# US 12,004,800 B2 · Systems and methods for therapeutic nasal neuromodulation

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,004,800 B2
- Document ID: US12004800B2
- Status: Granted
- Kind: B2
- Application number: 16/701,869
- Filed: 2019-12-03
- Published: 2020-06-11
- Granted: 2024-06-11
- Earliest claimed: 2018-12-11
- Assignees: Neurent Medical Limited
- Applicants: Neurent Medical Limited
- Inventors: David Townley; Brian Shields
- Web page: https://patentgrep.com/patent/US12004800B2

## CPC

- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61B 18/14: Probes or electrodes therefor
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61N 1/0546: {Nasal electrodes}
- A61N 1/403: {for thermotherapy, e.g. hyperthermia}
- G06T 7/0012: {Biomedical image inspection}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/1206: {Generators therefor}
- A61B 18/20: using laser
- A61B 90/94: coded with symbols, e.g. text
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2017/00424: {ergonomic, e.g. fitting in fist}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00303: {active, e.g. with a motor creating vibrations}
- A61B 2018/00327: {Ear, nose or throat}
- A61B 2018/00434: {Neural system}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00654: {with individual control of each of a plurality of energy emitting elements}
- A61B 2018/00678: {upper}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/00815: {measured by a thermistor}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00916: {with means for switching or controlling the main function of the instrument or device}
- A61B 2018/00922: {by switching or controlling the treatment energy directly within the hand-piece}
- A61B 2018/00946: {slidable}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/1253: {monopolar}
- A61B 2018/126: {bipolar}
- A61B 2018/1407: {Loop}
- A61B 2018/143: {multiple needles}
- A61B 2018/144: {Wire}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2018/1823: {Generators therefor}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2090/3735: {Optical coherence tomography [OCT]}
- A61B 2090/3762: {using computed tomography systems [CT]}
- A61B 2090/378: {using ultrasound}
- A61B 2218/007: Aspiration
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL

## Abstract

The invention generally relates to systems and methods for therapeutically modulating nerves in or associated with a nasal region of a patient for the treatment of a rhinosinusitis condition.

## Claims

### Claim 1

A device for treating a condition within a nasal cavity of a patient, the device comprising:
a multi-segment end effector operably associated with a shaft and comprising a first segment that is spaced apart from a separate and distinct second segment along a longitudinal axis along which a distal most portion of the shaft lies, wherein the second segment is positioned closer to a distal-most end of the shaft and the first segment is positioned closer to a proximal-most end of the shaft, each of the first and second segments is transformable between a retracted configuration and an expanded deployed configuration and comprises a respective architecture in the expanded deployed configuration, the first segment comprises a first architecture and the second segment comprises a second architecture that is different than the first architecture of the first segment,
wherein the first segment comprises:
a first set of a plurality of flexible support elements that extend in a first outward direction relative to the longitudinal axis and are positioned within a first half of the first segment and cooperatively form an inwardly extending first concave shape when the first segment is in the expanded deployed configuration; and
a second set of a plurality of flexible support elements that extend in a second outward direction relative to the longitudinal axis and substantially opposite the first outward direction and are positioned within a second half of the first segment and cooperatively form an inwardly extending second concave shape substantially mirroring the first concave shape when the first segment is in the expanded deployed configuration, the first and second sets of plurality of flexible support elements cooperatively define the first architecture of the first segment when in the expanded deployed configuration, and
wherein the second segment comprises a third set of flexible support elements that cooperatively form the second segment and define the second architecture of the second segment when in the expanded deployed configuration, wherein each flexible support element of the first, second, and third sets comprises one or more electrodes provided thereon; and
a handle operably associated with the shaft, the handle having a first user-manipulatable mechanism for deployment of each of the first and second segments of the multi-segment end effector from the retracted configuration to the expanded deployed configuration and a second user-manipulatable mechanism, separate from the first user-manipulatable mechanism, for control of energy output by each of the first, second, and third segments of the multi-segment end effector.

### Claim 2 (depends on 1)

The device of claim 1, wherein the handle comprises an ergonomically-designed grip portion comprising a shape, size, and contour providing for ambidextrous use for both left and right handed use and conforming to hand anthropometrics to allow for at least one of an overhand grip style and an underhand grip style during use in a procedure.

### Claim 3 (depends on 2)

The device of claim 2, wherein user input for the first user-manipulatable mechanism is positioned on a top portion of the handle adjacent the grip portion and user input for the second user-manipulatable mechanism is positioned on side portions of the handle adjacent the grip portion.

### Claim 4 (depends on 3)

The device of claim 3, wherein the user inputs for the first and second user-manipulatable mechanisms are positioned a sufficient distance to one another to allow for simultaneous one-handed operation of both user inputs during a procedure.

### Claim 5 (depends on 1)

The device of claim 1, wherein the first user-manipulatable mechanism comprises a rack and pinion assembly providing movement of at least one of the first and second segments of the multi-segment end effector between the retracted and deployed configurations in response to input from a user-operated controller.

### Claim 6 (depends on 5)

The device of claim 5, wherein the rack and pinion assembly comprises a set of gears for receiving input from the user-operated controller and converting the input to linear motion of a rack member operably associated with at least one of the shaft and the multi-segment end effector.

### Claim 7 (depends on 6)

The device of claim 6, wherein the rack and pinion assembly comprises a gearing ratio sufficient to balance a stroke length and retraction and deployment forces.

### Claim 8 (depends on 5)

The device of claim 5, wherein the user-operated controller comprises a slider mechanism operably associated with the rack and pinion rail assembly, wherein movement of the slider mechanism in a rearward direction towards a proximal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the deployed configuration and movement of the slider mechanism in a forward direction towards a distal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the retracted configuration.

### Claim 9 (depends on 5)

The device of claim 5, wherein the user-operated controller comprises a scroll wheel mechanism operably associated with the rack and pinion rail assembly, wherein rotation of the wheel in a rearward direction towards a proximal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the deployed configuration and rotation of the wheel in a forward direction towards a distal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the retracted configuration.

### Claim 10 (depends on 1)

The device of claim 1, wherein the second user-manipulatable mechanism comprises a user-operated controller configured to be actuated between an active position and an inactive position to thereby control delivery of energy from the first and second segments of the multi-segment end effector.

### Claim 11

A method for treating a condition within a nasal cavity of a patient, the method comprising:
providing a treatment device comprising: a multi-segment end effector operably associated with a shaft and comprising a first segment that is spaced apart from a separate and distinct second segment along a longitudinal axis along which a distal most portion of the shaft lies, wherein the second segment is positioned closer to a distal-most end of the shaft and the first segment is positioned closer to a proximal-most end of the shaft, each of the first and second segments is transformable between a retracted configuration and an expanded deployed configuration and comprises a respective architecture in the expanded deployed configuration, the first segment comprises a first architecture and the second segment comprises a second architecture that is different than the first architecture of the first segment, wherein the first segment comprises a first set of a plurality of flexible support elements that extend in a first outward direction relative to the longitudinal axis and are positioned within a first half of the first segment and cooperatively form an inwardly extending first concave shape when the first segment is in the expanded deployed configuration and a second set of a plurality of flexible support elements that extend in a second outward direction relative to the longitudinal axis and substantially opposite the first outward direction and are positioned within a second half of the first segment and cooperatively form an inwardly extending second concave shape substantially mirroring the first concave shape when the first segment is in the expanded deployed configuration, the first and second sets of plurality of flexible support elements cooperatively define the first architecture of the first segment when in the expanded deployed configuration, wherein the second segment comprises a third set of flexible support elements that cooperatively form the second segment and define the second architecture of the second segment when in the expanded deployed configuration, and wherein each flexible support element of the first, second, and third sets comprises one or more electrodes provided thereon; and a handle operably associated with the shaft, the handle having a first user-manipulatable mechanism for deployment of each of the first and second segments of the multi-segment end effector from the retracted configuration to the expanded deployed configuration and a second user-manipulatable mechanism, separate from the first user-manipulatable mechanism, for control of energy output by each of the first and second segments of the multi-segment end effector;
advancing the multi-segment end effector to one or more target sites within the nasal cavity of the patient, the multi-segment end effector configured for delivering energy to one or more target sites within the nasal cavity;
deploying, via user input with the first user-manipulatable mechanism on the handle, at least one of the first and second segments of the multi-segment end effector at the one or more target sites; and
delivering energy from at least one of the first and second segments of the multi-segment end effector, via user input with the second user-manipulatable mechanism, to tissue at the one or more target sites.

### Claim 12 (depends on 11)

The method of claim 11, wherein the handle comprises an ergonomically-designed grip portion comprising a shape, size, and contour providing for ambidextrous use for both left and right handed use and conforming to hand anthropometrics to allow for at least one of an overhand grip style and an underhand grip style during use in a procedure.

### Claim 13 (depends on 12)

The method of claim 12, wherein user input for the first user-manipulatable mechanism is positioned on a top portion of the handle adjacent the grip portion and user input for the second user-manipulatable mechanism is positioned on side portions of the handle adjacent the grip portion.

### Claim 14 (depends on 13)

The method of claim 13, wherein the user inputs for the first and second user-manipulatable mechanisms are positioned a sufficient distance to one another to allow for simultaneous one-handed operation of both user inputs during a procedure.

### Claim 15 (depends on 1)

The method of claim 1, wherein the first user-manipulatable mechanism comprises a rack and pinion assembly providing movement of at least one of the first and second segments of the multi-segment end effector between the retracted and deployed configurations in response to input from a user-operated controller.

### Claim 16 (depends on 15)

The method of claim 15, wherein the rack and pinion assembly comprises a set of gears for receiving input from the user-operated controller and converting the input to linear motion of a rack member operably associated with at least one of the shaft and the multi-segment end effector.

### Claim 17 (depends on 16)

The method of claim 16, wherein the rack and pinion assembly comprises a gearing ratio sufficient to balance a stroke length and retraction and deployment forces.

### Claim 18 (depends on 15)

The method of claim 15, wherein the user-operated controller comprises a slider mechanism operably associated with the rack and pinion rail assembly, wherein movement of the slider mechanism in a rearward direction towards a proximal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the deployed configuration and movement of the slider mechanism in a forward direction towards a distal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the retracted configuration.

### Claim 19 (depends on 15)

The method of claim 15, wherein the user-operated controller comprises a scroll wheel mechanism operably associated with the rack and pinion rail assembly, wherein rotation of the wheel in a rearward direction towards a proximal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the deployed configuration and rotation of the wheel in a forward direction towards a distal end of the handle results in transitioning of at least one of the first and second segments of the multi-segment end effector to the retracted configuration.

### Claim 20 (depends on 11)

The method of claim 11, wherein the second user-manipulatable mechanism comprises a user-operated controller configured to be actuated between at least an active position and an inactive position to thereby control delivery of energy from the first and second segments of the multi-segment end effector.