Apparatus, systems, and methods to improve atrial fibrillation outcomes involving the left atrial appendage

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.

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 of  claim 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 of  claim 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 of  claim 1 , further comprising at least one electrode configured for delivering ablation energy. 
     
     
         5 . The device of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 14 , wherein the actuator comprises a plunger slidable within the lumen of the delivery sheath. 
     
     
         19 . The system of  claim 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 of  claim 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 claim  29 , 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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 of  claim 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)