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 device comprising a multi-segment end effector for delivering energy to one or more target sites within the nasal cavity of the patient and further sensing one or more properties of the one or more target sites, the multi-segment end effector comprising a proximal segment that is spaced apart from a distal segment, wherein each of the proximal and distal segments has a specific geometry to complement anatomy at a respective location within the nasal cavity and associated with the one or more target sites; and
a console unit operably associated with the device and configured to receive data from the device associated with the one or more properties of the one or more target sites and process data to provide information to an operator related to the one or more target sites.
2. The system of claim 1 , wherein the console unit is configured to provide information associated with at least one of:
the identification and location of target and non-target neural structures at the one or more target sites prior to therapeutic modulation treatment thereof provided by at least one of the proximal and distal segments of the end effector;
the identification and location of target and non-target anatomical structures at the one or more target sites prior to therapeutic modulation treatment thereof provided by at least one of the proximal and distal segments of the end effector;
real-time feedback associated with efficacy of therapeutic modulation treatment on the one or more target neural and/or anatomic structures during therapeutic modulation treatment; and
feedback associated with efficacy of therapeutic modulation treatment on the one or more target neural and/or anatomic structures after therapeutic modulation treatment.
3. The system of claim 2 , wherein each of the proximal and distal segments of the end effector comprises flexible struts and a plurality of elements provided by the struts.
4. The system of claim 3 , wherein a first subset of the of the plurality of elements are configured to deliver non-therapeutic stimulating energy to tissue at the one or more target sites at a frequency for locating at least one of target neural structures, non-target neural structures, target anatomical structures, and non-target anatomical structures.
5. The system of claim 4 , wherein a second subset of the plurality of elements are configured to sense properties of at least one of the target neural structures, non-target neural structures, target anatomical structures, and non-target anatomical structures in response to the stimulating energy.
6. The system of claim 5 , wherein the properties comprise at least one of a physiological properties, bioelectric properties, and thermal properties.
7. The system of claim 6 , wherein the bioelectric properties comprises at least one of complex impedance, resistance, reactance, capacitance, inductance, permittivity, conductivity, nerve firing voltage, nerve firing current, depolarization, hyperpolarization, magnetic field, and induced electromotive force.
8. The system of claim 3 , wherein the proximal segment of the end effector comprises a first set of flexible struts arranged in a first configuration and the distal segment of the end effector comprises a second set of flexible struts arranged in a second configuration.
9. The system of claim 8 , wherein each of the proximal and distal segments is transformable between a retracted configuration and an expanded deployed configuration such that the first set of flexible struts conforms to and complements a shape of a first anatomical structure at a first location when the proximal segment is in the deployed configuration and the second set of flexible struts conforms to and complements a shape of a second anatomical structure at a second location when the distal segment is in the deployed configuration.
10. The system of claim 9 , wherein the first and second anatomical structures are selected from the group consisting of inferior turbinate, middle turbinate, superior turbinate, inferior meatus, middle meatus, superior meatus, pterygopalatine region, pterygopalatine fossa, sphenopalatine foramen, accessory sphenopalatine foramen(ae), and sphenopalatine micro-foramen(ae).
11. The system of claim 9 , wherein the first set of flexible struts and the second set of flexible struts are configured to position one or more of the respective plurality of elements provided by each at respective one or more target sites when in the deployed configurations.
12. The system of claim 9 , wherein, when in the expanded deployed configuration, the first set of flexible struts comprises:
a first pair of struts, each comprising a loop shape and extending upward; and
a second pair of struts, each comprising a loop shape and extending downward.
13. The system of claim 12 , wherein, when in the expanded deployed configuration, the second set of flexible struts comprises a second set of struts, each comprising a loop shape extending outward to form an open-ended circumferential shape.
14. The system of claim 9 , wherein the first and second sets of flexible struts comprise deformable composite wires.
15. The system of claim 14 , wherein the composite wires comprise shape memory material.
16. The system of claim 3 , wherein the console unit is configured to detect and/or map locations of at least one of the target neural structures, non-target neural structures, target anatomical structures, and non-target anatomical structures and control the delivery of therapeutic energy from at least one of the proximal and distal segments of the end effector in a modulation pattern based on the locations of at least one of the target neural structures, non-target neural structures, target anatomical structures, and non-target anatomical structures.
17. The system of claim 16 , wherein at least some of the elements provided by at least one of the proximal and distal segments are configured to deliver energy based on the modulation pattern at a level sufficient to therapeutically modulate one or more nerves associated with the locations of the target neural and/or target anatomical structures while avoiding locations of the non-target neural and/or target anatomical structures.
18. The system of claim 17 , wherein the at least some of the elements are configured to delivery energy based on the modulation pattern at a level insufficient to therapeutically modulate the non-target neural and/or non-target anatomical structures.
19. The system of claim 3 , wherein the console unit comprises a controller configured to selectively control energy output from elements of the proximal and/or distal segments of the end effector, wherein some of the elements are configured to be independently activated and controlled to thereby deliver energy independent of one another.
20. The system of claim 19 , wherein the controller is configured to adjust energy output from elements of the proximal and/or distal segments of the end effector based, at least in part, on the real-time feedback associated with the effectiveness of therapeutic modulation treatment on the one or more target anatomic and/or neural structures during therapeutic modulation thereof.