IMPLANTABLE INTRA-ATRIAL CONSTRAINTING DEVICE AND SYSTEM FOR SENSING AND IDENTIFYING THE LOCATION OF CHANGES TO CARDIAC TISSUE THAT AFFECT INTERNAL ELECTRICAL SIGNALS - Patent application

Abstract

Implantable atrial retraining devices and systems can be configured to sense and identify the location of changes relative to cardiac tissue that affect electrical signals therein. The implantable intra-atrial retraining device can include a septal electrode that traverses the septum, and multiple extension electrodes can extend therefrom along the endocardium of one or both atria. The extension electrodes can be used to sense electrical signals generated by the sinoatrial node and one or more electrical properties of the cardiac tissue. If there is any change in the electrical signal and / or the electrical properties of the cardiac tissue, a notification can be generated to notify a physician and / or patient.

Description

[Technical Field]

[0001] Related Applications

[0001] This application claims priority to a co-pending U.S. provisional patent application having serial number 63 / 486,438, filed February 22, 2023, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] Background of the Invention

[0002] Wires connected to pacemakers placed in the heart have been used on the right side of the human heart since 1957 (Earl Bakken - founder of Medtronic). Since then, millions of wires for cardiac sensing, pacing, and defibrillation have extended and saved lives worldwide. Despite this body of work, wires have not been used on the left side of the heart. Mitral valve devices, left atrial occlusion devices, and septal occlusion devices have been placed on the left side of the heart for decades.

[0003]

[0003] However, wires have not traditionally been placed on the left side of the heart because of the risk of blood clots gathering on wires floating in the heart becoming dislodged. If a blood clot develops and dislodges on a wire placed on the right side of the heart, it can only travel to the lungs, where endogenous enzymes can be used to break down the clot or clot. However, if a blood clot develops and dislodges on a wire placed on the left side of the heart, the clot can travel to the aorta and the brain. The brain lacks an intrinsic mechanism for dissolving the clot, potentially resulting in a stroke, which can be devastating.

[0004] Defibrillation of the human heart has saved many lives. Initially performed only externally (through the skin), defibrillators are now placed internally (intravascularly, intracardially, or extracardially) to defibrillate the heart in an emergency to stop dangerous arrhythmias. Current defibrillators require a relatively high energy (measured in joules) to defibrillate the heart. These shocks are painful and cause incredible anxiety for the patient. The energy used quickly depletes batteries, which then need to be replaced. Replacing generators and batteries is expensive (the batteries are built into the generator), and replacing them carries the risk of infection. Infections can be fatal and very costly to the healthcare system.

[0005]

[0005] Atrial fibrillation (AFIB or AF), the most common human cardiac arrhythmia, causes significant morbidity, mortality, and costs. AF causes the heart to beat irregularly, often excessively fast. One of the greatest concerns with AF is the risk of stroke. In fact, AF patients have approximately five times the risk of stroke than patients without AF. By 2030, it is estimated that approximately 12 million people in the United States will have AFIB. According to the Global Burden of Disease Project, approximately 46.3 million people suffer from AFIB, and approximately one-third of all AFIB patients are asymptomatic (also known as silent AF).

[0006] By way of background, during a normal heartbeat, the upper chambers (atria) and lower chambers (ventricles) of the heart work together to pump blood to the rest of the body. AFIB occurs when the upper chambers of the heart beat irregularly and do not pump all of the blood into the lower chambers, causing some blood to pool and potentially form a clot in the left atrium or elsewhere. If the clot breaks loose, it can travel through the bloodstream toward the brain, potentially leading to a stroke. Strokes associated with AFIB are often more severe than strokes with other underlying causes.

[0007]

[0007] Currently, AF is present only in the atrial cavity, but whole-heart defibrillation is performed for AF because the heart for defibrillation generally does not include a lead placed in the left atrium (LA). Therefore, it is difficult to detect whether an arrhythmia is occurring in the left atrium, making selective defibrillation difficult. Therefore, defibrillation of the heart in response to the left atrium generally requires whole-heart defibrillation.

[0008] Many devices have been used to detect AFIB to aid in its early diagnosis. Intermittent monitoring devices, such as electrocardiograms (ECGs), are used most of the time to measure the heart. Traditional ambulatory Holter monitors (HMs), connected to the chest with electrodes, are still used periodically but are inconvenient and can only be used at various times. Wearable devices, such as wrist-worn wearables, have been used more recently. Wrist-worn wearables are typically in the form of smartwatches (e.g., Apple Watch® and Fitbit®) that use photoplethysmography (PPG) to analyze cardiac rhythm and detect AFIB. Blood pressure monitors are also available. Patch ECG monitors can also be used. Implantable electronic devices, such as pacemakers, cardiac implantable electronic devices, and subcutaneous cardiac monitors, are also available. However, each of these types of devices (intermittent monitoring devices, Holter monitors, wearable devices, blood pressure monitors, and implanted electronic devices) is generally limited to determining whether AFIB is occurring or present, but does not provide much other information.

[0009] The primary surgical procedure for treating isolated AF is ablation, performed by an electrophysiologist. There are several types of ablation currently available. Ablation uses radiofrequency (heat) or cold energy (cryoablation) to damage small areas of heart tissue that a physician suspects are causing electrical problems. The heart relies on a steady flow of electrical impulses to coordinate the beating of the atria (upper chambers) and ventricles (lower chambers). If the electrical flow to the upper chambers of the heart does not function properly, improper electrical flow to the upper chambers of the heart can result in a fast, irregular rhythm. Eliminating the cause of the problem often allows the heart to return to its normal, healthy rhythm. Ablation can be performed surgically, usually at the same time as a patient undergoing heart surgery for another reason, such as to repair a heart valve. Ablation can also be performed with a less invasive procedure called pulmonary vein isolation, which is typically performed in a hospital electrophysiology or cardiac catheterization laboratory.

[0010]

[0010] To identify cardiac tissue that may be causing the AF problem, patients are typically admitted to an AF laboratory. The patient is often sedated or under general anesthesia when tests are performed to identify the cardiac tissue causing the AF problem, and then the patient's heart is typically placed in an AF state, allowing the physician to make the identification. Various tools can be used to identify the cardiac tissue causing the AF problem. One such tool is a catheter, which can map the heart on a computer screen and help the physician identify the problematic tissue. Patients often have unpleasant experiences with such procedures due to the pain and discomfort they experience after the procedure is performed. As is understood, cardiac tissue causing AF tends to recur at different locations over time. If a new AF occurs, the same process of identifying the cardiac tissue causing the AF must be performed again. Furthermore, the cost of such AF laboratory analysis can be significant, and of course, it causes further discomfort and pain to the patient. Therefore, there is a need for new technology outside of the EP laboratory that can identify cardiac tissue causing AF in real time. Summary of the Invention [Means for solving the problem]

[0011] Summary of the Invention

[0012] The embodiments described herein relate to various configurations of low-profile electrodes and associated structures configured to hold the electrodes and wires against the endocardium (eliminating free-floating wires) and be attached to or near the left atrium of the heart to enable low-energy recording, sensing, pacing, simulation, and / or defibrillation of both atria in response to atrial fibrillation or other atrial arrhythmias. The electrodes are attached to the atrial septum in a location favorable for easy and reliable deployment while maintaining a low-profile configuration. This attachment also allows for repeated crossing of the intra-atrial septum at a later date for additional ablation procedures or placement of additional closure or valve devices. The devices can be fitted with radiopaque markers to facilitate subsequent crossing of the intra-atrial septum.

[0012]

[0013] These electrodes and associated structures can be utilized to sense and map normal and abnormal electrical impulses and deliver energy to terminate initial abnormal foci, in addition to defibrillating the upper chambers of the heart. This device can also be used in conjunction with leads attached to the right atrium, right ventricle, coronary sinus, other devices within the atria, and leads outside the heart. In one embodiment, the electrodes are configured to attach to the atrial septum, with wire attachments holding the wires against cardiac tissue. In another embodiment, the electrode configuration is attached to an improved atrial septal closure device, which may also be an atrial septal opening device, but again with special attachments holding the wires firmly against the heart wall. In another embodiment, the electrodes are configured to be part of an atrial appendage closure device, which also includes special attachments that prevent the wires from floating freely either inside (endocardial surface) or outside (epicardial surface) of the heart. In yet another embodiment, the electrodes may be configured to be part of a mitral valve device or incorporated into any valve repair or replacement device, whether placed via traditional open-heart surgery or via endovascular techniques.

[0013]

[0014] A useful feature is that these embodiments allow the electrodes and wires to be held firmly against the cardiac tissue, which avoids thrombus formation on the electrodes and wires, as with commercially available mitral valve devices. The described devices then enable sensing, pacing, and / or defibrillation of the left side of the heart, which has not previously been addressed clinically. For example, these devices can be used to directly pace the left atrium. Traditionally, only the right atrium is accessible for pacing. In many patients, right atrial pacing is not always synchronized with the left atrium due to intrinsic conduction problems or atrial dilation. This new device, when placed in the intraatrial septum, left atrium, or near the left atrium, allows pacing of both atria in clinical practice. This may enable synchronous biatrial pacing, which improves the effectiveness of atrial pacing and improves cardiac output and ejection fraction in some patients.

[0014]

[0015] Because cardiac tissue causing AF tends to occur in different locations over time (i.e., different areas of cardiac tissue disrupt or block electrical signals over time), a system having an implantable cardiac sensing structure may be used to sense problematic areas of cardiac tissue using an electronic device (e.g., a pacemaker, defibrillator, mobile device, etc.). The implantable cardiac sensing structure may include multiple extension electrodes implanted and extending along the walls of one or more cardiac chambers that can sense electrical signals or electrical properties of cardiac tissue. Abnormal foci could be identified in real time outside of the EP laboratory, and focused therapy could also be provided in real time. In embodiments, the implantable cardiac sensing structure forms a matrix. In the event of an AF event, electrical signals indicative of a problematic cardiac issue are sensed and used to detect the location of the problematic cardiac tissue. The system may be configured to sense changes in the electrical properties of the heart wall over time, thereby enabling a physician to ablate the problematic tissue before an AF event occurs. In some circles, the ability to monitor a patient's heart after an AF event to identify and locate potential future AF events is considered an important criterion for minimizing or preventing future AF events.

[0015]

[0016] An embodiment of a method for detecting cardiac tissue causing atrial fibrillation (AFIB) may include measuring electrical signal characteristics via a plurality of electrical conductors disposed on the endocardium of a heart wall within at least one chamber of each of the heart. A determination may be made that the electrical signal characteristics are indicative of an AFIB event. In response to a determination that the electrical signal characteristics are indicative of an AFIB event, a location of the heart wall within the heart chamber relative to the location of the electrical conductor causing the AFIB event may be identified.

[0016]

[0017] One embodiment of an electronic device, such as a pacemaker, may include a non-transitory memory, an input channel configured to receive a plurality of electrical signals received from a plurality of extension electrodes extending along a heart wall within at least one chamber of the heart, and a processor in electrical communication with the non-transitory memory and the input channel. The processor may be configured to measure each of the electrical signals. Each measured electrical signal may be stored in the non-transitory memory. A determination is made as to whether any of the measured electrical signals are indicative of cardiac tissue that delays, accelerates, or attenuates electrical signals generated by the heart in a manner different from healthy cardiac tissue. In response to a determination that the electrical signal is indicative of cardiac tissue that delays, accelerates, or attenuates electrical signals generated by the heart in a manner different from healthy cardiac tissue, a notification signal may be generated indicating the location. Furthermore, identification of the location may be used to deliver specific energy to the location in some manner to treat or prevent degeneration into AF.

[0017] BRIEF DESCRIPTION OF THE DRAWINGS

[0018] For a detailed description of various embodiments, reference will now be made to the accompanying drawings. [Brief explanation of the drawings]

[0018] [Figure 1]

[0019] 1 shows the septal electrode attached to the atrial septum and the extension pressing the wire against the heart tissue. [Figure 2A]

[0020] 1 illustrates a series of steps for attaching a septal electrode during a surgical procedure. [Figure 2B]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2C]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2D]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2E]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2F]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2G]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2H]

[0020] A sequence of steps for installing a septal electrode during a surgical procedure is shown. [Figure 2I]

[0021] 10 illustrates an alternative exemplary embodiment of an electrical electrode that may be used in conjunction with a septal electrode and the sub-process for its implantation. [Figure 2I-A]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2I-B]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2J]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2K]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2L-1]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2L-2]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2M]

[0021] An exemplary alternative embodiment of an electrical electrode that may be used in conjunction with a septal electrode and a sub-process for its implantation is shown. [Figure 2N]

[0022] 1 is an embodiment of an exemplary leadless pacemaker attached to an exemplary septal electrode having electrical contacts extending therefrom. [Figure 2O]

[0022] An embodiment of an exemplary leadless pacemaker attached to an exemplary septal electrode having electrical contacts extending therefrom. [Figure 3A]

[0023] FIG. 10 shows a dose-up view of an example of a septal electrode that includes protrusions to help hold the septal electrode in place against the septum. [Figure 3B]

[0024] Another example of a septal electrode is shown, extending further into the left atrium, where the wire and electrode are again flush with the endocardium. [Figure 3C]

[0025] 10 shows yet another example of a septal electrode with deployable wings held in place against the atrial wall by a device. [Figure 3D]

[0026] 1 is a diagram of an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3E]

[0026] FIG. 1 is a diagram of an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3F]

[0026] FIG. 1 is a diagram of an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3G]

[0027] 10A-10C are views of an embodiment of a septal electrode including a central post with portions extending therethrough. [Figure 4A]

[0028] 1 shows an example of an implantable medical device with a septal electrode on one lead and a second electrode on a second lead to the right ventricle. [Figure 4B]

[0029] 1 shows an example of an implantable medical device with a septal electrode on one lead and two additional leads anchored in the right atrium and right ventricle. [Figure 5]

[0030] 10 shows another embodiment in which the electrodes are part of an atrial appendage closure device, the closure device being external to the atrial appendage and keeping the wires of the device rigid against the atrial wall. [Figure 6A]

[0031] 6 illustrates a medical procedure for implanting the closure device and associated electrodes of FIG. 5. [Figure 6B] A medical procedure for implanting the closure device and associated electrodes of FIG. 5 is shown. [Figure 6C] A medical procedure for implanting the closure device and associated electrodes of FIG. 5 is shown. [Figure 6D] A medical procedure for implanting the closure device and associated electrodes of FIG. 5 is shown. [Figure 7]

[0032] 6 shows an enlarged view of an example of an electrode configured to be coupled to the atrial appendage closure device of FIG. 5. [Figure 8A]

[0033] 10 shows another embodiment in which the electrodes are part of an atrial appendage closure device, the closure device being inside the atrial appendage. [Figure 8B]

[0033] Another embodiment is shown in which the electrodes are part of an atrial appendage closure device, the closure device being inside the atrial appendage. [Figure 8C]

[0033] Another embodiment is shown in which the electrodes are part of an atrial appendage closure device, the closure device being inside the atrial appendage. [Figure 8D]

[0033] Another embodiment is shown in which the electrodes are part of an atrial appendage closure device, the closure device being inside the atrial appendage. [Figure 8E]

[0034] 10A-10C are diagrams of an exemplary embodiment of another embodiment of extension electrodes integrated with respective grids connected (electrically and physically) to the septal electrode. [Figure 8F]

[0035] 10A-10C are views of an alternative embodiment of a septal electrode configured as a pair of springs forming the septal electrode. [Figure 9]

[0036] 10 shows an embodiment in which the electrodes are part of a mitral valve device, with wires connected to electrodes in the mitral valve annulus, hugging the atrial septum, and connected to electrodes implanted in the septum. [Figure 10]

[0037] 1 is a diagram of a heart with exemplary implantable cardiac sensing structures implanted in both atria that can be used to (i) pace and defibrillate one or both upper chambers of the heart, and (ii) sense problematic cardiac tissue that may cause atrial fibrillation. [Figure 11]

[0038] 1 is an electrocardiogram (ECG) graph showing the electrical signal of a typical healthy heartbeat captured by electrocardiography of the heart. [Figure 12A]

[0039] 1 is an ECG graph of an exemplary sequence of electrical signals. [Figure 12B] 1 is an ECG graph of an exemplary sequence of electrical signals. [Figure 12C] 1 is an ECG graph of an exemplary sequence of electrical signals. [Figure 12D]

[0040] 11 is a graph of an exemplary signal representing cardiac timing difference over time sensed by each of the electrodes of FIG. 10. [Figure 12E]

[0041] 11 is a graph of an exemplary signal representing cardiac R-wave amplitude differences over time sensed by each of the electrodes of FIG. 10. [Figure 13]

[0042] 1 is a chart of exemplary impedance measurements of heart wall tissue. [Figure 14A]

[0043] FIG. 1 is a diagram of an electronic device, such as an implanted pacemaker and / or defibrillator, that includes various hardware and software for performing the functions described herein. [Figure 14B]

[0043] FIG. 1 is a diagram of an electronic device, such as an implanted pacemaker and / or defibrillator, that includes various hardware and software for performing the functions described herein. [Figure 15]

[0044] FIG. 11 is a graphical illustration of the heart including the two extended electrode matrices of FIG. 10. DETAILED DESCRIPTION OF THE INVENTION

[0019] Detailed Description of the Invention

[0045] Described herein are low-profile restraining devices that eliminate the problem of current intracardiac leads, which are generally free to float within the interior volume of the corresponding heart chamber. The described embodiments include a mechanism for securing a portion of the lead to the endocardium of the left atrium, where the electrode and lead become embedded in the wall of the heart. Thus, thrombus formation is avoided with the described low-profile devices on the left side of the heart. Placing leads on the left side of the heart using these devices facilitates new therapies for treating cardiac disease. The restraining mechanisms described herein can be extended to other chambers of the heart. The device allows for repeated septal crossing. Indeed, using radiopaque markers on the septal portion of the device, repeated septal crossing can be performed more quickly and safely.

[0020]

[0046] Beneficially, the described examples are directed to leads connected to the left atrium. For atrial arrhythmias (arrhythmias in the upper chambers of the heart), a left atrial lead is a suitable method for detecting AF and selectively defibrillating the upper chambers. Compared to whole-heart defibrillation, much lower energy (1-10 joules) can be used. Therefore, patients experience much less discomfort and battery life is increased. The LA lead can also provide a record of the location where AF is initiating, which can guide further treatment and eliminate the focus. A left atrial lead requires careful design to avoid thrombus and embolism. The embodiments described herein relate to devices deployed entirely via a percutaneous route. The device is low-profile, lies flat against the endocardial wall, and is firmly embedded in tissue. The low-profile nature of the device avoids or reduces the risk of thrombus formation. The described device offers a solution for detecting and treating AF and other supraventricular arrhythmias with lower-power shocks that are less or no pain for the patient.

[0021]

[0047] The embodiments described herein relate to implantable devices connected to wires, including nitinol or other types of shape-memory metals or plastics or other metals or metal alloys or combinations, that press the wires against the heart wall, preventing them from free-floating, creating a degree of grip against the septum and twisting. These devices can be placed in or around the left atrium of the heart, as well as the right side of the heart. The restraining device applies passive force to the tissue by looping a curved wire, creating the appropriate amount of twisting. The device may have protrusions to hold the device in place and prevent slippage until tissue healing occurs. The electrode portion of the device may be coated with a material such as gold to increase its electrical conductivity. The curved wire incorporates conductor extensions and is coated with a material (such as gold plating) that improves electrical conductivity and increases the surface area of ​​the device. Beneficially, the twisting of the wire causes the extensions to impinge on the heart tissue. The device also incorporates insulated wires that hug the heart wall. The insulated portion of the device has an outer nitinol or other form of metal or plastic or other metal or composite that keeps the wires away from the blood flow. As with other cardiac devices adjacent to the endocardial surface, this device and its extensions are integrated into the atrial tissue and remain away from the flow of blood through the heart.

[0022]

[0048] The device then exits the heart and connects to a pacemaker, defibrillator, or transducer, or some combination of these, similar to commercially available devices. This allows the device to receive and transmit electrical charges from a remote site, such as a transducer or pacemaker. Transducer and pacemaker devices are available from several manufacturers, including Medtronic and St. Jude Medical. The device fits flat against the interatrial septum and is firmly embedded in the tissue. This low profile inhibits thrombus formation and therefore allows for placement of the device on the left side of the heart. Devices with extensions can also be used on the right side of the heart in clinical practice. The device has excellent electrical contact. The restraining device is passively held against the interatrial septum. The unique characteristics of the restraining device—its low profile and easy attachment to the interatrial septum—provide a safe deployment path. The extensions and wires are constructed of shape-memory metal or other materials that hold the extensions and wires against the endocardium, allowing the device to be deployed on the left side of the heart.

[0023]

[0049] Currently, transseptal puncture is common for electrophysiology (EP) testing. Device deployment wires, such as transseptal sheaths, guidewires, and obturators, are already ideally positioned during the transseptal puncture used to enter the left atrium. These EP tests are typically for the treatment of AF, including mapping, ablation, and closure of the left atrial appendage. Therefore, placing a restraining device during the EP procedure is straightforward. Previous methods for achieving good electrical contact within the heart include screws, barbs, hooks, pins, and electrode plates. All of these can be incorporated into the distal restraining device, extensions, and specialized wires to help hold the device to the heart wall. This also ensures good electrical contact. Devices can incorporate coatings, such as steroids, to prevent fibrosis, low contact, or high energy. Devices can include bioabsorbable components so that the remaining restraining portion of the device is resorbed after the electrode is implanted in tissue. Devices can also contain antithrombotic coatings, which help prevent thrombus formation until the device is surrounded by tissue ingrowth. The device is carefully designed to be low profile, yet strong enough to provide complete stability to the intra-atrial septum in the deployed position. The septal restraint device may also include materials that make certain portions of the device radiopaque to guide access for subsequent transseptal punctures, making future interstitial punctures faster, easier, and safer.

[0024]

[0050] The restraining device can be incorporated into any other device placed in or around the left or right atrium. The restraining device can be modified to work with any device placed in or around the right or left atrium, including, but not limited to, atrial septal closure devices, left atrial closure devices (both intracardiac and extracardiac), and valve repair or replacement devices. In the case of a septal occlusion device, the restraining device is modified to be incorporated into the ring of the septal occlusion device. Some possible iterations include three electrode-conducting rings around the area of ​​the septal device that abuts the endocardium of the septum. The exact configuration of the wire array can vary depending on the device configuration, surface area contact, and resistance encountered. In the case of mitral valve replacement, the retraining device can be modified to fit the groove where the valve device abuts the atrial tissue. The device's wire electrodes can be circular, cross-hatched, or other configurations that provide therapeutically sufficient electrical output at the lowest energy with an appropriate resistance profile.

[0025]

[0051] The retraining device may be delivered together with the valve or separately. The distal end of the lead may be attached, for example, to the atrial septum, to or around the left atrial appendage, or to a mitral valve device. This allows for low-energy defibrillation of the atria in response to atrial fibrillation or other atrial arrhythmias. The device may also be used to sense electrical activity on the endocardial surface. This information may be recorded and stored to determine the earliest and other sites of atrial arrhythmia. This information may then direct either therapy with the device, termination of the arrhythmia by pacing, or later treatment by other electrical stimulation via the device and / or ablation during an EP procedure.

[0026]

[0052] It can be used for atrial defibrillation and can be used in conjunction with other leads and wires in both atria of the heart, or in the left atrium and right ventricle, left ventricle, or coronary sinus. It can also be used in conjunction with electrodes outside the heart, such as epicardial leads and electrodes. Intra-atrial lead placement facilitates defibrillation using relatively low-energy (1-10 joules, J) waveforms, delivered in a variety of ways, to reliably defibrillate or pace the atria.

[0027]

[0053] The lead and associated extensions and wires can be introduced into the patient via blood vessels in the groin, neck, or other locations. The distal region of the lead carries an electrode and is placed in or around the left atrium (e.g., the atrial septum, or around the left atrial appendage, or a mitral valve device). A wire configuration anchors the wire to the heart wall. The proximal end of the wire can be connected to a miniature defibrillator unit or a transducer placed under the patient's skin. Such pacemakers and defibrillators can sense, pace, and defibrillate. This new device placement allows selective defibrillation of the upper chambers of the heart, i.e., the atria, enabling very low-energy defibrillation. The device can also directly sense within the left atrium, which can be used to detect the source of arrhythmias and, in many configurations, selectively pace the left atrium. If a transducer is used, power can be transmitted percutaneously from an external device to the transducer.

[0028]

[0054] In one embodiment, as described above, a restraining device is used to hold the left atrial wire in place against the atrial septum. The restraining device is a passive mechanical device that allows atrial defibrillation of both atria. Two devices are shown in Figures 1-4B. One has a spring effect that provides sufficient restraining force to hold the wire in place against the septum, but without damaging the septum. This device may have protrusions to help hold the device in place and prevent slippage until healing occurs. This device may have an extension that provides additional surface area for optimal sensing, pacing, and defibrillation. The extension may include a shape-memory metal or other similar material to provide a kink that applies the extension against the heart wall and prevents blood flow through the heart. The second device is an array that attaches to or replaces an atrial septal defect closure device. Both can be placed in a patient to treat atrial fibrillation at the end of a medical procedure, such as a catheter ablation procedure, or as a stand-alone procedure. A combined inguinal and subclavian approach (a left subclavian approach is illustrated) allows wires placed from the groin to be moved to a subcutaneous position in the subclavian region, where a defibrillator device can then be placed.

[0029]

[0055] FIG. 1 illustrates lead placement with one atrial lead 101 placed in the right atrium (similar to an atrial lead in a dual-chamber pacing configuration). Part of this embodiment is the placement of a second atrial lead 103 (device) in the left atrium, which allows for specific atrial sensing, pacing, and / or defibrillation with very low amounts of energy (approximately 1-10 Joules). The distal end of the left atrial lead 103 includes a shape memory structure or other solid or composite material configured to hold a portion of the lead 103 against the human endocardium. The shape memory structure in this example is configured to be restrained on the opposite side of the atrial septum.

[0030]

[0056] 1 also shows an electronics housing 110 that includes a sealed housing that houses a battery and circuitry. In one example, the circuitry can generate stimulation energy to electrodes at distal regions of the leads 101, 103 for pacing and / or defibrillation. Additionally or alternatively, the circuitry can sense and record electrical activity from the electrodes. The electronics housing device 110 can be a pacemaker, a defibrillator, a device that both paces and defibrillates, and / or a sensing or recording device.

[0031]

[0057] Figures 2A-2H illustrate the step-by-step procedure for attaching a lead to the heart. Figure 2A shows the initial transseptal puncture using a modified Seldinger technique. A guidewire 201 is inserted into the left atrium, for example, via the groin and through an obturator 202. Figure 2B shows the placement of a transseptal sheath 203 through a transseptal puncture site 205 in the atrial septum 250. Figure 2C shows the obturator 202 removed, leaving the transseptal sheath 203 in place above the anchor delivery sheath 206. The guidewire 201 has been removed. Figure 2D shows the septal electrode 230 (carrier or assembly) at the end of the exposed lead 103 in the left atrium. The obturator 202 has been removed. Figure 2E shows the anchor delivery sheath 206 being retracted, thereby exposing the septal electrode 230. The septal electrode 230 comprises a flexible, elongated electrode. As can be seen, the distal region of the septal electrode 230 has a natural angled bend thereto (approximately a right angle bend) as shown.

[0032]

[0058] FIG. 2F illustrates further retraction of anchor delivery sheath 206, exposing septal electrode 230 to the atrial septum. Septal electrode 230 may comprise gold, nitinol, or other suitable (e.g., inert, biocompatible) metal for conducting electricity to the heart. Septal electrode 230 maintains pressure against the atrial septum when deployed. Septal electrode 230 maintains slight pressure against the septum to prevent device movement after the device is deployed. As can be seen from the example in FIG. 3A, septal electrode 230 allows electrical current to flow from the electronics housing to (and across) septum 250.

[0033]

[0059] FIG. 2G shows the septal electrode 230 fully deployed against the atrial septum 250. A snare device 208 is then shown, allowing the distal region of the lead to be moved from its insertion site (e.g., the groin) to the subclavian region or some other chest location where the electronics housing is located. The portion 232 of the septal electrode 230 in the right atrium opposite the septum 250 is bent upward as shown using the snare device 208 from the portion of the septal electrode 230 in the left atrium, thereby forming the U-shaped structure shown. Due to the mechanical properties of the device (e.g., a shape-memory structure), the wire hugs the endocardial surface. The septal electrode 230 can have configurations other than a U-shaped dip that perform the same or similar functions as a U-shaped dip.

[0034]

[0060] In other examples, the portion of the electrode pressed against the atrial septum of the left atrium can be longer than that shown in FIG. 2G, or there can be additional arrays attached to the lead anchor 207 to increase the surface area along the atrial septum 250 and / or left atrium 235. For example, FIG. 2H shows an extension 245L of the septal electrode 230 to increase the surface area for defibrillation of the left atrium 235. Again, a shape-memory metal (e.g., nitinol) covering holds the extension firmly against the atrial wall. The electrode 230 may be coated with a material such as gold to enhance its electrical conductivity. The curved wire can be made of nitinol or other shape-memory material that can be straightened for implantation into the patient through a sheath—the curved shape can be formed inside the patient. The memory metal wire assembly can have memory metal or similar material as part of the wire with insulation covering the wire, or on the outer covering of the wire, as any combination of a steroid, heparin coating, or drug-eluting coating. The device lies relatively flat against the atrial wall (i.e., in continuous contact with the atrial wall, including the atrial septum), and ultimately becomes strongly embedded in the cardiac tissue. This low profile inhibits the formation of blood clots. The device has excellent electrical contact. The restraining device is passively held against the atrial septum. A low profile and easy attachment of the restraining device to the atrial septum provides a safe path of deployment.

[0035]

[0061] 2F also shows both lead 101 and lead 103 exiting in the left subclavian region or other location in the chest. An electrode 251 is shown at the distal end of lead 101, anchored in the right atrium 237.

[0036]

[0062] 2I-2M illustrate alternative exemplary embodiments of electrical contacts that may be used in conjunction with septal electrode 230. FIG. 2I illustrates septal electrode 230 with extension electrodes 245R and 245L (collectively 245) extending from septal electrode 230 in each of left and right atria 235 and 237, respectively, and configured to maintain contact with the endocardium (i.e., inner wall) of left and right atria 235 and 237, respectively. Extension electrodes 245 may have reflectively identical shapes. Alternatively, extension electrodes 245 may have different shapes. However, in both cases, the exposed metal of extension electrode 245 has a curved shape, allowing extension electrode 245 to passively maintain contact with the walls of left and right atria 235 and 237 by forming it into the shape of a shape-memory material that presses against the walls of left and right atria 235 and 237, respectively. As previously mentioned, the extension electrode 245 may be electrically connected to or extend from the septal electrode 230. The extension electrodes 245 may have the same or different lengths, and the lengths may be set based on the appropriate amount of resistance and current transfer. Such lengths may be predetermined or may be established during placement if the septal electrode 230 is configured to allow the length of the extension electrode 245 to be adjustable before or during implantation. That is, the septal electrode 230 may allow the extension electrode 245 to be slidably connected to or detachable / reattachable to the septal electrode 230, thereby allowing an operator to change the length of the extension electrode 245. In alternative embodiments, devices may be available that include a septal electrode 230 with extension electrodes 245 of different lengths. Alternatively, an operator may cut the extension electrode 245 depending on the desired size and performance (e.g., a smaller heart may be suitable for a shorter extension electrode 245). In an embodiment, the lead 103 may extend distally of the lead and opposite the side where the lead 103 connects to the septal electrode 230 to form an extension electrode 245, as further shown and described herein.

[0037]

[0063] With reference to Figures 2I-A, in embodiments, one or both of the extension electrodes 245 may include protrusions 246a-246n (collectively 246), such as hooks, saws, barbs, needles, or other shapes, which may be used to assist in maintaining contact between the extension electrodes 245 and the walls of the left atrium 235 and right atrium 237.

[0038]

[0064] With reference to FIGS. 2I-B, in embodiments, rather than being completely exposed, an extended electrode (e.g., conductive metal), such as electrode 245L, may be partially exposed and partially insulated. For example, insulator 247 may extend away from the wall, while the exposed electrode may be on the wall side, so that exposed electrode 245L presses against and extends along the endocardium of the wall. Insulator 247 may be impregnated with a polymer, for example, to inhibit thrombosis formation. Maintaining insulation on the side opposite the wall may result in a reduced risk of thrombus formation on extension electrode 245. As previously mentioned, a coating that reduces the risk of clotting may be applied to the insulator to avoid thrombus formation on the electrode and wire. Also, because the exposed electrode's length is extended to contact the endocardium, it may be possible to deliver lower energy and / or different signaling to the heart for pacing or other treatments, thereby allowing patients to perform the treatment themselves without the risks of traditional treatments that typically require the patient to be in a medical facility.

[0039]

[0065] With reference to FIG. 2J, an illustration of an alternative configuration of extension electrodes is shown including multiple extension electrodes 245L1-245L3 (collectively 245L) positioned in the left atrium 235 and extension electrodes 245R1-245R3 (collectively 245R) positioned in the right atrium 237. In this embodiment, there are three extension electrodes 245L and three extension electrodes 245R in each of the left atrium 235 and the right atrium 237. However, it should be understood that an alternative number, such as two or more extension electrodes, may be positioned in each of the left atrium 235 and the right atrium 237. It should also be understood that a different number of extension electrodes may be positioned in each of the left atrium 235 and the right atrium 237. With reference to the extension electrodes 245 of FIG. 2I, the extension electrodes 245L and 245R may be electrically connected to or otherwise extend from the septal electrode 230. The thickness and configuration of extension electrodes 245L and 245R can be such that the collective electrodes 245L and 245R can be deployable through a transseptal sheath, for example, as described above with respect to FIG. 2C. Extension electrodes 245 can be part of a lead (e.g., lead 103) or can be separate from the lead. The length of each extension electrode 245 can vary depending on the patient, the treatment, and the use of extension electrode 245.

[0040]

[0066] The extension electrodes 245L and 245R may have the same or similar physical properties (e.g., gold, nitinol, an inert and biocompatible metal, a preformed shape, etc.) as described above with respect to the extension electrode 245 of FIG. 2I. The extension electrodes 245L and 245R may further include optional connecting features 248a and 248b (collectively 248) between adjacent electrodes (e.g., 245R1-245R2, 245R2-245R3) such that adjacent electrodes have a maximum constrained spacing between one another. Although not shown, the extension electrode 245L in the left atrium 235 may also include connecting features the same as or similar to the connecting feature 248. In embodiments, the connecting features 248 may be conductive or non-conductive and may be formed of the same or similar materials as the extension electrode 245. Moreover, the connecting features 248 can be shaped to help maintain the extension electrodes 245L and 245R against the walls of the left atrium 235 and right atrium 237. It should be understood that the configuration can also be leadless, as provided further herein.

[0041]

[0067] With respect to FIG. 2K, an alternative exemplary embodiment of an extension electrode is shown in which extension electrode 249 is shown intramural (i.e., extending through and remaining within wall 252L). With respect to extension electrode 245L in FIG. 2I, extension electrode 249 may be electrically connected to or extend from septal electrode 230 held in the atrial septum 250. Leads 101 and 103 are both shown exiting the left subclavian region or other location in the chest. Electrode 251 is shown at the distal end of lead 101 and is anchored in the right atrium 237. It should be understood that lead 101 and electrode 251 may not be utilized when an extension electrode such as extension electrode 245R is positioned in the right atrium 237 as presented in FIG. 2I.

[0042]

[0068] In embodiments, the extension electrode 249 may be inserted into the wall 252L at the wall junction 252j between the left atrium 235 and the right atrium 237 because the wall junction 252j is slightly thicker than the wall 252L, making it slightly safer than entering the wall 252L directly. In one embodiment, the extension electrode 249 may extend through the epicardium of the wall 252L but remain inside the pericardium of the wall, which may hold the extension electrode 249 against the epicardium so that an electrical signal applied to the extension electrode 249 can be applied to the epicardium of the left atrium 235. In embodiments, the extension electrode 249 may not be completely insulated. Alternatively, an insulator may extend along the extension electrode 249 to a distance approximately where the wall 252L extends from the wall junction 252j, thereby limiting the electrical signal to the left atrium 235. Alternative configurations of the extension electrode 249 and the insulator thereon are possible.

[0043]

[0069] 2L-1, 2L-2, and 2M, an exemplary subprocess for inserting an alternative configuration of extension electrode 249a using anchor delivery sheath 206 of FIG. 2E is shown. However, rather than entering through the central portion of septum 250, extension electrode 249a can enter from right atrium 237 through wall junction 252j at the top of septum 250, thereby simplifying the insertion process into wall 252L of left atrium 235. As shown in FIG. 2M, extension electrode 249a may have a u-curve 249u that forms a curved bend so that extension electrode 249a extends along the wall of right atrium 237. The u-curve 249u may be preset so that the u-curve 249u is automatically formed when extension electrode 249a is released from the sheath. In embodiments, several different techniques may be utilized to secure the extension electrode 249a to the wall of the left atrium 235, including a septal electrode, which may be curved or may appear as a straight stud with retaining features that secure it to the septum 250, a post, a suture, or any other mechanism that may help maintain the position of the extension electrode 249a. In another embodiment, the extension electrode 249 may include protrusions anywhere along its length or in the u-curve 249u that may prevent the extension electrode 249a from exiting the wall 252L and wall junction 252j.

[0044]

[0070] If the lead 101 extends to the device, other procedural processes described above may be utilized. In embodiments, to support the curve of the u-curve 249u and the extension electrode 249a extending through the wall 252L of the left atrium 235 and into the wall, these portions (i.e., the u-curve 249u and the extension electrode 249a) may be formed of a material with shape memory, as described above. Because the extension electrode 249a extends into the wall, there is minimal or no ability for any coagulation to occur in the left atrium 235 because the extension electrode 249a does not enter the left atrium 235. Furthermore, if the extension electrode 249a is secured to the wall of the right atrium 237 without having to puncture the septum 250, other procedural and operational risks may be reduced.

[0045]

[0071] 2L-2, an exemplary subprocess for inserting an alternative configuration of extension electrode 249b using anchor delivery sheath 206 of FIG. 2E is shown. In this process, extension electrode 249b may extend through wall junction 252j and along the epicardium of wall 252L, rather than extending intramyocardially and intramurally. Extending through a thinner wall or wall junction 252j that is thicker than atrial septum 250, can reduce the risk of tearing or bleeding. While only one extension electrode 249b is shown, it should be understood that multiple extension electrodes 249b may be utilized and extend along the epicardium of wall 252L. In embodiments, a hemostat or tissue adhesive may be used to seal the opening through which extension electrode 249b extends to limit the ability of bleeding to occur from the right atrium to the outside of wall 252L through a hole formed by extension electrode 249b. In embodiments, a hemostatic agent may be disposed or pre-applied on extension electrode 249b such that the hemostatic agent is automatically applied when inserted into wall junction 252j, thereby restricting or preventing blood from flowing through wall junction 252j outside of wall 252L. Other mechanical, chemical, and / or biological techniques may be utilized to restrict or prevent blood flow from the opening created by extension electrode 249b.

[0046]

[0072] 2N is a diagram of an exemplary leadless pacemaker 260 attached to an exemplary septal electrode 230 having electrical electrodes 245R and 245L (collectively 245) extending therefrom. In this embodiment, the leadless pacemaker 260 may be elongated and extend along the septal electrode 230 and may be in electrical contact therewith, such that any electrical signals generated by the leadless pacemaker 260 may be transmitted to the septal electrode 230, thereby causing the electrical signals to extend along the extension electrode 245. It should be understood that if only the extension electrode 245L extends from the septal electrode 230, the electrical signals may extend into the left atrium 235 and along the endocardium of the wall of the left atrium 235. The septal electrode 230 and the leadless pacemaker 260 can be connected to each other in a variety of different ways, but should be physically connected in a manner that does not adversely affect the patient's heart or health. In embodiments, the housing of the leadless pacemaker 260 may have the septal electrode 230 integrated with each other (e.g., a monolithic single piece of material) during manufacturing. Alternatively, the two elements 230 and 260 may be connected to each other using attachment elements such as screws, bolts, clips, structural connecting elements, etc. Furthermore, the leadless pacemaker 260 does not require electrodes to extend from the heart to the implanted device (e.g., a controller), so no extensions are required from the leadless pacemaker 260 or the septal electrode 230.

[0047]

[0073] As further shown, there is a mobile device 262, such as a smartphone or other portable electronic device, and a controller 264, which may also be an electronic device attached to the mobile device 262 or capable of wirelessly communicating with the mobile device 262. Wireless communication channels 266, 268, and 270 may enable wireless communication between the leadless pacemaker 260 and the mobile device 262, between the leadless pacemaker 260 and the controller 264, and between the mobile device 262 and the controller 264. Data 272, 274, and 276 may be communicated via the respective communication channels 266, 268, and 270 and between the respective devices configured to communicate via the communication channels 266, 268, and 270. The communication channels 266, 268, and 270 may be local communication channels using a local wireless communication protocol (e.g., Bluetooth, WiFi, or others). Each of the mobile device 262 and the controller 264 can include a processor, memory, and wireless communication equipment to support the operation of the leadless pacemaker 260. The processors of the mobile device 262 and the controller 264 can be configured to process and transmit data and / or control signals between each other and the leadless pacemaker 260.

[0048]

[0074] During operation, the leadless pacemaker 260 can sense cardiac signals and / or motion (e.g., heart rate in either or both the left atrium 235 and the right atrium 237) via data signals 272 to the mobile device 262 over the communication channel 266. The mobile device 262 can be configured to receive and display data (e.g., graphics, text, text and graphics) for a user of the mobile device 262. In an embodiment, a mobile app (not shown) can be configured to receive and process the data signals communicated by the leadless pacemaker 260. The mobile app can further be configured to cause the mobile device 262 to communicate with the controller 264 over the communication path 270 by sending data signals 276, which can then cause the controller 264, running software on a processor, to send control signals to the leadless pacemaker 260, for example, to control the pacing of either or both the left atrium 235 and the right atrium 237, respectively. It should be understood that the same or similar configurations may be utilized in the left and right ventricles of the heart.

[0049]

[0075] The leadless device can communicate wirelessly with a phone or other device capable of delivering specific electrical energy in a specific configuration that can terminate abnormal atrial focus firing, with or without defibrillation. This leadless device can also be configured within the leadless device itself. Recording and storage of information from the atrial wall or other regions of the heart can be stored and analyzed within the device itself, or the information can be transmitted to another device that can analyze the information to guide further therapy.

[0050]

[0076] Because the extension electrodes 245 are positioned within the respective left and right atria 235 and 237, the same or different pace or other signals may be applied as conventionally applied. In other words, because the extension electrodes 245 are maintained against the endocardium, a lower-power signal (e.g., less than 1 joule) may be applied by the leadless pacemaker to properly pace or otherwise treat the heart. It should be understood that if a lead is used to connect to the septal electrode 230, a similarly low amount of energy may be applied to the extension electrode extending therefrom (see, e.g., FIG. 2I). It should be understood that the leadless pacemaker 260 may be configured with an energy source sufficient to operate for many years. Alternatively, for example, sufficient wireless energy may be transmitted from the controller 264 to the leadless pacemaker 260 to enable the wireless pacemaker 260 to perform the required function (e.g., applying a pacing signal).

[0051]

[0077] Because the configuration of the extension electrodes 245 applies a low amount of power to the heart, the patient can self-administer the therapy via the mobile device 262 and / or controller 264. Software executed by the mobile device 262 can allow the user to monitor their heart using a mobile app, which can notify the user of, for example, rhythm abnormalities. The patient can sit or lie down in front of the self-administered therapy, which is safe. Due to the lower energy, the patient may experience minimal or no discomfort. For example, if the software is configured to ramp up the electrical signaling and receive feedback after each signaling is applied, the process can deliver the therapy with minimal interaction by or risk to the patient.

[0052]

[0078] 2O, the leadless pacemaker 260 may be connected to the atrial septum 250 using an alternative septal electrode element 261R, which is connected to septal electrode element 261L to form the septal electrode 261. The septal electrode 261 may be the same as or similar to the septal electrode 400 (FIG. 3C) and provides the same or similar electrical and mechanical functions as the septal electrode 400, as described further herein. In this embodiment, the leadless pacemaker 260 may extend perpendicularly from the septal electrode element 261R, but may also be configured to extend along the wall or be integrated with the septal electrode element 261R. Nevertheless, the leadless pacemaker 260 may be connected to or integrated with the septal electrode element 261L. In either case, electrical connections are made between the leadless pacemaker 260 and the septal electrode elements 261R and 261L to provide various electrical stimulation support to the patient's heart. Rather than simply applying an electrical connection from the septal electrode 261, the extension electrodes 245R and 245L may extend along the endocardium of the left atrium 235 and right atrium 237. It should be understood that alternative configurations of the extension electrodes 245 may be utilized, as described further herein. In embodiments, the septal electrode element 261 may be configured to simply support the extension electrodes 245 and allow electrical communication between the leadless pacemaker 260 and the extension electrodes 245, without the ability to make an electrical connection with the endocardium at the atrial septum.

[0053]

[0079] 3A-3C show an example of a device that specifically enables atrial defibrillation using two electrodes. One of the electrodes is placed in the right atrium (e.g., electrode 251 shown in FIG. 2H), although other locations, such as the right ventricle, left ventricle, or coronary sinus, are possible as well. The other electrode comprises a septal electrode 230 positioned along the interatrial septum. FIG. 3A shows the septal electrode 230 hugging both sides of the interatrial septum 250. Prongs 255 (e.g., teeth) extend slightly toward the septum 250, allowing for secure positioning along the septal wall and helping to secure the septal electrode 230 in place on both sides of the septum 250.

[0054]

[0080] Figure 3B is similar to Figure 2H and shows a septal electrode 330 hugging the atrial septum with a left atrial (and possibly right atrial) extension 335 for additional surface area for defibrillation (compare septal electrode 230 of Figure 3A). In this embodiment, a protrusion 255 may also be included to help hold the septal electrode 330 and its extension 335 in place.

[0055]

[0081] FIG. 3C shows an alternative septal electrode 400 that covers both sides of the atrial septum 250. The septal electrode 400 includes a plug with an electrode array. The plug can have electrode properties, or the plug can incorporate electrodes with sufficient conductivity, such as gold plating. Additional electrodes can be woven into the plug, or can be circular electrodes on one or both sides of the device, or two or more electrodes in a circle around the circumference or radius, or between the plugs. The additional electrodes are attached to a wire 410 exiting the heart in the same manner as the device in FIGS. 3A and 3B. As shown, opposing wings 420 and 430 can be deployed (e.g., fanned out) to anchor the device against the septum 250.

[0056]

[0082] 3D-3F, diagrams of an exemplary septal electrode 360 ​​are shown, with extension electrodes 362a and 362b (collectively 362) extending from and supported by sleeves 364a and 364b (collectively 364). In this embodiment, the septal electrode 360 ​​is curved at an end region 366, forming a concave shape 367 along an inner radial surface 368 of the septal electrode 360 ​​and opposing convex shapes 370a and 370b (collectively 370) at the intersection between the end region 366 and protruding members 372a and 372b (collectively 372). The protruding members 372 may extend parallel or substantially parallel to one another (i.e., within a few degrees limited by the manufacturing process).

[0057]

[0083] The overall shape of the septal electrode 360 ​​may provide more inward pressure to be applied to the septum 250 by the sleeve 364 extending over the projection member 372 than by the end regions 366. The sleeves 364 may be tubular and may be identical in size and shape to one another. In embodiments, the sleeves 364 may include a radially rounded outer surface along the sleeve 364 and may have a flat surface 376 with a textured surface, such as triangles, sawtooth, protrusions, indentations, hooks, and / or any other textured or geometrically shaped surface that secures the flat surface 376 against the septum 250, thereby reducing slippage of the septal electrode 360 ​​against the septum 250. As shown, the sleeve 364 includes openings 378 and 380, where the opening 378 may be sized to provide an interference fit over the extension electrode 362 and the opening 380 may be configured to provide an interference fit over the projection member 372. The sleeve 374 may be non-conductive. The septal electrode 360 ​​may be conductive or may include a non-conductive coating or sleeve. Other configurations of the septal electrode 360 ​​may be utilized. If conductive, an electrical signal applied to one of the extension electrodes 362 (e.g., extension electrode 362a) by a pacemaker or other power source (e.g., a defibrillator) may flow through the septal electrode 360 ​​to the other of the extension electrodes 362 (e.g., conductor 362b), thereby applying an electrical signal to the wall 252L of the left atrium 235, where the extension electrode 362b may directly contact one or more of the endocardium, myocardium, and / or epicardium of the wall 352L of the left atrium 235.

[0058]

[0084] FIG. 4A shows an atrial defibrillator (or pacemaker, sensor, or recording device) implanted in a person with the septal electrode 230 of lead 103 connected to a battery-powered electronics housing 450 (similar to electronics housing 110 described above) and attached to the atrial septum, and another lead 510 located in the right ventricle and immobilized. The electronics housing includes a sealed housing, a battery housed therein, and circuitry for generating electrical stimulation signals provided to electrodes at the tips of the leads. FIG. 4B shows an atrial defibrillator implanted in a person with the septal electrode 230 of lead 103 attached to the atrial septum, a second lead 510 located in the right ventricle and immobilized therein, and a third lead 511 immobilized in the right atrium.

[0059]

[0085] Figures 5-7 illustrate an embodiment in which an atrial electrode is included in a device that occludes the opening of the atrial appendage from outside the heart. Figure 5 shows defibrillator lead placement in which one atrial lead 101 is placed in the right atrium 237. A second atrial lead 510 is placed in or around the atrial appendage 520 of the left atrium 235 and attached to an atrial appendage closure device used to administer stimulation to the opening between the left atrium 235 and the atrial appendage 520. Leads 101 and 510 and their electrodes can perform specific atrial defibrillation with very little energy (approximately 1-10 joules). The device extensions include a memory-shaped metal or another composition, such as plastic, to firmly secure the extensions to the outside of the left atrium. Figure 5 also shows a pulse generator 450 with a sealed housing containing a battery and circuitry that generates stimulation energy to the electrodes at the distal ends of leads 101 and 510.

[0060]

[0086] FIG. 6A shows a portion of a procedure for implanting an atrial appendage closure device around the atrial appendage 520. The placement of the atrial appendage closure device involves a magnet 525 positioned through a sheath 521 inside the atrial appendage 520. A second magnet 535 is approached from outside the heart through a sheath 540 inserted through a small incision in the patient's chest. An opening 521 is shown between the left atrium 235 and the atrial appendage 520. When the magnet 535 reaches a sufficient mass relative to the magnet 525, magnetic attraction brings the two magnets into contact with the wall of the atrial appendage 520 sandwiched between them. The magnet stabilizes the atrial appendage 520. FIG. 6A also shows the distal end of a sheath 545 containing a lariat (described below).

[0061]

[0087] Figure 6B shows a lariat 550 positioned around the base of the atrial appendage 520. The lariat 550 can be made of suture material or wire. Figure 6C shows a lead extension with electrodes 560 and 565 attached to the lariat 550. The electrodes can be placed on the lariat device before insertion into the body. The electrode array can vary depending on which configuration provides optimal joule delivery with the lowest resistance. There can be one or more electrodes affixed to the lariat. The electrodes can be longer and deploy against the outside of the LA upon deployment. The coating or composition of the extension can include a shape-memory metal or other material that ensures the extension remains in contact with the left atrium or other epicardial surface. The specific length and number of electrodes, and whether they expand, depend on the energy required to deliver adequate energy for defibrillation and the acceptable resistance encountered. Figure 6D shows the lariat 550 in place, clamped around the base of the atrial appendage 520, thereby closing the opening from the left atrium 235 into the atrial appendage. FIG. 6D also shows an electrode 560 positioned on the lariat 550 and therefore just outside the left atrium.

[0062]

[0088] FIG. 7 shows an electrode 560 separate from the lariat 550. In this example, the electrode 560 is a coiled spring electrode. The electrode may be flared and present at the base of the LAA and / or outside the LA. There may be more than one electrode. The configuration may be star-shaped, circular, or other shapes. However, the configuration of the electrode 560 may be other than that shown in FIG. 7 in other embodiments. In other examples, the portion of the electrode that presses against the left atrial tissue may be longer than that shown in FIG. 7, or there may be one or more additional electrodes on the lariat 550 to increase the surface area along the left atrium. The configuration of the electrode array may also vary somewhat to accommodate the size of the atrial appendage closure device.

[0063]

[0089] 8A-8D illustrate the closure of the opening between the left atrium 235 and the atrial appendage 520 from inside the heart using a plug 810 (also called a left atrial appendage occluder). The plug 810 is connected to a pulse generator (e.g., pulse generator 450) and includes one or more electrodes used for defibrillation. One or more other electrodes are placed in the right atrium, right ventricle, left ventricle, coronary sinus, or intra-atrial septum. The plug 810 is deployed through a sheath 805.

[0064]

[0090] 8B shows the retraction of the sheath 805 and plug deployment member 807. Inside the plug deployment member 807 is shown a lead 820. The lead 820 is exposed when the sheath 805 and plug deployment member 807 are retracted. An electrode 830 is shown on the lead 820 inside the atrial appendage 520. This device secures the wire tightly against the endocardial wall, preventing it from being removed from the blood flow. In this position, the wire is embedded in the atrial wall.

[0065]

[0091] In FIG. 8C , a lead 820 from the left atrial closure device (plug 810) extends from the device, carrying the attached lead 820 into the right atrium 237 as the sheath 805 and plug deployment member 807 are retracted. In the right atrium 237, the lead is then grasped or guided with a snare device 208 and delivered to the left or right subclavian vein or other vein for connection to a pulse generator 450, which is placed subcutaneously as described above. FIG. 8C also shows a lattice 812 coupled to a U-shaped dip 811 coupled to the septum 250. The lattice may include, for example, a first wire 812 and a second wire 813, both of which are coupled to the U-shaped dip 811 and configured to be restrained against the endocardium of the left atrium 235. More than two wires may be included if desired. Wires 812 and 813 are interconnected and spaced apart by one or more interconnecting wires 815, which are also constrained against the wall of the left atrium. U-shaped dip 811 and wires 813, 814, and 815 may be formed from any suitable type of shape memory metal, such as Nitinol.

[0066]

[0092] FIG. 8D shows the final configuration in which the left atrial lead 820 extends from the left atrial closure device (plug 810) and runs along and embraces the inner wall of the left atrium 235, with the plug 810 administering the atrial appendage 520. The wire then crosses the interatrial septum to the right atrium. The lead 820 then extends through the superior vena cava (alternatively, the inferior vena cava) to more peripheral veins that allow access to the pulse generator 450 (which may be configured to perform defibrillation and / or pacing). A right atrium (FIG. 1, lead 101) may be present and connected to the pulse generator 450. Such additional leads may also be leads located in the right ventricle, left ventricle, or coronary sinus, for example.

[0067]

[0093] 8C and 8D, an active electrode (providing stimulation or sensing capability) may be provided on the grid 812 (e.g., wire 814), in or on the plug 810, or on both the grid and plug. In one embodiment, the electrode is on one of the wires 813 or 814 of the grid 812, and the other wire 813, 814 of the grid, which has its shape memory, serves to maintain the electrode-carrying wire in continuous contact with the atrial wall. In one embodiment, the grid 812 is present but the plug 810 is not. Furthermore, the U-shaped dip 811 may or may not have an electrode. In one example, the dip 811 serves as an anchor for another structure (e.g., the grid 812, a pacing lead, etc.) and is not itself used for sensing or stimulation purposes.

[0068]

[0094] With reference to FIG. 8E, a diagram of an exemplary embodiment of another embodiment of extension electrodes 813L and 813R (collectively 813) integrated with respective grids 812L and 812R connected (electrically and physically) to the septal electrode 230 is shown. Wires 814L and 814R may also be configured with a shape preform (i.e., with shape memory) to extend along and maintain contact with the endocardium of the left atrium 235 and right atrium 237, respectively. In embodiments, the wires may be uninsulated or partially insulated (e.g., insulated along a portion, along a side with metal exposed on the opposite side for endocardial contact, or along a portion and a side). Although not shown, the septal electrode 230 may be connected to a lead (e.g., lead 103 of FIG. 2J) or to a leadless pacemaker (e.g., leadless pacemaker 260 of FIG. 2N) to provide an electrical signal to the septal electrode 230 for delivery to the extended electrode 813.

[0069]

[0095] 8F, a diagram of an alternative embodiment of a septal electrode 802 configured as a pair of springs 802R and 802L forming the septal electrode 802 is shown. The springs 802R and 802L may function to hold the extension electrode 245 along the atrial septum 250 and the endocardium of the left atrium 235 and right atrium 237. In this embodiment, the lead 103 may be electrically connected to the septal electrode 802. The springs 802R and 802L may be conductive or non-conductive. If non-conductive, electrical conductors may be integrated into the septal electrode 802 to provide electrical connection with the lead electrode 103 and the extension electrode 245. In embodiments, opposing plates (not shown) may be disposed between the springs 802R and 802L used to hold the septal electrode 802 on the atrial septum 250. Protrusions (not shown) may be disposed on springs 802R and 802L (and / or plates) facing the atrial septum 250 to provide additional support for maintaining the septal electrode 802 against the atrial septum 250. While springs 802R and 802L are shown, it should be understood that only a single spring, such as spring 802L, may be utilized, and that spring 802R may be a plate or other structural element. It should further be understood that various configurations of the septal electrode 802 may be utilized to perform the same or similar functions in providing both electrical conductivity and support for the extension electrode 245, as provided herein.

[0070]

[0096] In another embodiment, a left atrial lead can be incorporated into mitral valve replacement and / or repair, either via a percutaneous transseptal approach or a minimally invasive or open surgical approach. For example, an electrode array can be incorporated into a mitral valve device that touches or is near the left atrium. FIG. 9 shows a prosthetic mitral valve device 910 incorporating one or more electrodes 920 forming an electrode array. The electrode 920 is on the distal end of the atrial lead. A lead 930 is then routed through the atrial septum 250 and connected to the pulse generator 450 as described above. The mitral valve orifice, where most mitral valve devices (such as the mitral valve device 910) are located, is a suitable site for bi-chamber defibrillation using the devices described herein. One configuration for the electrode array is a thin, electrically conductive wire woven or otherwise attached to the valve device 910 when positioned around the mitral valve orifice. One or more mitral valve devices 910 may house the electrode array and lead 930. The lead 930 can extend and overlap the septal restraint device. The septal restraint device is then connected to an insulated wire that connects to a pacemaker and / or defibrillator or transducer. The mechanical properties of the device force the wire and extension against the atrial wall, where tissue ingrowth occurs, along with the implanted mitral valve. The lead 930 can also allow attachment to another grasping device (e.g., snare device 208) to bring the wire into the appropriate position near the defibrillator / pacemaker pocket.

[0071]

[0097] 3D-3F, one embodiment of placing an implantable device for treating atrial fibrillation (AFIB) may include clamping a septal electrode 360 ​​onto the septum 250, with an extension electrode 362 shown extending along walls 352R and 352L (e.g., along the endocardium, myocardium, and / or epicardium of walls 352R and 352L). Once clamped, measurements of cardiac electrical signals may be performed via the septum 250, which may include R waves, P waves, S waves, and / or any other segments of the cardiac electrical signal. Because the septal electrode 360 ​​is configured to clamp onto the septum 250, if measurements of the cardiac electrical signal are lower than expected (e.g., low amplitude), the protrusion member 372 may be disengaged, thereby disengaging the flat surface 376 of the sleeve 364 from the septum 250 and rotated, for example, to allow the extension electrode 362 to realign and engage a different region of the endocardium. If the extension electrode 362b extends into the wall junction 352j, the extension electrode 362b may be withdrawn to attempt to form a better contact location and reinserted into a different area.

[0072]

[0098] 3G, a diagram of an embodiment of a septal electrode 360 ​​is shown that includes a central post 382 with portions 382a, 382b, and 382c (collectively 382) extending therethrough. The central post 382 can be slid in and out of the septal electrode 360. Portion 382b can be biased outward at an angle theta (θ) such that when portion 382c of the central post 382 is withdrawn from the septal electrode 360, the projection members 372 rotate by angle θ so that they are parallel to one another, thereby clamping to the septum 250. If the extension electrode 362 is not sufficiently conducting cardiac electrical signals, the operator may slide the central post 382 back into the septal electrode 360, thereby causing portions 382b to expand the projection members 372, and rotate the septal electrode 360 ​​to re-clamp.

[0073]

[0099] 10 , a diagram of a heart 1000 is shown in which an exemplary implantable cardiac sensing structure 1002 is implanted in both atria, which may be used to (i) pace and defibrillate one or both of the upper chambers of the heart, and (ii) sense problematic cardiac tissue that may cause atrial fibrillation. In an alternative embodiment, rather than being implanted in both atria, the implantable cardiac sensing structure 1002 may be implanted in only one of the atria, such as the left atrium. The implantable cardiac sensing structure 1002 may include a septal electrode 1004 from which one or two extension electrode matrices 1006R and 1006L are electrically coupled. Extended electrode matrix 1006R is shown as including rows of extended electrodes 1008a-1008d and columns of extended electrodes 1008e-1008h (collectively 1008), thereby forming a 12×12 matrix of cells 1010a-1010l (collectively 1010R). Extended electrode matrix 1006L is shown as including rows of extended electrodes 1008i-1008l and columns of extended electrodes 1008m-1008p, thereby forming a 12×12 matrix of cells 1010m-1010x (collectively 1010L). In embodiments, rather than the columns of extended electrodes 1008e-1008h and 1008m-1008p being conductive, their structural elements may be non-conductive, thereby forming an arrangement of rows of conductive extended electrodes 1008a-1008d and 1008i-1008l. It should be understood that the orientation of the extension electrodes 1008 is exemplary, and that the orientation and configuration of the extension electrodes may be rotated or otherwise configured. For example, the extension electrodes may or may not be equidistant from one another, may be of different lengths, etc.

[0074]

[0100] It should be understood that the extension electrode matrices 1006R and 1006L are exemplary, and that matrices having more or fewer rows and columns of extension electrodes may be utilized. It should further be understood that the shape and configuration of the extension electrode matrices are exemplary, and that different sizes, shapes, and configurations may be utilized to provide more or less coverage of one or both of the left and right atria. For example, a mesh covering a larger surface area may be utilized to provide greater surface area coverage. While the septal electrode 1004 is shown as a single electrode, other embodiments may be utilized in which multiple septal electrodes are utilized. For example, each extension electrode or pair of extension electrodes may have a common septal electrode. The extension electrodes and the matrices formed thereby should be configured to remain in contact with the endocardium of the respective left and right atria while being sufficiently flexible to avoid restricting the natural movement of the walls of the heart chambers.

[0075]

[0101] 11, an electrocardiogram (ECG) graph 1100 is shown illustrating an electrical signal 1102 of a typical healthy heartbeat captured by electrocardiography of the heart. The ECG graph 1100 illustrates typical changes in the electrical signal 1102, in this case voltage, generated by the heart, as measured by electrodes placed on the patient's skin. The electrical signal 1102 includes several waves, including Q, R, and S waves, where the Q and S waves are downward deflections (each wave begins and ends at a horizontal line) and the R wave is upward deflection (each wave begins and ends at a horizontal line). The P and T features are indicators of the respective depolarization and repolarization of the heart's ventricles. The combination of the Q, R, and S waves is known as the QRS complex and occurs during ventricular contraction. Each heartbeat generates an electrical signal 1102 on the ECG graph 1100, and the continuous sequence of PT intervals over time is the person's heart rate (e.g., 60 beats per minute (bpm)). In other words, for successive heartbeats, the electrical signal 1102, with each PT interval signal, repeats such that a T feature is completed before another P feature begins, as is commonly understood in the art. It should be understood that the ECG graph is illustrative of a typical shape of an ECG graph. Furthermore, it should be understood that the electrical signal captured by an extended electrode such as that shown in FIG. 10 may be at a different scale or may be the result of direct contact with the epicardium of the heart wall.

[0076]

[0102] 12a-12c, ECG graphs 1200a-1200c (collectively 1200) are shown of exemplary electrical signal sequences 1202a1-1202a4 (collectively 1202a), 1202b1-1202b4 (collectively 1202b), and 1202c1202c4 (collectively 1202c). With reference to FIG. 12A, electrical signals 1202a are shown overlapping because signals 1202a1-1202a4 are sensed by four extension electrodes, such as extension electrodes 1008i-1008l, positioned within left atrium 235 and extending along the endocardium therein. Electrical signals 1202a are each identical to electrical signal 1102 of FIG. 11, have approximately equal amplitudes A1, and have approximately equal time delays ΔT1 between each other. The time delay ΔT1 is shown to be substantially the same because the extension electrodes 1008i, 1008j, 1008k, and 1008l have substantially the same spacing relative to one another, the heart wall tissue between each of the extension electrodes 1008i-1008l has consistent electrical properties (e.g., the heart wall tissue is free of problematic tissue (e.g., scar tissue, necrotic tissue, etc.) that would affect the electrical signal emitted from the sinoatrial (SA) node, which is an oval-shaped specialized myocardial region in the upper posterior wall of the right atrium and is composed of cells called pacemaker cells).

[0077]

[0103] 12B, electrical signals 1202b each have a common amplitude A1 at the peak of the R wave, but there is a time delay of ΔT2 between electrical signals 1202b2 and 1202b3, while a common time delay of ΔT1 exists between electrical signals 1202b1 and 1202b2 and between electrical signals 1202b3 and 1202b4. The reason the ΔT2 time delay between electrical signals 1202b2 and 1202b3 is long (compared to ΔT1) is because problematic heart wall tissue generates a time delay of ΔT2, which may indicate an increase in electrical impedance through the heart wall tissue compared to healthy heart wall tissue, while healthy heart wall tissue results in a time delay of ΔT1. Although not shown, it should be understood that a time delay shorter than ΔT1 may be detectable, which would indicate a short or decrease in electrical impedance through the heart wall tissue.

[0078]

[0104] It should be understood that the electrical signals and their timing are exemplary in illustrating how problematic heart wall tissue can result in chaotic electrical signals, such as time-shifted electrical signals 1202b3 and 1202b4, thereby resulting in chaotic contractions of the heart chambers. It should be understood that the extension electrodes sensing electrical signal 1202b are assumed to be equally spaced, with the only variable being the time-shifted electrical signal as a function of the heart wall tissue. It should also be understood that if the extension electrodes are unequally spaced (e.g., the spacing between 1008j-1008k is greater than the spacing between consecutive electrodes 1008i-1008j and consecutive electrodes 1008k-1008l), a consistent time delay ΔT2 can be measured. And, if such a time delay ΔT2 is consistently measured, a change (e.g., an increase) in that time delay ΔT2 is an indicator that the heart wall tissue is beginning to become problematic. As a result, initial measurements should be taken upon placement of the extension electrode matrices 1006L and 1006R, and if such time delay ΔT2 is determined to be normal (i.e., there is no obvious problematic heart wall tissue between extension electrodes 1008j and 1008k), a measurement system such as a pacemaker should use these measurements as a baseline from which future comparisons of the electrical signal from extension electrode 1008k can be made to determine whether or not there is a problem with the heart wall tissue beginning to develop.

[0079]

[0105] With reference to FIG. 12C , electrical signal 1202c1 has an amplitude A1 at the peak of the R wave, while electrical signals 1202c2-1202c4 have an amplitude A2 at the peak of the R wave. The attenuation in amplitude from A1 to A2 between electrical signals 1202c1 and 1202c2-1202c4 can be attributed to problematic heart wall tissue between the extension electrodes sensing electrical signals 1202c1 and 1202c2-1202c4. Once the amplitude of the electrical signal is attenuated at the heart wall, the electrical signal remains attenuated, thereby causing each of the extension electrodes 1008 to remain attenuated. It should be understood that further attenuation can occur naturally or as a result of problematic heart wall tissue over time. Electrical signal 1202c is exemplary and illustrates only a single variable that changes as a result of problematic heart wall tissue between two extension electrodes. As described with respect to FIG. 12B, if an initial measurement is made with an installed extended electrode matrix such as extended electrode matrix 1006L that exhibits an attenuation between amplitudes A1 and A2 of electrical signals 1202c1 and 1202c2-1202c4, future electrical signal measurements to determine whether heart wall tissue is a concern should be based, for example, on initial electrical signal 1202c.

[0080]

[0106] Although not shown, it should be understood that both the decrease in time delay (or acceleration of the time shift) and the attenuation in amplitude can also result from problematic tissue formation (as well as the angle, distance, or other physical differences between the extension electrodes used to sample the electrical signal). Although there are many other examples of electrical signals that can be measured as a result of heart wall tissue, extension electrode connections, and many other factors, changes in the measured electrical signals over time can indicate that heart wall tissue is becoming problematic. Furthermore, such changes between measured electrical signals can be used to identify the location of problematic tissue and prevent future AFIB events (or the development of other cardiac conditions) by performing ablation to remove or correct the heart wall tissue.

[0081]

[0107] While only four electrical signals 1202a1-1202a4 are shown, it should be understood that there may be more depending on the number of extended electrodes in the mesh with nodes along rows and columns. From these electrical signals 1202a1-1202a4, identification of a location in the extended electrode matrix 1006L or 1006R may be performed based on timing, phase, etc., as provided with respect to FIG. 14B.

[0082]

[0108] An example is provided, and FIGS. 12A-12B illustrate actual measurements. However, a faster or slower time shift of an electrical signal may not occur instantaneously, but rather may occur gradually over time. That is, if time delay ΔT2 is shown to have a longer duration than time delay ΔT1, the time delay from ΔT1 to ΔT2 (assuming an initial measurement of ΔT1) may occur over a significantly longer period (e.g., over months or years). Accordingly, the principles described herein may use various algorithms to monitor the shift in the time delay of electrical signal 1202b3. As described below with respect to FIG. 14, an electronic device, such as a pacemaker, may establish the initial timing of electrical signals 1202a1-1202a4 (using an ECG graph as a baseline) and establish timing thresholds that may be used to notify the patient and / or physician and / or trigger alarms. Measurements may be individual measurements, average measurements, or any other mathematical calculation of measurements that minimizes false positives and / or false negatives. For example, derivatives (rate), second derivatives (acceleration), and integrals (average, volume under the curve) can be performed to determine changes in measurements over time. Using the same principles, a baseline is established and the electrical signal is monitored with respect to the amplitude of the peak R wave (or any other portion of the electrical signal) to determine if problematic cardiac tissue is developing. Again, notifications and / or alarms for crossing either a high or low threshold notification may be used to notify the patient and / or physician that the amplitude of the electrical signal has changed over time from the baseline measurement.

[0083]

[0109] In addition to, or instead of, using electrical signals to identify problematic cardiac issues, electrical properties, such as the impedance of cardiac wall tissue, can be measured using extension electrodes, such as extension electrode 1008 of FIG. 10 . Using extension electrodes to sense electrical properties allows the extension electrodes to be used to sense both the electrical properties of cardiac wall tissue and electrical signals generated by the heart, as previously described. However, the circuitry within the electronic device used to sense the two different signals may be different. The extension electrodes can be connected to a septal electrode, such as septal electrode 1004, formed of a single conductor or multiple conductors that are electrically isolated from each other.

[0084]

[0110] Referring to FIG. 12D, a graph 1200d of exemplary signals 1202d1-1202d4 is shown, representing the heartbeat timing difference sensed by each electrode of FIG. 10 over time. The x-axis is time in days, and the y-axis is the time difference in milliseconds (indicating the change in timing of the electrical signal between each of the consecutive electrodes). As shown, the timing difference between the third extension electrode (e.g., extension electrode 1008j) and the second extension electrode 1008k begins to increase at approximately 60 days and accelerates until approximately 75 days. The time difference then continues to increase, dropping off at approximately 150 days. The increase in timing difference in signal 1202d3 beginning at approximately 60 days may indicate that the heart wall tissue between the second and third extension electrodes 1008k and 1008j is becoming problematic. The timing difference for each of the other electrodes remains approximately 0 ms, meaning that the heart wall tissue is likely still healthy.

[0085]

[0111] 12E, a graph 1200e of exemplary signals 1202e1-1202e4 representing cardiac R wave amplitude differences sensed by each electrode of FIG. 10 over time is shown. The x-axis is time in days, and the y-axis is the amplitude in millivolts sensed by each extension electrode. As shown, the amplitude of the electrical signal over time of the first extension electrode 1008l to the sinoatrial node remains constant over time (i.e., the amplitude of the electrical signal does not decrease because the cardiac tissue prior to receiving the electrical signal is healthy). However, as shown, the second through fourth extension electrodes 1008k, 1008j, and 1008i sense lower amplitude signals of the R wave beginning at approximately 60 days, indicating that the heart wall tissue is attenuating the electrical signal to the sinoatrial node after the first extension electrode 1008l and before the second extension electrode 1008k (and the third and fourth extension electrodes 1008j and 1008i, respectively). It should be understood that the amplitude of the R wave may be one of several amplitude measurements (i.e., additionally or alternatively, other electrical signal characteristics may be measured and used to determine whether an area of ​​heart wall tissue is becoming problematic over time). It should be understood that because the data points monitored for the signal measurements in FIG. 12 are limited (e.g., peak R wave data points sensed by each extension electrode, timing differences between each electrical signal sensed by each extension electrode, time differences between successive extension electrodes receiving electrical signals, etc.), the amount of memory used to store the collected data may be limited.

[0086]

[0112] The electrical impedance (Z) of myocardial or heart wall tissue is defined as the voltage (V) measured across the tissue divided by the sinusoidal current (I) applied across the tissue (Z = V / I). Because cell membranes have capacitive properties, heart wall tissue is not purely resistive; therefore, there is a time delay between the voltage and current waves that can be determined from the phase angle of the tissue impedance. In this context, impedance (Z) is defined as a complex number (Z = R + jX), where R is the resistance (phase component of V with respect to i), j is the imaginary unit (j), and X is the reactance (quadrature component of V with respect to i). Therefore, heart wall tissue impedance can be precisely defined by two components: tissue resistivity (R) and phase angle (θ = arctan(X / R)).

[0087]

[0113] 13, a chart 1300 of exemplary impedance measurements 1302a-1302c (collectively 1302) of heart wall tissue is shown. Three impedance measurements 1302 are performed between successive extended electrodes, such as 1008i-1008l, in the left atrium 235 of FIG. 10. The three impedance measurements 1302 are performed over time. Heart wall tissue typically has an impedance of less than 300 ohm-cm (e.g., 278-283 ohm-cm). As shown, the impedance measurements in each of regions A, B, and C (e.g., cells 1010u, 1010q, 1010m between respective extended electrodes 1008i-1008j, 1008j-1008k, 1008k-1008l) are stable from time T0 to T1 (approximately 160 days), with the impedance measurement 1302c in region C being approximately 281 ohm-cm. However, at time T1, the impedance measurement 1302c in region C begins to rise rapidly from about 281 ohm-cm to about 350 ohm-cm at time T1 (about 200 days). From there, the impedance measurement 1302c begins to slow but continues to increase to about 480 ohm-cm at time T2 (about 375 days).

[0088]

[0114] As the extension electrodes are maintained along the heart wall, changes in impedance can be monitored and locations of problematic heart wall tissue (e.g., cells or areas located between the extension electrodes in the heart wall) can be identified (e.g., electrical properties of the tissue area change, leading to disruption of the electrical signal), thereby reducing or eliminating the need for the patient to be admitted to an examination room to determine the location of problematic heart wall tissue. Impedance measurements can account for both real and imaginary values, where Z=square root(R 2 +(X L -X C )2), where Z is the impedance, R is the resistance, XL is the inductive reactance, and XC is the capacitive reactance. Electronics capable of performing such impedance measurements may be incorporated into electronic devices such as pacemakers, to which an extension electrode matrix (or a row of extension electrodes) is connected.

[0089]

[0115] When performing impedance measurements, the measurements can be either passive or active. If active, a low-level electrical signal may be applied to a series pair of extended electrodes, and the current or voltage drop may be measured to determine the resistance or impedance between the two electrodes. The low-level electrical signal may be run over one or more frequencies (e.g., a swept-frequency test), which may provide additional information if a particular tissue problem can be sensed at different frequencies. Other impedance sensing techniques may be utilized in accordance with the principles described herein.

[0090]

[0116] Whether using electrical signal measurements or cardiac tissue electrical properties, locating problematic tissue involves mapping the extension electrodes ( FIG. 10 ) relative to one or more features of the heart or the location to which the septal electrode 1004 extends through the septum 250. The mapping can be (i) knowing measurements of the extension electrode matrices 1006R and 1006L relative to the septal electrode 1004, (ii) imaging (e.g., X-ray, CT scan, etc.), or (iii) other. The mapping can be performed using Cartesian coordinates, polar coordinates, etc. In embodiments, the mapping can be created, for example, simply by providing the location of the problematic heart wall tissue relative to the cells 1010R and 1010L formed by the extension electrode matrices 1006R and 1006L, thereby providing a relative position for the physician to locate the problematic tissue for ablation, as described further herein. As previously described, the upper and lower thresholds can be set after a baseline of each impedance value has been established. Upper and lower thresholds may be set as 10% above and below the initial impedance value, and if the upper or lower threshold is reached, a notification may be generated and communicated to the physician and / or patient. Additionally, maximum and minimum thresholds may be set that, when reached, may generate an alarm and communicate to the physician and / or patient. Such thresholds may be set in the electronic device or other devices with which the electronic device communicates to perform monitoring, charting, notification, and alert functions, among other functions.

[0091]

[0117] 14A and 14B, a diagram of an electronic device 1400, such as an implanted pacemaker and / or defibrillator, is shown that includes various hardware and software for performing the functions described herein. The electronic device may include a processor 1402 that executes software 1404 for performing the functions of sensing and measuring cardiac-generated electrical signals and cardiac wall tissue impedance measurements, as described herein. The processor 1402 may be in communication with a memory 1406, an input / output (I / O) unit 1408, and a pacemaker / defibrillator function 1410. The memory 1406 may be separate from the processor 1402, or may be an embedded memory. The I / O unit 1408 may include electronics configured to (i) communicate electrical signals with other implanted devices, such as the septal electrode 360 ​​and the extension electrode 1008, and (ii) communicate data signals to a remote device, such as a mobile device (e.g., a smartphone, a server, etc.), using any communication protocol (e.g., Bluetooth, Wi-Fi, etc.) to communicate real-time and / or non-real-time information to the remote device. The pacemaker / defibrillator function 1410 may be electronics and a power source (e.g., a capacitor) configured to perform the pacing and defibrillation functions of a pacemaker, as understood in the art.

[0092]

[0118] As previously described, for sensing functions when monitoring and identifying problematic heart wall tissue using implanted extension electrodes, software 1404 may be configured to monitor and collect electrical signals collected by extension electrodes positioned against the inner heart wall of the left and / or right atrium. Because a limited number of data points may be needed to perform an appropriate analysis of whether heart wall tissue is becoming problematic (e.g., forming an area that may lead to afib or other cardiac abnormality or event), maximum data points, minimum data points, or other data points measured independently or otherwise relative to time may be measured and recorded. Because it typically takes a relatively long period of time for heart wall tissue to become problematic, software 1404 may be configured to store desired data points (e.g., for each extension electrode or for successive extension electrodes) and then monitor the values ​​to detect changes over time (e.g., days, weeks, months, years). Because it is difficult to know whether a sensed signal is accurate, a typical process for performing monitoring may be performed relatively. For example, the timing between sensing of electrical signals between successive extension electrodes may be made to vary over time as opposed to the actual timing of sensing the electrical signals.

[0093]

[0119] In an embodiment, two primary measurement functions and two management functions may be performed in monitoring cardiac wall tissue. As shown in FIG. 14B , the two measurement functions may include, and be implemented using, software modules of software 1404, including (i) a measuring cardiac-generated electrical signal sensing module 1412 and (ii) a cardiac wall tissue impedance sensing module 1414. While it is possible to perform one of the two measurement functions and infer that cardiac wall tissue is shifting in a problematic manner, it should be understood that being able to perform both functions may provide additional information to the physician. Two management functions may include and be implemented using software modules of the software 1404, including: (i) a monitoring measurement module 1416 for monitoring measurement signals over time or when an AFIB event is detected, which may include performing mathematical calculations in determining values ​​to store (e.g., averaging, median, peak sensing, etc.), and (ii) a notification module 1418 for reporting to a physician and / or patient whether any of the measurement and stored signals exceed a threshold in response to detecting that one or more measurement values ​​exceed a threshold.

[0094]

[0120] The electronic device 1400 may also include a clock, such as a real-time clock, that generates a timestamp that can be stored with the data being generated from the monitoring, thereby associating the collected and generated data with the timestamp. The monitor measurement module 1416 and / or notification module 1418 may be configured to collect and report periodic or aperiodic measurements from the electronic device 1400 to a remote electronic device, either locally or on the cloud. Such a remote device may be configured to perform the same or additional statistical monitoring of the heart wall tissue. In embodiments, one such function may include generating a mapping of the measurements to a graphical heart to facilitate identification of the location of the heart wall tissue by a physician and / or patient.

[0095]

[0121] The cardiac wall tissue treatment module 1420 may be configured to enable the electronic device 1400 to deliver therapy by applying energy to locations where either or both of modules 1412 or 1414 determine that problematic cardiac tissue is present. If an AFIB event is determined to be occurring, the cardiac wall tissue treatment module 1420, in embodiments, may detect the AFIB event, determine the amount and type (e.g., amplitude and frequency) of energy signal to apply, and cause the pacemaker / defibrillator function 1410 to activate therapy. A command signal generated by the processor 1402 may be transmitted to the pacemaker / defibrillator function 1410 to apply energy by transmitting an energy signal to a specified location using one or both of the extension electrode matrices 1006R and 1006L of FIG. 10 . The electronic device 1400 may be configured to transmit the energy signal via a specific extension electrode 1008 to a specific location on the extension electrode matrices 1006R and 1006L, and possibly to a specific node along the extension electrode 1008. The energy treatment can be a temporary or permanent treatment that can immediately correct the AF event, slow or slow the progression of the problematic tissue, or possibly completely treat the event. Ablation can also be performed by the operator at a later time, if desired.

[0096]

[0122] The cardiac wall tissue treatment module 1420 may be configured to identify the type of problem occurring and automatically or semi-automatically select and apply a therapy. If performed semi-automatically, the module may provide suggestions to the electrocardiologist and receive confirmation to proceed with the proposed therapy. The module 1420 may be configured to generate therapy signals for the pacemaker / defibrillator function 1410 to perform or notify the function 1410 of the problem and enable the function 1410 to determine an appropriate therapy. It should be understood that the number and types of modules in the software 1404 are exemplary, and additional and / or alternative modules may be configured to sense, identify, locate, notify, and / or treat problematic tissue. Additionally, modules may be configured to cause the processor 1402 to communicate with the I / O unit 1408 to communicate with remote devices, allowing a physician using the remote devices to obtain information and perform certain functions manually, semi-automatically, or automatically, thereby providing additional information and capabilities in treating the patient. Depending on the configuration of the electronic device and the extension electrodes 1008, the electronic device may include a multiplexer for connecting a particular extension electrode to a power source that generates the electrical signal used to treat an identified region of the heart wall.

[0097]

[0123] 15, an exemplary graphical heart diagram is shown including the two extended electrode matrices 1006R and 1006L of FIG. 10. In this case, based on sensing performed as described with respect to FIGS. 12A-13 and using the systems and functionality described with respect to FIGS. 14A and 14B, a graphical representation of a heart 1500 indicative of heart wall tissue quality may be represented in the various cells 1010R and 1010L defined by the respective extended electrode matrices 1006R and 1006L in the respective right and left atria 237 and 235. In the example shown in FIG. 15, in the right atrium 237, the entire heart wall tissue within the extended electrode matrix 1006R may be represented as "healthy" tissue using a color (e.g., green) or other graphical representation. However, in the left atrium 235, based on sensed cardiac-generated electrical signals and / or measured heart wall tissue impedance signals measured using the extended electrode matrix 1006L, some heart wall tissue may be classified as healthy, other heart wall tissue may be classified as somewhat healthy, and other heart wall tissue may be classified as poor, using color coding or other graphical representation.

[0098]

[0124] It should be understood that while it is possible to monitor the heart wall tissue for possible changes over time, the system may be configured to detect an actual AFIB event, identified as a significant change in the electrical signal and / or electrical signal characteristics of the heart wall tissue. If such an AF event is sensed and detected, an immediate alert signal may be generated and communicated to the physician and / or patient. As part of the alert, a graphic or other representation (e.g., coordinates of the location of the heart wall tissue that likely triggered the AFIB event) may be generated and communicated to the event. The location may be relative to a cardiac feature or relative to the location of the septum where the septal electrode entered. The affected area may then be modified by delivering energy in several different ways to terminate activity from the focus.

[0099]

[0125] As shown, the top row of cells 1010m-1010p and 1010w-1010x are designated as healthy (e.g., colored green), cells 1010q and 1010r are classified as poor (e.g., colored red), and cells 1010s-1010v are classified as semi-healthy (e.g., colored yellow). It should be understood that the measurements are generated dynamically, such that the color may change dynamically over time based on the measurements. The cell 1010 is based on the configuration of the extended electrode matrices 1006R and 1006L and the ability of the electronic device to measure and detect electrical signals and / or electrical parameters within the cell. In some configurations, only rows are measured, and in other configurations, only columns are measured. If both rows and columns are measured, the conductivity and measurement functions provide these measurements. In embodiments, the timing of the measurement signals can be used to determine the location along the different extended electrodes and / or nodes that the measurements represent.

[0100]

[0126] Some embodiments are directed to a support structure for a pacemaker lead. The support structure is coupled to the pacemaker lead and configured to constrain a portion of the pacemaker lead against the atrial wall of a person. Examples of support structures are described herein and include, for example, a U-shaped dip, a lattice, etc., and the support structure may include a shape memory material (e.g., nitinol).

[0101]

[0127] An embodiment of a process for manufacturing an implantable cardiac device may include forming a structure configured to be retained on the atrial septum, wherein an extension electrode may be attached to a portion of the structure for positioning the extension electrode against the endocardium of the atrial septum, and the extension electrode may be configured with its elongated portion to maintain contact with the endocardium of the left atrium away from the atrial septum.

[0102]

[0128] Attaching the extension electrodes can include attaching extension electrodes formed of a shape memory material. The process can further include connecting leads to the structure for conducting electrical signals to the structure and the extension electrodes. Alternatively, the leadless pacemaker can be a structure that applies electrical signals to the structure and the extension electrodes.

[0103]

[0129] An embodiment of a method for implanting a cardiac device may include introducing an extension electrode into a blood vessel. The extension electrode may traverse the blood vessel into the right atrium of the patient's heart. The extension electrode may be inserted into the left atrial wall through the right-side wall junction, such that the extension electrode is intramural with the left atrium.

[0104]

[0130] The extension electrode may be fixed to remain within the wall of the left atrium. Fixing the extension electrode may include applying a structure to the interatrial septum. Fixing the extension electrode may include inserting a fixation device at the right wall junction that prevents the extension electrode from exiting the wall.

[0105]

[0131] The process may further include extending a lead from the extension electrode and connecting the lead to a pacemaker. Securing the extension electrode may include securing the extension electrode without breaching the endocardium of the left atrium.

[0106]

[0132] A method for implanting a lead in the left side of the heart using the structures described herein may include introducing the lead into a blood vessel, advancing the lead into the left atrium, securing a distal region of the lead flush with the atrial septum using anchor elements on either side of the atrial septum, and attaching an electrode to the lead that contacts the endocardium of the heart. Further, advancing the lead into the left atrium may include advancing the electrode across the septum and into continuous contact with the atrial wall. A lattice may be positioned in the left atrium to maintain the distal region of the lead in contact with the atrial wall.

[0107]

[0133] AFIB monitoring and prevention of future AFIB events

[0108]

[0134] An embodiment of a method for detecting cardiac tissue causing atrial fibrillation (AFIB) may include measuring electrical signal characteristics via a plurality of electrical conductors disposed on the endocardium of a heart wall within at least one chamber of each of the heart. A determination may be made that the electrical signal characteristics are indicative of an AFIB event. In response to a determination that the electrical signal characteristics are indicative of an AFIB event, a location of the heart wall within the heart chamber relative to the location of the electrical conductor causing the AFIB event may be identified.

[0109]

[0135] Measuring via electrical conductors may include measuring via multiple electrical conductors extending along the surface of the wall of the heart cavity. Measuring via electrical conductors extending along the endocardium of the wall of the heart cavity may include measuring via multiple electrical conductors having a mesh configuration. Identifying a location in the heart wall that caused the AFIB event may include identifying a location bounded by a mesh region. Measuring may include measuring electrical signal values ​​at nodes of the mesh of electrical conductors. Measuring an electrical characteristic may include measuring an impedance of the heart wall between successive electrical conductors extending along a common wall.

[0110]

[0136] Measuring the electrical signal characteristics may include measuring a current or voltage generated by each electrical conductor by the sinus node of the heart. In response to determining that the electrical signal characteristics are indicative of an AFIB event, data indicative of the current sensed by each of the electrical conductors may be stored.

[0111]

[0137] The process may further include storing the identified location of the heart wall in a non-transitory memory of the electronic device, recording by the electronic device a time associated with the AFIB event in association with the identified location, and communicating the identified location of the heart wall to an electronic display to present the location to a user. The collected information may be used to deliver energy in one of many configurations to terminate the abnormal signal, thereby eliminating the focus of the initiating AF event.

[0112]

[0138] Coordinates of electrical conductors within the patient's heart relative to features of the heart cavity within which the conductors reside can be stored, thereby enabling mapping of the walls of at least one cavity of the heart. Storing in a non-transitory memory of the electronic device can include storing in a non-transitory device of a pacemaker or defibrillator. Measuring electrical signal characteristics can include measuring impedance between successive conductors. The process can further include comparing the measured impedance between successive conductors over time to identify changes between successive conductors over time.

[0113]

[0139] One embodiment of an electronic device, such as a pacemaker, may include a non-transitory memory, an input channel configured to receive a plurality of electrical signals received from a plurality of extension electrodes extending along a heart wall within at least one chamber of the heart, and a processor in electrical communication with the non-transitory memory and the input channel. The processor may be configured to measure each of the electrical signals. Each measured electrical signal may be stored in the non-transitory memory. A determination is made as to whether any of the measured electrical signals are indicative of cardiac tissue that delays, accelerates, or attenuates electrical signals generated by the heart in a manner different from healthy cardiac tissue. In response to a determination that the electrical signals are indicative of cardiac tissue that delays, accelerates, or attenuates electrical signals generated by the heart in a manner different from healthy cardiac tissue, a notification signal may be generated indicative of the location.

[0114]

[0140] The electrical signal may be an electrical signal sensed by a sinoatrial node of the heart that is sensed by each of the extension electrodes. The extension electrodes may extend along at least one endocardium of the atrium of the heart. The electronic device may be a pacemaker.

[0115]

[0141] The input channel may include receiver electronics configured to sense electrical signals generated by the heart. The input channel may include electronics configured to sense the impedance of heart wall tissue between successive extension electrodes. The extension electrodes may be at least partially parallel to one another (e.g., some of the extension electrodes are parallel to one another, but not completely parallel due to the configuration of the heart cavity). The extension electrodes may define a matrix of rows and columns.

[0116]

[0142] The illustrations contained herein are not meant to be actual diagrams of any particular system, memory device, architecture, or process, but merely idealized representations used to describe embodiments of the present specification. Elements and features common between the figures may, for the most part, retain the same numerical designations for ease of subsequent description, except that the reference number begins with the number of the drawing in which the element was introduced or most fully described. Additionally, the elements shown in the figures are schematic in nature, and many details regarding the physical layout and structure of the memory array and / or all the steps required to access data may not be described, as will be understood by those skilled in the art.

[0117]

[0143] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0118]

[0144] As used herein, "or" includes any and all combinations of one or more of the associated listed items, both conjunctive and disjunctive. Any intended recitation of an "exclusive or" relationship is specifically called out.

[0119]

[0145] As used herein, the term "configured" refers to at least one structure of size, shape, material composition, physical structure, logical structure (e.g., programming, operational parameter settings) or other operational configuration and other operational configuration of at least one device that facilitates its operation in a defined manner (e.g., to perform a particular function or set of functions).

[0120]

[0146] As used herein, the phrases "coupled to" or "coupled with" refer to structures that are operatively connected to each other, such as connected via a direct connection or via an indirect connection (e.g., via another structure or component).

[0121]

[0147] The foregoing method descriptions and / or any process flow diagrams are provided merely as illustrative examples and are not intended to require or imply that the steps of the various embodiments must be performed in the order presented. As will be understood by one of ordinary skill in the art, the steps in the foregoing embodiments may be performed in any order. Words such as "then," "next," and the like are not intended to limit the order of the steps; these words are merely used to guide the reader through the method descriptions. Although the process flow diagrams may describe operations as a sequential process, many of the operations may be performed in parallel or simultaneously. Additionally, the order of operations may be rearranged. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. Where a process corresponds to a function, its termination may correspond to a return to the function from which the function was called or to the main function.

[0122]

[0148] The various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. Those skilled in the art may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as a departure from the scope of the present disclosure.

[0123]

[0149] Embodiments implemented in computer software may be implemented in software, firmware, middleware, microcode, hardware description languages, or any combination thereof. A code segment or machine-executable instructions may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a class, or any combination of instructions, data structures, or program statements. A code segment may be coupled to and / or communicate with another code segment or a hardware circuit by passing and / or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. may be communicated (e.g., passed, forwarded, and / or transmitted) via any suitable means including memory sharing, message passing, token passing, network transmission, etc.

[0124]

[0150] The actual software code or specialized control hardware used to implement these systems and methods is not a limitation of this disclosure. Thus, the operation and behavior of the systems and methods are described without reference to specific software code, with the understanding that software and control hardware can be designed to implement the systems and methods based on the description herein.

[0125]

[0151] If implemented in software, the functions may be stored as one or more instructions or code on a non-transitory computer-readable or processor-readable storage medium. The steps of a method or algorithm disclosed herein may be embodied in a processor-executable software module, which may reside on a computer-readable or processor-readable storage medium. Non-transitory computer-readable or processor-readable media includes both computer storage media and tangible storage media that facilitate transfer of a computer program from one place to another. Non-transitory processor-readable storage media may be any available medium that can be accessed by a computer. By way of example, and not limitation, such non-transitory processor-readable media may include RAM, ROM, EEPROM, CD-ROM or other optical disk storage devices, magnetic disk storage devices or other magnetic storage devices, or any other tangible storage medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer or processor. As used herein, disk and disc include compact discs (CDs), laser discs, optical discs, digital versatile discs (DVDs), floppy disks, and Blu-ray discs, although disks typically reproduce data magnetically, while discs reproduce data optically with lasers. Combinations of the above should also be included within the scope of computer-readable media. Additionally, the operations of a method or algorithm may reside as one or any combination or set of code and / or instructions on a non-transitory processor-readable medium and / or computer-readable medium, which may be embodied in a computer program product.

[0126]

[0152] While the foregoing description is of various preferred embodiments for carrying out the present disclosure, the scope of the invention should not necessarily be limited by this description. Instead, the scope of the invention is defined by the claims.

Claims

1. 1. A method for detecting cardiac tissue causing atrial fibrillation (AFIB), comprising: measuring electrical signal characteristics via a plurality of electrical conductors extending along the endocardium of a heart wall within at least one heart chamber of the heart; determining that the electrical signal characteristic is indicative of an AFIB event; responsive to determining that the electrical signal characteristics are indicative of an AFIB event, identifying a location of the heart wall within the at least one heart chamber relative to a location of the electrical conductor that caused the AFIB event; A method comprising:

2. The method of claim 1 , wherein measuring via a plurality of electrical conductors comprises measuring via a plurality of electrical conductors extending along a surface of the heart wall of the at least one heart cavity.

3. 3. The method of claim 2, wherein measuring via a plurality of electrical conductors extending along the endocardium of the heart wall of the at least one heart chamber comprises measuring via a plurality of electrical conductors having a mesh configuration.

4. The method of claim 3 , wherein identifying a location in the heart wall that caused the AFIB event comprises identifying a location bounded by a mesh region.

5. The method of claim 4 , wherein said measuring comprises measuring electrical signal values ​​at nodes of said mesh of said electrical conductors.

6. The method of claim 1 , wherein measuring the electrical signal characteristics comprises measuring the impedance of the heart wall between successive electrical conductors extending along a common wall.

7. The method of claim 1 , wherein measuring the electrical signal characteristics comprises measuring the current generated by the sinus node of the heart through each of the electrical conductors.

8. 8. The method of claim 7, further comprising storing data indicative of the current through each of the electrical conductors in response to determining that the electrical signal characteristics are indicative of an AFIB event.

9. storing the identified location of the heart wall in a non-transitory memory of an electronic device; recording, by the electronic device, a time associated with the AFIB event in association with the identified location; communicating the identified location of the heart wall to cause an electronic display to present the location for a user; The method of claim 1 further comprising:

10. 10. The method of claim 9, further comprising storing coordinates of the electrical conductor within the patient's heart relative to features of the at least one heart cavity within which the electrical conductor resides, thereby enabling mapping of the heart wall of the at least one heart cavity of the heart.

11. 10. The method of claim 9, wherein storing in a non-transitory memory of the electronic device comprises storing in a non-transitory device of a pacemaker or defibrillator.

12. The method of claim 1 , wherein measuring the electrical signal characteristics comprises measuring impedance between successive electrical conductors.

13. The method of claim 1 , further comprising comparing the measured impedance between successive conductors over time to identify changes between the successive conductors over time.

14. generating an energy signal; applying the energy signal to the identified location of the heart wall; The method of claim 1 further comprising:

15. 1. An electronic device comprising: a non-transient memory; an input channel configured to receive a plurality of electrical signals received from a plurality of extension electrodes extending along a heart wall within at least one chamber of the heart; a processor in electrical communication with the non-transitory memory and the input channel, measuring each of said electrical signals; storing each of the measured electrical signals in the non-transitory memory; determining whether any of the measured electrical signals are indicative of cardiac tissue that slows, accelerates, or attenuates cardiac-generated electrical signals differently than healthy cardiac tissue; generating a location-indicative notification signal in response to determining that the electrical signal is indicative of cardiac tissue that delays, accelerates, or attenuates cardiac-generated electrical signals in a manner different from healthy cardiac tissue; a processor configured to: , an electronic device.

16. 16. The electronic device of claim 15, wherein the electrical signal is an electrical signal generated by a sinoatrial node of the heart that is sensed by each of the plurality of extension electrodes.

17. 16. The electronic device of claim 15, wherein the extension electrode extends along at least one endocardium of an atrium of the heart.

18. The electronic device of claim 15, wherein the electronic device is a pacemaker.

19. 16. The electronic device of claim 15, wherein the input channel includes receiving electronics configured to sense electrical signals generated by the heart.

20. 16. The electronic device of claim 15, wherein the input channel includes electronics configured to sense the impedance of cardiac wall tissue between successive extension electrodes.

21. The electronic device of claim 15 , wherein the extension electrodes are at least partially parallel to each other.

22. The electronic device of claim 15 , wherein the extension electrodes define a matrix of rows and columns.

23. The processor: Generates an energy signal, The electronic device of claim 15 , further configured to cause the energy signal to be applied to the identified location of the heart wall.

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