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 electrode configured for intravascular placement within a renal artery of a human patient;
an energy source coupled to the electrode and configured to deliver radio frequency (RF) energy via the electrode to target neural fibers proximate to a wall of the renal artery,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 a 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 electrode;
evaluate the set of treatment data in view of one or more criteria to determine if a valuation of the completed treatment is within a pre-determined range; and
provide an indication as to whether the valuation of the completed treatment is within the pre-determined range.
1 Assignment
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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.
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Citations
21 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 electrode configured for intravascular placement within a renal artery of a human patient; an energy source coupled to the electrode and configured to deliver radio frequency (RF) energy via the electrode to target neural fibers proximate to a wall of the renal artery, 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 a 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 electrode; evaluate the set of treatment data in view of one or more criteria to determine if a valuation of the completed treatment is within a pre-determined range; and provide an indication as to whether the valuation of the completed treatment is 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 medium encoded with instructions that, when executed by a processor, perform operations comprising:
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increasing energy delivery to an electrode carried by a renal denervation catheter, wherein the electrode is intravascularly positioned to deliver radio frequency (RF) energy to target renal nerves adjacent to a wall of a renal artery of a human patient, and wherein energy delivery is increased to a pre-determined first power level over a first period of time; maintaining energy delivery at the first power level for a second period of time; increasing energy delivery to a second predetermined power level if a 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 electrode; evaluating the set of treatment data in view of one or more criteria to determine if a valuation of the completed treatment is within a pre-determined range; and providing an indication as to whether the valuation of the completed treatment is within the pre-determined range. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification