High resolution multi-function and conformal electronics device for diagnosis and treatment of cardiac arrhythmias
Inventors
Efimov, Igor R. • Aras, Kedar • Rogers, John A. • Gremi, Erdit • Pospisil, David
Assignees
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Publication Number
US-12533179-B2
Publication Date
2026-01-27
Expiration Date
Abstract
The present invention is a high resolution, multi-function, conformal electronics device generally having a flexible and stretchable, high-density electrode array, integrated with a catheter (e.g., balloon catheter) for mapping, ablating, pacing and sensing of cardia tissue associated with heart arrhythmias. The active sensing electrode array can acquire diagnostic information including electrical (e.g., electrograms), mechanical (e.g., strain measurements), impedance (e.g., resistance), metabolic (e.g., pH or NADH measurement) from the underlying heart tissue surface with which it is in contact. The electrode array may be designed to be of various sizes and shapes to conform to the targeted cardiac tissue architecture (e.g. atrial, ventricle, right ventricular outflow tract, coronary sinus, pulmonary veins, etc.) corresponding to the specific type of cardiac arrhythmia. The present invention can precisely locate the source of arrhythmia as described above and deliver therapy from the same electrode array. This is achieved using a capacitive sensing electrode array that can not only monitor but also deliver electrical stimulation.
Core Innovation
A cardiac tissue mapping system is described for introducing to heart tissue of a heart formed by a wall and having a passage leading thereto. The system includes a catheter probe having a distal end, where the distal end includes a flexible and stretchable circuit formed as a single unitary chiplet structure. The circuit is embedded with multiple electrode-layer functions including stimulation-only electrodes, ablation-only actuators, and arrhythmia-only sensors, together with temperature and pressure sensor electrodes.
The arrhythmia-only sensors deliver arrhythmic pacing energy to detect electrical, mechanical, impedance, and metabolic characteristics of the heart tissue. Using those detected characteristics, the system verifies that the Atrioventricular Nodal Reentrant Tachycardia (AYNRT) pathway has been sufficiently ablated. The circuit further maps the wall of cardiac tissue using a processor and performs real-time ablation therapy and localized stimulation therapy concurrently.
Real-time ablation therapy is performed only via ablation-only actuators, using duration and force based on detected arrhythmia severity in the cardiac tissue and the detected temperature and pressure. Localized stimulation therapy is delivered in real time only via stimulation-only electrodes based on the detected arrhythmia severity and to restore normal heart function. The electrode layers are aligned in rows and columns that are evenly spaced apart, with the second electrode array overlaying the first and the third overlaying the second, within the flexible and stretchable multi-layer arrangement.
Claims Coverage
The independent claim defines a catheter-based cardiac tissue mapping system with a flexible, stretchable single unitary chiplet circuit that simultaneously supports sensing, mapping, ablation, and localized stimulation, with verification of sufficiently ablated Atrioventricular Nodal Reentrant Tachycardia (AYNRT) pathway using arrhythmia-only sensors and concurrent real-time therapy using temperature and pressure feedback.
Flexible and stretchable single unitary chiplet catheter circuit
A catheter probe having a distal end comprising a flexible and stretchable circuit formed as a single unitary chiplet structure, embedded with electrode layers and sensor/actuator components.
Stimulation-only electrode layer for localized electrical stimulation
A first electrode array forming a first electrode layer having a plurality of stimulation-only electrodes configured to deliver an electrical stimulation signal to the heart tissue.
Ablation-only actuator layer delivering ablation signal
A second electrode array forming a second electrode layer coupled to the first electrode layer, having one or more ablation-only actuators different from the stimulation-only electrodes, configured to deliver an ablation signal to the heart tissue.
Arrhythmia-only sensor layer for arrhythmia pacing and verification
The first electrode array further includes one or more arrhythmia-only sensors different from the stimulation-only electrodes, where the arrhythmia-only sensors deliver arrhythmic pacing energy to detect electrical, mechanical, impedance, and metabolic characteristics and verify that the Atrioventricular Nodal Reentrant Tachycardia (AYNRT) pathway has been sufficiently ablated.
Temperature and pressure sensor layer for therapy guidance
A third electrode array forming a third electrode layer coupled to the first and second electrode layers, having a plurality of temperature and pressure sensor electrodes different from the stimulation-only electrodes, the ablation-only actuators, and the arrhythmia-only sensors, wherein the temperature and pressure sensor electrodes detect temperature and pressure.
Processor-based real-time mapping and simultaneous therapy control
A processor configured to map the wall of cardiac tissue, detect arrhythmia severity in the cardiac tissue only via the one or more arrhythmia-only sensors, simultaneously perform real-time ablation therapy only via the ablation-only actuators with duration and force based on the detected arrhythmia severity and the detected temperature and pressure, and simultaneously deliver in real-time only via the stimulation-only electrodes the electrical stimulation signal to provide localized stimulation therapy based on the detected arrhythmia severity and restore normal heart function.
Stacked aligned electrode arrays with overlay relationships
The first and second electrode arrays are formed in rows and columns that are evenly-spaced apart, aligned with and parallel to each other, and the second electrode array overlays the first electrode array and the third electrode array overlays the second electrode array.
The claim coverage centers on a flexible, stretchable single unitary chiplet catheter circuit that stacks distinct electrode, sensor, and actuator layers: stimulation-only electrodes, ablation-only actuators, arrhythmia-only sensors that deliver arrhythmic pacing energy for detecting electrical, mechanical, impedance, and metabolic characteristics and verifying sufficiently ablated AYNRT pathway, and temperature and pressure sensor electrodes. A processor uses these detections to map the cardiac tissue wall and to simultaneously run real-time ablation therapy and localized stimulation therapy to restore normal heart function.
Stated Advantages
High-resolution mapping of the cardiac tissue wall, including a mapping resolution range (about 300 micrometers to about 5 millimeters) in dependent refinements.
Simultaneous mapping, real-time ablation therapy, and localized stimulation therapy using a single catheter probe with the multi-layer conformal circuit.
Verification that the Atrioventricular Nodal Reentrant Tachycardia (AYNRT) pathway has been sufficiently ablated.
Real-time ablation therapy controlled based on detected arrhythmia severity and detected temperature and pressure.
Localized stimulation therapy based on detected arrhythmia severity to restore normal heart function.
Documented Applications
Cardiac arrhythmia diagnosis and treatment by mapping cardiac tissue and verifying sufficiently ablated Atrioventricular Nodal Reentrant Tachycardia (AYNRT) pathway, including real-time ablation therapy and pacing-based localized stimulation to restore normal heart function.
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