Devices, systems and methods for evaluation and feedback of neuromodulation treatment

摘要

The present disclosure relates to devices, systems and methods for evaluating the success of a treatment applied to tissue in a patient, such as a radio frequency ablative treatment used to neuromodulate nerves associated with the renal artery. A system monitors parameters or values generated during the course of a treatment. Feedback provided to an operator is based on the monitored values and relates to an assessment of the likelihood that a completed treatment was technically successful. In other embodiments, parameters or values generated during the course of an incomplete treatment (such as due to high temperature or high impedance conditions) may be evaluated to provide additional instructions or feedback to an operator.

主权项

1. An energy source for renal neuromodulation configured for connecting to a catheter having a distal portion comprising an energy delivery element configured for placement at a treatment site within a renal blood vessel, the energy source adapted to be coupled to the energy delivery element and configured to deliver energy via the energy delivery element to target neural fibers proximate to a wall of the renal blood vessel,
wherein the energy source comprises a component configured to—
increase energy delivery to a predetermined first power level over a first period of time;maintain energy delivery at the first power level for a second period of time; andincrease energy delivery to a second predetermined power level if the temperature value is less than a preset threshold temperature following the second period of time; and wherein the energy source further comprises a component configured to—
obtain a set of treatment data corresponding to a completed treatment performed using the catheter, the energy source, and the energy delivery element;evaluate the set of treatment data in view of one or more criteria to determine if a valuation of the completed treatment is likely within a pre-determined range; andprovide an indication as to whether the valuation of the completed treatment is likely within the pre-determined range.