Systems, devices, and methods for determining the location of arrhythmogenic foci

Abstract

A method for determining a location of an arrhythmogenic focus 632 in or near a heart 101 includes positioning a locator assembly 100 in the heart 101, the locator assembly 100 including a plurality of electrodes 102 for receiving electrical signals from the heart 101, generating a first signal array 733 from the electrical signals received by the plurality of electrodes 102 to determine an actual location of the arrhythmogenic focus 632, artificially stimulating the heart 101 based on the actual location determined by the first signal array 733 to generate a second signal array 735, and ascertaining the actual location of the arrhythmogenic focus 632 by comparing the first signal array 733 to the second signal array 735. In some embodiments, the locator assembly 100 includes a plurality of bipolar electrodes 102.

Description

[Technical Field]

[0001] This application claims priority to U.S. Application No. 17 / 505,263, filed October 19, 2021, entitled "SYSTEM, DEVICE, AND METHOD FOR DETERMINING LOCATION OF ARRHYTHMOGENIC FOCI," U.S. Application No. 17 / 571,152, filed January 7, 2022, entitled "SYSTEM, DEVICE, AND METHOD FOR DETERMINING LOCATION OF ARRHYTHMOGENIC FOCI," and U.S. Application No. 17 / 582,328, filed January 24, 2022, entitled "SYSTEM, DEVICE, AND METHOD FOR DETERMINING LOCATION OF ARRHYTHMOGENIC FOCI." To the extent permitted, the contents of U.S. Application Nos. 17 / 505,263, 17 / 571,152, and 17 / 582,328 are incorporated herein by reference in their entirety. [Background technology]

[0002] Atrial fibrillation is an irregular and sometimes rapid heart rate that may increase the risk of stroke, heart failure, and other heart-related complications. During atrial fibrillation, the heart's two upper chambers (atria) beat chaotically and irregularly, out of coordination with the two lower chambers (ventricles). Symptoms of atrial fibrillation often include palpitations, shortness of breath, and weakness. While atrial fibrillation is not usually life-threatening, it is a serious condition that may require treatment. Atrial fibrillation can arise from focal sources within the atria (referred to herein as "arrhythmogenic foci") or from other locations in or around the heart.

[0003] Catheter ablation of atrial fibrillation is currently performed using an anatomical approach to the atrial base. Previous models hypothesize that most clinical atrial fibrillation disease phases arise within the pulmonary veins. Patients eligible for atrial fibrillation ablation are not representative of typical patients with atrial fibrillation (e.g., on average, patients eligible for atrial fibrillation ablation generally have fewer comorbidities and are 10 years younger). As a result, pulmonary vein isolation is unlikely to be an effective strategy to cure atrial fibrillation in the overall population of patients with atrial fibrillation.

[0004] The anatomic approach to the atrial base surrogates the clinician's ability to provide relevant electrophysiological information during the clinical phase of atrial fibrillation. Problems with the anatomic approach include (1) propagation of recurrence across isolated ablation lesions developed at the pulmonary vein orifice / pylorus and (2) sudden onset of atrial fibrillation events from sites other than the pulmonary veins. Recurrent atrial fibrillation events involve many patients, including those in whom pulmonary vein isolation fails to control atrial fibrillation recurrence. In all patients who have previously had successful pulmonary vein isolation, there is still a recurrent phase.

[0005] Alternative mapping areas to the pulmonary veins, which generate the excessive heartbeats that suddenly trigger atrial fibrillation, are currently precluded by the inability to monitor sudden onset of atrial fibrillation in real time. Other approaches to real-time mapping, such as surrogate strategies, are used to represent catecholamine-induced atrial fibrillation during ablation procedures. However, surrogate strategies are not standardized, time-consuming, and ineffective (drug-induced atrial fibrillation does not represent spontaneous atrial fibrillation). Another major problem is the ability to accurately determine the exact location of the arrhythmogenic foci that cause atrial fibrillation. Summary of the Invention

[0006] The present invention is directed to a method for locating an arrhythmogenic focus in or near a heart. In various embodiments, the method includes the steps of positioning a locator assembly in the heart, the locator assembly including a plurality of electrodes that receive electrical signals from the heart, generating a first signal array from the electrical signals received by the plurality of electrodes to determine the actual location of the arrhythmogenic focus, artificially stimulating the heart based on the actual location determined by the first signal array to generate a second signal array, and confirming the actual location of the arrhythmogenic focus by comparing the first signal array with the second signal array.

[0007] In some embodiments, the locator assembly includes a plurality of bipolar electrodes.

[0008] In certain embodiments, the method further includes displaying the first signal array and the second signal array on a graphical user interface.

[0009] In various embodiments, the method further includes superimposing the first signal array and the second signal array on one another on a graphical user interface.

[0010] In some embodiments, the locator assembly includes an inner layer and an outer layer configured to act cooperatively to protect one or more components of the locator assembly.

[0011] In certain embodiments, at least one of the inner layer and the outer layer includes an eluting agent configured to counteract the prothrombotic and inflammatory potential of the locator assembly.

[0012] In various embodiments, the positioning step includes deploying the locator assembly in the coronary sinus of the heart via a percutaneous transcatheter.

[0013] In some embodiments, the positioning step includes inflating a balloon to expand the locator assembly so that the locator assembly is in circumferential contact with the heart.

[0014] The present invention is also directed to a method for locating an arrhythmogenic focus in or near a heart. In some embodiments, the method includes the steps of: positioning a locator assembly in the heart, the locator assembly including a plurality of electrodes that receive electrical signals from the heart; generating a first signal array from the electrical signals received by the plurality of electrodes to determine an actual location of the arrhythmogenic focus; artificially stimulating the heart based on the actual location determined by the first signal array to generate a second signal array; and superimposing the first signal array and the second signal array on a graphical user interface.

[0015] In various embodiments, the locator assembly includes an expandable stent configured to be inserted into the heart.

[0016] In some embodiments, the locator assembly includes a plurality of electrodes positioned longitudinally along the locator assembly.

[0017] In certain embodiments, the locator assembly includes a plurality of routing layers interconnecting the plurality of electrodes, each of the plurality of routing layers being stretchable.

[0018] In various embodiments, the locator assembly includes a communicator configured to enable communication between the locator assembly and an external device.

[0019] In some embodiments, the locator assembly includes a communicator configured to enable communication between the locator assembly and an external device.

[0020] In certain embodiments, the locator assembly includes a battery configured to (i) store electrical power and (ii) power one or more components of the locator assembly.

[0021] In various embodiments, the locator assembly includes an interior diameter configured to be expandable using an inflatable balloon.

[0022] In some embodiments, the locator assembly includes multiple components equally spaced around the circumference of the locator assembly.

[0023] In certain embodiments, the locator assembly includes an inner layer and an outer layer configured to act cooperatively to protect one or more components of the locator assembly.

[0024] In various embodiments, the locator assembly is configured to be movable between (i) a contracted state in which the locator assembly has a contracted diameter, and (ii) an expanded state in which the locator assembly has an expanded diameter.

[0025] In some embodiments, the ratio of expanded diameter to contracted diameter is less than 20:1 and greater than 1:1.

[0026] The present invention is also directed to a method for locating an arrhythmogenic focus in or near a heart. In certain embodiments, the method includes the steps of: positioning a locator assembly in the heart, the locator assembly including at least 12 bipolar electrodes that receive electrical signals from the heart; generating a first signal array from the electrical signals received by the plurality of bipolar electrodes to determine the actual location of the arrhythmogenic focus; artificially stimulating the heart based on the actual location determined by the first signal array to generate a second signal array; superimposing the signal arrays on one another on a graphical user interface; and comparing the first signal array with the second signal array to confirm the actual location of the arrhythmogenic focus.

[0027] The present invention is also directed to a locator assembly for determining the location of an arrhythmogenic focus in or near a heart. The locator assembly has a longitudinal axis and a periphery. In various embodiments, the locator assembly includes a device body and a plurality of components coupled to the device body. The plurality of components are distributed about the longitudinal axis and the periphery.

[0028] In certain embodiments, the device body is movable between (i) a contracted state in which the device body contracts, and (ii) an expanded state in which the device body expands outward from the contracted state such that the device body has an increased circumference.

[0029] In various embodiments, the locator assembly further includes an inner layer coupled to the device body and an outer layer coupled to the device body, the inner layer and the outer layer configured to act in concert to protect the multiple components.

[0030] In some embodiments, at least one of the inner layer and the outer layer comprises an eluting agent configured to counteract the prothrombotic and inflammatory potential of the locator assembly.

[0031] In certain embodiments, the device body is detachable from the outer layer.

[0032] In some embodiments, the locator assembly further includes a locking assembly that selectively locks the exterior layer and the device body together.

[0033] In various embodiments, the device body comprises an expandable stent configured to be inserted into and engage the heart.

[0034] In certain embodiments, the locator assembly further includes a plurality of electrodes that receive electrical signals from the heart to determine the location of the arrhythmogenic focus, the plurality of electrodes being coupled to the device body and the plurality of electrodes being distributed around the longitudinal axis and the circumference.

[0035] In some embodiments, the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

[0036] In various embodiments, the locator assembly further includes a plurality of routing layers interconnecting the plurality of electrodes, each of the plurality of routing layers being stretchable.

[0037] The present invention is also directed to a locator assembly for determining the location of an arrhythmogenic focus in or near a heart. The locator assembly has a longitudinal axis and an outer periphery. In various embodiments, the locator assembly includes a device body and an outer layer coupled to the device body. The outer layer is configured to protect the device body. The device body is detachable from the outer layer.

[0038] In certain embodiments, the device body is movable between (i) a contracted state in which the device body contracts, and (ii) an expanded state in which the device body expands outward from the contracted state such that the device body has an increased circumference.

[0039] In some embodiments, the locator assembly further includes a plurality of components coupled to the device body, the plurality of components being distributed around the longitudinal axis and the periphery, the plurality of components including a plurality of electrodes.

[0040] In various embodiments, the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

[0041] In certain embodiments, a plurality of electrodes are configured to receive electrical signals from the heart to determine the location of arrhythmogenic foci, the plurality of electrodes being distributed around the longitudinal axis and the circumference.

[0042] In some embodiments, the locator assembly further includes a plurality of routing layers interconnecting the plurality of electrodes, each of the plurality of routing layers being stretchable.

[0043] In various embodiments, the outer layer includes an eluting agent configured to counteract the prothrombotic and inflammatory potential of the locator assembly.

[0044] In certain embodiments, the locator assembly further includes a locking assembly that selectively locks the exterior layer and the device body together.

[0045] In some embodiments, the device body comprises an expandable stent configured to be inserted into and engage the heart.

[0046] The present invention is further directed to a locator assembly for determining the location of an arrhythmogenic focus in or near the heart. The locator assembly has a longitudinal axis and a periphery. In various embodiments, the locator assembly includes a device body, a plurality of electrodes, an outer layer, and a locking assembly. The device body is movable between (i) a contracted state in which the device body contracts and (ii) an expanded state in which the device body expands outward from the contracted state so as to have an increased periphery. The plurality of electrodes receives electrical signals from the heart to determine the location of the arrhythmogenic focus. The plurality of electrodes is coupled to the device body. The plurality of electrodes is distributed about the longitudinal axis and the periphery. The outer layer is selectively coupled to the device body. The locking assembly is configured to selectively lock the outer layer and the device body together.

[0047] The present invention is also directed to a locator assembly for determining the location of an arrhythmogenic focus in or near the heart. In various embodiments, the locator assembly includes a device body and a plurality of electrodes. The plurality of electrodes can be coupled to the device body to receive electrical signals from the heart to determine the location of the arrhythmogenic focus.

[0048] In certain embodiments, at least two of the plurality of electrodes are positioned longitudinally around the device body.

[0049] In various embodiments, at least two of the plurality of electrodes are positioned circumferentially around the device body.

[0050] In some embodiments, at least two of the plurality of electrodes are positioned circumferentially around the device body.

[0051] In certain embodiments, the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

[0052] In some embodiments, the locator assembly further includes a routing layer that positions the plurality of electrodes relative to the device body, the routing layer being stretchable.

[0053] In various embodiments, the plurality of electrodes is configured to receive electrical signals from the heart.

[0054] In certain embodiments, the electrodes are evenly spaced from one another around the periphery of the device body.

[0055] In some embodiments, the plurality of electrodes comprises at least 12 electrodes.

[0056] In various embodiments, multiple electrodes can be positioned in direct contact with the heart.

[0057] The present invention is also directed to a locator assembly for determining the location of an arrhythmogenic focus in or near the heart. In various embodiments, the locator assembly includes a device body and a plurality of electrodes. The plurality of electrodes receive electrical signals from the heart to determine the location of the arrhythmogenic focus. The plurality of electrodes can be coupled to the device body. At least two of the plurality of electrodes are positioned circumferentially around the device body. The plurality of electrodes can be positioned such that the plurality of electrodes are in electrical communication with the heart.

[0058] In certain embodiments, the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

[0059] In some embodiments, the locator assembly further includes a routing layer that positions the plurality of electrodes, the routing layer being stretchable.

[0060] In various embodiments, at least two of the plurality of electrodes are positioned circumferentially around the device body and at least two of the plurality of electrodes are positioned longitudinally around the device body.

[0061] In certain embodiments, the plurality of electrodes includes electrocardiogram electrodes.

[0062] In some embodiments, multiple electrodes may be positioned in direct contact with the heart.

[0063] In various embodiments, the plurality of electrodes includes at least 12 electrodes.

[0064] In certain embodiments, the plurality of electrodes includes at least 16 electrodes forming at least 28 bipoles.

[0065] In some embodiments, the electrodes are equally radially spaced from one another around the periphery of the device body.

[0066] The present invention is also directed to a locator assembly for determining the location of an arrhythmogenic focus in or near a heart. In various embodiments, the locator assembly includes a device body including an outer periphery and a plurality of electrodes. The plurality of electrodes can be coupled to the device body. The plurality of electrodes can be configured to receive electrical signals from the heart to determine the location of the arrhythmogenic focus. The plurality of electrodes can be configured to record electrical signals from the heart. Each of the plurality of electrodes can be evenly spaced from one another around the periphery. The plurality of electrodes can include at least 16 electrodes forming at least 28 bipolar electrodes.

[0067] This summary is an overview of some of the teachings of the present invention and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which should not be construed in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0068] The invention itself, together with the novel features of the invention, both as to its structure and its operation, can best be understood from the accompanying drawings in conjunction with the accompanying description, in which like reference numerals refer to like parts. [Brief explanation of the drawings]

[0069] [Figure 1A] 1 is a simplified perspective view of one embodiment of a locator assembly and external device for locating an arrhythmogenic focus in or near the heart, the locator assembly incorporating features of the present invention. [Figure 1B] 1 is a simplified illustration of a heart and one embodiment of a locator assembly for identifying arrhythmogenic foci in or near the heart, the locator assembly being positioned within a portion of the heart. [Figure 2A] FIG. 1 is a simplified end view of one embodiment of a locator assembly shown in a collapsed state. [Figure 2B] FIG. 1 is a simplified end view of one embodiment of a locator assembly shown in an expanded state. [Figure 3] FIG. 1 is a simplified, partially transparent, perspective view of one embodiment of a locator assembly illustrating the bipolar relationship between pairs of electrodes within the locator assembly. [Figure 4A] FIG. 1 is a simplified end view of one embodiment of a locator assembly. [Figure 4B] FIG. 10 is a simplified end view of yet another embodiment of a locator assembly. [Figure 4C] FIG. 4C is a simplified end view of a portion of the embodiment of the locator assembly shown in FIG. 4B. [Figure 4D] FIG. 4C is a simplified end view of yet another portion of the embodiment of the locator assembly shown in FIG. 4B. [Figure 5A] 1 is a simplified, partially transparent view of a portion of a heart, an embodiment of a locator assembly, and an embodiment of a deployment catheter, the locator assembly being shown in a collapsed state. [Figure 5B]1 is a simplified, partially transparent view of a portion of a heart, an embodiment of a locator assembly, and an embodiment of a deployment catheter, the locator assembly being shown in an expanded state. [Figure 6] 1 is a simplified illustration of one embodiment of a locator assembly positioned within a portion of the heart containing sinus rhythm foci, arrhythmogenic foci, and predicted foci within the heart. [Figure 7] FIG. 1 is a simplified diagram illustrating a sinus signal array, a first signal array, and a second signal array generated during one embodiment of a method for locating an arrhythmogenic focus in or near a heart. [Figure 8] FIG. 1 is a simplified diagram illustrating a first signal array and a second signal array superimposed on each other, the superimposition being shown in a non-aligned state, generated during one embodiment of a method for locating an arrhythmogenic focus. [Figure 9] FIG. 1 is a simplified diagram illustrating a first signal array and a second signal array superimposed on each other, the superimposition being shown in alignment, generated during one embodiment of a method for determining the location of an arrhythmogenic focus. [Figure 10] 1 is a flowchart outlining one embodiment of a method for determining the location of arrhythmogenic foci within a heart. [Figure 11] 10 is a flow chart outlining another embodiment of a method for determining the location of an arrhythmogenic focus within a heart. [Figure 12] 10 is a flowchart outlining yet another embodiment of a method for determining the location of an arrhythmogenic focus within a heart. DETAILED DESCRIPTION OF THE INVENTION

[0070] While embodiments of the present invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and drawings and are herein described in detail. It will be understood, however, that the scope of the present specification is not limited to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present specification.

[0071] The arrhythmogenic focus location systems, devices, and associated methods are configured to enable mapping of abrupt onset phases of clinical atrial fibrillation during a patient's daily life. In particular, a locator assembly 100 can be implanted within a patient such that the locator assembly 100 can identify the location of a source of clinical atrial fibrillation within or near the patient's heart 101. As used herein, "heart" is understood to mean the heart, including the atria, ventricles, septum, pulmonary veins, coronary sinus, fossa ovalis, superior vena cava, inferior vena cava, muscular sleeve, vessel walls, connected electrically active tissue, and all other supporting cardiac structures within or near the heart.

[0072] Locator assembly 100 can be used in the systems and methods described herein for determining the location of an arrhythmogenic focus 632 (e.g., as illustrated in FIG. 6 ) in or near a patient's heart 101. The systems, methods, and devices described herein for determining the location of an arrhythmogenic focus 632 in or near a heart 101 can vary.

[0073] Those skilled in the art will realize that the following detailed description of the invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the invention will readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to implementations of the invention as illustrated in the accompanying drawings.

[0074] In the interest of clarity, not all of the routine features of the implementations described herein are shown or described. Of course, it will be recognized that in the development of any such actual implementation, numerous implementation-specific decisions will be made to achieve the developer's specific objectives, such as compliance with application-related and business-related constraints, and that those specific objectives will vary from implementation to implementation and from developer to developer. Moreover, such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0075] 1A is a simplified perspective view of one embodiment of a locator assembly 100 and external device 105 for locating an arrhythmogenic focus 632 (illustrated in FIG. 6) within or near a heart 101. As provided herein, the locator assembly 100 is deliverable to a portion of a patient's heart 101. The locator assembly 100 can map the abrupt onset of clinical atrial fibrillation during the patient's daily life. The locator assembly 100 can be expandable so that it becomes anchored within a portion of the patient's heart 101.

[0076] In various embodiments, locator assembly 100 can be configured to provide electrocardiogram telemetry monitoring and sampling of electrophysiological signals from the patient's heart 101. By providing locator assembly 100 with telemetry capabilities, locator assembly 100 can be more suitable for patients with asymptomatic, infrequent, or intermittent atrial fibrillation disease phases.

[0077] In one embodiment, the locator assembly 100 may periodically sample electrocardiogram signals from the patient's heart 101 (either at equal or unequal time increments) throughout the sampling period. In some embodiments, the sampling period may be between one hour and one year. In other embodiments, the sampling period may be less than one hour or greater than one year. By providing a longer sampling period, the locator assembly 100 may capture arrhythmias or arrhythmogenic foci 632 that may not be captured during a shorter sampling period.

[0078] In certain embodiments, locator assembly 100 is positioned and expanded within a patient's heart 101. In some embodiments, locator assembly 100 can operate somewhat similarly to an expandable stent. Locator assembly 100 can be permanently positioned within a patient. Alternatively, locator assembly 100 can be removed from the patient, such as after locator assembly 100 has depleted stored power, for replacement or repair of various components, or for any other suitable purpose. Locator assembly 100 has a longitudinal axis 100a, but can have other axes as well. Locator assembly 100 has a periphery 100c.

[0079] In some embodiments, if the cross section of locator assembly 100 were a perfect circle and longitudinal axis 100a were perfectly centered through the edge of locator assembly 100, all positions on periphery 100c would be equidistant from longitudinal axis 100a. In various embodiments, locator assembly 100 and its incorporated elements and components can be rechargeable. In one embodiment, locator assembly 100 can be wirelessly recharged while locator assembly 100 is positioned within a patient.

[0080] Locator assembly 100 can vary depending on its design requirements. It will be understood that locator assembly 100 can include additional components, systems, subsystems, and elements other than those specifically shown and / or described herein. Additionally or alternatively, locator assembly 100 can omit one or more of the components, systems, subsystems, and elements specifically shown and / or described herein. In some embodiments, the various components of locator assembly 100 can be positioned in a different manner than specifically illustrated in FIG. 1A . In some embodiments, locator assembly 100 can have the same or somewhat similar design as a bare metal stent, as one non-limiting, non-exhaustive example.

[0081] The components of locator assembly 100 may be configured to operate for a finite period or life expectancy of the patient, if not longer. If necessary, some or all of the components and / or elements of locator assembly 100 may potentially be stationary during extraction and / or replacement of locator assembly 100.

[0082] 1A, locator assembly 100 may include a plurality of electrodes 102 (only one electrode is identified in FIGS. 1A, 2A-2B, and 3-4, with the other electrodes shown as black dots), a communicator 104, a controller 106, a routing layer 108, a battery 110, and a device body 112. As used herein, the "components" of locator assembly 100 may include a plurality of electrodes 102, a communicator 104, a controller 106, a routing layer 108, and a battery 110.

[0083] In various embodiments, locator assembly 100 can be configured for use by a patient while the patient is undergoing a magnetic resonance imaging scan or other imaging procedure. In other words, locator assembly 100 can have variable types of shielding and / or resistance to external electromagnetic radiation. In some embodiments, locator assembly 100 can be automatically activated and / or powered on. In certain embodiments, locator assembly 100 can be manually activated and / or powered on by the patient or a medical professional.

[0084] 1A , the components of the locator assembly 100, such as the electrodes 102, the communicator 104, the controller 106, the routing layer 108, and the battery 110, can be radially spaced apart from one another around the periphery 100c. For example, in various non-exhaustive embodiments, the components of the locator assembly 100 can be spaced apart by 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, or 180 degrees around the periphery 100c. In other embodiments, the components of the locator assembly 100 can be spaced apart by less than 1 degree or by some other radial spacing other than those noted herein.

[0085] The components of the locator assembly 100 can be positioned as provided above even if the cross-sectional shape of the locator assembly 100 is something other than a circle. The cross-sectional shape of the locator assembly 100 can be any suitable shape. Non-limiting, non-exhaustive examples of cross-sectional shapes of the locator assembly 100 include a circular shape, an elliptical shape, an oval shape, a pentagonal shape, a hexagonal shape, a heptagonal shape, an octagonal shape, a decagonal shape, or any suitable shape. The cross-sectional shape of the locator assembly 100 can have any number of sides and any type of curvature.

[0086] In some embodiments, the components of locator assembly 100 can be spaced substantially equidistant from one another around perimeter 100c. Locator assembly 100 can include multiple platforms (not shown) configured to hold corresponding components of locator assembly 100 around perimeter 100c. In other embodiments, components of locator assembly 100, such as those shown in FIG. 1, can incorporate platforms configured to enable coupling to locator assembly 100.

[0087] The electrodes 102 record and sense electrical signals (e.g., electrophysiological signals) transmitted from the heart 101 and nearby parts of the body. In some embodiments, the electrodes 102 can record atrial activity and associated electrical impulses.

[0088] The type of electrodes 102 can vary depending on the design requirements of the locator assembly 100. In some embodiments, the electrodes 102 can be positioned in a different configuration than that specifically illustrated in FIG. 1A.

[0089] The electrodes 102 may include any suitable type of electrode, including one or more electrocardiogram electrodes (as non-limiting, non-exhaustive examples). The electrodes 102 may form bipolar electrodes when positioned in pairs. The electrodes 102 may be coupled and detached from the locator assembly 100 to repair or replace defective or otherwise inoperable electrodes 102 of the locator assembly 100. The locator assembly may include any suitable number of electrodes 102. In some embodiments, such as FIG. 1A , the locator assembly 100 may include 16 electrodes 102. In other embodiments, the locator assembly 100 may include 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, or 32 electrodes 102. In certain embodiments, the locator assembly 100 may include more than 32 electrodes.

[0090] The electrodes 102 may be distributed in a pattern either longitudinally and / or circumferentially or around the periphery 100c on any suitable portion of the locator assembly 100. The electrodes 102 may be spaced 10, 20, 30, 45, 60, 72, 90, 120, or 180 degrees apart around the periphery 100c of the locator assembly 100. In other embodiments, the electrodes 102 may be positioned at approximately 5, 15, 25, 35, 40, 50, 55, 65, 70, 75, 80, 85, 95, 100, 105, 110, 115, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, or any other suitable interval from one another along the periphery 100c of the locator assembly 100.

[0091] In some embodiments, the electrodes 102 may be distributed in a somewhat circular pattern, an elliptical pattern, a cylindrical pattern, or any suitable pattern around the locator assembly 100. In one embodiment, the electrodes 102 may be evenly spaced apart from one another along the longitudinal axis 100a and / or around the periphery 100c of the locator assembly 100. In alternative embodiments, the electrodes 102 may be unevenly, asymmetrically, quasi-randomly, or randomly spaced apart from one another along the longitudinal axis 100a and / or around the periphery 100c of the locator assembly 100.

[0092] The communicator 104 is used by the locator assembly 100 for wireless communication between the locator assembly 110 and an external device 105 (e.g., a computing device). Data collected by the locator assembly 100 can be transmitted wirelessly to the external device 105 via the communicator 104. In other words, the communicator 104 is configured to enable communication between the locator assembly 100 and the external device 105. Alternatively, the communicator 104 can enable wired communication between the locator assembly 100 and the external device 105.

[0093] The type of communicator 104 and / or the positioning of communicator 104 can vary depending on the design requirements of locator assembly 100. Communicator 104 can include any suitable wireless communication device, such as, by way of non-limiting, non-exhaustive example, a radio frequency, Bluetooth, low energy antenna, and / or any suitable antenna. Communicator 104 can also include any suitable wired communication device, such as a wired antenna, a dipole antenna, a monopole antenna, a loop antenna, a transmission line antenna, etc. In some embodiments, communicator 104 can be positioned differently than specifically illustrated in FIG. 1A .

[0094] The external device 105 can communicate via the communicator 104 to enable (i) the transfer of data between the locator assembly 100 and the external device 105, (ii) utilization of memory in the external device 105 to increase the processing speed of the locator assembly 100, and / or (iii) storage of data in the external device 105 after transfer of data from the locator assembly 100 to the external device 105. In some embodiments, the external device 105 can communicate with the communicator 104 to execute a set of processing instructions on the locator assembly 100. For example, the external device 105 can communicate via the communicator 104 to power the locator assembly 100 on or off.

[0095] The external device 105 can vary depending on the design requirements of the locator assembly 100. The connection between the communicator 104 and the external device 105 is illustrative only. The connection can represent a wired and / or wireless connection between the locator assembly 100, the communicator 104, and / or the external device 105.

[0096] The controller 106 can control the components of the locator assembly 100. The controller 106 can be variable depending on the design requirements of the locator assembly 100. In some embodiments, the controller 106 can be positioned differently than specifically illustrated in FIG. 1A.

[0097] The controller 106 may include (by way of non-limiting, non-exhaustive example only) processors, microprocessors, diodes, capacitors, power storage elements, ASICs, sensors, imagers (e.g., CMOS, CCD imagers), amplifiers, A / D and D / A converters, associated differential amplifiers, buffers, microprocessors, light collectors, transducers including electro-mechanical transducers, piezoelectric actuators, light-emitting electronics including LEDs, logic, memory, clocks, and transistors including active matrix switching transistors, and combinations thereof. Electronic devices or components within devices are described herein and include those components described herein. Components can be one or more of any of the electronic devices described herein and / or may include photodiodes, LEDs, TUFTs, electrodes, semiconductors, other light collecting / detecting components, transistors, contact pads that can contact device components, thin-film devices, circuit elements, control elements, microprocessors, interconnects, contact pads, capacitors, resistors, inductors, memory elements, power storage elements, antennas, logic elements, buffers, and / or other passive or active components. The components of the locator assembly 100 may be connected to one or more contact pads as known in the art, such as by metal deposition, wire bonding, application of a solid or conductive paste, etc. A processor within the controller 106 may process and store data from each of the multiple electrodes 102.

[0098] The routing layer 108 routes the components of the locator assembly 100 and / or the controller 106 to properly connect the components according to the design of the locator assembly 100 and / or the controller 106. The routing layer 108 can be variable depending on the design requirements of the locator assembly 100 and / or the controller 106. In some embodiments, the routing layer 108 can be positioned differently than specifically illustrated in FIG. 1A. The routing layer 108 can include wiring, substrates, and / or other circuitry encapsulated within a non-conductive dielectric material.

[0099] Battery 110 stores and provides power to various components of locator assembly 100. Battery 110 can be variable depending on the design requirements of locator assembly 100. In some embodiments, battery 110 can be positioned differently than specifically illustrated in FIG. 1A.

[0100] The battery 110 can be disposable / disposable, or the battery 110 can be rechargeable. The battery 110 can be any suitable battery for use within the locator assembly 100. Non-limiting, non-exhaustive examples of batteries 110 that can be used within the locator assembly 100 include alkaline, lithium, lithium ion, lithium iron phosphate, lithium silicon, magnesium, mercury, mercury oxide, silver oxide, silver zinc, zinc air, zinc carbon, zinc chloride, lead, lead acid gel, nickel cadmium, nickel oxyhydroxide, nickel metal hydride, nickel zinc, and Absolyte® batteries. The battery 110 can also be a solid-state battery. The battery 110 can be any suitable size and / or shape for use within the locator assembly 100, such as the partial cylindrical shape illustrated in the embodiment shown in FIG. 1A.

[0101] In some embodiments, battery 110 may be configured to power locator assembly 100 for five years or more. In particular embodiments, battery 110 may be configured to power locator assembly 100 for less than five years. In various embodiments, battery 110 may be rechargeable wirelessly. In another embodiment, battery 110 may include a capacitor.

[0102] Device body 112 provides at least some structure to locator assembly 100. Device body 112 can provide a substrate for securing various components of locator assembly 100. Device body 112 can include a framework and / or lattice structure for expansion and contraction. In some embodiments, when the framework within device body 112 expands at the periphery, the longitudinal length of device body 112 does not expand. In other embodiments, when the framework within device body 112 expands at the periphery, the longitudinal length of device body 112 expands.

[0103] In certain embodiments, when the framework within device body 112 expands in perimeter and / or longitudinal length, the electrodes 102, communicator 104, controller 106, routing layer 108, and battery 110 also expand in perimeter and / or longitudinal length. Alternatively, in some such embodiments, when the framework within device body 112 contracts in perimeter and / or longitudinal length, the electrodes 102, communicator 104, controller 106, routing layer 108, and battery 110 also contract in perimeter and / or longitudinal length. Various components of locator assembly 100, including electrodes 102, communicator 104, controller 106, routing layer 108, and battery 110, may be formed from stretchable and / or expandable materials.

[0104] The device body 112 can expand and contract as needed to deploy and withdraw the locator assembly 100 within various regions of the patient's heart 101 and body. The device body 112 can be variable depending on the design requirements of the locator assembly 100. In some embodiments, the device body 112 can be configured differently than that specifically illustrated in FIG. 1A . The device body 112 can be any suitable structure known in the art that allows for expansion and contraction only in the circumference. The cross-sectional shapes of the device body 112 in the contracted and expanded states can be variable. Non-limiting, non-exhaustive examples of cross-sectional shapes of the device body 112 include a circular shape, an elliptical shape, an oval shape, a pentagonal shape, a hexagonal shape, a heptagonal shape, an octagonal shape, a decagonal shape, or any suitable shape.

[0105] FIG. 1B is a simplified illustration of a heart 101 and one embodiment of a locator assembly 100 positioned within the heart 101. The heart 101 includes a right atrium 101a and a left atrium 101b. As shown, the locator assembly 100 can be telescopic to conform to portions of the heart 101, such as valves, veins, and sinuses. In particular, in the embodiment shown in FIG. 1B, the locator assembly 100 can be positioned within the coronary sinus 127 near the middle cardiac vein 128. However, it will be understood that the locator assembly 100 can equally be positioned in other locations within or around the heart 101.

[0106] FIG. 2A is a simplified front view of one embodiment of a locator assembly 200 shown in a contracted state. As used herein, it will be understood that a "contracted state" means that the locator assembly 200 and / or the device body 212 are contracted or unexpanded. In the contracted state, structures and / or components within the locator assembly 200, including the electrodes 202, the communicator 204, the controller 206, the routing layer 208, and the battery 210, can be at least partially contracted. For example, in one embodiment of the locator assembly 200 shown in FIG. 2A, the device body 212 is in a contracted state when the framework within the device body 212 is contracted or unexpanded. For ease of understanding, the contracted state of the device body 212 in FIG. 2A is exaggerated to illustrate the flexibility and / or contraction of the device body 212.

[0107] 2A, device body 212 is the only component shown in the reduced state. While in the reduced state, locator assembly 200 has a reduced diameter 214. In some embodiments, reduced diameter 214 illustrated and described herein can be between approximately 0.01 millimeters and 20.00 millimeters. In various non-exhaustive examples, the reduced diameter 214 may be approximately 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, Metric, 4mm, 4.1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, 5mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, 6mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm, 8mm, 8.1mm, 8.2mm, 8.3mm, 8.4mm, 8.5mm, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm, 10mm, 10.1mm, 10.2mm, 10.3mm, 10.4mm, 10.5mm, 10.6mm 10.7mm, 10.8mm, 10.9mm, 11mm, 11.1mm, 11.2mm, 11.3mm, 11.4mm, 11.5mm, 11.6mm, 11.7mm, 11.8mm, 11.9mm, 12mm, 12.1mm, 12.2mm, 12.3mm, 12.4mm, 12.5mm, 12.6mm, 12.7mm, 12.8mm, 12.9mm , 13mm, 13.1mm, 13.2mm, 13.3mm, 13.4mm, 13.5mm, 13.6mm, 13.7mm, 13.8mm, 13.9mm, 14mm, 14.1mm, 14.2mm, 14.3mm, 14.4mm, 14.5mm, 14.6mm, 14.7mm, 14.8mm, 14.9mm, 15mm, 15.1mm, 15.2mm, 15 .3mm, 15.4mm, 15.5mm, 15.6mm, 15.7mm, 15.8mm, 15.9mm, 16mm, 16.1mm, 16.2mm, 16.3mm, 16.4mm, 16.5mm, 16.6mm, 16.7mm, 16.8mm, 16.9mm, 17mm, 17.1mm, 17.2mm, 17.3mm, 17.4mm, 17.5mm, 17.The reduced diameter 214 can be 6 mm, 17.7 mm, 17.8 mm, 17.9 mm, 18 mm, 18.1 mm, 18.2 mm, 18.3 mm, 18.4 mm, 18.5 mm, 18.6 mm, 18.7 mm, 18.8 mm, 18.9 mm, 19 mm, 19.1 mm, 19.2 mm, 19.3 mm, 19.4 mm, 19.5 mm, 19.6 mm, 19.7 mm, 19.8 mm, 19.9 mm, or 20 mm. In other embodiments, the reduced diameter 214 can be less than approximately 0.01 mm or greater than approximately 20.00 mm.

[0108] 2B is a simplified front view of one embodiment of locator assembly 200 shown in an expanded state. As used herein, "expanded state" is understood to mean that locator assembly 200 and / or device body 212 expand outward from a contracted state such that locator assembly 200 and / or device body 212 have an increased circumference. Locator assembly 200 is movable between the contracted state and the expanded state.

[0109] While in the expanded state, locator assembly 200 has an expanded diameter 216 that is larger than reduced diameter 214. In some embodiments, expanded diameter 216 as illustrated and described herein can be between approximately 0.01 millimeters and 20.00 millimeters. In various non-exhaustive examples, the expanded diameter 216 may be approximately 0.01 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4 mm, 4. .1mm, 4.2mm, 4.3mm, 4.4mm, 4.5mm, 4.6mm, 4.7mm, 4.8mm, 4.9mm, 5mm, 5.1mm, 5.2mm, 5.3mm, 5.4mm, 5.5mm, 5.6mm, 5.7mm, 5.8mm, 5.9mm, 6mm, 6.1mm, 6.2mm, 6.3mm, 6.4mm, 6.5mm, 6.6mm, 6.7mm, 6.8mm, 6.9mm, 7mm, 7.1mm, 7.2mm, 7.3mm, 7.4mm, 7.5mm, 7.6mm, 7.7mm, 7.8mm, 7.9mm, 8mm, 8.1mm, 8.2mm, 8.3mm, 8.4mm, 8.5mm, 8.6mm, 8.7mm, 8.8mm, 8.9mm, 9mm, 9.1mm, 9.2mm, 9.3mm, 9.4mm, 9.5mm, 9.6mm, 9.7mm, 9.8mm, 9.9mm, 10mm, 10.1mm, 10.2mm, 10.3mm, 10.4mm, 10.5mm, 10.6mm, 10.7mm, 10.8mm, 10.9 mm, 11mm, 11.1mm, 11.2mm, 11.3mm, 11.4mm, 11.5mm, 11.6mm, 11.7mm, 11.8mm, 11.9mm, 12mm, 12.1mm, 12.2mm, 12.3mm, 12.4mm, 12.5mm, 12.6mm, 12.7mm, 12.8mm, 12.9mm, 13mm, 13.1mm, 13.2mm Liter, 13.3mm, 13.4mm, 13.5mm, 13.6mm, 13.7mm, 13.8mm, 13.9mm, 14mm, 14.1mm, 14.2mm, 14.3mm, 14.4mm, 14.5mm, 14.6mm, 14.7mm, 14.8mm, 14.9mm, 15mm, 15.1mm, 15.2mm, 15.3mm, 15.4mm, 15.5 mm, 15.6mm, 15.7mm, 15.8mm, 15.9mm, 16mm, 16.1mm, 16.2mm, 16.3mm, 16.4mm, 16.5mm, 16.6mm, 16.7mm, 16.8mm, 16.9mm, 17mm, 17.1mm, 17.2mm, 17.3mm, 17.4mm, 17.5mm, 17.6mm, 17.7mm, 17.8 mm, 17.9 mm, 18 mm, 18.1 mm, 18.2 mm, 18.3 mm, 18.4 mm, 18.5 mm, 18.6 mm, 18.7 mm, 18.8 mm, 18.9 mm, 19 mm, 19.1 mm, 19.2 mm, 19.3 mm, 19.4 mm, 19.5 mm, 19.6 mm, 19.7 mm, 19.8 mm, 19.9 mm, or 20 mm. In other embodiments, expanded diameter 216 can be less than approximately 0.01 mm or greater than approximately 20.00 mm.

[0110] In certain embodiments, the ratio of expanded diameter 216 to contracted diameter 214 of locator assembly 200 herein can be approximately 1:1 to 20:1. In some such non-exhaustive embodiments, the ratio of expanded diameter 216 to contracted diameter 214 of locator assembly 200 can be approximately 1:1, 1.1:1, 1.2:1, 1.3:1, 1.4:1, 1.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, 2:1, 2.1:1, 2.2:1, 2.3:1, 2.4:1, 2.5:1, 2.6:1, 2.7:1, 2.8:1, 2.9:1, 3:1, 3.1:1, 3.2:1, 3.3:1, 3.4:1, 3.5:1, 3.6:1, 3.7:1, 3.8:1, 3.9:1, 4.0:1, 4.10:1, 4.11:1, 4.12:1, 4.13:1, 4.14:1, 4.15:1, 4.16:1, 4.17:1, 4.18:1, 4.19:1, 4.20:1, 4.21:1, 4.22:1, 4.23:1, 4.24:1, 4.25:1, 4.26:1, 4.27:1, 4.28:1, 4.29:1, 4.30:1, 4.31:1, 4.32:1, 4.33:1, 4.34:1, 4.35:1, 4.36:1, 1, 3.9:1, 4:1, 4.1:1, 4.2:1, 4.3:1, 4.4:1, 4.5:1, 4.6:1, 4.7:1, 4.8:1, 4.9:1, 5:1, 5.1:1, 5.2:1, 5.3:1, 5.4:1, 5.5:1, 5.6:1, 5.7:1, 5.8:1, 5.9:1, 6:1, 6.1:1, 6.2:1, 6.3:1, 6.4:1, 6.5:1, 6.6:1, 6.7:1, 6.8:1, 6.9:1, 7:1, 7.1:1, 7.2:1, 7.3:1, 7.4:1, 7.5:1, 7.6:1, 7.7:1, 7.8 :1, 7.9:1, 8:1, 8.1:1, 8.2:1, 8.3:1, 8.4:1, 8.5:1, 8.6:1, 8.7:1, 8.8:1, 8.9:1, 9:1, 9.1:1, 9.2:1, 9.3:1, 9.4:1, 9.5:1, 9.6:1, 9.7:1, 9.8:1, 9.9:1, 10:1, 10.1:1, 10.2:1, 10.3:1, 10.4:1, 10.5:1, 10.6:1, 10.7:1, 10.8:1, 10.9:1, 11:1, 11.1:1, 11.2:1, 11.3:1, 11.4:1, 11.5 :1, 11.6:1, 11.7:1, 11.8:1, 11.9:1, 12:1, 12.1:1, 12.2:1, 12.3:1, 12.4:1, 12.5:1, 12.6:1, 12.7:1, 12.8:1, 12.9:1, 13:1, 13.1:1, 13.2:1, 13.3:1, 13.4:1, 13.5:1, 13.6:1, 13.7:1, 13.8:1, 13.9:1, 14:1, 14.1:1, 14.2:1, 14.3:1, 14.4:1, 14.5:1, 14.6:1, 14.7:1, 14.8:1, 14.9:1, 15:1, 15.1:1, 15.2:1, 15.3:1, 15.4:1, 15.5:1, 15.6:1, 15.7:1, 15.8:1, 15.9:1, 16:1, 16.1:1, 16.2:1, 16.3:1, 16.4:1, 16.5:1, 16.6:1, 16.7:1, 16.8:1, 16.9:1, 17:1, 17.1:1, 17.2:1, 17.3:1, 17.4:1, 17.5:1 , 17.6:1, 17.7:1, 17.8:1, 17.9:1, 18:1, 18.1:1, 18.2:1, 18.3:1, 18.4:1, 18.5:1, 18.6:1, 18.7:1, 18.8:1, 18.9:1, 19:1, 19.1:1, 19.2:1, 19.3:1, 19.4:1, 19.5:1, 19.6:1, 19.7:1, 19.8:1, 19.9:1, or 20:1. Alternatively, in some embodiments, the ratio of expanded diameter 216 to contracted diameter 214 of locator assembly 200 can be greater than approximately 20:1 or less than approximately 1:1.

[0111] FIG. 3 is a simplified, partially transparent perspective view of one embodiment of a locator assembly 300 illustrating the bipolar relationship between electrodes 302 within the locator assembly 300. In the embodiment illustrated in FIG. 3, the locator assembly 300 can include a device body 312 and multiple bipolar electrodes 318a-bb. The electrodes 302 can be bipolar electrodes having negative or positive polarity. In FIG. 3, the bipolar electrodes 318a-bb are illustrated as vectors representing the bipolarity of current passing through the locator assembly 300 from electrodes 302 having negative polarity to electrodes 302 having positive polarity. The electrodes 302 having negative polarity are referred to herein as cathodes, and the electrodes 302 having positive polarity are referred to herein as anodes.

[0112] Bipoles 318a-bb are formed between two electrical components (such as an anode and a cathode) of opposite polarity. In bipoles 318a-bb, current passes through locator assembly 300 between electrical components of opposite polarity. Electrodes 302 can be excited by applying a current or voltage between the anode and cathode to create bipoles 318a-bb. The current or voltage can be applied to electrodes 302 by locator assembly 300 and / or external device 105 (illustrated in FIG. 1 ).

[0113] The number of bipoles 318a-bb can vary depending on the design requirements of the locator assembly 300 and / or the electrodes 302. In some embodiments, a network of bipoles 318a-bb including multiple anodes and cathodes, such as that illustrated in FIG. 3, is arranged on the locator assembly 300. The multiple bipoles 318a-bb or multiple bipole networks can be arranged in any suitable portion of the locator assembly 300. The bipoles 318a-bb can be distributed in a pattern around the longitudinal axis 100a (illustrated in FIG. 1), either longitudinally and / or circumferentially, or around or along any other suitable axis.

[0114] In some embodiments, the bipoles 318a-bb can be distributed in a somewhat circular pattern, an elliptical pattern, a cylindrical pattern, or any suitable pattern around the locator assembly 300. In one embodiment, the bipoles 318a-bb can be evenly spaced from one another along the longitudinal axis 300a and / or around the circumference of the locator assembly 300. In alternative embodiments, the bipoles 318a-bb can be non-uniformly, quasi-randomly, or randomly spaced from one another along the longitudinal axis 300a and / or around the circumference of the locator assembly 300. While 28 bipoles 318a-bb are shown in the embodiment shown in FIG. 3 , it will be understood that more than 28 bipoles 318a-bb or fewer than 28 bipoles 318a-bb can be utilized by the locator assembly 300.

[0115] 4A is a simplified front view of one embodiment of a locator assembly 400A. In particular, in the embodiment illustrated in FIG. 4A, the locator assembly 400A includes an inner layer 420A and an outer layer 422A. The inner layer 420A and the outer layer 422A can act in concert to substantially enclose and / or protect components of the locator assembly 400A, including the electrodes 402A, the communicator 404A, the controller 406A, the routing layer 408A, the battery 410A, and / or the device body 412A.

[0116] In other embodiments, the interior layer 420A can be coupled to the exterior layer 422A to completely enclose the components of the locator assembly 400A, including the electrodes 402A, the communicator 404A, the controller 406A, the routing layer 408A, the battery 410A, and / or the device body 412A. In certain embodiments, only one layer (e.g., the interior layer 420A or the exterior layer 422A) can completely enclose the components of the locator assembly 400A, including the electrodes 402A, the communicator 404A, the controller 406A, the routing layer 408A, the battery 410A, and / or the device body 412A.

[0117] Inner layer 420A and outer layer 422A can cooperate to improve protection of the patient and components of locator assembly 400A upon deployment of locator assembly 400A within a patient. Inner layer 420A can provide a substantially uniform surface for improved protection of deployment balloon 526 (illustrated in FIG. 5 ) upon contact of inner layer 420A with deployment balloon 526. Outer layer 422A can reduce the likelihood of injury when outer layer 422A contacts one or more interior walls of a portion of heart 101 (illustrated in FIG. 1B ).

[0118] The interior layer 420A and / or the exterior layer 422A can be in electrical communication with the electrode 402A and the heart 101. The interior layer 420A and the exterior layer 422A can be at least partially formed from an electrically conductive material. In other examples, the interior layer 420A and / or the exterior layer 422A can be formed with holes or apertures configured to allow the electrode 402A to come into direct contact with one or more interior walls of a portion of the heart 101.

[0119] In its deployed position (e.g., one deployed position is depicted in FIGS. 5A-5B ), the inner layer 420A and / or the outer layer 422A can release an eluting drug over a period of time to prevent the prothrombotic and inflammatory potential of the locator assembly 400A. In other embodiments, one or more drug-eluting layers (not shown in FIG. 4A ) can be coupled to each of the inner layer 420A and / or the outer layer 422A such that the inner layer 420A and / or the outer layer 422A are positioned between the one or more drug-eluting layers and the device body 412A. In certain embodiments, the inner layer 420A and / or the outer layer 422A can include multiple layers, including one or more drug-eluting layers. In various embodiments, other components of the locator assembly 400A (e.g., the device body 412A) can include an eluting drug and / or one or more drug-eluting layers.

[0120] Additionally, in the embodiment depicted in FIG. 4A , locator assembly 400A is shown in an expanded state, with locator assembly 400A having an expanded diameter 416. While the expanded state is depicted in FIG. 4A , it will be appreciated that inner layer 420A and outer layer 422A can be movable between the contracted state and the expanded state. Inner layer 420A can be variable depending on the design requirements of locator assembly 400A. In some embodiments, inner layer 420A can be positioned differently than specifically illustrated in FIG. 4A .

[0121] Inner layer 420A can be formed from any suitable material. In certain embodiments, inner layer 420A can be at least partially formed from a lubricious and / or continuous material. Inner layer 420A can be resilient, stretchable, and / or elastic. In some embodiments, inner layer 420A can be at least partially formed from a metal, plastic, composite, polymer, coating, biocompatible material, and / or biodegradable material. Non-limiting, non-exhaustive examples of suitable metals from which inner layer 420A can be formed include iron, magnesium, zinc, and their corresponding alloys. Non-limiting, non-exhaustive examples of suitable polymers that can be used to form inner layer 420A include polylactic acid, tyrosine polycarbonate, salicylic acid, poly DL lactide, and everolimus.

[0122] Inner layer 420A may include drugs to counteract the prothrombotic and inflammatory potential of locator assembly 400A, such as immunosuppressants and antiproliferative agents. Specific, non-limiting, non-exhaustive drugs that may be used in inner layer 420A include sirolimus, paclitaxel, and everolimus. However, it will be appreciated that any suitable elutable drug may be utilized in inner layer 420A.

[0123] The outer layer 422A can vary depending on the design requirements of the locator assembly 400A. In some embodiments, the outer layer 422A can be positioned differently than specifically illustrated in FIG. 4A . The outer layer 422A can be formed from any suitable material. In certain embodiments, the outer layer 422A can be at least partially formed from a lubricious and / or continuous material. The outer layer 422A can be resilient, stretchable, and / or elastic. In some embodiments, the outer layer 422A can be at least partially formed from a metal, a plastic, a composite, a polymer, a coating, a biocompatible material, and / or a biodegradable material. Non-limiting, non-exhaustive examples of suitable metals from which the outer layer 422A can be formed include iron, magnesium, zinc, and their corresponding alloys. Non-limiting, non-exhaustive examples of suitable polymers that can be used to form the outer layer 422A include polylactic acid, tyrosine polycarbonate, salicylic acid, poly DL lactide, and everolimus.

[0124] The outer layer 422A may include drugs to counteract the prothrombotic and inflammatory potential of the locator assembly 400A, such as immunosuppressants and antiproliferative agents. Specific, non-limiting, non-exhaustive drugs that may be used in the outer layer 422A include sirolimus, paclitaxel, and everolimus. However, it will be appreciated that any suitable elutable drug may be utilized in the outer layer 422A.

[0125] 4B is a simplified end view of yet another embodiment of a locator assembly 400B. In particular, in the embodiment illustrated in FIG. 4B, the locator assembly 400B includes an inner layer 420B and an outer layer 422B. The inner layer 420B and the outer layer 420B can act in concert to substantially enclose and / or protect components of the locator assembly 400B, including the electrodes 402B, the communicator 404B, the controller 406B, the routing layer 408B, the battery 410B, and / or the device body 412B. Locator assembly 400B, electrodes 402B, communicator 404B, controller 406B, routing layer 408B, battery 410B, device body 412B, internal layer 420B, and / or external layer 420B can be substantially similar to locator assembly 400A, electrodes 402A, communicator 404A, controller 406A, routing layer 408A, battery 410A, device body 412A, internal layer 420A, and / or external layer 420A described with respect to FIG. 4A and other embodiments described herein.

[0126] Locator assembly 400B is movable between a locked state and an unlocked state. In the embodiment illustrated in FIG. 4B , locator assembly 400B is shown in a locked state. In some embodiments, locator assembly 400B is in an unlocked state and outer layer 422B can be deployed separately from the remainder of locator assembly 400B. In other embodiments, outer layer 422B can remain deployed in a deployed position (e.g., the position shown in FIGS. 5A-5B, 6 ) and the remainder of locator assembly 400B is removed from the deployed position. In the deployed position, a new locator assembly 400B can be deployed and engaged within outer layer 422B. In certain embodiments, locator assembly 400B can include a locking assembly 480.

[0127] The locking assembly 480 can facilitate locking and / or separating the outer layer 422B from the locator assembly 400B and / or the remainder of the device body 412B. For example, the locking assembly 480 can be enabled to facilitate locking and / or separating the outer layer 422B from the locator assembly 400B and / or the remainder of the device body 412B by mechanical manipulation of a deployment catheter 524 (illustrated in FIG. 5 ). The deployment catheter 524 can lock and unlock the locking assembly 480, such that the locator assembly 400B can be separately positioned relative to the outer layer 422B. In other embodiments, the patient, clinician, and / or external device 105 (illustrated in FIG. 1 ) can lock and unlock the locking assembly 480 without mechanical manipulation of the deployment catheter 524. For example, in some embodiments, external device 105 may wirelessly send lock and / or unlock commands to lock assembly 480 (e.g., via communicator 404B) to lock and unlock lock assembly 480.

[0128] Lock assembly 480 can vary depending on the design requirements of locator assembly 400 and / or outer layer 422. It will be understood that lock assembly 480 can include additional components, systems, subsystems, and elements other than those specifically shown and / or described herein. Additionally or alternatively, lock assembly 480 can omit one or more of the components, systems, subsystems, and elements specifically shown and / or described herein. In some embodiments, lock assembly 480 and various components of lock assembly 480 can be positioned in a different manner than specifically illustrated in FIG. 4B .

[0129] Locking assembly 480 may include a first locking mechanism 482 and a second locking mechanism 484. First locking mechanism 482 and second locking mechanism 484 lock and / or engage with one another such that outer layer 422B is secured to locator assembly 400B and / or device body 412B. First locking mechanism 482 may be coupled to device body 412B and / or any suitable component of locator assembly 400B. Second locking mechanism 484 may be coupled to outer layer 422B and / or any suitable component of locator assembly 400B.

[0130] While locking assembly 480 includes two locking mechanisms in FIG. 4B , it will be appreciated that locking assembly 480 can include any number of locking and / or engaging structures or elements that enable locking and / or engaging outer layer 422B to locator assembly 400B and / or device body 412B. In some embodiments, by way of non-limiting, non-exhaustive example, first locking mechanism 482 and second locking mechanism 484 can include one or more of a male / female hook-up assembly, a teeth / recess assembly, a tongue / groove assembly, a latch, an anchor, a coupling, an interlocking shoulder, a bolt, a cable, a clamp, a connector, a hook, a loop, a flange protrusion, a joint, a seam, a channel, a guide, a linkage, a track, and / or a tray. First locking mechanism 482 and second locking mechanism 484 are simplified for ease of understanding.

[0131] Figure 4C is a simplified end view of a portion of the embodiment of locator assembly 400B shown in Figure 4B. As shown in Figure 4C, locator assembly 400B, including electrodes 402B, communicator 404B, controller 406B, routing layer 408B, battery 410B, device body 412B, inner layer 420B, and / or first locking mechanism 482, can be selectively unlocked and / or disengaged from outer layer 422B and / or second locking mechanism 484.

[0132] Figure 4D is a simplified end view of yet another portion of the embodiment of the locator assembly shown in Figure 4B. As shown in Figure 4D, the exterior layer 422B and / or second locking mechanism 484 can be selectively unlocked and / or disengaged from the electrodes 402B, the communicator 404B, the controller 406B, the routing layer 408B, the battery 410B, the device body 412B, the interior layer 420B, and / or the first locking mechanism 482.

[0133] 5A is a simplified, partially transparent view of one embodiment of a locator assembly 500, along with an embodiment of a deployment catheter 524, a guidewire 525, and a balloon 526. As illustrated in FIG. 5A, the locator assembly 500 is positioned within the coronary sinus 527 of the heart 101 (illustrated in FIG. 1) near the middle cardiac vein 528.

[0134] The deployment catheter 524 deploys the locator assembly 500 within a portion of the heart 101. The deployment catheter 524 may deploy the locator assembly 500 in the same or similar manner as the deployment catheter 524 deploys an expandable stent. The deployment catheter 524 may advance the locator assembly 500 to a target site within the coronary sinus 527. In some embodiments (such as the embodiment shown in FIGS. 5A-5B ), the target site may be near the bifurcation between the coronary sinus 527 and the middle cardiac vein 528. It will be appreciated that the target site illustrated in FIGS. 5A-5B is merely illustrative, and the locator assembly 500 may be deployed within any suitable position within the patient. The deployment catheter 524 may deploy the locator assembly 500 while the device is in a contracted state, an expanded state, or a state in between (FIG. 5A shows the locator assembly 500 in a contracted state).

[0135] The deployment catheter 524 can vary depending on the design requirements of the locator assembly 500. It will be understood that the deployment catheter 524 can include additional components, systems, subsystems, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the deployment catheter 524 can omit one or more of the components, systems, subsystems, and elements specifically shown and / or described herein. Notably, the deployment catheter 524 in FIGS. 5A-5B has been simplified and some elements of the deployment catheter 524 have been omitted for ease of understanding. In some embodiments, the deployment catheter 524 can be positioned differently than specifically illustrated in FIGS. 5A-5B.

[0136] In some embodiments, deployment catheter 524 can be a percutaneous transcatheter or any suitable catheter. Deployment catheter 524 can include a guidewire 525 and an inflatable balloon 526 (sometimes simply referred to herein as a "balloon"). Deployment catheter 524 can be configured to travel over guidewire 525.

[0137] The guidewire 525 can advance components (such as the locator assembly 500 and / or the balloon 526) through openings in the deployment catheter 524. The guidewire 525 can be advanced simultaneously with the deployment catheter 524 within the patient's body. The guidewire 525 can be variable depending on the design requirements of the locator assembly 500 and / or the deployment catheter 524. In some embodiments, the guidewire 525 can be positioned differently than specifically illustrated in FIGS. 5A-5B.

[0138] Balloon 526 can be coupled to deployment catheter 524 and / or guidewire 525. Balloon 526 can be inflatable to move locator assembly 500 between a contracted state and an expanded state. Balloon 526 can be deflated and removed from within locator assembly 500 after locator assembly 500 has moved from the expanded state to the contracted state. Balloon 526 can also be deflated and removed from within locator assembly 500 when locator assembly 500 is between the contracted state and the expanded state.

[0139] The balloon 526 can be variable depending on the design requirements of the locator assembly 500, the deployment catheter 524, and / or the guidewire 525. In some embodiments, the balloon 526 can be positioned differently than specifically illustrated in Figures 5A-5B. The balloon 526 illustrated in Figures 5A-5B has been simplified for ease of understanding.

[0140] Figure 5B is a simplified, transparent view of one embodiment of locator assembly 500, and one embodiment of deployment catheter 524, guidewire 525, and balloon 526. In the embodiment shown in Figure 5B, locator assembly 500 can be positioned within coronary sinus 526 of heart 101 (illustrated in Figure 1), with locator assembly 500 shown in an expanded state. As shown in Figure 5B, guidewire 525 can retract balloon 526 from within locator assembly 500. Balloon 526 can be deflated to allow it to shrink within deployment catheter 524.

[0141] Figure 6 is a simplified illustration of a heart 601, including a right atrium 601a and a left atrium 601b, and one embodiment of a locator assembly 600 for determining the location of an arrhythmogenic focus 632 within or near the heart 601. In Figure 6, the locator assembly 600 is positioned within a portion of the heart 601. For ease of understanding, Figure 6 displays exemplary locations of a sinus rhythm focus 630, an arrhythmogenic focus 632, and a predicted focus 634 within the heart 601.

[0142] Sinus rhythm focus 630 is a focal point of the patient's normal sinus rhythm. In particular, in some embodiments, sinus rhythm focus 630 represents the origin of the normal sinus rhythm electrical activation sequence, such as from the sinoatrial node. An example of an electrical activation sequence signal array recorded by locator assembly 600 at sinus rhythm focus 630 is illustrated in the left column in FIG. 7.

[0143] The arrhythmogenic focus 632 illustrated in Figure 6 represents the actual location of one of the focal points of an arrhythmia in a patient. It will be appreciated that the arrhythmogenic focus 632 shown in Figure 6 is merely illustrative and / or representative and may be located anywhere within and / or near the heart 601.

[0144] 6 represents a location of artificial stimulation to determine and / or confirm whether the predicted focus 634 is the same as or different from the actual arrhythmogenic focus 632. The predicted focus 634 and the arrhythmogenic focus 632 can be located at the same location (referred to herein as a "matched state") or at different locations (referred to herein as a "non-matched state"), as described in further detail herein.

[0145] The artificial stimulation can be generated using any suitable device known in the art, including, by way of non-exhaustive example, an ablation catheter, an electrical stimulator, and / or a pacemaker. The artificial stimulation device can stimulate any suitable number of predicted lesions 634 during a single manipulation and / or insertion of the artificial stimulation device into the patient. In other words, the artificial stimulation device can continuously test various predicted lesion 634 locations.

[0146] FIG. 7 is a simplified diagram displaying electrical signal array data collected by locator assembly 100 (e.g., as illustrated in FIG. 1). As shown in FIG. 7, signal array data collected by bipoles 318a-bb (as illustrated in FIG. 3) are illustrated in descending rows as electrical signals 719a-bb. For example, FIG. 7 illustrates a sinus signal array 731 collected by locator assembly 100 from sinus rhythm focus 630 (as illustrated in FIG. 6), a first signal array 733 collected by locator assembly 100 from arrhythmogenic focus 632 (as illustrated in FIG. 6), and a second signal array 735 collected by locator assembly 100 from predicted focus 634 (as illustrated in FIG. 6).

[0147] FIG. 7 illustrates a sinus signal array 731, a first signal array 733, and a second signal array 735 as displayed on a graphical user interface (GUI) of external device 105 (illustrated in FIG. 1). It will be understood that the actual display of sinus signal array 731, first signal array 733, and / or second signal array 735 may look different than that shown in FIG. 7, and that the sinus signal array 731, first signal array 733, and second signal array 735 illustrated in FIG. 7 are provided as one type of display for ease of understanding and are not intended to be limiting in any way. Any other suitable visual and / or audio display is contemplated and is intended to be included as an alternative example. Further alternatively, tactile responses can be incorporated into the display of sinus signal array 731, first signal array 733, and second signal array 735.

[0148] Sinus signal array 731 illustrates an electrical activation sequence recorded by locator assembly 100 implanted within coronary sinus 527 (illustrated in FIG. 5 ) during a patient's normal sinus rhythm. In particular, sinus signal array 731 is recorded by each of bipoles 318a-bb to generate corresponding electrical signals 719a-bb in descending rows. For example, bipole 318a receives electrical signal 719a from sinus rhythm focus 630 during the patient's normal sinus rhythm, which is then displayed in the first row of sinus signal array 731. Each additional bipole 318b-bb similarly receives a corresponding electrical signal 319b-bb, which is then similarly displayed in subsequent rows of sinus signal array 731.

[0149] Sinus signal array 731 can be used for comparative assessment of different sequences between two sources of cardiac impulse origin. In particular, sinus signal array 731 can represent the electrical activation sequence of a patient in sinus rhythm. Sinus signal array 731 can be used in comparison with first signal array 733 and / or second signal array 735.

[0150] 7, sinus signal array 731 includes event onset 738A, which is represented as a vertical line within sinus signal array 731. Event onset 738A represents the onset of an actual event, such as an electrophysiological event that includes an electrical signal arising from a sinus rhythm focus (or sinoatrial node). Event onset 738A represents a time (e.g., T0) after which electrical signals 719a-bb occur.

[0151] First signal array 733 illustrates an electrical activation sequence recorded by locator assembly 100 located at arrhythmogenic focus 632 and implanted within coronary sinus 527 during a clinical phase of a patient's atrial fibrillation. In particular, first signal array 733 is recorded by each of bipoles 318a-bb to generate corresponding electrical signals 719a-bb in descending rows. For example, bipole 318a records an electrical activation sequence during a clinical phase of the patient's atrial fibrillation, and corresponding electrical signal 719a is displayed in the first row of first signal array 733. First signal array 733 can be used in comparison with second signal array 735, as provided in further detail herein.

[0152] 7, the first signal array 733 includes an event onset 738B, which is represented as a vertical line within the first signal array 733. The event onset 738B represents the start of an actual event, such as an electrophysiological event that includes an electrical signal arising from the arrhythmogenic focus 632. The event onset 738B represents a time (e.g., T0) after which the electrical signals 719a-bb occur.

[0153] Second signal array 735 illustrates an electrical activation sequence taken at predicted lesion 634 and recorded by locator assembly 100 implanted in coronary sinus 527 during artificial stimulation of the patient at predicted lesion 634. In particular, second signal array 735 is recorded by each of bipoles 318a-bb to generate corresponding electrical signals 719a-bb in descending rows. For example, bipole 318a records an electrical activation sequence during artificial stimulation of the patient at predicted lesion 634, and corresponding electrical signal 719a is displayed on the first row in second signal array 735. Second signal array 735 can be used in comparison with first signal array 733, as provided in further detail herein.

[0154] 7, second signal array 735 includes event onset 738C, which is represented as a vertical line in second signal array 735. Event onset 738C represents the start of an actual event, such as, for example, an artificial stimulus that generates an electrical signal resulting from predicted focus 634. Event onset 738C represents a time (e.g., T0) after which electrical signals 719a-bb occur.

[0155] Figure 8 is a simplified diagram illustrating the superposition of a first signal array 833 and a second signal array 835 on one another, generated during one embodiment of a method for identifying arrhythmogenic foci 632 (illustrated in Figure 6). Misaligned superposition is shown in Figure 8. As shown in the example displayed in Figure 8, electrical signals 819a-bb are recorded by bipoles 318a-bb (illustrated in Figure 3) in descending rows.

[0156] In the example illustrated in FIG. 8 , the first signal array 833 includes an event onset 838B, which is represented as a vertical line in the first signal array 833, and the second signal array 835 includes an event onset 838C, which is represented as a vertical line in the second signal array 835. In this example, the event onsets 838B, 838C are aligned, and thus a direct comparison between the first signal array 833 and the second signal array 835 can be achieved. Based on the overlay displayed in FIG. 8 , the clinician and / or patient can determine and / or confirm that the arrhythmogenic focus 632 and the predicted focus 634 (illustrated in FIG. 6 ) are not in the same location as one another. In this example, the signal arrays 833, 835 are not substantially similar or identical.

[0157] To assist the clinician and / or patient in determining that the arrhythmogenic focus 632 and the predicted focus 634 are not co-located (e.g., misaligned) with one another, a negative sensory response can be incorporated into the locator assembly 100 (illustrated in FIG. 1 ), the deployment catheter 524 (illustrated in FIG. 5 ), and / or associated systems. For example, in some embodiments, a negative sensory response can be incorporated into the displays of the signal arrays 833, 835 or into the handle (not shown) of the deployment catheter 524. The negative sensory response can be touch and / or movement vibration or similar stimuli. The negative sensory response can be included on any appropriate portion of the deployment catheter 524 or any suitable system and / or device. In other embodiments, the negative audio response can include a beep or any suitable audio feedback that is triggered when the overlap is misaligned. In certain embodiments, the negative visual response can include a red visual indicator and / or any suitable visual indicator when the overlap is misaligned.

[0158] 9 is a simplified diagram illustrating the superposition of a first signal array 933 and a second signal array 935 on one another, showing aligned superposition, generated during one embodiment of a method for determining the location of an arrhythmogenic focus 632 (illustrated in FIG. 6). As shown in the embodiment displayed in FIG. 9, electrical signals 919a-bb are recorded by bipoles 318a-bb (illustrated in FIG. 3) in descending rows.

[0159] 9, the first signal array 933 includes an event onset 938B, which is represented as a vertical line within the first signal array 933, and the second signal array 935 includes an event onset 938C, which is represented as a vertical line within the first signal array 935. In this example, the event onsets 938B, 938C are aligned, and thus a direct comparison can be achieved between the first signal array 933 and the second signal array 935. Based on the overlay displayed in FIG. 9, a clinician and / or patient can determine and / or confirm that the arrhythmogenic focus 632 and the predicted focus 634 (illustrated in FIG. 6) are in the same location as each other because the signal arrays 833, 835 are substantially similar or identical.

[0160] To assist the clinician and / or patient in determining that the arrhythmogenic focus 632 and the predicted focus 634 are co-located (e.g., aligned) with one another, a positive sensory feedback can be incorporated into the locator assembly 100 (illustrated in FIG. 1 ), the deployment catheter 524 (illustrated in FIG. 5 ), and / or associated systems. For example, in some embodiments, a positive sensory feedback can be incorporated into the displays of the signal arrays 833, 835 or into the handle (not shown) of the deployment catheter 524. The positive sensory feedback can be touch and / or movement vibration or similar stimulation. The positive sensory feedback can be included on any suitable portion of the deployment catheter 524 or any suitable system and / or device. In other embodiments, the positive audio feedback can include a beep or any suitable audio feedback that is triggered when the overlap is aligned. In certain embodiments, the positive visual feedback can include a green visual indicator and / or any suitable visual indicator when the overlap is aligned.

[0161] FIG. 10 is a flowchart outlining one embodiment of a method for determining the location of an arrhythmogenic focus within a heart. It will be understood that a method according to the disclosure herein can include more or fewer steps than those shown and described in connection with FIG. 10 . The method can omit one or more steps illustrated in FIG. 10 . The method can add additional steps not shown and described in FIG. 10 and still be within the scope of the present invention. Furthermore, the order of the steps can be varied from the order shown and described in connection with FIG. 10 . The order of the steps illustrated in FIG. 10 is not intended to limit the order of the steps in any way.

[0162] In the example illustrated in FIG. 10 , in step 1040, a locator assembly is positioned within the heart. The locator assembly may include a plurality of electrodes that receive electrical signals from the heart. The locator assembly may be positioned within the heart using any suitable method known in the art, including those described herein. In some examples, the locator assembly may be positioned within the patient's coronary sinus. However, other locator assembly designs may be utilized with the methods described herein. The locator assembly may include an expandable stent configured to be inserted into the heart.

[0163] In step 1042, a first signal array is generated from the electrical signals recorded by the locator assembly to determine the actual location of the arrhythmogenic focus. The locator assembly may use multiple electrodes arranged in a bipolar relationship to receive the electrical signals. The electrical signals recorded by the multiple electrodes may include atrial electrical activation signals. As used herein, arrhythmogenic focus may also include any focal location within the human body associated with the development of atrial fibrillation.

[0164] In step 1044, the heart is artificially stimulated based on the actual locations determined by the first signal array to generate a second signal array. The heart can be artificially stimulated by any suitable device known in the art. The second signal array can include electrical activation sequences taken at predicted foci during a clinical phase of the patient's atrial fibrillation and recorded by a locator assembly.

[0165] In step 1046, the second signal array is superimposed on the first signal array. The superimposition of the signal array data can be completed in the same and / or similar manner as the embodiment illustrated in Figures 8-9. In some embodiments, the superimposing step can be displayed on a graphical user interface (GUI) on an external device.

[0166] The superimposed signal arrays are compared in step 1048. If the signal arrays match, the method proceeds to step 1050. If the signal arrays do not match, the method resumes at step 1040.

[0167] In step 1050, the actual location of the arrhythmogenic focus is confirmed, completing the method for determining the location of arrhythmogenic focus in or near the heart.

[0168] FIG. 11 is a flowchart outlining one embodiment of a method for determining the location of an arrhythmogenic focus within a heart. It will be understood that a method according to the disclosure herein can include more or fewer steps than those shown and described in connection with FIG. 11. The method can omit one or more steps illustrated in FIG. 11. The method can add additional steps not shown and described in FIG. 11 and still be within the scope of the present invention. Furthermore, the order of the steps can vary from the order shown and described in connection with FIG. 11. The order of the steps illustrated in FIG. 11 is not intended to limit the order of the steps in any way.

[0169] 11 , a locator assembly is positioned within the heart in step 1152. The locator assembly may include multiple electrodes that receive electrical signals from the heart. However, other designs of locator assemblies may be used with the methods described herein.

[0170] In step 1154, a first signal array is generated from the electrical signals received by the locator assembly to determine the actual location of the arrhythmogenic foci.

[0171] In step 1156, the heart is artificially stimulated based on the actual location determined by the first signal array to generate a second signal array. The heart can be artificially stimulated by any suitable device known in the art.

[0172] In step 1158, the second signal array is superimposed on the first signal array. The superimposition of signal data can be the same and / or similar to the embodiment illustrated in Figures 8-9. In some embodiments, the superimposing step can be displayed on a graphical user interface (GUI) on an external device.

[0173] The superimposed signal arrays are compared in step 1160. If the signal arrays match, the method proceeds to step 1162. If the signal arrays do not match, the method resumes at step 1156.

[0174] In step 1162, the actual location of the arrhythmogenic focus is confirmed, completing the method for determining the location of arrhythmogenic focus in or near the heart.

[0175] FIG. 12 is a flowchart outlining one embodiment of a method for determining the location of an arrhythmogenic focus within a heart. It will be understood that a method according to the disclosure herein may include more or fewer steps than those shown and described in connection with FIG. 12. The method may omit one or more steps illustrated in FIG. 12. The method may add additional steps not shown and described in FIG. 12 and still be within the scope of the present invention. Furthermore, the order of the steps may vary from the order shown and described in connection with FIG. 12. The order of the steps illustrated in FIG. 12 is not intended to limit the order of the steps in any way.

[0176] 12, a locator assembly is positioned within the heart in step 1264. The locator assembly may include multiple electrodes that receive electrical signals from the heart. However, other designs of locator assemblies may be used with the methods described herein.

[0177] In step 1266, a first signal array is generated from the electrical signals received by the locator assembly.

[0178] In step 1268, the actual location of the arrhythmogenic focus is determined.

[0179] In step 1270, the heart is artificially stimulated based on the actual location determined by the first signal array to generate a second signal array. The heart can be artificially stimulated by any suitable device known in the art.

[0180] In step 1272, at least one of the first signal array and the second signal array is processed by a processor.

[0181] In step 1274, the first signal array and the second signal array are superimposed.

[0182] The superimposed signal array is displayed on a graphical user interface in step 1276. The superimposition of signal data can be the same and / or similar to the embodiment illustrated in Figures 8-9.

[0183] In step 1278, the actual location of the arrhythmogenic focus is confirmed using the superimposed signal array.

[0184] The present technology provides systems, devices, and methods for determining the location of arrhythmogenic foci. The locator assembly can utilize protective materials, such as inner and outer layers, and can be equipped with drug elution. The eluted drug is released over time to prevent prothrombotic and inflammatory potential by the expanded locator assembly in its final position. In addition, the present technology provides a secure enclosure between the inner and outer layers to host the various elements that make up the locator assembly (integrated circuits, routing layer, battery, antenna).

[0185] The systems, devices, and methods provided herein address several potential problems with the performance, reliability, and proper use of deliverable locator assemblies, particularly locator assemblies that utilize multiple bipolar electrodes to determine the location of atrial fibrillation focal points. Specific problems solved by the systems, devices, and methods disclosed herein include: 1) The technology disclosed herein improves deliverable locator technology to enable mapping of sudden onset disease phases of clinical atrial fibrillation during a patient's daily life; 2) The techniques disclosed herein improve the accuracy of determining the location of the focal point of atrial fibrillation; 3) The techniques disclosed herein reduce the time required to determine the location of the focal point of atrial fibrillation; 4) the technology disclosed herein provides recharging capabilities for the locator assembly while implanted within a patient; 5) The techniques disclosed herein reduce the risk of thrombus formation and mural hemorrhage when the locator assembly is delivered and removed.

[0186] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content and / or context clearly dictate otherwise. It should also be noted that the term "or" is used in its sense throughout, including "and / or," unless the content and / or context clearly dictate otherwise.

[0187] It should also be noted that the phrase "configured" as used in this specification and the appended claims refers to a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured, and arranged.

[0188] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to provide organizational guidance. These headings should not be construed as limiting or characterizing the invention(s) set forth in any claims that may issue from this disclosure. As an example, a description of a technology in the "Background" section is not an admission that the technology is prior art to any invention(s) in this disclosure. Nor is a "Summary" or "Abstract" admitted as characterizing the invention(s) set forth in the issued claims.

[0189] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise form disclosed in the detailed description provided herein. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. Accordingly, aspects have been described with reference to various specific preferred embodiments and techniques. However, it will be understood that many variations and modifications may be made while remaining within the spirit and scope of the description.

[0190] Although several different embodiments of systems, devices, and methods for determining the location of arrhythmogenic foci have been illustrated and described herein, one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, provided that such combinations fulfill the intent of the invention.

[0191] While several exemplary aspects and embodiments of systems, devices, and methods for determining the location of arrhythmogenic foci have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims hereafter issued are intended to be construed to include all such modifications, permutations, additions, and subcombinations that are within the true spirit and scope of the claims, and no limitations are intended to the details of construction or design herein shown.

Claims

1. 1. A locator assembly for determining the location of an arrhythmogenic focus in or near a heart, said locator assembly having a longitudinal axis and a periphery; an outer layer configured to be deployed within the heart of a patient; a plurality of components bondable to the outer layer; a plurality of electrodes coupleable to the plurality of components and the outer layer, the plurality of electrodes configured to receive electrical signals from the heart and determine the location of the arrhythmogenic focus; an internal layer connectable to the plurality of components, the internal layer and the external layer configured to cooperate to protect the plurality of components, the internal layer and the plurality of components being detachable from the external layer and the heart, respectively; A locator assembly containing:

2. 10. The locator assembly of claim 1, wherein at least one of the inner layer and the outer layer includes an eluting agent configured to counteract prothrombotic and inflammatory potential of the locator assembly.

3. The locator assembly of claim 1 , wherein the plurality of components includes a communicator configured to enable communication between the locator assembly and an external device.

4. A locator assembly as described in claim 1, wherein the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

5. The locator assembly of claim 1 , wherein the plurality of components further includes a routing layer interconnecting the plurality of electrodes, the routing layer being stretchable.

6. A locator assembly as described in claim 1, wherein the plurality of electrodes includes at least 12 electrodes.

7. A locator assembly as described in claim 1, wherein the outer layer is configured to be permanently positioned within the heart of the patient.

8. A locator assembly as described in claim 1, wherein the plurality of components includes a controller that controls other components of the plurality of components.

9. A locator assembly as described in claim 1, wherein at least one of the inner layer and the outer layer is configured to electrically communicate with the plurality of electrodes and the heart.

10. A locator assembly as described in claim 1, wherein at least one of the inner layer and the outer layer is at least partially formed from a conductive material.

11. 1. A locator assembly for determining the location of an arrhythmogenic focus in or near a heart, said locator assembly having a longitudinal axis and a periphery; an outer layer configured to be deployed within the heart of a patient; a plurality of components bondable to the outer layer; a plurality of electrodes coupleable to each of the plurality of components and the outer layer, the plurality of electrodes configured to receive electrical signals from the heart and determine the location of the arrhythmogenic focus; an internal layer connectable to the plurality of components, the internal layer and the plurality of components being detachable from the external layer and the heart, respectively; A locator assembly containing:

12. 12. The locator assembly of claim 11, wherein at least one of the inner layer and the outer layer includes an eluting agent configured to counteract prothrombotic and inflammatory potential of the locator assembly.

13. The locator assembly of claim 11 , wherein the plurality of components includes a communicator configured to enable communication between the locator assembly and an external device.

14. The locator assembly of claim 11, wherein the plurality of electrodes includes a plurality of anodes and cathodes forming a plurality of bipoles.

15. A locator assembly as described in claim 11, wherein the plurality of electrodes includes at least 12 electrodes.

16. A locator assembly as described in claim 11, wherein the outer layer is configured to be permanently positioned within the heart of the patient.

17. The locator assembly of claim 11, wherein the plurality of components includes a controller that controls other components of the plurality of components.

18. A locator assembly as described in claim 11, wherein at least one of the inner layer and the outer layer is configured to electrically communicate with the plurality of electrodes and the heart.

19. A locator assembly as described in claim 11, wherein at least one of the inner layer and the outer layer is at least partially formed from a conductive material.

20. 1. A locator assembly for determining the location of an arrhythmogenic focus in or near a heart, said locator assembly having a longitudinal axis and a periphery; an outer layer configured to be deployed within the heart of a patient, the outer layer configured to be permanently positioned within the heart of the patient; a plurality of components coupleable to the outer layer, the plurality of components including at least a plurality of electrodes configured to receive electrical signals from the heart and determine the location of the arrhythmogenic focus, the plurality of electrodes including a plurality of anodes and cathodes forming a plurality of bipoles, the plurality of components including a routing layer interconnecting the plurality of electrodes, the routing layer being stretchable; an internal layer coupled to the plurality of components, the internal layer and the external layer configured to cooperate to protect the plurality of components, the internal layer and the plurality of components being removable from the external layer and the heart, respectively; A locator assembly containing:

Images