Universal Pacing Catheter

Abstract

A method is provided that includes pacing cardiac tissue with pulses via an electrode on a catheter. The method includes observing, via the electrode, a period of electrophysiological repolarization of the cardiac tissue. The period of electrophysiological repolarization is induced by the pacing. The method also includes measuring, via the electrode, an electrical signal in the cardiac tissue after the period of electrophysiological repolarization.

Description

[Technical Field]

[0001] The present invention relates to signal processing, and more particularly to catheter-based universal pacing to enable improved cardiac signal analysis. [Background technology]

[0002] Treatment of cardiac disorders, such as cardiac arrhythmias, often requires analyzing specific regions or focal points of cardiac tissue via pacing. Pacing is a technique used in electrophysiology for a variety of reasons, including identifying critical conduction pathways, investigating tissue viability, controlling and overtaking cardiac rhythms, confirming blocks, detecting gaps, and identifying possible sources of arrhythmias. Pacing is performed using catheter electrodes to deliver very short current pulses to activate tissue in a given region and generate electrical waves from specific points. Summary of the Invention [Problem to be solved by the invention]

[0003] Currently, pacing is performed either as unipolar pacing (one source electrode and one larger distal return electrode) or, more often, as bipolar pacing (between two adjacent electrodes). However, no technology currently exists for simultaneously using multiple electrodes for pacing (whether simultaneous bipolar pacing from multiple electrodes or simultaneous bipolar pacing from multiple electrodes to a single larger electrode). Following such a maneuver, it would be possible to synchronize a large tissue region (beneath the pacing electrodes) and establish a conduction pattern beneath the electrodes following the tissue's refractory period. For example, such a technique could be useful for identifying lesions within this region. [Means for solving the problem]

[0004] According to one embodiment, a method is provided. The method includes pacing cardiac tissue with pulses via an electrode on a catheter. The method includes observing, via the electrode, a period of electrophysiological repolarization of the cardiac tissue. The period of electrophysiological repolarization is induced by the pacing. The method also includes measuring, via the electrode, an electrical signal in the cardiac tissue after the period of electrophysiological repolarization.

[0005] According to one or more embodiments, the above method embodiments may be implemented as an apparatus, a system, and / or a computer program product. [Brief explanation of the drawings]

[0006] A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings, in which like reference numerals indicate similar elements and in which: [Figure 1] 1 shows a diagram of a cardiac pacing and diagnostic device capable of implementing one or more features of the presently disclosed subject matter, according to one or more embodiments. [Figure 2] 1 shows a diagram of a cardiac pacing and diagnostic system capable of implementing one or more features of the presently disclosed subject matter, according to one or more embodiments. [Figure 3] 1 shows a diagram of a method according to one or more embodiments. [Figure 4] 1 illustrates an example of a catheter according to one or more embodiments. [Figure 5] 1 shows a diagram of a method according to one or more embodiments. [Figure 6] 1 illustrates an exemplary operation of a catheter and method according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0007] Disclosed herein is a cardiac pacing and diagnostic device that utilizes simultaneous pacing by all electrodes of a catheter (e.g., a mapping catheter) to generate periods of simultaneous activation of patches of tissue in direct contact with the catheter electrodes. In one embodiment, pacing is used in atrial fibrillation (AFIB) to monitor intracardiac electrocardiograph (ECG) signals immediately after the end of the pacing artifact (e.g., between 20 ms and 30 ms before current is applied). In another embodiment, pacing is used to understand whether a lesion exists within the paced region. The cardiac pacing and diagnostic device includes processor-executable code or software, necessarily resident in the processing operations and processing hardware of a medical device, to provide a method for analyzing specific regions or focal points of cardiac tissue in response to pacing. According to one embodiment, the cardiac pacing and diagnostic device provides specific pacing and capture operations involving multi-step manipulation of electrical signals to cardiac tissue to more accurately understand the electrophysiology of the cardiac tissue.

[0008] In this regard, and during operation, the cardiac pacing and diagnostic device controls pacing of a cardiac tissue region from multiple electrodes of a catheter. For example, each of the electrodes simultaneously provides a pulse to one specific isolated region. This pacing occurs during a period of electrophysiological repolarization of the cardiac tissue region and a refractory period of the tissue underlying the cardiac tissue region. After this period of electrophysiological repolarization, the cardiac pacing and diagnostic device utilizes the multiple electrodes to measure where within the cardiac tissue region a first electrical signal begins. The cardiac pacing and diagnostic device further utilizes the multiple electrodes to measure the progression of return activity patterns within the cardiac tissue region (e.g., originating within the electrodes, or at the border, or both) to isolate and analyze possible focal points of interest.

[0009] For example, if the heart is tachycardial (e.g., a heart rate above 100 beats per minute), a physician may want to examine a specific region for the presence of a tachycardia source. The problem physicians face (with respect to afib) is that this region is constantly exposed to activity originating from various directions. When pacing from an electrode, captured tissue (if pacing is successful) propagates throughout the heart. The normal conduction velocity in healthy tissue is approximately 0.7 mm / ms, and in an unhealthy heart it is much slower. This means that for a 15 mm catheter across, the signal has 20 ms to propagate from one end to the other. Importantly, tissue is activated gradually, and this is true for both sinus rhythm and foci. Alternatively, if simultaneous pacing captures tissue and activates it together, this extra 20 ms of propagation along the catheter is saved. Note that once pacing is terminated and the tissue is depolarized, each cell begins to repolarize at its own pace. The 20-ms window provides a longer test time regardless of whether the tachycardia source originates within or outside the electrode range. In afib, recovery time can be between 75 ms and 200 ms. Therefore, extending the test time by at least 20 ms is important. If the tachycardia source originates within the boundary, but not the boundary, this is interpreted as an indication that the tissue beneath the electrode is producing a treatable lesion. Even if this is not the case, it is unclear whether waves from an external source may have prevented activation of the tissue beneath the electrode.

[0010] The technical effects and benefits of the cardiac pacing and diagnostic device include providing cardiologists and medical personnel with a way to observe how specific focal points in cardiac tissue respond after pacing. Thus, the cardiac pacing and diagnostic device utilizes and modifies, among other things, catheter and medical device equipment to enable / perform pacing procedures and signal analyses that are not currently available or currently performed by cardiologists and medical personnel.

[0011] 1 shows a diagram of a cardiac pacing and diagnostic system 100 capable of implementing one or more features of the presently disclosed subject matter, according to one or more embodiments. Cardiac pacing and diagnostic system 100 may be generally referred to as a medical device. All or a portion of cardiac pacing and diagnostic system 100 may be used to collect vital signs data through universal pacing operations, and / or all or a portion of system 100 may be used to implement the cardiac pacing and diagnostic software described herein.

[0012] Cardiac pacing and diagnostic device 100 includes probe 110 having a shaft that a physician or medical professional 115 can navigate into a body part, such as heart 120, of patient 125 reclining on bed (or table) 130, as shown in inset 139. According to an exemplary embodiment, multiple probes may be provided, but for simplicity, a single probe 110 is described herein. However, it is understood that probe 110 may represent multiple probes. Inset 140 shows an enlarged view of a first end of the probe within a chamber of heart 120. As shown in inset 140, probe 110 includes catheter 141 (e.g., a mapping catheter), shaft 143, and sheath 146. Probe 110 also includes manipulator 148 and is connected to (in communication with) console 160, which stores and executes cardiac pacing and diagnostic software therein.

[0013] According to embodiments, medical professional 115 can insert shaft 143 through sheath 146 while manipulating the distal end of shaft 143 using a manipulator 148 near the proximal end of catheter 141 and / or deflection from sheath 146. As shown in inset 140, catheter 141 can be attached to the distal end of shaft 143. Catheter 141 can be inserted through sheath 146 in a collapsed state and then expanded within heart 120. Catheter 141 includes one or more elements (e.g., at least one electrode 151).

[0014] According to one or more embodiments, catheter 141 can be any shape or type of catheter that includes one or more elements used to implement the embodiments disclosed herein. Note that one or more elements can be any element configured to pace, ablate, and / or collect vital signs data. More specifically, in one embodiment, one or more elements can be an electrode (e.g., at least one electrode 151), a transducer, or one or more other elements. Furthermore, while catheter 141 is illustrated as being a point catheter (including at least one electrode 151 and a catheter needle), it will be understood that catheter 141 is representative of one or more catheters. According to other embodiments, multiple elements can be connected via splines that define the shape of catheter 141.

[0015] Other examples of the catheter 141 include a linear catheter with multiple electrodes, a balloon catheter including electrodes distributed on multiple spines forming a balloon, a lasso or loop catheter with multiple electrodes, or any other applicable shape. The linear catheter may be fully or partially elastic, so that it can twist, bend, or change its shape based on received signals and / or the application of an external force (e.g., cardiac tissue) to the linear catheter. The balloon catheter may be designed so that its electrodes can be held in close contact against the endocardial surface when deployed within a patient's body. As an example, the balloon catheter can be inserted into a lumen such as a pulmonary vein (PV). The balloon catheter can be inserted into the PV in a deflated state so that the balloon catheter does not occupy the full volume of the PV while inserted within the PV. The balloon catheter can be inflated inside the PV with such electrodes on the balloon catheter in contact with the entire circular area of ​​the PV. Such contact with the entire circular portion of the PV, or any other lumen, enables efficient pacing, mapping, and / or ablation.

[0016] According to one or more embodiments, catheter 141 comprises a mesh catheter, a balloon catheter, or a spoon catheter having multiple electrodes. For example, the mesh catheter, balloon catheter, or spoon catheter can have at least 40 electrodes, or in some cases, exactly 48 electrodes.

[0017] The catheter 141 may be configured to injure a tissue region of an internal organ, such as by ablating a tissue region of a chamber of the heart 120. The catheter 141 may also be further configured to pace with pulses and observe / acquire biometric data in response to those pulses. In this regard, the catheter 141 may be positioned within the body of the patient 125 (e.g., within the heart 120), and the position of the catheter 141 may be determined by the console 160 based on signals transmitted and received between one or more electrodes 151 of the catheter in conjunction with body patches and / or body surface electrodes. The electrodes 151 may further sense biometric data (e.g., cardiac electrical signals such as sinus rhythm or sinus rhythm) from within the body of the patient 125 (e.g., within the heart 120). The biometric data may be associated with the determined catheter position, such that a rendering of the patient's body part (e.g., the heart 120) may be displayed showing the biometric data superimposed on the shape of the body. Note that sinus rhythm can be any cardiac rhythm in which depolarization of the myocardium begins at the sinus node. For example, sinus rhythm can include heartbeats with a normal heart rate and rhythm (e.g., a human heart rate typically ranges between 60 and 100 beats per minute).

[0018] In operation, cardiac pacing and diagnostic device 100 can be utilized to detect, diagnose, and treat cardiac conditions. Cardiac disorders such as cardiac arrhythmias (particularly atrial fibrillation) exist as common and dangerous medical ailments, especially in the aging population. In a patient (e.g., patient 125) with normal sinus rhythm, the heart (e.g., heart 120) is composed of atria, ventricles, and excitatory conduction tissue, which are electrically stimulated to beat in a synchronous, patterned manner (note that this electrical excitation can be detected as intracardiac signals).

[0019] In a patient with cardiac arrhythmia (e.g., patient 125), abnormal regions of cardiac tissue do not follow the synchronous beating cycle associated with normal conductive tissue, as in a patient with normal sinus rhythm. Conversely, the abnormal regions of cardiac tissue conduct abnormally to adjacent tissue, thereby disrupting the cardiac cycle into an asynchronous cardiac rhythm (note that this asynchronous cardiac rhythm can also be detected as an intracardiac signal). Such abnormal conduction has long been known and occurs in various regions of the heart (e.g., heart 120), along the conduction pathways of the atrioventricular (AV) node, for example, in the region of the sino-atrial (SA) node, or in the myocardial tissue that forms the walls of the ventricular and atrial chambers.

[0020] Furthermore, cardiac arrhythmias, including atrial arrhythmias, may be multi-wavelet reentrant, characterized by multiple asynchronous loops of electrical impulses scattered and often self-propagating around the atria (e.g., another example of intracardiac signals). Alternatively, or in addition to multi-wavelet reentrant, cardiac arrhythmias may also have focal sources (e.g., which may be focal points of interest for the cardiac pacing and diagnostic device 100), such as when isolated regions of tissue within the atria are autonomously excited in a rapid, repetitive manner. Ventricular tachycardia (V-tach or VT) is a tachycardia or fast cardiac rhythm originating from one of the ventricles. It is a potentially fatal arrhythmia because it can lead to ventricular fibrillation and sudden death.

[0021] Atrial fibrillation, a type of arrhythmia, occurs when normal electrical impulses (e.g., sinus rhythm) generated by the sinoatrial node are overwhelmed by chaotic electrical impulses originating in the atria and pulmonary veins, resulting in irregular impulses being conducted to the ventricles. This results in an irregular heartbeat that can persist for minutes to weeks, or even years. Atrial fibrillation (AF) is often a chronic condition that carries a small increased risk of death, often from stroke. The first-line treatment for AF is medication to slow the heart rate or restore normal heart rhythm. Furthermore, patients with AF are often given anticoagulants to protect themselves from the risk of stroke. The use of such anticoagulants carries its own risks: internal bleeding. In some patients, medication is insufficient, and their AF is deemed drug-refractory, meaning it cannot be treated with standard pharmacological interventions. Synchronized cardioversion, a procedure that uses electrical current to reset the heart rhythm to normal sinus rhythm, may be used to convert AF to a normal heart rhythm.

[0022] As described herein, cardiac pacing and diagnostic device 100 provides cardiologists and medical personnel with a way to observe how specific focal points in cardiac tissue respond after pacing. Thus, cardiac pacing and diagnostic device 100 utilizes and modifies, among other things, catheter 141 and console 160 to enable / perform pacing procedures and signal analyses that are not currently available or performed by cardiologists and medical personnel.

[0023] More specifically, console 160 is connected to and communicates with probe 110 and catheter 141. Console 160 is capable of storing and executing cardiac pacing and diagnostic software. According to one embodiment, console 160 includes at least a processor and memory, where the processor executes computer instructions related to the cardiac pacing and diagnostic software described herein and the memory stores instructions for execution by the processor.

[0024] Console 160 can be any computing device, including software and / or hardware, such as a general-purpose computer, with appropriate front-end and interface circuitry for transmitting and receiving signals to and from catheter 141 and for controlling other components of system 100. The front-end and interface circuitry includes an input / output (I / O) communication interface that allows console 160 to receive signals from and / or transfer signals to at least one electrode 151. In some embodiments, console 160 can be further configured to receive biometric data, such as electrical activity, and determine whether a given tissue region conducts electricity. According to one embodiment, console 160 can be located, for example, within catheter 151, an external device, a mobile device, a cloud-based device, or can be a standalone processor / computer.

[0025] As mentioned above, console 160 may include a general-purpose computer that can be programmed with software (e.g., cardiac pacing and diagnostic software) to perform the functions of cardiac pacing and diagnostic device 100 described herein. The software may be downloaded to the general-purpose computer in electronic form, for example, over a network, or alternatively or additionally, may be provided and / or stored on a non-transitory tangible medium such as magnetic, optical, or electronic memory (e.g., any suitable volatile and / or non-volatile memory, such as random access memory or a hard disk drive). The exemplary configuration shown in FIG. 1 may be modified to implement embodiments disclosed herein. Embodiments of the present disclosure may be similarly applied using other system components and configurations. Additionally, cardiac pacing and diagnostic device 100 may include additional components, such as elements for sensing electrical activity, wired or wireless connectors, processing and display devices, etc.

[0026] According to one embodiment, a display is connected to the console 160. During a procedure, the console 160 can facilitate the presentation of body part renderings to the medical professional 115 on the display and can store data representing the body part renderings in memory. In some embodiments, the medical professional 115 can manipulate the body part renderings using one or more input devices, such as a touchpad, mouse, keyboard, or gesture recognizer. For example, the input device can be used to change the position of the catheter 141 so that the renderings are updated. In alternative embodiments, the display can include a touchscreen that can be configured to receive input from the medical professional 115 in addition to presenting the body part renderings. Note that the display can be located at the same location or at a remote location, such as in a separate hospital or separate healthcare provider network. Furthermore, the cardiac pacing and diagnostic device 100 can be part of a surgical system configured to obtain anatomical and electrical measurements of a patient's organs, such as the heart 120, and to perform cardiac ablation procedures. One example of such a surgical system is the Carto® system sold by Biosense Webster.

[0027] The console 160 can be connected by a cable to body surface electrodes, which can include adhesive skin patches that are applied to the patient 125. The processor of the console 160, in conjunction with the current tracking module, can determine position coordinates of the catheter 141 within a body part (e.g., the heart 120) of the patient 125. The position coordinates can be based on impedance or electromagnetic fields measured between the body surface electrodes and electrodes or other electromagnetic components (e.g., at least one electrode 151) of the catheter 141. Additionally or alternatively, location pads can be placed on the surface of the bed 130 or can be separate from the bed 130.

[0028] Cardiac pacing and diagnostic device 100 can also, and optionally, acquire biometric data, such as anatomical measurements of heart 120, using ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), or other medical imaging techniques known in the art. Cardiac pacing and diagnostic device 100 can acquire ECG or electrical measurements using a catheter (e.g., catheter 141) or other sensor that measures electrical properties of heart 120. The biometric data, including the anatomical and electrical measurements, can then be stored in a non-transitory tangible medium of console 160. The biometric data can be transmitted from the non-transitory tangible medium to a server, which can be local or remote, using a network, as further described herein.

[0029] According to one or more embodiments, a catheter (e.g., catheter 141) containing a position sensor can be used to determine the trajectories of points on the heart surface. These trajectories can be used to infer motion characteristics, such as the contractile force of the tissue. A map indicative of such motion characteristics can be constructed when trajectory information is sampled at a sufficient number of points within the heart.

[0030] 2, a cardiac pacing and diagnostic system 200 capable of implementing one or more features of the presently disclosed subject matter is illustrated in accordance with one or more embodiments. Cardiac pacing and diagnostic system 200 includes a local computing device 206, a remote computing system 208, a first network 210, and a second network 211 for a patient 201 (e.g., an example of patient 125 of FIG. 1 ). Additionally, cardiac pacing and diagnostic device 220 may include patient vital signs sensors 221, a processor 222, a user input (UI) sensor 223, a memory 224, and a transmitter-receiver (i.e., transceiver) 225. It should be noted that patient vital signs sensors 221 may be an example of catheter 141 of FIG. 1, and cardiac pacing and diagnostic device 220 may be an example of console 160 of FIG. 1.

[0031] Local computing device 206 and / or remote computing system 208, together with cardiac pacing and diagnostic device 220, can be any combination of software and / or hardware that individually or collectively stores, executes, and implements cardiac pacing and diagnostic software and its functionality. Furthermore, as described herein, local computing device 206 and / or remote computing system 208, together with cardiac pacing and diagnostic device 220, can be an electronic computer framework comprising and / or using any number and combination of computing devices and networks utilizing various communication technologies. Local computing device 206 and / or remote computing system 208, together with cardiac pacing and diagnostic device 220, can be easily scalable, extensible, and modular, with the ability to change to different services or reconfigure some features independently of other features.

[0032] According to one embodiment, local computing device 206 and remote computing system 208, along with cardiac pacing and diagnostic device 220, include at least a processor (e.g., processor 222 described herein) and memory (e.g., memory 224 described herein), where the processor executes computer instructions related to cardiac pacing and diagnostic software and the memory stores computer instructions for execution by the processor.

[0033] Local computing device 206 of cardiac pacing and diagnostic system 200 may be configured to communicate with cardiac pacing and diagnostic device 220 and act as a gateway to remote computing system 208 through second network 211. Local computing device 206 may be, for example, a smartphone, smartwatch, tablet, or other portable smart device configured to communicate with other devices via network 211. Alternatively, local computing device 206 may be a fixed or standalone device, such as, for example, a fixed base station, desktop, or laptop computer including modem and / or router capabilities, that uses executable programs to communicate information between cardiac pacing and diagnostic device 220 and remote computing system 208, for example, via a modem, router, wireless module, and / or USB dongle. The physiological data may be communicated between the local computing device 206 and the cardiac pacing and diagnostic device 220 using short-range wireless technology standards (e.g., Bluetooth, Wi-Fi, ZigBee, Z-wave, and other short-range wireless standards) over a short-range wireless network 210, such as a local area network (LAN) (e.g., a personal area network (PAN)). In some embodiments, the local computing device 206 may also be configured to display the observed / acquired patient electrical signals and information associated with the acquired patient electrical signals, as described in further detail herein.

[0034] In some embodiments, remote computing system 208 can be configured to receive at least one of the monitored patient's vital signs and information associated with the monitored patient via network 211, which is a long-range network. For example, if local computing device 206 is a cellular phone, network 211 can be a wireless cellular network, and information can be communicated between local computing device 206 and remote computing system 208 via a wireless technology standard, such as any of the wireless technologies described above. As described in further detail herein, remote computing system 208 can be configured to provide (e.g., visually display and / or audibly provide) the patient's vital signs and / or information associated therewith to a medical professional, physician, healthcare professional, or the like.

[0035] 2, network 210 is an example of a short-range network (e.g., a local area network (LAN) or a personal area network (PAN)). Information may be transmitted over short-range network 210 between cardiac pacing and diagnostic device 220 and local computing device 206 using any one of a variety of short-range wireless communication protocols, such as Bluetooth, Wi-Fi, Zigbee, Z-Wave, near field communications (NFC), Ultraband, ZigBee, or infrared (IR).

[0036] Network 211 may be a wired network, a wireless network, or may include one or more wired and wireless networks, such as an intranet, a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a direct connection or series of connections, a cellular telephone network, or any other network or medium capable of facilitating communication between local computing device 206 and remote computing system 208. Information may be transmitted over network 211 using any one of a variety of long-range wireless communication protocols (e.g., TCP / IP, HTTP, 3G, 4G / LTE, or 5G / New Radio). Wired connections may be implemented using Ethernet, Universal Serial Bus (USB), RJ-11, or any other wired connection commonly known in the art. Wireless connections may be implemented using Wi-Fi, WiMAX, Bluetooth, infrared, cellular networks, satellite, or any other wireless connection technique. Furthermore, several networks may operate alone or in communication with each other to facilitate communication within network 211. In some cases, the remote computing system 208 may be implemented as a physical server on the network 211. In other cases, the remote computing system 208 may be implemented as a virtual server on a public cloud computing provider (e.g., Amazon Web Services (AWS)) on the network 211.

[0037] During operation, cardiac pacing and diagnostic device 220 utilizes cardiac pacing and diagnostic software to observe / acquire patient 201 biometric data (e.g., electrical signals, blood pressure, temperature, blood glucose levels, or other biometric data) from patient biometric sensors 221 and / or receive at least a portion of the biometric data representative of any acquired patient biometric information, as well as additional information (e.g., diagnostic information) associated with any acquired patient biometric information from one or more other patient biometric diagnostic devices. The cardiac pacing and diagnostic software is processor-executable code or software inherently rooted in processing operations by, and processing hardware of, cardiac pacing and diagnostic device 220 that provides methods for analyzing specific regions or focal points of cardiac tissue in response to pacing. According to one embodiment, the cardiac pacing and diagnostic software of cardiac pacing and diagnostic device 220 provides specific pacing and capture operations involving multi-step manipulation of electrical signals to cardiac tissue to more accurately understand the electrophysiology of the cardiac tissue. Cardiac pacing and diagnostic device 220 can use cardiac pacing and diagnostic software to process data, including acquired / observed / acquired biometric data and any biometric data received from one or more other patient biometric diagnostic devices. For example, when processing data in this regard, the cardiac pacing and diagnostic software includes a neural network that is used to learn latent representations (or data encodings) from the biometric data in an unsupervised manner. Furthermore, the cardiac pacing and diagnostic software learns to detect specific data by training the neural network.

[0038] Cardiac pacing and diagnostic device 220 can continuously or periodically monitor, store, process, and communicate any number of various patient biometrics (e.g., acquired biometric data) via network 210. As described herein, examples of patient biometrics include electrical signals (e.g., ECG signals and brain biometrics), blood pressure data, blood glucose data, and temperature data. Patient biometrics can be monitored and communicated for treatment across any number of various diseases, such as cardiovascular diseases (e.g., arrhythmias, cardiomyopathies, and coronary artery disease) and autoimmune diseases (e.g., type I and type II diabetes).

[0039] The patient vital signs sensor 221 can include, for example, one or more transducers configured to convert one or more environmental conditions into electrical signals so that different types of vital signs data can be observed, acquired, or obtained. For example, the patient vital signs sensor 221 can include one or more of an electrode (e.g., electrode 151 of FIG. 1 ), a temperature sensor (e.g., a thermocouple), a blood pressure sensor, a blood glucose sensor, a blood oxygen sensor, a pH sensor, an accelerometer, and a microphone.

[0040] Processor 222, in executing the cardiac pacing and diagnostic software, may be configured to receive, process, and manage biometric data acquired by patient biometric sensors 221 and communicate the biometric data to memory 224 for storage and / or across network 210 via transceiver 225. As described in more detail herein, data from one or more other cardiac pacing and diagnostic devices 220 may also be received by processor 222 through transceiver 225. Also, as described in more detail herein, processor 222 may be configured to selectively respond to different tapping patterns (e.g., single tap or double tap) received from UI sensor 223 (e.g., an internal capacitance sensor) such that different tasks of the patch (e.g., data acquisition, storage, or transmission) can be initiated based on the detected pattern. In some embodiments, processor 222 can generate audible feedback regarding the detection of a gesture.

[0041] UI sensor 223 may include, for example, a piezoelectric or capacitive sensor configured to receive user input, such as a tap or touch. For example, UI sensor 223 may be controlled to provide capacitive coupling in response to patient 201 tapping or touching the surface of cardiac pacing and diagnostic device 220. Gesture recognition may be provided via any one of a variety of capacitive types, such as resistive-capacitive, surface-capacitive, projected-capacitive, surface ultrasonic, piezoelectric, and infrared touch. Capacitive sensors may be positioned over a small area or length of the surface such that a tap or touch on the surface activates the monitoring device.

[0042] Memory 224 is any non-transitory, tangible medium, such as magnetic, optical, or electronic memory (e.g., any suitable volatile and / or non-volatile memory, such as random access memory or a hard disk drive). Memory 224 stores cardiac pacing and diagnostic software for execution by processor 222.

[0043] The transceiver 225 may include a separate transmitter and a separate receiver, or the transceiver 225 may include a transmitter and receiver integrated into a single device.

[0044] According to one embodiment, cardiac pacing and diagnostic device 220 may be a device internal to the body of patient 201 (e.g., subcutaneously implantable). Cardiac pacing and diagnostic device 220 may be inserted into patient 201 by any applicable method, including oral infusion, surgical insertion via a vein or artery, endoscopic procedure, or laparoscopic procedure. According to one embodiment, cardiac pacing and diagnostic device 220 may be a device external to patient 201. For example, as described in further detail herein, cardiac pacing and diagnostic device 220 may include an attachable patch (e.g., attached to the patient's skin). According to one embodiment, cardiac pacing and diagnostic device 220 may include both patient internal and patient external components. While a single cardiac pacing and diagnostic device 220 is shown in FIG. 2 , an exemplary system may include multiple patient vital signs diagnostic devices. For example, cardiac pacing and diagnostic device 220 may be in communication with one or more other patient vital signs diagnostic devices. Additionally or alternatively, one or more other patient vital signs diagnostic devices may be in communication with network 210 and other components of cardiac pacing and diagnostic system 200 .

[0045] 3 shows a diagram of a method 300 (performed in the cardiac pacing and diagnostic device 100 of FIG. 1 and / or the cardiac pacing and diagnostic system 200 of FIG. 2) according to one or more embodiments. Method 300 addresses the need to observe large focal points in cardiac tissue so that the lesions can be understood.

[0046] The method begins at block or step 320, in which multiple electrodes of a catheter (e.g., electrode 151 of catheter 141) pace cardiac tissue with multiple pulses. Note that each of the multiple electrodes delivers one pulse of the multiple pulses to one specific isolated region of the cardiac tissue. Each of the multiple pulses can pace together and simultaneously (e.g., in unison) at an isolated portion of the cardiac tissue (e.g., at the same specific focal point). For example, pacing may include a series of stimulations or current (pace by pace) increases to capture the tissue simultaneously with all electrodes by attempting to synchronize and then listening to the tissue under the electrodes. The catheter may be a mesh catheter, balloon catheter, or spoon catheter as described herein.

[0047] In block or step 340, the catheter electrodes observe periods of electrophysiological repolarization of the cardiac tissue caused by pacing (or periods of atrial tissue inactivity during which reactivation is not possible). That is, pacing with multiple electrodes at a focal point itself generates periods of atrial tissue inactivity. Periods of electrophysiological repolarization can include periods during which the cardiac tissue does not generate an activity pattern.

[0048] In block or step 360, the catheter's multiple electrodes measure electrical signals in the cardiac tissue after a period of electrophysiological repolarization. Because pacing at the same specific focal point in the cardiac tissue is performed in unison and is followed by a period of inactivity, the measured electrical signals indicate a first portion of the cardiac tissue that responds. In this manner, the cardiac tissue or the focal point in the cardiac tissue can be analyzed and evaluated. According to one or more embodiments, the catheter's multiple electrodes can further measure the progression of the return activity pattern after the electrical signals are measured in the cardiac tissue. Cardiac pacing and diagnostic software (e.g., the cardiac pacing and diagnostic software of the cardiac pacing and diagnostic device 220 of FIG. 2) can then isolate and analyze the focal point of interest in the cardiac tissue under the electrodes based on the progression of the return activity pattern.

[0049] Technical effects and benefits of method 300 include allowing a cardiologist to capture a large area (of heart 120 in FIG. 1) at once, allowing for a more accurate understanding of the electrophysiology of cardiac tissue.

[0050] FIG. 4 illustrates an example of a catheter 400 according to one or more embodiments. The catheter 400 may be a mesh catheter, a balloon catheter, or a spoon catheter having a plurality of electrodes 434, such as at least 40 electrodes. As shown, the plurality of electrodes may include exactly 48 electrodes distributed across or on a plurality of spines 437. Using such a large number of electrodes 434 distributed over a wide area by the spines 437, a wide area can be reached at once. According to an embodiment, the plurality of spines 437 may be passed through a sheath 439 in a collapsed state and then expanded in one go within a patient (e.g., patient 125 of FIG. 1 ).

[0051] Electrical activity at any focal point within the heart can typically be measured by advancing the catheter 400, contacting cardiac tissue with the catheter 400, and acquiring data at that point. Contacting cardiac tissue involves pacing each electrode 434 in unison simultaneously in the region of interest to create a period of inactivity in a given region, thereby making the electrodes 434 available for signal analysis.

[0052] According to one or more embodiments, activation of electrodes 434 may vary in number and location, such as pacing from any electrode to any electrode, or pacing from all electrodes to larger electrodes further away. In one embodiment, results from previous pacing may be used to simultaneously activate fewer electrodes to capture a smaller area. In one embodiment, results from previous pacing may be used to simultaneously activate a selected number of electrodes around a specific location to measure correlation of ventricular activity. That is, specific groupings of pulses may be used to manipulate the duration of electrophysiological repolarization based on a desired number and / or location. For example, as shown in FIG. 4, electrode subset 450 may be selected by cardiac pacing and diagnostic software to implement specific groupings of pulses. In this regard, the remaining electrodes 460 remain unused for pacing.

[0053] 5 illustrates a block diagram of a method 500 (performed in the cardiac pacing and diagnostic device 100 of FIG. 1 and / or the cardiac pacing and diagnostic system 200 of FIG. 2) according to one or more embodiments. Method 500 addresses the need to observe large focal points in cardiac tissue so that the lesions can be understood.

[0054] Generally, during AF, there is no repeatable pattern of wavefront activation. Note that AF is the result of many causes that are still being debated. That is, some researchers have identified rotors as the cause, while others have not (e.g., identified different foci). Rotors and foci may be treated differently. In either case, it is important to understand the cause of AF and which cardiac tissue regions are involved in order to provide the best treatment and proactively alter treatment outcomes. Method 500 provides a mechanism for understanding whether certain cardiac regions have foci using pacing from multiple electrodes. Image 510 generally shows the outline of the left atrium 511 as projected from the patient's back. Image 510 also shows regions 512 that may be scarred or inactive.

[0055] Assuming a physician (e.g., medical professional 115 of FIG. 1 ) believes that this region 512 is significant with respect to tachycardia and that there may be a focus originating within that region, the physician is still faced with the problem of not being able to properly observe this focus because impinging waves 514 are entering region 512 and creating chaotic repolarization of the cardiac tissue. This chaotic repolarization is a known condition that perpetuates AF, regardless of the reasons described herein. Traditionally, physicians consider shocking the heart to bring the heart out of the AF state, allowing the cardiac cells to "reset" and allowing sinus rhythm a chance to take control (often this is not feasible, e.g., with AFIB, the patient quickly reverts to AFIB).

[0056] Alternatively, as shown in image 520, a catheter 521 is placed over this area 512. The catheter 521 may be a mesh catheter, a balloon catheter, or a spoon catheter as described herein.

[0057] In block 530, an electrode of catheter 421 (e.g., electrode 151 of catheter 141) paces region 512 with multiple pulses. Note that each of the multiple electrodes provides a pulse to region 512 of left atrium 511. Each of the multiple pulses may pace region 512 of left atrium 511 together and simultaneously (e.g., in unison) (e.g., the same specific focal point) together. Based on how the diagnostic system selects and groups the multiple electrodes, it is possible to pace all locations in region 512 of left atrium 511 or only isolated portions of region 512 of left atrium 511.

[0058] In block 540, the multiple electrodes of catheter 521 observe periods of pacing-induced electrophysiological repolarization (or periods of atrial tissue inactivity that are not reactivatable) of region 512 of left atrium 511. That is, pacing with multiple electrodes at a single focal point itself generates periods of atrial tissue inactivity.

[0059] As shown in image 560, by pacing from all electrodes at once, method 500 essentially creates a specific region with a (nearly) aligned wavefront 565, and importantly, prevents other waves from entering this region until the refractory period of the region returns. This time allows the diagnostic system time to listen for the presence or absence of an origin within this region (i.e., whether cells within this tissue patch under the electrodes behave as a focus). Next, in block 570, multiple electrodes on catheter 521 measure electrical signals (in mV) within region 512 of left atrium 511 (e.g., the diagnostic system identifies and analyzes the focus point of interest and how the wave propagates across the region). Note that any activity originating within region 512 can also be used as a target for ablation.

[0060] 6 illustrates an exemplary operation 600 of a catheter (e.g., catheter 400) and method (e.g., method 500) according to one or more embodiments. As shown in exemplary operation 600, electrodes 601 are positioned according to a grid in which a first direction is designated by letters A-F and a second direction is designated by numbers 1-8. The grid is aligned with a tissue region suspected of containing a lesion 605. Then, after a period of electrophysiological repolarization, a wavefront 610 propagates from lesion 605 and is detected by each electrode 601. In parallel, an external wave 615 enters the region of tissue and is also detected by electrodes 601.

[0061] As shown in measurement result 650, electrodes D4, D3, and D5 detect wavefront 610 at different times. Note that morphology 651 represents focus 605. Furthermore, electrode F4 detects extraneous wave 615 (i.e., morphology 652), and electrode E4 detects a combination of morphologies 651 and 652 (i.e., morphology 653). For universal pacing with a grid, extraneous wave 615 can be ignored and / or subtracted from the measurements. Importantly, according to the signal propagation sequence of the electrodes (and possibly their morphologies), it may be possible to understand the presence of a focus source beneath the electrode patch.

[0062] Technical effects and benefits of method 500 include allowing a cardiologist to capture a large region (of heart 120 in FIG. 1 ) at once, enabling a more accurate understanding of the electrophysiology of cardiac tissue. For example, depending on the catheter size and electrode coverage, a large region (larger than a single pacing) may be equivalent to approximately 2.5×2.5 cm in size. In contrast, with the region size of a single pacing from one electrode (related to the size and location of the electrode), the regions would not be synchronized simultaneously, resulting in contamination by traveling waves outside the tissue due to AF.

[0063] The flowcharts and block diagrams in the figures illustrate the structure, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of instructions, which includes one or more executable instructions for implementing the depicted logical function(s). In some alternative implementations, the functions shown in the blocks may occur out of the order shown in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending on the functionality involved. It should also be noted that each block of the block diagrams and / or flow diagrams, and combinations of blocks in the block diagrams and / or flow diagrams, may be implemented by a dedicated hardware-based system that performs the specified function or operation, or may be operated or executed by a combination of dedicated hardware and computer instructions.

[0064] While features and elements have been described above in particular combinations, those skilled in the art will understand that each feature or element can be used alone or in combination with other features and elements. Additionally, the methods described herein can be implemented in a computer program, software, or firmware embodied in a computer-readable medium for execution on a computer or processor. As used herein, computer-readable medium should not be construed as a signal that is itself ephemeral, such as an electric wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium (e.g., a light pulse passing through a fiber optic cable), or an electrical signal transmitted through a current line.

[0065] Examples of computer-readable media include electrical signals (transmitted over wired or wireless connections) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, registers, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, optical media such as compact disks (CDs) and digital versatile disks (DVDs), random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), and memory sticks. A processor together with software can be used to implement a radio frequency transceiver for use in a terminal, base station, or any host computer.

[0066] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural unless the context clearly dictates otherwise. It should be understood that the terms "comprise" and / or "comprising," as used herein, indicate the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0067] The description of different embodiments herein is provided for illustrative purposes, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terms used herein are selected to best explain the principles, practical applications, or technical improvements of the embodiments compared to technologies found on the market, or to enable those skilled in the art to understand the embodiments disclosed herein.

[0068] [Embodiment] (1) A method comprising: pacing the cardiac tissue with a plurality of pulses via a plurality of electrodes of the catheter; monitoring a period of electrophysiological repolarization of the cardiac tissue caused by the pacing with the plurality of electrodes of the catheter; measuring electrical signals in the cardiac tissue with the plurality of electrodes of the catheter after the period of electrophysiological repolarization; A method comprising: (2) The method of embodiment 1, wherein each of the plurality of electrodes delivers one pulse of the plurality of pulses to one specific isolated region of the cardiac tissue. (3) The method of embodiment 1, wherein the period of electrophysiological repolarization includes a period during which the cardiac tissue is in a refractory period. (4) measuring a progression of a return activity pattern after the electrical signal is measured in the cardiac tissue. 3. The method of embodiment 1. (5) further comprising isolating and analyzing focal points of interest within the cardiac tissue based on the progression of the return activity pattern. The method of embodiment 4.

[0069] (6) The method of embodiment 1, wherein the catheter comprises a mesh catheter, a balloon catheter, or a spoon catheter. (7) The method of claim 1, wherein the plurality of electrodes comprises at least 40 electrodes. (8) The method of embodiment 1, wherein each of the multiple pulses is paced together and simultaneously. (9) The method of embodiment 1, wherein the multiple pulses are paced to control the time between each pace. (10) The method of embodiment 1, wherein the number or position of each of the plurality of pulses is varied to manipulate the duration of the electrophysiological repolarization.

[0070] (11) The method of embodiment 1, wherein the isolated portion of the cardiac tissue is paced. (12) An apparatus comprising: a catheter including a plurality of electrodes; 1. A cardiac pacing and diagnostic device comprising: a memory storing processor-executable instructions for cardiac pacing and diagnostic software; and a processor executing the processor-executable instructions for the cardiac pacing and diagnostic software to cause the device to: pacing cardiac tissue with a plurality of pulses via the plurality of electrodes of the catheter; a period of electrophysiological repolarization of the cardiac tissue caused by the pacing is monitored by the plurality of electrodes of the catheter; measuring electrical signals in the cardiac tissue with the plurality of electrodes of the catheter after the period of electrophysiological repolarization; a cardiac pacing and diagnostic device including a processor configured to: An apparatus comprising: (13) The device described in embodiment 12, wherein each of the plurality of electrodes delivers one pulse of the plurality of pulses to one specific isolated region of the cardiac tissue. (14) The device described in embodiment 12, wherein the period of electrophysiological repolarization includes a period during which the cardiac tissue is in a refractory period. (15) The processor executes the processor-executable instructions of the cardiac pacing and diagnostic software to cause the device to: measuring the progression of a return activation pattern after the electrical signal is measured in the cardiac tissue; 13. The device of claim 12, configured as follows:

[0071] (16) The processor executes the processor-executable instructions of the cardiac pacing and diagnostic software to cause the device to: isolating and analyzing focal points of interest within the cardiac tissue based on the progression of the return activity patterns. 16. The device of embodiment 15, configured as follows: (17) The device of embodiment 12, wherein the catheter comprises a mesh catheter, a balloon catheter, or a spoon catheter. (18) The device of embodiment 12, wherein the plurality of electrodes comprises at least 40 electrodes. (19) The device described in embodiment 12, wherein each of the multiple pulses is paced together and simultaneously. (20) The device described in embodiment 12, wherein the multiple pulses are paced to control the time between each pace.

Claims

1. 1. An apparatus comprising: a catheter including a plurality of electrodes; 1. A cardiac pacing and diagnostic device comprising: a memory storing processor-executable instructions for cardiac pacing and diagnostic software; and a processor executing the processor-executable instructions for the cardiac pacing and diagnostic software to cause the device to: pacing cardiac tissue with a plurality of pulses via the plurality of electrodes of the catheter; a period of electrophysiological repolarization of the cardiac tissue caused by the pacing is monitored by the plurality of electrodes of the catheter; measuring electrical signals in the cardiac tissue with the plurality of electrodes of the catheter after the period of electrophysiological repolarization; a cardiac pacing and diagnostic device including a processor configured to: Equipped with each of the plurality of pulses is paced together and simultaneously from all of the plurality of electrodes such that the wavefronts generated by the pacing create a region that is aligned and no other waves enter that region until the refractory period of that region has returned; Device.

2. The device of claim 1 , wherein each of the plurality of electrodes delivers one pulse of the plurality of pulses to one particular isolated region of the cardiac tissue.

3. The device of claim 1 , wherein the period of electrophysiological repolarization comprises a period during which the cardiac tissue is in a refractory period.

4. The processor executes the processor-executable instructions of the cardiac pacing and diagnostic software to cause the device to: measuring a signal propagation sequence after the electrical signal is measured in the cardiac tissue; The device of claim 1 , configured to:

5. The processor executes the processor-executable instructions of the cardiac pacing and diagnostic software to cause the device to: isolating and analyzing a focal point of interest within the cardiac tissue based on the signal propagation sequence; 5. The apparatus of claim 4, wherein the apparatus is configured to:

6. The device of claim 1 , wherein the catheter comprises a mesh catheter, a balloon catheter, or a spoon catheter.

7. The device of claim 1 , wherein the plurality of electrodes comprises at least 40 electrodes.

8. 10. The device of claim 1, wherein the plurality of pulses are paced to control the time between each pace.

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