the nasal cavity includes further advancing the pulse field ablation delivery member to a treatment site in the nasal cavity responsive to PFA ablation to treat for Rhinitis.

### Claim 9 (depends on 1)

The method of claim 1, wherein advancing the pulse field ablation delivery member into the nasal cavity includes further advancing the pulse field ablation delivery member to a treatment site in the nasal cavity responsive to PFA ablation to treat a nasal obstruction.

### Claim 10

A system for treating a patient having a medical condition related to an upper respiratory location, the medical condition being at least one of a group consisting of a chronic daily headache, cluster headache, tension headache, migraine, or acute headache, the system comprising:
a pulse field ablation (PFA) delivery member having a distal end and a proximal end, the distal end of the pulse field ablation delivery member adapted to have a probe tip with a plurality of electrodes for insertion into a nasal cavity of a patient; and
a pulse generator and control module adapted to be operatively coupled to the proximal end of the pulse field ablation delivery member, the pulse generator and control module adapted to energize the probe tip with the plurality of electrodes to ablate tissue in the nasal cavity via a train of pulses having a predetermined time duration and amplitude level or voltage level.

### Claim 11 (depends on 10)

The system of claim 10, wherein the probe tip is adapted to stimulate various areas proximate to the SPG nerve tissue.

### Claim 12 (depends on 10)

The system of claim 10, wherein the train of pulses includes individual pulses with a time duration from 100-900 microseconds and a voltage level of 5V to 5000V.

### Claim 13 (depends on 10)

The system of claim 10, wherein the probe tip is adapted to ablate various areas proximate the SPG nerve tissue.

### Claim 14 (depends on 12)

The system of claim 12 wherein the train of pulses are either mono or biphasic.

### Claim 15 (depends on 4)

The method of claim 4 wherein the PFA delivery member includes a probe tip adapted to stimulate various areas proximate to the SPG nerve tissue.

### Claim 16 (depends on 15)

The method of claim 15, wherein the probe tip provides a train of pulses that includes individual pulses with a time duration from 100-900 microseconds and a voltage level of 5V to 5000V.

### Claim 17 (depends on 15)

The method of claim 15, wherein the probe tip is adapted to ablate various areas proximate the SPG nerve tissue.

### Claim 18 (depends on 16)

The method of claim 16 wherein the train of pulses are either mono or biphasic.
