SYSTEMS AND METHODS FOR THERAPEUTIC NASAL TREATMENT
The invention generally relates to systems and methods for providing detection, identification, and precision targeting of specific tissue(s) of interest in a nasal region of a patient for the treatment of a rhinosinusitis condition while minimizing or avoiding collateral damage to surrounding or adjacent non-targeted tissue, such as blood vessels, bone, and non-targeted neural tissue.
1 . A system for treating a condition within a sino-nasal cavity of a patient, the system comprising:
a treatment device including a multi-segment end effector comprising a plurality of sets of support structures, wherein each set comprises one or more support structures and each support structure comprises one or more electrodes for delivering energy to one or more target sites within the sino-nasal cavity of the patient; and
a console unit operably associated with the treatment device and configured to:
receive, via user input with an interactive interface associated with the console unit, a request to initiate treatment of a selected one of a left side and a right side of the sino-nasal cavity of the patient;
identify, in response to the request, one or more sets of support structures to be activated for treating the selected one of the left and right side of the sino-nasal cavity;
calculate a treatment pattern for controlling delivery of energy from electrodes associated with at least one of a single, a pair, and a multitude of the plurality of support structures of a given identified set;
receive feedback data associated with each of the plurality of support structures upon supplying treatment energy to respective electrodes; and
process the feedback data to determine a status of each of the plurality of support structures with respect to the treatment pattern.
2 . The system of claim 1 , wherein the status comprises an incomplete state, a successful state, and an unsuccessful state.
3 . The system of claim 2 , wherein the treatment pattern comprises at least one of a predetermined treatment time, a level of energy to be delivered from the electrodes, and a predetermined impedance threshold.
4 . The system of claim 3 , wherein the feedback data comprises impedance measurement data associated with tissue at the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity.
5 . The system of claim 4 , wherein the console unit is configured to process the impedance measurement data to calculate at least one of:
a baseline impedance value prior to delivery of energy from electrodes to the tissue for the determination of whether at least one of a single, a pair, and a multitude of the plurality of support structures is available; and
an active impedance value during delivery of energy from electrodes of an available one of the at least one of the single, pair, and multitude of the plurality of support structures to the tissue.
6 . The system of claim 5 , wherein the console unit is configured to determine availability of each of the at least one of the single, pair, and multitude of the plurality of support structures for a given set based on a comparison of the calculated baseline impedance value with a predetermined range of baseline impedance values.
7 . The system of claim 6 , wherein at least one support structure is determined to be available for applying treatment when the calculated baseline value falls within the predetermined range of baseline impedance values and unavailable for applying treatment when the calculated baseline value falls outside the predetermined range of baseline impedance values.
8 . The system of claim 5 , wherein the feedback data further comprises an elapsed time of delivery of energy from electrodes of an available one of the at least one of the single, pair, and multitude of the plurality of support structures to the tissue.
9 . The system of claim 8 , wherein the console unit is configured to compare the elapsed time with the predetermined treatment time to determine a status of the at least one of the single, pair, and multitude of the plurality of support structures.
10 . The system of claim 9 , wherein the console unit determines one or more support structures to be in a successful state when the elapsed time of delivery of energy exceeds the predetermined treatment time, all available support structures of a given set have delivered treatment, and no incomplete support structures of that given set are present.
11 . The system of claim 9 , wherein the console unit determines one or more support structures to be in an unsuccessful state, and disables energy delivery from electrodes associated with the one or more support structures, when the elapsed time of delivery of energy exceeds the predetermined treatment time, all available support structures of a given set have delivered treatment, and the one or more support structures remain currently active and incomplete upon the elapsed time exceeding the predetermined treatment time by greater than or equal to three seconds.
12 . The system of claim 9 , wherein, if the elapsed time is less than the predetermined treatment time, the console unit is configured to process the active impedance value to determine a status of one or more support structures.
13 . The system of claim 12 , wherein the processing of the active impedance value comprises using an algorithm to determine whether the one or more support structures is in at least one of a successful state or an unsuccessful state based on a comparison of the active impedance value with at least one of a predetermined minimum impedance value, a predetermined low terminal impedance value, and a predetermined high terminal impedance value.
14 . The system of claim 13 , wherein the console unit determines the one or more support structures to be in an unsuccessful state if the active impedance value is less than the predetermined minimum impedance value and disables energy delivery from electrodes associated with the one or more support structures.
15 . The system of claim 13 , wherein, if the active impedance value is greater than the predetermined minimum impedance value and greater than the predetermined low terminal impedance value, the console unit is configured to calculate a slope change for the detection of a slope event.
16 . The system of claim 15 , wherein, upon detecting a slope event, the console unit:
determines that the at least one of the single, pair, and multitude of the plurality of support structures to be in a successful state if a negative slope event is detected and disables energy delivery from electrodes associated with the support structures; and
determines the at least one of the single, pair, and multitude of the plurality of support structures to be in an unsuccessful state if a negative slope event is not detected and disables energy delivery from electrodes associated with the support structures.
17 . The system of claim 15 , wherein, in the absence of detecting a slope event, the console unit determines the at least one of the single, pair, and multitude of the plurality of support structures to be in an in an unsuccessful state if the active impedance value is greater than the predetermined high terminal impedance value and disables energy delivery from electrodes associated with the at least one of the single, pair, multitude of the plurality of support structures.
18 . The system of claim 2 , wherein the console unit is further configured to output, via the interactive interface, an alert to a user indicating a status of each of the at least one of the single, pair, and multitude of the plurality of support structures.
19 . The system of claim 18 , wherein the console unit is configured to output at least a visual alert indicating a status of each of the at least one of the single, pair, and multitude of the plurality of support structures of a given set.
20 . The system of claim 19 , wherein the visual alert comprises at least one of a color and text displayed on a graphical user interface (GUI) and indicating each of the incomplete state, successful state, and unsuccessful state.