# US 12,004,805 B2 · Tissue mapping and treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,805 B2 - Document ID: US12004805B2 - Status: Granted - Kind: B2 - Application number: 18/461,431 - Filed: 2023-09-05 - Published: 2023-12-28 - Granted: 2024-06-11 - Earliest claimed: 2015-12-30 - Assignees: Schuler Scientific Solutions, LLC - Applicants: Schuler Scientific Solutions, LLC - Inventors: Brian Schuler; David Bernstein; David G. Matsuura; Phillip J. Simpson; Patricia Ellen Eisenhardt - Web page: https://patentgrep.com/patent/US12004805B2 ## CPC - A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)} - A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons - A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS] - A61B 5/6858: {with a distal basket, e.g. expandable basket} - A61B 18/02: by cooling, e.g. cryogenic techniques - A61B 2018/00041: {Heating, e.g. defrosting} - A61B 2018/0022: {Balloons} - A61B 2018/00267: {having a basket shaped structure} - A61B 2018/00351: {Heart} - A61B 2018/00577: {Ablation} - A61B 2018/00642: {with feedback, i.e. closed loop control} - A61B 2018/00791: {Temperature} - A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG} - A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes} - A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter} - A61M 25/09: Guide wires - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Methods, systems, and devices are described for mapping and treating tissue during a medical procedure. In some cases, a device includes a mesh of wires with sensors coupled thereto. The device can be coupled to an expandable treatment element. The expandable treatment element can include multiple segments. The sensors can be used to map a tissue area and monitor the tissue during a medical procedure. ## Claims ### Claim 1 A mapping overlay of a mapping catheter, the mapping overlay comprising: an elongate, flexible tubular body; a mesh of wires forming a tubular sidewall of a cavity configured to self-expand and receive a device therein, the mesh of wires comprising: a first plurality of wires, and a second plurality of wires formed of a different material than the first plurality of wires, wherein the first plurality of wires and the second plurality of wires are braided to form the mesh of wires, wherein expansion of the mesh of wires is shape set; a plurality of electrodes on the first plurality of wires; a connector coupled to a distal end of the mesh of wires, the connector comprising a lumen extending through the connector to permit a wire to extend past a distal end of the connector; and a catheter body coupled to the mesh of wires, the catheter body comprising: one or more inner layers, one or more outer layers being coupled to the one or more inner layers such that the one or more outer layers are axially fixed relative to the one or more inner layers, and a lumen extending through the catheter body and opening into the cavity to permit the device to be expanded within the cavity; wherein at least a portion of the mesh of wires is located between the one or more inner layers and the one or more outer layers, and the mesh of wires extends past a distal end of the catheter body. ### Claim 2 (depends on 1) The mapping overlay of claim 1, wherein the first plurality of wires comprises a plurality of conductor wires, and wherein the second plurality of wires comprises a plurality of structural wires. ### Claim 3 A catheter configured to deliver electroporation energy to a target tissue, the catheter comprising: a catheter body comprising: at least one lumen; one or more inner layers; and one or more outer layers being coupled to the one or more inner layers such that the one or more outer layers are axially fixed relative to the one or more inner layers, a mesh of wires configured to extend from a distal end of the catheter body and self-expand to form a cavity, the mesh of wires comprising: a first plurality of wires, and a second plurality of wires, wherein the first plurality of wires and the second plurality of wires are braided to form the mesh of wires, wherein at least a portion of the mesh of wires is located between the one or more inner layers and the one or more outer layers of the catheter body, and the mesh of wires extends past a distal end of the catheter body; an inflatable balloon configured to pass through the at least one lumen into the cavity formed by the mesh of wires; and a plurality of electrodes on the first plurality of wires, the plurality of electrodes configured to: map a non-target tissue; and treat a target tissue region with electrical energy sufficient to cause irreversible electroporation of the target tissue. ### Claim 4 (depends on 3) The catheter of claim 3, wherein the mesh of wires comprises one or more of: steel, polyester-coated copper, nitinol, composite material, platinum, a metal-coated nitinol, tungsten. ### Claim 5 (depends on 3) The catheter of claim 3, wherein the mesh of wires further comprises one or more radiopaque wires. ### Claim 6 (depends on 3) The catheter of claim 3, wherein the first plurality of wires and the second plurality of wires further comprise a biocompatible coating. ### Claim 7 (depends on 6) The catheter of claim 6, wherein the coating is one or more of: polytetrafluoroethylene (PTFE), polyester, and polyimide. ### Claim 8 (depends on 3) The catheter of claim 3, wherein the mesh of wires is shape set. ### Claim 9 (depends on 8) The catheter of claim 8, wherein the shape set mesh of wires is further configured to be expanded by the inflatable balloon. ### Claim 10 (depends on 3) The catheter of claim 3, wherein the mesh of wires further comprises at least one sensor. ### Claim 11 (depends on 10) The catheter of claim 10, wherein the at least one sensor is one of: a radiofrequency electrode, a flow sensor, a temperature sensor, an optical sensor, or a force sensor. ### Claim 12 (depends on 3) The catheter of claim 3, wherein the catheter is configured to be connected to a controller, the controller configured to instruct the plurality of electrodes to one or more of: map the non-target tissue and treat the target tissue. ### Claim 13 (depends on 3) The catheter of claim 3, wherein the plurality of electrodes are further configured to treat the target tissue region by delivering at least one pulse of electrical energy to the target tissue region. ### Claim 14 A method for ablating tissue, the method comprising: activating one or more electrodes carried by a self-expanding mesh of wires of a catheter device to stimulate a target or non-target tissue proximate a treatment site, the catheter device further comprising: at least one lumen; and a catheter body comprising: one or more inner layers; and one or more outer layers being coupled to the one or more inner layers such that the one or more outer layers are axially fixed relative to the one or more inner layers, wherein at least a portion of the mesh of wires is located between the one or more inner layers and the one or more outer layers, and the mesh of wires extends past a distal end of the catheter body, determining a location of at least a proximal portion of the non-target tissue based at least in part on said activating; determining a risk level associated with treatment of the treatment site, prior to commencement of the treatment, based at least in part on the determined location of the proximal portion of the non-target tissue; inflating a balloon within the self-expanding mesh of wires; and treating the target tissue at the treatment site with electrical energy via the one or more electrodes based at least in part on the determined risk level, wherein the electrical energy causes irreversible electroporation of the target tissue. ### Claim 15 (depends on 14) The method of claim 14, wherein the target tissue site comprises a cardiac tissue, and the non-target tissue comprises an extracardiac nervous tissue. ### Claim 16 (depends on 15) The method of claim 15, wherein the cardiac tissue comprises a pulmonary vein, and wherein the extracardiac nervous tissue comprises a phrenic nerve. ### Claim 17 (depends on 14) The method of claim 14, wherein the self-expanding mesh of wires comprises one or more of: steel, coated copper polyester, nitinol, composite material, platinum, a coated nitinol, tungsten. ### Claim 18 (depends on 14) The method of claim 14, wherein treating the tissue at the target tissue site comprises delivering at least one pulse of electrical energy to the treatment site.