Devices for therapeutic nasal neuromodulation and associated methods and systems

12268,433

18/678536

May 30, 2024

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.

National University of Ireland, Galway (Galway, IE)

National University of Ireland, Galway (Galway, IE)

1. A method for treating a condition within a nasal cavity of a subject, the method comprising: providing a treatment device comprising a shaft and a treatment element arranged at a distal portion of the shaft, 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 comprising a thermocouple positioned between at least two electrodes of the plurality of electrodes, wherein the treatment element is sized and shaped to fit within a nasal cavity and contact nasal tissue, and wherein the treatment element is angled with respect to the shaft to facilitate contacting the nasal tissue within the nasal cavity; 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 through a conductive media, 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; continuously monitors a treatment delivery time; monitors impedance during delivery of a treatment application of RF energy via 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; for each of the first and second pairs of bipolar electrodes, monitors temperature of adjacent tissue and impedance 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 time threshold, the predetermined temperature threshold, and a predetermined impedance 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 at the target site 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; automatically terminates the treatment application of RF energy when the temperature reaches the predetermined temperature threshold; and terminates the treatment application of RF energy when the impedance reaches the predetermined impedance 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 and displaying an impedance measurement.

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 soft 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 two electrodes arranged side by side and in proximity to the thermocouple.

9. The method of claim 8 , wherein the plurality of electrodes comprises at least four electrodes arranged in a grid pattern and in proximity to the thermocouple.

10. The method of claim 9 , wherein the plurality of electrodes comprises at least eight electrodes arranged in a grid pattern and in proximity to the thermocouple.

11. 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.

12. The method of claim 11 , wherein RF energy treatment of the condition generates heat within submucosal tissue around a region of PNN tissue to improve symptoms of chronic rhinitis.

13. The method of claim 1 , wherein the predetermined threshold temperature is greater than 37° C. and less than 90° C.

14. The method of claim 1 , wherein at least two of the plurality of electrodes extend beyond surface of the shaft and are oriented at an angle relative to the shaft for the delivery of RF energy.

15. The method of claim 14 , wherein the plurality of electrodes comprises at least six electrodes that extend beyond surface of the shaft and are oriented at an angle relative to the shaft for the delivery of RF energy.

16. The method of claim 15 , wherein the plurality of electrodes comprises at least eight electrodes that extend beyond surface of the shaft and are oriented at an angle relative to the shaft for the delivery of RF energy.

17. The method of claim 1 , further providing, via a display, feedback information to an operator during delivery of the one or more treatment applications, wherein said feedback information comprises the treatment delivery time, actual temperature of tissue, and an impedance measurement during delivery of RF energy to tissue.

18. The method of claim 17 , wherein the display is a touchscreen monitor for inputting treatment parameters to the console unit and displaying an impedance measurement, wherein the plurality of electrodes comprises at least eight electrodes that extend beyond surface of the shaft and are oriented at an angle relative to the shaft for the delivery of RF energy, and wherein the shaft of the treatment device is deformable and configured to be bent by an operator.

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.

20. The method of claim 19 , further comprising displaying, via the display, an impedance measurement during the treatment application of RF energy.

21. The method of claim 20 , further comprising displaying, via the display, a treatment delivery time and temperature of tissue proximate to the PNN tissue during a treatment application of RF energy.

22. The method of claim 21 , wherein the treatment element comprises at least eight electrodes of the plurality of electrodes that extend beyond surface of the shaft and are oriented at an angle relative to the shaft for the delivery of RF energy, and wherein the shaft of the treatment device is deformable and configured to be bent by an operator.

23. The method of claim 22 , wherein the nasal 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.

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