# US 12,178,500 B2 · Mapping catheter with flex panel electrode assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,500 B2 - Document ID: US12178500B2 - Status: Granted - Kind: B2 - Application number: 16/942,825 - Filed: 2020-07-30 - Published: 2021-03-04 - Granted: 2024-12-31 - Earliest claimed: 2019-09-03 - Assignees: Biosense Webster (Israel) Ltd. - Applicants: Biosense Webster (Israel) Ltd. - Inventors: Debby E. Highsmith - Web page: https://patentgrep.com/patent/US12178500B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations - A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] - A61B 2018/00029: {open} - A61B 2018/00059: {Material properties} - A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array} - A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon} - A61B 2018/00351: {Heart} - A61B 2018/00577: {Ablation} - A61B 2018/00666: {using a threshold value} - A61B 2018/00797: {measured by multiple temperature sensors} - A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG} - A61B 2018/126: {bipolar} - A61B 2018/1465: {Deformable electrodes} - A61B 2018/1467: {using more than two electrodes on a single probe} - A61B 2018/1475: {Electrodes retractable in or deployable from a housing} - A61B 2034/2048: {using an accelerometer or inertia sensor} - A61B 2034/2051: {Electromagnetic tracking systems} - A61B 2034/2055: {Optical tracking systems} - A61B 2034/2063: {Acoustic tracking systems, e.g. using ultrasound} - A61B 2090/065: {for measuring contact or contact pressure} - A61B 2218/002: Irrigation - A61B 2562/046: in a matrix array - A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier - A61B 2562/166: the sensor is mounted on a specially adapted printed circuit board - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An apparatus includes a catheter assembly and an end effector. The catheter assembly includes an outer sheath with a distal end. The end effector is associated with a distal end of the catheter assembly. The end effector includes a panel assembly with microelectrodes for electrophysiological (EP) mapping. The microelectrodes are configured in a matrix within the panel assembly and provide multiple points of contact with the target tissue for EP mapping. The panel assembly can transition between a first contracted state and a second expanded state. The panel assembly can fit within the outer sheath in the first state. The panel assembly can expand outwardly away from a longitudinal axis defined by the catheter assembly in the second state once exposed distally relative to the distal end of the outer sheath. ## Claims ### Claim 1 An apparatus comprising: (a) a catheter assembly having a proximal end and a distal end, the catheter assembly defining a longitudinal axis, the catheter assembly including an outer sheath with a distal end; and (b) an end effector associated with the distal end of the catheter assembly, the end effector comprising a panel assembly, the panel assembly being configured to transition between a confined state and an expanded state, the panel assembly being configured to fit within the outer sheath in the confined state, the panel assembly being configured to expand outwardly away from the longitudinal axis into a generally planar configuration in the expanded state when exposed distally relative to the distal end of the outer sheath, the panel assembly comprising: (i) a common flexible circuit substrate, (ii) a plurality of spines extending along and attached to the common flexible circuit substrate, the plurality of spines being connected to each other at their proximal ends and unconnected from each other at their distal ends, (iii) a plurality of microelectrodes positioned along the plurality of spines, and (iv) at least one control wire attached to the plurality of spines, the plurality of spines being connected to each other at their proximal ends via the at least one control wire, the at least one control wire being configured to adjust tension in the plurality of spines such that the plurality of spines actuate the panel assembly between the confined state and the expanded state. ### Claim 2 (depends on 1) The apparatus of claim 1, the outer sheath being operable to translate relative to the end effector between a first longitudinal position and a second longitudinal position, the outer sheath being configured to contain the end effector in the first longitudinal position, the outer sheath being configured to expose the end effector in the second longitudinal position. ### Claim 3 (depends on 1) The apparatus of claim 1, the end effector being operable to translate relative to the outer sheath between a first longitudinal position and a second longitudinal position, the end effector being configured to be contained in the outer sheath in the first longitudinal position, the end effector being configured to be exposed from the outer sheath in the second longitudinal position. ### Claim 4 (depends on 1) The apparatus of claim 1, the plurality of spines being expandable outwardly away from the longitudinal axis in the expanded state when exposed distally relative to the distal end of the outer sheath. ### Claim 5 (depends on 1) The apparatus of claim 1, the plurality of spines extending distally from the at least one control wire. ### Claim 6 (depends on 1) The apparatus of claim 1, the at least one control wire operable to expand the panel assembly such that the panel assembly adopts the generally planar configuration in the expanded state. ### Claim 7 (depends on 6) The apparatus of claim 6, the at least one control wire being configured to cause the plurality of spines to deflect outward from the longitudinal axis such that the panel assembly adopts the generally planar configuration of the expanded state in response to adding the tension to the at least one control wire. ### Claim 8 (depends on 1) The apparatus of claim 1, the at least one control wire operable to contract the panel assembly to thereby cause the panel assembly to collapse inwardly toward the longitudinal axis to adopt a collapsed state. ### Claim 9 (depends on 8) The apparatus of claim 8, the at least one control wire being configured to cause the plurality of spines to move inward toward the longitudinal axis such that the panel assembly adopts a cylindraceous configuration of the collapsed state in response to removing the tension from the at least one control wire. ### Claim 10 (depends on 1) The apparatus of claim 1, the panel assembly defining a profile, the profile having a first surface area in the collapsed state and a second surface area in the expanded state, the surface area in the expanded state being larger than the surface area in the collapsed state. ### Claim 11 (depends on 1) The apparatus of claim 1, the plurality of microelectrodes being arranged in a matrix configuration. ### Claim 12 (depends on 1) The apparatus of claim 1, the plurality of microelectrodes comprising at least one pair of bipolar sensing microelectrodes configured to sense potentials in tissue. ### Claim 13 (depends on 1) The apparatus of claim 1, further comprising a position sensor, the position sensor being operable to generate a signal indicative of a position of one or both of at least a portion of the catheter assembly or at least a portion of the end effector in three-dimensional space. ### Claim 14 (depends on 13) The apparatus of claim 13, the position sensor being located on a portion of the panel assembly. ### Claim 15 (depends on 1) The apparatus of claim 1, the plurality of spines being resiliently biased to expand outwardly away from the longitudinal axis in the expanded state when exposed distally relative to the distal end of the outer sheath. ### Claim 16 (depends on 1) The apparatus of claim 1, the plurality of spines comprising a shape memory material. ### Claim 17 (depends on 16) The apparatus of claim 16, the shape memory material comprising a temperature sensitive material, such that the shape memory material is configured to transition from a first shape to a second shape in response to a change in temperature. ### Claim 18 An apparatus for performing electrophysiological mapping comprising: (a) a catheter assembly having a proximal end and a distal end, the catheter assembly defining a longitudinal axis, the catheter assembly including an outer sheath with a distal end; and (b) an end effector associated with the distal end of the catheter assembly, the end effector comprising a panel assembly comprising: (i) a common flexible circuit substrate, (ii) a plurality of spines extending along and attached to the common flexible circuit substrate, the plurality of spines being connected to each other at their proximal ends and unconnected from each other at their distalmost ends, (iii) a plurality of microelectrodes positioned along the plurality of spines and configured to sense potentials in tissue, and (iv) a control wire attached to the plurality of spines, the plurality of spines being connected to each other at their proximal ends via the control wire, the control wire being configured to adjust a tension within the plurality of spines to thereby flex the common flexible circuit substrate, the end effector being operable to transition between a first state, a second state, and a third state, the panel assembly being configured to fit within the outer sheath in the first state, the panel assembly being configured to extend distally from the distal end of the outer sheath in the second state with the panel assembly collapsed inwardly toward the longitudinal axis, and the panel assembly being configured to adopt a flat, planar configuration in the third state. ### Claim 19 A method comprising: (a) actuating a user input feature of a catheter assembly to transition an end effector of the catheter assembly from a first state to a second state, the catheter assembly including an outer sheath, the end effector comprising a panel assembly including an array of microelectrodes arranged in a matrix and configured for electrophysiological mapping, the panel assembly including a common flexible substrate attached to the microelectrodes and a plurality of spines attached to and extending along the common flexible substrate, the plurality of spines being connected to each other at their proximal ends and unconnected from each other at their distalmost ends, the panel assembly being contained in the outer sheath in the first state, the panel assembly being exposed relative to the outer sheath in the second state with the panel assembly expanded outwardly away from a longitudinal axis defined by the catheter assembly in the second state; and (b) actuating the end effector to transition from the second state to the first state by adjusting a tension value of the plurality of spines such that the plurality of spines flexes the common flexible substrate, the panel assembly returning to within the outer sheath in the first state.