Epicardial implant system for ablation, electrical stimulation, and lesion integrity monitoring

Abstract

Example embodiments disclosed herein relate to implantable cardiac technologies. An example implantable cardiac device can include an electrode module configured for chronic implantation within a pericardial space of a subject. The device can also include at least one lead to operably couple the electrode module and a control module. Some disclosed embodiments can be used to perform sensing, monitoring, and ablation of a heart.

Description

PCT Application Attorney Docket No.: 009062.8579.WOOO EPICARDIAL IMPLANT SYSTEM FOR ABLATION, ELECTRICAL STIMULATION,AND LESION INTEGRITY MONITORINGCROSS-REFERENCE TO RELATED APPLICATION

[0001] This patent document claims priority to and benefits of U.S. Provisional Application 63 / 754,467, entitled, “EPICARDIAL IMPLANT SYSTEM FOR ABLATION, ELECTRICAL STIMULATION, AND LESION INTEGRITY MONITORING,” and filed on February 5, 2025. The entire content of the above identified patent application is incorporated by reference as part of the disclosure of this patent document.TECHNICAL FIELD

[0002] The present patent document generally relates to the field of cardiology and, although not exclusively, to implantable epicardial devices.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] FIG. 1 shows different views of an example implantable cardiac device based on the disclosed technology.

[0004] FIG. 2 shows different views of another example implantable cardiac device based on the disclosed technology.

[0005] FIG. 3 shows a schematic of a heart and example pericardial space.

[0006] FIG. 4 shows different views of yet another example implantable cardiac device based on the disclosed technology.

[0007] FIG. 5 shows a schematic of a heart and example pericardial space.

[0008] FIG. 6 shows different views of yet another example implantable cardiac device based on the disclosed technology.

[0009] FIG. 7 shows different views of yet another example implantable cardiac device based on the disclosed technology.

[0010] FIG. 8 shows a schematic of yet another example implantable cardiac device based on the disclosed technology.

[0011] FIG. 9 shows an example implementation of a system based on the disclosed technology.

[0012] FIG. 10 shows a three-dimensional image of an example implementation of anPCT Application Attorney Docket No.: 009062.8579.WOOO implantable cardiac device based on the disclosed technology.

[0013] FIG. 11 shows a three-dimensional image of another example implementation of an implantable cardiac device based on the disclosed technology.

[0014] FIG. 12 shows a block diagram of an example hardware implementation in accordance with some embodiments based on the disclosed technology.

[0015] FIG. 13 shows a flowchart of an example method based on the disclosed technology.

[0016] FIG. 14 shows a block diagram of an example implementation of a control module, according to some embodiments of the disclosed technology.DETAILED DESCRIPTION

[0017] Disclosed herein are methods, devices, and systems relating to an implantable device that can perform repeated ablations on the atrial epicardium. Some example embodiments include a re-usable device that can monitor the status of previous ablations, perform a repeat procedure, and measure the electrical conduction of the heart tissue. The disclosed embodiments, among other features and benefits, can provide better treatment of conditions such as arrhythmias and atrial fibrillation (AF) without the need for repeated surgeries. Similar to a pacemaker, some disclosed devices could remain in-situ for a long time to provide better cardiac monitoring and treatment of arrhythmia in a less invasive fashion.

[0018] Atrial arrhythmias are a common heart condition, often treated with surgical ablation. The main problem with this treatment is that ablation lesions often lose effectiveness over time and require repeat surgery. Repeated ablations may temporarily alleviate the condition, but they are also risky and can lead to worse longer-term outcomes. Producing an implantable, long term device could reduce the need for repeated surgeries, resulting in better treatments for patients with these conditions.

[0019] Current solutions to ablation of atrial arrhythmias such as AF are suboptimal, as success rates beyond 1 year are low, especially for patients with non-paroxysmal AF. Two of the biggest issues are that (i): acute non-conductive lesions might lose integrity over time and results in repeat procedures; and (ii): more ablations might be more effective in eliminating AF but also lead to worse long-term outcomes. The best amount of ablation is not known.

[0020] Current approaches that aim to improve on the current state-of-the-art aim to make procedures as fast as possible (e.g. Pulmonary vein isolation (PVI) using pulsed field ablation) orPCT Application Attorney Docket No.: 009062.8579.WOOO aim to get the longest time until AF recurrence using a more invasive approach or lesion set (e.g. maze-procedure or hybrid ablation).

[0021] One goal of the disclosed technology is to improve on this by implanting a device that can perform repeat ablations without the need of a full repeat procedure, using the already implanted device. Due to the contact with the epicardium, the device can be implemented to deliver medication to the tissue, control / terminate AF, repeat lesion sets, extend lesion sets, check the electrical conduction of the heart, and check if a lesion set still provides a full nonconducting barrier of electrical propagation. Depending on the individual AF progression of the patient, different strategies can be used. As an example, possible applications range from terminating arrythmias once they occur (e.g. patients with rare atrial arrythmias), to repeat ablation as needed (e.g. for patients that recur because of new or old gaps in prior lesion sets), and to extending lesion sets (e.g. for patients with progressing persistent AF).

[0022] FIG. 1 shows different views of an example implantable, flexible cardiac device based on the disclosed technology. The device 100 includes a flexible substrate 110 which can be disposed on an epicardial surface of the heart. The device 100 includes a surface 120 which can be disposed on an epicardial surface (e.g., the posterior wall) of the heart. The flexible substrate 110 and surface 120 can both include electrodes configured to activate tissue, record electrical tissue signals, and. / or ablate cardiac tissue. A plurality of electrodes may be disposed on the flexible substrate 110. For example, a bottom side of the surface 120 can include a flexible electrode array comprising flexible or semi-flexible electrodes configured to contact the epicardial surface. The device 100 includes an electrical wire 130 to enable communication between the device 100 and a control module (unpictured) such as an implantable microcontroller. Exemplary relative dimensions of the device 100 are shown on the lower middle panel in FIG. 1. In some implementations, dimensions of the device 100 can be customized based on the individual geometry of a patent or fabricated in standard sizes.

[0023] FIG. 2 shows different views of another example implantable, flexible cardiac device based on the disclosed technology. The device 200 includes a flexible substrate 210 which can be disposed on an epicardial surface of the heart. The device 200 includes a surface 220 which can be disposed on an epicardial surface (e.g., the posterior wall) of the heart. The flexible substrate 210 and the surface 220 can both include electrodes configured to activate tissue, record electrical tissue signals, and ablate cardiac tissue. A plurality of electrodes may be disposed onPCT Application Attorney Docket No.: 009062.8579.WOOO the flexible substrate 210. The device 200 includes an electrical wire 230 to enable communication between the device 200 and a control module (unpictured) such as an implantable microcontroller. The device 200 has a gap 240, enabling positioning of the device 200 around an anatomical structure of the heart (e.g., pulmonary veins). The device 200 includes a surface 250 comprising electrodes which can contact the epicardial surface. Exemplary relative dimensions of the device 200 are shown on the lower middle panel in FIG. 2. In some implementations, dimensions of the device 200 can be customized based on the individual geometry of a patent or fabricated in standard sizes.

[0024] FIG. 3 shows a schematic of a heart and example pericardial space, where example configurations of some disclosed embodiments (e.g., devices 100 and 200) may be positioned. Specifically, FIG. 3 shows a posteroanterior view (FIG. 3, left) from outside the heart to the atrium and an anterior view (FIG. 3, right) from within the inside of the left atrium. Pericardial reflections, major vessels, and oblique / transverse sinus are marked in FIG. 3. In FIG. 3, the dotted lines 300 and the area 310 located near the oblique sinus indicate areas in which some example devices can be placed within the pericardial space. In some disclosed embodiments, a portion of the device may be flexible at the area 310 as indicated in FIG. 3 and its geometry may be adapted in a patient specific manner. This portion of the device may be of various possible shapes (e.g., rounded, square, rectangular etc.). In FIG. 3, the line shown within the circled region 320 indicates an area in which the pericardial reflection may be opened or punctured, in accordance with some disclosed embodiments, for full circumferential lesions set around the pulmonary veins. Some disclosed embodiments may not puncture the pericardial reflections and / or use two separate devices (e.g., one on either side of the pericardial reflection) for maximum lesion coverage in areas of interest.

[0025] FIG. 4 shows different views of another example implantable, flexible cardiac device based on the disclosed technology. The device 400 includes a flexible substrate 410 which can be disposed on an epicardial surface of the heart. The device includes surface 420 which can be disposed on an epicardial surface (e.g., the posterior wall) of the heart. The flexible substrate 410 and the surface 420 can both include electrodes suitable to activate tissue, record electrical tissue signals, and ablate cardiac tissue. A plurality of electrodes may be disposed on the flexible substrate 410. The device 400 includes an electrical wire 430 to enable communication between the device 400 and a control module (unpictured) such as an implantable microcontroller. ThePCT Application Attorney Docket No.: 009062.8579.WOOO device 400 includes a surface 450 comprising electrodes which can contact the epicardial surface. In this example, the flexible substrate 410 provides two “arms” of the device 400. Exemplary relative dimensions of the device 400 are shown on the lower middle panel in FIG. 4. In some implementations, dimensions of the device 400 can be customized based on the individual geometry of a patent or fabricated in standard sizes.

[0026] FIG. 5 shows a schematic of a heart and pericardial space, where example configurations of some disclosed embodiments (e.g., device 400) may be positioned. Specifically, FIG. 5 shows a posteroanterior view (FIG. 5, left) from outside the heart to the atrium and an anterior view (FIG. 5, right) from within the inside of the left atrium. Pericardial reflections, major vessels, and oblique / transverse sinus are marked in FIG. 5. In FIG. 5, the dotted lines 500 and area 510 located near the oblique sinus indicate areas in which some example devices can be placed within the pericardial space. In some disclosed embodiments, a portion of the device may be flexible at the area 510 as indicated in FIG. 5 and its geometry may be adapted in a patient specific manner. This portion of the device may be of various possible shapes (e.g., rounded, square, rectangular etc.). In FIG. 5, the line shown within the circled region 520 indicates an area in which the pericardial reflection may be opened or punctured, in accordance with some disclosed embodiments, for full circumferential lesions set around the pulmonary veins. In contrast to FIG. 3, this example configuration avoids manipulation of the Ligament of Marshall or the transverse sinus, which provides increased safety. In some implementations of the disclosed embodiments (e.g., device 400), gaps around the pulmonary veins may be isolated via an endocardial ablation procedure.

[0027] FIG. 6 shows different views of yet another example implantable, flexible cardiac device based on the disclosed technology. The device 600 includes a flexible substrate 610 which can be disposed on an epicardial surface of the heart. The device 600 includes a surface 620 which can be disposed on an epicardial surface (e.g., the posterior wall) of the heart. The flexible substrate 610 and the surface 620 can both include electrodes configured to activate tissue, record electrical tissue signals, and ablate cardiac tissue. A plurality of electrodes may be disposed on the flexible substrate 610. The device 600 includes two electrical wires 630 to enable communication between the device 600 and a control module (unpictured) such as an implantable microcontroller. The device 600 includes a surface 650 comprising electrodes which can contact the epicardial surface. Exemplary relative dimensions of the device 600 are shownPCT Application Attorney Docket No.: 009062.8579.WOOO on the lower middle panel in FIG. 6. Tn some implementations, dimensions of the device 600 can be customized based on the individual geometry of a patent or fabricated in standard sizes. In the example of FIG. 6, the flexible substrate 610 includes a first arm and a second arm. As shown in FIG. 6, the first arm comprises a first portion of the flexible substrate 610 and an electrical wire 630. As further shown in FIG. 6, the second arm comprises a second portion of the flexible substrate 610, the surface 620. and another electrical wire 630. The first arm can be removably coupled to second arm. In some embodiments, the first arm and the second arm are removably coupled to define an opening configured to receive a cardiac structure therethrough. In some embodiments, at least one of the first arm or the second arm comprises a surface configured for placement on the epicardial surface of the heart. In some embodiments, the first arm and the second arm each comprise a lead configured to couple the first arm or the second arm to a control module. In some embodiments, the first arm and / or the second arm include electrodes disposed on a surface of the first arm or the second arm.

[0028] FIG. 7 shows different views of yet another example implantable, flexible cardiac device based on the disclosed technology. The device 700 includes a flexible substrate 710 which can be disposed on an epicardial surface of the heart. The device includes a surface 720 which can be disposed on an epicardial surface (e.g., the posterior wall) of the heart. The flexible substrate 710 and the surface 720 can both include electrodes suitable to activate tissue, record electrical tissue signals, and ablate cardiac tissue. A plurality of electrodes may be disposed on the flexible substrate 710. The device 700 includes an electrical wire 730 to enable communication between the device 700 and a control module (unpictured) such as an implantable microcontroller. The device 700 includes a surface (“arm”) 750 comprising electrodes which can contact the epicardial surface. An example configuration 760 of the electrodes on the surface 750 is shown in FIG. 7. In the example of FIG. 7, the configuration 760 includes at least I row of electrodes. In some disclosed devices, electrodes may be configured on the surface 750 in an array or other configuration. The distance between electrodes is selected to be low enough to facilitate the placement of ablation lesions that do not lead to immediate conduction gaps between lesions. The device 700 can be fixated using a mechanism 770 (e.g., mechanical or adhesive) that allows a stable and permanent conductive contact between electrodes and the tissue. Examples of possible fixation mechanisms 770 include hydrogels, biocompatible glues, mesh structures, sutures, silicon microstructures, or a combination thereof.PCT Application Attorney Docket No.: 009062.8579.WOOO

[0029] In some implementations, any of the devices 100, 200, 400, 600, and 700 can include a flexible arrangement of electrodes on the flexible substrate (110, 210, 410, 610, and 710) and / or the surface (120, 220, 420, 620. and 720).

[0030] FIG. 8 shows an example device 800 which may be included as part of some disclosed embodiments. In certain implementations of some disclosed embodiments, navigation and placement of tight pericardial spaces or puncturing a pericardial reflection (e.g. inferior vena cava) may be needed. Some disclosed embodiments may include multiple devices 800 that are placed in different areas in the pericardial space. Such devices 800 may be activated together or separately by a control module (e.g., microcontroller). In an example implementation of some disclosed embodiments, a device 800 can be placed around the right pulmonary veins. Another device 800 may be used to mainly target the left pulmonary veins, the posterior wall, or other. The device 800 can include electrodes (e.g., on a bottom surface of the device 800) and may have several configurations in which the electrodes can be controlled, activated, and / or communicated with.

[0031] Some disclosed embodiments include one or more of the devices 800. In some embodiments, each electrode of the device 800 may be activated independently for a specific functionality, e.g., ablation, stimulation, recording, etc.. Some disclosed embodiments may include specialized electrodes that fulfill different roles. For example, some disclosed devices (e.g., 400 and 600) can include middle electrodes, disposed on the amis of the device, which may be used to deliver ablation (e.g., via pulsed electric fields). Some disclosed devices (e.g., 100, 200, 400, 600, 700) can include outer electrodes which may be solely or primarily used for stimulation and recording of electrical signals. Some disclosed devices can include electrodes which may contact a surface or region of the heart located on the rectangular patches shown in FIG. 3 and FIG. 5, respectively. In some disclosed embodiments, a microcontroller can communicate with certain electrodes in a group, e.g., electrodes used to perform ablation.

[0032] Some disclosed embodiments include one or more housings, such as housings for a battery, electronics, and / or transmission coils. In some disclosed embodiments, the housing comprises alumina ceramic (AI2O3). Some disclosed embodiments include connectors and / or cables (e.g. IS-1 plug or Craggs connectors) comprising gold or platinum. In some disclosed embodiments, a flexible support structure for electrodes can comprise a titanium sheet coated in polydimethylsiloxane (PDMS), or Parylene C or Polyurethane to provide stability. In somePCT Application Attorney Docket No.: 009062.8579.WOOO disclosed embodiments, some or all of the electrodes comprise platinum or a platinum alloy (e.g., platinum iridium alloy). In some disclosed embodiments, adhesion to the cardiac epicardial surface within the pericardial space can be achieved using a bio-compatible glue such as NBCA chemical adhesive.

[0033] FIG. 9 shows an example implementation of a system based on the disclosed technology. The system 900 includes an implantable medical device 910 (e.g., devices 100, 200, 400, 600, 700, 800) and an implantable microcontroller 920 with a battery. The microcontroller 920 can activate / enable ablation, stimulation, or recording functionalities of the device. The microcontroller 920 can include a storage to store cardiac information regarding, e.g., arrythmia type and burden. The microcontroller 920 can communicate with external hardware (e.g., computer 930) to provide information such as status of lesions, arrythmia. battery, and device functionality. The microcontroller 920 may communicate with the computer 930 in a wired or wireless manner. The computer 930 can transmit signals to and receive signals from the microcontroller 920. The microcontroller 920 can be implemented to readout data obtained using the medical device 910, perform data analysis, and / or provide instructions to the device 910 (e.g., instructions to ablate a particular anatomical region), among other functionalities. The system 900 can include an ablation energy generator 940 and / or a stimulation energy generator 940, coupled to the device 910, which can generate electrical or ablative energy which can be used by the device 910 to deliver an energetic stimulus to the heart.

[0034] In one example, the device 910 comprises a flexible arrangement of electrodes disposed on an epicardial surface of a heart within the pericardial space. The device 910 can be connected to the microcontroller 920 and battery using a standard wire configuration. The microcontroller 920 can be located under the skin in the upper chest and may record electrical signals from the electrodes of the device 910 or by itself. The microcontroller 920 can stimulate one or more electrodes of the device 910 and send signals to the device 910 necessary to enable tissue ablation via an external ablation energy generator (e.g., pulsed electric fields). The microcontroller 920 can send information to an external hardware (e.g., a computer system or device) using wireless communication or through a wired connection. This external hardware can be implemented to analyze live and / or stored signals from the microcontroller 920. The external hardware can be implemented to visualize electrical activity and lesion integrity, including arrhythmias, and can send instructions to the device e.g., to ablate and / or stimulate.PCT Application Attorney Docket No.: 009062.8579.WOOO Ablation can be carried out using an external ablation energy generator and / or stimulation energy generator. Ablation can be performed using various different methodologies, including radio frequency or pulsed electric fields.

[0035] FIG. 10 and FIG. 11 show three-dimensional images of an example implementation of an implantable cardiac device 1000 and 1100, respectively, based on the disclosed technology. In the examples of FIG. 10 and FIG. 11, a device 1000 or 1100 (e.g.. 100. 200, 400, 600, 700, 800) may be disposed on a surface of the heart in accordance with a configuration shown in FIG.3.

[0036] In one aspect, an implantable medical device for the treatment of atrial arrhythmias, such as AF is disclosed. The implantable medical device can be implemented as a system capable of performing ablation lesion sets, repeat or new, on the atria, to create non-conducting lines. The device may use ablation energy that can be provided either from a battery and ablation energy generator (e.g. pulsed field generator) implanted inside the body or connected to an ablation energy generator outside of the body.

[0037] In another aspect, a medical implantable device capable of detecting atrial arrhythmias using electrodes or electrical connections placed on the epicardial surface in the pericardial space is disclosed. In addition to the detection of arrhythmias, the device can also estimate the activation pattern and voltage amplitude of the arrhythmia. Furthermore, the device can analyze the electrical propagation of signals inside the heart in areas where electrodes have been placed.

[0038] In yet another aspect, a medical implantable device capable of controlling or terminating atrial arrhythmias is disclosed. The device uses electrodes or electrical connections placed on the epicardial surface in the pericardial space that can create stimuli which can interact or interfere with the arrhythmia.

[0039] In yet another aspect, a medical implantable device that can deliver medications to the atrial and surrounding tissue from the pericardial space, via a coating, is disclosed.

[0040] In yet another aspect, a medical implantable device and its method to check the integrity of ablation lesions at any time using one or more electrodes on each side of an ablation lesion and electrical stimuli are disclosed. The integrity of a lesion refers to unidirectional or bidirectional conduction block.

[0041] In yet another aspect, a medical implantable device that can have an external and / orPCT Application Attorney Docket No.: 009062.8579.WOOO internal power supply is disclosed. In one example embodiment, functionalities such as sensing and stimulating are powered by a subcutaneous battery in the pectoral region, while cables are connected to an area below the skin the pectoral region and powered externally for ablation energy.

[0042] In yet another aspect, a medical implantable device that can store information and communicate with the outside world (e.g. Bluetooth, WIFI, radio signals) to communicate the status of the patient (e.g. AF presence / absence, activation patterns, voltage amplitudes, ablation line integrity, battery status and to receive instructions from the outside) is disclosed.

[0043] In one example embodiment, an implantable medical device based on the disclosed technology includes: a flexible or semi-flexible arrangement of electrodes (e.g. array or mesh), positioned and fixated on the atrial epicardium within the pericardial space. This electrode array can deliver electric stimuli, sense electrical activity, and deliver ablation energy, e.g. high voltage pulsed field ablation pulses. The arrangement of electrodes can have specialized electrodes for delivering stimuli, sensing, and ablation. The arrangement of electrodes may be divided into subsets of electrodes, with each subset being able to be activated independently, for example to ablate a particular region of the epicardium, such as the pulmonary veins, the posterior wall, or ganglionated Plexi.

[0044] The implantable medical device can include a module to monitor lesion integrity. This module can use electrodes from the array for sensing, stimulation, or ablation, and checks for electrical conduction between two sides of an ablation line or more generally between two electrodes, in a unidirectional or bi-directional fashion. This module detects incomplete ablation lines right after delivery of ablation energy, and reconnections of previously isolated structures at any point after. It can further check and quantify conduction through scar tissue and can check the conductive capabilities of the atrial tissue in contact or between electrodes. Conduction or conduction block can be confirmed via measurement of electrical signals, impedance, or electrogram based features such as activation times / maps.

[0045] The implantable medical device can provide ablation or re-ablation on demand. For example, the device can automatically or semi-automatically (e.g., under the supervision of a medical doctor) deliver ablation energy into the cardiac tissue, without requiring a new catheter ablation procedure. This ablation or re-ablation can restore the integrity of ablation lines (or points), or extend the previous lesions set.PCT Application Attorney Docket No.: 009062.8579.WOOO

[0046] The implantable medical device can be coated with a series of drugs and medications that assist with a variety of functions, such as reduction of scar tissue formation, reduction of infection, or maintenance of good electrode contact (e.g. anti-proliferation medications on the electrodes). Other example medications may be anti- arrhythmic, affect the extracellular matrix, or affect the cardiomyocyte metabolism (e.g. antioxidants).

[0047] The implantable medical device can include a subcutaneous battery used for low-energy capabilities such as generating stimuli (e.g. pacing), sensing, and lesion monitoring. For the ability to deliver ablation energy, an electrical connection (e.g. cable or cables) is used that can be connected to the outside of the patient. For example, an internal connection to the ablation system may be placed subcutaneously under the skin of the left pectoral area and can be accessed from outside and connected to an ablation energy system after a shallow skin cut.

[0048] In the example implantable medical device presently disclosed, fixation of the electrodes can be achieved using a mechanical or adhesive mechanism that allows a stable and permanent conductive contact between electrodes and the tissue. Examples of possible fixation mechanism include hydrogels, biocompatible glues, mesh structures, sutures, silicon microstructures, or a combination of them.

[0049] In the example implantable medical device presently disclosed, one-side or two-sided communication with the outside world can be achieved by wired or wireless telemetry that allows data to be sent out (such as lesion integrity information and sensing data) and data to be sent in (like commands for stimuli, pacing, sensing, ablation, parameter adjustment). Some example embodiments integrate ablation, stimulation, sensing, and lesion integrity monitoring, with the aim of reducing atrial fibrillation (AF) recurrences and minimizing invasive repeat procedures.

[0050] Some disclosed embodiments relate to an implantable medical device that can, among other capabilities, create transmural non-conductive lesions “on demand” on the left and right atria of the heart. The device can be implemented, for example, for the treatment of atrial fibrillation or atrial flutter. The device may be fixed in place for extended durations (days, weeks, months, years) and placed inside the pericardial space on the epicardium. In one example, the device comprises multiple single electrodes or an electrode mesh or a conductive surface. The device may include some or all of the following capabilities.

[0051] The device can create non-conductive lesions without the need for a repeat procedurePCT Application Attorney Docket No.: 009062.8579.WOOO in the traditional sense, for example via outside activation or using a shallow cut to connect an outside power or ablation energy source. The lesions can be created by delivering ablation energy into the atrial tissue, for example using pulsed electric fields that lead to irreversible electroporation of cardiac tissue. A subset of electrodes can be activated at the same time to create specific non-conducting transmural lesions at desired sites (e.g., the pulmonary veins (independently or two at a time - left and right), the posterior wall, ganglionated Plexi, and others). All subsets together can create a lesion set pattern similar to a maze-procedure (like Coxmaze IV) with the addition of ganglionated Plexi and the entire posterior wall similar to the epicardial part of the convergent procedure, although a smaller subset can be chosen based on the individual patient’s history.

[0052] The device can check the integrity of existing lesion sets using a pair of electrodes that are located on both sides of a lesion. The device can use a sequence of stimuli, bi-directional or uni-directional isolation. If a stimulus pattern originating from one side of the lesion leads to a similar pattern on the other side of a lesion, this indicates that the lesion has lost its integrity.

[0053] The device can deliver medications into the cardiac tissue. A coating or coatings can be applied to the device to achieve different effects, ranging from anti-arrhythmic medications to regenerative medications to medications reducing scar tissue formation.

[0054] The device can control an atrial arrythmia by using low-energy pacing maneuvers below the human pain threshold, such as deacceleration pacing, overdrive pacing, or others. This pacing can control or terminate atrial arrythmias.

[0055] The device can check for the presence of AF using some of its electrodes in contact with the epicardium.

[0056] One example usage of the device is the following. A patient with AF is selected to receive a device that covers most of the pericardially accessible left atrium (with connections through the pericardial reflections). In the first step and using either a laparoscopic, subxiphoid, or similar access to the pericardial space, the device is carefully placed on the epicardium and secured. The right and left pulmonary veins are immediately isolated and the acute lesion integrity is verified. A year later, the patient recurs with AF. The lesion integrity of the pulmonary vein lesions is checked, and a gap is found - the specific pair of pulmonary veins are re-ablated using the device, which successfully treats atrial fibrillation. A year later, the patient recurs. All lesions have intact integrity. Using pacing maneuvers, AF is eliminated and the timePCT Application Attorney Docket No.: 009062.8579.WOOO to recurrence is checked. A decision is made to expand the lesion set as AF is recurring too fast -another subset of the device is activated that can isolate the posterior wall, the region identified to have problematic electrical conduction from the stimulus maneuvers.

[0057] In one example embodiment of an electrode module based on the disclosed technology, electrodes might be placed in a flexible polymer substrate (e.g. silicone, polyurethane, PDMS. or parylene c), with a total thickness of approx. 1-2 mm. Multiple electrodes can be embedded or bonded into the substrate, in either a patch or mesh design with regularly or irregularly spaced electrodes. A subset of electrodes that affect a common spatial region (e.g. ablating the posterior wall) might have a common electrical connection. Electrodes that deliver ablation energy might be aligned in 2 parallel rows, regularly spaced 1-4 mm apart, with a maximal offset towards each other. Each electrode might have a contact area between 0.5-4 mm2and a spacing of 1-4 mm apart. On the side of both rows, embedded in the same substrate, may be electrodes with the same or higher spacing responsible for sensing, electrical stimuli (e.g. pacing), and monitoring lesion integrity. However, electrodes for sensing / stimuli / lesion monitoring might also be used for ablation and vice versa. Possible electrode materials may include platinum-iridium or titanium-iridium coated metal due for high-voltage durability (e.g. for pulsed field irreversible electroporation pulses) and corrosion resistance.

[0058] In one example embodiment of an ablation energy module based on the disclosed technology, ablation energy may be delivered in the form of short pulsed electric fields (e.g., 500-2000V), similar to pulsed field ablation commonly used for catheter ablation. These bursts typically have a duration between microseconds to milliseconds and induce irreversible electroporation in the cardiac / atrial tissue. Pulse waveform parameters can be adjusted any time and can be monophasic or biphasic to optimize tissue selectivity and reduce collateral damage or unwanted muscle stimuli. Parameters can be adjusted for each subset of electrodes. An alternative to pulsed electrical fields can be radiofrequency energy, in which case a saline cooling system can be added.

[0059] In one example embodiment of an electrical stimulation module based on the disclosed technology, low-voltage pacing may be achieved using pulses in the range between, e.g., 0.5-10 V. Pacing algorithms may be used to terminate or control re-entrant atrial tachyarrhythmias, bradyarrhytmias, or spiral waves using one or many pulses from one or more electrodes.PCT Application Attorney Docket No.: 009062.8579.WOOO

[0060] Some disclosed embodiments may provide lesion integrity monitoring, either periodically or on demand (with or without recurrence of an arrhythmia). In one example device, the device may deliver electric test pulses or bipole signals on either or both sides of an ablation lesion or cardiac structure to test whether the \ ablation lines are still complete. Electrodes on either side of the ablation lesion may be used to measure local impedances or to create an activation map that can help with localizing a potential reconnection of previously electrically isolated areas. If a reconnection is detected, the controller of the device (that may be implanted outside the pericardial space by the power supply) logs and saves the reconnection event including any data helpful to localize the reconnection area(s).

[0061] Some disclosed devices may include sensing capabilities. In one example implanted device, the device can measure electrical impedance and / or electrical voltage at or between some or all of its electrodes. This data can be used to detect atrial tachyarrhythmias or bradyarrhytmias, check the impedance at or by ablation lesions, as well as other areas in the atria. This allows for the identification of areas in the atria with low impedance or conduction besides other parameters that might indicate the presence of scar tissue. This data can be saved and compared over time to monitor recurrence rates, termination times, and electrical remodeling, among other things.

[0062] Some disclosed devices include features powered by a subcutaneously implanted battery, although the capabilities for an external power supply are also given. This battery may be charged invasively or non-invasively or replaced via a minor surgical procedure once the battery life has reached a certain threshold. For the ablation energy and more energy-demanding tasks, a subcutaneous port that connects the device in the pericardial space to a port or connection just below the skin may be used. This design minimizes the internal battery size and allows the ablation to be performed under medical supervision. The device circuits can switch between standard operation modes (e.g. monitoring, sensing, pacing, controlling, communication) and ablation modes, to save the internal electronics from the high energies required for ablation. In some example embodiments, the power and ablation energy generator is completely subcutaneous and may increase the size of the power supply.

[0063] Some disclosed devices are configured to operate in one of a plurality of modes. In some implementations, the device is operable in one of the plurality of modes to deliver energy to the heart, obtain electrical signals from the heart, deliver a pacing therapy to the heart, orPCT Application Attorney Docket No.: 009062.8579.WOOO communicate with a control module and / or an external device.

[0064] Some example devices include fixations that allow the device to maintain electrical contact between electrodes and the epicardial surface for a desired duration (e.g., >10 years) and might use techniques and materials such as hydrogels, biocompatible glues, mesh structures, sutures or silicon microstructures. Mechanical solutions such as anchors or sutures aim to attach the device at multiple points to the endocardium, while adhesive solutions such as bio glues or hydrogels aim to establish a short-term to medium-term mechanical connection that might be combined with a porous mesh to allow long-term fixation via tissue ingrowth. All materials can selected based on their features of low immunogenicity and being able to withstand long-term mechanical stress and atrial remodeling.

[0065] Some disclosed devices may continuously or periodically monitor for tachyarrhythmias or bradyarrhythmias including arrythmia burden, based on desired setting and battery health. Data can be stored in a microcontroller and may include timestamps, event logs, battery charge, lesion integrity status, or intracardiac signals. Such data may be communicated to the outside or a medical provider using a communication technology such as Bluetooth, WIFI, or radio. In a similar fashion, physicians can check the device status, lesion maps, and any logs or data stored.

[0066] In one example use case, a disclosed device may be implanted using a subxiphoid, thoracoscopic, or different approach to enter the pericardial space. To allow full circumferential access to the pulmonary veins or other cardiac structures that may be monitored or ablated, openings in the pericardial reflection can be made. The device can be carefully secured in the selected areas, which include the pulmonary veins, the posterior wall, and potentially other structures, similar to the Cox-maze IV ablation lesion set, the posterior wall, and including the area of the ganglionated Plexi, if the indication is given. A first ablation may be performed, and the acute integrity of the lesion checked. The battery and control module can be placed in a subcutaneous pocket and connected to device containing the electrodes, such that the device is in place and functions.

[0067] AF ablation is an established field that lacks a technology capable of achieving high short-term or long-term freedom from AF. This is mainly due to incomplete lesion sets, reconnections, and atrial remodeling. Among other features and benefits, the disclosed embodiments can be implemented to improve all of these fields.PCT Application Attorney Docket No.: 009062.8579.WOOO

[0068] Some disclosed embodiments can be implemented to electrically isolate all 4 pulmonary veins with one ring to provide stimulation, sensing, and / or ablation.

[0069] Some disclosed embodiments include a surface to provide stimulation, sensing, and / or ablation to a posterior wall of the heart.

[0070] FIG. 12 shows a block diagram of an example hardware implementation in accordance with some disclosed embodiments. Referring to FIG. 3, a system or device 1200 can include an electrode module 1210 operably coupled to a control module 1220. The control module 1220 and / or the electrode module 1210 can be communicatively coupled to a receiver 1230 (e.g., a computer or external device). In some embodiments, the electrode module 1210 and the control module 1220 are coupled using at least one lead.

[0071] The present patent document discloses methods, system, and apparatus related to a procedure that creates tissue regions that are electrically isolated (e.g. placement of electrical isolations) in the hearts smaller chambers to stop heart rhythm disorders in the upper chambers of the heart. Current surgeries use heat. cold, or electrical energy to place electrical isolation in areas that disrupt the normal heartbeat. However, these isolations may have gaps or get gaps over time, which means that a patient needs to undergo surgery again. It is also not known how much of the heart should be treated during the surgery. The disclosed technology includes an implantable device that is directly placed on the outside of the heart the check the status of the heart.

[0072] The device may use energy to electrically isolate structures in the heart, and can re-do isolation whenever necessary to make sure isolations stay intact. The disclosed device may also include functionalities to check the status of these isolations and, using small electrical signals, functionalities to check the current conduction of the heart’s structure. This allows the device to only treat areas in the heart that need to be treated, which may lead to better lives for patients that have these heart rhythm disorders.

[0073] FIG. 13 shows a flow chart of an example method 1300 based on the disclosed technology. At step 1310, the method 1300 comprises positioning an electrode module on an epicardial surface of a heart within a pericardial space. In some implementations, the electrode module comprises: a flexible substrate, and a plurality of electrodes disposed on the flexible substrate and organized into a plurality of independently activatable electrode subsets, each electrode subset corresponding to an anatomical region of the heart. At step 1320, the methodPCT Application Attorney Docket No.: 009062.8579.WOOO 1300 comprises coupling the electrode module to a control module via at least one lead. At step 1330, the method 1300 comprises selectively activating at least one of the plurality of electrode subsets to deliver energy to a targeted anatomical region of the heart or sense electrical signals from the heart

[0074] In some embodiments, the flexible substrate (e.g., 110, 210, 710) defines an opening configured to receive a cardiac structure therethrough, enabling the flexible substrate to at least partially circumscribe the cardiac structure and positioning of at least a portion of the plurality of electrodes in contact with epicardial tissue of or adjacent to the cardiac structure.

[0075] In some embodiments, an implantable cardiac device (e.g., 100, 200, 400, 600, 700) is configured to operate in one of a plurality of modes to deliver energy to a heart, obtain the electrical signals from the heart, deliver a pacing therapy to the heart, or communicate with a control module or an external device.

[0076] In some embodiments, a control module is configured to transmit a notification to an external device upon detection of electrical signals indicative of a condition including at least one of an atrial fibrillation, an activation pattern of an arrhythmia, a voltage amplitude, an integrity of an ablation line, an electrical conductivity, or a status of a component of the implantable cardiac device (e.g., 100, 200, 400, 600, 700).

[0077] FIG. 14 shows a block diagram of an example hardware platform 1400 that may be a part of a control module in accordance with some disclosed embodiments. The hardware platform 1400 includes at least one processor 1410 and a memory 1405 having instructions stored thereupon. The instructions upon execution by the processor 1410 configure the hardware platform 1400 to perform the operations described in, e.g., FIG. 13 and in the various embodiments described in this patent document. The transmitter 1415 transmits or sends information or data to another device. For example, a control module can send a message or signal (e.g., one or more control signal) to, or receive a message or signal (e.g., one or more electrical signals detected by one or more electrodes of device 100 / 200 / 400 / 600 / 700 / 800) from, an implantable cardiac device. The receiver 1420 exchanges information or data with (e.g., transmits to or receives from) another device. For example, a control module can receive a message from or transmit a message to another device (e.g., 930).

[0078] Embodiments of the disclosed technology support inter alia the following technical solutions.PCT Application Attorney Docket No.: 009062.8579.WOOO

[0079] 1. An implantable cardiac device, comprising: an electrode module configured for chronic implantation within a pericardial space of a subject, the electrode module comprising: a flexible substrate configured for placement on an epicardial surface of a heart within the pericardial space, and a plurality of electrodes disposed on the flexible substrate to contact the epicardial surface of the heart, wherein the plurality of electrodes are organized into a plurality of independently activatable electrode subsets, each electrode subset including at least one electrode and corresponding to an anatomical region of the heart, and the plurality of electrodes are configured to deliver energy to the heart or obtain electrical signals from the heart; and at least one lead configured to operably couple the electrode module and a control module.

[0080] 2. The implantable cardiac device of solution 1, wherein the flexible substrate defines an opening configured to receive a cardiac structure therethrough, enabling the flexible substrate to at least partially circumscribe the cardiac structure and positioning of at least a portion of the plurality of electrodes in contact with epicardial tissue of or adjacent to the cardiac structure.

[0081] 3. The implantable cardiac device of solution 1, wherein the flexible substrate comprises a first arm and a second arm, wherein: the first arm and the second arm are removably coupled to define an opening configured to receive a cardiac structure therethrough, and at least one of the first arm or the second arm comprises a surface configured for placement on the epicardial surface of the heart.

[0082] 4. The implantable cardiac device of solution 3, wherein each of the first arm and the second arm comprises a respective group of the plurality of electrodes.

[0083] 5. The implantable cardiac device of solution 3. wherein the first arm and the second arm are configured for independent activation to deliver energy to different anatomical regions of the heart.

[0084] 6. The implantable cardiac device of solution 1. wherein the flexible substrate comprises a gap to enable positioning of the implantable cardiac device around an anatomical structure of the heart.

[0085] 7. The implantable cardiac device of solution 6, wherein the anatomical structure comprises a pulmonary vein.

[0086] 8. The implantable cardiac device of solution 1, wherein the anatomical region corresponding to at least one electrode subset comprises at least one of: a pulmonary veinPCT Application Attorney Docket No.: 009062.8579.WOOO ostium, a posterior wall of an atrium, or a ganglionated plexus.

[0087] 9. The implantable cardiac device of solution 1, wherein the energy comprises pulsed electric field energy configured to induce irreversible electroporation in cardiac tissue.

[0088] 10. The implantable cardiac device of solution 1, wherein the flexible substrate comprises a drug-eluting coating configured to release a therapeutic agent to adjacent tissue.

[0089] 11. The implantable cardiac device of solution 1, comprising an electrically conductive interface material disposed between at least some of the electrodes and the epicardial surface.

[0090] 12. The implantable cardiac device of solution 11, wherein the electrically conductive interface material comprises at least one of a hydrogel, a biocompatible glue, a mesh structure, sutures, or a silicon microstructure.

[0091] 13. The implantable cardiac device of solution 1, wherein the flexible substrate comprises at least one of silicone, polyurethane, polydimethylsiloxane (PDMS), or parylene c.

[0092] 14. The implantable cardiac device of solution 1, wherein the flexible substrate comprises a titanium sheet coated in polydimethylsiloxane (PDMS), parylene c, or polyurethane.

[0093] 15. The implantable cardiac device of solution 1, wherein the implantable cardiac device is configured to operate in one of a plurality of modes, wherein the implantable cardiac device is operable in one of the plurality of modes to deliver the energy to the heart, obtain the electrical signals from the heart, deliver a pacing therapy to the heart, or communicate with the control module or an external device.

[0094] 16. The implantable cardiac device of solution 1, wherein one or more of the electrical signals obtained using the electrode module are indicative of: an atrial fibrillation, an activation pattern of an arrhythmia, a voltage amplitude, an integrity of an ablation line, an electrical conductivity, or a status of a component of the implantable cardiac device.

[0095] 17. The implantable cardiac device of solution 1, wherein the energy delivered by the plurality of electrodes comprises pacing pulses configured to provide pacing therapy to the heart.

[0096] 18. An implantable cardiac system, comprising: an implantable cardiac device of any one of solutions 1-18, and a control module operably coupled to the electrode module via a lead and configured to selectively activate at least one of a plurality of electrode subsets to deliver energy to a targeted anatomical region, monitor electrical signals from the heart, andPCT Application Attorney Docket No.: 009062.8579.WOOO transmit data relating to the electrical signals to an external device via a communication interface.

[0097] 19. The implantable cardiac system of solution 18, wherein the control module is configured for subcutaneous placement external to the pericardial space.

[0098] 20. The implantable cardiac system of solution 18, wherein the control module is configured to assess integrity of an ablation lesion by detecting electrical conduction between a first electrode positioned on a first side of the ablation lesion and a second electrode positioned on a second side of the ablation lesion.

[0099] 21. The implantable cardiac system of solution 20, wherein the control module is configured to initiate delivery of ablation energy upon detection of electrical conduction indicative of reconnection across the ablation lesion.

[0100] 22. The implantable cardiac system of solution 18, wherein the control module is configured to transmit a notification to the external device upon detection of electrical signals indicative of a condition including at least one of an atrial fibrillation, an activation pattern of an arrhythmia, a voltage amplitude, an integrity of an ablation line, an electrical conductivity, or a status of a component of the implantable cardiac device.

[0101] 23. The implantable cardiac device of solution 19, wherein the control module is configured to transmit the electrical signals obtained using the electrode module to the external device via wireless telemetry.

[0102] 24. The implantable cardiac device of solution 19, comprising: wherein the control module is configured to receive one or one or more measurements obtained using at least some of the plurality of electrodes, wherein the one or more measurements characterize: (i) an electrical conductivity of a tissue in contact with the electrode module or disposed between at least some of the electrodes, or (ii) an electrical conductivity between two or more of the electrodes.

[0103] 25. The implantable cardiac system of solution 18, comprising: a subcutaneous battery configured to power sensing and stimulation functions, and a subcutaneous port configured to receive ablation energy from an external ablation energy source.

[0104] 26. A method for cardiac condition treatment and sensing using an implantable cardiac device or system according to any one of solutions 1-25.

[0105] 27. A method, comprising: positioning an electrode module on an epicardialPCT Application Attorney Docket No.: 009062.8579.WOOO surface of a heart within a pericardial space, the electrode module comprising: a flexible substrate, and a plurality of electrodes disposed on the flexible substrate and organized into a plurality of independently activatable electrode subsets, each electrode subset corresponding to an anatomical region of the heart; coupling the electrode module to a control module via at least one lead; and selectively activating at least one of the plurality of electrode subsets to deliver energy to a targeted anatomical region of the heart or sense electrical signals from the heart.

[0106] 28. An implantable apparatus, comprising: a flexible arrangement of electrodes disposed on an epicardial surface of a heart and configured to provide stimulation pulses to the heart; one or more modules, communicatively coupled to the flexible arrangement of electrodes, including at least one module configured to monitor electrical conduction between at least some of the electrodes in the flexible arrangement; and a communication element configured to provide data acquired using the implantable apparatus to one or more processing devices.

[0107] 29. The implantable apparatus of solution 28, wherein the flexible arrangement of electrodes is divided into subsets of electrodes, wherein each of the subsets is configured to deliver electric stimuli to the heart, sense electrical activity of the heart, or deliver ablation energy to the heart.

[0108] 30. The implantable apparatus of solution 28, wherein the implantable apparatus is configured to deliver electric test pulses periodically or on demand to one or more sides of an ablation lesion or cardiac structure of the heart.

[0109] 31. The implantable apparatus of solution 28, wherein the stimulation pulses are provided in response to an abnormal heart rhythm.

[0110] Only a few implementations and examples are described and other implementations, enhancements and variations can be made based on what is described and illustrated in this patent document.

Claims

PCT Application Attorney Docket No.: 009062.8579.WOOO What is claimed is:

1. An implantable cardiac device, comprising:an electrode module configured for chronic implantation within a pericardial space of a subject, the electrode module comprising:a flexible substrate configured for placement on an epicardial surface of a heart within the pericardial space, anda plurality of electrodes disposed on the flexible substrate to contact the epicardial surface of the heart, whereinthe plurality of electrodes are organized into a plurality of independently activatable electrode subsets, each electrode subset including at least one electrode and corresponding to an anatomical region of the heart, and the plurality of electrodes are configured to deliver energy to the heart or obtain electrical signals from the heart; andat least one lead configured to operably couple the electrode module and a control module.

2. The implantable cardiac device of claim 1, wherein the flexible substrate defines an opening configured to receive a cardiac structure therethrough, enabling the flexible substrate to at least partially circumscribe the cardiac structure and positioning of at least a portion of the plurality of electrodes in contact with epicardial tissue of or adjacent to the cardiac structure.

3. The implantable cardiac device of claim 1, wherein the flexible substrate comprises a first arm and a second arm. wherein:the first arm and the second arm are removably coupled to define an opening configured to receive a cardiac structure therethrough, andat least one of the first arm or the second arm comprises a surface configured for placement on the epicardial surface of the heart.

4. The implantable cardiac device of claim 3, wherein each of the first aim and the second arm comprises a respective group of the plurality of electrodes.PCT Application Attorney Docket No.: 009062.8579.WOOO5. The implantable cardiac device of claim 3, wherein the first arm and the second arm are configured for independent activation to deliver energy to different anatomical regions of the heart.

6. The implantable cardiac device of claim 1, wherein the flexible substrate comprises a gap to enable positioning of the implantable cardiac device around an anatomical structure of the heart.

7. The implantable cardiac device of claim 6, wherein the anatomical structure comprises a pulmonary vein.

8. The implantable cardiac device of claim 1, wherein the anatomical region corresponding to at least one electrode subset comprises at least one of: a pulmonary vein ostium, a posterior wall of an atrium, or a ganglionated plexus.

9. The implantable cardiac device of claim 1, wherein the energy comprises pulsed electric field energy configured to induce irreversible electroporation in cardiac tissue.

10. The implantable cardiac device of claim 1, wherein the flexible substrate comprises a drug-eluting coating configured to release a therapeutic agent to adjacent tissue.

11. The implantable cardiac device of claim 1, comprising an electrically conductive interface material disposed between at least some of the electrodes and the epicardial surface.

12. The implantable cardiac device of claim 11, wherein the electrically conductive interface material comprises at least one of a hydrogel, a biocompatible glue, a mesh structure, sutures, or a silicon microstructure.

13. The implantable cardiac device of claim 1, wherein the flexible substrate comprises at least one of silicone, polyurethane, polydimethylsiloxane (PDMS), or parylene c.PCT Application Attorney Docket No.: 009062.8579.WOOO14. The implantable cardiac device of claim 1, wherein the flexible substrate comprises a titanium sheet coated in polydimethylsiloxane (PDMS), parylene c, or polyurethane.

15. The implantable cardiac device of claim 1, wherein the implantable cardiac device is configured to operate in one of a plurality of modes, wherein the implantable cardiac device is operable in one of the plurality of modes to deliver the energy to the heart, obtain the electrical signals from the heart, deliver a pacing therapy to the heart, or communicate with the control module or an external device.

16. The implantable cardiac device of claim 1, wherein one or more of the electrical signals obtained using the electrode module are indicative of: an atrial fibrillation, an activation pattern of an arrhythmia, a voltage amplitude, an integrity of an ablation line, an electrical conductivity, or a status of a component of the implantable cardiac device.

17. The implantable cardiac device of claim 1, wherein the energy delivered by the plurality of electrodes comprises pacing pulses configured to provide pacing therapy to the heart.

18. An implantable cardiac system, comprising:an implantable cardiac device of any one of claims 1-17, the implantable cardiac device comprising an electrode module and a lead, anda control module operably coupled to the electrode module via the lead and configured to selectively activate at least one of a plurality of electrode subsets to deliver energy to a targeted anatomical region, monitor electrical signals from the heart, and transmit data relating to the electrical signals to an external device via a communication interface.

19. The implantable cardiac system of claim 18, wherein the control module is configured for subcutaneous placement external to the pericardial space.PCT Application Attorney Docket No.: 009062.8579.WOOO 20. The implantable cardiac system of claim 18, wherein the control module is configured to assess integrity of an ablation lesion by detecting electrical conduction between a first electrode positioned on a first side of the ablation lesion and a second electrode positioned on a second side of the ablation lesion.

21. The implantable cardiac system of claim 20, wherein the control module is configured to initiate delivery of ablation energy upon detection of electrical conduction indicative of reconnection across the ablation lesion.

22. The implantable cardiac system of claim 18, wherein the control module is configured to transmit a notification to the external device upon detection of electrical signals indicative of a condition including at least one of an atrial fibrillation, an activation pattern of an arrhythmia, a voltage amplitude, an integrity of an ablation line, an electrical conductivity, or a status of a component of the implantable cardiac device.

23. The implantable cardiac device of claim 19, wherein the control module is configured to transmit the electrical signals obtained using the electrode module to the external device via wireless telemetry.

24. The implantable cardiac device of claim 1 , comprising:wherein the control module is configured to receive one or more measurements obtained using at least some of the plurality of electrodes,wherein the one or more measurements characterize at least one of: (i) an electrical conductivity of a tissue in contact with the electrode module or disposed between at least some of the electrodes, or (ii) an electrical conductivity between two or more of the electrodes.

25. The implantable cardiac system of claim 18, comprising:a subcutaneous battery configured to power sensing and stimulation functions, and a subcutaneous port configured to receive ablation energy from an external ablation energy source.PCT Application Attorney Docket No.: 009062.8579.WOOO26. A method for cardiac condition treatment and sensing using an implantable cardiac device or system according to any one of claims 1-25.

27. A method, comprising:positioning an electrode module on an epicardial surface of a heart within a pericardial space, the electrode module comprising:a flexible substrate, anda plurality of electrodes disposed on the flexible substrate and organized into a plurality of independently activatable electrode subsets, each electrode subset corresponding to an anatomical region of the heart;coupling the electrode module to a control module via at least one lead; and selectively activating at least one of the plurality of electrode subsets to deliver energy to a targeted anatomical region of the heart or sense electrical signals from the heart.

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