US 12,268,433 B2
Devices for therapeutic nasal neuromodulation and associated methods and systems
David Townley, Clare (IE); Brian Shields, Galway (IE); Ivan Keogh, Galway (IE); Michele Qi Zhan, Antioch, CA (US); and Conor Farrell, Mayo (IE)
Assigned to National University of Ireland, Galway, Galway (IE)
Filed by National University of Ireland, Galway, Galway (IE)
Filed on May 30, 2024, as Appl. No. 18/678,536.
Application 18/678,536 is a continuation of application No. 16/703,263, filed on Dec. 4, 2019.
Application 16/703,263 is a continuation of application No. 15/153,217, filed on May 12, 2016, granted, now 11,026,746, issued on Jun. 8, 2021.
Claims priority of provisional application 62/160,289, filed on May 12, 2015.
Prior Publication US 2024/0307110 A1, Sep. 19, 2024
Int. Cl. A61B 18/12 (2006.01); A61B 18/14 (2006.01); A61B 34/00 (2016.01); A61B 17/00 (2006.01); A61B 18/00 (2006.01); A61B 18/02 (2006.01); A61B 18/18 (2006.01); A61B 18/20 (2006.01); A61B 90/00 (2016.01)
CPC A61B 18/1485 (2013.01) [A61B 18/1206 (2013.01); A61B 34/25 (2016.02); A61B 2017/00199 (2013.01); A61B 2017/00292 (2013.01); A61B 2017/00862 (2013.01); A61B 2017/00867 (2013.01); A61B 2018/00273 (2013.01); A61B 2018/00327 (2013.01); A61B 2018/00434 (2013.01); A61B 2018/00577 (2013.01); A61B 2018/00648 (2013.01); A61B 2018/00672 (2013.01); A61B 2018/00815 (2013.01); A61B 2018/00821 (2013.01); A61B 2018/00875 (2013.01); A61B 18/02 (2013.01); A61B 2018/1253 (2013.01); A61B 2018/126 (2013.01); A61B 2018/1467 (2013.01); A61B 2018/1807 (2013.01); A61B 2018/1823 (2013.01); A61B 18/20 (2013.01); A61B 2090/3735 (2016.02); A61B 2090/376 (2016.02); A61B 2090/3762 (2016.02); A61B 2090/378 (2016.02)] 23 Claims
OG exemplary drawing
 
19. A method for treating a condition within a nasal cavity of a patient, the method comprising:
providing a treatment device comprising a treatment element including a plurality of electrodes and comprising at least a first pair of bipolar electrodes and a second pair of bipolar electrodes and at least one temperature sensor;
coupling the treatment device to a console unit via a cable connection, the console unit comprising a radiofrequency (RF) energy generator that generates RF energy to be delivered by the treatment element and a display for displaying treatment parameters;
advancing the treatment element into the nasal cavity of a subject such that two or more of the plurality of electrodes of the treatment element contact mucosa overlying an area of posterior nasal nerve (PNN) tissue within a posterior region of the nasal cavity defined by an inferior turbinate and a middle meatus;
controlling, via the console unit, delivery of one or more treatment applications of RF energy, each treatment application comprising delivering RF energy via the two or more of the plurality of electrodes through a conductive media to the PNN tissue, wherein delivery of the RF energy is conducted a plurality of times at a plurality of discrete sites along the PNN tissue in the posterior region,
wherein delivering RF energy alters the transmission of signals through the PNN tissue to treat a nasal condition,
wherein each treatment application of RF energy delivers RF energy for a predetermined treatment delivery time period of about 10 seconds to about 12 seconds and at a level sufficient to cause therapeutic neuromodulation of PNN tissue while preventing temperature of tissue from exceeding a predetermined threshold maximum temperature of less than 90° C.,
assessing the contact between the at least two electrodes of the plurality of electrodes and the PNN tissue by measuring impedance via at least two electrodes of the plurality of electrodes during a treatment application of RF energy;
continuously monitoring a temperature of tissue proximate to the PNN tissue based on one or more temperature readings received from the at least one temperature sensor during the treatment application of RF energy;
for each of the first and second pairs of bipolar electrodes, monitoring temperature of adjacent tissue and impedance during delivery of RF energy therefrom;
automatically terminating the treatment application of RF energy if the temperature of tissue proximate the PNN tissue exceeds the predetermined threshold maximum temperature;
automatically terminating the treatment application of RF energy exceeds a predetermined time threshold, wherein the predetermined time threshold is about 10 seconds to about 12 seconds; and
terminating the treatment application of RF energy if the impedance exceeds a predetermined maximum impedance threshold, the predetermined maximum impedance threshold indicating insufficient contact between the at least two electrodes of the plurality of electrodes and the PNN tissue.