# US 11,998,262 B1 · Systems and methods for improving sleep with therapeutic nasal treatment

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- Number: US 11,998,262 B1
- Document ID: US11998262B1
- Status: Granted
- Kind: B1
- Application number: 18/411,476
- Filed: 2024-01-12
- Published: 2024-06-13
- Granted: 2024-06-04
- Earliest claimed: 2020-04-09
- Assignees: Neurent Medical Limited
- Applicants: Neurent Medical Limited
- Inventors: David Townley
- Web page: https://patentgrep.com/patent/US11998262B1

## 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 rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of a patient, the method comprising:
advancing a multi-electrode end effector into the sino-nasal cavity of the patient, the multi-electrode end effector being operably associated with a shaft of a treatment device and configured for delivering energy to one or more target sites within the sino-nasal cavity of the patient, the multi-electrode end effector comprising a first electrode that is spaced apart from a separate and distinct second electrode along a length of the multi-electrode end effector, wherein each of the first and second electrodes comprises an active state and an inactive state and comprises a respective location on the multi-electrode end effector, wherein:
the first electrode is exposed from a surface of the multi-electrode end effector and is positioned at a separate and discrete portion thereon, the first electrode extending in a first outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a first location within the nasal cavity; and
the second electrode is exposed from a surface of the multi-electrode end effector and is positioned at a separate and discrete portion thereon, the second electrode extending in a second outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a second location within the nasal cavity; and
delivering energy, via the first and second electrodes, to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals to, and/or result in local hypoxia of, mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminating one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the one or more target sites 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 multi-electrode end effector comprises at least four electrodes.

### Claim 4 (depends on 3)

The method of claim 3, wherein the multi-electrode end effector comprises at least eight electrodes.

### Claim 5 (depends on 1)

The method of claim 1, wherein radiofrequency (RF) energy is delivered from the first and second electrodes to tissue at the one or more target sites and is controlled via a console unit operably associated with the treatment device and multi-electrode end effector.

### Claim 6 (depends on 5)

The method of claim 5, 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 7 (depends on 6)

The method of claim 6, wherein the RF energy comprises at least bipolar RF energy.

### Claim 8 (depends on 5)

The method of claim 5, wherein the console unit is configured to receive feedback from at least one temperature sensor arranged relative to the first and second electrodes and configured to sense temperature at an interface between tissue and the first and second electrodes, wherein the console unit is configured to control energy output from the first and second electrodes based, at least in part, on the feedback in order to maintain a predetermined temperature of tissue at the one or more target sites.

### Claim 9 (depends on 8)

The method of claim 8, 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 tissue at the one or more target sites below a predetermined threshold.

### Claim 10 (depends on 9)

The method of claim 9, wherein the console unit is configured to monitor temperature of tissue at the one or more target sites 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 one or more target sites.

### Claim 11 (depends on 9)

The method of claim 9, wherein the console unit is configured to provide, via a display, feedback information to an operator during each treatment application, wherein said feedback information comprises at least an elapsed time during delivery of RF energy to tissue at the one or more target sites.

### Claim 12 (depends on 11)

The method of claim 11, wherein the display is a touchscreen monitor.

### Claim 13 (depends on 9)

The method of claim 9, wherein the console unit is configured to control RF energy output from the first and second electrodes in separate and discrete treatment applications of RF energy to be delivered to tissue at the one or more target sites, wherein each separate and discrete treatment application comprises a predetermined elapsed time period for each treatment application and a predetermined threshold maximum temperature of tissue during delivery of RF energy to ensure that application of said RF energy results in the desired effect of reduced engorgement of the tissue at the target site for a given treatment application.

### Claim 14 (depends on 13)

The method of claim 13, 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 first and second electrodes for each treatment application based, at least in part, on the predetermined elapsed time period and the predetermined threshold maximum temperature.

### Claim 15 (depends on 14)

The method of claim 14, wherein the predetermined threshold maximum temperature is less than 90ºC.

### Claim 16 (depends on 14)

The method of claim 14, wherein the predetermined threshold maximum temperature is greater than 37° C. and less than 90° C.

### Claim 17 (depends on 14)

The method of claim 14, the predetermined elapsed time period for each separate and discrete treatment application is between 1 second to 20 seconds.

### Claim 18 (depends on 17)

The method of claim 17, wherein the predetermined elapsed time period for each separate and discrete treatment application is between 5 seconds and 10 seconds.

### Claim 19 (depends on 17)

The method of claim 17, wherein the predetermined elapsed time period for each separate and discrete treatment application is between 8 seconds and 10 seconds.

### Claim 20 (depends on 17)

The method of claim 17, wherein the predetermined elapsed time period for each separate and discrete treatment application is between 10 seconds and 12 seconds.