Systems and methods for cardiac conduction block

Abstract

To provide electrophysiology cardiac ablation devices, methods and systems.SOLUTION: This disclosure relates to electrophysiology cardiac ablation devices, methods and systems. In particular, this disclosure relates to devices, methods and systems that create a reversible non-ablative blockade of cardiac tissue, test the cardiac tissue, and ablate the cardiac tissue.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] INCORPORATION BY REFERENCE OF PRIOR APPLICATIONS This application claims the nonprovisional benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 628,810, filed February 9, 2018, which is incorporated herein by reference in its entirety. Any application that is subject to a claim of foreign or domestic priority identified in an Application Data Sheet filed with this application is incorporated herein by reference under 37 CFR §1.57.

[0002] The present disclosure relates to electrophysiological cardiac ablation devices, methods, and systems. In particular, the present disclosure relates to devices, methods, and systems for providing cardiac tissue blockage, verifying cardiac tissue, and ablating cardiac tissue. [Background technology]

[0003] Electrophysiological (EP) cardiac ablation procedures currently require sequential ablation of cardiac tissue followed by a subsequent evaluation of whether a particular ablation resulted in an alteration, reduction, or correction of abnormal cardiac activity, including arrhythmias. This process often requires lengthy periods of time (e.g., hours) and use of a procedure room, and can result in unnecessary or non-therapeutic ablation of cardiac tissue that typically does not regenerate. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 10,071,241 [Patent Document 2] U.S. Patent No. 9,008,800 [Patent Document 3] US Patent Application Publication No. 2018 / 0280691 Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, in some embodiments, it is desirable to provide devices and / or methods that allow verification of whether a particular piece of cardiac tissue is suitable for either therapeutic or iatrogenic ablation (e.g., to reversibly verify whether ablation of a given tissue is indeed therapeutic, possibly followed by permanent ablation of the tissue). This can be done by applying a direct current and / or a high frequency alternating current to the cardiac tissue, resulting in a reversible blockage of the cardiac tissue without ablation. DC systems and methods can be implemented to prevent ablation during application of DC current, thus protecting the tissue. [Means for solving the problem]

[0006] The methods and apparatus or devices disclosed herein each have multiple aspects, no one of which is solely responsible for its desirable properties. Without limiting the scope of this disclosure, as expressed, for example, by the appended claims, its more prominent features will now be discussed briefly.

[0007] In some configurations, a method of performing a cardiac electrophysiology test on a patient is disclosed herein. The method can include sensing electrical activity of a first cardiac target tissue, determining that the electrical activity of the first cardiac target tissue has a characteristic of interest, delivering a first non-ablative direct current to the first cardiac target tissue sufficient to produce a reversible conduction block in the first cardiac target tissue, and observing the presence of the characteristic of interest after delivering the first non-ablative direct current.

[0008] In some configurations, the characteristic of interest includes abnormal electrical activity. In some configurations, the method may further include ablating the first cardiac target tissue if the characteristic of interest is not present after delivering a first non-ablative direct current to the first cardiac target tissue. The method may also include sensing electrical activity of a second cardiac target tissue and determining that the electrical activity of the first cardiac target tissue has the characteristic of interest.

[0009] In some configurations, the method may further include delivering a second non-ablative direct current to the second cardiac target tissue sufficient to effect a reversible conduction block in the second cardiac target tissue, and observing the presence of the feature of interest after delivering the second non-ablative direct current.

[0010] In some configurations, the method may further include ablating the second cardiac target tissue if the pathological arrhythmia is not present after the step of delivering a second non-ablative direct current to the second cardiac target tissue.

[0011] In some configurations, the first non-ablative DC current can include a cathodic DC current circulated with an anodic DC current.

[0012] In some configurations, the first non-ablative direct current has a frequency of less than about 1 Hz, less than about 0.5 Hz, less than about 0.1 Hz, less than about 0.05 Hz, less than about 0.01 Hz, between about 0.01 Hz and 1 Hz, and in a range including any two of the foregoing numbers.

[0013] In some configurations, the first non-ablative direct current has an amplitude of less than about 100 mA, less than about 50 mA, less than about 20 mA, less than about 10 mA, less than about 5 mA, less than about 1 mA, or even lower, or a range including any two of the foregoing values.

[0014] In some configurations, the first cardiac target tissue includes myocardium, endocardium, or epicardium. The first cardiac target tissue may include left atrial and / or right atrial tissue, and / or left ventricular and / or right ventricular tissue. The first cardiac target tissue may further include pulmonary artery tissue or pulmonary vein tissue.

[0015] In some configurations, the method is for treating arrhythmias, including but not limited to atrial fibrillation, atrial flutter, PSVT, or ventricular tachycardia.

[0016] In some configurations, ablating the first cardiac target tissue includes delivering an ablation direct current.

[0017] In some configurations, ablating the first cardiac target tissue includes delivering RF energy, microwave energy, ultrasound energy, cryoablation, thermal energy, and / or laser energy, hi some configurations, ablating the first cardiac target tissue includes delivering cryoablation.

[0018] In some configurations, a method of performing a cardiac electrophysiology test in a patient is disclosed. The method includes sensing electrical activity of a first cardiac target tissue, delivering a first non-ablative current to the first cardiac target tissue sufficient to produce a reversible conduction block in the first cardiac target tissue, and observing abnormal electrical activity of the patient's heart after delivering the first non-ablative current. The non-ablative current can include HFAC and / or direct current. The method can also further include ablating the first cardiac target tissue if the abnormal electrical activity is not present after delivering the first non-ablative current to the first cardiac target tissue.

[0019] In some configurations, an electrophysiological cardiac ablation system is disclosed herein. The system includes a first generator configured to generate a non-ablative blocking current, a second generator configured to generate an ablation energy modality, and a catheter. The catheter has a proximal end configured to be coupled to a second ablation reservoir, which can be the first generator and the second generator, and a distal end. The catheter can further include a conductor extending from a proximal zone of the catheter to a distal zone of the catheter. The conductor can be disposed within the integrated catheter. The system can also include at least one blocking electrode disposed at a distal end of the catheter and configured to be conductively connected to the first generator, and at least one ablation end effector disposed at a distal end of the catheter and configured to be conductively connected to the second ablation reservoir, which can be, for example, an RF generator, an ultrasound generator, a microwave generator, a cryoreservoir, etc. The system may be configured to effect a reversible block in the cardiac tissue by delivering a blocking current from the first generator to the cardiac tissue via the at least one blocking electrode, and the system may be further configured to ablate the cardiac tissue by delivering an ablation energy modality from the second generator to the at least one ablation electrode.

[0020] In some configurations, at least one blocking electrode comprises a high charge density material.

[0021] In some configurations, at least one blocking electrode is made from silver and / or silver chloride and / or titanium nitride.

[0022] In some configurations, the first generator is configured to generate non-ablative DC or HFAC.

[0023] In some configurations, the conductor comprises a wire.

[0024] In some configurations, the at least one blocking electrode is configured to sense cardiac tissue activity.

[0025] In some configurations, at least one ablation electrode covers a portion of the circumference of the distal end of the catheter.

[0026] In some configurations, at least one ablation electrode is an RF ablation electrode.

[0027] In some configurations, the catheter has sufficient flexibility to allow contact between the at least one blocking electrode and the cardiac tissue.

[0028] In some configurations, the at least one blocking electrode is disposed on an expandable member, such as a balloon, disposed near the distal end of the integrated catheter, the balloon being configured to be inflated such that the at least one blocking electrode may directly contact cardiac tissue.

[0029] In some configurations, an electrophysiological cardiac ablation system is disclosed herein. The system may include a generator configured to generate a non-ablative blocking current and a catheter. The catheter may include a proximal end and a distal end configured to be coupled to the generator. The catheter may include an internal lumen extending from a proximal zone of the integrated catheter to a distal zone of the integrated catheter and defining openings in the proximal and distal zones. The internal lumen is configured to facilitate a conductive fluid flow from the proximal zone of the catheter to the distal zone of the catheter. The catheter may also further include at least one ablation electrode disposed near the distal zone of the integrated catheter and configured to be conductively connected to the generator. The system may be configured to reversibly block cardiac tissue by delivering a non-ablative blocking current from the generator to the cardiac tissue via the conductive fluid. The system may also be configured to ablate cardiac tissue by delivering a current from the generator to the at least one ablation electrode. The conductive fluid can be a volume of conductive fluid, including, for example, saline, and can be configured to carry a DC current to reversibly block cardiac tissue. The ablation electrode can be, for example, an RF electrode or another end effector, such as a microwave antenna, a laser, a cryoport, or an ultrasound transducer.

[0030] In some configurations, an integrated catheter is disclosed herein. The catheter includes a proximal end configured to be coupled to a generator, a distal end, at least one blocking electrode disposed near the distal end of the integrated catheter and configured to be conductively connected to the generator, and at least one ablation electrode disposed near the distal end of the integrated catheter and configured to be conductively connected to the generator. The integrated catheter is configured to block cardiac tissue by delivering a blocking current from the generator to the cardiac tissue via the at least one blocking electrode, and is configured to ablate cardiac tissue by delivering a current from the generator to the at least one ablation electrode. In some embodiments, at least one of the electrodes is configured to sense cardiac tissue activity. In some embodiments, the sensing electrode may be integrated with the ablation end effector and / or a non-ablative current electrode, or a separate electrode.

[0031] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, the same numerals generally identify similar components unless otherwise stated in the context. Thus, in some embodiments, part numbers may be used for similar components in multiple drawings or may vary from drawing to drawing. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit and scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings, can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are expressly contemplated and form part of the present disclosure. [Brief description of the drawings]

[0032] [Figure 1A]1 is an example graph showing blocking DC amplitude as a function of time. [Figure 1B] 1 is an example graph showing EP assessment verifying the effectiveness of direct current block on cardiac tissue as a function of time. [Figure 1C] 1 is an example graph showing ablation applied to cardiac tissue as a function of time. [Diagram 2] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using conductive fluid. [Diagram 3] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using non-fluid conductors. [Figure 4] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using a non-fluid conductor and a particulate container. [Figure 5A] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using an integrated catheter and conductive fluid. [Figure 5B] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using an integrated catheter and conductive fluid. [Figure 6A] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using an integrated catheter and non-fluid conductors. [Figure 6B] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using an integrated catheter, non-fluid conductor, and particulate container. [Figure 7] 1 is an example graph showing the required ablation level for cardiac tissue as a function of DC current amplitude. [Figure 8A] FIG. 2 is a schematic diagram of an example block mode. [Figure 8B] FIG. 1 is a schematic diagram of an example ablation mode. [Figure 9] 1 is a schematic diagram of an example mapping catheter. [Figure 10] FIG. 1 is a schematic diagram of an example EP cardiac ablation system using a deformable mesh. [Figure 11]FIG. 1 is a schematic diagram of an example EP cardiac ablation system using a balloon. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Although specific embodiments and examples are described below, the scope of the disclosure extends beyond the specifically disclosed embodiments and / or uses, as well as to obvious modifications and equivalents thereof. Thus, the scope of the disclosure is not intended to be limited by any of the specific embodiments described below.

[0034] Application of direct current (DC) can advantageously produce reversible non-ablative cardiac tissue block. Without being limited by theory, DC can advantageously inactivate sodium channels, thereby producing robust tissue block at low amplitudes. In addition, DC can further produce continuous inward ionic currents (ions such as calcium, sodium, or potassium), thereby producing robust tissue block at low amplitudes. Alternatively or additionally, application of high frequency alternating current (AC) can produce reversible block of cardiac tissue. In some embodiments, high frequency AC can be applied in combination with DC. This can be contrasted with the use of DC for conventional tissue ablation (or tissue defibrillation). Some embodiments involve systems and electrodes for safely delivering blocking direct current (DC) to non-neural tissue, such as cardiac tissue, by delivering cyclic cathodic and anodic currents with high charge chemistry.

[0035] Without being limited by theory, for example, the propagation of action potentials in non-neural tissues, such as cardiac tissue, results in a refractory period, which is on the order of milliseconds for sodium channels, typically 1-20 ms for the combined absolute and relative refractory periods, and therefore a very low frequency AC current waveform with a half-period significantly longer than this refractory period (e.g., longer than about 50 ms) can still be utilized to effect tissue block, which is perceived by cardiac tissue as a direct current stimulus. Thus, direct current as defined herein encompasses low frequency AC current waveforms that are perceived as direct current from the perspective of the tissue whose action potentials are to be modulated, and is functionally a direct current. The frequency can be, for example, less than about 1 Hz, less than about 0.5 Hz, less than about 0.1 Hz, less than about 0.05 Hz, less than about 0.01 Hz, less than about 0.005 Hz, less than about 0.0001 Hz, or a range including any two of the preceding values, so long as the direction of current flow is constant at least throughout the refractory period of the target cardiac tissue.

[0036] Direct current has been utilized to block nervous tissue, including brain tissue, central nerves, and peripheral nerves, including but not limited to somatic and autonomic nerves (e.g., sympathetic and parasympathetic nervous systems). In some embodiments as described herein, non-nervous electrically excitable / conductive tissues may be advantageously treated to produce a reversible block, including myocardial tissue.

[0037] In some embodiments, one or more parts of the cardiac conduction system, including the sinoatrial node, the atrioventricular node, the His bundle, the left bundle branch, the right bundle branch, the Bachmann bundle, the anatomically diverse accessory pathways, such as the Kent bundle, or the Purkinje fibers, can be reversibly treated using non-ablative DC and / or HFAC. In some embodiments, the treatment does not include one or all of the aforementioned parts of the cardiac conduction system. Alternatively or additionally, cardiac tissue, such as myocardial tissue that is not part of the cardiac electrical conduction system, as described above, can be treated using the systems and methods disclosed herein.

[0038] Direct current systems and methods can be implemented to prevent ablation (and thus protect tissue) during DC application, which can facilitate verification of whether a particular piece / zone of cardiac tissue is suitable for either therapeutic or iatrogenic ablation (e.g., to reversibly verify whether ablation of a given tissue is in fact therapeutic).

[0039] Ablation can then be performed on the tissue, including, but not limited to, electromagnetic energy delivery (such as RF energy, microwave energy, ultrasound energy, laser energy, and / or magnetic energy), thermal ablation, cryoablation, chemical ablation, mechanical ablation (such as the Maze procedure), and combinations thereof. In some embodiments, the ablative DC may be further utilized to ablate or otherwise permanently alter tissue (such as DC of much higher intensity than that utilized for generating heat and / or damaging / ablative electrochemical species, or for reversible blockade with alternative electrodes).

[0040] The DC current utilized to effect a temporary block of cardiac tissue may have a dramatically lower amplitude than that which results in ablation. For example, 0.1-20 mA, 0.1-5 mA, 0.1-10 mA, 1.0-10 mA, 5-20 mA, 10-20 mA, 5-50 mA, or 20-100 mA may be utilized to temporarily block cardiac tissue, or less than about 100 mA, less than about 50 mA, less than about 20 mA, less than about 10 mA, less than about 5 mA, less than about 1 mA, less than about 0.5 mA, less than about 0.1 mA, or even lower, or a range including any two of the preceding values. The systems described herein may facilitate safe and non-ablative delivery of DC within these ranges. The amplitude of this DC may be upwardly or downwardly sloping in some instances, including a non-linear gradient function. In some embodiments, the DC delivery period may be applied for only the period during which the practitioner desires to effect a block (e.g., simulated ablation, etc.).In some embodiments, any delivery period or interphase period may be, for example, at least about 1 second, at least about 5 seconds, at least about 10 seconds, at least about 15 seconds, at least about 20 seconds, at least about 25 seconds, at least about 30 seconds, at least about 35 seconds, at least about 40 seconds, at least about 45 seconds, at least about 50 seconds, at least about 55 seconds, at least about 60 seconds, or at least more than about 1 second, about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, about 45 seconds, about 50 seconds, about 55 seconds, about 60 seconds, or more, or less than about 1 second, less than about 5 seconds, less than about 10 seconds, less than about 15 seconds, less than about 20 seconds, less than about 25 seconds, less than about 30 seconds, less than about 35 seconds, less than about 40 seconds, less than about 45 seconds, less than about 50 seconds, less than about 55 seconds, less than about 60 seconds, or more, at least about 1 minute, at least about 2 minutes, at least about 3 minutes, at least about 4 minutes, at least about 4 minutes, at least about 5 minutes, at least about 10 minutes, at least about 15 minutes, at least about 20 minutes, at least about 25 minutes, at least about 30 minutes, at least about 35 minutes, at least about 40 minutes, at least about 45 minutes, at least about 50 minutes, at least about 55 minutes, at least about 60 minutes, or at least more than about 1 minute, about 2 minutes, about 3 minutes, about 4 minutes, about 5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 25 minutes, about 30 minutes, about 35 minutes, about 40 minutes, about The time can be about 1, 2, 3, 4, 5, 6, or more minutes, or less than about 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, or more minutes, or less than about 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, or more minutes, or a range including any two of the foregoing values.

[0041] In some embodiments, high frequency as used herein with reference to an alternating current (e.g., HFAC) can refer to a frequency of about 1 kHz or higher, such as between about 1.5 kHz and about 100 kHz, between about 3 kHz and about 50 kHz, between about 5 kHz and about 20 kHz, about 1 kHz, about 2 kHz, about 3 kHz, about 5 kHz, about 10 kHz, about 15 kHz, about 20 kHz, about 25 kHz, about 30 kHz, about 40 kHz, about 50 kHz, about 75 kHz, about 100 kHz, or higher kHz, or a range including any two of the preceding values, etc. In some embodiments, the amplitude of this signal can range from about 0.1 mA to about 20 mA, about 0.5 mA to about 10 mA, about 0.5 mA to about 4 mA, about 0.5 mA to about 2.5 mA, or other ranges including any two of the preceding values, or other amplitudes as disclosed elsewhere herein. The amplitude of the applied signal may be ramped up or down in some instances, including a non-linear ramp function. The frequency or amplitude of the alternating current may also be modulated.

[0042] With reference to the figures disclosed herein, the blocking device may be separate / separate from the ablation device. In some embodiments, the blocking device and the ablation device can be integrated. Exemplary systems include, but are not limited to, those shown in the figures disclosed herein.

[0043] With reference to Figures 1A-1C, blocking DC may alternatively be applied with ablation modalities including, but not limited to, RF (or other ablation techniques) to guide tissue ablation depth or therapeutic ablation region, which may be more tissue sparing or faster than ablation without the use of blocking DC.

[0044] 1A shows an example graph 100 of blocking DC amplitude as a function of time when applied to cardiac tissue. The vertical axis 102 is the blocking DC amplitude metric. The horizontal axis 104 is time. Blocking DC amplitude 106 is the trend when time equals zero. Blocking DC amplitude 108 is the trend at a later time. Blocking DC amplitude 108 can be a higher DC amplitude than blocking DC amplitude 106. In some embodiments, blocking DC amplitude 108 can have the same or a smaller amplitude than blocking DC amplitude 106.

[0045] 1B shows an example graph 110 illustrating EP assessment validating the effectiveness of DC block applied to cardiac tissue as a function of time. The vertical axis 112 is the EP assessment metric. The horizontal axis 114 is time. A first validation 116 of the block occurs after time zero and after the blocking DC is applied to the cardiac tissue. A second validation 118 occurs at some point after the time associated with the first validation 116. A third validation 119 (and subsequent validations) occurs at some point after the time associated with the second validation 118.

[0046] 1C shows an example graph 120 of ablation as a function of time. The vertical axis 122 is the ablation metric. The horizontal axis 124 is time. A first ablation 126 is applied some time after the first validation 116 in FIG. 1B. A second ablation 128 is applied at a time after the first ablation 126. The ablation metric 128 can be a higher or lower ablation metric compared to the ablation metric 126. In some embodiments, the ablation metric 128 can have the same or a smaller amplitude as the ablation metric 126.

[0047] In some embodiments, additional ablations such as a third, fourth, fifth, and subsequent ablations may be performed. In some embodiments, multiple evaluations / verifications may be performed before or after an ablation event, such as about two, about three, about four, about five, or more evaluations / verifications (e.g., observing the presence of features of interest such as pathological arrhythmias and / or abnormal electrical activity, and application of non-ablative blocking currents). In some embodiments, at least one, at least two, or at least more ablation events may be performed after the evaluation, such as about two, about three, about four, about five, or more ablation events, or at least two, at least three, at least four, at least five, or at least more ablation events. In some embodiments, the evaluations / verifications are performed only during the procedure without any ablation events, including when no clear etiology for the patient's symptoms has been identified.

[0048] 2 shows an example system 200 having a fluid catheter coupled to an external generator. The system 200 may have a generator 202. In some embodiments, the generator 202 may provide a DC current. In some embodiments, the generator 202 may provide an AC current, such as HFAC. The generator 202 may have a cathode (and / or anode) conductor 204. The generator may include a return anode and / or a return cathode (e.g., a patch electrode placed on the patient's skin, etc.).

[0049] The generator 202 may be configured to couple to a catheter 206. The catheter 206 may have a proximal end and a distal end. In some embodiments, the generator 202 may be removably coupled to the proximal end of the catheter 206.

[0050] The catheter 206 can be an elongated tube. The catheter 206 can have an internal cavity that extends from the proximal end of the catheter 206 to the distal end (or from another distal point partially along the catheter 206 to or near the distal end of the catheter 206). The catheter 206 can have an outer diameter of a variable size. The internal cavity can define an inner diameter of the catheter 206 of a variable size. The catheter 206 can be of various lengths that extend from the proximal end to the distal end of the catheter 206.

[0051] The interior cavity of the catheter 206 may be configured to hold a conductive fluid 208. In some embodiments, the conductive fluid 208 may be saline and / or another suitable fluid. In some embodiments, the generator 202 may cause an electrical current to flow through the conductive fluid 208.

[0052] The internal cavity of the catheter 206 may be configured to carry the conductive fluid 208 from a proximal zone to an opening in a distal zone, which may comprise one or more openings along a sidewall of an elongated body, such as a tubular structure. In some embodiments, the openings are arc-shaped, such as circular, elliptical, or other apertures, but may also comprise partially circular, longitudinal, or helical slots, and / or other geometric shapes. The distal end of the catheter 206 may be positioned within the patient via an anatomical lumen, such that the distal end of the catheter 206 is positioned adjacent to cardiac tissue. Once positioned, the generator 202 may generate an electrical current that is carried through the conductive fluid 208. The conductive fluid 208 is carried from the proximal zone to the distal zone of the catheter 206, and ultimately in direct contact or at least electrical contact with the patient's cardiac tissue.

[0053] The catheter 206 may be made from a variety of materials that are electrically conductive in order to carry the electrically charged conductive fluid 208 and / or be inserted into the patient's body.

[0054] 3 shows an example system 300 for using an electrode located at the distal end of a catheter. The example system 300 can include a generator 302. The generator 302 can have features of the generator 202.

[0055] The generator 302 may be configured to couple to a catheter 306. The catheter 306 may have features of the catheter 206. The catheter 306 may have a non-fluid conductor 304 disposed within the catheter 306. In some embodiments, the non-fluid conductor 304 is a wire. In some embodiments, the generator 302 may be coupled to the non-fluid conductor 304.

[0056] The catheter 306 may have an electrode 308 disposed at or near a distal end of the catheter 306. In some embodiments, the electrode 308 is a non-ablative DC electrode. In some embodiments, the electrode 308 may apply DC and / or AC (e.g., HFAC) current. In some embodiments, the electrode 308 is configured to apply a non-ablative current to the patient's cardiac tissue. In some embodiments, the electrode 308 surrounds all or a portion of the outer edge of the catheter 306. In some embodiments, the electrode 308 comprises multiple electrodes.

[0057] The electrodes 308 may be made from a variety of materials. In some embodiments, the electrodes 308 may be made from silver (Ag) and / or silver chloride (AgCl). In some embodiments, the electrodes 308 may be made from titanium nitride (TiN). In some embodiments, the electrodes 308 may be made from carbon (C). In some embodiments, the electrodes 308 have an ion-selective coating or membrane. In some embodiments, the electrodes 308 do not have an ion-selective coating or membrane.

[0058] In some embodiments, the electrodes may include contacts that include a high charge capacity material. The electrode contacts may be approximately 1 mm thick. 2 ~about 10mm 2Between or about 1 mm 2 , about 2 mm 2 , about 3mm 2 , about 4mm 2 , about 5mm 2 , about 6mm 2 , about 7mm 2 , about 8mm 2 , approx. 9mm 2 , about 10mm 2 , about 20mm 2 , about 50 mm 2 , about 100 mm 2, or a range inclusive of any two of the preceding values. The electrode contact itself may be made from a high charge capacity material, such as those described in U.S. Pat. No. 10,071,241 to Bhadra et al., which is incorporated herein by reference in its entirety. Alternatively, the electrode contact may comprise a base that is at least partially or entirely coated with a high charge capacity material. In some embodiments, the high charge capacity material may have a Q value of at least about 25 μC, at least about 50 μC, at least about 100 μC, at least about 200 μC, at least about 300 μC, at least about 400 μC, at least about 500 μC, at least about 1,000 μC, at least about 2,500 μC, at least about 5,000 μC, at least about 10,000 μC, at least about 50,000 μC, at least about 100,000 μC, at least about 500,000 μC, or higher, or a range including any two of the preceding values. This Q value of the electrode contact may indicate the total amount of charge that can be delivered through the electrode contact before the electrode contact begins to undergo irreversible chemical reactions, such as oxygen or hydrogen evolution, or dissolution of the electrode material. Non-limiting examples of high charge capacity materials are platinum black, iridium oxide, titanium nitride, tantalum, silver chloride, poly(ethylenedioxythiophene), and suitable combinations thereof. The electrode can be a fractal coated electrode in some embodiments. To generate a larger surface area for electrochemical reactions to occur, conventional electrodes can be made from structures with a high surface area to volume ratio, such as roughened surfaces, woven surfaces, patterned surfaces, reticulated foam structures, porous sintered bead structures, nanopatterned structures, or micropatterned structures, to expose additional material surface area.In some embodiments, the electrode can be a SINE (separated-interface nerve electrode) or EICCC (electron to ion current conversion cell) electrode, in which the electrode is immersed in an electrolyte solution in contact with an ion-conducting material-electrolyte solution interface with the ion-conducting material in electrical contact with or near a region of cardiac tissue, as described, for example, in U.S. Patent No. 9,008,800 to Ackermann et al. and U.S. Patent Application Publication No. 2018 / 0280691 to Ackermann et al., which are incorporated herein by reference in their entireties.

[0059] In some embodiments, the system can include a silver electrode and / or a silver chloride electrode, such as those described in U.S. Patent Application Publication No. 2018 / 0280691 to Ackermann et al., which is incorporated herein by reference in its entirety. In some examples, a system for blocking a patient's cardiac tissue can use a regenerative electrode. The system can include a direct current generator and / or at least one electrode including silver chloride. The system can further include a controller configured to signal the direct current generator to deliver a first direct current through the electrode, the first direct current having a first polarity sufficient to block conduction in the cardiac tissue and / or sufficient to reduce the amount of silver chloride in the electrode, thereby forming silver chloride and chloride ions. The controller can further be configured to signal the direct current generator to deliver a second direct current through the electrode, the second direct current having a second polarity sufficient to regenerate the electrode by increasing the amount of silver chloride. The system can further include a cardiac tissue interface separated from the electrode by a selective barrier. The selective barrier may also be further configured to allow certain ions, such as chloride ions, to pass through the barrier to block the cardiac tissue. The system may also include a sensor configured to determine whether a reaction, such as a predominant silver / silver chloride reaction, is occurring. The controller may further be configured to receive data from the sensor and to stop or modulate at least one of the first or second direct current signals if an undesirable activity, such as water being electrolyzed, is occurring. The selective barrier may also be further configured to prevent silver ions from passing through the barrier to the cardiac tissue interface. The electrodes may be housed in an insulated housing. The selective barrier may include an ion exchange membrane and / or a hydrogel. The system may not have any mechanically moving parts in some examples. The controller may be configured to deliver the first direct current such that the amount of reduced silver chloride is greater than the surface area of ​​the electrode before delivery of the first direct current.The controller may be further configured to deliver the first direct current such that the amount of reduced silver chloride is, for example, greater than about 1.25 times, greater than about 1.5 times, greater than about 2 times, greater than about 3 times, greater than about 4 times, greater than about 5 times, greater than about 10 times, greater than about 15 times, greater than about 20 times, greater than about 50 times, greater than about 100 times, greater than about 1,000 times, greater than about 5,000 times, greater than about 10,000 times, or a higher multiple, or a range including any two of the foregoing values, of the amount that can uniformly cover a surface area, such as the entire functional surface area, of the electrode prior to delivery of the first direct current.

[0060] The distal end of the catheter 306 and the electrode 308 may be positioned adjacent to cardiac tissue. The generator 302 may generate an electrical current that is carried to the electrode 308 via the non-fluid conductor 304. The electrical current may travel from the electrode 308 to the target cardiac tissue.

[0061] 4 shows an example system 400 that may use Ag and / or AgCl electrodes for use without an ion-selective coating. The system 400 may have a generator 302. The system 400 may include a catheter 306.

[0062] In some embodiments, the electrodes 308 can be made of Ag and / or AgCl and used without an ion-selective coating. This configuration may be suitable for temporary use since Ag dissolution during the ablation procedure is minimized.

[0063] A particulate container 402 may be positioned around the electrode 308. In some embodiments, the particulate container 402 can be a sponge, basket, mesh, and / or some other similar device to prevent leakage of particulates. In some embodiments, the particulate container 402 is not positioned around the electrode 308. The particulate container 402 may be made from a variety of materials that are electrically conductive to surround the electrode 308 and trap particulates that may become detached from the electrode 308.

[0064] 5A shows an example system 500 for an integrated blocking and ablation catheter. In some embodiments, blocking is performed by DC and / or AC current. In some embodiments, ablation is performed using another suitable ablation technique, such as RF ablation, or thermal or cryoablation, or other techniques such as those disclosed elsewhere herein. This configuration can be incorporated into any of the delivery techniques disclosed herein.

[0065] The system 500 may include a generator 502. The generator 502 may have features of other generators disclosed herein. The generator 502 may be coupled to a proximal end of a catheter 506. The catheter 506 may have features of other catheters disclosed herein. A conductive fluid 504 may flow through the catheter 506 from the proximal end to an opening at the distal end. An electrical current generated by the generator 502 may be carried by the conductive fluid 504 from the proximal end to the distal end of the catheter 506. The electrically charged conductive fluid 504 may be applied to cardiac tissue.

[0066] An electrode 508 may be positioned on the distal end of the catheter 506. The electrode 508 may be an RF ablation electrode. In some embodiments, the electrode 508 may be another suitable ablation electrode, such as one that facilitates thermal or cryoablation. In some embodiments, the electrode 508 is conductively connected to the generator 502 such that a generated electrical current may flow to the electrode 508. The electrode 508 may be made from a variety of materials. The electrode 508 may have features of other electrodes disclosed herein.

[0067] 5B shows a partial view 512 of the system 500. The conductive fluid 504 may exit the interior cavity of the catheter 506 by flowing out a distal or side opening 510.

[0068] The configuration described above with reference to Figures 5A and 5B may be advantageous because blocking and ablation delivery are integrated into the same catheter. This configuration may facilitate verification and ablation of the same cardiac tissue with blocking currents (e.g., which would otherwise be difficult to achieve using two or more catheters). This configuration may increase the speed of EP cardiac ablation procedures. In some embodiments, the conductive fluid 504 may function both as current conduction for non-ablative blockade and also as temperature regulation during pre-ablation (e.g., by cooling the system after a thermal event caused by RF ablation).

[0069] 6A illustrates an example system 600 for an integrated blocking and ablation catheter. The example system 600 can include a generator 602. The generator 602 can have features of other generators disclosed herein.

[0070] The generator 602 may be coupled to a catheter 606. The catheter 606 may have features of other catheters disclosed herein. The catheter 606 may have a non-fluid conductor 604 configured to carry electrical current from the generator 602 to a distal end of the catheter 606. The distal end of the catheter 606 may have an opening that exposes an electrode core 610. In some embodiments, the electrode core 610 is a non-ablative DC electrode. In some embodiments, the electrode core 610 is made of Ag and / or AgCl. In some embodiments, the electrode core is made of another conductive material. Electrical current may be carried from the generator 602 via the non-fluid conductor 604 and applied to the patient's cardiac tissue via the electrode core 610.

[0071] The distal end of the catheter 606 may have an electrode 608. The electrode 608 may have features of other electrodes disclosed herein. In some embodiments, the electrode 608 is an RF ablation electrode. The electrode 608 may be conductively connected to the generator 602 such that the generated electrical current may flow from the generator 602 to the generator 602.

[0072] 6B shows an example system 614 that includes an integrated blocking and ablation catheter with a particulate container. The particulate container 612 can be disposed around the electrode 608. In some embodiments, the entire electrode 608 is covered by the particulate container 612. The particulate container 612 can be a mesh, a sponge, a basket, and / or some other device that prevents leakage of particulates.

[0073] The configuration described above with reference to Figures 6A and 6B can be advantageous because blocking and ablation delivery are integrated into the same catheter.

[0074] 7 shows an example graph 700 illustrating required ablation level as a function of DC current amplitude, which may be correlated. RF ablation, cryoablation, or other ablation may be delivered at a dosage level predicted by the DC current amplitude required to achieve a desired therapeutic block, such as to achieve a desired ablation depth.

[0075] The vertical axis 702 is the required ablation level. The horizontal axis 704 is the DC current amplitude. For example, if a DC amplitude "x" 708 is required to achieve a desired level of therapeutic effect, then an ablation level (e.g., power and / or duration) of about "y" 706 or above or below it would be delivered to ablate a similar cardiac tissue volume.

[0076] FIG. 8A illustrates an example block mode 800. Application of the block mode 800 may include applying an integrated catheter 804 to cardiac tissue 806. Current may be applied to the cardiac tissue 806 via a blocking conductor 802, which may be an electrode, an electrode core, a non-fluid conductor, and / or a conductive fluid of the integrated catheter 804. In some embodiments, the blocking conductor 802 applies a blocking DC current to the cardiac tissue 806. Preferably, a cathodic current may be applied over an anodic current to directly block the cardiac tissue 806 below the blocking conductor 802. A region 808 may represent a blocked volume of the cardiac tissue 806 resulting from the current flowing from the blocking conductor 802 to the cardiac tissue 806. The delivered current may be the "x" 708 illustrated in FIG. 7.

[0077] An anodic current may also be applied (e.g., an anodic current at a lower amplitude may increase excitability of cardiac tissue in the vicinity of the electrode to confirm a role in arrhythmia). In some embodiments, the integrated catheter 804 may be articulatable to have one or more degrees of freedom to introduce a bend in the integrated catheter 804. In some embodiments, the integrated catheter 804 may be used to measure biopotentials from the cardiac tissue 806. In some embodiments, the blocking conductor 802 may be used to measure biopotentials when not delivering a blocking current and / or concurrent with current delivery.

[0078] 8B illustrates an example ablation mode 810. Application of the ablation mode 810 may include applying an integrated catheter 804 to tissue 806. An ablation electrode 812, which may be positioned around the exterior of the blocking conductor 802, may ablate the cardiac tissue 806. Region 814 may indicate the ablated volume of the cardiac tissue 806. In some embodiments, the volume of region 814 is similar to the volume of region 808. The ablation level may be "y" 706, as shown in FIG. 7.

[0079] 9 shows an example mapping catheter 900. The mapping catheter may have an elongated portion 902 that does not have contacts. The mapping catheter 900 may have a set of contacts 904 positioned on and / or near the distal end of the mapping catheter 900. The contacts 904 may be electrodes. In some embodiments, the contacts 904 may have the characteristics of the electrodes disclosed herein.

[0080] In some embodiments, the contacts 904 surround a peripheral portion of the catheter 900. In some embodiments, the contacts 904 are evenly spaced from one another. In some embodiments, the contacts 904 have different spacings between one another. In some embodiments, the contacts 904 are evenly sized. In some embodiments, the contacts 904 have different sizes.

[0081] In some embodiments, the contacts 904 are made of Ag and / or AgCl. In some embodiments, the contacts 904 are coated, such as with an anion exchange membrane. In some embodiments, the contacts 904 are surrounded by a particulate container, which may include a basket, mesh, and / or other covering. In some embodiments, the contacts 904 are coated together, such as through an anion exchange membrane. In some embodiments, the contacts 904 are made of a high charge density material, such as TiN or porous TiN.

[0082] Electrical current may be delivered through one or more contacts 904 of the mapping catheter 900. In some embodiments, DC and / or AC current is delivered. This may facilitate evaluation of whether one or more ablations may be therapeutic. In some embodiments, the contacts 904 may be selected individually or in multiples, e.g., multiples may be selected to record, block, and / or stimulate.

[0083] The contacts 904 may be used to direct the current and / or to select the portion of the cardiac tissue to be blocked.

[0084] The contact 904, and any blocking electrodes disclosed herein, can have one or more other features, such as ultrasound.

[0085] Any catheter disclosed herein may have the form of a mapping catheter, such as mapping catheter 900. Catheter 900 and any catheter disclosed herein may have a flexible element that allows for intimate contact with cardiac tissue. Catheter 900 and any catheter disclosed herein may have an addressable DC blocking contact that can deliver DC to cardiac tissue to achieve safe and reversible blocking of action potentials in the target tissue.

[0086] 10 illustrates an example system 1000. The example system 1000 may include a generator 1002. The generator 1002 may have the characteristics of the generators disclosed herein. The generator 1002 may be coupled to a catheter 1006. The catheter 1006 may have the characteristics of other catheters disclosed herein.

[0087] The catheter 1006 may have a non-fluid conductor 1004 that conducts electrical current from the generator 1002 to contacts, electrodes, and / or wires positioned on the mesh member 1008. The mesh member 1008 may be positioned on a distal end of the catheter 1006. In some embodiments, the mesh member 1008 is deformable upon contact with cardiac tissue. In some embodiments, the mesh member 1008 may be a mesh deformable sphere with surface contacts (electrodes) positioned along its outer periphery. The mesh member 1008 may be a mesh deformable sphere with wires extending along its outer periphery. In some embodiments, the surface contacts and / or wires may be positioned to follow a longitudinal or perpendicular direction to a major axis of the mesh member 1008. In some embodiments, the surface contacts and / or wires may be individually or separately addressable by the non-fluid conductor 1004.

[0088] 11 illustrates an example system 1100. The example system 1100 may include a generator 1102. The generator 1102 may have the characteristics of the generators disclosed herein. The generator 1102 may be coupled to a catheter 1106. The catheter 1106 may have the characteristics of other catheters disclosed herein.

[0089] The catheter 1106 may have a non-fluid conductor 1104 that conducts current from the generator 1102 to a conductor 1110 (such as a contact, electrode, and / or wire) positioned on the exterior of an expandable member, such as a balloon 1008 or an expandable cage. The conductor 1110 can be a DC blocking electrode contact. In use, the balloon 1008 may be inflated to compress the conductor 1110 against the cardiac tissue. In some embodiments, this may facilitate improved current delivery to block cardiac tissue, which may include DC current delivery.

[0090] In some embodiments, the electrodes and / or contacts, which may include DC blocking electrode contacts, may sense activity in cardiac tissue. This may apply to any of the electrodes, contacts, and / or systems disclosed herein. In some embodiments, other sensing contacts may be positioned adjacent to the electrodes and / or contacts, which may include DC blocking electrode contacts. This may apply to any of the electrodes, contacts, and / or systems disclosed herein.

[0091] In some embodiments, the return path of the electrical circuit may be via a distal electrode and / or a catheter-based electrode. The distal electrode may comprise a patch electrode placed on the skin, a distal catheter. The distal electrode may be used to allow for a more thorough symmetrical approximation of the tissue volume ablated by the delivery of the ablation modality.

[0092] Next, an embodiment of a method for performing electrophysiology testing and ablation procedures will be described. Vascular access can be obtained by percutaneous techniques (e.g., femoral, internal jugular, radial, or brachial arteries) or cut-down techniques. A guidewire can be inserted and a catheter can be inserted over the guidewire to a desired location near the heart. Imaging, such as fluoroscopic guidance or other guidance, can be utilized. In some examples, a sensing electrode can be moved along the conduction pathway and along and within the endocardium of the heart to measure electrical activity. The heart or its chambers can then be paced to observe abnormalities. An arrhythmia can then be induced with a stimulation current and / or an arrhythmia drug (including but not limited to epinephrine, dopamine, phenylephrine, isoproterenol, aminophylline, calcium, atropine, or other drugs) in an attempt to induce an arrhythmia, and the sensing electrode can be moved to locate the source of the abnormal electrical activity. Non-ablative DC or HFAC can be delivered to the first target area of ​​the cardiac tissue that is believed to be the source of abnormal electrical activity via the electrode on the catheter. If the arrhythmia stops, this first target area can be effectively ablated using RF ablation technology or other ablation technology such as that disclosed herein. If the arrhythmia does not stop, the first target area is spared and a second target area is treated with non-ablative DC or HFAC. If the arrhythmia stops, this second target area can be effectively ablated using RF ablation technology or other ablation technology such as that disclosed herein. If the arrhythmia does not stop, the second target area can be spared and the search for a third target area can begin, and this process can be repeated.

[0093] In some embodiments, a non-ablative block may be utilized in conjunction with a pulmonary vein isolation procedure. After transseptal advancement of the catheter to the pulmonary vein ostium, a non-ablative block is performed circumferentially around the pulmonary vein ostium, thereby creating a temporary circumferential ablation zone that effectively blocks electrical propagation between the pulmonary veins and the left atrium. If arrhythmia is not inducible, a permanent circumferential ablation lesion may be created by ablation modalities, including those described elsewhere herein.

[0094] In some embodiments, some non-limiting conditions that may be treated with the systems and methods as disclosed herein may include, but are not limited to, atrial fibrillation (chronic or paroxysmal), long QT syndrome, Wolff-Parkinson-White syndrome, torsades de pointes, atrial premature beats, wandering atrial pacemaker, multifocal atrial tachycardia, atrial flutter, supraventricular tachycardia (including PSVT), atrioventricular nodal reentrant tachycardia, junctional rhythm, junctional tachycardia, atrioventricular nodal premature beats, ventricular premature beats, tachycardial idioventricular rhythm, monomorphic ventricular tachycardia, polymorphic ventricular tachycardia, right ventricular outflow tract tachycardia, and ventricular fibrillation.

[0095] Although the present disclosure has been described in the context of certain embodiments and examples, those skilled in the art will understand that the present disclosure extends to other alternative embodiments and / or uses other than the specifically disclosed embodiments, as well as obvious modifications and equivalents thereof. Furthermore, while several variations of the embodiments of the present disclosure have been shown and described in detail, other modifications that fall within the scope of the present disclosure will be readily apparent to those skilled in the art. It is also anticipated that various combinations or subcombinations of specific features and aspects of these embodiments may be made and still fall within the scope of the present disclosure. For example, features described above in connection with one embodiment may be used with different embodiments described herein, and the combinations will still fall within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form various aspects of the embodiments of the present disclosure. It is therefore intended that the scope of the disclosure herein should not be limited by the specific embodiments described above. Thus, unless otherwise stated or clearly incompatible, each embodiment of the present invention may comprise, in addition to its essential features described herein, one or more features as described herein from each other embodiment of the invention disclosed herein.

[0096] A feature, material, characteristic, or group described in combination with a particular aspect, embodiment, or example should be understood as applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless incompatible. All features disclosed in this specification (including any accompanying claims, abstract, and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. The scope of protection is not limited to the details of any of the foregoing embodiments. The scope of protection extends to any novel one or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings) or to any novel one or any novel combination of steps of any method or process so disclosed.

[0097] Moreover, certain features that are described within the disclosure in the context of separate implementations can also be implemented in combination in a single implementation. In contrast, various features that are described in the context of a single embodiment can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features may be described above as operating in a particular combination, in some instances, one or more features in a claimed combination can be deleted from the combination, and the combination can be claimed as a subcombination or a variation of the subcombination.

[0098] Furthermore, although operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown or in sequential order, or all of the operations need not be performed to achieve a desired result. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously with, or between any of the described operations. Furthermore, these operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. In some embodiments, some of the steps described above may be omitted and others may be added. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in different ways to form further embodiments, all of which are within the scope of the present disclosure. It should also be understood that the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and that the described components and systems may typically be integrated together in a single product or packaged into multiple products.

[0099] In the present disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, it will be understood by those skilled in the art that the present disclosure may be embodied or implemented in a manner that achieves one advantage or a combination of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0100] Conditional expressions used herein, such as "can," "could," "may," "might," and "for example," among others, are generally intended to express that certain embodiments include certain features, elements, and / or steps, but other embodiments do not, unless expressly stated otherwise or understood otherwise within the context as used. Thus, such conditional expressions are generally not intended to suggest that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without other input or instruction, whether those features, elements, and / or steps are to be included or performed in any particular embodiment. Terms such as "comprises," "including," and "having" are synonymous and used inclusively without limiting and do not exclude additional elements, features, acts, operations, and the like. Furthermore, the term "or" is used in an inclusive sense (and non-exclusive sense), so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in that list.

[0101] Unless expressly stated otherwise, conjunctions such as "at least one of X, Y, and Z" are understood by their context as being generally used in other cases to express that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctions are not generally intended to suggest that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z.

[0102] Degree expressions used herein, such as the terms "approximately," "about," and "substantially," as used herein, refer to a number, amount, or feature that is close to the stated number, amount, or feature that still performs a desired function or achieves a desired result. For example, the terms "about," "about," and "substantially" may refer to an amount that falls within a range of less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated amount. In another example, in some embodiments, the terms "approximately parallel" and "substantially parallel" refer to a number, amount, or feature that deviates from exact parallelism by 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, 0.1 degrees or less, or another angle.

[0103] Any methods disclosed herein need not be performed in the order listed. Methods disclosed herein include specific actions performed by a practitioner, but may further include any third-party instruction of those actions, either explicit or implied. For example, an action such as "control the motor speed" includes "instructing the control of the motor speed."

[0104] Any of the methods and tasks described herein may be performed and fully automated by a computer system. In some examples, a computer system may comprise multiple different computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Typically, each such computing device comprises a processor (or multiple processors) that executes program instructions or program modules stored in memory or other persistent computer-readable storage media or devices (e.g., solid-state storage devices, disk drives, etc.). Various functions disclosed herein may be embodied in such program instructions and / or implemented in the computer system's application-specific circuitry (e.g., ASIC or FPGA). When a computer system comprises multiple computing devices, these devices may, but need not, be collocated. Results of the disclosed methods and tasks may be persistently stored by converting physical storage devices, such as solid-state memory chips and / or magnetic disks, into different states. In some embodiments, the computer system may be a cloud-based computing system with processing resources shared by multiple separate business entities or other users.

[0105] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this chapter or elsewhere herein, but may be defined by the claims as set forth in this chapter or elsewhere herein or as set forth in the future. The language in the claims should be interpreted broadly based on the language used in the claims and not limited to the examples described herein or during prosecution, which examples should be interpreted as non-limiting. [Explanation of symbols]

[0106] 100 Graphs 102 Vertical axis 104 horizontal axis 106 Blocking DC Amplitude 108 Blocking DC Amplitude 110 Graph 112 Vertical axis 114 horizontal axis 116 First Validation 118 Second Validation 119 Third Validation 120 Graphs 122 Vertical axis 124 horizontal axis 126 First Ablation, Ablation Metrics 128 Second Ablation, Ablation Metrics 200 Systems 202 Generator 204 Cathode (and / or Anode) Conductor 206 Catheter 208 Conductive fluid 300 Systems 302 Generator 304 Non-fluid conductors 306 Catheter 308 Electrode 400 Systems 402 Particulate container 500 Systems 502 Generator 504 Conductive fluid 506 Catheter 508 Electrode 510 Distal or lateral opening 600 System 602 Generator 604 Non-fluid conductors 606 Catheter 608 Electrode 610 Electrode Core 612 Particulate container 614 System 700 graphs 702 Vertical axis 704 horizontal axis 800 Block Mode 802 Blocking Conductor 804 Catheter 806 Heart Tissue 808 area 810 Ablation Mode 812 Ablation Electrode 814 areas 900 Mapping Catheter 902 Elongated part 904 Contact 1000 Systems 1002 Generator 1004 Non-fluid conductors 1006 Catheter 1008 Mesh material, balloon 1100 System 1102 Generator 1104 Non-fluid conductors 1106 Catheter 1110 Conductor

Claims

1. An electrophysiological cardiac system, comprising: a first generator configured to generate a non-ablative blocking current; at least one blocking electrode configured to be conductively connected to the first generator; Equipped with The electrophysiological cardiac system comprises: sensing electrical activity of a first cardiac target tissue via the at least one blocking electrode; determining that the electrical activity of the first cardiac target tissue has a characteristic of interest; delivering a first non-ablative direct current from the first generator to the first cardiac target tissue via the at least one blocking electrode sufficient to produce a reversible conduction block in the first cardiac target tissue; observing the presence of a feature of interest after applying the first non-ablative direct current; 1. An electrophysiological cardiac system configured to:

2. The electrophysiological cardiac system of claim 1, wherein the feature of interest includes abnormal electrical activity.

3. The electrophysiological cardiac system comprises: and at least one ablation electrode configured to be conductively connected to a second generator configured to generate ablation energy; The electrophysiological cardiac system further comprises:

2. The electrophysiological cardiac system of claim 1, configured to ablate the first cardiac target tissue via the at least one ablation electrode in the absence of a feature of interest after delivering the first non-ablative direct current to the first cardiac target tissue.

4. The electrophysiological cardiac system further comprises: Sensing electrical activity of a second cardiac target tissue; The electrophysiological cardiac system of claim 1 , configured to determine that the electrical activity of the first cardiac target tissue has the characteristic of interest.

5. The electrophysiological cardiac system further comprises: delivering a second non-ablative direct current to the second cardiac target tissue sufficient to produce a reversible conduction block in the second cardiac target tissue; 5. The electrophysiological cardiac system of claim 4, configured to observe the presence of a feature of interest after applying the second non-ablative direct current.

6. The electrophysiological cardiac system further comprises:

6. The electrophysiological cardiac system of claim 5, configured to ablate the second cardiac target tissue in the absence of a pathological arrhythmia after delivering the second non-ablative direct current to the second cardiac target tissue.

7. An electrophysiological cardiac system as described in claim 1, wherein the first non-ablative direct current includes a cathodic direct current circulated together with an anodic direct current.

8. The electrophysiological cardiac system of claim 1, wherein the first non-ablative direct current includes a frequency of less than about 1 Hz.

9. The electrophysiological cardiac system of claim 1, wherein the first non-ablative direct current has an amplitude of less than approximately 100 mA.

10. The electrophysiological cardiac system of claim 1, wherein the first non-ablative direct current has an amplitude of less than about 20 mA.

11. The electrophysiological cardiac system of claim 1, wherein the first non-ablative direct current has an amplitude of less than about 10 mA.

12. The electrophysiological cardiac system of claim 1, wherein the first non-ablative direct current has an amplitude of less than about 5 mA.

13. The electrophysiological cardiac system of claim 1, wherein the first cardiac target tissue includes myocardium.

14. The electrophysiological cardiac system of claim 1, wherein the first cardiac target tissue includes left atrial tissue or right atrial tissue.

15. The electrophysiological cardiac system of claim 1, wherein the first cardiac target tissue includes left ventricular tissue or right ventricular tissue.

16. The electrophysiological cardiac system of claim 1, wherein the first cardiac target tissue includes pulmonary vein tissue.

17. An electrophysiological cardiac system as described in claim 1, a system for treating arrhythmia, the arrhythmia including atrial fibrillation, atrial flutter, PSVT, or ventricular tachycardia.

18. An electrophysiological cardiac system as described in claim 1, wherein ablation of the first cardiac target tissue includes supplying an ablation direct current.

19. The electrophysiological cardiac system of claim 1, wherein ablation of the first cardiac target tissue includes delivery of RF energy.

20. The electrophysiological cardiac system of claim 1, wherein ablation of the first cardiac target tissue includes delivery of cryoablation.

21. An electrophysiological cardiac system, comprising: a first generator configured to generate a non-ablative blocking current; at least one blocking electrode configured to be conductively connected to the first generator; the electrophysiological cardiac system comprising: Sensing electrical activity of a first cardiac target tissue; delivering a non-ablative current to the first cardiac target tissue sufficient to produce a reversible conduction block in the first cardiac target tissue; observing the abnormal electrical activity of the patient's heart after delivering the non-ablative current; 1. An electrophysiological cardiac system configured to:

22. The electrophysiological cardiac system of claim 21, wherein the non-ablative current includes HFAC.

23. The electrophysiological cardiac system further comprising:

22. The electrophysiological cardiac system of claim 21 , configured to ablate the first cardiac target tissue if the abnormal electrical activity is absent after delivering the non-ablative current to the first cardiac target tissue.

24. The electrophysiological cardiac system of claim 21, wherein the non-ablative current includes a direct current.

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