US20200269059A1 - Apparatus, systems, and methods to improve atrial fibrillation outcomes involving the left atrial appendage - Google Patents

Abstract

Apparatus, systems, and methods are provided for monitoring AF episodes, delivering ATP pulses, and/or achieving electrical isolation of the left atrial appendage (LAA) of a patient's heart and/or preventing thrombus formation after electrical isolation. For example, devices are provided that may implanted from within the left atrium, e.g., to isolate the LAA, prevent thrombus formation within the LAA, facilitate endothelialization, and/or deliver pacing.

Description

RELATED APPLICATION DATA
• The present application claims benefit of co-pending provisional application Ser. No. 62/808,130, filed Feb. 20, 2019, the entire disclosure of which is expressly incorporated by reference herein.
FIELD OF THE INVENTION
• The present invention relates to apparatus, systems, and methods for improving atrial fibrillation outcomes involving the left atrial appendage. More specifically, implantable devices are provided that are designed for placement within a patient's body, e.g., within the left atrial appendage of the atrium of a patient's heart to monitor and treat abnormal rhythms.
BACKGROUND
• Atrial fibrillation (“AF”) is the most common sustained cardiac arrhythmias. Cardiac ablation of atrial fibrillation is one of most common cardiac procedures. The cornerstone of AF ablation procedures have been pulmonary vein isolation (“PVI”). However, in recent years, non-pulmonary vein triggers have been identified. One of the most common non-pulmonary vein triggers is the left atrial appendage (“LAA”). Therefore, there is a growing interest in performing LAA isolation during ablation procedures. However, there are technical difficulties in creating electrical isolation of the LAA. In addition, numerous reports suggest that there is increased risk of thromboembolic events following LAA isolation. Inadequate function of the LAA after electrical isolation is felt to be responsible. After electrical isolation, the LAA does not squeeze adequately. As a result, blood can coagulate to form a thrombus in the LAA. This thrombus can then embolize to other parts of the body.
• The LAA has various morphologies and sizes. An ablation tool needs to be adaptive enough to accommodate these differences. Some LAA have a straight structure (‘windsock’ morphology) while other LAA morphologies include a sharp bend (‘chicken-wing’ morphology). In addition, an ablation tool that prevents thrombus formation within the LAA is optimal. There are data that suggest that some patients who are in sinus rhythm remain at risk for thrombus formation in the LAA after electrical isolation of the LAA.
• The only commercially available leadless pacemaker is intended to be placed in the right ventricle. There are apparently next generation leadless pacemakers under development to enable placement within the right atrium. However, there are no known devices available or in development that describes a leadless pacemaker designed to be placed within the left atrium.
• Therefore, improved tools to improve AF ablation procedures, e.g., by monitoring AF episodes, delivering ATP pulses, and/or isolating the LAA without the increased risk of thromboembolic events, may be useful.
SUMMARY
• The present invention relates to apparatus, systems, and methods for monitoring AF episodes, delivering ATP pulses, and/or achieving electrical isolation of the left atrial appendage (LAA) of a patient's heart and/or preventing thrombus formation after electrical isolation.
• More particularly, the systems and methods herein may include a device that is implanted from within the left atrium, isolates the LAA, and prevents thrombus formation within the LAA. In addition, the device may include material that facilitates endothelialization. In an exemplary embodiment, the device may be placed within the body through a sheath and takes a desired shape after leaving the deployment sheath.
• Anti-tachycardia pacing (ATP) delivered from traditional pacemakers has been shown to reduce atrial fibrillation burden. It is likely that a leadless pacemaker implanted within the left atrial appendage can also deliver ATP pulses to terminate atrial arrhythmias. A pacemaker in the left atrial appendage can reduce AF burden and prevent thrombus from forming in the left atrial appendage.
• In general, patients who go into AF need to be on blood thinners to prevent thrombus formation. A medical device placed into the LAA may help prevent thrombus from forming inside the LAA. In addition, the LAA also provides potential space for a processor and battery. In addition, this space may be used for monitoring purposes. This enables the device to monitor for AF recurrence and alert patients and/or their caretakers. In addition, if the implanted device is able to deliver anti-tachycardia pacing (ATP) pulses to the atrial tissue, the device may help pace-terminate AF episodes if the ablation/isolation procedure is unsuccessful. In addition, patients with AF often demonstrate both fast heart rates (tachycardia) as well as slow heart rates (bradycardia). The device may pace the heart in response to slow heart rates to treat these abnormal rhythms.
• Most AF triggers or initiators originate from the left atrium. Specifically, the large majority of atrial tachycardia episodes that initiate and sustain AF episodes come from the pulmonary veins (which connect to the left atrial) and the left atrial appendage. These atrial tachycardia episodes can be interrupted and terminated via anti-tachycardia pacing (ATP). However, ATP episodes are more effective if the ATP pulses are in proximity to the originator of the atrial tachycardia. Therefore, delivering ATP pulses from the left atrium is likely to be more effective than ATP delivery from the right atrium.
• Anti-tachycardia pacing (ATP) may be delivered from an implantable pacemaker implanted within the left atrial appendage to terminate atrial tachycardia and atrial flutter. By terminating regular rhythms, a pacemaker in the left atrial appendage may reduce AF burden and prevent thrombus from forming in the left atrial appendage.
• In accordance with one embodiment, the LAA isolating device is aligned with electrodes. These electrodes may enable the device to be visualized on mapping systems. This enables mapping systems that use impedance-based mapping or magnetically-based mapping to be visualized to help deploy the device optimally into the LAA. In some embodiments, the device may also include materials to enhance visualization using other methods, such as echocardiography and fluoroscopy, to further aid optimal deployment and placement into the LAA.
• In addition, the system may include a monitor of the patient's rhythm. In one embodiment, after the device is deployed and the LAA is isolated, the system is still able to sense and pace the heart. In one embodiment, the device may pace the heart in order to terminate abnormal rhythms. In another embodiment, the device may identify atrial fibrillation and send messages outside of the body. In order to record and send transmissions, in some embodiments, the device may include a battery and/or other implanted power source. In some embodiments, the battery may be charged from the outside world, e.g., inductively, using ultrasound, electromagnetic energy, or otherwise using an external device that communicates with the implanted device.
• In accordance with another embodiment, the system may include an elongate member that is designed to be deployed through a specialized deployment sheath into the left atrial appendage. The device coils on itself to fill, attach, and then close off the left atrial appendage from the rest of the left atrium. In addition, electrodes may align the elongate member. These electrodes permit deployment using standard mapping systems (e.g., using impedance or magnetic based systems) as well as ablation to electrically isolate the left atrial appendage. In other embodiments, the device may use electroporation and laser ablation to ablate tissue. In other embodiments, the device may be cooled to freeze LAA tissue to isolate the appendage. In addition, the device may provide a radial force to compress the tissue to induce electrical isolation.
• The elongate member may be designed to coil on itself. In addition or alternatively, an inner cable or the like, the materials of the coil itself, or positioning from the delivery system may be utilized to enlarge the coil to optimize contact and force. In other embodiments, electrodes are used to help guide the closure device into place and are then withdrawn. In another embodiment, many or all of the electrodes are deployed and left within the left atrium and/or left atrial appendage.
• In some embodiments, detailed imaging is performed on the left atrium and left atrial appendage to better determine the anatomy to facilitate electrical isolation and device deployment. Imaging may be obtained using normal mapping electrodes used during the ablation procedure, or using catheters and electrodes specifically designed to map the LA and LAA. In another embodiment, ultrasound imaging, such as obtained from a transesophageal echocardiogram (“TEE”) images or intracardiac echocardiogram images are combined with other mapping techniques to best understand the LAA anatomy. For example, an intracardiac echocardiography (“ICE”) catheter may be advanced into the LAA to determine the anatomy. The walls and anatomy of the LAA may be visualized and identified on ultrasound imaging and then incorporated into a three-dimensional map to determine optimal ablation device size/length as well as device deployment within the LAA. A specialized tip may be placed on the tip of the ICE catheter to prevent traumatic damage to the LAA.
• In another embodiment, the isolation device combines aspects of an LAA closure device. In one embodiment, electrodes are used to guide device deployment which combines self-expanding nitinol with electrodes for positioning and electrical isolation. In another embodiment, a sponge-like material is used to occlude the LAA. By leading the sponge-like material with electrodes, the sponge-like material may be optimally deployed within the LAA. The sponge-like material may then help lock the electrodes in place and decrease the risk of device embolization.
• In another embodiment, after detailed mapping is created, the sponge-like material is cut to optimally fit within the LAA. For example, a desired mass or section of sponge-like material may be formed using a 3D printing system. In one embodiment, the LAA closure material is printed using a specially-designed 3D printer. In another embodiment, the sponge-like material is trimmed to fit the LAA anatomy. In this embodiment, the 3D printer only carves the outside of the sponge-like material—it does not lay down the material. The sponge-like material can then be collapsed to fit within a delivery sheath and deployed within the LAA. The sponge-like material may be aligned with electrodes. In another embodiment, there are electrodes leading the sponge-like material, behind the sponge-like material, located between the beginning and end of the sponge-like material, or a combination thereof.
• In another embodiment, two sheaths are used to electrically isolate and then close the LAA. In this embodiment, one sheath is used to map the LAA and facilitate safe deployment of the second sheath into the LAA.
• In exemplary embodiments, electrical isolation may occur through pinching or clamping tissue of the LAA. The closure device may be coated with insulation material to force electrical current to optimize tissue ablation.
• The connection between the electrodes on the closure device and the external world need to be cut or released at some point. This connection may be rotated to release (a screw mechanism), pulled into the delivery sheath to release, or may be designed to break away with force. In another embodiment, electrical current is used to burn or electrolytically separate the connection to facilitate release.
• In another embodiment, the closure device is used to deliver a chemical that prevents the body from healing the ablation. In one embodiment, the device is covered with chemotherapy agents that prevent electrical reconnection. Therefore, the electrodes may deliver RF or electrical current to induce electroporation ablation to the LAA. The device may combine electroporation, chemical ablation, and pressure to maintain electrical isolation. The device may also contain distal electrodes capable of sensing distal LAA electrical signals in order to verify electrical isolation. The closure device may include a battery to maintain electrical ablation. In addition, the closure device may include a communication system to communicate outside of the body. In one embodiment, the closure device can be charged from outside the body using ultrasound energy. The device may then use this energy to measure left atrial pressure or pace the heart.
• In response sinus slow heart rates such as bradycardia or sinus arrest, the devices herein may be configured to pace the atrium to speed up the heart rate. However, pacing the LAA after electrical isolation may not increase the heart rate since the LAA will be electrically isolated from the rest of the heart. Therefore, the device needs to be implanted within the LAA to prevent thrombus formation; however, the electrodes need to have contact to atrial tissue outside of the LAA in order to affect the heart rate. Therefore, in an alternatively embodiment, the device may be configured to be positioned within the LAA but has electrodes adjacent atrial tissue outside the LAA in order to pace heart tissue to speed up the heart rate.
• Furthermore, AF is often initiated by fast and sometimes irregular heart rhythms such as atrial flutter or atrial tachycardia. By deliver pacing pulses at a rate faster than the sensed atrial rate, overdrive pacing is often able to terminate the abnormal atrial rhythm. Therefore, delivering ATP from the device can help terminate tachyarrhythmias. In addition, even though the device is positioned in the left atrial appendage, this location is often overhanging the left ventricle. Therefore, by delivering high output pacing, the device may be designed to treat abnormally slow ventricular rates in the setting of poor atrio-ventricular conduction, such as heart block.
• In addition, the closure device may be covered in drug eluting material that prevents the body from healing the lesion. In one embodiment, the closure device delivers an agent that prevents electrical reconnection; this agent may include one or more of sirolimus, paclitaxel, zotarolimus, everolimus, biolinx polymer, a steroid, and ridaforolimus material. In addition or alternatively, the device may include a steroid eluting agent. In another embodiment, the closure device is designed to facilitate endothelialization, including containing endothelial progenitor cell capture material, basic polymeric woven or non-woven materials, or surfaces roughened through mechanical or chemical methods. In another embodiment, the closure device is covered with radioactive material that facilitates electrical isolation.
• Other aspects and features including the need for and use of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side view of an exemplary embodiment of a leadless pacemaker device designed for implantation within the left atrial appendage that includes three portions deployed from a distal portion of a delivery sheath.
• FIG. 2 is a cross-sectional view of a region of a heart showing the device ofFIG. 1 being introduced into a left atrial appendage of the heart.
• FIG. 3 is a schematic illustration of the device ofFIGS. 1 and 2 being deployed.
• FIG. 4 is a schematic illustration of a view of the device ofFIGS. 1-3 fully deployed within the left atrial appendage as seen from the left atrium.
• FIG. 5 is a cross-sectional view of a region of a heart showing another embodiment of a leadless pacemaker advancing into the left atrial appendage after conformational change within the left atrium.
• FIG. 6 is a schematic illustration of an exemplary embodiment of a device for electrical isolation of a left atrial appendage before deployment.
• FIG. 7 is a cross-sectional view of a region of a heart showing another embodiment of a device for electrical isolation of a left atrial appendage of the heart after deployment.
• FIG. 8 is a cross-sectional view of a region of a heart showing yet another embodiment of a device being deployed within a left atrial appendage of the heart.
• FIG. 9 is a schematic illustration of an exemplary embodiment of an electrical connection for a device for electrical isolation of a left atrial appendage, such as that shown inFIG. 8.
• FIG. 10 is a schematic illustration of another embodiment of a leadless pacemaker device designed for implantation within or near a left atrial appendage.
• FIG. 11 is a simplified functional block diagram of an exemplary embodiment of a leadless pacemaker device.
• FIG. 12 is a schematic illustration of still another embodiment of a leadless pacemaker designed for implantation within the left atrial appendage.
• FIGS. 13A-16B show an exemplary method for delivering the device ofFIG. 10.
• FIGS. 17A-19B show an exemplary method for delivering another leadless pacemaker into the left atrial appendage.
• FIG. 20 is a schematic illustration of yet another embodiment of a leadless pacemaker designed for deployment into or near a left atrial appendage.
• FIG. 21A-26 shows an exemplary method for deploying the device ofFIG. 20.
• FIGS. 27A-27B show other exemplary embodiments of a leadless pacemaker designed for deployment within the left atrial appendage.
• FIG. 28 is a flow diagram of an exemplary method for deploying a leadless pacemaker device.
• FIG. 29 is a flow diagram of another exemplary method for deploying a leadless pacemaker device.
• FIGS. 30A-30C are cross-sectional views of a region of a heart showing another embodiment of a leadless pacemaker device being deployed within the left atrial appendage of a heart.
• FIGS. 31A-31D show an exemplary method for manipulating a leadless pacemaker device for introduction into a left atrial appendage of a heart.
• FIGS. 32A and 32B are side views of another exemplary embodiment of a leadless pacemaker device.
• FIG. 33 is a side view of still another example of a leadless pacemaker device.
• FIGS. 34A-34C are cross-sectional views of a region of a heart showing a method for deploying the device ofFIG. 33 within the left atrial appendage of a heart.
• FIGS. 35A and 35B are side views of yet another example a leadless pacemaker device in expanded and contracted conditions, respectively.
• FIGS. 36A-36D are side views of yet another example a leadless pacemaker device being manipulated between expanded and contracted conditions.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
• Before the exemplary embodiments are described, it is to be understood that the invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
• Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
• Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.
• It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.
• Turning to the drawings,FIG. 1 shows an exemplary embodiment of anablation device8 for electrical isolation of a left atrial appendage (“LAA”). In this example, theablation device8 includes three components, segments, or portions that are introduced, deployed, and remain within the vicinity of the LAA: an occludingportion21, an ablation/compression portion31, and an anchoringportion41. The components of thedevice8 may be introduced and/or deployed using a deployment sheath or other tubular and/or elongatemember11. The components may be separate devices that may be deployed sequentially or they may be components of a single integral device including different regions. In the embodiment shown, thedeployment sheath11 includes one or more electrodes12 (two shown) on its distal end to facilitate positioning the components of thedevice8. In some embodiments, the distal end of thesheath11 may be biased to a predetermined shape, e.g., including a bend or curve to facilitate the components of thedevice8 being deployed from thedeployment sheath11 in a controlled method.
• The occludingportion21 may also be lined by or otherwise include a plurality ofelectrodes22. The occludingportion21 may be a self-expanding disc to close off the LAA from the rest of the left atrium (“LA”) of a subject's heart. In another embodiment, the occludingportion21 is biased to a predetermined helical and/or conical shape, e.g., that spirals on itself like a pyramid, that may be shaped to completely close off the LAA when deployed. Optionally, the occludingportion21 may be made of or covered in certain material that facilitates endothelialization and/or minimizes platelet aggregation.
• The ablation/compression portion31 is designed to be enlarged at the ostium of the LAA to electrically isolate the LAA. The ablation/compression portion31 may be lined by and/or otherwise includeelectrodes32 that may be monitored and/or identified, e.g., using an external imaging and/or mapping system (not shown). In addition, the ablation/compression portion31 includes one ormore electrodes32, e.g., a plurality of spaced-apart electrodes as shown, which may be used to deliver radiofrequency energy, electroporation, freezing temperature, or force to the tissue at the LAA ostium to electrically isolate the LAA from the rest of the LA. The ablation/compression portion31 may also include one or more tines orother fixturing elements33 to prevent device movement and/or embolization of thedevice8 after deployment. The ablation/compression portion31 may have an inner cable or plunger (not shown) that enables theportion31 to be enlarged after deployment to optimize radially force and tissue contact.
• With continued reference toFIG. 1, the anchoringportion41 may also include one or moreanchoring portion electrodes42, e.g., a plurality of spaced-apart electrodes as shown, to help position the anchoringportion41 within the LAA. The anchoringportion41 may also include a plurality of anchoring portion tines orother fixturing elements43 spaced apart along the anchoringportion41 to help anchor thedevice8 within the LAA to prevent movement and/or embolization of thedevice8.
• In addition, thedevice8 may also include anelectrical connector25, e.g., for detachably coupling one or more components of thedevice8 to an elongate deliver member (not shown). For example, as shown inFIG. 1, anelectrical connector25 may be included on a proximal end of the occludingportion21, although, in addition or alternatively, an electrical connector may also be included on the ablation/compression portion31, or even the anchoring portion41 (not shown). Theelectrical connector25 includes one or more electrical connections, e.g., coupled to one or more wires or electrical leads (not shown) between theelectrodes22,32,42 on the device components and a controller and/or other devices external to the patient (not shown) to facilitate device positioning and ablation of cardiac tissue.
• Optionally, theelectrical connector25 may have a specialized cover (not shown) that once the connection is decoupled, the electrical components are covered to prevent exposure within the heart. For example, theelectrical connector25 may be part of the ablation/compression segment31, such that after the electrical connections are decoupled, the electrical connections will not have access to blood within the LA by the occludingportion21.
• In another embodiment, the occludingportion electrodes22 may be used to measure impedance across the occludingsection21, e.g., to monitor for complete coverage of the LAA ostium. In one embodiment, the impedance between the occludingportion electrodes22 may be used as a surrogate for comprehensive contact between loops of the pyramid shape to identify if there are any gaps in the occludingportion21.
• FIG. 2 is a cross-sectional view of a portion of a patient's heart, showing thedevice8 ofFIG. 1 located within a leftatrial appendage92 adjacent aleft atrium90 of the heart. As shown, a distal end of thedeployment sheath11 carryingdeployment sheath electrodes12 may be introduced into the patient's body, e.g., percutaneously into the patient's vasculature, and advanced into theLA90 and into theLAA92, e.g., by manipulating a proximal end of the sheath11 (not shown), to introduce and deploy thecomponents21,31,41 of thedevice8. For example, as shown, when thedevice8 is fully deployed, the occludingportion21 has been coiled like a rounded pyramid or cylindrical coil to cover the leftatrial appendage ostium91. The ablation/compression portion31 is located at theostium91 distal to the occludingportion21 in order to injure the tissue to facilitate electrical isolation of theLAA92. The ablation/compression portion31 includes one or more ablation/compression portion electrodes32 to perform ablation on the tissue. In another embodiment, the ablation portion may include one or more electrodes orother elements32 that enable laser therapy or electroporation to isolate tissue at the leftatrial appendage ostium91, or may use ultrasound to deliver ablation energy to the tissue.
• The anchoringportion41 is deployed deep within theLAA92, i.e., distally beyond the ablation/compression portion31, with anchoringportion tines43 and anchoringportion electrodes42 to help guide the device into theLAA92.
• FIG. 3 shows an exemplary method for sequentially deploying the components of thedevice8 within the leftatrial appendage92. In this embodiment, thedeployment sheath11 withdeployment sheath electrodes12 may be used, first, to deploy the anchoringportion41 of thedevice8 into the deep aspects of theLAA92. In the exemplary embodiment shown, the anchoringportion41 may be a spiral catheter that may be enlarged to enable optimal contact and force against the cardiac tissue. The anchoringportion tines43 are used to prevent embolization and anchoringportion electrodes42 are used for positioning and deployment of the anchoringportion41. In some embodiments, the anchoringportion electrodes42 may be used to verifyLAA92 electrical isolation, e.g., by a controller (not shown) communicating with theelectrodes42. In another embodiment, the anchoringportion electrodes42 may also deliver energy to ablate cardiac tissue, e.g., via a power source operated via the controller.
• In this embodiment, a distal portion of thedeployment sheath11 may have a predetermined shape, e.g., biased to include a bend or angle, e.g., an acute angle not more than ninety degrees, proximal to theelectrodes12 to facilitate device deployment. In another embodiment, the bend may be able to rotate freely along the axis of thedeployment sheath11. In yet another embodiment, the angle may be controlled to a certain angle, e.g., using a steering element (not shown) extending from the distal portion to an actuator on the proximal end of the sheath, and/or the rotation may be controlled e.g., by rotating the proximal end of thedeployment sheath11 from outside the patient's body.
• FIG. 4 is a cross-sectional view showing thedevice8 deployed within the LAA looking at the ostium of the LAA en face. The ablation/compression portion electrodes32 are aligned along theLAA ostium91. In one embodiment, the electrodes may be configured to deliver RF energy between the electrode and a grounding pad (e.g., in a uni-polar configuration). In addition or alternatively, RF energy may be delivered between two different electrodes (e.g., in a bi-polar configuration). By performing numerous ablations between one electrode and the ground; as well as each electrode to its closest neighbors, the LAA may be successfully electrically isolated. The closest neighboring electrode may be the electrode next along the device length, or against the closest electrode in the neighboring loop.
• The ablation/compression portion31 may be spring loaded, e.g., to a diameter or other cross-section larger than the LAA, such that it may be released to create radial force against theLAA ostium91. In another embodiment, the ablation/compression portion31 may have an inner cable or plunger (not shown) to enlarge the spiral/coils in order to control the size and resulting radial force. After the ablation/compression portion31 is successfully positioned in theLAA92, the occludingportion21 may then be positioned to form a spiral pyramid to completely occlude theLAA92 from the left atrium.
• Turning toFIGS. 5-6, another embodiment of adevice8′ is shown for electrical isolation of a leftatrial appendage92. In this embodiment, thedevice8′ includes an expandingportion61, e.g., made of nitinol or other metal, such that the self-expandingportion61 self-expands in blood, similar to a sponge. In one embodiment, the expandingportion61 has anelongate member68 extending from a distal end of the expandingportion61. Theelongate member68 may have one ormore guiding electrodes62, e.g., a plurality of electrodes spaced apart along its length. In addition, one ormore ablation electrodes65, e.g., a plurality of spaced-apart electrodes, may also be provided on theelongate member68. Theelongate member68 may be biased to coil around a distal portion of adeployment sheath11 used to deliver and/or deploy thedevice8′. Theablation electrodes65 may also function as guidingelectrodes62 and are not mutually exclusive in any embodiment.
• In this embodiment, thedevice8′ may be advanced into thedeployment sheath11, e.g., through a lumen of thedeployment sheath11 previously positioned within theleft atrium90. Once inside theleft atrium90, thedevice8′ may be advanced such that theelongate member68 with guidingelectrodes62 extends out of the tip of thedeployment sheath11, e.g., as shown inFIG. 5. Theelongate member68 may automatically coil in front of the self-expandingportion61 to help deployment into theLAA92. In another embodiment, theelongate member68 may automatically coil around thedeployment sheath11 once deployed. By surrounding thesheath11 withelectrodes62, thedeployment sheath11 may be safely advanced into theLAA92, e.g., using external imaging and/or mapping, similar to other embodiments herein. In addition, the guidingelectrodes62 may be seen on a mapping system to make sure thedevice8′ anddeployment sheath11 have the correct orientation when advanced into theLAA92.
• In one embodiment, the expandingportion61 is self-expanding, e.g., formed from superelastic and/or temperature-activated material that is biased to assume the coil shape when deployed from thesheath11 within theleft atrium90. In another embodiment, the expandingportion61 may be expanded using to an external force, including inflating a balloon, delivering current through the material, or using a plunger/mechanical mechanism (not shown).
• Once thedeployment sheath11 is advanced into theLAA92, the guidingelectrodes62 may enlarge, uncoil, or change shape to facilitate contact with theLAA92 tissue. RF energy may then be delivered through the guidingelectrodes62 to electrically isolate theLAA92. Next, thedeployment sheath11 may be withdrawn, exposing the expandingmember61 within theLAA92, e.g., within theostium91. The expandingmember61 may then expand and completely occlude theLAA92 from the rest of theleft atrium90. The expandingmember61 then locks thedevice8′ within theLAA92.
• Optionally, the expandingmember61 may include material to facilitate endothelialization. In another embodiment, a cover may be provided proximal to the expandingmember61 to completely occlude theLAA92 from theLA90. The expandingmember61 may be designed to deliver radial force to isolate theLAA92 through compression, e.g., similar to other embodiments herein. In another embodiment, a covering disc69 (not shown, seeFIG. 6) is positioned proximal to the expandingmember61 to deliver radial force to isolate theLAA92.
• The covering disc may also occlude theLAA92 from the rest of theLA90. A useful aspect of thedevice8′ shown inFIG. 5 is that thedevice8′ is deployed within theLA90 such thedevice8′ makes a conformational change within theLA90 before it is advanced into theLAA92. Current LAA devices are generally designed to have the device deployed directly into theLAA92. A unique aspect of thedevice8′ is that it is deployed into theLA90 and then changes shape before being advanced into theLAA92. This confirmation change may be easily performed within the open space of theLA90 without being confined to theLAA92 structure, which is known to be quite friable. By enabling thedevice8′ to be deployed and change shape within theLA90, new opportunities are available to positioning thedevice8′. Similar to a ship-in-a-bottle, thedevice8′ may be prepared in theLA90 and then advanced and deployed into theLAA92.
• FIG. 6 is a cross-sectional view of a distal end of thedeployment sheath11 including thedevice8′ positioned within a lumen of thedeployment sheath11. In this embodiment, the coveringdisc69, the enlargingmember61, theelongate member68 with guidingelectrodes62 are all positioned sequentially within the lumen of thedeployment sheath11. As thedevice8′ is advanced, theelongate member68 initially is deployed and coils. Theelongate member68 includeselectrodes62 to guide thedeployment sheath11 into theLAA ostium91. Theelongate member68 may then bend into a certain pre-specified structure. Similar to a ship-in-a-bottle, theelongate member68 may assume a complex shape to facilitate thedeployment sheath11 into theLAA92, position thedevice8′ optimally, expand to deliver radial force against the ostium of theLAA91, and/or deliver RF energy. The expandingmember61 may then further lock thedevice8′ into place.
• Turning toFIG. 7, another embodiment of adevice8″ is shown for electrical isolation of a leftatrial appendage92 generally similar to other embodiments herein. In this embodiment, thedevice8″ includes anelongate member68 including one ormore electrodes62. e.g., a plurality of spaced-apart electrodes similar to other embodiments herein. After leaving the deployment sheath (not shown), theelongate member68 coils into a predetermined shape, e.g., a spherical shape, within theLAA92. By having theelongate member68 lined byelectrodes62 into a spherical structure, any orientation of thedevice8″ may be used isolate theLAA92 electrically.
• Turning toFIG. 8, another embodiment of adevice8′″ is shown for electrical isolation of a leftatrial appendage92. In this embodiment, thedevice8′″ includes anexpandable member71 carrying one ormore electrodes72, e.g., a plurality of spaced apart electrodes. Theseelectrodes72 may be used to guide deployment as well ablate cardiac tissue to isolate theLAA92, e.g., similar to other embodiments herein. The ablation may be performed utilizing ultrashort high voltage ablation, e.g., to induce electroporation to induceLAA92 electrical isolation. Theablation electrodes72 may be connected to thedeployment sheath11 through one ormore connectors73, which transmit electrical signals from an external controller (not shown) to theelectrodes72.
• FIG. 9 is a schematic illustration of an exemplary embodiment of an electrical connection to thedevice8′″ shown inFIG. 8. Theclosure device71 is transported through a lumen of thedeployment sheath11, e.g., previously introduced into the left atrium, similar to other embodiments herein. Theclosure device71 maybe deployed using aplunger78, e.g., movable relative to thesheath11, that includes one ormore connectors75 to transmit electricity from the external controller.
• Theplunger78 andclosure device71 may include one or more cooperating and/or detachable connectors for releasing theclosure device71 from theplunger78 after deployment. For example, in an exemplary embodiment, theplunger78 andclosure device71 may include mating threads such that theplunger78 may be rotated to disconnect theclosure device71. After theplunger78 andconnectors75 are disconnected and withdrawn, acap79 covers the connection site between theconnectors75 and theclosure device71.
• Turning toFIGS. 10 and 13-16, another embodiment of adeployable device8G is shown including an elongate spiralingmember110 carrying one ormore batteries117, a controller orprocessor120, and acover130, e.g., formed from Nitinol or other elastic material. As shown, adelivery sheath11 may be used to deliver thedevice8G, e.g., to sequentially deploy the components to isolate theLAA92. Optionally, the spiralingmember110 may include one ormore tines113, e.g., to help stabilizing thedevice8G within theLAA92. In the embodiment shown, the spiralingmember110 may carry a plurality ofbattery subunits117 connected to one another by connectors orelectrodes112, e.g., in series. Theconnectors112 may be flexible to allow the spiralingmember110 to spiral or fold upon deployment. In other embodiments, theconnectors112 may include electrodes, which may be configured to be visualized on a mapping system. In addition, theconnectors112 may be coupled to theprocessor120, e.g., to deliver ablation energy to electrically isolate the left atrial appendage, similar to other embodiments herein. Optionally, theconnectors112 may also measure local electrical activity. For example,connectors112 in the proximal portion of theLAA92 may deliver ablation energy, whileconnectors112 in the distal portion of theLAA92 may be used to identify that theLAA92 has been successfully electrically isolated. Optionally, some of thedistal connectors112 may also deliver electrical energy to facilitate adherence or attachment to tissue. The energy may be delivered while theconnectors112 are in contact with theLAA92, thereby making the tissue ‘stick’ to theconnectors112. In another embodiment, the created heat may be used to cause a confirmation change in thetines113 to have better contract or even screw into theLAA92.
• The spiralingmember110 may also house thebattery units117 for thedevice8G. In general, thebattery units117 may be made similar to components that power other implantable devices, including but not limited to lithium-metal, lithium-ion, silver oxide, lithium iodide, and lithium/manganese dioxide. In some embodiments, the batteries are firm; in other embodiments the batteries are flexible to facilitate deployment. In other embodiments, the spiralingmember110 is able to create electrical energy from heart movement. In other embodiments, thedevice8G may be powered by ultrasound or electromagnetic energy.
• In some embodiments, the spiralingmember110 includes a series of repeatingbattery subunits117 that are flexible. However, not all batteries are flexible. Therefore, in order for thebattery subunits117 to change shape to fit and/or attach within theLAA92, thebattery subunits117 may not be flexible but theconnectors112 are flexible. In some embodiments of thedevice8G, the battery portion of theelongate member110 includes at least two or more similarrepeating subunits117. Thesebattery subunits117 are connected by one ormore connectors112. Theconnector112 enables a hinge point that allows thebattery subunits117 to change orientation for deployment within theLAA92.
• Thedevice8G may be deployed from the distal end of thedelivery sheath11 using aplunger140, e.g., movable within a lumen of thesheath11. In some embodiments, theplunger140 may include inner connecting wires (not shown), e.g., coupled to theconnectors112 until thedevice8G is released. In the exemplary embodiment shown, theplunger140 on the distal end includes ascrew122 that may be turned to release theplunger140 from the rest of thedevice8G, although it will be appreciated that other releasable connectors may be used, e.g., similar to other embodiments herein.
• In some embodiments, thedevice8G includes acover portion130 designed to prevent thrombus from leaving theLAA92. Thiscover portion130 may be configured to enclose most or all of thedevice8G within theLAA92, e.g., expand across theostium91 of theLAA92, similar to other embodiments herein. Any blood clots that form within theLAA92 are then trapped within theLAA92 and cannot embolize. Thecover portion130 may include one or more sensors that help measure left atrial pressure or physical movement.
• Optionally, thecover portion130 may also include one ormore pacing electrodes132. The pacing electrode(s)132 enable thedevice8G to sense and pace the heart even if theLAA92 is electrically isolated. For example, thecover portion130 may be designed to extend beyond theostium91 of theLAA92 to contact atrial tissue within the main chamber of theleft atrium90. Therefore, when thecover portion130 covers theLAA92, the pacingelectrodes132 may contact atrial tissue outside theLAA92. These pacing electrode(s)132 may be a few millimeters away from theostium91 of theLAA92 or extend several millimeters away from theostium91 of theLAA92. This enables the proceduralist to freely electrically isolate theLAA92 without concern that thedevice8G will not be able to sense and pace the heart. In some embodiments, thecover130 is able to freely rotate relative to theprocessor120. This enables thecover130 to completely close off theLAA92. In addition, this enables thecover130 to be pulled back and rotated to reposition the pacing electrodes (132). This may be done if the pacing electrodes (132) do not have adequate sensing and capture parameters to adequately sense and pace the heart, respectively. In some embodiments, the pacingelectrodes132 extend outward from thecover portion130 to facilitate good tissue contact.
• FIG. 11 shows a simplified functional block diagram of one embodiment of thedevice8G. The components include thecontrol processor120,battery component117,memory component250, pacingelectrodes132,implantation electrodes142,various sensors231, and atelemetry interface257. Thecontrol processor120 receives input information from various components in order to determine the function of the different components to treat the patient. The pacingelectrodes132 are used to sense and pace the heart. The pacingelectrodes132 are coupled to pacingcircuitry255 that is coupled to thecontrol processor120.
• Optionally, thedevice8G may include one ormore implantation electrodes142, which may visualized by a mapping system in order to help deploy thedevice8G within theLAA92, similar to other embodiments herein. In addition, optionally, theimplantation electrodes142 may be used to deliver electrical or electroporation energy in order to electrically isolate theLAA92. In other embodiments, theimplantation electrodes142 may deliver energy to help attach theelectrodes142 toLAA92 tissue to preventdevice8G embolization.
• Theprocessor120 may also be connected to one ormore sensors231. In one embodiment, the sensors include a three-axis accelerometer. Signals from the three-axis accelerometer may be used by theprocessor120 to detect patient activity in the presence of cardiac motion.Alternative sensors231 may include vibration or movement sensing abilities, which may sense sound or vibrations, e.g., to correlate with valve closure. By determining valve closure, thedevice8G may determine what the ventricle of the heart is doing. In another embodiment, one or more temperature and/or movement/accelerometer sensors may be provided that may be coupled to theprocessor120 to determine if the patient is exerting or moving in order to determine the pacing rate of thedevice8G.
• In another embodiment, thedevice8G may include one ormore sensors231 that correlate with the blood pressure within theleft atrium90. These sensor(s)231 may help identify a heart failure admission similar to the CardioMEMs device. These sensor(s)231 may also be used to optimize medical therapy. In another embodiment, various measurements between electrodes are used to guidedevice8G therapy. Both near-field and far-field electrical activity may be used to determine atrial and ventricular activity as well as diagnose conduction abnormalities.
• The pacing circuitry55 connects to pacingelectrodes132 to thecontrol processor120. These connections allow for multiple capacities to sense electrical activity (such as myocardial depolarizations), deliver pacing stimulations, and/or deliver defibrillation or cardioversion shocks. Thecontrol processor120 may be connected to atelemetry interface257. Thetelemetry interface257 may wirelessly send and/or receive data from anexternal programmer262, which may be coupled to adisplay module264 in order to facilitate communication between thecontrol processor120 and other aspects of the system external to the patient.
• Turning toFIG. 12, another exemplary embodiment of aleadless pacemaker device8H is shown that generally includes anelongate member110 carryingbattery subunits117, aprocessor120, and acover130, configured to be deployed sequentially from adelivery sheath11 for implantation within the left atrial appendage (LAA)92, generally similar to other embodiments herein. In this embodiment, thebattery subunits117 are connected byflexible connectors112 that allow thebatteries117 to fold on themselves. In this manner, theelongate member110 carrying thebattery subunits117 may be advanced out of thedelivery sheath11 and packed into theLAA92. After thebattery subunits117 have been advanced into theLAA92, theprocessor120 may be advanced into theLAA92. Finally, thecover portion130 may be placed over the ostium of theLAA92. Optionally, in some embodiments, thedevice8H may include a separate anchor system (not shown) that anchors thedevice8H into theLAA92. In another embodiment, theconnectors112 are set to lock in place. By locking in place, the entire structure is locked into position within theLAA92. In some embodiments, theelongate member110 may include a plurality of tines (not shown) that help attach thedevice8H within theLAA92.
• Turning toFIGS. 13A and 16B, an exemplary method is shown for deploying thedevice8G shown inFIG. 10. Initially, as shown inFIG. 13A, the distal end of thedelivery sheath11 may be advanced to theostium91 of the leftatrial appendage92. Theplunger140 is then moved relative to thedelivery sheath11, e.g., advanced while thedelivery sheath11 is held stationary. Moving on toFIG. 13B, as the spiralingmember110 is deployed from thedelivery sheath11, the spiralingmember110 coils around theostium91 of the leftatrial appendage92. In some embodiments, thedelivery sheath11 has a curved distal end. The distal end of thedelivery sheath11 may help position the spiralingmember110 against the tissue of the leftatrial appendage92.
• As shown, the spiralingmember electrodes112 may be evenly spaced along the spiralingmember110. In other embodiments, the spiralingmember electrodes112 are not evenly spaced. For example, the spiralingmember electrodes112 may be more closely spaced adjacent the distal end in order to have more electrodes located near the proximal portion of the leftatrial appendage92, while there may be just a few spiralingmember electrodes112 more proximally which are then positioned deeper into the leftatrial appendage92. This is because in some embodiments, as theplunger140 is advanced, this action several loops of the spiralingmember110 to coil deeper and deeper into the leftatrial appendage92.
• In some embodiments, a mechanism as used to dilate the spiralingmember110. In one embodiment, the spiralingmember110 is placed entirely within the leftatrial appendage92, and then the coils are released to create a radial force outwardly. This radial force holds the spiralingmember110 firmly against leftatrial appendage112 tissue. This mechanism includes a spring mechanism that can be released as well as an inner cable (not shown) that can be pulled or pushed to dilate/enlarge the coils of the spiralingmember110.
• Moving toFIG. 14A, theplunger140 continues to be advanced while thedelivery sheath11 remains stationary. The spiralingmember110 continues to coil distally into the leftatrial appendage92. Moving ontoFIG. 14B, theprocessor component120 is advanced into the leftatrial appendage92. Theprocessor component120 may fit within an open central region of the spiralingmember110 after it's deployed. Theconnector component110 may have stabilizing tines (not shown) to position theprocessor component120 within the center of the spiralingmember110.
• Moving on toFIG. 15A, the spiralingmember110 has several loops wrapping around the inside of the leftatrial appendage92. In addition, as shown, theprocessor component120 is located within the spiralingmember110. In some embodiments, one or more indicators may be provided on the proximal end of thedelivery sheath11 located outside of the body (not shown), e.g., to indicate that the spiralingmember110 andprocessor component120 should not be located entirely within the leftatrial appendage92. The deliversheath11 may then be withdrawn while theplunger140 is fixed.
• Moving toFIG. 15B, by withdrawing the deliversheath11 over theplunger140, theNitinol cover130 is released. TheNitinol cover130 is designed to self-expand. This causes theNitinol cover130 to cover theostium91 of the leftatrial appendage92. ThisNitinol cover130 may substantially occlude or otherwise isolate the leftatrial appendage92 from the rest of the left atrium (not shown).
• Moving toFIG. 16A, thedevice8G is now completely located within the leftatrial appendage92. Thedelivery sheath11 may be withdrawn to provide space between thedelivery sheath11 and thedevice8G. Theplunger140 may now be withdrawn to confirm thedevice8G is firmly positioned within the leftatrial appendage92. This is a ‘tug test’ to verify the device is unlikely to dislodge and embolize.
• Energy may then be delivered to the optimally positionedspiral member electrodes112. This energy may ablate the proximal portion of the leftatrial appendage92 tissue to electrically isolate the leftatrial appendage92. More distalspiral member electrodes112 may be used to monitor electrical activity from the leftatrial appendage92 to verify the leftatrial appendage92 has been electrically isolated.
• Moving toFIG. 16B, theplunger140 may then be rotated or otherwise manipulated to release thedevice8G. For example, as shown, rotation spins thescrew122 to release theplunger140 from thedevice8G. Theplunger140 may then be withdrawn. The distal end of theplunger140 includes connectingelectrodes125. These connectingelectrodes125 connect the inner wires within theplunger140 to electrodes within theconnector component120. Once theplunger140 leaves theNitinol cover130, theNitinol cover130 may have a self-closing valve (not shown) to completely close off thedevice8G.
• Turning toFIGS. 17A-19B, another embodiment of adevice8J is shown for electrical isolation of a leftatrial appendage92 generally similar to thedevice8H shown inFIG. 12 with several differences. In this embodiment, instead of aconnector component122 described inFIG. 12, thedevice8J includes aprocessor170 electrically connected to the spiralingmember electrodes112, e.g., located between a spiraling member100 carrying theelectrodes112 and acompression portion180. In addition, the spiralingmember110 may be deployed from the distal end of thedelivery sheath11 whereupon the spiralingmember110 may automatically coil towards a preset shape. Once coiled inside of theleft atrium90, thesheath11 may then be safely advanced towards theleft atrium appendage92.
• Moving on toFIG. 17B, thedevice8J may then be advanced deep into the leftatrial appendage92. The depth of thedevice8J may be determined and verified using a mapping system (not shown), e.g., connected to the spiralingmember electrodes112 such that the mapping system receives signals from theelectrodes112 that may be analyzed to confirm the position of the spiralingmember110. Theelectrodes112 may be coupled to the mapping system via wires that extend through thedelivery sheath11; alternatively, the signals may be sent wirelessly, e.g., via a wireless communications interface (not shown) communicating with theprocessor170. A battery (not shown) for theprocessor170 may be stored in the processor portion, e.g., mounted on a substrate (also not shown) that carries theprocessor170. In another embodiment, the spiralingmember110 has energy stored within this segment. The spiralingmember110 may therefore also function as a battery. Once the spiralingmember110 andsheath11 are optimally placed within the leftatrial appendage92, the spiralingmember110 may be enlarged to stabilize within the leftatrial appendage92.
• Moving on toFIG. 18A, once the spiralingmember110 is properly positioned, thedelivery sheath11 may be withdrawn, thereby releasing theprocessor170 within the leftatrial appendage92. In some embodiments, theprocessor170 itself may coil within the leftatrial appendage92 or theprocessor170 may maintain its original linear orientation. Moving toFIG. 18B, as thedelivery sheath11 is further withdrawn,processor stabilizing rods172 may be deployed, e.g., that expand radially outwardly from theprocessor170 to help position theprocessor170 within the leftatrial appendage92.
• Now moving toFIG. 19A, as thedelivery sheath11 is further withdrawn, thecompression portion180 is released, e.g., byplunger140, which may cause thecompression portion180 to resiliently expand to at least partially seal theostium91 of theLAA92. Thecompression portion180 is designed to deliver radial force against tissue within the leftatrial appendage92 to electrically isolate the leftatrial appendage92. The spiralingmember electrodes112 may be used to verify electrical isolation. These signals may be sent via theprocessor170 through wireless connection or coupled through theplunger140. Theprocessor170 may also be charged wirelessly from outside the body, e.g., using an inductive charging system (not shown). In some circumstances, electrodes (not shown) may be attached to or otherwise provided on thecompression portion180, e.g., configured to deliver energy to electrically isolate the leftatrial appendage92, e.g., if compression alone does not isolate the leftatrial appendage92.
• Moving on toFIG. 19B, theplunger140 may be rotated or otherwise decoupled to free theplunger140 from the rest of the device. Thedelivery sheath11 andplunger140 may then be removed from the body. As can be seen in this figure, sometimes theprocessor stabilizing rods172 are oriented in a different way to optimally position the device within the leftatrial appendage92.
• Optionally, theprocessor170 may continue to measure one or more patient characteristics based on electrical signals from theelectrodes112, e.g., to identify heart rate, recurrence of atrial fibrillation, or other arrhythmias. The electrodes112 (or other electrodes) on thedevice8J may measure both local electrical signals to identify electrical activity of the leftatrial appendage92 as well as far-field signals of the left atrium and ventricular activation. By measuring the interval between the ventricular signals, thedevice8J may identify atrial fibrillation. Theprocessor170 may send these signals to devices outside of the body for medical intervention.
• In another embodiment, thedevice8J may identify if local electrical reconnection has occurred within the leftatrial appendage92. In yet another embodiment, thedevice8J may measure left atrial pressure, oxygen saturation, cardiac output, and patient activity. In addition or alternatively, an accelerometer may be included on thedevice8J, and thedevice8J may measure heart rate and patient movement to determine if the heart rate is congruent with patient activity.
• Turning toFIGS. 20-21, another exemplary embodiment of thedevice8K is shown that includes a plurality of repeating subunits301-311 connected sequentially to one another byconnectors301c-311c. Although, thedevice8K includes eleven subunits301-311, it will be appreciated that thedevice8K may include any desired number of subunits. As shown, the subunits include a first subset that include battery subunits to provide abattery117 for thedevice8K, e.g., the distal two repeating subunits301-302, as shown inFIG. 20. Theconnectors301c-311cconnecting the subunits301-311 may be flexible to allow the subunits301-311 to move in a desired manner, e.g., during advancement through thedelivery sheath11, yet bias thedevice8K to adopt a desired shape when deployed. For example, theconnectors301c-311cmay provide hinge points that permit the subunits301-311 to fold on themselves to provide a desired expanded configuration. Optionally, theconnectors301c-311cmay include one or more tines (not shown), electrodes (not shown), or other components to facilitate deployment, e.g., similar to other embodiments described elsewhere herein.
• Turning toFIGS. 21A-21B, an exemplary method is shown for deploying thedevice8K when thedevice8K is advanced out of thedelivery sheath11. Initially, as shown inFIG. 21A, thedistal subunit301 is deployed from thedelivery sheath11, whereupon theconnector301cprovides a hinge point, e.g., biased to cause thedistal subunit301 to have an orientation change to theadjacent subunit302. For example, theconnector301cmay be biased to a “U” or other shape, e.g., to cause thedistal subunit301 to rotate or otherwise translate one hundred eighty degrees relative to thesecond subunit302. Moving ontoFIG. 21B, as thedevice8K is further advanced out of thedelivery sheath11, the subunits302-311 are deployed sequentially, and automatically fold relative to the adjacent subunits into a designed orientation. In some embodiments, theconnectors302c-311cof thedevice8K are configured to automatically orient the subunits302-311 as thedevice8K emerges from thedelivery sheath11.
• In other embodiments, an external force may be used to force the change in orientation. For example, theconnectors301c-311cmay have a hinge type joint where the degrees of freedom are designed to fold thedevice8K into the pre-designed orientation.
• FIG. 22 demonstrates an exemplary expanded configuration where the subunits301-311 orient themselves into a structure depicted, e.g., where the subunits301-311 are aligned axially adjacent one another with theconnectors301c-311calternating between opposite ends of the expanded structure. In this embodiment, the subunits301-311 are relatively fixed; while theconnectors301c-311cenable thedevice8K to fold into the depicted structure.
• FIG. 23 demonstrates another exemplary expanded configuration of thedevice8K where the subunits301-311 extend radially outwardly from a central region, to provide a conformational change once positioned inside the LAA (not figured). In this example, theconnectors303c,305c,307c,309c, and311care designed to expand along their hinge joint, whileother connectors301c,302c,304c,306c,308c, and310care designed to maintain a closed position.
• Optionally, one or more tines and/or leads (not shown) may be provided on theconnectors304c,306c,308c, and310cthat make contact against the LAA (not shown), e.g., to prevent embolization or to confirm contact through electrical signals, similar to other embodiments herein. In other embodiments, theconnectors304c,306c,308c, and310cmay include electrodes (not shown) that may be used for visualization, cardiac pacing, tissue heating (for tissue ‘sticking’), ablating, and/or electroporation, as previously described elsewhere herein.
• Alternatively, the example shown inFIG. 23 may represent the configuration of thedevice8K wherein initially deployed within the left atrium, e.g., when fully deployed from thesheath11. Features such as tines, hooks, loops, or the like (not shown) on the distal portion of theconnectors304c,306c,308c,310cmay be manipulated to narrow the device profile to the configuration presented inFIG. 22 for advancement into theLAA92.
• For example, with reference toFIG. 24, thedevice8K may be deployed within theleft atrium90 in the configuration shown inFIG. 23 and then folded or otherwise constrained into the configuration shown inFIG. 22, whereupon the foldeddevice8K may be advanced into theLAA92, e.g., overguide330. In this embodiment, thedelivery sheath11 has been advanced into theleft atrium90 through theinteratrial septum94. Once inside theleft atrium90, theelongate device8G may be advanced to create the desired shape within theleft atrium90, e.g., the deployed configuration shown inFIG. 23. Similar to a ship-in-a-bottle, thedevice8K may be manipulated to take on a conformational change within theleft atrium90 to take on a desired shape or structure, e.g., that shown inFIGS. 22 and 24. The conformeddevice8K may then be advanced into theLAA92. Once inside theLAA92, thedevice8K may take on a second conformational change to deploy thedevice8K into theLAA92, e.g., by releasing thedevice8K to allow the subunits to resiliently return towards the configuration shown inFIG. 23. The second conformational change locks thedevice8G in place within theLAA92.
• In the embodiment depicted inFIG. 24, anelongate guide member330 is provided that is configured to pass through a delivery lumen of thedelivery sheath11, theproximal connector311c(not shown), and theproximal subunit311. In exemplary embodiments, theelongate guide member330 may be a wire or may be a steerable catheter. In other embodiments, theelongate guide member330 may be similar to a pigtail catheter with an inner lumen that allows an inner wire to advance through theelongate guide member330. For example, a distal portion of theelongate guide member330 may be exposed from thesheath11 and advanced or otherwise directed into theLAA92, and then thedevice8K may be advanced over theelongate guide member330 in order to position thedevice8K optimally within theLAA92. In some embodiments, theelongate guide member330 passes through an inner lumen of theconnector311candsubunit311 orconnector301c.
• In some embodiments, at least the distal portion of theelongate guide member330 may have a substantially square or other non-circular cross-section. By being square, theelongate guide330 may be spun to deliver force to thedevice8G. For example, if theelongate guide member330 and an inner lumen of thesubunit311 have a similar cross-section, rotating theelongate guide member330 about its longitudinal axis may be used to spin thesubunit311. This spinning motion may be designed to expand thedevice8K into a desired expanded configuration, for example, the configuration shown inFIG. 23.
• In other embodiments, theelongate guide member330 may include a balloon or other expanded member on the distal portion that may be inflated or otherwise expanded to expand or otherwise deploy thedevice8K once in place in theLAA92. The balloon portion may be asymmetric in order to expand the distal or proximal connectors. In other embodiments, theelongate guide member330 may also include docking features (not pictured) to interface with the distal portion of thedevice8K, e.g., providing an additional landmark for visibility during device placement.
• Alternatively, other mechanisms may be provided to orient thedevice8K, e.g., including one or more of springs, ratchets, Nitinol or other elastic material, temperature-activated materials, and/or through electricity. As an example,FIG. 33 shows thedevice8K in the delivery configuration, with the articulating members of thedevice8K including springs and micro-ratchets. Deployment of theFIG. 33 device into the atrium, advancement into the LAA, and further expansion in the LAA are shown inFIGS. 34A-C, respectively. In some embodiments, one of the connectors used to orient thedevice8K may also serve as an atraumatic lead in the tip of thedelivery sheath11.
• In other embodiments, a string or wire may run through thedevice8K, e.g., as shown inFIG. 35A where the device has been deployed in the left atrium. As shown inFIG. 35B, the string may be pulled or otherwise actuated from outside the patient, e.g., using an actuator on the proximal end (not shown) of thesheath11, to force the subunits to collapse as or after thedevice8K is advanced out of thedelivery sheath11. Once thedevice8G is positioned within theLAA92, the string may be relaxed. The relaxation may then cause certain connectors (or all the connectors) to elongate in prescribed directions and/or force to lock thedevice8K within theLAA92. For example, once the string is relaxed, thedevice8K may expand automatically through a variety of methods, including but not limited to a spring mechanism, Nitinol, temperature-activated materials, and/or electrical energy. Optionally, the string may be tightened to collapse thedevice8K in a desired manner, e.g., into the configuration as illustrated in FIG.22. As exemplified inFIGS. 36A-36D, repositioning within theLAA92 while in the narrowed configuration ofFIG. 22 may be repeated as needed, by relaxing the string to expand thedevice8G (FIG. 36A), verifying the position, and tightening the string to reposition as necessary (FIGS. 36 B-C). After the string is relaxed and placement within theLAA92 is confirmed (FIG. 36D), the string may then be cut or otherwise separated and withdrawn from thedevice8K to leave thedevice8K in place within theLAA92.
• In another embodiment, e.g., as illustrated inFIG. 30A, a balloon may be provided on a distal tip (not shown) of theelongate guide member330, which may be filled with saline and/or other inflation media to expand the subunits301-311 of thedevice8K in a desired manner, e.g., opening the proximal connectors to assume the shape inFIG. 23, creating contact with the distal portion of thedevice8K and theLAA92. As shown inFIG. 30B, if thedevice8K needs to be advanced into theLAA92, the balloon may be inflated within the proximal connectors, thereby expanding the proximal profile of thedevice8K and narrowing the position of the distal connectors. The balloon may then be collapsed, thedevice8K advanced further into theLAA92, and the balloon inflated within the distal connectors, e.g., as shown inFIG. 30C. In another embodiment, features on the distal connectors remain captured by the delivery system using a string method similar to that described above, and are leveraged to collapse the device after balloon expansion.
• In another embodiment, thedelivery sheath11 may be used to collapse thedevice8K in a desired manner, e.g., as shown inFIGS. 31A-31D. In this embodiment, thedistal tip11bof thedelivery sheath11 may include a plurality ofaxial slots11cand one or more circumferential strings, wires, orother filaments11dcoupled to the subunits301-311. The filament(s)11dmay be relaxed to widen the sheath distal diameter, e.g., as shown inFIG. 31B, and then thesheath11 is advanced over the proximal connectors, as shown inFIG. 13C. Once the proximal connectors and part of the rigid subunits are captured, thecircumferential filament11dmay be tightened to collapse thedistal tip11cof thesheath11 and narrow the device profile, as shown inFIG. 31D, for introduction into the LAA (not shown).
• Turning toFIGS. 25A and 25B, an exemplary method is for implanting thedevice8K, i.e., deploying, introducing and anchoring thedevice8K within theLAA92. Initially, the device8K8G is advanced into theLAA92 in a constrained condition, e.g., similar to the configuration shown inFIG. 22. Moving ontoFIG. 25B, the device8kmay then be enlarged or otherwise deployed to connect within the walls of theLAA92, e.g., similar to the configuration shown inFIG. 23. Thedevice8K may then undergo tug testing from outside the patient's body to make sure thedevice8K is adequately fixed within theLAA92, visually assessed using fluoroscopy, echocardiography, or other visual mapping methods to confirmdevice8G shape and depth of position, and/or contact with the LAA may be confirmed by electrical signal. If needed, the device may be recaptured, repositioned, and then re-deployed, e.g., using any of the methods described elsewhere herein. In another embodiment, if fixation is insufficient, the proximal hinges may be further elongated or otherwise manipulated in order to widen the angle between the rigid subunits, providing greater apposition to theLAA92.
• Moving on toFIG. 26, once thedevice8K is satisfactorily deployed within theLAA92, a cover or occludingportion21 may be deployed to cover the ostium of theLAA92. Thecover21 may be made out of a variety of materials. Thecover21, which may be similar to cover130 or any of the other embodiments described elsewhere herein, is designed to cap the ostium of theLAA92 and prevent thrombus or clot that may form within theLAA92 from leaving theLAA92. In some embodiments, thecover21 includes one ormore pacing electrodes132, e.g., located on theLAA92 side of thecover21. These pacingelectrodes132 may be configured to contact the wall ofleft atrium90 outside of theLAA92. Therefore, if theLAA92 is electrically isolated, the pacingelectrodes132 are still able to sense and capture atrial tissue. The pacingelectrodes132 may be single or bipolar electrodes. The pacingelectrodes132 are therefore able to sense atrial depolarizations and deliver pacing stimulations to pace the atrial tissue. In some embodiments, atrial anti-tachycardia pacing (ATP) may be delivered from oneelectrode132 and sensed by other electrodes. Therefore, pacing stimulations may be delivered at one location; and distant electrodes are able to determine if the pacing stimulations are capturing heart tissue. The ATP algorithm may then change pacing strategies based on whether the pacing stimulations are capturing the atria.
• In some embodiments, the center of thecover21 is deployed first, followed by the outer circumference of thecover21. In other embodiments, the outer circumference is deployed first, contact with ostium verified through methods described above, and the remainder of thecover21 deployed. If the leads in thecover21 are unable to obtain sufficient contact with the ostium, thecover21 may be recovered into the delivery system, repositioned, and redeployed.
• Turning toFIGS. 32A and 32B, in other embodiments, thecover21 may include two regions, afirst region21athat caps the ostium of the LAA and amiddle member21bthat sits within the LAA. In some embodiments, themiddle member21bmay include one or more temporary orpermanent leads21cfor electrical isolation of the LAA, e.g., as shown inFIG. 32B. Themiddle member21bmay be deployed before thecap21ato allow for electrical isolation treatments to be conducted before thecap21ais deployed. In some embodiments, thecover21 andmiddle member21bmay include one or more channels through which theleads21cused for electrical isolation or materials for electroporation may be advanced and removed. In other embodiments, themiddle member21bitself may be composed of materials that may be utilize to complete established isolation methods. Furthermore, in some embodiments, themiddle member21bprovides tension between thecover21aand the remainder of thedevice8K implanted further in the LAA, ensuring apposition between thecover21aand the ostium of theLAA92. In other embodiments, the deployment of thecover21aormiddle member21bfurther widens the angle between the rigid subunits in the distal portion of thedevice8K.
• Turning toFIGS. 27A and 27B, two different expanding devices are shown that include a different number of subunits.FIG. 27A shows a device with seven (7) subunits301-307, whileFIG. 27B shows a device with eleven (11) subunits301-311. In either embodiment (or any of the others wherein), the device may include two or more subunits that provide a housing to contain the various components previously described, e.g., a processor, battery, communications interface, and the like. The subunits may take on various lengths and sizes. For example, in the embodiments shown inFIG. 21-FIG. 26, the subunits may have lengths longer than about ten millimeters (10 mm) and less than about thirty millimeters (30 mm). The diameter of the subunits may be larger than about three millimeters (3 mm) and less than about six millimeters (6 mm). In some embodiments, the subunits are sized to be about twenty one millimeters (21 mm) in length (+/−5 mm) and about four millimeters (4 mm) in diameter (+/−1 mm).
• Turning toFIG. 28, a flow diagram is shown illustrating an exemplary method for implanting a device, such as thedevice8K (or any other devices herein). Instep401, access of the left atrium is obtained. A delivery sheath is typically placed across from the right atrium into the left atrium. Instep402, the device is advanced into the left atrium. Moving to step403, once part of the device is located within the left atrium, and the device changes shape (e.g., automatically upon deployment or upon being actuated). The shape change may be described as a conformation change or a configuration change. Moving to step404, the conformed or configured device may then be advanced into or near the left atrial appendage. Instep405, the device may then undergo a second shape change within or near the left atrial appendage (e.g., constrained or otherwise manipulated into a smaller profile). This second shape change may also be described as a second conformational or second configuration change. In some embodiments, this second shape change is utilized to keep the device within or near the left atrial appendage. Instep406, the device may then be deployed within or near the left atrial appendage. The delivery tools may then be removed from the left atrium.
• FIG. 29 is another flow diagram describing another exemplary embodiment implanting any of the devices described herein. Instep411, trans-septal puncture is obtained. Instep412, the left atrial appendage is electrically isolated. Electrical isolation may be achieved through heating, freezing, laser energy, or electroporation. Electrical isolation may be achieved through an ablation catheter that is separate from the device that will be deployed within or near the left atrial appendage. Therefore, in one embodiment, an ablation catheter may be used to electrical isolate the left atrial appendage. After the left atrial appendage is electrically isolated, we move to step413 where the device is deployed within or near the left atrial appendage. In other embodiments, the device that will be deployed into or near the left atrial appendage achieves electrical isolation. Moving to step414, at least one electrode is positioned against the left atrium but outside the left atrial appendage. Instep415, the device is deployed to monitor and treat atrial arrhythmias by pacing from the electrode positioned against the left atrium but outside the left atrial appendage. In some embodiments, the device has at least two electrodes spaced apart from each other against left atrial tissue but outside the left atrial appendage. By having two electrodes spaced apart, one electrode can delivery anti-tachycardia pacing (ATP) while the second electrode can monitor for local electrical activity to determine if the ATP pacing pulses are capturing at least a section of atrial tissue.
• In another embodiment, an electrode is placed deep into the left atrial appendage. This electrode may be used to sense electrical activity. For example, ventricular activity may be determined. In another embodiment, high output pacing from an electrode positioned near the left ventricle can be used to pace the left ventricle. The device may deliver high-powered shocks or defibrillations to convert both atrial and ventricular arrhythmias. When delivering atrial cardioversions, these high powered pulses should be synced to ventricular activity.
• Further, in describing representative embodiments, the specification may have presented the method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims.
• While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.

Claims (21)

1. A leadless pacemaker device for implantation within or near a left atrial appendage extending from a left atrium of a heart to monitor and/or treat a patient with conduction abnormalities and/or cardiac dysrhythmias, the device comprising:

a battery capable of storing electrical energy;

at least one electrode capable of sensing and pacing the left atrium;

a control processor capable of processing data;

a communication module to communicate outside of the patient; and

a cover portion designed to prevent thrombus from within the left atrial appendage of the left atrium to embolize out of the left atrial appendage of the left atrium;

wherein at least a portion of the device comprises a linear chain of subunits coupled together by connectors, wherein the connectors configured to allow each subunit to change orientation relative to any adjacent subunits.

2. The device ofclaim 1, wherein the subunits are cylindrical in shape, wherein subunits define a length that is between about ten and thirty millimeters (10-30 mm), and a diameter that is between about three and six millimeters (3-6 mm).

3. The device ofclaim 1, further comprising that the at least one electrode capable of sensing and pacing the left atrium is configured to be located against the wall of the left atrium outside of the left atrial appendage and at least two millimeters (2 mm) away from the ostium of the left atrial appendage.

4. The device ofclaim 1, further comprising at least one electrode configured for delivering ablation energy.

5. The device ofclaim 1, wherein the subunits are configured to undergo a first conformational change upon entering the left atrium and then undergo a second conformational change after being positioned within the left atrial appendage.

6-13. (canceled)

14. A leadless pacemaker system, comprising:

a delivery sheath comprising a proximal end, a distal end sized for introduction into a left atrium of a heart, and a lumen extending between the proximal and distal ends;

a pacemaker device comprising a plurality of elements deployable sequentially through the lumen from the distal end into the left atrium, the elements configured to adopt an expanded configuration within the left atrium;

an actuator for advancing the elements from the left atrium into the left atrial appendage, and releasing the elements to implant the device within the left atrial appendage.

15. The system ofclaim 14, wherein the elements are connected sequentially together by connectors between adjacent elements, the connectors biased to a nonlinear shape such that, when the elements are deployed from the distal end of the delivery sheath, the connectors automatically cause the elements to spiral or fold into the expanded configuration.

16. The system ofclaim 15, further comprising a constraining mechanism for constraining the elements in a contracted configuration having a lower profile than the expanded configuration before advancing the elements into the left atrial appendage.

17. The system ofclaim 16, wherein the actuator is configured to release the elements from the contracted configuration once advanced into the left atrial appendage such that the connectors bias the elements back towards the expanded configuration to secure the elements within the left atrial appendage.

18. The system ofclaim 14, wherein the actuator comprises a plunger slidable within the lumen of the delivery sheath.

19. The system ofclaim 14, wherein the elements are connected sequentially together by connectors between adjacent elements, and wherein the actuator is coupled to the connectors to direct the connectors to a nonlinear shape and cause the elements to spiral or fold into the expanded configuration.

20. The system ofclaim 19, further comprising a constraining mechanism for constraining the elements in a contracted configuration having a lower profile than the expanded configuration before advancing the elements into the left atrial appendage.

21. The system of claim29, wherein the actuator is further configured to direct the elements from the contracted configuration towards the expanded configuration to secure the elements within the left atrial appendage.

22. The system ofclaim 14, further comprising a cover operatively coupled to the elements and slidably received within the lumen such that the cover is deployed from the lumen after deploying the elements, the cover expandable for isolating the left atrial appendage from the left atrium after advancing the elements into the left atrial appendage.

23. The system ofclaim 22, further comprising one or more electrodes carried by the cover, the one or more electrodes configured to contact a wall of the left atrium outside the left atrial appendage when the left atrial appendage is isolated by the cover.

24. The system ofclaim 23, further comprising a processor coupled to the one or more electrodes configured to:

identify a cardiac condition of the heart warranting pacing; and

deliver electrical pacing via at least one of the one or more electrodes until the cardiac condition is remedied.

25. The system ofclaim 14, wherein the pacemaker device further comprises a plurality of electrodes coupled to a power source, the electrodes configured to deliver energy to ablate atrial tissue to electrically isolate the left atrial appendage from the rest of the left atrium.

26. The system ofclaim 14, wherein the electrodes carry one or more electrodes, the system further comprising a power source coupled to the one or more electrodes to deliver energy to heat tissue adjacent tissue to secure the elements within the left atrial appendage.

27. A method for implanting a leadless pacemaker device within a left atrial appendage extending from a left atrium of a heart, comprising:

introducing a distal end of a delivery sheath into the left atrium;

deploying a plurality of elements of the pacemaker device sequentially from the distal end into the left atrium, the elements adopting an expanded configuration within the left atrium;

advancing the elements from the left atrium into the left atrial appendage; and

releasing the elements to implant the device within the left atrial appendage.

28-41. (canceled)

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