Devices for therapeutic nasal neuromodulation and associated methods and systems
Devices for therapeutic nasal neuromodulation and associated systems and methods are disclosed herein. A system for therapeutic neuromodulation in a nasal region configured in accordance with embodiments of the present technology can include, for example, a shaft and a therapeutic element at a distal portion of the shaft. The shaft can locate the distal portion intraluminally at a target site inferior to a patient's sphenopalatine foramen. The therapeutic element can include an energy delivery element configured to therapeutically modulate postganglionic parasympathetic nerves at microforamina of a palatine bone of the human patient for the treatment of rhinitis or other indications. In other embodiments, the therapeutic element can be configured to therapeutically modulate nerves that innervate the frontal, ethmoidal, sphenoidal, and maxillary sinuses for the treatment of chronic sinusitis.
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 arranged at a distal portion of a shaft of the treatment device, the treatment element comprising a plurality of electrodes arranged in a substantially symmetrical distribution and comprising at least a first pair of bipolar electrodes and a second pair of bipolar electrodes and at least one temperature sensor,
operably coupling the treatment device to a 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 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; and
controlling, via the console unit, delivery of one or more treatment applications applied via the treatment element, wherein the treatment application comprises delivery of radiofrequency (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 a predetermined time threshold and a predetermined temperature threshold,
wherein, during delivery of a treatment application of RF energy, the console unit:
continuously monitors temperature of tissue proximate the PNN tissue based on one or more temperature readings received from the at least one temperature sensor;
for each of the first and second pairs of bipolar electrodes, monitors temperature of adjacent tissue during delivery of RF energy therefrom;
continuously monitors a treatment delivery time;
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;
automatically controls the treatment application of RF energy emitted from the two or more electrodes, based on 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, 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.;
automatically terminates the treatment application of RF energy when the elapsed time reaches the predetermined time threshold; and
automatically terminates the treatment application of RF energy when the temperature reaches the predetermined temperature threshold.
2 . The method of claim 1 , further comprising providing, via a 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 actual temperature of tissue during delivery of RF energy thereto.
3 . The method of claim 2 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit.
4 . The method of claim 1 , wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by the two or more of the plurality of electrodes.
5 . The method of claim 4 , wherein the console unit incorporates a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device and the treatment element.
6 . The method of claim 1 , wherein the treatment device includes a handle arranged on a proximal portion of the shaft, and the treatment element is disposed at a distal tip of the shaft and the plurality of electrodes includes electrodes which are disposed in a side by side arrangement.
7 . The method of claim 1 , wherein the shaft of the treatment device comprises a sufficiently rigid material such that the shaft can be inserted into the nasal cavity and the device is configured such that the electrodes can reach the PNN tissue in the posterior region.
8 . The method of claim 1 , wherein the plurality of electrodes comprises at least eight electrodes arranged in a grid pattern and in proximity to the thermocouple.
9 . The method of claim 1 , wherein the condition is selected from the group consisting of allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, chronic sinusitis, acute sinusitis, chronic rhinosinusitis, acute rhinosinusitis, and medical resistant rhinitis.
10 . The method of claim 9 , wherein RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.
11 . A method for treating a condition within a nasal cavity of a subject, the method comprising:
providing a treatment device comprising a treatment element arranged at a distal portion of a shaft of the treatment device, the treatment element comprising a plurality of electrodes arranged in a substantially symmetrical distribution and comprising at least a first pair of bipolar electrodes and a second pair of bipolar electrodes and at least one temperature sensor;
operably coupling the treatment device to a 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 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; and
controlling, via the console unit, delivery of one or more treatment applications applied via the treatment element, wherein the treatment application comprises delivery of radiofrequency (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 one or more of a plurality of treatment parameters, wherein the treatment parameters comprise at least a predetermined time threshold and a predetermined temperature threshold,
wherein, during delivery of a treatment application of RF energy, the console unit:
for each of the first and second pairs of bipolar electrodes, monitors temperature of adjacent tissue during delivery of RF energy therefrom;
continuously monitors a treatment delivery time;
stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter includes at least the predetermined time threshold;
automatically controls the treatment application of RF energy emitted from the two or more electrodes, based, at least in part, on the 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, wherein the predetermined treatment delivery time period is about 10 seconds to about 12 seconds; and
automatically terminates the treatment application of RF energy when the elapsed time reaches the predetermined time threshold.
12 . The method of claim 11 , further comprising providing, via a 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 actual temperature of tissue during delivery of RF energy thereto.
13 . The method of claim 12 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit.
14 . The method of claim 11 , wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by the two or more of the plurality of electrodes.
15 . The method of claim 14 , wherein the console unit incorporates a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device and the treatment element.
16 . The method of claim 11 , wherein the treatment device includes a handle arranged on a proximal portion of the shaft, and the treatment element is disposed at a distal tip of the shaft and the plurality of electrodes includes electrodes which are disposed in a side by side arrangement.
17 . The method of claim 11 , wherein the shaft of the treatment device comprises a sufficiently rigid material such that the shaft can be inserted into the nasal cavity and the device is configured such that the electrodes can reach the PNN tissue in the posterior region.
18 . The method of claim 11 , wherein the plurality of electrodes comprises at least eight electrodes arranged in a grid pattern and in proximity to the thermocouple.
19 . The method of claim 1 , wherein the condition is selected from the group consisting of allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, chronic sinusitis, acute sinusitis, chronic rhinosinusitis, acute rhinosinusitis, and medical resistant rhinitis.
20 . The method of claim 19 , wherein RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.
21 . A method for treating a condition within a nasal cavity of a subject, the method comprising:
providing a treatment device comprising a treatment element arranged at a distal portion of a shaft of the treatment device, the treatment element comprising a plurality of electrodes arranged in a substantially symmetrical distribution and comprising at least a first pair of bipolar electrodes and a second pair of bipolar electrodes and at least one temperature sensor;
operably coupling the treatment device to a 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 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; and
controlling, via the console unit, delivery of one or more treatment applications applied via the treatment element, wherein the treatment application comprises delivery of radiofrequency (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 one or more of a plurality of treatment parameters, wherein the treatment parameters comprise at least a predetermined time threshold and a predetermined temperature threshold,
wherein, during delivery of a treatment application of RF energy, the console unit:
continuously monitors temperature of tissue proximate the PNN tissue based on one or more temperature readings received from the at least one temperature sensor;
for each of the first and second pairs of bipolar electrodes, monitors temperature of adjacent tissue during delivery of RF energy therefrom;
stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter includes at least the predetermined temperature threshold;
automatically controls the treatment application of RF energy emitted from the two or more electrodes, based, at least in part, on the one or more temperature readings, to thereby 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, wherein the predetermined threshold temperature is less than 90° C.; and
automatically terminates the treatment application of RF energy when the temperature reaches the predetermined temperature threshold.
22 . The method of claim 21 , further comprising providing, via a 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 actual temperature of tissue during delivery of RF energy thereto.
23 . The method of claim 22 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit.
24 . The method of claim 21 , wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by the two or more of the plurality of electrodes.
25 . The method of claim 24 , wherein the console unit incorporates a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device and the treatment element.
26 . The method of claim 21 , wherein the treatment device includes a handle arranged on a proximal portion of the shaft, and the treatment element is disposed at a distal tip of the shaft and the plurality of electrodes includes electrodes which are disposed in a side by side arrangement.
27 . The method of claim 21 , wherein the shaft of the treatment device comprises a sufficiently rigid material such that the shaft can be inserted into the nasal cavity and the device is configured such that the electrodes can reach the PNN tissue in the posterior region.
28 . The method of claim 21 , wherein the plurality of electrodes comprises at least eight electrodes arranged in a grid pattern and in proximity to the thermocouple.
29 . The method of claim 21 , wherein the condition is selected from the group consisting of allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, chronic sinusitis, acute sinusitis, chronic rhinosinusitis, acute rhinosinusitis, and medical resistant rhinitis.
30 . The method of claim 29 , wherein RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.