# US 12,108,979 B2 · Systems and methods for improving sleep with therapeutic nasal treatment

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- Number: US 12,108,979 B2
- Document ID: US12108979B2
- Status: Granted
- Kind: B2
- Application number: 18/411,460
- Filed: 2024-01-12
- Published: 2024-05-02
- Granted: 2024-10-08
- Earliest claimed: 2020-04-09
- Assignees: Neurent Medical Limited
- Applicants: Neurent Medical Limited
- Inventors: David Townley
- Web page: https://patentgrep.com/patent/US12108979B2

## CPC

- A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy}
- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/082: {Probes or electrodes therefor}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2018/00267: {having a basket shaped structure}
- 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 2018/00583: {Coblation, i.e. ablation using a cold plasma}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The invention generally relates to systems and methods for improving sleep by treating at least one of rhinitis, congestion, and/or rhinorrhea to thereby reduce or eliminate symptoms associated therewith, including, but not limited to, nasal congestion, coughing, sneezing, and nasal or throat irritation and itching.

## Claims

### Claim 1

A method for improving a patient's sleep by treating at least one of congestion, obstruction, and blockage within a sino-nasal cavity of the patient, the method comprising:
advancing an end effector of a treatment device into the sino-nasal cavity of the patient, the end effector being positioned at a distal portion of a shaft of the treatment device, wherein the end effector comprises:
an array of bipolar electrodes provided thereon and comprising at least first electrode that is spaced apart from a separate and distinct second electrode along a length of the end effector, wherein each of the first and second electrodes comprises an active state and an inactive state and comprises a separate respective location on the end effector and extends beyond surface of the shaft, wherein each of the first and second electrodes is configured to deliver temperature-controlled radiofrequency (RF) energy to tissue at one or more target sites within the nasal cavity of the patient; and
at least one temperature sensor arranged relative to the array of electrodes;
positioning the end effector at a target site to thereby cause at least the first and second electrodes to be in direct contact with tissue at a target site within the sino-nasal cavity; and
delivering RF energy from the first and second electrodes to tissue at the target site at a level and for a period of time sufficient to cause reduced engorgement of the tissue and thereby increase volumetric flow through an associated nasal passage of the patient to improve nasal breathability of the patient;
wherein delivery of RF energy is controlled via a console unit operably coupled to the array of bipolar electrodes and the at least one temperature sensor based, at least in part, on feedback received from the at least one temperature sensor in order to maintain a predetermined temperature of the tissue at the target site.

### Claim 2 (depends on 1)

The method of claim 1, wherein the target site comprises an inferior turbinate within the nasal cavity and the tissue comprises submucosal tissue associated with the inferior turbinate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the console unit is operably coupled to an energy generator configured to generate RF energy to be delivered by the first and second electrodes.

### Claim 4 (depends on 3)

The method of claim 3, wherein the RF energy comprises at least bipolar RF energy.

### Claim 5 (depends on 1)

The method of claim 1, wherein the array of electrodes comprises at least four electrodes.

### Claim 6 (depends on 5)

The method of claim 5, wherein the array of electrodes comprises at least eight electrodes.

### Claim 7 (depends on 1)

The method of claim 1, wherein the console unit is configured to receive one or more temperature readings from the at least one temperature sensor and process the readings to determine a level of RF energy to be delivered by the first and second electrodes that is sufficient to maintain a temperature of the tissue at the target site below a predetermined threshold maximum temperature of tissue during delivery of energy to ensure that application of the RF energy results in the desired effect of reduced engorgement of the tissue at the target site for a given treatment application.

### Claim 8 (depends on 7)

The method of claim 7, wherein the console unit is configured to monitor temperature of tissue at the target site during delivery of RF energy thereto based on temperature readings from the at least one temperature sensor and further monitor an elapsed time during delivery of RF energy to tissue at the target site.

### Claim 9 (depends on 7)

The method of claim 7, wherein the console unit is configured to provide, via a display, feedback information to an operator during delivery of RF energy, wherein said feedback information comprises at least an elapsed time during delivery of RF energy to tissue at the target site.

### Claim 10 (depends on 9)

The method of claim 9, wherein the display is a touchscreen monitor.

### Claim 11 (depends on 7)

The method of claim 7, wherein the console unit comprises a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console unit to automatically control and adjust RF energy output from the array of electrodes based, at least in part, on a predetermined elapsed time period and the predetermined threshold maximum temperature.

### Claim 12 (depends on 11)

The method of claim 11, wherein the predetermined threshold maximum temperature is less than 90° C.

### Claim 13 (depends on 11)

The method of claim 11, wherein the predetermined threshold maximum temperature is greater than 37° C. and less than 90° C.

### Claim 14 (depends on 11)

The method of claim 11, the predetermined elapsed time period is from about 1 second to about 20 seconds.

### Claim 15 (depends on 14)

The method of claim 14, wherein the predetermined elapsed time period is from about 5 seconds to about 10 seconds.

### Claim 16 (depends on 14)

The method of claim 14, wherein the predetermined elapsed time period is from about 8 seconds to about 10 seconds.

### Claim 17 (depends on 14)

The method of claim 14, wherein the predetermined elapsed time period is from about 10 seconds to about 12 seconds.
