An advanced implantable, intravascular, low-profile, intracardiac left atrial restraint device for low-energy atrial defibrillation, pacing, and sensing

Abstract

Various configurations of electrodes and wires with associated extensions are disclosed that are configured to be attached at or near the left atrium of the heart to allow the device to be held tight against the endocardium and out of the bloodstream for low energy defibrillation of the atrium in response to atrial fibrillation and other atrial arrhythmias. The portion of the lead that is inside the atrium (e.g., the left atrium) is restrained against the endocardium of the left atrium by a restraining mechanism. In one example, the electrode is configured to be attached to the atrial septum and the wire includes a shape memory metal that holds the wire against the heart wall. In yet another example, the electrode is configured to be part of a mitral valve device.

Description

[Background technology]

[0001] Related Applications This application claims priority to a co-pending U.S. provisional patent application having Serial No. 63 / 312,773, filed February 22, 2022, the contents of which are incorporated herein by reference in their entirety.

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

[0003] However, wires are not traditionally placed on the left side of the heart due to the risk of dislodging a blood clot that has collected on the wire floating freely within the heart. If the wire is on the right side of the heart and a blood clot develops and dislodges, the blood clot can only travel to the lungs, where endogenous enzymes can be used to break down the clot or clot. However, if the wire is on the left side of the heart and a blood clot develops and dislodges, the clot can travel into the aorta and reach the brain. Because the brain does not have the natural mechanism to dissolve blood clots, a potentially devastating stroke can occur.

[0004] Defibrillation of the human heart has saved many lives. Initially only external (through the skin), defibrillators are now placed internally (intravascular, intracardiac, or extracardiac) to urgently defibrillate the heart to stop dangerous arrhythmias. Current defibrillators require a relatively high amount of energy (measured in joules) to defibrillate the heart. These shocks are painful for the patient and cause incredible anxiety. The energy used quickly depletes batteries, requiring replacement. Generators and batteries are expensive to replace (they are built into the generator) and there is a risk of infection associated with replacing the generator and battery. Infection can be fatal in some cases and represents a significant cost to the healthcare system.

[0005] Atrial fibrillation (AF), the most common human cardiac arrhythmia, causes significant morbidity, mortality, and cost. Currently, AF is present only in the atrial chambers of the heart, but defibrillation leads to the heart generally do not include leads placed in the left atrium (LA), so the entire heart is defibrillated in the event of AF. Thus, it is difficult to sense the LA for arrhythmia occurrences and difficult to selectively defibrillate the LA. Thus, defibrillation of the whole heart is generally required to defibrillate the heart in response to AF. Summary of the Invention

[0006] The embodiments described herein relate to various configurations of low profile electrodes and associated structures configured to hold the electrodes and wires against the endocardium (eliminating free-floating wires) and to be attached at or near the left atrium of the heart to enable low energy recording, sensing, pacing, and / or defibrillation of both atria in response to atrial fibrillation and other atrial arrhythmias. The electrodes are attached to the atrial septum in a location suitable for easy and safe deployment while maintaining a low profile arrangement. This attachment also allows for repeated crossing of the atrial septum at a later date for additional ablation procedures or placement of additional closure or valve devices. The novel devices can be fitted with radiopaque markers to facilitate later crossing of the atrial septum.

[0007] These electrodes and associated structures can be used to sense and map normal and abnormal electrical impulses in addition to defibrillating the upper chambers of the heart. The device can also be used in combination with leads implanted in the right atrium, right ventricle, coronary sinus, leads attached to other devices in the atrium, and leads outside the heart. In one embodiment, the electrodes are configured to attach to the atrial septum and have a wire attachment that holds the wire against the heart tissue. In another embodiment, the electrode configuration is attached to a modified atrial septum closure device, which may be an atrial septum opening device, and also has a special attachment that holds the wire securely against the heart wall. In another embodiment, the electrodes are configured to be part of an atrial appendage closure device and also have a special attachment that prevents the wire from floating freely either inside (endocardial surface) or outside (epicardial surface) of the heart. In yet another embodiment, the electrodes are configured to be part of a mitral valve device or can be incorporated into any valve repair or replacement device, whether placed by traditional open-heart surgery or by endovascular techniques.

[0008] An advantageous feature is that these embodiments allow the electrodes and wires to be held firmly against the heart tissue, avoiding thrombus formation on the electrodes and wires, as with commercially available mitral valve devices. And the described devices allow sensing, pacing and / or defibrillation of the left side of the heart, which has not been addressed clinically before. For example, these devices can be used to directly pace the left atrium. Traditionally, only the right atrium can be accessed for pacing. In many patients, pacing of the right atrium is not always synchronized with the left atrium due to intrinsic conduction problems and atrial enlargement. With new devices in the atrial septum, in the left atrium or near the left atrium, both atria can be paced in clinical practice. This allows for synchronized bi-atrial pacing, improving the effectiveness of atrial pacing and improving cardiac output and ejection fraction in some patients.

[0009] For a detailed description of the various examples, reference is made to the accompanying drawings. [Brief description of the drawings]

[0010] [Figure 1] 1 shows the septal electrode attached to the atrial septum and its extension holding the wire against the heart tissue. [Figure 2A] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2B] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2C] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2D] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2E] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2F] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2G] 1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2H]1 illustrates a sequence of steps for attaching a septal electrode during a surgical procedure. [Figure 2I] 1A-1C are diagrams of exemplary alternative embodiments of electrical electrodes that may be used in combination with a septal electrode and the sub-process for their implantation. [Figure 2J] 1A-1C are diagrams of exemplary alternative embodiments of electrical electrodes that may be used in combination with a septal electrode and the sub-process for their implantation. [Figure 2K] 1A-1C are diagrams of exemplary alternative embodiments of electrical electrodes that may be used in combination with a septal electrode and the sub-process for their implantation. [Figure 2L] 1A-1C are diagrams of exemplary alternative embodiments of electrical electrodes that may be used in combination with a septal electrode and the sub-process for their implantation. [Figure 2M] 1A-1C are diagrams of exemplary alternative embodiments of electrical electrodes that may be used in combination with a septal electrode and the sub-process for their implantation. [Figure 2N] 1 is an embodiment of an exemplary leadless pacemaker attached to an exemplary septal electrode having electrical contacts extending therefrom. [Figure 2O] 1 is an embodiment of an exemplary leadless pacemaker attached to an exemplary septal electrode having electrical contacts extending therefrom. [Figure 3A] 1 shows a close-up view of an example of a septal electrode that includes protrusions that help hold the septal electrode in place against the septum. [Figure 3B] 13 shows another example of a septal electrode extended further into the left atrium, also with the wire and electrode flush against the endocardium. [Figure 3C] 13 shows yet another example of a septal electrode having deployable wings that are held in place against the atrial wall by a device. [Figure 3D] 1 shows an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3E] 1 shows an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3F] 1 shows an exemplary septal electrode with an extension electrode extending therefrom and supported by a sleeve. [Figure 3G] 1A-1C are diagrams of an embodiment of a septal electrode including a central post having portions extending therethrough. [Figure 4A] An example of an implantable medical device is shown having a septal electrode on one lead and another electrode on a second lead to the right ventricle. [Figure 4B] An example of an implantable medical device is shown having a septal electrode on one lead and two additional leads fixed to the right atrium and right ventricle. [Diagram 5] 13 shows another embodiment in which the electrodes are part of an atrial appendage closure device, which is external to the atrial appendage and holds the wires of the device firmly against the atrial wall. [Figure 6A] 6 illustrates a medical procedure for implanting the closure device and associated electrodes of FIG. 5. [Figure 6B] 6 illustrates a medical procedure for implanting the closure device and associated electrodes of FIG. 5. [Figure 6C] 6 illustrates a medical procedure for implanting the closure device and associated electrodes of FIG. 5. [Figure 6D] 6 illustrates a medical procedure for implanting the closure device and associated electrodes of FIG. 5. [Figure 7] 6 shows an enlarged view of an example of an electrode configured to be coupled to the atrial appendage closure device of FIG. 5. [Figure 8A] 13 shows another embodiment in which the electrodes are part of the atrial appendage closure device, where the closure device is inside the atrial appendage. [Figure 8B] 13 shows another embodiment in which the electrodes are part of the atrial appendage closure device, where the closure device is inside the atrial appendage. [Figure 8C] 13 shows another embodiment in which the electrodes are part of the atrial appendage closure device, where the closure device is inside the atrial appendage. [Figure 8D] 13 shows another embodiment in which the electrodes are part of the atrial appendage closure device, where the closure device is inside the atrial appendage. [Figure 8E] FIG. 13 is a diagram of an exemplary embodiment of another embodiment of extension electrodes integrated with respective grids connected (electrically and physically) to the septal electrode. [Figure 8F] 13A-13C are diagrams of alternative embodiments of the septal electrode configured as a pair of springs forming the septal electrode. [Figure 9] 13 shows an embodiment in which the electrode is part of a mitral valve device with wires connected to electrodes on the mitral valve annulus, attached to the atrial septum, and connected to electrodes implanted in the septum. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Described herein are low profile restraining devices that overcome the problem of current intracardiac leads that are typically free to float within the interior volume of the corresponding heart chamber. The described embodiment includes a mechanism that keeps a portion of the lead fixed against the endocardium of the left atrium, resulting in the electrode and lead being embedded against the wall of the heart. Thus, using the described low profile devices on the left side of the heart avoids thrombus. Placing the leads on the left side of the heart with these devices facilitates new therapies for the treatment of cardiac disease. The restraining mechanisms described herein can be extended to the other ventricles of the heart. The device allows for repeated crossing of the septum. In fact, the use of radiopaque markers on the septal portion of the device makes repeated crossing of the septum faster and safer.

[0012] Beneficially, the described examples are directed to a lead connected to the left atrium. In the case of atrial arrhythmias (arrhythmias in the upper chambers of the heart), the left atrial lead is a better way to sense AF and selectively defibrillate the upper chambers. Much lower energy (1-10 Joules) can be used compared to defibrillation of the whole heart. Thus, the patient experiences much less discomfort and battery life is increased. The LA lead can also provide a record of where the AF is starting, potentially guiding further treatment to eliminate the focus. The left atrial lead needs to be carefully designed to avoid thrombus and embolism. The embodiments described herein relate to a device that is placed entirely by a percutaneous route. The device is low profile, will be placed flat against the endocardial wall and will be firmly embedded in the tissue. The low profile of the device avoids or reduces the risk of thrombus formation. The described device provides a solution to sense and treat AF and other supraventricular arrhythmias with lower power and less painful or painless shocks for the patient.

[0013] The embodiments described herein relate to implantable devices connected to wires comprising Nitinol, other types of shape memory metals or plastics, or other metals or metal alloys, or combinations thereof, which create a constant grip on the septum and a twist that holds the wire against the wall of the heart and prevents it from floating freely. These devices can be placed in or around the left atrium of the heart, as well as on the right side of the heart. The restraining device applies a passive force to the tissue by a curved wire that is bent into a loop to provide the appropriate amount of twist. The device can have protuberances to hold the device in place until the tissue heals and to prevent slippage. The electrode portion of the device can be coated with a material such as gold to enhance electrical conductivity. The curved wire incorporates a conductor extension, which is also coated with a material that improves conductivity (such as gold plating) to increase the surface area of ​​the device. Advantageously, the extension will contact the heart tissue due to the twist of the wire. The device also incorporates an insulated wire(s) that fits tightly against the heart wall. The insulated portion of the device has an outer Nitinol or other form of metal or plastic or other metal or composite material that keeps the wires from entering the bloodstream. As with other devices in the heart adjacent to the endocardial surface, this device and its extensions become embedded in the atrial tissue and keep them from entering the bloodstream through the heart.

[0014] The device then exits the heart and connects to a pacemaker, defibrillator, transducer, or combination thereof, similar to commercially available devices. This allows the device to send and receive electrical charges from a remote location, such as a transducer or pacemaker. Transducer and pacemaker devices are available from several manufacturers, including Medtronic and St. Jude Medical. The device sits flat against the atrial septal wall and is firmly embedded in the tissue. This low profile allows the device to be placed on the left side of the heart to prevent clot formation. In clinical practice, devices with extensions can also be used on the right side of the heart. This device has excellent electrical contact. The restraining device is passively held against the atrial septum. The unique properties of the restraining device, its low profile and easy attachment to the atrial septum, provide a safe path of deployment. The extensions and wires are constructed of shape memory metal or other materials that hold the extensions and wires against the endocardium, allowing the device to be deployed on the left side of the heart.

[0015] Currently, transseptal puncture is common in electrophysiology (EP) studies. Wires for placing devices such as transseptal sheaths, guidewires, and obturators are already ideally positioned during the transseptal puncture utilized to enter the left atrium. Typically, these EP studies are aimed at treating AF, including mapping, ablation, and closure of the left atrial appendage, so placing a restraining device during an EP procedure is straightforward. Conventional methods for achieving good electrical contact within the heart include screws, barbs, hooks, pins, and electrode plates. All of these can be incorporated into the distal restraining device, extensions, and special wires to help hold the device against the heart wall. This also ensures good electrical contact. The device can incorporate coatings such as steroids to prevent fibrosis, low contact, or high energy. The device can include a bioabsorbable component such that the remaining restraining portion of the device resorbs after the electrode is implanted in tissue. The device may include an anti-thrombogenic coating to help prevent thrombus formation until the device is surrounded by tissue ingrowth. The device is carefully designed to be low profile, yet strong enough in the deployed position to provide complete stability to the atrial septum. The septal restraining device may include materials that make certain portions of the device radiopaque to guide access for subsequent transseptal punctures, potentially making future transseptal punctures faster, easier, and safer.

[0016] The restraining device can be incorporated into any other device placed in or around the left or right atrium. The restraining device can be modified to work with any device placed in or around the right or left atrium, including but not limited to atrial septal closure devices, left atrial closure devices (both intracardiac and extracardiac), and valve repair or replacement devices. In the case of septal closure devices, the restraining device is modified to be incorporated into the ring of the septal closure device. Some possible iterations include three electrode conducting rings around the area of ​​the septal device that contacts the endocardium of the septum. The exact configuration of the wire array can be changed depending on the device configuration, the surface area contacted, and the resistance created. In the case of mitral valve replacement, the restraining device can be modified to fit into the groove where the valve device contacts the atrial tissue. The wire electrodes of the device can be circular, cross-hatched, or other configurations to provide a therapeutically sufficient electrical output at the lowest energy with an appropriate resistance profile.

[0017] The restraining device can be delivered with the valve or separately. The distal end of the lead can be attached, for example, to the atrial septum, in or around the left atrial appendage, or in a mitral valve device. This allows for low-energy defibrillation of the atria in response to atrial fibrillation or other atrial arrhythmias. The device can also be used to sense electrical activity on the endocardial surface. This information can be recorded and stored to identify the earliest and other sites of atrial arrhythmia. This information can direct treatment with the device, termination of the arrhythmia by pacing or other electrical stimulation via the device, and / or subsequent treatment by ablation during the EP procedure.

[0018] They can be used in combination with other leads and wires in either the atria of the heart, or the left atrium and right ventricle, or the left ventricle or coronary sinus, to defibrillate the atria. They can also be used in combination with electrodes that are outside the heart, such as epicardial leads and electrodes. Leads placed within the atria facilitate defibrillation using relatively low energy (1-10 Joules, J) waveforms delivered in a variety of ways, ensuring defibrillation or pacing of the atria.

[0019] The lead and associated extensions and wires can be inserted into the patient through a blood vessel in the groin, neck, or other locations. The distal region of the lead has an electrode and is placed in or around the left atrium (e.g., in or around the atrial septum, the left atrial appendage, or in a mitral valve device). The wire configuration keeps the wire in close contact with the heart wall. The proximal end of the wire can be connected to a miniature defibrillator unit or transducer placed subcutaneously in the patient. Such pacemakers and defibrillators can sense, pace, and defibrillate. The novel placement of this device allows selective defibrillation of the atrium, the upper chamber of the heart, allowing for very low energy defibrillation. This device also allows for direct sensing in the left atrium, which may be used to detect the origin of arrhythmias, and may be used to selectively pace the left atrium in various configurations. If a transducer is used, power can be transferred percutaneously from an external device to the transducer.

[0020] In one embodiment, as described above, a restraining device is used to hold the left atrial wire in place against the atrial septum. The restraining device is a passive mechanical device that allows atrial defibrillation of both atria. Two devices are shown in Figures 1-4B. One is a device with a spring effect that provides enough restraining force to hold the wire in place against the septum without damaging the septum. This device can have protrusions to help hold the device in place until healing and prevent slippage. This device can have extensions to provide additional surface area for optimal sensing, pacing and defibrillation. The extensions include shape memory metals or other similar materials that provide a twist that keeps the extensions in contact with the walls of the heart and out of the flow of blood through the heart. The second device is an array that attaches to or replaces an atrial septal defect closure device. Both can be placed in the patient's body at the end of a medical procedure, such as a catheter ablation procedure to treat atrial fibrillation, or as a stand-alone procedure. A combined inguinal and subclavian approach (left subclavian approach shown) allows wires placed from the groin to be brought into subcutaneous position in the subclavian region for subsequent placement of the defibrillator.

[0021] FIG. 1 shows lead placement with one cardiac atrial lead 101 (similar to an atrial lead in a dual chamber pacing configuration) placed in the right atrium. Part of this embodiment is the placement of a second cardiac atrial lead 103 (device) in the left atrium, which allows for specific atrial sensing, pacing and / or defibrillation with a very small amount of energy (approximately 1-10 Joules). The distal end of the left atrial lead 103 includes a shape memory structure or other solid or composite material configured to hold a portion of the lead 103 against the human endocardium. The shape memory structure in this example is configured to be restrained on the opposite side of the atrial septum.

[0022] 1 also shows an electronics housing 110 that includes a sealed housing that houses a battery and circuitry. In one example, the circuitry can generate stimulation energy to electrodes at distal regions of the lead(s) 101, 103 for pacing and / or defibrillation. The circuitry can additionally or alternatively sense and record electrical activity from the electrode(s). The electronics housing device 110 may be a pacemaker, a defibrillator, a device that both paces and defibrillates, and / or a sensing or recording device.

[0023] 2A-2H show a step-by-step procedure for attaching a lead to the heart. FIG. 2A shows an initial transseptal puncture with a modified Seldinger technique. A guidewire 201 is inserted, for example via the groin, through an obturator 202 into the left atrium. FIG. 2B shows the placement of a transseptal sheath 203 through a transseptal puncture site 205 in the atrial septum 250. FIG. 2C shows the obturator 202 is removed, the transseptal sheath 203 remains in place, and the anchor delivery sheath 206 is delivered first. The guidewire 201 is removed. FIG. 2D shows the septal electrode 230 (carrier or assembly) at the end of the lead 103 exposed in the left atrium. The obturator 202 is removed. FIG. 2E shows the anchor delivery sheath 206 being retracted, thereby exposing the septal electrode 230. The septal electrode 230 comprises a flexible elongated electrode. As can be seen, the distal region of the septal electrode 230 has a natural angled bend (approximately a right angle bend) thereto, as shown.

[0024] FIG. 2F shows anchor delivery sheath 206 being further retracted, exposing septal electrode 230 against the atrial septum. Septal electrode 230 may comprise gold, nitinol, or other suitable (e.g., inert and biocompatible) metal to transmit electricity to the heart. Septal electrode 230 maintains pressure against the atrial septum upon deployment. Septal electrode 230 maintains slight pressure on the septum to prevent device migration after deployment. As seen in the example of FIG. 3A, septal electrode 230 allows current to flow from the electronics housing to septum 250 (and beyond).

[0025] 2G shows the septal electrode 230 fully deployed against the atrial septum 250. Next, a snare device 208 is shown that can move the distal region of the lead from its insertion site (e.g., groin) to the subclavian region or other chest location where the electronics housing is located. The portion 232 of the septal electrode 230 in the right atrium, which is on the opposite side of the septum 250 from the portion of the septal electrode 230 in the left atrium, is bent upward as shown using the snare device 208, thereby forming a U-shaped structure as shown. The mechanical properties of the device (e.g., shape memory structure) cause the wire to adhere closely to the endocardial surface. The septal electrode 230 may have configurations other than a U-shaped dip that perform the same or similar functions as a U-shaped dip.

[0026] In other examples, the portion of the electrode pressed against the atrial septum in the left atrium may be longer than that shown in FIG. 2G, and additional arrays may be attached to the lead anchor 207 to increase the surface area along the atrial septum 250 and / or left atrium 235. For example, FIG. 2H shows an extension 245L of the septal electrode 230 to increase the surface area for defibrillation of the left atrium 235. Again, a coating of shape memory metal (e.g., Nitinol) holds the extension firmly to the atrial wall. The electrode 230 may be coated with a material such as gold to increase its electrical conductivity. The curved wire may be made of Nitinol or other shape memory material that can be straightened for implantation in the patient through a sheath, and the curved shape may be formed inside the patient. The shape memory metal wire assembly may have a shape memory metal or similar material on the outer coating of the wire, as part of the wire with insulation covering the wire, or any combination of steroid, heparin coating, or drug eluting coating. The device lies relatively flat against the atrial wall (i.e., in continuous contact with the atrial wall, such as the atrial septal wall) and ultimately embeds strongly into the cardiac tissue. This low profile discourages thrombus formation. The device has excellent electrical contact. The restraining device is passively held against the atrial septum. A low profile and easily attached restraining device to the atrial septum provides a safe route of deployment.

[0027] 2F also shows both leads 101 and 103 exiting from the left subclavian region or other location in the chest. An electrode 251 is shown at the distal end of lead 101, which is anchored within the right atrium 237.

[0028] 2I-2M show exemplary alternative embodiments of electrical contacts that may be used in combination with the septal electrode 230. FIG. 2I shows the septal electrode 230 having extension electrodes 245R and 245L (collectively 245) extending from the septal electrode 230 to the right atrium 235 and left atrium 237, respectively, and configured to maintain contact with the endocardium (i.e., inner wall) of the left atrium 235 and right atrium 237, respectively. The extension electrodes 245 may have reflectively identical shapes. Alternatively, the extension electrodes 245 may have different shapes. However, in both cases, the exposed metal of the extension electrodes 245 may have a curved shape and be formed of a shape memory material to passively maintain contact with the walls of the left atrium 235 and right atrium 237, respectively, thereby allowing the extension electrodes 245 to be pressed against the walls of the left atrium 235 and right atrium 237, respectively. As previously mentioned, the extension electrodes 245 may be electrically connected to or extend from the septal electrode 230. The extension electrodes 245 may have the same or different lengths, and the lengths may be set based on the appropriate amount of resistance and current transfer. Such lengths may be predetermined or may be established during attachment if the septal electrode 230 is configured to allow the length of the extension electrodes 245 to be adjusted before or during implantation. The operator may be allowed to change the length of the extension electrodes 245. By allowing the extension electrodes 245 to be connected to or detachable / reattachable from the septal electrode 230, i.e., the septal electrode 230 may be slidable to the septal electrode 230, in alternative embodiments, devices including septal electrodes 230 with extension electrodes 245 of different lengths may be available. Alternatively, the operator may cut the extension electrode(s) 245 depending on the desired size and performance (e.g., a shorter extension electrode 245 may be suitable for a smaller heart). In one embodiment, the lead 103 can extend through an extension electrode 245 on the distal side of the lead and opposite the side where the lead 103 connects to the septal electrode 230 to form an extension electrode 245, as further shown and described herein.

[0029] With reference to Figures 2I-A, in one embodiment, one or both of the extension electrodes 245 may include hooks, serrations, barbs, needles, or other shaped protrusions 246a-246n (collectively 246) that may be used to help maintain contact between the extension electrodes 245 and the walls of the left atrium 235 and right atrium 237.

[0030] With reference to FIG. 2I-B, in one embodiment, rather than an extended electrode (e.g., conductive metal), such as electrode 245L, being completely exposed, the electrode may be partially exposed and partially insulated. For example, insulation 247 may extend to the other side of the wall and exposed electrode may be on the side of the wall, such that exposed electrode 245L may press against and extend along the endocardium of the wall. Insulation 247 may be, for example, an impregnated polymer that inhibits clot formation. Maintaining insulation on the other side of the wall may result in a reduced risk of clot formation on the extended electrode 245. As previously mentioned, a coating that reduces the risk of clotting may be applied to the insulation to avoid clot formation on the electrode or wire. Also, the extended length of exposed electrode in contact with the endocardium may provide lower energy and / or different signals to the heart for pacing or other therapy, thereby allowing the patient to administer therapy themselves without the risks of traditional therapy that typically requires the patient to be in a medical facility.

[0031] With reference to FIG. 2J, a view of an alternative configuration of extension electrodes is shown including a plurality of extension electrodes 245L1-245L3 (collectively 245L) disposed in the left atrium 235 and extension electrodes 245R1-245R3 (collectively 245R) disposed in the right atrium 237. In this embodiment, there are three extension electrodes 245L and three extension electrodes 245R in each of the left atrium 235 and right atrium 237. However, it should be understood that an alternative number of extension electrodes, such as two or more extension electrodes, may be disposed in each of the left atrium 235 and right atrium 237. Additionally, it should be understood that a different number of extension electrodes may be disposed in each of the left atrium 235 and right atrium 237. Similar to the extension electrode 245 of FIG. 2I, the extension electrodes 245L and 245R may be electrically connected or otherwise extend from the septal electrode 230. The thickness and configuration of the extension electrodes 245L and 245R may be such that the collection electrodes 245L and 245R are deployable through a transseptal sheath, for example as previously shown with respect to FIG. 2C. The extension electrodes 245 may be part of a lead (e.g., lead 103) or may be separate from the lead. The length of each extension electrode 245 may vary depending on the patient, the treatment, and the use of the extension electrodes 245.

[0032] The extension electrodes 245L and 245R may have the same or similar physical characteristics (e.g., gold, nitinol, an inert and biocompatible metal, preformed shape, etc.) as described above with respect to the extension electrode 245 of FIG. 2I. The extension electrodes 245L and 245R may further have optional connection features 248a and 248b (collectively 248) between adjacent electrodes (e.g., 245R1-245R2, 245R2-245R3) such that the spacing between adjacent electrodes is maximized. Although not shown, the extension electrode 245L in the left atrium 235 may also have connection features the same or similar to the connection feature 248. In one embodiment, the connection features 248 may be electrically conductive or non-conductive and may be formed of the same or similar material as the extension electrode 245. Additionally, the connection features 248 can be shaped to help maintain the extension electrodes 245L and 245R against the walls of the left atrium 235 and right atrium 237. It should be understood that the configuration can be leadless, as described further herein.

[0033] With reference to FIG. 2K, a diagram of an alternative exemplary embodiment of the extension electrode(s) is shown. In this embodiment, the extension electrode 249 is shown to be intramural (i.e., extending through and remaining within the wall 252L). Similar to the extension electrode 245L of FIG. 2I, the extension electrode 249 may be electrically connected to or extend from the septal electrode 230 held in the atrial septum 250. Both leads 101 and 103 are shown exiting the left subclavian region or other site in the chest. An electrode 251 is shown at the distal end of lead 101 and is secured to the right atrium 237. It should be understood that if an extension electrode such as the extension electrode 245R is placed within the right atrium 237 as shown in FIG. 2I, the lead 101 and electrode 251 may not be utilized.

[0034] In one embodiment, the extension electrode 249 is inserted into the wall 252L at the wall junction 252 between the left atrium 235 and the right atrium 237 because the wall junction 252j is slightly thicker than the wall 252L, which may be slightly safer than inserting directly into the wall 252L. In one embodiment, the extension electrode 249 extends through the epicardium of the wall 252L but may remain inside the pericardium of the wall, which may hold the extension electrode 249 against the epicardium to apply an electrical signal applied to the extension electrode 294 to the epicardium of the left atrium 235. In one embodiment, the extension electrode 249 may be completely non-insulated. Alternatively, insulation may extend along the extension electrode 249 to a distance approximately where the wall 252L extends from the wall junction 252j, thereby limiting the electrical signal to the left atrium 235. Alternative configurations of the extension electrode 249 and insulation thereon are possible.

[0035] 2L-1, 2L-2, and 2M, an exemplary sub-process for inserting an alternative configuration of the extension electrode 249a using the anchor delivery sheath 206 of FIG. 2E is shown. However, instead of entering through the middle portion of the septum 250, the extension electrode 249a may enter through a wall junction 252j at the top of the septum 250 from the right atrium 237, thereby simplifying the insertion process into the wall 252L of the left atrium 235. As shown in FIG. 2M, the extension electrode 249a may have a U-shaped curve 249u that forms a curved bend so that the extension electrode 249a extends along the wall of the right atrium 237. The U-shaped curve 249u may be preset such that the U-shaped curve 249u is automatically formed when the extension electrode 249a is released from the sheath. In one embodiment, many different techniques may be utilized to secure the extension electrode 249a to the wall of the left atrium 235, including a septal electrode that is curved or looks like a straight stud with a retention mechanism that secures it to the septum 250, a post, a suture, or any other mechanism that may help maintain the position of the extension electrode 249a. In another embodiment, the extension electrode 249 may include protrusions anywhere along its length or at the U-curve 249u that may prevent the extension electrode 249a from backing out of the wall 252L and wall junction 252j.

[0036] If the lead 101 extends to the device, other procedural processes as previously described may be utilized. In one embodiment, to support the U-shaped curve 249u and the curve of the extension electrode 249a extending through the wall 252L of the left atrium 235 and into the wall, those portions (i.e., the U-shaped curve 249u and the extension electrode 249a) may be formed of a material having shape memory, as previously described. The extension electrode 249a extends into the wall, and therefore, there is minimal or no possibility of clotting occurring within the left atrium 235, since the extension electrode 249a does not enter the left atrium 235. Furthermore, if the extension electrode 249a is fixed to the wall of the right atrium 237 without puncturing the septum 250, other procedural and surgical risks may be reduced.

[0037] 2L-2, another exemplary sub-process for inserting an alternative configuration of extension electrode 249b using anchor delivery sheath 206 of FIG. 2E is shown. In this process, rather than extending into the myocardium and being intramural, extension electrode 249b may extend through wall junction 252j along the epicardium of wall 252L. By extending through a thinner wall or wall junction 252j thicker than atrial septum 250, it is possible to reduce the risk of tearing or bleeding. Although only one extension electrode 249b is shown, it should be understood that multiple extension electrodes 249b may be utilized and extend along the epicardium of wall 252L. In one embodiment, a hemostatic agent or tissue adhesive may be used to seal the opening through which the extension electrode 249b extends to limit the possibility of bleeding from the right atrium through the hole created by the extension electrode 249b to the outside of the wall 252L. In one embodiment, a hemostatic agent may be placed or pre-applied on the extension electrode 249b such that the hemostatic agent is automatically applied upon insertion into the wall junction 252j, thereby limiting or preventing blood from flowing through the wall junction 252j on the outside of the wall 252L. Other mechanical, chemical, and / or biological techniques may be utilized to limit or prevent blood flow from the opening created by the extension electrode 249b.

[0038] 2N illustrates an exemplary leadless pacemaker 260 attached to an exemplary septal electrode 230 having electrical electrodes 245R and 245L (collectively 245) extending therefrom. In this embodiment, the leadless pacemaker 260 may be elongated and extend along the septal electrode 230 and may be in electrical contact with the septal electrode 230 such that an electrical signal generated by the leadless pacemaker 260 is transferred to the septal electrode 230 and extends the electrical signal along the extension electrode 245. It should be understood that if only the extension electrode 245L extends from the septal electrode 230, the electrical signal may extend into the left atrium 235 and along the endocardium of the wall of the left atrium 235. The septal electrode 230 and the leadless pacemaker 260 may be connected to each other in a variety of different ways, but should be physically connected in a manner that does not adversely affect the patient's heart or health. In one embodiment, the housing of the leadless pacemaker 260 may have the septal electrode 230 integrated together during manufacture (e.g., a monolithic single piece of material). Alternatively, the two elements 230 and 260 may be connected together using attachment elements, such as screws, bolts, clips, structural connecting elements, etc. Furthermore, the leadless pacemaker 260 does not need to have electrodes extending from the heart to the implantable device (e.g., a controller), and therefore does not require leads extending from the leadless pacemaker 260 or the septal electrode 230.

[0039] As further shown, there is a mobile device 262, such as a smartphone or other portable electronic device, and a controller 264, which may also be an electronic device attached to the mobile device 262 or capable of wirelessly communicating with the mobile device 262. Wireless communication channels 266, 268, and 270 may enable wireless communication between the leadless pacemaker 260 and the mobile device 262, between the leadless pacemaker 260 and the controller 264, and between the mobile device 262 and the controller 264. Data 272, 274, and 276 may be communicated via the respective communication channels 266, 268, and 270 between the respective devices configured to communicate via the communication channels 266, 268, and 270. The communication channels 266, 268, and 270 may be local communication channels using a local wireless communication protocol (e.g., Bluetooth, WiFi, or other). Each of the mobile device 262 and the controller 264 may include a processor, memory, and wireless communication devices to support the operation of the leadless pacemaker 260. The processors of the mobile device 262 and the controller 264 may be configured to process and transmit data and / or control signals between each other and to the leadless pacemaker 260.

[0040] During operation, the leadless pacemaker 260 may sense cardiac signals and / or motion (e.g., heart rate in either or both of the left atrium 235 and right atrium 237) via data signals 272 over communication channel 266 to the mobile device 262. The mobile device 262 may be configured to receive and display data (e.g., graphics, text, text and graphics) for a user of the mobile device 262. In one embodiment, a mobile app (not shown) may be configured to receive and process data signals communicated by the leadless pacemaker 260. The mobile app may further be configured for the mobile device 262 to communicate with the controller 264 over communication path 270 by sending data signals 276 that may cause the controller 264, running software on a processor, to send control signals to the leadless pacemaker 260, for example, to control the pacing of either or both of the left atrium 235 and right atrium 237, respectively. It should be understood that the same or similar configurations may be utilized for the left and right ventricles of the heart.

[0041] The leadless device can communicate wirelessly with a phone or other device that can deliver specific electrical energy in a specific configuration that can terminate abnormal atrial focal discharges with or without defibrillation. This leadless device can also be configured on the leadless device itself. Recording and storage of information from the atrial wall or other regions of the heart can be stored and analyzed on the device itself or the information can be transmitted to other devices that can analyze the information to guide further therapy.

[0042] Because the extension electrodes 245 are positioned within the respective left and right atria 235 and 237, the same or different pace or other signals may be applied as conventionally applied. In other words, because the extension electrodes 245 are maintained against the endocardium, a lower power signal (e.g., less than 1 Joule) may be applied by the leadless pacemaker to adequately pace the heart or provide other therapy. It should be understood that if a lead is used to connect to the septal electrode 230, a similar low amount of energy may be applied to the extension electrodes extending from the septal electrode 230 (see, e.g., FIG. 2I). It should be understood that the leadless pacemaker 260 may be configured with a sufficient energy source to operate for many years. Alternatively, sufficient wireless energy may be transferred from the controller 264 to the leadless pacemaker 260, for example, to enable the wireless pacemaker 260 to perform the required functions (e.g., applying a pacing signal).

[0043] Due to the low amount of power applied to the heart by the configuration of the extension electrode(s) 245, the patient may self-administer the therapy via the mobile device 262 and / or the controller 264. The software executed by the mobile device 262 allows the user to monitor their heart using a mobile app that may notify the user of any arrhythmias, for example. The patient may sit or lie down before self-administering the therapy, which is safe. Due to the low energy, the patient may experience no or minimal discomfort. For example, if the software is configured to apply increasing electrical signals and receive feedback after each signal is applied, the process may perform the therapy with minimal intervention by the patient and minimal risk to the patient.

[0044] With reference to FIG. 2O, the leadless pacemaker 260 may be connected to the atrial septum 250 using an alternative septal electrode element 261R that is connected to the septal electrode element 261L to form the septal electrode 261. The septal electrode 261 may be the same as or similar to the septal electrode 400 ( FIG. 3C ) and may provide the same or similar electrical and mechanical functions as the septal electrode 400, as described further herein. In this embodiment, the leadless pacemaker 260 may extend perpendicularly from the septal electrode element 261R, but may also be configured to extend along the wall or be integrated with the septal electrode element 261R. Additionally, the leadless pacemaker 260 may be connected to or integrated with the septal electrode element 261L. In either case, an electrical connection is made between the leadless pacemaker 260 and the septal electrode element(s) 261R and 261L to provide a variety of electrical stimulation support to the patient's heart. Rather than simply applying an electrical connection from the septal electrode 261, the extension electrodes 245R and 245L may extend along the endocardium of the left atrium 235 and right atrium 237. It should be understood that alternative configurations of the extension electrodes 245 may be utilized, as described further herein. In one embodiment, the septal electrode element 261 may not have the ability to electrically connect with the endocardium of the atrial septum, but rather may be configured to simply support the extension electrode 245 and enable electrical communication between the leadless pacemaker 260 and the extension electrode 245.

[0045] 3A-3C show an example of a device that specifically enables atrial defibrillation using two electrodes. One electrode is placed in the right atrium (e.g., electrode 251 shown in FIG. 2H), but other locations such as the right ventricle, left ventricle, or coronary sinus are also possible. The other electrode includes a septal electrode 230 that is placed along the atrial septum. FIG. 3A shows the septal electrode 230 in intimate contact with either side of the atrial septum 250. Protuberances 255 (e.g., teeth) extend toward and slightly into the septum 250, allowing for secure positioning along the septal wall and helping to secure the septal electrode 230 in place on opposite sides of the septum 250.

[0046] Figure 3B is similar to Figure 2H and shows a septal electrode 330 with a left atrial (or alternatively right atrial) extension 335 that fits snugly against the atrial septum to provide additional surface area for defibrillation (compared to the septal electrode 230 of Figure 3A). This embodiment may include a protrusion 255 that helps hold the septal electrode 330 and its extension 335 in place.

[0047] FIG. 3C shows an alternative septal electrode 400 that covers both sides of the atrial septum 250. The septal electrode 400 includes a plug with an electrode array. The plug can have electrode properties or the plug may incorporate an electrode(s) with sufficient electrical conductivity, such as gold plating. The additional electrode(s) can be braided into the plug, or can be circular electrodes on one or both sides of the device, or multiple electrodes in a circle around the circumference or radius, or between the plugs. The additional electrodes are attached to a wire 410 exiting the heart in the same manner as the device in FIGS. 3A and 3B. Opposing wings 420 and 430 can be deployed (e.g., fanned out) to secure the device against the septum 250 as shown.

[0048] 3D-3F, a diagram of an exemplary septal electrode 360 ​​is shown with extension electrodes 362a and 362b (collectively 362) extending from and supported by sleeves 364a and 364b (collectively 364). In this embodiment, the septal electrode 360 ​​is curved at an end region 366 to form a concave shape 367 along an inner diameter surface 368 of the septal electrode 360 ​​and convex shapes 370a and 370b (collectively 370) opposite the intersection of the end region 366 with the projection members 372a and 372b (collectively 372). The projection members 372 may extend parallel or substantially parallel to one another (i.e., within a few degrees limited by the manufacturing process). The overall shape of the septal electrode 360 ​​may provide for more inward pressure to be applied to the septum 250 by the sleeves 364 extending over the projection members 372 than over the end region 366. The sleeves 364 may be tubular and may be identical in size and shape to one another. In one embodiment, the sleeves 364 may have a flat surface 376 that includes a rounded outer surface radially along the sleeve 364 and has a textured surface, such as triangular, sawtooth, protuberances, dimples, hooks, and / or any other textured or geometrically shaped surface, that secures the flat surface 376 against the septum 250, thereby reducing slippage of the septal electrode 360 ​​relative to the septum 250.

[0049] As shown, the sleeve 364 includes openings 368 and 380, where the opening 378 may be sized to fit snugly over the extension electrode 362 and the opening 380 may be configured to fit snugly over the protruding member 372. The sleeve 374 may be non-conductive. The septal electrode 360 ​​may be conductive and may include a non-conductive coating or sleeve. Other configurations of the septal electrode 360 ​​may be utilized. If conductive, an electrical signal applied to one of the extension electrodes 362 (e.g., extension electrode 362a) by a pacemaker or other power source (e.g., defibrillator) may flow through the septal electrode 360 ​​to the other of the extension electrodes 362 (e.g., electrical conductor 362b) to apply an electrical signal to the wall 252L of the left atrium 235, where the extension electrode 362b may be in direct contact with one or more of the endocardium, myocardium, and / or epicardium of the wall 352L of the left atrium 235.

[0050] FIGURE 4A shows an atrial defibrillator (or pacemaker, sensor, or recording device) implanted in a human with a septal electrode 230 of lead 103 connected to a battery-powered electronics housing 450 (similar to electronics housing 110 described above) and attached to the atrial septum, and another lead 510 provided in and anchored to the right ventricle. The electronics housing includes a sealed housing, a battery contained therein, and circuitry that generates electrical stimulation signals provided to electrodes at the distal ends of the leads. FIGURE 4B shows an atrial defibrillator implanted in a human with a septal electrode 230 of lead 103 attached to the atrial septum, a second lead 510 provided in and anchored to the right ventricle, and a third lead 511 anchored within the right atrium.

[0051] 5-7 show an embodiment in which an atrial electrode is included in a device that occludes the atrial appendage opening from outside the heart. FIG. 5 shows the defibrillator lead placement with one atrial lead 101 placed in the right atrium 237. A second atrial lead 510 is placed in or around the atrial appendage 520 of the left atrium 235 and attached to an atrial appendage closure device that is used to occlude the opening between the left atrium 235 and the atrial appendage 520. The leads 101 and 510 and their electrodes allow specific atrial defibrillation of the atrium with very small amounts of energy (approximately 1-10 Joules). The device extension includes another composition, such as a shape memory metal or plastic, that holds the extension firmly against the outside of the left atrium. FIG. 5 also shows a pulse generator 450 that includes a sealed housing that includes a battery and circuitry that generates stimulation energy to the electrodes at the distal ends of the lead(s) 101 and 510.

[0052] FIG. 6A shows a portion of a procedure for implanting an atrial appendage closure device around the atrial appendage 520. Placement of the atrial appendage closure device includes a magnet 525 positioned inside the atrial appendage 520 via a sheath 521. A second magnet 535 is brought close to the magnet 525 from outside the heart via a sheath 540 inserted through a small incision in the patient's chest. An opening 521 is shown between the left atrium 235 and the atrial appendage 520. When the magnet 535 is close enough to the magnet 525, magnetic attraction causes the two magnets to contact the wall of the atrial appendage 520 sandwiched between them. The magnet stabilizes the atrial appendage 520. FIG. 6A also shows the distal end of a sheath 545 that contains a lariat (described below).

[0053] FIG. 6B shows the deployment of a lariat 550 around the base of the atrial appendage 520. The lariat 550 may be made of suture material or wire. FIG. 6C shows a lead extension with electrodes 560 and 565 attached to the lariat 550. The electrodes may be placed on the lariat device prior to insertion into the body. The electrode array may vary depending on which configuration best delivers the joule with the lowest resistance. The lariat may have one or more electrodes fixed. The electrodes may be longer and deployed against the outside of the LA upon deployment. The coating or composition of the extension includes a shape memory metal or other material that ensures that the extension remains in contact with the left atrium or other epicardial surface. The specific length and number of electrodes and whether they deploy will depend on the energy required to deliver the appropriate energy for defibrillation and the acceptable resistance created. FIG. 6D shows the lariat 550 in place and tightened around the base of the atrial appendage 520, thereby occluding the opening from the left atrium 525 to the atrial appendage. FIG. 6D also shows an electrode 560 positioned on the lariat 550, just outside the left atrium.

[0054] FIG. 7 shows the electrode 560 separated from the lariat 550. In this example, the electrode 550 is a coiled spring electrode. The electrode may be deployed and present at the base of the LAA and / or outside the LA. There may be multiple electrodes. The configuration may be star-shaped, circular, or other shapes. However, in other embodiments, the configuration of the electrode 560 may be other than that shown in FIG. 7. In other examples, the portion of the electrode pressed against the left atrial tissue may be longer than that shown in FIG. 7, or there may be one or more additional electrodes on the lariat 550 to increase the surface area along the left atrium. The configuration of the electrode array may also be modified somewhat to accommodate the size of the atrial appendage closure device.

[0055] 8A-8D show the use of a plug 810 (also called a left atrial appendage occluder) to occlude the opening between the left atrium 235 and the atrial appendage 520 from inside the heart. The plug 810 is fitted with one or more electrodes that are connected to a pulse generator (e.g., pulse generator 450) and used for defibrillation. One or more other electrodes are placed in the right atrium, right ventricle, left ventricle, coronary sinus, or atrial septum. The plug 810 is deployed through a sheath 805.

[0056] 8B shows retraction of the sheath 805 and plug deployment member 807. The lead 820 is shown inside the plug deployment member 807. The lead 820 is exposed once the sheath 805 and plug deployment member 807 are retracted. An electrode 830 is shown on the lead 820 inside the atrial appendage 520. This device keeps the wire tight against the inner heart wall, thereby keeping the wire out of the blood stream. In this position, the wire becomes embedded in the atrial wall.

[0057] In FIG. 8C, the lead 820 from the left atrial closure device (plug 810) extends from the device, and as the sheath 805 and plug deployment member 807 are retracted, the attached lead 820 is introduced into the right atrium 237. In the right atrium 237, the lead is then grasped or directed with a snare device 208 for delivery to the left or right subclavian vein or other vein for connection to a pulse generator 450 that is placed subcutaneously as described above. FIG. 8C also shows a lattice 812 coupled to a U-shaped dip 811 coupled to the septum 250. The lattice includes, for example, a first wire 812 and a second wire 813 both coupled to the U-shaped dip 811 and configured to be restrained against the endocardium of the left atrium 235. More than two wires can be included if desired. The wires 812 and 813 are interconnected and spaced apart by one or more interconnecting wires 815, which are also restrained against the wall of the left atrium. U-shaped dip 811 and wires 813, 814 and 815 may be formed from any suitable type of shape memory metal, such as Nitinol.

[0058] FIG. 8D shows the final configuration of the plug 810, with the left atrial lead 820 extending from the left atrial closure device (plug 810) and extending along the inner wall of the left atrium 235, blocking the atrial appendage 520 in close contact with the inner wall of the left atrium 235. The wire then passes through the atrial septum to the right atrium. The lead 820 then passes through the superior vena cava (or alternatively the inferior vena cava) to a more peripheral vein that allows access to the pulse generator 450 (which may be configured to perform defibrillation and / or pacing). A right atrium (lead 101 in FIG. 1) is also present and may be connected to the pulse generator 450. Such additional leads may be, for example, leads placed in the right ventricle, left ventricle, or a coronary sinus lead.

[0059] In the example of Figures 8C and 8D, active electrodes (providing stimulation or sensing capabilities) can be provided on the grid 812 (e.g., wires 814), in or on the plug 810, or on both the grid and the plug. In one embodiment, the electrodes are on one of the wires 813 or 814 of the grid 812, and the other of the wires 813, 814 of the grid with its shape memory serves to keep the wire carrying the electrode in continuous contact with the atrial wall. In one embodiment, the grid 812 is present but the plug 810 is not. Furthermore, the U-shaped dip 811 may or may not have an electrode. In one example, the dip 811 serves as an anchor for another structure (e.g., grid 812, pacing lead, etc.) and is not itself used for sensing or stimulation purposes.

[0060] With reference to FIG. 8E, a diagram of an exemplary embodiment of another embodiment of extension electrodes 813L and 813R (collectively 813) integrated with grids 812L and 812R, respectively, connected (electrically and physically) to the septal electrode 230 is shown. The wires 814L and 814R extend along the endocardium of the left atrium 235 and right atrium 237, respectively, and may be constructed with a shape preform (i.e., having shape memory) to maintain contact with the endocardium. In one embodiment, the wires may be uninsulated or partially insulated (e.g., insulated along a side with exposed metal on the other side for endocardial contact along a portion). Although not shown, the septal electrode 230 may be connected to a lead (e.g., lead 103 of FIG. 2J) or a leadless pacemaker (e.g., leadless pacemaker 260 of FIG. 2N) to provide an electrical signal to the septal electrode 230, which transmits the electrical signal to the extension electrode 813.

[0061] With reference to FIG. 8F, a diagram of an alternative embodiment of the septal electrode 802 configured as a pair of springs 802R and 802L forming the septal electrode 802 is shown. The springs 802R and 802L may function to hold the extension electrode 245 along the atrial septum 250 and the endocardium of the left atrium 235 and right atrium 237. In this embodiment, the lead 103 may be electrically connected to the septal electrode 802. The springs 802R and 802L may be conductive or non-conductive. If non-conductive, a conductor may be integrated with the septal electrode 802 to provide an electrical connection with the lead 103 and the extension electrode 245. In one embodiment, an opposing plate (not shown) may be disposed between the springs 802R and 802L used to hold the septal electrode 802 together with the atrial septum 250. Protrusions (not shown) may be disposed on springs 802R and 802L (and / or plates) facing the atrial septum 250 to provide additional support to maintain the septal electrode 802 against the atrial septum 250. Although springs 802R and 802L are shown, it should be understood that only a single spring, such as spring 802L, may be utilized and that spring 802R may be a plate or other structural element. It should further be understood that various configurations of the septal electrode 802 may be utilized to perform the same or similar functions of providing both electrical conductivity and support for the extension electrode 245 as provided herein.

[0062] In another embodiment, a left atrial lead can be incorporated into a mitral valve replacement and / or repair, either by a transseptal approach via a percutaneous approach, or by a minimally invasive or open surgical approach. For example, an electrode array can be incorporated into a mitral valve device that contacts or is near the left atrium. FIG. 9 shows a prosthetic mitral valve device 910 incorporating one or more electrodes 920 forming an electrode array. The electrodes 920 are on the distal end of the atrial lead. The lead 930 is then routed through the atrial septum 250 and connected to a pulse generator 450, as described above. The mitral valve opening, where most mitral valve devices (such as the mitral valve device 910) are located, is a suitable site for bi-atrial defibrillation by the devices described herein. One configuration of the electrode array would be a thin conductive wire that is woven or otherwise attached to the valve device 910 when positioned around the mitral valve orifice. The mitral valve device 910 or multiple devices may accommodate the electrode array and the lead 930. The lead 930 can extend to overlap the septal restraint device, which then connects to an insulated wire that connects to a pacemaker and / or defibrillator or transducer. The mechanical properties of the device hold the wire and extension against the atrial wall where tissue ingrowth occurs, as in the case of an implanted mitral valve. The lead 930 can also allow for attachment to another grasping device (e.g., snare device 208) to guide the wire to the appropriate site near the defibrillator / pacemaker pocket.

[0063] 3D-3F, one embodiment of placing an implantable device for treating AFIB may include clamping a septal electrode 360 ​​onto the septum 250 having an extension electrode 362 extending along the wall(s) 352R and 352L (e.g., the endocardium, myocardium, and / or epicardium of the wall(s) 352R and 352L). Once clamped, a measurement of the cardiac electrical signal is performed, which may include R waves, P waves, S waves, and / or other segments of the cardiac electrical signal. Because the septal electrode 360 ​​is configured to be clamped up to the septum 250, if the cardiac electrical signal measurements are worse or lower than expected (e.g., lower amplitude), the protruding member 372 may be separated such that the flat surface 376 of the sleeve 364 is separated from the septum 250, and rotated, for example, to reposition the extension electrode 362 and engage a different region of the endocardium. If the extension electrode 362b extends into the wall junction 352j, the extension electrode 362b may be withdrawn and reinserted into another area to try to make a better contact location.

[0064] 3G, a diagram of an embodiment of a septal electrode 360 ​​is shown that includes a central post 382 having portions 382a, 382b, 382c (collectively 382) that extend through the central post 382. The central post 382 may be slid in and out of the septal electrode 360. The portion 382b may be biased outward at an angle theta (θ) such that when the portion 382c of the central post 382 is withdrawn from the septal electrode 360, the extension members 372 are rotated by the angle theta so that they are parallel to one another and clamped to the septum 250. If the extension electrode 362 is not properly conducting the cardiac electrical signal, the operator may rotate the septal electrode 360 ​​by sliding the central post 382 back into the septal electrode 360, causing the portion 382b to spread the extension members 372 for re-clamping.

[0065] Some embodiments relate to a support structure for a pacemaker lead. The support structure is coupled to the pacemaker lead and configured to constrain a portion of the pacemaker lead against a human atrial wall. Examples of the support structure are described herein and include, for example, a U-shaped dip, a lattice, etc., and the support structure may include a shape memory material (e.g., Nitinol).

[0066] An embodiment of a manufacturing process for an implantable cardiac device may include forming a structure configured to be retained on the atrial septum. An extension electrode may be attached to a portion of the structure such that the extension electrode is positioned against the endocardium of the atrial septum, and the extension electrode may be configured to have its elongated portion to maintain contact with the endocardium of the left atrium away from the atrial septum.

[0067] Attaching the extension electrodes may include attaching extension electrodes formed of a shape memory material. The process may further include connecting a lead to the structure to conduct an electrical signal to the structure and the extension electrodes. Alternatively, a leadless pacemaker may be attached to the structure to apply an electrical signal to the structure and the extension electrodes.

[0068] One embodiment of a process for implanting a cardiac device may include introducing an extension electrode into a blood vessel. The extension electrode may pass through the blood vessel to reach the right atrium of the patient's heart. The extension electrode may be inserted into the wall of the left atrium through the right lateral wall junction such that the extension electrode is in the wall of the left atrium.

[0069] The extension electrode may be anchored to remain within the wall of the left atrium. Securing the extension electrode may include applying a structure to the interatrial septum. Securing the extension electrode may include inserting a fixation device into the right side wall junction to prevent the extension electrode from exiting the wall.

[0070] The process may further include extending a lead from the extension electrode and connecting the lead to a pacemaker. The step of anchoring the extension electrode may include anchoring the extension electrode without breaching the endocardium of the left atrium.

[0071] A method of implanting a lead in the left side of the heart using the structures described herein includes introducing the lead into a blood vessel, advancing the lead into the left atrium, fixing a distal region of the lead in a flush position against the atrial septum using anchor elements on either side of the atrial septum, and attaching an electrode to the lead in contact with the endocardium of the heart. Further, advancing the lead into the left atrium may include advancing the electrode across the septum to make continuous contact with the atrial wall. A lattice may be positioned within the left atrium to maintain contact of the distal region of the lead with the atrial wall.

[0072] Modifications of the described embodiments are possible, and other embodiments are possible, within the scope of the claims.

Claims

1. 1. An implantable medical device comprising: a cardiac lead having a distal region and a proximal end, the proximal end of the cardiac lead adapted to be coupled to an electronics housing, the distal region of the cardiac lead having structure configured to hold a portion of the distal region of the lead against a human endocardium, the structure configured for attachment to opposite sides of an atrial septum, The distal region of the lead also has an electrode extending away from the structure, an elongated portion of the electrode configured to maintain contact with the human endocardium.

2. The implantable medical device of claim 1 , wherein the structure comprises a septal closure device.

3. The implantable medical device of claim 1 , wherein the elongated portion of the electrode extends along the endocardium of the left atrium, away from the atrial septum.

4. 4. The implantable medical device of claim 3, further comprising a second electrode connected to the structure, extending away from the human endocardium and configured to maintain contact with the human endocardium.

5. 5. The implantable medical device of claim 4, wherein the elongated portion of the electrode extends from the structure in the left atrium of the patient's heart and the second electrode connected to the structure extends away from the structure in the right atrium of the patient's heart.

6. The implantable medical device of claim 1 , wherein the structure comprises a shape memory material.

7. The implantable medical device of claim 1 , wherein the structure includes a protrusion configured to mate with the endocardium.

8. The implantable medical device of claim 1 , wherein the structure comprises a U-shaped dip.

9. The implantable medical device of claim 8 , wherein the electrode is on the U-shaped dip.

10. The implantable medical device of claim 1 , wherein the distal region includes a wire extension coupled to the structure and configured to be restrained against the human endocardium.

11. The implantable medical device of claim 10 , wherein the electrodes are on the wire extensions.

12. The implantable medical device of claim 1 , wherein the structure comprises a lattice.

13. The implantable medical device of claim 12 , wherein the lattice is configured to constrain the distal region of the cardiac lead to the human endocardium.

14. The implantable medical device of claim 12 , wherein the electrodes are on the grid.

15. The lattice further comprises a U-shaped dip configured to be attached to the human septum, the lattice comprising: a first wire coupled to the U-shaped dip and configured to be restrained against the human endocardium; a second wire also coupled to the U-shaped dip and configured to be restrained against the human endocardium; 13. The implantable medical device of claim 12, further comprising: an interconnect wire connected to the first and second wires for spacing the first and second wires apart while being constrained against the human endocardium.

16. 10. The implantable medical device of claim 1, wherein the elongated portion of the electrode includes a plurality of electrodes extending along the endocardium of the left atrium away from the atrial septum.

17. 17. The implantable medical device of claim 16, further comprising a second plurality of electrodes connected to the structure, extending away from the human endocardium and configured to maintain contact with the human endocardium.

18. 18. The implantable medical device of claim 17, wherein the plurality of electrodes extend from the structure in the left atrium of the patient's heart and the second electrode connected to the structure extends away from the structure in the right atrium of the patient's heart.

19. The implantable medical device of claim 1 , further comprising a mitral valve device, the electrode being part of the mitral valve device.

20. the shape memory structure includes a U-shaped dip configured to be attached to the human septum; 20. The implantable medical device of claim 19, wherein the electrode is coupled to the U-shaped dip via a shape memory wire configured to be constrained against the human endocardium between the mitral valve device and the U-shaped dip.

21. a cardiac lead having a distal end and a proximal end, the proximal end of the cardiac lead adapted to be coupled to an electronics housing and the distal end of the cardiac lead functioning as an elongated electrode that provides an electrical signal to an endocardium of the heart; a support structure coupled to the cardiac lead and configured to constrain a portion of the cardiac lead against an atrial wall of the human, the elongated electrode extending away from the support structure against the atrial wall of the human, the elongated portion of the electrode extending along the endocardium and maintained against the endocardium.

22. The implantable medical device of claim 21 , wherein the support structure is a lattice.

23. 22. The implantable medical device of claim 21, wherein the support structure comprises a U-shaped dip.

24. 22. The implantable medical device of claim 21, wherein the support structure comprises a shape memory material.

25. 22. The implantable medical device of claim 21, wherein the elongated electrode extends along the endocardium of the left atrium, away from the atrial septum.

26. 1. A method for implanting a lead in the left side of the heart, comprising: introducing the lead into a blood vessel; advancing the lead into the left atrium; fixing a distal region of the lead in a flush position against the atrial septum with anchor elements on either side of the atrial septum; and attaching an electrode on the lead in contact with an endocardium of the heart, an elongated portion of the electrode extending along the endocardium away from the anchor element.

27. 27. The method of claim 26, wherein advancing the lead into the left atrium includes advancing the electrode across the septum and into continuous contact with the atrial wall.

28. 27. The method of claim 26, further comprising positioning a lattice within the left atrium to maintain the elongated portion of the distal region of the lead in contact with a left atrial wall.

29. 1. A method of manufacturing an implantable cardiac device, the method comprising: forming a structure configured to be retained in the atrial septum; and positioning an extension electrode against the endocardium of the atrial septum by attaching the extension electrode to a portion of the structure, the extension electrode being configured to have an elongated portion to maintain contact with the endocardium of the left atrium away from the atrial septum.

30. 30. The method of claim 29, wherein attaching the extension electrodes comprises attaching extension electrodes formed of a shape memory material.

31. 30. The method of claim 29, further comprising the step of connecting a lead to the structure for conducting an electrical signal to the structure and to the extension electrode.

32. 30. The method of claim 29, further comprising the step of connecting a leadless pacemaker to the structure for applying an electrical signal to the structure and to the extension electrodes.

33. 1. A method of implanting a cardiac device, comprising: Introducing an extension electrode into a blood vessel; passing the extension electrode through the blood vessel into the right atrium of the patient's heart; inserting the extension electrode through the right side wall junction and into the wall of the left atrium such that the extension electrode is within the wall of the left atrium; and anchoring the extension electrode so that it remains within the wall of the left atrium.

34. 34. The method of claim 33, wherein the step of securing the extension electrode comprises applying a structure to the atrial septum.

35. 34. The method of claim 33, wherein securing the extension electrode comprises inserting a securing device into the right side wall junction to prevent the extension electrode from exiting the wall.

36. extending a lead from the extension electrode; 34. The method of claim 33, further comprising the step of: connecting the lead to a pacemaker.

37. 34. The method of claim 33, wherein anchoring the extension electrode comprises anchoring the extension electrode without breaching the endocardium of the left atrium.

38. 34. The method of claim 33, further comprising the step of extending the extension electrode through the epicardium of the left atrium and holding the extension electrode against the epicardium.

39. 39. The method of claim 38, wherein inserting the extension electrode includes inserting the extension electrode coated with a hemostatic agent into the portion of the extension electrode that enters the right side wall junction.

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