EP-4739199-A2 - CARDIAC DIAGNOSTIC SYSTEM

Abstract

Provided herein are systems, devices, and methods for performing a cardiac diagnostic procedure. A system for locating segments of a cardiac conduction pathway in a patient includes: a plurality of sensors placed on the surface of the body of the patient, a data collection system for collecting sensor data from the plurality of sensors; a data processing system for calculating CEA data from the sensor data; and a display system for presenting a three-dimensional model of the location of the segments of the cardiac conduction pathway based on the calculated CEA data.

Inventors

• MEGLAN, DWIGHT
• BARDSLEY, RYAN SCOTT
• BERENSON, RICHARD
• CRAIG, BRIAN H.

Assignees

• Cardathea, Inc

Dates

Publication Date

20260513

Application Date

20240628

Claims (1)

1. Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 CLAIMS What is claimed is: 1. A system for mapping at least a portion of a cardiac conduction pathway in a patient, the system comprising: a plurality of sensors; a data collection system for collecting sensor data from the plurality of sensors; a data processing system for calculating a center of electrical activity (CEA) data from the sensor data; and a display system for presenting a three-dimensional (3D) model of a portion of the cardiac conduction pathway based on the calculated CEA data. 2. The system of claim 1, wherein the CEA data is determined by calculating a single equivalent dipole (SED). 3. The system of claim 1, wherein the 3D model of the portion the cardiac conduction pathway is displayed with respect to images of a gross anatomy of a heart. 4. The system of claim 1, wherein the plurality of sensors detect a signal propagating through segments of the cardiac conduction pathway during a PR segment of a cardiac cycle. 5. The system of claim 1, wherein the display system displays the portion of the cardiac conduction pathway located between an atrioventricular (AV) node and Purkinje fibers of a heart. 6. The system of claim 1, wherein the data collecting system comprises a digital converter for generating high resolution data from very low voltage signals sensed by the plurality of sensors. 7. The system of claim 6, wherein the voltage signals are below 0.1 mV. Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 8. The system of claim 1, wherein the data processing system enhances the sensor data via one or more of a low pass filter; a high pass filter; common mode reduction; and/or differentially weighting data from different sensors of the plurality of sensors. 9. The system of claim 1, further comprising a sensor location system for identifying a location of each sensor of the plurality of sensors in a 3D space. 10. The system of claim 9, wherein the sensor location system comprises a scanner, a CT machine, and/or an MRI machine configured to generate a 3D image. 11. The system of claim 10, wherein a machine learning algorithm trained to identify sensors in a 3D image identifies and locates the plurality of sensors in the 3D image generated by the sensor location system. 12. The system of claim 9, further comprising a garment and/or a harness for receiving the plurality of sensors. 13. The system of claim 1, wherein the data collection system is configured to indicate to a user whether a particular sensor of the plurality of sensors is improperly positioned and/or malfunctioning. 14. The system of claim 1, wherein the data collection system is configured to cause one or more sensors of the plurality of sensors to transmit one or more signals. 15. The system of claim 1, wherein the system is configured to filter the sensor data by applying a different broad band pass filter and/or narrow band pass filter to selected frequencies. 16. The system of claim 15, wherein the selected frequencies are between about 0.5 and 55 Hz or between about 65 and 300 Hz. 17. The system of claim 15, wherein the data processing system is configured to remove CEA data corresponding to timepoints for which a voltage at a particular timepoint of the timepoints is below a threshold value. Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 18. The system of claim 1, wherein each sensor of the plurality of sensors is weighted when determining a CEA based on a voltage-drop across at least one chord between sensors of the plurality of sensors. 19. The system of claim 1, wherein a location of a portion of the cardiac conduction pathway is determined by combining CEA data from multiple cardiac cycles. 20. The system of claim 19, wherein the combined CEA data from multiple cardiac cycles accounts for discrepancies due to motion of a heart during each cardiac cycle. 21. The system of claim 19, wherein the combined CEA data comprises combining the CEA data from the multiple cardiac cycles into a best fit a model. 22. The system of claim 21, wherein the system is further configured to determine a location of a septum of a patient’s heart using data collected from an emitting device. 23. The system of claim 22, wherein the location of the septum constrains the best fit model of the cardiac conduction pathway. 24. The system of claim 22, wherein the system is used for navigating a catheter to a target on the septum. 25. The system of claim 22 wherein a probability distribution for the location of the cardiac conduction pathway is graphically displayed on an image of the septum. 26. The system of claim 1, further comprising an emitting device, wherein the data processing system is configured to determine a location of the emitting device relative to the location of a portion of the cardiac conduction pathway. 27. The system of claim 26, further comprising a control device connected to a proximal end of the emitting device. Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 28. The system of claim 27, wherein the control device activates and/or controls a signal emitted by the emitting device. 29. The system of claim 27, wherein the control device controls movement of the emitting device. 30. The system of claim 1, further comprising an emitting device, wherein the data processing system is configured to determine an orientation of the emitting device relative to a location of the portion of the cardiac conduction pathway. 31. The system of claim 1, wherein a location of the portion of the cardiac conduction pathway is determined before and after a therapy is applied to the patient. 32. The system of claim 1, wherein the data processing system enhances the sensor data by selecting a filter based on whether or not an implanted pacing lead has recently delivered a pacing signal. 33. The system of claim 1 where the system is also used for navigating a catheter to a target in a heart. 34. The system of claim 1, wherein the system can also be used to develop a pacing strategy for a patient. 35. The system of claim 1, wherein the system can also be used to determine whether conduction system pacing has been achieved. 36. A method of mapping at least a portion of a cardiac conduction pathway comprising: sensing, via sensors, signals indicative of cardiac electrical signals propagating through the cardiac conduction pathway; combining the signals from each sensor, via a data collection system, to generate a first data stream; identifying, via a data processing system, a waveform from the data stream via a low resolution sampling of the first data stream; Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 sampling, via the data processing system, a segment of the identified waveform of the first data stream at a high-resolution to generate a second data stream; determining, via the data processing system, center of electrical activity (CEA) data based on the second data stream; and generating, via a display system, a three-dimensional (3D) model of the CEA data in real time, wherein the 3D model is indicative of the cardiac conduction pathway. 37. The method of claim 36, wherein determining the CEA data comprises performing single equivalent dipole (SED) analysis of the second data stream. 38. The method of claim 36, further comprising generating a real time image of a heart and overlaying the 3D model with reference to the real time image of the heart. 39. The method of claim 36, wherein the identified waveform is an electrocardiogram comprising a P wave, QRS complex and T wave. 40. The method of claim 39, wherein the segment of the identified waveform is a PR segment of the identified waveform. 41. The method of claim 36, further comprising determining locations of the sensors with respect to a heart of a subject. 42. The method of claim 41, wherein determining locations of the sensors comprises scanning the subject and the sensors, wherein the sensors are disposed on a body of the subject. 43. The method of claim 41, wherein determining CEA data is further based on the determined locations of the sensors. 44. The method of claim 36, further comprising sensing, via the sensors, a single dipole signal from an emitting device disposed within a heart of a subject. 45. The method of claim 44, further comprising determining, via the processing system, a location and orientation of the emitting device using SED analysis. Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 46. The method of claim 45, further comprising generating, via the display system, a 3D representation of the emitting device with respect to the 3D model indicative of the cardiac conduction pathway, wherein the 3D representation indicates a location and orientation of the emitting device in real time. 47. The method of claim 46, further comprising navigating the emitting device so that it is proximate to a desired portion of the cardiac conduction pathway based on the 3D representation. 48. The method of claim 46, further comprising detecting an electrode has been placed so as to capture proximal to the cardiac conduction pathway.

Description

Attorney Docket No.: 0277-0001WO1 CARDIAC DIAGNOSTIC SYSTEM CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority to U.S. Provisional Application No.63/511,783, filed July 3, 2023, the entirety of which is incorporated herein by reference. FIELD [0002] The embodiments disclosed herein relate generally to methods, systems, and devices for (1) imaging an organic conduction pathway, such as a cardiac conduction pathway; (2) navigating a therapy device to such an organic conduction pathway; and (3) determining whether a therapy device has engaged an organic conduction system pathway. BACKGROUND [0003] Normal heart function relies on delivering contraction-triggering electrical impulses to cardiomyocytes in a well-defined spatiotemporal pattern known as “sinus rhythm.” This pattern is maintained by the cardiac conduction pathway (sometimes referred to herein as “conduction system”), as shown in FIG.1. An electrical signal propagating through the cardiac conduction pathway initiates in the Sinoatrial ("SA”) node, and then travels around the right atrium to the left atrium and to the Atrioventricular (“AV”) node, where it pauses before propagating through the His Bundle, then through the left bundle branch (“LBB”) and the right bundle branch (“RBB”) – both of which are located in the septum between the ventricles, and then through the branching Purkinje fibers, before spreading across the ventricles. This electrical activity in the heart produces an electric field that can be detected, such as by skin surface electrodes in a pattern called an electrocardiogram (“ECG”), as shown in FIG. 2. An ECG shows how the electrical field strength fluctuates during each heartbeat. When detected, for example, as the difference between the voltages detected on a left arm electrode and a right arm electrode, the electric field produced in a single cardiac beat that shows a characteristic pattern of “waves” that are labeled/named by a letter P, Q, R, S, and T. Each wave spans a section of the ECG pattern that has a peak. It is common for both the section and the peak to be referred to by the same letter. The P section or “P wave” corresponds to the propagation of electrical activity across the surface of the atria. The Q-R-S complex comprises the Q, R, and S waves and corresponds to the propagation of electrical activity across the surface of the ventricles. The T wave corresponds to the repolarization of the ventricles. [0004] Complementing the waves are sections of the cardiac cycle called “segments” that start at the end of one wave and end at the beginning of another. For example, a PR segment starts at the end of the P wave and ends just before the beginning of the Q wave (FIG.2). It is Attorney Docket No.: 0277-0001US1 Client Docket No.: CDT-001-US1 also sometimes useful to divide the cardiac cycle into sections called “intervals.” Some intervals start at the peak of one wave and end at the peak of another. For example, an RR interval starts at the peak of the R wave of a first cardiac beat and ends at the peak of an R wave of a subsequent cardiac beat. Some intervals start at the beginning of the wave and end at the beginning of the next wave. For example, the PR interval starts at the beginning of the P wave and ends at the beginning of the Q wave. [0005] Disease may disrupt the cardiac conduction pathway and, thus, the sinus rhythm, leading to reduced cardiac output, morbidity, and mortality associated with reduced oxygen delivery to the body. For example, disruptions in this conduction pathway can cause irregular heartbeats (“arrhythmias”) that, if left untreated, can reduce heart output and lead to severe conditions such as heart failure. Arrhythmias, such as tachycardia, affect heart rate. The most common types of tachycardia (e.g., heartbeats greater than 100 bpm) are atrial fibrillation (“AF”) and ventricular tachycardia (“VT”). Another type of arrhythmia, Bradycardia (e.g., heartbeats less than 50 bpm), can be caused by sinus node dysfunction or AV block. [0006] To mitigate arrhythmias, many patients receive implantable devices for pacing the electrical system of the heart to induce sinus rhythm. For example, implantable cardiac defibrillators (“ICD”s) may be used to prevent tachycardia, while pacemakers (“PPM”s) may be used to prevent bradycardias (and sometimes for tachycardias). Pacing leads (implantable electrical leads, or wires, containing one or more electrodes) for these devices are wired into at least one of three locations in the heart to deliver precisely timed electrical impulses. The locations are typically the right atrium (“RA”), the right ventricle (“RV”), and sometimes the left ventricle (“LV”). The electrical impulses “pace” the cardiac electrical system and restore the heart to a normal sinus rhythm. [0007] Pacing leads for PPMs and ICDs are typically delivered to the heart percutaneously through the neck. A clinician guides the pacing lead through a patient’s vein to t