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 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.
2. The method of claim 1 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit.
3. The method of claim 1 , 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.
4. The method of claim 1 , wherein the console unit monitors impedance during delivery of a treatment application of RF energy via the at least two electrodes of the plurality of electrodes to assess contact between the at least two electrodes of the plurality of electrodes and the PNN tissue.
5. The method of claim 4 , wherein, for each of the first and second pairs of bipolar electrodes, the console unit monitors impedance during delivery of RF energy therefrom.
6. The method of claim 4 , wherein the maximum parameter comprises a predetermined impedance threshold.
7. The method of claim 6 , wherein the console unit terminates the treatment application of RF energy when the impedance reaches the predetermined impedance threshold.
8. The method of claim 4 , wherein the console unit provides, via the display, an impedance measurement.
9. The method of claim 1 , wherein the treatment element is arranged at a distal portion of a shaft of the treatment device.
10. The method of claim 9 , 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.
11. The method of claim 1 , wherein the plurality of electrodes includes electrodes which are disposed in a side by side arrangement.
12. 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 at least one temperature sensor.
13. The method of claim 1 , wherein the plurality of electrodes are arranged in a substantially symmetrical distribution.
14. The method of claim 1 , wherein the condition comprises chronic rhinitis and RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.
15. A method for treating a condition within a nasal cavity of a subject, the method comprising:
operably coupling a treatment device to a console unit via a cable connection;
advancing a treatment element of the treatment device into the nasal cavity of a subject such that two or more of a plurality of electrodes of the treatment element 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 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 pursuant to one or more of a plurality of treatment parameters, wherein the treatment parameters comprise at least one of a predetermined time threshold and a predetermined temperature threshold, 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 console unit:
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 associated with 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; and
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, the console unit 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.
16. The method of claim 15 , 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 one of the treatment delivery time and temperature of tissue during delivery of RF energy thereto.
17. The method of claim 16 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit.
18. The method of claim 15 , 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.
19. The method of claim 18 , 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.
20. The method of claim 15 , wherein the treatment element is arranged at a distal portion of a shaft of the treatment device.
21. The method of claim 20 , 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.
22. The method of claim 20 , 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.
23. The method of claim 15 , wherein the plurality of electrodes includes electrodes which are disposed in a side by side arrangement.
24. The method of claim 23 , wherein the plurality of electrodes comprises at least four electrodes arranged in a grid pattern and in proximity to the at least one temperature sensor.
25. The method of claim 24 , wherein the plurality of electrodes comprise eight electrodes arranged in a grid pattern and in proximity to the at least one temperature sensor.
26. The method of claim 15 , wherein the plurality of electrodes are arranged in a substantially symmetrical distribution.
27. The method of claim 15 , 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.
28. The method of claim 27 , wherein RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.