Systems and methods for therapeutic nasal neuromodulation
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.
1. A system for treating a condition within a nasal cavity of a patient, the system comprising:
a treatment device comprising:
a multi-segment end effector comprising a first retractable and expandable segment that is spaced apart and separate from a second retractable and expandable segment, wherein the first segment comprises a first set of a plurality of support elements that extend in a first direction and form a first concave shape when the first segment is in an expanded configuration, and a second set of a plurality of support elements that extend in a second direction opposing the first direction and form a second concave shape opposing the first concave shape when the first segment is in an expanded configuration;
a shaft operably associated with the multi-segment end effector, the shaft comprising one or more visual markers for providing a user with a visual indication, under image guidance, of a spatial orientation of at least the first segment while the multi-segment end effector is within a nasal cavity of a patient; and
a handle operably associated with the multi-segment end effector and the shaft, the handle comprising a controller mechanism for providing independent, controlled deployment of each of the first and second segments from a retracted configuration to an expanded configuration within the nasal cavity; and
an image guidance assembly to provide a visual depiction of at least the shaft and visual marker relative to surrounding anatomy of the nasal cavity to thereby assist a user in deployment and positioning of at least the first segment within the nasal cavity.
2. The system of claim 1 , wherein at least a first marker of the one or more visual markers is associated with a spatial orientation of a portion of the first segment when the first segment is in an expanded configuration.
3. The system of claim 2 , wherein the first segment has a geometry to complement a shape of the middle turbinate and/or a lateral attachment of the middle turbinate when in the expanded configuration.
4. The system of claim 3 , wherein one or more support elements from the first and/or second sets of plurality of support elements of the first segment conform to and complement a shape of the middle turbinate and/or the lateral attachment of the middle turbinate when the first segment is in the expanded configuration.
5. The system of claim 2 , wherein the second segment has a geometry to complement a shape of another anatomical structure within the nasal cavity when in an expanded configuration.
6. The system of claim 1 , wherein the controller mechanism comprises a rack and pinion assembly providing movement of the at least one of the first and second segments between the retracted configuration and expanded configuration in response to user input from an associated user-operated controller.
7. The system of claim 6 , wherein the rack and pinion assembly comprises a set of gears for receiving user input from the user-operated controller and converting the user input to linear motion of a rack member operably associated with the multi-segment end effector.
8. The system of claim 7 , wherein the controller mechanism further comprises a detent feature positioned relative to the first and second segments and configured to provide active feedback to a user indicative of deployment of at least one of the first and second segments.
9. The system of claim 7 , wherein the controller mechanism further comprises a friction-based feature configured to provide stable movement of at least one of the first and distal segments between the retracted and expanded configurations and active feedback to a user indicative of deployment of at least one of the first and second segments.
10. The system of claim 9 , wherein the friction-based feature comprises a lock mechanism providing constant friction between one or more portions of the rack and pinion assembly sufficient to maintain a position of at least one of the first and second segments during deployment thereof.
11. The system of claim 6 , 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 first direction results in transitioning of at least one of the first and second segments to an expanded configuration and movement of the slider mechanism in a second opposite direction results in transitioning of at least one of the first and second segments to the retracted configuration.
12. The system of claim 6 , 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 first direction results in transitioning of at least one of the first and second segments to an expanded configuration and rotation of the wheel in a second opposite direction results in transitioning of at least one of the first and second segments to the retracted configuration.