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 device for treating a condition within a nasal cavity of a patient, the device comprising:
a shaft comprising a multi-segment end effector comprising at least a first retractable and expandable segment comprising a micro-electrode array arranged about a plurality of struts conforming to and accommodating an anatomical structure within the nasal cavity when the first segment is in an expanded state, the plurality of struts comprising:
a first set of support elements comprising a first pair of loop-shaped struts having a bilateral geometry when the first segment is in the expanded state, wherein a first one of the first pair of loop-shaped struts extends in a first direction perpendicular to a longitudinal axis along which a distal most portion of the shaft lies and is positioned within a first side of a first half of the first segment and a second one of the first pair of loop-shaped struts extends in a second direction perpendicular to the longitudinal axis and is positioned within a second side of the first half of the first segment such that the first pair of looped-shaped struts cooperatively form an inwardly extending concave shape relative to the longitudinal axis,
a second set of support elements comprising a second pair of loop-shaped struts having a bilateral geometry when the first segment is in the expanded state, wherein a first one of the second pair of loop-shaped struts extends in a third direction perpendicular to the longitudinal axis and is positioned within a first side of a second half of the first segment and a second one of the second pair of loop-shaped struts extends in a fourth direction perpendicular to the longitudinal axis and is positioned within a second side of the second half of the first segment such that the second pair of looped-shaped struts cooperatively form an inwardly extending concave shape relative to the longitudinal axis,
wherein each of the first and second pairs of loop-shaped struts comprises one or more electrodes of the micro-electrode array;
wherein, when in the expanded state, at least the first pair and the second pair of loop-shaped of struts contact multiple locations along multiple portions of the anatomical structure and electrodes of the micro-electrode array are configured to emit energy at a level sufficient to create multiple micro-lesions in tissue of the anatomical structure that interrupt neural signals to mucus producing and/or mucosal engorgement elements.
2. The device of claim 1 , wherein the first one of the first pair of loop-shaped struts conforms to and accommodates a first side of the anatomical structure and the second one of the first pair of loop-shaped struts conforms to and accommodates a second side of the anatomical structure when the first segment is in the expanded state and the first pair of loop-shaped are in the deployed configurations.
3. The device of claim 2 , wherein the first one of the first pair of loop-shaped struts contacts multiple locations along the first side of the anatomical structure and a first set of electrodes of the micro-electrode array provided by the first one of the first pair of loop-shaped struts is configured to emit energy at a level sufficient to create multiple respective micro-lesions in tissue along the first side of the anatomical structure.
4. The device of claim 2 , wherein the second one of the first pair of loop-shaped struts contacts multiple locations along the second side of the anatomical structure and a second set of electrodes of the micro-electrode array provided by the second one of the first pair of loop-shaped struts are configured to emit energy at a level sufficient to create multiple respective micro-lesions in tissue along the second side of the anatomical structure.
5. The device of claim 2 , wherein the plurality of struts comprise deformable composite wires, the composite wires comprising shape memory material.
6. The device of claim 2 , wherein the anatomical structure is 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).
7. The device of claim 2 , wherein at least the first and second pairs of loop-shaped struts comprises multiple electrodes of the electrode array positioned at separate and discrete portions of each strut.
8. The device of claim 7 , wherein, when the first segment is in the expanded state and the first pair of loop-shaped struts is in the deployed configuration, each strut positions at least one associated electrode of the micro-electrode array into contact with tissue at a separate respective location on a respective side of the anatomical structure for delivery of energy thereto.
9. The device of claim 8 , wherein the electrodes of the micro-electrode array are configured to be independently activated and controlled to thereby deliver energy independent of one another.
10. A method for treating a condition within a nasal cavity of a patient, the method comprising:
advancing a device comprising a shaft comprising a multi-segment end effector to a location within the nasal cavity of the patient, the multi-segment end effector comprising a first retractable and expandable segment comprising micro-electrode array arranged about a plurality of struts to conform to and accommodate an anatomical structure within the nasal cavity when the first segment is in the expanded state, the plurality of struts comprising:
a first set of support elements comprising a first pair of loop-shaped struts having a bilateral geometry when the first segment is in the expanded state, wherein a first one of the first pair of loop-shaped struts extends in a first direction perpendicular to a longitudinal axis along which a distal most portion of the shaft lies and is positioned within a first side of a first half of the first segment and a second one of the first pair of loop-shaped struts extends in a second direction perpendicular to the longitudinal axis and is positioned within a second side of the first half of the first segment such that the first pair of looped-shaped struts cooperatively form an inwardly extending concave shape relative to the longitudinal axis,
a second set of support elements comprising a second pair of loop-shaped struts having a bilateral geometry when the first segment is in the expanded state, wherein a first one of the second pair of loop-shaped struts extends in a third direction perpendicular to the longitudinal axis and is positioned within a first side of a second half of the first segment and a second one of the second pair of loop-shaped struts extends in a fourth direction perpendicular to the longitudinal axis and is positioned within a second side of the second half of the first segment such that the second pair of looped-shaped struts cooperatively form an inwardly extending concave shape relative to the longitudinal axis,
wherein each of the first and second pairs of loop-shaped struts comprises one or more electrodes of the micro-electrode array;
deploying the first segment at the location to an expanded state such that at least the first pair and the second pair of loop-shaped of struts contact multiple locations along multiple portions of the anatomical structure; and
delivering energy, via one or more electrodes of the micro-electrode array, at a level sufficient to create multiple micro-lesions in tissue of the anatomical structure that interrupt neural signals to mucus producing and/or mucosal engorgement elements.
11. The method of claim 10 , wherein the first one of the first pair of loop-shaped struts conforms to and accommodates a first side of the anatomical structure and the second one of the first pair of loop-shaped struts conforms to and accommodates a second side of the anatomical structure when the first segment is in the expanded state and the first pair of loop-shaped are in the deployed configurations.
12. The method of claim 11 , wherein the first one of the first pair of loop-shaped struts contacts multiple locations along the first side of the anatomical structure and a first set of electrodes of the micro-electrode array provided by the first one of the first pair of loop-shaped struts is configured to emit energy at a level sufficient to create multiple respective micro-lesions in tissue along the first side of the anatomical structure.
13. The method of claim 11 , wherein the second one of the first pair of loop-shaped struts contacts multiple locations along the second side of the anatomical structure and a second set of electrodes of the micro-electrode array provided by the second one of the first pair of loop-shaped struts are configured to emit energy at a level sufficient to create multiple respective micro-lesions in tissue along the second side of the anatomical structure.
14. The method of claim 11 , wherein the plurality of struts comprise deformable composite wires, the composite wires comprising shape memory material.
15. The method of claim 11 , wherein the anatomical structure is 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).
16. The method of claim 11 , wherein at least the first and second pairs of loop-shaped struts comprises multiple electrodes of the electrode array positioned at separate and discrete portions of each strut.
17. The method of claim 16 , wherein, when the first segment is in the expanded state and the first pair of loop-shaped struts is in the deployed configuration, each strut positions at least one associated electrode of the micro-electrode array into contact with tissue at a separate respective location on a respective side of the anatomical structure for delivery of energy thereto.
18. The method of claim 17 , wherein the electrodes of the micro-electrode array are configured to be independently activated and controlled to thereby deliver energy independent of one another.