DEVICES, SYSTEMS AND METHODS FOR EVALUATION AND FEEDBACK OF NEUROMODULATION TREATMENT
First Claim
1. A system for renal neuromodulation, the system comprising:
- a catheter comprising an elongated shaft having a proximal portion and a distal portion, wherein the distal portion comprises an energy delivery element configured for placement within a renal blood vessel;
an energy source 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 toincrease 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; and
increase 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 toobtain 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 was likely within a pre-determined range; and
provide an indication as to whether the valuation of the completed treatment was likely within the pre-determined range.
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Accused Products
Abstract
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.
245 Citations
22 Claims
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1. A system for renal neuromodulation, the system comprising:
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a catheter comprising an elongated shaft having a proximal portion and a distal portion, wherein the distal portion comprises an energy delivery element configured for placement within a renal blood vessel; an energy source 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; and increase 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 was likely within a pre-determined range; and provide an indication as to whether the valuation of the completed treatment was likely within the pre-determined range. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A computer-readable storage medium containing instructions that, when executed by a computer, perform operations comprising:
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increasing energy delivery to an energy delivery element carried by a catheter, wherein energy delivery is increased to a pre-determined first power level over a first period of time, and wherein the energy delivery element is positioned to deliver energy to target neural fibers proximate to a wall of a renal blood vessel of a human patient; maintaining energy delivery at the first power level for a second period of time; increasing 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; obtaining a set of treatment data corresponding to a completed treatment performed using the energy delivery element; evaluating the set of treatment data in view of one or more criteria to determine if a valuation of the completed treatment was likely within a pre-determined range; and providing an indication as to whether the valuation of the completed treatment was within the pre-determined range. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification