# US 11,439,460 B2 · Catheter system and electrode assembly for intraprocedural evaluation of renal denervation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,460 B2 - Document ID: US11439460B2 - Status: Granted - Kind: B2 - Application number: 15/630,134 - Filed: 2017-06-22 - Published: 2017-12-28 - Granted: 2022-09-13 - Earliest claimed: 2016-06-23 - Assignees: St. Jude Medical, Cardiology Division, Inc. - Applicants: St. Jude Medical, Cardiology Division, Inc. - Inventors: John Sliwa; Stephen A. Morse; Cary Hata - Web page: https://patentgrep.com/patent/US11439460B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 5/0215: by means inserted into the body - A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)} - A61B 5/6858: {with a distal basket, e.g. expandable basket} - A61B 5/6859: {with multiple distal splines} - A61N 7/02: Localised ultrasound hyperthermia - A61B 5/201: {Assessing renal or kidney functions} - A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect} - A61B 2018/00267: {having a basket shaped structure} - A61B 2018/00404: {Blood vessels other than those in or around the heart} - A61B 2018/00434: {Neural system} - A61B 2018/00511: {Kidney} - A61B 2018/00577: {Ablation} - A61B 2018/00642: {with feedback, i.e. closed loop control} - A61B 2018/00821: {measured by a thermocouple} - A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG} - A61B 2018/00863: {Fluid flow} - A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter} - A61B 2018/1465: {Deformable electrodes} - A61B 2018/1467: {using more than two electrodes on a single probe} - A61N 2007/003: {Destruction of nerve tissue} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract The present disclosure provides catheter systems, electrode assemblies, and methods for electrically stimulating one or more points about the circumference of the renal artery to provide real time intraprocedural operational feedback to the operator of a renal denervation procedure to allow for more precise and thorough ablation of the renal artery and better patient outcomes. In many embodiments, an electrode assembly is provided that includes multiple splines that extend from an insulated proximal hub to an insulated distal hub and are interconnected to an electrical wire to allow the splines to independently function as electrical stimulation electrodes. The electrically active splines can then be energized at one or more desired points during a renal denervation procedure to provide operational feedback. ## Claims ### Claim 1 A catheter system comprising: a catheter shaft; and an electrode assembly carried by the catheter shaft and including: a proximal hub; a distal hub; a first spline extending between the proximal hub and the distal hub; a first ablation electrode positioned at a first axial location defined at a first distance between the proximal hub and the distal hub, wherein the first spline includes a proximal portion and a distal portion that are configured to be electrically activated together, and that are configured to be electrically activated independent of the first ablation electrode, and wherein the first ablation electrode is positioned on the first spline between the proximal portion and the distal portion of the first spline; and a second spline extending between the proximal hub and the distal hub, the second spline spaced circumferentially apart from the first spline, wherein the second spline includes a second ablation electrode positioned at a second axial location defined at a second distance between the proximal hub and the distal hub, the second axial location different from the first axial location, whereby the second ablation electrode is axially offset from the first ablation electrode, and whereby no ablation electrode of the electrode assembly is located in a same radial plane as any other ablation electrode of the electrode assembly, wherein the first spline is interconnected with a first electrical wire to allow the first spline to function as a first stimulation electrode, wherein the second spline is interconnected with a second electrical wire to allow the second spline to function as a second stimulation electrode, and wherein the first stimulation electrode and the second stimulation electrode are configured to elicit a physiological response capable of being measured when energized. ### Claim 2 (depends on 1) The catheter system of claim 1, wherein the proximal hub and the distal hub are constructed from an electrically insulating material. ### Claim 3 (depends on 2) The catheter system of claim 2, wherein the insulating material is a high temperature liquid crystal polymer. ### Claim 4 (depends on 1) The catheter system of claim 1, wherein the first spline and the first ablation electrode are constructed from the same material. ### Claim 5 (depends on 4) The catheter system of claim 4, wherein the first spline and the first ablation electrode are constructed from a metal alloy of nickel and titanium. ### Claim 6 (depends on 1) The catheter system of claim 1, wherein the first spline and the second spline are configured to function as stimulation electrodes for evaluating success of renal denervation performed using the first ablation electrode and the second ablation electrode. ### Claim 7 (depends on 6) The catheter system of claim 6, wherein the first spline and the first ablation electrode are configured to operate as a bipolar pair of stimulation electrodes in one mode of operation, whereby the first ablation electrode is selectively operable as both an ablation electrode and a stimulation electrode. ### Claim 8 (depends on 7) The catheter system of claim 7, further comprising a third spline that includes a third ablation electrode and a fourth spline that includes a fourth ablation electrode. ### Claim 9 (depends on 8) The catheter system of claim 8, wherein the third spline and fourth spline are interconnected with an electrical wire to allow the third spline and the fourth spline to function as a stimulation electrode. ### Claim 10 (depends on 1) The catheter system of claim 1, wherein the electrode assembly further includes at least one thermocouple.