Heart jacket for pulsed field ablation

Abstract

A medical system, ablation device, and method for delivering PF A treatment to patients. In one example, the ablation device includes a jacket configured to harness around a heart. The jacket includes a set of anatomical anchors configured to mate with respective anatomical landmarks of the heart for reduced error, and in some cases, substantially error-proof positioning of the jacket on the heart. The ablation device also includes first electrodes attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes. In some examples, the pattern corresponds to a Cox-maze IV lesion set. In some examples, the ablation device also includes second electrodes attached to the jacket and configured for collecting electrogram signals from the heart or for confirming an exit or entrance block in an isolated area of the heart.

Description

Attorney Docket No.215364-0065-WO01 (A0010806WO01) HEART JACKET FOR PULSED FIELD ABLATION CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 655,958 filed on June 4, 2024, and entitled “HEART JACKET FOR PULSED FIELD ABLATION,” the contents of which are incorporated herein by reference. FIELD

[0002] This application relates generally to pulsed field ablation and to systems, instruments, devices, and accessories for delivering pulsed-field-ablation treatment to patients. BACKGROUND

[0003] Pulsed field ablation (PFA) involves application of pulsed electric fields, which may reversibly or irreversibly destabilize cell membranes through electro-permeabilization, but generally do not affect the structural integrity of tissue components. The nature of PFA allows for very brief periods of therapeutic energy delivery, e.g., milliseconds to microseconds in duration. In many cases, PFA does not cause collateral damage to non-targeted tissue as frequently or severely as thermal ablation. SUMMARY

[0004] Disclosed herein are various examples, embodiments, features, and aspects of a medical system, ablation device, and method for delivering PFA treatment to patients. In one example, the ablation device includes a jacket configured to harness around a heart. The jacket includes a set of anatomical anchors configured to mate with respective anatomical landmarks of the heart for reduced error, and in some cases, substantially error-proof positioning of the jacket on the heart. The ablation device also includes a plurality of first electrodes attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of first electrodes. In some examples, the pattern corresponds to a Cox-maze IV lesion set. In other examples, other lesion patterns or subsets of the Cox-maze IV lesion set can also be implemented. In some examples, the ablation device alsoAttorney Docket No.215364-0065-WO01 (A0010806WO01) includes a plurality of second electrodes attached to the jacket and configured for collecting electrogram signals from the heart or for delivering pacing signals to the heart.

[0005] In one example, an ablation device includes a jacket and a plurality of first electrodes attached to the jacket. The jacket is configured to harness around a heart and includes a first anatomical anchor configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart. The plurality of first electrodes is arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes.

[0006] In another example, a medical system includes an ablation device, an electrical generator, and an electrode selector switch. The ablation device includes a jacket configured to harness around a heart and including a first anatomical anchor configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart. The ablation device also includes a plurality of first electrodes attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes. The electrical generator is configured to provide the pulsed energy. The electrode selector switch is configured to selectively connect the first electrodes to the electrical generator via an electrical cable including a plurality of electrical wires connected to individual ones of the first electrodes. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG.1 is a block diagram illustrating a medical system according to some examples.

[0008] FIG.2 is a schematic diagram illustrating a Cox-maze IV lesion set according to one example.

[0009] FIG.3 is a schematic diagram illustrating a PFA maze jacket that can be used with the medical system of FIG.1 according to some examples.

[0010] FIG.4 is a schematic diagram illustrating an anterior view of the PFA maze jacket illustrated in FIG.3 placed on the patient heart according to one example.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0011] FIG.5 is a schematic diagram illustrating a posterior view of the PFA maze jacket illustrated in FIG.3 placed on the patient heart according to one example.

[0012] FIG.6 is a schematic diagram illustrating an anterior view of another PFA maze jacket that can be used with the medical system of FIG.1 according to some additional examples.

[0013] FIG.7 is a schematic diagram illustrating an anterior view of yet another PFA maze jacket that can be used with the medical system of FIG.1 according to further examples.

[0014] FIG.8 is a schematic diagram illustrating an anterior view of yet another PFA maze jacket that can be used with the medical system of FIG.1 according to one example.

[0015] FIG.9 is a flowchart illustrating a PFA method performed using the medical system of FIG.1 according to some examples.

[0016] FIG.10 is a block diagram illustrating a computer used in the medical system of FIG. 1 according to some examples. DETAILED DESCRIPTION

[0017] Pulsed field ablation (PFA) involves the application of pulsed electric fields directed through tissues intended for ablation and subsequent lesion formation. The mode of cell death involves irreversible destabilization of cell membranes and loss of homeostasis through electro- permeabilization without a requirement of heat or cold to achieve the intended lesions. This non- thermal mode of cell death allows for epicardial energy deliveries to achieve transmural lesion formation on beating hearts as opposed to thermal technologies where endocardial blood flow prevents lesion formation near the endocardium. PFA also achieves lesion formation relatively quickly, with very brief periods of therapeutic energy delivery, e.g., microseconds to milliseconds in duration, while minimizing the risk of collateral damage to non-targeted tissue.

[0018] Tissue ablation is used in numerous medical procedures to treat a patient. In some examples, ablation procedures involve modification of target tissue, e.g., to stop electrical propagation through the tissue in patients with an arrhythmia. Such ablation procedures areAttorney Docket No.215364-0065-WO01 (A0010806WO01) often performed by passing energy, such as electrical energy, through one or more electrodes proximate to the heart. The energy causes modifications to the target tissue in the heart.

[0019] Maze is a surgical procedure used to treat atrial fibrillation. A surgeon creates a pattern (maze) of scar tissue in the upper chambers of the heart (atria) using a scalpel or a device that delivers ablation energy. The maze interferes with cardiac conduction patterns that cause or sustain atrial fibrillation.

[0020] The Cox-maze (CM) IV procedure implements the cut-and-sew CM III lesion set using bipolar RF energy and / or cryoablation to replace most of the incisions of the cut-and-sew CM III. Clinical results indicate that the CM IV procedure achieves a similarly high success rate as the CM III procedure while beneficially possessing the capability for significantly reducing operative time and lowering complication rates. In some cases, the CM IV procedure can be performed via sternotomy or minimally invasive right minithoracotomy (RMT). The selection of a minimally invasive approach as opposed to a standard surgical approach is typically based on the presence of concomitant cardiac pathology, patient-specific anatomic characteristics, the experience of the operating surgeon, etc.

[0021] Some embodiments disclosed herein provide a PFA maze lesion jacket designed to harness around the heart with anatomical landmark anchors used for positioning. Once the jacket is positioned properly, the embedded PFA electrodes can be activated to complete the maze lesion set without repositioning the jacket. In some examples, the jacket also has pacing and / or sensing electrodes strategically placed for testing the entrance / exit conduction block. In at least some use cases, the PFA maze jacket can beneficially be used in a minimally invasive key-hole procedure off-pump with a significant procedure-time reduction. For example, in some cases, a surgeon can create maze lesions, such as the above-mentioned CM IV lesion set, and gather atrial fibrillation electrograms (EGMs) for analysis in a matter of seconds. The use of the disclosed PFA maze jacket in minimally invasive procedures is expected to beneficially lessen the cardiopulmonary bypass time, cross-clamp time, operative risk, and / or overall morbidity while maintaining or improving the efficacy of the corresponding atrial fibrillation treatment.

[0022] Some embodiments of the heart jacket disclosed herein can be configured and used to treat various arrhythmias and / or valve conditions, such as mitral valve regurgitation, mitral valveAttorney Docket No.215364-0065-WO01 (A0010806WO01) stenosis, atrial flutter, micro / macro reentry circuits, focal sites, etc. In some examples, the heart jacket is adapted for overcoming certain challenges of positioning the device around the left atrium and pulmonary veins due to the pericardial reflections. For example, those reflections can be dissected away from the heart to allow the device to pass. Example locations where the reflections may be dissected include the transverse sinus and the oblique sinus. In some examples, these pericardial reflections can be used as anatomical landmarks for positioning. After dissecting the pericardial reflection away from the epicardial surface of the heart to allow passage of the device, when such passage is relatively small in size, it may be beneficial to incorporate connections between portions of the heart jacket which are of smaller dimensions to allow for placement of the jacket from either side of the reflection as opposed to passing the full bulk of the jacket through a dissected part.

[0023] FIG.1 is a block diagram illustrating a medical system 100 according to some examples. In one configuration, the medical system 100 can be used with a PFA maze jacket 120, e.g., as described in more detail below in reference to FIGS.3-9. In other configurations, the medical system 100 can also be used with one or more other ablation devices, such as catheters and surgical instruments having PFA capabilities. In the example shown, the medical system 100 includes a signal generator 102, an EGM signal processor 104, an impedance analyzer 106, an electrode selector switch 108, a cardiac stimulator 110, a mapping and navigation module 112, a sensor controller 114, and a computer 116 and is connected to the PFA maze jacket 120 that is secured on a heart 132 of a patient 130. In some examples, the medical system 100 may be connected to two or more ablation devices. Although some components of the medical system 100 are shown in FIG.1 as discrete devices for purposes of illustration, it is to be understood that, in some embodiments, the functionality ascribed to such components may be combined into fewer components or broken out into additional discrete components.

[0024] The signal generator 102 is configured to generate electrical waveforms suitable for ablating a target tissue, such as, for example, the cardiac tissue targeted for the above-mentioned CM IV lesion set. In operation, the signal generator 102 is electrically connected, via a cable 118, to the PFA maze jacket 120 for delivery of energy to the target tissue. In at least some configurations, the signal generator 102 is also electrically connected, via a cable 122, to a patch electrode 124 attached to the skin of the patient 130.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0025] The EGM signal processor 104 is configured to receive EGM signals collected from the patient 130 and to process the received signals for heart monitoring purposes. Herein, an EGM signal is a cardiac signal detected through pacing or sensing electrodes of the PFA maze jacket 120. In some examples, the amplification and filtering of the collected EGM signals in the EGM signal processor 104 may be similar to sense-amplifier signal processing. The EGM signal processor 104 may execute code to process the collected EGM signals using beat-detection, beat- comparison, and beat-classification criteria to obtain information on the present condition of the heart 132. The EGM signal pathways are typically well-isolated from the PFA signal delivery pathways and from the high voltage circuitry of the signal generator 102. This isolation can be accomplished, e.g., by employing suitable switching circuits in the electrode selector switch 108. In some examples, the electrode selector switch 108 includes a switch matrix that is used to controllably switch various electrical connections between different electrode pairs of the PFA maze jacket 120 and the signal generator 102, the EGM signal processor 104, and the impedance analyzer 106, e.g., as directed by the control software of the medical system 100. Some implementations of the electrode selector switch 108 may benefit from at least some circuit features disclosed in U.S. Patent Application No.63 / 617,683, which is incorporated herein by reference in its entirety.

[0026] The impedance analyzer 106 is configured to perform signal processing directed at determining electrical impedances corresponding to variously selected electrodes of the PFA maze jacket 120. For impedance measurements, the signal generator 102 may be configured to apply an ac voltage to a selected pair of electrodes of the PFA maze jacket 120 or to drive an ac current to a selected pair of electrodes. Then, based on the measurements of the corresponding current or voltage, the impedance analyzer 106 operates to determine and record the complex electrical impedance (e.g., in the form of magnitude and phase angle) corresponding to the selected pair of electrodes. In some examples, the impedance may be recorded as a function of time. Example operations performed with the impedance analyzer 106 include but are not limited to: (i) generating a dc bias voltage; (ii) generating an ac voltage or current having a selected frequency and amplitude; (iii) changing the frequency of the ac voltage or current; (iv) sensing an electrical current flowing between electrodes in response to the applied voltage; and (v) sensing a voltage between electrodes in response to the electrical current drivenAttorney Docket No.215364-0065-WO01 (A0010806WO01) therethrough. The impedance measurements, as described, may be performed before therapeutic pulsed waveforms are delivered, and / or such measurements may be made after the initial therapeutic waveforms are delivered at various timepoints. Such measurements can beneficially provide starting impedance values as well as a measure of impedance change following the delivery of one or more therapeutic waveforms.

[0027] The cardiac stimulator 110 is configured to provide a heart pacing signal for the patient’s cardiac stimulation. In some examples, the PFA maze jacket 120 has pacing electrodes suitably coupled to the heart 132. Based on medical indication for the pacing signal, the cardiac stimulator 110 operates to generate a corresponding pacing pulse waveform, e.g., of 0.5-2 ms pulse width at up to 10 V or 20 mA, and apply it to the pacing electrodes of the PFA maze jacket 120 at a rate that may be adjusted based on the intrinsic cardiac cycle.

[0028] The (optional) mapping and navigation system 112 may be used for guiding a medical procedure. In some examples, the mapping and navigation system 112 is designed to help visualize the real-time position and orientation of catheters, ablation devices, and / or auxiliary devices within the patient’s body, e.g., to increase the accuracy of targeted ablation and reacquisition of pacing sites for re-ablation. In various implementations, the mapping and navigation system 112 enables one or both of impedance-based tracking and electromagnetic tracking.

[0029] In some examples, the use of electromagnetic tracking in the system 112 is preferred for certain medical procedures described herein. For example, when devices are being positioned within the thoracic cavity, air spaces may create voids in the conductive tissue that may disrupt conductive paths used to accurately depict position. However, the magnetic forms of navigation will maintain accuracy as long as the patient remains stable in position on the operating table with respect to the electromagnetic transmitting system, and any disturbances to location of the heart and associated tissues remains stable or relatively undisturbed during the medical procedure. To allow for electromagnetic positioning of the maze-jacket, the maze-jacket may have a plurality of electromagnetic sensors / coils embedded within the device or within each segment of the devices. Electromagnetic positioning may beneficially provide accurate information on the location of the jacket electrodes with respect to each other and may proveAttorney Docket No.215364-0065-WO01 (A0010806WO01) most useful when the surgeon is actively working to position the jacket through anatomical passages, such as the transverse sinus or the oblique sinus and, in particular, when attempting to join one end of the jacket to the other end while being passed through tissue passages. Once the device is positioned, the navigation system can also be used to provide a graphical depiction of the locations of various electrodes and energy delivery areas with an option of superimposing ablation and impedance data associated with energy deliveries in each location. When the patient has undergone pre-procedure imaging to quantify the locations and thickness of epicardial fat, such data may be added to the anatomical rendering of the heart to assist in making informed decisions on where the therapeutic energy is to be delivered and at what levels based on the locations of the electrodes with respect to the thickness of the underlying epicardial fat in those locations. In some cases, adjunctive energy deliveries not limited to high intensity focused ultrasound or radiofrequency energy may be chosen for specific locations based on the thickness of underlying fat.

[0030] The sensor controller 114 is configured to operate various sensors included in the PFA maze jacket 120 and to process readout signals received therefrom. In some examples, such sensors include temperature sensors (such as thermocouples or thermistors) located at multiple locations associated with the electrodes of the PFA maze jacket 120. Temperature readouts from these sensors may be used, e.g., to ensure patient safety in various medical procedures.

[0031] The computer 116 is configured to receive digital signals from various ones of the above- described components of the medical system 100 for processing and analysis. For example, the computer 116 may perform algorithmic processing of pertinent data to determine one or more parameters for the waveforms to be generated by the signal generator 102. In some other examples, the computer 116 may execute various modules, processes, and functions, such as control functions for PFA delivery in accordance with the determined parameters, cardiac pacing synchronization, and electrode tracking and visualization performed in and by the medical system 100. Example implementations of the computer 116 are described in more detail below in reference to FIG.10.

[0032] FIG.2 is a schematic diagram illustrating a CM IV lesion set 200 according to one example. Depending on the specific medical procedure, other CM IV lesion-set variants can alsoAttorney Docket No.215364-0065-WO01 (A0010806WO01) be implemented. For example, a CM IV lesion set implemented via median sternotomy may differ from a CM IV lesion set implemented via right minithoracotomy (RMT). In various examples, at least a portion of the selected CM IV lesion set, such as the lesion set 200, can be implemented using a corresponding embodiment of the PFA maze jacket 120. Example embodiments of the PFA maze jacket 120 suitable for different specific medical procedures are described in more detail below in reference to FIGS.3-8.

[0033] In the example shown, the lesion set 200 includes several types of lesions, which can be classified based on the specific techniques used to make such lesions. Such lesion types include bipolar RF lesions, surgical incision lesions, and cryoablation lesions. In some cases, some surgical incision lesions can be replaced by bipolar RF lesions, and vice versa. In some other cases, some cryoablation lesions can be replaced by bipolar RF lesions, and vice versa. The bipolar RF lesions can be formed via PFA using the corresponding embodiment of the PFA maze jacket 120. In some examples, all lesions of the lesion set 200 can be created using a corresponding embodiment of the PFA maze jacket 120.

[0034] In the example shown, the lesion set 200 includes lesions of different geometric shapes. One example geometric shape is a spot-like shape. A spot-like shape is a 2D shape whose two characteristic dimensions, such as the largest dimension and the smallest dimension, differ by a relatively small factor, e.g., smaller than three. Another example geometric shape is a track-like shape. A track-like shape has an approximately constant width (transverse dimension) that is smaller than the shape’s length (longitudinal dimension) by a relatively large factor, e.g., larger than three. Different track-like shapes may be linear or curved and closed-loop or open. An open track has two opposite ends. A closed-loop track is continuous in that it can be traveled in full multiple times without reversing the direction of travel, e.g., multiple times in the clockwise direction.

[0035] In the example shown, the lesion set 200 includes a plurality of lesions labeled A-N. The lesions F, L, N include spot-like cryoablation lesions. The remaining lesions include track-like lesions. More specifically, the lesion A is a closed-loop lesion encircling the left pulmonary veins, i.e., the left superior pulmonary vein (LSPV) and left inferior pulmonary vein (LIPV). The lesion B is a closed-loop lesion encircling the right pulmonary veins, i.e., the right superiorAttorney Docket No.215364-0065-WO01 (A0010806WO01) pulmonary vein (RSPV) and right inferior pulmonary vein (RIPV). The lesion C is the superior connecting lesion, from the LSPV to the RSPV (roof). The lesion D is the inferior connecting lesion, from the LIPV to the RIPV (floor). The lesion E is the mitral annulus lesion connecting to the floor portion of the lesions B and / or D. The lesion G is the coronary sinus lesion connecting to the lesion F. The lesion H is a track-like lesion on the left atrial free wall connecting the lesion A to the left atrial appendage (LAA). The lesion I is the SVC-to-IVC connecting lesion. Herein the acronyms SVC and IVC stand for superior vena cava and inferior vena cava, respectively. The lesion J is a track-like lesion on the right atrial free wall. The lesion K is the tricuspid valve lesion (at 10 o’clock) connecting the lesion L to the right atrial appendage (RAA). The lesion M is the right atrial free wall lesion connecting to a middle portion of the lesion I.

[0036] FIG.3 is a schematic diagram illustrating the PFA maze jacket 120 according to one example. In the example shown, the PFA maze jacket 120 is made of a stretchable material (e.g., a fabric or film) and has a sock-like portion including a cuff 302 and a closed-end covering 306. In some examples, the cuff 302 is ribbed, patterned, and / or optionally reinforced with an elastic band (such as an elastic band 303) and has an opening 301 that may be (slightly) narrower than the transverse cross-sectional size of the covering 306. To place the PFA maze jacket 120 on the heart 130, the cuff 302 is stretched out to enlarge the opening 301 such that the covering 306 can be pulled up to cover the bottom portion of the heart 130 (also see FIGS.4-5). The cuff 302 is then allowed to contract to grip the upper portion of the heart 130 around the aorta and the pulmonary trunk, thereby substantially fixing the covering 306 in a desired position and orientation on the heart 130.

[0037] In some examples, the cuff 302 is reversibly separable into two or more portions. In the example shown, the cuff 302 includes separable flaps 3121, 3122that are reconnectable using a flap connector 314. The flaps 3121, 3122 are permanently connected to the covering 306 such that they do not fall off when the flap connector 314 is disconnected. In different examples, the flap connector 314 can be implemented using a fastener, a zipper, a magnetic connector, a Velcro connector, one or more suture loops, or any other suitable reversibly disconnectable connector.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0038] In the example shown, the PFA maze jacket 120 also includes a sleeve 320 connected to the covering 306. The sleeve 320 includes an upper sleeve portion 3221 and a lower sleeve portion 3222. The upper sleeve portion 3221 is configured to be wrapped around the SVC of the heart 130. The lower sleeve portion 3222is similarly configured to be wrapped around the IVC of the heart 130. In some examples, the sleeve 320 may have only one of the sleeve portions 3221, 3222. Similar to the cuff 302, each of the sleeve portions 3221, 3222 may include respective separable flaps that are reconnectable using one or more suitable flap connectors. As an illustration, one of such flap connectors, labeled 324, is explicitly shown in FIG.3. In some examples, the sleeve 320 includes one or more additional flap connectors (not directly visible in the view presented in FIG.3).

[0039] In general, the PFA maze jacket 120 may be provided with multiple connectors configured to reversibly connect and disconnect different portions of the jacket to enable the jacket to be properly placed on the heart 130 and secured thereon in a desired position and orientation. In various examples, the overall shape of the PFA maze jacket 120 provides one or more anatomical landmark anchors for properly positioning the jacket on the heart 130. In the example shown in FIG.3, such anatomical landmark anchors include the opening 301, which is configured to accommodate the aorta and the pulmonary trunk of the heart 130, and the sleeve 320, which is configured to accommodate one or both of the SVC and the IVC of the heart 130. Additional examples of such anatomical landmark anchors that can be incorporated into various embodiments of the PFA maze jacket 120 are described in more detail below, e.g., in reference to FIGS.5-8.

[0040] In some examples, the fabric used in the PFA maze jacket 120 is a “gripping” fabric including one or more gripping features. Such features may include but are not limited to suction cups and / or other small gripping devices configured to be locally securable to an area of tissue via a pressure differential, reversible adhesion, or surface tension. Such gripping features are useful, e.g., for improving stabilization of the jacket on a beating heart and accurately holding the jacket’s PFA electrodes at the intended targeted locations.

[0041] The PFA maze jacket 120 also includes a plurality of electrodes, each of which can be individually connected to the corresponding electrical components of the medical system 100 viaAttorney Docket No.215364-0065-WO01 (A0010806WO01) the cable 118. As an illustration, FIG.3 explicitly shows first and second types of electrodes used in the PFA maze jacket 120. The first type of electrodes can be referred to as the PFA electrodes. The second type of electrodes can be referred to as the pacing or sensing electrodes. In some examples, the PFA maze jacket 120 may include more than two types of electrodes, with the additional types being adapted for other functional features of the medical system 100.

[0042] The PFA electrodes of the PFA maze jacket 120 can be viewed as being arranged in sets. Each of such electrode sets is configured to reproduce the track shape of a respective one of the lesions of the intended lesion set, such as the lesion set 200 illustrated in FIG.2. The PFA electrodes are schematically represented in FIG.3 by the dashed lines. In various examples, the PFA maze jacket 120 is designed to include a plurality of PFA electrode sets corresponding to the full set of track-like lesions of the lesion set 200 or to a selected subset of track-like lesions of the lesion set 200. In operation, the PFA electrodes of the PFA maze jacket 120 are variously connected, via the electrode selector switch 108, to the signal generator 102 and / or to the impedance analyzer 106.

[0043] The pacing / sensing electrodes of the PFA maze jacket 120 are arranged in pairs, as indicated in FIG.3 to provide an option of bipolar pacing or monopolar pacing as desired. Different ones of such electrode pairs are attached to the fabric of the PFA maze jacket 120 in locations that line up with the intended sensing or pacing locations on the heart 130 when the jacket is secured thereon. In operation, the sensing electrodes are electrically connected to the EGM signal processor 104, and the pacing electrodes are electrically connected to the cardiac stimulator 110. In some examples, the same electrode pair can be used as a sensing electrode pair at one time and as a pacing electrode pair at another time.

[0044] FIG.4 is a schematic diagram illustrating an anterior view of the PFA maze jacket 120 illustrated in FIG.3 placed on the heart 130 according to one example. In particular, FIG.4 illustrates how various parts of the PFA maze jacket 120 accommodate or conform to the corresponding anatomical features of the heart 130. For example, the upper sleeve portion 3221 of the sleeve 320 is wrapped around the SVC of the heart 130. The lower sleeve portion 3222of the sleeve 320 is similarly wrapped around the IVC of the heart 130. The opening 301 of the cuff 302 accommodates the aorta (AO) and the pulmonary trunk (PT) of the heart 130. TheAttorney Docket No.215364-0065-WO01 (A0010806WO01) covering 306 of the PFA maze jacket 120 encloses the coronary sinus (CS), the right ventricle (RV), the left ventricle (LV), the right atrium (RA), and the left atrium (LA) of the heart 130.

[0045] FIG.5 is a schematic diagram illustrating a posterior view of the PFA maze jacket 120 illustrated in FIG.3 placed on the heart 130 according to one example. In this view, another anatomical landmark anchor incorporated into the PFA maze jacket 120 is visible. This marker, labeled 501, includes an opening in the covering 306 of the PFA maze jacket 120 configured to accommodate the pulmonary veins LSPV, LIPV, RSPV, and RIPV of the heart 130. An upper border of the opening 501 is defined by the flaps 3121, 3122of the cuff 302 connected to one another using the flap connector 314. When the flaps 3121, 3122 are connected as shown in FIGS.3 and 5, a closed loop track 510 of PFA electrodes 502 is formed to fully encircle the base of the pulmonary veins LSPV, LIPV, RSPV, and RIPV on the heart 130. The closed loop track 510 has a shape corresponding to the shape formed by combining a left portion of the lesion A, the lesion C, a right portion of the lesion B, and the lesion D (also see FIG.2). In some literature, this combined lesion is referred to as the pulmonary veins (PV) box lesion. It can be said therefore that the closed loop track 510 of PFA electrodes 502 in the PFA maze jacket 120 illustrated in FIGS.3-5 is configured to make or corresponds to the PV box lesion.

[0046] FIG.6 is a schematic diagram illustrating an anterior view of the PFA maze jacket 120 according to another example. The PFA maze jacket 120 of FIG.6 is generally analogous to the PFA maze jacket 120 illustrated in FIGS.3-5, but with several modifications. One modification includes incorporation of a panel connector 610 configured to connect a left front panel 612 of the covering 306 and a right front panel 614 of the covering 306. In the example shown, the connector 610 runs the entire height of the jacket 120, from the bottom portion thereof all the way up to the opening 301. In various examples, the panel connector 610 can be implemented using a fastener, a zipper, a magnetic connector, a Velcro connector, or any other suitable reversibly disconnectable connector. Another modification is that the covering 306 now has two additional openings, which are labeled 602 and 604. The opening 602 is configured to accommodate the RAA of the heart 130. The opening 604 is similarly configured to accommodate the LAA of the heart 130. Each of the openings 602, 604 and the corresponding structural details of the jacket defining the opening represent a respective anatomical landmark anchor incorporated into the PFA maze jacket 120. In some examples, the embodiment of theAttorney Docket No.215364-0065-WO01 (A0010806WO01) PFA maze jacket 120 illustrated in FIG.6 and other embodiments employing panels and / or panel connectors similar to the elements 610, 612, 614 can be designed to fit tightly around the heart and be made in various physical sizes selected to accommodate relatively large and relatively small hearts. For example, some patients with heart disease (hypertrophic cardiomyopathy) have enlarged hearts and will benefit from large jacket sizes.

[0047] FIG.7 is a schematic diagram illustrating a posterior view of the PFA maze jacket 120 according to yet another example. The PFA maze jacket 120 of FIG.7 is generally analogous to the PFA maze jacket 120 illustrated in FIGS.3-5 but has a modification. This particular modification includes removing the bottom portion of the covering 306, thereby converting the previously described sock-like portion 306 (e.g., see FIG.5) into a harness-like portion 706. In operation, the harness-like portion 706 is fixated onto the right and left atrium only.

[0048] FIG.8 is a schematic diagram illustrating a posterior view of the PFA maze jacket 120 according to yet another example. The PFA maze jacket 120 of FIG.8 includes a PV collar 802 configured to be wrapped around the pulmonary veins of the heart 130 as indicated in FIG.8. In the example shown, the inner opening of the PV collar 802 has the same shape as the opening 501 described above (also see FIG.5). The upper portion of the PV collar 802 has separable flaps 8121, 8122that are reconnectable using a flap connector 814. In some examples, the flap connector 814 is similar to the above-described flap connector 314 (also see FIGS.3, 5, and 7). The PFA maze jacket 120 of FIG.8 also includes an elastic band 806 connected to the PV collar 802 such that, when the PV collar 802 is wrapped around the base of the pulmonary veins on the heart 130, the elastic band 806 can be wrapped around the heart 130, SCV, and IVC to secure the jacket on the heart. The elastic band 806 also includes an additional connector (not directly visible in the view shown in FIG.8) that enables the band to initially have a shape of a substantially flat stripe the ends of which can be connected to one another to form the closed loop shape wrapped around the heart 130 as indicated in FIG.8. The PFA maze jacket 120 of FIG.8 further includes a set of PFA electrodes 502 and a pair of pacing / sensing electrodes 504. The set of PFA electrodes 502 is arranged to form the above-described closed loop track 510 when the flaps 8121, 8122are connected to one another.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0049] FIG.9 is a flowchart illustrating an example of a PFA method 900 performed using the medical system 100 according to some examples. The method 900 can be performed with any of the above-described embodiments of the PFA maze jacket 120 connected to the medical system 100.

[0050] The method 900 includes a plurality of setup operations (in a block 902). Example setup operations of the block 902 include selecting a surgical approach, selecting a suitable one of the plurality of PFA maze jackets 120 based on the selected surgical approach, positioning and aligning the selected PFA maze jacket 120 with respect to the anatomical landmarks of the patient’s heart 130, and electrically connecting the PFA maze jacket 120 with the cable 118 to the console including or connected to the medical system components 102-116. For example, the selected surgical approach can be the median sternotomy or the minithoracotomy. The plurality of PFA maze jackets 120 from which a suitable one is selected may include different embodiments of the PFA maze jacket 120 described above in reference to FIGS.3-8, with each being available in two or more different sizes to fit different heart sizes, etc.

[0051] The method 900 also includes determining whether the selected PFA maze jacket 120 is positioned correctly (in a decision block 904). In some examples, such determination is made by acquiring EGM signals from one or more pairs of the sensing electrodes 504 in the PFA maze jacket 120 and analyzing the acquired EGM signals with the EGM signal processor 104. In some cases, the determination of the block 904 is aided by the use of the mapping and navigation module 112 and / or ultrasound fat measurements performed on the pertinent heart tissue. In some examples, operations of the block 904 may also include additional medical imaging of the thoracic cavity, e.g., directed at confirming proper positioning of the PFA maze jacket 120. When it is determined that a position adjustment is needed (“No” at the decision block 904), the processing of the method 900 is directed back to the block 902. When it is determined that the PFA maze jacket 120 is positioned correctly (“Yes” at the decision block 904), the processing of the method 900 is directed to a block 906.

[0052] Operations of the block 906 include delivering energy to selected PFA electrodes 502. In a first instance of the block 906, different PFA electrodes 502 in the PFA maze jacket 120 may be selected in a sequence, with a corresponding control algorithm operating the electrode selectorAttorney Docket No.215364-0065-WO01 (A0010806WO01) switch 108 such that the lesions corresponding to the above-described electrode patterns are formed in the heart tissue. In any subsequent instances of the block 906, different subsets of the PFA electrodes 502 in the PFA maze jacket 120 are selected to provide additional energy delivery to the heart tissue areas that are judged (via subsequent assessment) not to have formed adequate lesions during the previous energy deliveries in the preceding instances of the block 906.

[0053] The method 900 also includes assessing whether the intended lesion pattern is fully formed in the heart tissue (in a decision block 908). In various examples, the assessment operations of the block 908 are directed at verifying the endpoint and include: (i) acquiring EGM signals from one or more pairs of the sensing electrodes 504 in the PFA maze jacket 120 and analyzing the acquired EGM signals with the EGM signal processor 104; (ii) performing conduction block testing using the electrode selector switch 108 and the impedance analyzer 106; and (iii) evaluating the line of conduction block from the ablation by delivering pacing to the heart via the electrodes 504 of the PFA maze jacket 120. When it is determined that the intended lesion pattern is not fully formed (“No” at the decision block 908), the processing of the method 900 is directed back to the block 906. When it is determined that the intended lesion pattern is fully formed (“Yes” at the decision block 904), the method 900 is terminated.

[0054] In various examples, one or more of the following features can be incorporated into the method 900. An appropriately selected PFA maze jacket 120 is placed around four pulmonary veins (PVs), including a passage through the transverse sinus, to form a continuous path encircling the four PVs. This ablation positioning will deliver energy to create the box lesion (e.g., corresponding to the closed loop track 510 of PFA electrodes 502) that encompasses all four PV’s. Pacing / sensing electrodes 504 are located in strategically selected locations and are used in the determination of conduction block post-ablation. Temperature sensors may be placed in tissue contact at multiple locations associated with the PFA electrodes 502 around the PFA maze jacket 120.

[0055] The relative thickness of adipose tissue underlying each PFA electrode 502 is an important factor in achieving a successful continuous line of conduction block in the atrial tissue. In various examples, various approaches may be employed to manage this factor:Attorney Docket No.215364-0065-WO01 (A0010806WO01) a. In cases of closed chest, minimally invasive procedures, a pre-procedure CT scan or MRI may be performed to determine the thickness of the epicardial fat in the regions of interest. These data are superimposed onto an anatomical rendering of the heart chambers, which can then be used for intraprocedural positioning of the PFA electrode arrays. b. In one embodiment of the system 100, the electrode selector switch 108 is used to perform impedance analysis of the tissue underlying each of the electrodes. In operation, prior to the PFA delivery, an inter-electrode impedance analysis can be performed. This analysis may include measurements of the impedance between each pair of adjacent electrodes 502 as well as the impedance between each individual electrode 502 and the body reference electrode or patient return electrode patch 124. In some systems, electrical impedance tomography (EIT) can be used to produce images of the tissue regions of interest to show the distribution of adipose tissue. c. In one embodiment of the PFA maze jacket 120, the electrode array also has embedded ultrasound transducers configured to provide measurements of the epicardial fat thickness for each location around the electrode array. The obtained data can then be used to determine an appropriate dose of therapeutic energy at each electrode 502 around the array. d. In another embodiment of the PFA maze jacket 120, the ultrasound transducers are configured to serve two purposes: (i) provide diagnostic information regarding the thickness of the underlying adipose tissue and (ii) deliver high intensity ultrasound energy with an objective of reducing the adipose thickness under the electrodes. Such high intensity ultrasound may utilize a frequency of about 1 MHz and deliver an ultrasound intensity greater than about 1 W / cm2.

[0056] Energy can be vectored in multiple configurations and using different parameters as needed to produce a continuous transmural lesion. The data collected via the impedance and / or ultrasound scans will show which electrodes are most likely positioned over adipose tissue. When possible, the PFA maze jacket 120 may be repositioned or replaced by a different embodiment thereof to minimize the underlying adipose tissue thickness. A localized PFA dose at each electrode position can be determined using an impedance scan. Pulsed electric fields canAttorney Docket No.215364-0065-WO01 (A0010806WO01) be delivered during the block 906 in differing energy vector configurations, e.g., including: (i) an individual electrode 502 to an adjacent electrode 502; (ii) an individual electrode 502 to a non- adjacent electrode 502; (iii) an individual electrode 502 to sets of electrodes 502 that are positioned in a diametrically opposite location (such as on the opposite side of the heart chamber); (iv) sets of electrodes 502 to non-adjacent sets of electrodes 502; (v) an individual electrode 502 to the patient return electrode (skin patch) 124; (vi) an individual electrode 502 or a set of electrodes 502 to an indwelling electrode or set of electrodes positioned within a heart chamber.

[0057] An alternative example of the system 100 is configured to produce a brief period of heating during the ablation procedure. This optional feature enables the surgeons to produce a visible thermal injury to the surface of the tissue to mark the lesion line when so desired by the operator of the medical system 100. The heat may be produced near the start of the PFA energy delivery, during such delivery, or at the end of such delivery. With such an embodiment, the thermal injury “marking” is available as an option to be selected when desired by the operator. In some examples, the heating is limited to a thin surface layer of the tissue that underlies the PFA electrodes 502. In different examples, such heating is accomplished using different methods, including but not limited to: (1) RF energy, such as at the frequency of about 500 kHz; (2) relatively long PFA pulse widths, such as about 100 ^s or longer; and (3) PFA pulse train deliveries with relatively high duty cycle values, such as greater than about 10%.

[0058] FIG.10 is a block diagram illustrating the computer 116 according to various examples. In some examples, the computer 116 can be used to implement various control operations in the medical system 100, including but not limited to a set of control operations corresponding to the method 900.

[0059] The computer 116 of FIG.10 is illustrated as having a number of components, but any one or more of these components may be omitted or duplicated, as suitable for the application and setting. In some embodiments, some or all of the components included in the computer 116 may be attached to one or more motherboards and enclosed in a housing. In some embodiments, some of those components may be fabricated onto a single system-on-a-chip (SoC) (e.g., the SoC may include one or more electronic processors 1002 and memory or storage 1004).Attorney Docket No.215364-0065-WO01 (A0010806WO01) Additionally, in various embodiments, the computer 116 may not include one or more of the components illustrated in FIG.10, but may include interface circuitry for coupling to the one or more components using any suitable interface (e.g., a Universal Serial Bus (USB) interface, a High-Definition Multimedia Interface (HDMI) interface, a Controller Area Network (CAN) interface, a Serial Peripheral Interface (SPI) interface, an Ethernet interface, a wireless interface, or any other appropriate interface). For example, the computer 116 may not include a display 1010, but may include display interface circuitry (e.g., a connector and driver circuitry) to which an external display 1010 may be coupled.

[0060] The computer 116 includes a processor 1002 (e.g., one or more electronic processors). As used herein, the terms “electronic processor” and “processing device” interchangeably refer to any device or portion of a device that processes electronic data from registers and / or memory to transform that electronic data into other electronic data that may be stored in registers and / or memory. In various embodiments, the processor 1002 may include one or more digital signal processors (DSPs), application-specific integrated circuits (ASICs), central processing units (CPUs), graphics processing units (GPUs), server processors, or any other suitable processing devices.

[0061] The computer 116 also includes a storage 1004 (e.g., memory or one or more storage devices). In various embodiments, the storage 1004 may include one or more memory devices, such as random-access memory (RAM) (e.g., static RAM (SRAM), magnetic RAM (MRAM), dynamic RAM (DRAM), resistive RAM (RRAM), or conductive-bridging RAM (CBRAM)), hard drive-based memory, solid-state memory, networked drives, cloud drives, or a combination of memory. In some embodiments, the storage 1004 may include memory that shares a die with the processor 1002. In such an embodiment, the memory may be used as cache memory and include embedded dynamic random-access memory (eDRAM) or spin transfer torque magnetic random-access memory (STT-MRAM), for example. In some embodiments, the storage 1004 may include non-transitory computer readable media having instructions thereon that, when executed by one or more electronic processors (e.g., the processor 1002), cause the computer 116 to perform any appropriate ones of the methods disclosed herein below or portions of such methods.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0062] The computer 116 further includes an interface device 1006 (e.g., one or more interface devices 1006). In various embodiments, the interface device 1006 may include one or more communication chips, connectors, and / or other hardware and software to govern communications between the computer 116 and other computing devices. For example, the interface device 1006 may include circuitry for managing wireless communications for the transfer of data to and from the computer 116. The term “wireless” and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data via modulated electromagnetic radiation through a nonsolid medium. The term does not imply that the associated devices do not contain any wires, although in some embodiments they might not. Circuitry included in the interface device 1006 for managing wireless communications may implement any of a number of wireless standards or protocols, including but not limited to Institute for Electrical and Electronic Engineers (IEEE) standards including Wi-Fi (IEEE 802.11 family), IEEE 802.16 standards, Long-Term Evolution (LTE) project along with any amendments, updates, and / or revisions (e.g., advanced LTE project, ultramobile broadband (UMB) project (also referred to as “3GPP2”), etc.). In some embodiments, circuitry included in the interface device 1006 for managing wireless communications may operate in accordance with a Global System for Mobile Communication (GSM), General Packet Radio Service (GPRS), Universal Mobile Telecommunications System (UMTS), High Speed Packet Access (HSPA), Evolved HSPA (E-HSPA), or LTE network. In some embodiments, circuitry included in the interface device 1006 for managing wireless communications may operate in accordance with Enhanced Data for GSM Evolution (EDGE), GSM EDGE Radio Access Network (GERAN), Universal Terrestrial Radio Access Network (UTRAN), or Evolved UTRAN (E-UTRAN). In some embodiments, circuitry included in the interface device 1006 for managing wireless communications may operate in accordance with Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Digital Enhanced Cordless Telecommunications (DECT), Evolution-Data Optimized (EV-DO), and derivatives thereof, as well as any other wireless protocols that are designated as 3G, 4G, 5G, and beyond. In some embodiments, the interface device 1006 may include one or more antennas (e.g., one or more antenna arrays) configured to receive and / or transmit wireless signals.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0063] In some embodiments, the interface device 1006 may include circuitry for managing wired communications, such as electrical, optical, or any other suitable communication protocols. For example, the interface device 1006 may include circuitry to support communications in accordance with Ethernet technologies. In some embodiments, the interface device 1006 may support both wireless and wired communication, and / or may support multiple wired communication protocols and / or multiple wireless communication protocols. For example, a first set of circuitry of the interface device 1006 may be dedicated to shorter-range wireless communications such as Wi-Fi or Bluetooth, and a second set of circuitry of the interface device 1006 may be dedicated to longer-range wireless communications such as global positioning system (GPS), EDGE, GPRS, CDMA, WiMAX, LTE, EV-DO, or others. In some other embodiments, a first set of circuitry of the interface device 1006 may be dedicated to wireless communications, and a second set of circuitry of the interface device 1006 may be dedicated to wired communications.

[0064] The computer 116 also includes battery / power circuitry 1008. In various embodiments, the battery / power circuitry 1008 may include one or more energy storage devices (e.g., batteries or capacitors) and / or circuitry for coupling components of the computer 116 to an energy source separate from the computer 116 (e.g., to AC line power).

[0065] The computer 116 also includes a display device 1010 (e.g., one or multiple individual display devices). In various embodiments, the display device 1010 may include any visual indicators, such as a heads-up display, a computer monitor, a projector, a touchscreen display, a liquid crystal display (LCD), a light-emitting diode display, or a flat panel display.

[0066] The computer 116 also includes additional input / output (I / O) devices 1012. In various embodiments, the I / O devices 1012 may include one or more data / signal transfer interfaces, audio I / O devices (e.g., microphones or microphone arrays, speakers, headsets, earbuds, alarms, etc.), audio codecs, video codecs, printers, sensors (e.g., thermocouples or other temperature sensors, humidity sensors, pressure sensors, vibration sensors, etc.), image capture devices (e.g., one or more cameras), human interface devices (e.g., keyboards, cursor control devices, such as a mouse, a stylus, a trackball, or a touchpad), etc.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0067] Depending on the specific embodiment, various components of the interface devices 1006 and / or I / O devices 1012 can be configured to output suitable control signals, receive suitable control / telemetry signals, and receive and transmit data streams. In some examples, the interface devices 1006 and / or I / O devices 1012 include one or more analog-to-digital converters (ADCs) for transforming received analog signals into a digital form suitable for operations performed by the processing device 1002 and / or the storage device 1004. In some additional examples, the interface devices 1006 and / or I / O devices 1012 include one or more digital-to- analog converters (DACs) for transforming digital signals provided by the processing device 1002 and / or the storage device 1004 into an analog form suitable for being transmitted through a communication channel.

[0068] According to an example embodiment disclosed above, e.g., in the summary section and / or in reference to any one or any combination of some or all of FIGS.1-10, provided is an ablation device comprising: a jacket configured to harness around a heart and including a first anatomical anchor configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart; and a plurality of first electrodes attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes.

[0069] In some embodiments of the above device, the device further comprises an electrical cable including a plurality of electrical wires to individually electrically connect each of the first electrodes to a source of the pulsed energy.

[0070] In some embodiments of any of the above devices, the jacket comprises a fabric and has a separable pair of flaps or panels provided with a reversibly disconnectable connector for connecting the flaps or panels to one another when the jacket is positioned on the heart.

[0071] In some embodiments of any of the above devices, the reversibly disconnectable connector is selected from the group consisting of a fastener, a zipper, a magnetic connector, a set of suture loops, and a Velcro connector.

[0072] In some embodiments of any of the above devices, the first anatomical anchor is configured to be mated with the first anatomical landmark selected from the group consisting of:Attorney Docket No.215364-0065-WO01 (A0010806WO01) a blood vessel set including an aorta and a pulmonary trunk; a superior vena cava; an inferior vena cava; a blood vessel set including the superior vena cava and the inferior vena cava; a blood vessel set including a left superior pulmonary vein, a left inferior pulmonary vein, a right superior pulmonary vein, and a right inferior pulmonary vein; a left atrial appendage; and a right atrial appendage.

[0073] In some embodiments of any of the above devices, the jacket comprises a stretchable sock-like portion including an elastic cuff configured to accommodate a blood vessel set including an aorta and a pulmonary trunk of the heart.

[0074] In some embodiments of any of the above devices, the jacket further comprises a sleeve portion connected to the sock-like portion and configured to accommodate a superior vena cava, an inferior vena cava, or a blood vessel set including the superior vena cava and the inferior vena cava.

[0075] In some embodiments of any of the above devices, the sock-like portion has an opening configured to accommodate a blood vessel set including a left superior pulmonary vein, a left inferior pulmonary vein, a right superior pulmonary vein, and a right inferior pulmonary vein.

[0076] In some embodiments of any of the above devices, the sock-like portion is configured to cover a coronary sinus, a right ventricle, a left ventricle, a right atrium, and a left atrium of the heart.

[0077] In some embodiments of any of the above devices, the jacket comprises: a collar configured to be wrapped around pulmonary veins of the heart; and an elastic band connected to the collar such that, when the collar is wrapped around a base of the pulmonary veins, the elastic band is configured to be wrapped around the heart to secure the jacket thereon.

[0078] In some embodiments of any of the above devices, the collar has a separable pair of flaps provided with a reversibly disconnectable connector for connecting the flaps to one another when the jacket is positioned on the heart.Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0079] In some embodiments of any of the above devices, the jacket includes a second anatomical anchor configured to be mated with a second anatomical landmark of the heart for positioning the jacket on the heart.

[0080] In some embodiments of any of the above devices, the pattern corresponds to a Cox- maze IV lesion set.

[0081] In some embodiments of any of the above devices, the pattern corresponds to the lesion set selected from the group consisting of: a closed-loop lesion encircling left pulmonary veins; a closed-loop lesion encircling right pulmonary veins; a superior connecting lesion; an inferior connecting lesion; a mitral annulus lesion; a coronary sinus lesion; a lesion on a left atrial free wall connecting to a left atrial appendage; a lesion connecting a superior vena cava and an inferior vena cava; a lesion on a right atrial free wall; a tricuspid valve lesion; and a pulmonary veins box lesion.

[0082] In some embodiments of any of the above devices, the device further comprises a plurality of second electrodes attached to the jacket and configured for collecting electrogram signals from the heart.

[0083] In some embodiments of any of the above devices, the device further comprises a plurality of second electrodes attached to the jacket and configured for delivering pacing signals to the heart.

[0084] In some embodiments of any of the above devices, the jacket comprises a gripping fabric having one or more gripping features configured to attach to an area of tissue via a pressure differential, reversible adhesion, or surface tension.

[0085] According to another example embodiment disclosed above, e.g., in the summary section and / or in reference to any one or any combination of some or all of FIGS.1-10, provided is a medical system comprising: an ablation device including: a jacket configured to harness around a heart and including a first anatomical anchor configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart; and a plurality of first electrodes attached to the jacket and arranged in a pattern corresponding to a lesion set to beAttorney Docket No.215364-0065-WO01 (A0010806WO01) formed in the heart by passing pulsed energy through selected sets of the first electrodes; an electrical generator configured to provide the pulsed energy; and an electrode selector switch configured to selectively connect the first electrodes to the electrical generator via an electrical cable including a plurality of electrical wires connected to individual ones of the first electrodes.

[0086] In some embodiments of the above system, the system further comprises an impedance analyzer, wherein the electrode selector switch is further configured to selectively connect the first electrodes via the electrical cable to the impedance analyzer for impedance measurements.

[0087] In some embodiments of any of the above systems, the system further comprises a computing device (e.g., a computer or an electronic controller) configured to control the electrical generator, the electrode selector switch, and the impedance analyzer.

[0088] In some embodiments of any of the above systems, the system further comprises an electrogram signal processor and a cardiac stimulator, wherein the ablation device further includes a plurality of second electrodes attached to the jacket and configured to deliver pacing signals generated by the cardiac stimulator to the heart or to collect electrogram signals from the heart for being processed by the electrogram signal processor.

[0089] With regard to the processes, systems, methods, heuristics, etc. described herein, it should be understood that, although the steps of such processes, etc. have been described as occurring according to a certain ordered sequence, such processes could be practiced with the described steps performed in an order other than the order described herein. It further should be understood that certain steps could be performed simultaneously, that other steps could be added, or that certain steps described herein could be omitted. In other words, the descriptions of processes herein are provided for the purpose of illustrating certain implementations and should in no way be construed to limit the claims.

[0090] Accordingly, it is to be understood that the above description is intended to be illustrative and not restrictive. Many embodiments and applications other than the examples provided would be apparent upon reading the above description. The scope should be determined, not with reference to the above description, but should instead be determined withAttorney Docket No.215364-0065-WO01 (A0010806WO01) reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. It is anticipated and intended that future developments will occur in the technologies discussed herein, and that the disclosed systems and methods will be incorporated into such future embodiments. In sum, it should be understood that the application is capable of modification and variation.

[0091] All terms used in the claims are intended to be given their broadest reasonable constructions and their ordinary meanings as understood by those knowledgeable in the technologies described herein unless an explicit indication to the contrary in made herein. In particular, use of the singular articles such as “a,” “the,” “said,” etc. should be read to recite one or more of the indicated elements unless a claim recites an explicit limitation to the contrary.

[0092] Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value or range.

[0093] The use of figure numbers and / or figure reference labels (if any) in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.

[0094] Although the elements in the following method claims, if any, are recited in a particular sequence with corresponding labeling, unless the claim recitations otherwise imply a particular sequence for implementing some or all of those elements, those elements are not necessarily intended to be limited to being implemented in that particular sequence.

[0095] Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”Attorney Docket No.215364-0065-WO01 (A0010806WO01)

[0096] Unless otherwise specified herein, the use of the ordinal adjectives “first,” “second,” “third,” etc., to refer to an object of a plurality of like objects merely indicates that different instances of such like objects are being referred to, and is not intended to imply that the like objects so referred-to have to be in a corresponding order or sequence, either temporally, spatially, in ranking, or in any other manner.

[0097] Unless otherwise specified herein, in addition to its plain meaning, the conjunction “if” may also or alternatively be construed to mean “when” or “upon” or “in response to determining” or “in response to detecting,” which construal may depend on the corresponding specific context. For example, the phrase “if it is determined” or “if [a stated condition] is detected” may be construed to mean “upon determining” or “in response to determining” or “upon detecting [the stated condition or event]” or “in response to detecting [the stated condition or event].”

[0098] Throughout the detailed description, the drawings, which are not to scale, are illustrative only and are used in order to explain, rather than limit the disclosure. The use of terms such as height, length, width, top, bottom, is strictly to facilitate the description of the embodiments and is not intended to limit the embodiments to a specific orientation. For example, height does not imply only a vertical rise limitation, but is used to identify one of the three dimensions of a three-dimensional structure as shown in the figures. Such "height" would be vertical where the electrodes are horizontal but would be horizontal where the electrodes are vertical, and so on. Similarly, while all figures show the different layers as horizontal layers such orientation is for descriptive purpose only and not to be construed as a limitation.

[0099] Also, for purposes of this description, the terms “couple,” “coupling,” “coupled,” “connect,” “connecting,” or “connected” refer to any manner known in the art or later developed in which energy is allowed to be transferred between two or more elements, and the interposition of one or more additional elements is contemplated, although not required. Conversely, the terms “directly coupled,” “directly connected,” etc., imply the absence of such additional elements. The same type of distinction applies to the use of terms “attached” and “directly attached,” as applied to a description of a physical structure. For example, a relatively thin layerAttorney Docket No.215364-0065-WO01 (A0010806WO01) of adhesive or other suitable binder can be used to implement such “direct attachment” of the two corresponding components in such physical structure.

[0100] The described embodiments are to be considered in all respects as only illustrative and not restrictive. In particular, the scope of the disclosure is indicated by the appended claims rather than by the description and figures herein. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

[0101] The functions of the various elements shown in the figures, including any functional blocks labeled as “processors” and / or “controllers,” may be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions may be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which may be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and may implicitly include, without limitation, digital signal processor (DSP) hardware, network processor, application specific integrated circuit (ASIC), field programmable gate array (FPGA), read only memory (ROM) for storing software, random access memory (RAM), and nonvolatile storage. Other hardware, conventional and / or custom, may also be included. Similarly, any switches shown in the figures are conceptual only. Their function may be carried out through the operation of program logic, through dedicated logic, through the interaction of program control and dedicated logic, or even manually, the particular technique being selectable by the implementer as more specifically understood from the context.

[0102] As used in this application, the term “circuitry” may refer to one or more or all of the following: (a) hardware-only circuit implementations (such as implementations in only analog and / or digital circuitry); (b) combinations of hardware circuits and software, such as (as applicable): (i) a combination of analog and / or digital hardware circuit(s) with software / firmware and (ii) any portions of hardware processor(s) with software (including digital signal processor(s)), software, and memory(ies) that work together to cause an apparatus, such as a mobile phone or server, to perform various functions); and (c) hardware circuit(s) and or processor(s), such as a microprocessor(s) or a portion of a microprocessor(s), that requiresAttorney Docket No.215364-0065-WO01 (A0010806WO01) software (e.g., firmware) for operation, but the software may not be present when it is not needed for operation.” This definition of circuitry applies to all uses of this term in this application, including in any claims. As a further example, as used in this application, the term circuitry also covers an implementation of merely a hardware circuit or processor (or multiple processors) or portion of a hardware circuit or processor and its (or their) accompanying software and / or firmware. The term circuitry also covers, for example and if applicable to the particular claim element, a baseband integrated circuit or processor integrated circuit for a mobile device or a similar integrated circuit in server, a cellular network device, or other computing or network device.

[0103] It should be appreciated by those of ordinary skill in the art that any block diagrams herein represent conceptual views of illustrative circuitry embodying the principles of the disclosure. Similarly, it will be appreciated that any flow charts, flow diagrams, state transition diagrams, pseudo code, and the like represent various processes which may be substantially represented in computer readable medium and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.

Claims

Attorney Docket No.215364-0065-WO01 (A0010806WO01) CLAIMS What is claimed is:

1. An ablation device, comprising: a jacket (120) configured to harness around a heart and including a first anatomical anchor (302, 320) configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart; and a plurality of first electrodes (502) attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes.

2. The ablation device of claim 1, further comprising an electrical cable (118) including a plurality of electrical wires to individually electrically connect each of the first electrodes to a source of the pulsed energy.

3. The ablation device of claim 1 or 2, wherein the jacket comprises a fabric and has a separable pair of flaps (3121, 3122) or panels (612, 614) provided with a reversibly disconnectable connector (314, 610) for connecting the flaps or panels to one another when the jacket is positioned on the heart.

4. The ablation device of claim 3, wherein the reversibly disconnectable connector is selected from the group consisting of a fastener, a zipper, a magnetic connector, a set of suture loops, and a Velcro connector.

5. The ablation device of any one of claims 1-4, wherein the first anatomical anchor is configured to be mated with the first anatomical landmark selected from the group consisting of: a blood vessel set including an aorta and a pulmonary trunk; a superior vena cava; an inferior vena cava; a blood vessel set including the superior vena cava and the inferior vena cava;Attorney Docket No.215364-0065-WO01 (A0010806WO01) a blood vessel set including a left superior pulmonary vein, a left inferior pulmonary vein, a right superior pulmonary vein, and a right inferior pulmonary vein; a left atrial appendage; and a right atrial appendage.

6. The ablation device of any one of claims 1-5, wherein the jacket comprises a stretchable sock-like portion (306) including an elastic cuff (302) configured to accommodate a blood vessel set including an aorta and a pulmonary trunk of the heart.

7. The ablation device of claim 6, wherein the jacket further comprises a sleeve portion (320) connected to the sock-like portion and configured to accommodate a superior vena cava, an inferior vena cava, or a blood vessel set including the superior vena cava and the inferior vena cava.

8. The ablation device of claim 6, wherein the sock-like portion has an opening configured to accommodate a blood vessel set including a left superior pulmonary vein, a left inferior pulmonary vein, a right superior pulmonary vein, and a right inferior pulmonary vein.

9. The ablation device of claim 6, wherein the sock-like portion is configured to cover a coronary sinus, a right ventricle, a left ventricle, a right atrium, and a left atrium of the heart.

10. The ablation device of any one of claims 1-5, wherein the jacket comprises: a collar (802) configured to be wrapped around pulmonary veins of the heart; and an elastic band (806) connected to the collar such that, when the collar is wrapped around a base of the pulmonary veins, the elastic band is configured to be wrapped around the heart to secure the jacket thereon; and wherein the collar has a separable pair of flaps (8121, 8122) provided with a reversibly disconnectable connector (814) for connecting the flaps to one another when the jacket is positioned on the heart.Attorney Docket No.215364-0065-WO01 (A0010806WO01) 11. The ablation device of any one of claims 1-10, wherein the jacket includes a second anatomical anchor (302, 320) configured to be mated with a second anatomical landmark of the heart for positioning the jacket on the heart; and wherein the pattern corresponds to a Cox-maze IV lesion set.

12. The ablation device of any one of claims 1-11, wherein the pattern corresponds to the lesion set selected from the group consisting of: a closed-loop lesion encircling left pulmonary veins; a closed-loop lesion encircling right pulmonary veins; a superior connecting lesion; an inferior connecting lesion; a mitral annulus lesion; a coronary sinus lesion; a lesion on a left atrial free wall connecting to a left atrial appendage; a lesion connecting a superior vena cava and an inferior vena cava; a lesion on a right atrial free wall; a tricuspid valve lesion; and a pulmonary veins box lesion.

13. The ablation device of any one of claims 1-12, further comprising a plurality of second electrodes (504) attached to the jacket and configured for collecting electrogram signals from the heart or for delivering pacing signals to the heart.

14. The ablation device of any one of claims 1-13, wherein the jacket comprises a gripping fabric having one or more gripping features configured to attach to an area of tissue via a pressure differential, reversible adhesion, or surface tension.

15. A medical system, comprising: an ablation device including:Attorney Docket No.215364-0065-WO01 (A0010806WO01) a jacket (120) configured to harness around a heart and including a first anatomical anchor configured to be mated with a first anatomical landmark of the heart for positioning the jacket on the heart; and a plurality of first electrodes (502) attached to the jacket and arranged in a pattern corresponding to a lesion set to be formed in the heart by passing pulsed energy through selected sets of the first electrodes; an electrical generator (102) configured to provide the pulsed energy; and an electrode selector switch (108) configured to selectively connect the first electrodes to the electrical generator via an electrical cable (118) including a plurality of electrical wires connected to individual ones of the first electrodes.

Images