US 12,446,953 B1
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 Neurent Medical Limited, Galway (IE)
Filed by National University of Ireland, Galway, Galway (IE)
Filed on Jun. 23, 2025, as Appl. No. 19/246,304.
Application 19/246,304 is a continuation of application No. 19/172,339, filed on Apr. 7, 2025.
Application 19/172,339 is a continuation of application No. 18/678,536, filed on May 30, 2024, granted, now 12,268,433, issued on Apr. 8, 2025.
Application 18/678,536 is a continuation of application No. 16/703,263, filed on Dec. 4, 2019, abandoned.
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.
This patent is subject to a terminal disclaimer.
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)] 28 Claims
OG exemplary drawing
 
1. A method for treating a condition within a nasal cavity of a subject, the method comprising:
providing a treatment device comprising a treatment element comprising a plurality of electrodes;
providing a console unit comprising a radiofrequency (RF) energy generator that generates RF energy to be delivered by the treatment element and a display;
operably coupling the treatment device to the console unit via a cable connection;
advancing the treatment element into the nasal cavity of a subject such that two or more of the plurality of electrodes contact a portion of the nasal cavity 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; and
controlling, via the console unit, delivery of one or more treatment applications applied via the treatment element, wherein each of the one or more treatment applications comprises delivery of RF energy from the two or more of the plurality of electrodes for altering transmission of signals through 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 the treatment element delivers RF energy pursuant to a plurality of treatment parameters, wherein the treatment parameters comprise at least one of a predetermined time threshold and a predetermined temperature threshold,
wherein the console unit:
stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter includes at least the predetermined time threshold and the predetermined temperature threshold;
continuously monitors, during delivery of a treatment application of RF energy, a treatment delivery time and temperature of tissue proximate the PNN tissue based on one or more temperature readings received from at least one temperature sensor provided on the treatment element and, for each of a first pair and a second pair of bipolar electrodes of the plurality of electrodes, monitors temperature of adjacent tissue during delivery of RF energy therefrom;
provides, via the display, feedback information to an operator during delivery of the one or more treatment applications, wherein said feedback information comprises at least the treatment delivery time and temperature of tissue during delivery of RF energy thereto;
automatically controls the treatment application of RF energy emitted from the two or more electrodes, based on at least one of the one or more temperature readings and elapsed time, to thereby maintain delivery of RF energy of the given treatment application for a predetermined treatment delivery time period and maintain a level of RF energy at a level sufficient to cause therapeutic neuromodulation of PNN tissue while preventing temperature of tissue from exceeding the predetermined threshold temperature; and
automatically terminates the treatment application of RF energy when at least one of the elapsed time reaches the predetermined time threshold and the temperature reaches the predetermined temperature threshold,
wherein the predetermined treatment delivery time period is about 10 seconds to about 12 seconds and the predetermined threshold temperature is less than 90° C.