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 system for treating a condition within a nasal cavity of a patient, the system comprising:
a treatment device comprising a shaft and a therapeutic assembly arranged at a distal portion of a shaft of the treatment device, wherein the therapeutic assembly comprises:
a flexible circuit comprising a plurality of electrodes arranged on a deformable support structure, wherein the deformable support structure is transformable between a low-profile delivery state, to facilitate delivery of the therapeutic assembly to a target site within a nasal cavity of a patient, and an expanded state, such that, when in the expanded state, the deformable support structure is configured to place one or more of the plurality of electrodes into direct contact with target tissue at the target site.
2 . The system of claim 1 , further comprising a console unit operably associated with the treatment device and configured to control operation thereof, including:
controlling emission of RF energy from at least two electrodes of the plurality of electrodes for the detection of one or more properties of tissue at the target site; and
controlling delivery of a plurality of treatment applications comprising emission of RF energy from the at least two electrodes of the plurality of electrodes for altering transmission of signals through the target tissue at the target site.
3 . The system of claim 2 , wherein the console unit is configured to control output of RF energy from the at least two electrodes to obtain one or more impedance measurements.
4 . The system of claim 3 , wherein the at least two electrodes comprise a pair of bipolar electrodes.
5 . The system of claim 3 , wherein the console unit comprises a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console unit to:
receive one or more impedance measurements 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 target tissue; and
provide, via a display, feedback information to an operator, wherein said feedback information comprises an indication of contact between the at least two electrodes of the plurality of electrodes and the target tissue.
6 . The system of claim 5 , wherein said feedback information comprises an impedance measurement indicating whether contact exists between the at least two electrodes of the plurality of electrodes and the target tissue.
7 . The system of claim 5 , wherein, prior to delivery of a treatment application of RF energy, the console unit is configured to receive an initial impedance measurement via the at least two electrodes of the plurality of electrodes to establish a baseline impedance measurement.
8 . The system of claim 7 , wherein, during delivery of a treatment application of RF energy, the console unit is configured to continuously monitor impedance 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 target tissue.
9 . The system of claim 8 , wherein the console unit stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter comprises at least one of a predetermined impedance threshold and a predetermined maximum impedance rise threshold in relation to the initial impedance measurement.
10 . The system of claim 9 , wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of electrodes when: the impedance reaches the predetermined impedance threshold and/or when a rise in impedance matches the predetermined maximum impedance rise threshold.
11 . The system of claim 5 , wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by the at least two electrodes of the plurality of electrodes.
12 . The system of claim 5 , wherein the console unit incorporates a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device and the therapeutic assembly.
13 . The system of claim 5 , wherein the therapeutic assembly delivers RF energy pursuant to a plurality of treatment parameters, wherein the treatment parameters comprise at least a predetermined time threshold.
14 . The system of claim 13 , wherein, during delivery of a treatment application of RF energy, the console unit is configured to continuously monitor a treatment delivery time.
15 . The system of claim 14 , 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.
16 . The system of claim 15 , wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of 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 target tissue.
17 . The system of claim 16 , wherein the console unit is configured to automatically terminate the treatment application of RF energy when the elapsed time reaches the predetermined time threshold.
18 . The system of claim 1 , wherein the shaft of the treatment device is bendable.
19 . The system of claim 1 , wherein the treatment device further comprises a handle with which an operator can manipulate the therapeutic assembly and control emission of RF energy therefrom.
20 . The system of claim 1 , wherein the plurality of electrodes comprises one or more pairs of bipolar electrodes.