Description:TECHNICAL FIELD
[0001] The present disclosure relates generally to the field of cardiac ablation; and more specifically, to cardiac ablation devices for Radio Frequency Ablation (RFA) and Pulse Field Ablation (PFA) of one or more damaged cardiac tissues.
BACKGROUND
[0002] Cardiac ablation has emerged as a pivotal technique for treatment of various heart rhythm disorders, particularly Atrial Fibrillation (AFib). AFib is a type of cardiac arrhythmia characterized by erratic beating of certain chambers of heart, caused by abnormalities in the heart's electrical signaling system. Nowadays, two advanced ablation techniques have gained prominence in addressing these cardiac issues, namely, Radiofrequency Ablation (RFA) and Pulse Field Ablation (PFA). The RFA is a well-known medical procedure that utilizes thermal energy to treat various conditions, including cardiac arrhythmias, tumors, and chronic pain. In RFA, high-frequency alternating current is employed to generate heat, which is then used to ablate or destroy targeted tissue. The heat produced during the procedure causes coagulation necrosis, effectively disrupting abnormal electrical pathways or eliminating unwanted tissue. Such thermal approach has been widely adopted due to its effectiveness in treating a range of medical conditions. In contrast, the PFA is an emerging non-thermal ablation technique that offers a novel approach to cardiac ablation. In the PFA, high-voltage electric pulses are employed to create irreversible electroporation (IRE) in targeted cells, leading to cell death. Unlike the RFA, which relies on thermal energy, the PFA uses electric fields to permeabilize cell membranes, allowing for selective targeting of abnormal tissue while sparing surrounding structures. This mechanism of action makes PFA particularly advantageous in the treatment of AFib. By virtue of non-thermal nature, the PFA provides several advantages in cardiac ablation procedures. By avoiding the use of heat, the PFA minimizes collateral damage to adjacent tissues, reducing the risk of complications commonly associated with thermal ablation techniques. This aspect is especially prominent in sensitive areas of the heart where precision is paramount. Furthermore, the PFA has shown promise in treating both paroxysmal and persistent forms of atrial fibrillation, addressing a wide spectrum of AFib cases. Both RFA and PFA represent advanced techniques designed to improve patient outcomes through minimally invasive procedures. While the RFA has a longer history of clinical use and has proven effective across various medical applications, the PFA is gaining traction specifically in the field of cardiac electrophysiology. The unique mechanisms of these techniques allow for tailored approaches to different types of cardiac arrhythmias and patient-specific conditions.
[0003] As medical technology continues to advance, the development and refinement of these ablation techniques play a significant role in enhancing the treatment of cardiac arrhythmias. Ongoing research and clinical trials continue to explore the full potential of these techniques, particularly the emerging field of PFA, in revolutionizing the management of atrial fibrillation and other cardiac rhythm disorders. Thus, there exists a technical problem of how to enhance the efficiency of both thermal and non-thermal ablation options either independently or collectively to address complex cardiac issues, potentially leading to improved success rates and reduced procedural risks.
[0004] Therefore, in light of the foregoing discussion, there exists a need to overcome the aforementioned limitations associated with the conventional RFA and PFA cardiac ablation techniques.
SUMMARY
[0005] The present disclosure provides cardiac ablation devices for Radio Frequency Ablation (RFA) and Pulse Field Ablation (PFA) of one or more damaged cardiac tissues. The present disclosure provides a solution to the existing problem of how to enhance the efficiency of both thermal and non-thermal ablation options either independently or collectively to address complex cardiac issues, potentially leading to improved success rates and reduced procedural risks. An aim of the present disclosure is to provide a solution that overcomes at least partially the problems encountered in prior art, and provide improved cardiac ablation devices with improved accuracy and effectiveness of cardiac tissue ablation.
[0006] The object of the present disclosure is achieved by the solutions provided in the enclosed independent claims. Advantageous implementations of the present disclosure are further defined in the dependent claims.
[0007] In one aspect, the present disclosure provides a cardiac ablation device comprising a catheter shaft with a distal end and a proximal end, a plurality of mapping electrodes arranged on the catheter shaft, where the plurality of mapping electrodes are configured to map one or more damaged cardiac tissues in a defined area, a center electrode positioned at the distal end of the catheter shaft, configured to ablate the one or more damaged cardiac tissues via Radio Frequency Ablation (RFA) when in operation, an expandable basket structure arranged near the distal end of the catheter shaft, wherein the expandable basket structure comprises a plurality of ring electrodes configured to ablate the one or more damaged cardiac tissues via Pulse Field Ablation (PFA) when in operation and a handle attached to the proximal end of the catheter shaft, the handle is configured to control an expansion and contraction of the expandable basket structure and transmit a controlled amount of energy to the center electrode and the expandable basket structure for RFA and PFA, respectively, of the one or more damaged cardiac tissues.
[0008] The disclosed cardiac ablation device combines mapping capabilities with both radio frequency ablation and pulse field ablation in a single catheter. The disclosed cardiac ablation device serves as a multi-functional device and offers several advantages in the treatment of cardiac arrhythmias. Firstly, the disclosed cardiac ablation device eliminates the requirement for surgeons to switch between different catheters during the ablation procedure, saving time and simplifying the workflow. The catheter features mapping electrodes that identify abnormal pathways or areas responsible for the arrhythmia, allowing for targeted treatment. The center electrode can be used as a radiofrequency ablation tip electrode to deliver heat energy for ablation of the damaged tissue, while the expandable basket structure, equipped with the plurality of ring electrodes, enables PFA by delivering high-voltage electric pulses. The expandable basket structure can cover a larger area around the damaged tissue, eliminating the requirement for multiple rotations as required in conventional catheter systems. The comprehensive approach to ablation provides surgeons with flexibility in selecting the most appropriate method based on the patient's requirements and tissue characteristics. Overall, the combination of mapping, RFA, and PFA in one device streamlines the procedure, potentially reducing costs and improving patient outcomes.
[0009] It is to be appreciated that all the aforementioned implementation forms can be combined. All steps which are performed by the various entities described in the present application as well as the functionalities described to be performed by the various entities are intended to mean that the respective entity is adapted to or configured to perform the respective steps and functionalities. It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the appended claims.
[0010] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative implementations construed in conjunction with the appended claims that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
FIG. 1A illustrates a cardiac ablation device in an expanded configuration for Pulse Field Ablation (PFA) of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 1B illustrates a cardiac ablation device in a non-expanded configuration for Radio Frequency Ablation (RFA) of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 2 illustrates an arrangement of an expandable basket structure in a catheter shaft of a cardiac ablation device, in accordance with an embodiment of the present disclosure;
FIG. 3A is a superior view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 3B is a top view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 3C is a top view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with another embodiment of the present disclosure;
FIG. 3D is a lateral view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 4A illustrates another cardiac ablation device in an expanded configuration for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 4B illustrates another cardiac ablation device in a non-expanded configuration for mapping of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 5 illustrates an arrangement of an expandable basket structure in a catheter shaft of a cardiac ablation device, in accordance with another embodiment of the present disclosure;
FIG. 6A is a top view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 6B illustrates a three-quarter or oblique view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure;
FIG. 6C illustrates a side view or lateral view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure; and
FIG. 6D illustrates a side view or lateral view of an expandable basket structure for PFA of damaged cardiac tissues on further expansion, in accordance with another embodiment of the present disclosure.
In the accompanying drawings, an underlined number is employed to represent an item over which the underlined number is positioned or an item to which the underlined number is adjacent. A non-underlined number relates to an item identified by a line linking the non-underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the non-underlined number is used to identify a general item at which the arrow is pointing.
DETAILED DESCRIPTION OF EMBODIMENTS
[0012] The following detailed description illustrates embodiments of the present disclosure and ways in which they can be implemented. Although some modes of carrying out the present disclosure have been disclosed, those skilled in the art would recognize that other embodiments for carrying out or practicing the present disclosure are also possible.
[0013] FIG. 1A illustrates a cardiac ablation device in an expanded configuration for Pulse Field Ablation (PFA) of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. With reference to FIG. 1A, there is shown a cardiac ablation device 100A in an expanded configuration. The cardiac ablation device 100A comprises a catheter shaft 102, a plurality of mapping electrodes 104, a center electrode 106, an expandable basket structure 108 comprising a plurality of ring electrodes 110 and a handle 112. The catheter shaft 102 has a distal end 102A and a proximal end 102B. The handle 112 comprises a push-pull switch 114, a rotating switch 116 and an energy delivery switch 118. There is further shown that the energy delivery switch 118 comprises four functional level controls, such as a first functional level control 118A, a second functional level control 118B, a third functional level control 118C and a fourth functional level control 118D. The cardiac ablation device 100A is represented by a dashed box, which is used for illustration purpose only. The plurality of mapping electrodes 104 is represented by a dashed box, which is used for illustration purpose only.
[0014] The cardiac ablation device 100A may be referred to as a medical instrument designed to monitor, measure, and treat damaged tissues of heart or nervous system. The cardiac ablation device 100A is primarily used in electrophysiology studies to diagnose and manage arrhythmias (irregular heartbeats) by detecting and analyzing abnormal electrical signals in the heart. The cardiac ablation device 100A may also be referred to as an electrophysiology Radio Frequency Ablation (RFA) and Pulse Field Ablation (PFA) catheter. The cardiac ablation device 100A is designed to perform both RFA and PFA of damaged cardiac tissues along with mapping capabilities. The dual-function catheter allows for delivery of both high-frequency alternating current for thermal ablation and high-voltage electric pulses for non-thermal ablation, providing a comprehensive approach to treating cardiac arrhythmias. In the expanded configuration, the cardiac ablation device 100A is used for PFA of damaged cardiac tissues.
[0015] The handle 112 may be referred to as a component of the cardiac ablation device 100A that is designed to provide a means of gripping and manipulating the cardiac ablation device 100A during surgical procedures.
[0016] The push-pull switch 114 may be referred to as a type of mechanical switch (e.g., a slider) that is designed to be actuated by pushing or pulling a lever, thereby opening or closing the expandable basket structure 108.
[0017] The rotating switch 116 may be referred to as a mechanical switch that is used for deflecting the distal end 102A of the catheter shaft 102. The rotating switch 116 allows the surgeon to control the catheter's tip and move it in two directions, typically in a clockwise or counter clockwise rotation within the heart's chambers. By pulling/releasing tension on these steering wires, the catheter tip can be deflected in two opposite directions, usually left/right. The handle 112 at the proximal end 102B of the catheter shaft 102 often has a control knob that adjusts the tension in these steering wires, allowing the surgeons to steer the catheter shaft 102 in a bidirectional manner.
[0018] The energy delivery switch 118 may be configured to control the transmission or interruption of energy in the cardiac ablation device 100A.
[0019] In operation, the cardiac ablation device 100A comprises the catheter shaft 102 with the distal end 102A and the proximal end 102B. The catheter shaft 102 may be referred to as an elongated tubular structure that provides structural support to the cardiac ablation device 100A. The distal end 102A may be referred to as a farthest end of the catheter shaft 102, which is typically inserted into a patient's body and is used for performing medical procedures or delivering therapeutic agents. The proximal end 102B may be referred to as an end of the catheter shaft 102 that is closer to an operator or a control unit, and is typically used for manipulation, control, or connection to external devices. The handle 112 is attached at the proximal end 102B of the catheter shaft 102.
[0020] In accordance with an embodiment, the catheter shaft 102 has a diameter ranging from 7.5 French gauge (Fr) to 9 Fr. The term "French gauge (Fr)" refers to a unit of measurement used to determine the size of medical devices, particularly catheters, where one French gauge is equal to 0.33 millimeters in diameter. The catheter shaft 102 is designed to be used for both mapping and ablating damaged cardiac tissues using either RF energy or PFA energy. By incorporating the diameter range from 7.5 Fr to 9 Fr, the catheter shaft 102 can accommodate the required components for ablating the damaged cardiac tissues, such as, the plurality of mapping electrodes 104, the center electrode 106 for RF ablation, and the expandable basket structure 108 with the plurality of ring electrodes 110 for pulse field ablation. This allows for efficient and effective treatment of atrial fibrillation and other related conditions.
[0021] The cardiac ablation device 100A comprises the plurality of mapping electrodes 104 arranged on the catheter shaft 102, wherein the plurality of mapping electrodes 104 is configured to map one or more damaged cardiac tissues in defined area. Each of the plurality of mapping electrodes 104 may be referred to as a specialized electrode used in the cardiac ablation device 100A to detect and record electrical signals from the heart, aiding in the identification and localization of abnormal electrical pathways. As shown in FIG. 1A, the cardiac ablation device 100A comprises three mapping electrodes arranged on the catheter shaft 102. The term "damaged cardiac tissues" refers to areas of the heart that have undergone structural or functional changes due to injury, disease, or other pathological conditions, potentially leading to abnormal electrical activity. The term "defined area" refers to a specific region within the heart that is precisely delineated or demarcated, typically for the purpose of targeting therapeutic interventions, such as ablation or stimulation. The plurality of mapping electrodes 104 are crimped on the surface of the catheter shaft 102. When the cardiac ablation device 100A (or the catheter) is inserted into the heart through blood vessels, the plurality of mapping electrodes 104 map the electrical activity of the heart to identify areas responsible for abnormal heart rhythm. The mapping process leads to identifying and locating the damaged cardiac tissues within the defined area. The mapping process assists the surgeons (or doctors) to determine the most appropriate ablation method for treatment, whether it is RFA or PFA of the damaged cardiac tissues. Additionally, the use of mapping electrodes on the same catheter shaft eliminates the requirement for multiple catheters, simplifying the procedure and potentially reducing overall costs and procedure times.
[0022] The cardiac ablation device 100A comprises the center electrode 106 positioned at the distal end 102A of the catheter shaft 102, configured to ablate the one or more damaged cardiac tissues via Radio Frequency Ablation (RFA) when in operation. The center electrode 106 may be referred to as an electrode located at core of the cardiac ablation device 100A, which is responsible for delivering RF energy to the targeted tissue during the RF ablation procedure. The direct contact of the center electrode 106 with the damaged cardiac tissues is required for effective RF ablation. By making the direct contact, the cardiac ablation device 100A ensures that the high-frequency alternating current for thermal ablation is delivered precisely to the targeted areas, resulting in the creation of lesions and treatment of cardiac arrhythmias. Moreover, the direct contact approach allows for a comprehensive and versatile treatment of a wide range of cardiac conditions. The center electrode 106 is used for ablating the damaged cardiac tissue(s) using RF energy when the cardiac ablation device 100A is used in the non- expanded configuration, as shown in FIG. 1B. In the non-expanded configuration of the cardiac ablation device 100A, the center electrode 106 is used for RF ablation and the three mapping electrodes are used for identifying and locating the damaged cardiac tissue(s).
[0023] The cardiac ablation device 100A comprises the expandable basket structure 108 arranged near the distal end 102A of the catheter shaft 102, wherein the expandable basket structure 108 comprises the plurality of ring electrodes 110 configured to ablate the one or more damaged cardiac tissues via Pulse Field Ablation (PFA) when in operation. The expandable basket structure 108 may be referred to as a flexible and adjustable framework that can be expanded to form a three-dimensional (3D) structure, typically used in medical devices for procedures, such as cardiac ablation. The expandable basket structure 108 can be made of different diameters ranging minimum of 15mm to maximum of 35mm. Each of the plurality of ring electrodes 110 may be referred to as a collection of multiple electrodes arranged in a specific pattern on the expandable basket structure 108, typically used in medical devices for delivering electrical pulses to the damaged cardiac tissues. The term "Pulse Field Ablation (PFA)" refers to a technique for cardiac ablation that involves the application of high-voltage electrical pulses to create localized tissue damage and achieve therapeutic effects. The expandable basket structure 108 is made up of a Polyether Block Amide (PEBAX), which is a family of high-performance thermoplastic elastomers known for their flexibility, lightweight nature, and excellent mechanical properties. The expandable basket structure 108 can be expanded further by pushing the push-pull switch 114 further using the handle 112. The expansion allows the expandable basket structure 108 to cover a larger area around the damaged tissue, specifically the Pulmonary Vein (PV), facilitating the ablation process. By expanding the basket structure, more ring electrodes on the basket structure come in contact with the damaged tissue, allowing for precise and effective tissue ablation. This eliminates the limitation of rotating the basket structure multiple times to cover a larger area. The use of the expandable basket structure 108 ensures the ablation in the heart, which have the capability to cover a diameter in a range of, for example, from minimum of 15 mm to maximum of 35 mm. The ablation area may be in the range of, for example, 15 mm to 20 mm or 20 mm to 25 mm or 25 mm to 30 mm or 30 mm to 35 mm.
[0024] In accordance with an embodiment, the plurality of mapping electrodes 104 are made of Platinum and Iridium or Gold. In accordance with an embodiment, the plurality of ring electrodes 110 are made of Platinum and Iridium. The inclusion of mapping electrodes made of Platinum and Iridium, or Gold is required for several reasons. The metal “Gold” possesses biocompatibility, excellent conductivity, corrosion resistance, malleability, and ductility, making the mapping electrodes suitable for use in the cardiac ablation device 100A. The metals, such as Platinum (Pt) and Iridium (Ir) are also chosen for their desirable properties in terms of electrical conductivity and biocompatibility. The combination of these materials ensures accurate mapping of the heart's electrical activity and identification of abnormal areas responsible for abnormal heart rhythm. In an exemplary scenario, the plurality of mapping electrodes 104 can be made of a combination of Platinum (90%) and Iridium (10%), Pt90Ir10 or Gold.
[0025] As shown in FIG. 1A, the plurality of mapping electrodes 104 comprises three mapping electrodes crimped on the surface of the catheter shaft 102. The center electrode 106 is used as the RF ablation electrode (RF ablation tip electrode) in the non-expanded configuration of the cardiac ablation device 100A, as shown in FIG. 1B. In an implementation scenario, the plurality of ring electrodes 110 arranged on the expandable basket structure 108 may include 48 ring electrodes in the cardiac ablation device 100A. The arrangement of the plurality of ring electrodes 110 on the expandable basket structure 108 is shown and described in detail, for example, in FIGs. 3A, 3B, 3C and 3D.
[0026] The cardiac ablation device 100A comprises the handle 112 attached to the proximal end 102B of the catheter shaft 102, configured to control expansion and contraction of the expandable basket structure 108 and transmit a controlled amount of energy to the center electrode 106 and the expandable basket structure 108 for RFA and PFA, respectively, of the one or more damaged cardiac tissues. The term "Radio Frequency Ablation (RFA)" refers to a medical procedure in which high-frequency electrical currents are utilized to generate heat and destroy abnormal tissue, particularly in the context of cardiac ablation devices. The handle 112 is provided to conveniently manipulate the cardiac ablation device 100A during ablation procedures.
[0027] In accordance with an embodiment, the handle 112 comprises the push-pull switch 114 configured to expand and compress the expandable basket structure 108, the rotating switch 116 configured for bidirectional deflection of the catheter shaft 102 and the energy delivery switch 118 with multiple functional levels configured to selectively generate and transmit RFA energy and PFA energy to the center electrode 106 and the plurality of ring electrodes 110, respectively. The push-pull switch 114 in the handle 112 provides an easy expansion of the basket structure (i.e., the expandable basket structure 108) to ablate a larger area around the Pulmonary Vein (PV). Consequently, effectiveness of the ablation procedure can be enhanced by ensuring a more comprehensive treatment of the targeted region. Additionally, the push-pull switch 114 simplifies the handling of the cardiac ablation device 100A during ablation procedures. The integration of the rotating switch 116 into the handle 112 provides an easy-to-use solution for surgeons. The push-pull switch 114 allows for convenient opening of the expandable basket structure 108 from the catheter shaft 102, while the rotating switch 116 enables bidirectional deflection of the catheter shaft 102. This combination of features simplifies the operation of the cardiac ablation device 100A, reducing the complexity and potential risks associated with multiple mechanisms. Additionally, the energy delivery switch 118 within the handle 112 facilitates the generation and transmission of heat energy for radiofrequency ablation and electric pulses for pulse field ablation, enabling the cardiac ablation device 100A to perform both ablation methods. This versatility results in shorter procedure durations and reduced costs, by eliminating the requirement to switch between different catheters for different ablation techniques. By providing the option to switch between RFA and PFA, the cardiac ablation device 100A can adapt to the specific requirements of the patient and the characteristics of the damaged tissue being treated. This flexibility enhances the effectiveness of the ablation procedure.
[0028] In accordance with an embodiment, the push-pull switch 114 is configured to provide at least two stages of expansion of the expandable basket structure 108 to cover additional tissues surrounding the one or more damaged cardiac tissues for the PFA. The push-pull switch 114 of the cardiac ablation device 100A is designed to enable the expandable basket structure 108 to undergo at least two stages of expansion. This expansion allows the basket to cover additional tissues surrounding the one or more damaged cardiac tissues (or the PV) for the PFA. The purpose of providing at least two stages of expansion is to ensure that a larger area around the damaged cardiac tissues can be covered during the PFA. The two stages of expansion of the expandable basket structure 108 have significance for effectively ablating the targeted tissues and minimizing damage to the surrounding healthy tissues.
[0029] In accordance with an embodiment, the push-pull switch 114 comprises a wire configured to expand the expandable basket structure 108 when pushed in a forward direction and compress the expandable basket structure 108 when pulled in a backward direction. The push-pull switch 114 of the cardiac ablation device 100A is equipped with a single pull wire. This pull wire is specifically designed to expand the expandable basket structure 108 when pushed forward and compress the expandable basket structure 108 when pulled backward. The advantage of such configuration is to enable the cardiac ablation device 100A to effectively treat a larger area around the Pulmonary Vein. By expanding the basket structure further, the ring electrodes are pushed to come in contact with the PV, ensuring thorough ablation of any damaged tissue that may have been missed during the initial expansion. The use of the push-pull switch 114 allows for precise control over the expansion and compression of the basket structure. This mechanism provides ease of handling for operators (or surgeons), as the use of push-pull switch 114 simplifies the operation of the cardiac ablation device 100A.
[0030] In accordance with an embodiment, the energy delivery switch 118 comprises at least three functional level controls, where the first functional level control 118A is configured to transmit the PFA energy to a first set of ring electrodes from the plurality of ring electrodes 110, wherein the first set of ring electrodes is arranged on a front surface of the expandable basket structure 108. The first functional level control 118A is used to activate the first set of ring electrodes for the PFA of the one or more damaged cardiac tissues. The arrangement of the first set of ring electrodes on the front surface of the expandable basket structure 108 leads to a direct contact with the PV or any part of heart, ensuring thorough ablation and reducing the risk of leaving any damaged tissue behind. The arrangement of the first set of ring electrodes on the front surface of the expandable basket structure 108 is shown and described in detail, for example, in FIG. 3B.
[0031] The energy delivery switch 118 comprises the second functional level control 118B configured to transmit the PFA energy to a second set of ring electrodes from the plurality of ring electrodes 110, where the second set of ring electrodes is arranged on side surfaces of the expandable basket structure 108. The second functional level control 118B is used to activate the second set of ring electrodes to cover a larger area around the PV for ablation ensuring that all damaged tissues are treated. The expandable basket structure 108 when expanded further, the basket gets stretched due to which the second set of ring electrodes arranged on side surfaces of the expandable basket structure 108 comes in contact with the damaged tissues for PFA. This design allows for faster ablation compared to traditional systems, reducing the time required for surgeons to ablate the tissue. The arrangement of the second set of ring electrodes on the side surfaces of the expandable basket structure 108 for faster ablation of damaged tissues, results in reduced procedural times compared to conventional catheters used for cardiac ablation. The arrangement of the second set of ring electrodes on the side surfaces of the expandable basket structure 108 is shown and described in detail, for example, in FIG. 3A, 3C and 3D.
[0032] The energy delivery switch 118 comprises the third functional level control 118C configured to transmit the RFA energy to the center electrode 106 for RF ablation of the one or more damaged cardiac tissues. The use of the third functional level control 118C to transmit RFA energy to the center electrode 106 enables effective tissue ablation. By delivering high-frequency alternating current to the damaged cardiac tissues, thermal energy is generated, causing coagulation necrosis and effectively disrupting abnormal electrical pathways or unwanted tissue. The combination of RFA and PFA capabilities in one device also improves safety by offering a non-thermal approach (PFA) that minimizes collateral damage to surrounding tissues, reducing the risk of complications.
[0033] The fourth functional level control 118D is additionally provided in the energy delivery switch 118 for OFF condition.
[0034] In another implementation scenario, the first functional level control 118A may be used for OFF condition, the second functional level control 118B may be used for RFA of damages cardiac tissues, the third functional level control 118C may be used for PFA of damaged cardiac tissues by activating the first set of ring electrodes arranged on front surface of the expandable basket structure 108 and the fourth functional level control 118D may be used for PFA of damaged cardiac tissues by activating the second set of ring electrodes arranged on side surfaces of the expandable basket structure 108. Moreover, the functions of each of the functional level controls of the energy delivery switch 118 are interchangeable depending on requirement.
[0035] The cardiac ablation device 100A (or the catheter) is inserted into blood vessels, typically through the groin area, and guided to the heart. The plurality of mapping electrodes 104 crimped on the catheter shaft 102 are made of Pt90Ir10 or Gold and are used to map the heart's electrical activity, identifying areas responsible for abnormal heart rhythm. Once mapping is complete, depending on the damaged cardiac tissues, the surgeon can make decision which ablation energy can be used for ablating the damaged cardiac tissues. The RF ablation can be done using the center electrode 106 (i.e., RF ablation tip electrode). The center electrode 106 is embedded with a temperature sensor for sensing the temperature of the tip of the center electrode 106 during ablation and with an irrigation port for supplying saline water to reduce the heat around the ablation site. Thereafter, either the high-energy electrical pulse trains or high frequency alternating currents are then delivered through the expandable basket structure 108 or the center electrode 106, respectively, to the targeted areas comprising the one or more damaged cardiac tissues using the energy delivery switch 118. The expandable basket structure 108 made of PEBAX is pulled out of the catheter shaft 102 (or the catheter tube) using the push-pull switch 114 of the handle 112, forming the shape of the basket as shown and described in detail, for example, in FIGs. 3A, 3B, 3C and 3D and making direct contact with one or more of the damaged cardiac tissues. The high frequency alternating currents and pulse trains for RFA and PFA, respectively, are short in duration but have a high peak in power, allowing for precise and effective tissue ablation while minimizing damage to surrounding healthy tissue. The thickness of the targeted tissue determines the delivery of the high frequency alternating currents or the pulse train.
[0036] FIG. 1B illustrates a cardiac ablation device in a non-expanded configuration for Radio Frequency Ablation (RFA) of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 1B is described in conjunction with elements from FIG. 1A. With reference to FIG. 1B, there is shown a cardiac ablation device 100B in a non-expanded (or deflated or compressed) configuration. The cardiac ablation device 100B is similar to the cardiac ablation device 100A (of FIG. 1A) except a difference. The difference is that the expandable basket structure 108 is in the non-expanded configuration (or deflated position) and the center electrode 106 arranged on the distal end 102A of the catheter shaft 102 is used for RF ablation of the damaged cardiac tissues. In such configuration, this may be stated, that the cardiac ablation device 100B comprises three mapping electrodes for mapping of the damaged cardiac tissues. The cardiac ablation device 100B is used for mapping of the one or more damaged cardiac tissues using the plurality of mapping electrodes 104 and RF ablation of the at least one or more damaged cardiac tissues using the center electrode 106. Therefore, the center electrode 106 may also be referred to as the RF ablation tip electrode in the non-expanded configuration of the cardiac ablation device 100B. The cardiac ablation device 100B is represented by a dashed box, which is used for illustration purpose only.
[0037] FIG. 2 illustrates an arrangement of an expandable basket structure in a catheter shaft of a cardiac ablation device, in accordance with an embodiment of the present disclosure. FIG. 2 is described in conjunction with elements from FIGs. 1A and 1B. With reference to FIG. 2, there is shown that the expandable basket structure 108 is arranged in the catheter shaft 102 (or the catheter tube) of the cardiac ablation device 100B (of FIG. 1B) in form of splines made of PEBAX material. The expandable basket structure 108 is in the compressed form. There is further shown the arrangement of the plurality of mapping electrodes 104 on the catheter shaft 102. Furthermore, the center electrode 106 is used for RF ablation of the damaged cardiac tissues in the cardiac ablation device 100B.
[0038] FIG. 3A is a superior view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 3A described in conjunction with elements from FIGs. 1A and 1B. With reference to FIG. 3A, there is shown a superior view 300A (or top-down view) of the expandable basket structure 108. There is shown a temperature sensor 302 and an irrigation port 304 arranged on the center electrode 106. The superior view 300A illustrates the arrangement of the plurality of ring electrodes 110 on the expandable basket structure 108. The superior view 300A further illustrates that the expandable basket structure 108 comprises a plurality of splines 306 (for example, 12 splines) on which the plurality of ring electrodes 110 are arranged. For example, each spline carries four ring electrodes, out of which three ring electrodes are arranged on top surface of each spline and fourth ring electrode is arranged on a side surface (i.e., slightly far away from third ring electrode) of each spline. Therefore, the plurality of ring electrodes 110 are divided into two sets, for example, the first set of ring electrodes (i.e., the set of ring electrodes arranged on the top surface of each spline) and the second set of ring electrodes (i.e., the set of ring electrodes arranged on side surface (i.e., slightly far away from third ring electrode) of each spline). The first set of ring electrodes is configured to make the direct contact with the heart to ablate the damaged cardiac tissues. The second set of ring electrodes is configured to cover more area around the damaged tissues in the heart. Moreover, the superior view 300A of the expandable basket structure 108 illustrates the expanded configuration of the expandable basket structure 108 in which the expandable basket structure 108 take the shape of a flower.
[0039] In accordance with an embodiment, the center electrode 106 comprises the temperature sensor 302 configured to measure temperature at a surgical site during RF ablation of the one or more damaged cardiac tissues, where the surgical site corresponds to the defined area comprising the one or more damaged cardiac tissues. The term "surgical site" refers to the specific area on a patient's body where a surgical procedure is being performed, such as the region where the cardiac ablation procedure is being conducted. The center electrode 106 includes the temperature sensor 302 that is specifically designed to measure the temperature of the surgical site as well as tip of the center electrode 106 during the ablation procedure. The temperature sensor 302 is integrated into the center electrode 106 and is positioned to accurately measure the temperature at the surgical site. The inclusion of the temperature sensor 302 in the center electrode 106 of the cardiac ablation device 100A allows for real-time monitoring of the temperature at the surgical site. The measurement of the temperature at the surgical site during ablation of the damaged cardiac tissues is required for ensuring the effectiveness and safety of the procedure. By monitoring the temperature, the medical practitioner can ensure that the ablation is performed at the optimal temperature range for effective tissue destruction while minimizing the risk of overheating or damaging surrounding healthy tissue. This temperature measurement provides valuable feedback to guide the ablation process and ensure successful treatment outcomes.
[0040] In accordance with an embodiment, the center electrode 106 comprises the irrigation port 304 configured to supply an irrigation fluid to the surgical site during RF ablation of the one or more damaged cardiac tissues. The irrigation port 304 may be referred to as a small aperture or opening in a medical device, such as the cardiac ablation device 100A, which is specifically designed to allow the flow of irrigation fluid. The irrigation fluid (saline fluid/water) may also be referred to as an irrigation hole. The term "irrigation fluid" refers to a sterile liquid solution, typically saline, that is used to irrigate and cleanse the target area during a medical procedure, such as cardiac ablation, to maintain a clear field of view and remove debris or blood. The purpose of incorporating the irrigation port 304 in the expandable basket structure 108 is to provide a continuous supply of irrigation fluid during the RF ablation process. The irrigation fluid performs multiple functions, such as to cool down the ablation site (or the surgical site), prevents excessive heat buildup and minimizes the risk of thermal damage to surrounding healthy tissues and maintains a clear field of view of the surgical site for the surgeon by flushing away debris and charred tissue, and therefore, improves the overall efficacy of the ablation procedure. The irrigation fluid maintains a moist environment, which can enhance the conductivity of the ablation energy and improve the efficiency of tissue ablation.
[0041] FIG. 3B is a top view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 3B described in conjunction with elements from FIGs. 1A, 1B and 3A. With reference to FIG. 3B, there is shown a top view 300B of the expandable basket structure 108. In top view 300B of the expandable basket structure 108, the second set of ring electrodes (i.e., the set of ring electrodes arranged on side surface of each spline) is not visible. Merely, the first set of ring electrodes (i.e., the set of ring electrodes arranged on the top surface of each spline) is visible in the top view 300B.
[0042] FIG. 3C is a top view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with another embodiment of the present disclosure. FIG. 3C described in conjunction with elements from FIGs. 1A, 1B, 3A and 3B. With reference to FIG. 3C, there is shown a top view 300C of the expandable basket structure 108. In top view 300C of the expandable basket structure 108, the second set of ring electrodes (i.e., the set of ring electrodes arranged on side surface of each spline) is also visible. When the expandable basket structure 108 is expanded further, the basket structure gets stretched due to which the second set of ring electrodes arranged on side surfaces comes in direct contact with the damaged cardiac tissues for PF ablation and also become visible.
[0043] FIG. 3D is a lateral view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 3D described in conjunction with elements from FIGs. 1A, 1B, 3A, 3B and 3C. With reference to FIG. 3D, there is shown a lateral view 300D (or side view) of the expandable basket structure 108.
[0044] The plurality of splines 306 (or plurality of arms) can be seen running from the center electrode 106 to the base of the basket structure. The plurality of splines 306 appear to have a mesh structure, which represents the plurality of ring electrodes 110 used for ablation of the one or more damaged cardiac tissues. At the bottom, the plurality of splines 306 converge into the catheter shaft 102. The lateral view 300D clearly demonstrates how the expandable basket structure 108 can be collapsed for insertion into blood vessels and then, expanded once inside the heart chamber. The lateral view 300D is particularly useful for understanding the collapsible nature of the basket structure and how it transits from the narrow catheter shaft to the wider basket structure. The lateral view 300D provides a good sense of the three-dimensional form of the expandable basket structure 108 and how it might look as it's being deployed or retracted during the ablation procedure.
[0045] FIG. 4A illustrates another cardiac ablation device in an expanded configuration for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. With reference to FIG. 4A, there is shown a cardiac ablation device 400A in an expanded configuration. The cardiac ablation device 400A comprises a catheter shaft 402, a plurality of mapping electrodes 404, a center electrode 406, an expandable basket structure 408 comprising a plurality of ring electrodes 602 (not visible in FIG. 4A) and a handle 412. The catheter shaft 402 has a distal end 402A and a proximal end 402B. The handle 412 comprises a push-pull switch 414, a rotating switch 416 and an energy delivery switch 418. There is further shown that the energy delivery switch 418 comprises three functional level controls, such as a first functional level control 418A, a second functional level control 418B, and a third functional level control 418C. The cardiac ablation device 400A is represented by a dashed box, which is used for illustration purpose only. The plurality of mapping electrodes 404 is represented by a dashed box, which is used for illustration purpose only.
[0046] There is provided the cardiac ablation device 400A comprising the catheter shaft 402 with a distal end 402A and a proximal end 402B, the plurality of mapping electrodes 404 arranged on the catheter shaft 402, where each of the plurality of mapping electrodes 404 is configured to map one or more damaged cardiac tissues in a defined area, and the center electrode 406 positioned at the distal end 402A of the catheter shaft 402, configured to map the one or more damaged cardiac tissues. The cardiac ablation device 400A further comprises the expandable basket structure 408 arranged near the distal end 402A of the catheter shaft 402, where the expandable basket structure 408 comprises the plurality of ring electrodes 602 configured to ablate the one or more damaged cardiac tissues via Pulse Field Ablation (PFA) and the handle 412 attached to the proximal end 402B of the catheter shaft 402, the handle 412 is configured to control an expansion and contraction of the expandable basket structure 408 and transmit a controlled amount of energy to the expandable basket structure 408 for the PFA of the one or more damaged cardiac tissues.
[0047] The cardiac ablation device 400A may also be referred to as an electrophysiology Pulse Field Ablation (PFA) catheter. The cardiac ablation device 400A is designed to perform only PFA of damaged cardiac tissues along with mapping capabilities. The cardiac ablation device 400A is configured for non-thermal ablation of the damaged cardiac tissues using high-voltage electric pulses. The cardiac ablation device 400A (or the PFA catheter) is used to cure cardiac arrhythmia, especially Atrial fibrillation (AFib) that is paroxysmal and persistent AFib, a type of heart arrhythmia which is caused within the heart’s signaling system which allows certain chambers of the heart to beat erratically. The cardiac ablation device 400A comprises multi-electrodes (for example, 10 mapping electrodes and 36 ring electrodes) and catheter tube (i.e., size of the catheter shaft 402) size ranging from 7.5Fr - 9Fr which is inserted into the femoral vein or in some cases subclavian vein. The plurality of mapping electrodes 404 arranged on the catheter shaft 402 identifies the abnormal pathway or area responsible for the AFib. Once mapping is done, the expandable basket structure 408 is then pushed out from the distal end 402A of the catheter shaft 402 using the push-pull switch 414 provided on the handle 412 which takes the shape of the basket around pulmonary vein and comes in direct contact with it to ablate the tissue. While ablation, high energy electrical pulse trains are delivered to the targeted areas to create lesions. These pulse trains are sent through the energy delivery switch 418 (may also be referred to as cardiac pulse field ablation generator/system) to the plurality of ring electrodes arranged on the expandable basket structure 408, these pulse trains are very short in duration but have high peak in power, which allows for precise and effective tissue ablation while minimizing damage to surrounding healthy tissue. The pulse train delivery depends on the thickness of the targeted tissue.
[0048] The functions of each component of the cardiac ablation device 400A are same as that of each component of the cardiac ablation device 100A (of FIG. 1A). The center electrode 406 is used as a mapping electrode. Moreover, the center electrode 406 does not have any temperature sensor and irrigation port.
[0049] The cardiac ablation device 400A is different from the cardiac ablation device 100A (of FIG. 1A). The cardiac ablation device 100A is designed to perform both RFA and PFA of damaged cardiac tissues along with mapping capabilities. However, the cardiac ablation device 400A is designed to perform only the PFA of the damaged cardiac tissues. Additionally, there are few structural differences between the cardiac ablation device 100A and the cardiac ablation device 400A, for example, the structure of the expandable basket structure 408 is different from the expandable basket structure 108 (of FIG. 1A). The number of mapping electrodes and the ring electrodes are also different. For example, the cardiac ablation device 100A comprises 3 mapping electrodes and 48 ring electrodes whereas, the cardiac ablation device 400A comprises 10 mapping electrodes and 36 ring electrodes. Moreover, the material of construction (MOC) of the basket structure is also different, that is the expandable basket structure 108 of the cardiac ablation device 100A is made of PEBAX whereas, the expandable basket structure 408 of the cardiac ablation device 400A is made of braided Nitinol.
[0050] In accordance with an embodiment, the catheter shaft 402 has a diameter ranging from 7.5 French gauge (Fr) to 9 Fr. The catheter shaft 402 is designed to be used for both mapping and ablating damaged cardiac tissues using PFA energy. By incorporating the diameter range from 7.5 Fr to 9 Fr, the catheter shaft 402 can accommodate the required components for ablating the damaged cardiac tissues, such as, the plurality of mapping electrodes 404, the center electrode 406 for mapping, and the expandable basket structure 408 with the plurality of ring electrodes 602 for pulse field ablation. This allows for efficient and effective treatment of atrial fibrillation and other related conditions.
[0051] In accordance with an embodiment, the energy delivery switch 418 comprises at least two functional level controls, where the first functional level control 418A is configured to transmit the PFA energy to a first set of ring electrodes from the plurality of ring electrodes 602, wherein the first set of ring electrodes is arranged on a front surface of the expandable basket structure 408 and the second functional level control 418B is configured to transmit the PFA energy to a second set of ring electrodes from the plurality of ring electrodes 602, wherein the second set of ring electrodes is arranged on side surfaces of the expandable basket structure 408. Moreover, the energy delivery switch 418 comprises three functional level controls, such as the first functional level control 418A, the second functional level control 418B, and the third functional level control 418C. The first functional level control 418A is used to activate a first set of ring electrodes (e.g., eighteen ring electrodes arranged on front surface of the expandable basket structure 408) for the PFA of the one or more damaged cardiac tissues. The arrangement of the plurality of ring electrodes on the expandable basket structure 408 is shown and described in detail, for example, in FIGs. 6A and 6B. The second functional level control 418B is configured to transmit the PFA energy to a second set of ring electrodes, where the second set of ring electrodes is arranged on side surfaces of the expandable basket structure 408. The second set of ring electrodes comes in contact with the damaged tissues when the expandable basket structure 408 is further expanded to cover a larger area around the PV for ablation ensuring that all damaged tissues are treated. This design also allows for faster energy delivery compared to traditional catheter systems, reducing the time required for surgeons to ablate the tissue. The third functional level control 418C is additionally provided in the energy delivery switch 418 for OFF condition.
[0052] In another implementation scenario, the first functional level control 418A can be used for switching on the surface ring electrodes (i.e., the first set of ring electrodes arranged on front surface of the expandable basket structure 408), the second functional level control 418B can be used for off condition and the third functional level control 418C can be used for switching on the side ring electrodes (i.e., the second set of ring electrodes arranged on side surfaces of the expandable basket structure 408). In this way, the functions of each of the functional level control of the energy delivery switch 418 can be interchanged depending on the future use of the cardiac ablation device 400A.
[0053] In accordance with an embodiment, the expandable basket structure 408 is made of braided Nitinol. The term "braided Nitinol" refers to a material composed of a shape memory alloy called Nitinol, which has been intricately woven or braided into a flexible and durable structure, typically used in medical devices, such as cardiac ablation devices for delivering therapeutic treatments. The use of braided Nitinol for the expandable basket structure 408 offers several technical advantages. Firstly, the braided structure provides enhanced flexibility and manoeuvrability, allowing the basket to easily adapt to the anatomy of the targeted area. This ensures improved contact between the ring electrodes and the pulmonary vein, maximizing the effectiveness of the ablation procedure. Moreover, the biocompatibility of Nitinol reduces the risk of adverse reactions or complications when the device comes into contact with the patient's body. Overall, the use of braided Nitinol in the expandable basket structure 408 enhances the device's performance, safety, and efficacy in cardiac ablation procedures.
[0054] Besides of these structural differences, both of the cardiac ablation device 100A and the cardiac ablation device 400A has unique design and can be used depending on the application scenario. Both of the catheters (i.e., the cardiac ablation device 100A and the cardiac ablation device 400A) have mapping capabilities along with delivery of ablation energies in a single catheter resulting in shorter and safer procedure durations leading to enhanced procedural efficiency. Both of the catheters have uniquely designed handle, to open the basket structure using the push-pull mechanism, for making the bidirectional deflection of the catheter shafts using the rotating mechanism and the energy delivery switch for controlling ablation energy to the basket structure.
[0055] FIG. 4B illustrates another cardiac ablation device 400B in a non-expanded configuration for mapping of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 4B is described in conjunction with elements from FIGs. 1A, 1B and 4A. With reference to FIG. 4B, there is shown a cardiac ablation device 400B in a non-expanded (or deflated or compressed) configuration. The cardiac ablation device 400B is similar to the cardiac ablation device 400A (of FIG. 4A) except a difference. The difference is that the expandable basket structure 408 is in the non-expanded configuration (or deflated position). The cardiac ablation device 400B is used for only mapping of the one or more damaged cardiac tissues and not for ablation of the damaged cardiac tissues. The cardiac ablation device 400B is represented by a dashed box, which is used for illustration purpose only.
[0056] The center electrode 406 arranged on the distal end 402A of the catheter shaft 402 is used for mapping of the damaged cardiac tissues. In such configuration, this may be stated, that the cardiac ablation device 400B comprises ten mapping electrodes for mapping of the damaged cardiac tissues.
[0057] FIG. 5 illustrates an arrangement of an expandable basket structure in a catheter shaft of a cardiac ablation device, in accordance with another embodiment of the present disclosure. FIG. 5 is described in conjunction with elements from FIGs. 1A, 1B, 4A and 4B. With reference to FIG. 5, there is shown that the expandable basket structure 408 is arranged in the catheter shaft 402 (or the catheter tube) of the cardiac ablation device 400B (of FIG. 4B) in braided form. The expandable basket structure 408 is in the compressed form. There is further shown the arrangement of the plurality of mapping electrodes 404 on the catheter shaft 402. Furthermore, the center electrode 406 is also used as the mapping electrode in the cardiac ablation device 400B. The center electrode 406 may also be referred to as a mapping tip electrode.
[0058] FIG. 6A is a top view of an expandable basket structure 408 for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 6A described in conjunction with elements from FIGs. 4A and 4B. With reference to FIG. 6A, there is shown a top view 600A of the expandable basket structure 408. The top view 600A illustrates the arrangement of a plurality of ring electrodes 602 on the expandable basket structure 408. The top view 600A further illustrates that the expandable basket structure 408 comprises a circular, symmetrical arrangement of braiding arms radiating outward from the center electrode 406. The braiding arms form a complete 360-degree basket-like structure. Each braiding arm of the expandable basket structure 408 appears to have a wavy or curved shape, likely to allow for making direct contact with the damaged cardiac tissues. There's a dense mesh-like pattern created by the interconnected braiding arms, which represents the array of electrodes used for ablation of damaged cardiac tissues in the heart. The plurality of ring electrodes 602 are arranged on the braiding arms of the expandable basket structure 408. For example, the first set of ring electrodes (e.g., eighteen electrodes) are arranged on the braiding arms in such a way that the first set of ring electrodes makes the direct contact with the damaged cardiac tissues for the PFA. Similarly, the second set of ring electrodes (e.g., eighteen electrodes) are arranged on the braiding arms in such a way that the second set of ring electrodes is configured to cover larger area for ablation in the surroundings of the PV. Moreover, the top view 600A of the expandable basket structure 408 illustrates the expanded configuration of the expandable basket structure 408 in which the expandable basket structure 408 take the shape of a flower.
[0059] FIG. 6B illustrates a three-quarter or oblique view of an expandable basket structure 408 for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 6B is described in conjunction with elements from FIGs. 4A, 4B, and 6A. With reference to FIG. 6B, there is shown an oblique view 600B (or a three-quarter view) of the expandable basket structure 408 (of FIG. 4A). The expandable basket structure 408 is shown in its expanded state, forming a rounded, parachute-like shape. The braiding pattern can be seen radiating out from the center electrode 406 (or the mapping tip electrode), creating the basket structure. The expandable basket structure 408 is arranged at the distal end 402A of the catheter shaft 402. This gives a good sense of how the device transitions from the narrow shaft (i.e., the catheter shaft 402) to the expanded basket (i.e., the expandable basket structure 408). The oblique view 600B provides a strong sense of the three-dimensional (3D) shape and depth of the basket catheter. The oblique view 600B illustrates the overall circular shape of the expandable basket structure 408 while also showing its depth and connection to the catheter shaft 402. This perspective gives a comprehensive understanding of the device's structure and how it would appear when deployed inside a heart chamber for ablation procedures.
[0060] FIG. 6C illustrates a side view or lateral view of an expandable basket structure for PFA of damaged cardiac tissues, in accordance with an embodiment of the present disclosure. FIG. 6C is described in conjunction with elements from FIGs. 4A, 4B, 6A and 6B. with reference to FIG. 6C, there is shown a side view 600C (or lateral view) of the expandable basket structure 408. The expandable basket structure 408 is displayed in its expanded state, forming a hemispherical or dome-like shape. The braiding arms can be seen creating the basket structure. There is a mesh-like pattern visible, created by the intersecting Nitinol wires. This mesh represents the array of electrodes used for ablation of damages cardiac tissues in the heart. The catheter shaft 402 is clearly visible in the side view 600C. The side view 600C is particularly useful for understanding the basket catheter's deployed form and how it would appear when expanded inside a heart chamber. The side view 600C clearly shows the relationship between the expandable basket structure 408 and the catheter shaft 402, as well as the curvature of the braiding pattern that allow the plurality of ring electrodes 602 to make direct contact with cardiac tissue for ablation procedures.
[0061] FIG. 6D illustrates a side view or lateral view of an expandable basket structure, in accordance with another embodiment of the present disclosure. FIG. 6D is described in conjunction with elements from FIGs. 4A, 4B, 6A, 6B and 6C. with reference to FIG. 6D, there is shown a side view 600D (or lateral view) of the expandable basket structure 408. The expandable basket structure 408 is displayed in its fully expanded state, forming a conical or funnel-like shape. The braiding arms can be seen radiating out from the center electrode 406 (or the mapping tip electrode), creating the basket structure. These Nitinol structure extend from the narrow tip to the wider base of the cone. A mesh-like pattern is visible, formed by the intersecting Nitinol wires. This mesh represents the array of electrodes used for ablation of damaged cardiac tissues. The catheter shaft 402 is clearly visible in the side view 600D. The side view 600D effectively illustrates the basket catheter's deployed form in the fully expanded state, showcasing the conical shape of the expandable basket structure 408.
[0062] Modifications to embodiments of the present disclosure described in the foregoing are possible without departing from the scope of the present disclosure as defined by the accompanying claims. Expressions such as "including", "comprising", "incorporating", "have", "is" used to describe and claim the present disclosure are intended to be construed in a non-exclusive manner, namely allowing for items, components or elements not explicitly described also to be present. Reference to the singular is also to be construed to relate to the plural. The word "exemplary" is used herein to mean "serving as an example, instance or illustration". Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments. The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments". It is appreciated that certain features of the present disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the present disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable combination or as suitable in any other described embodiment of the disclosure.
, Claims:We Claim:
1. A cardiac ablation device (100A) comprising:
a catheter shaft (102) with a distal end (102A) and a proximal end (102B);
a plurality of mapping electrodes (104) arranged on the catheter shaft (102), wherein the plurality of mapping electrodes (104) are configured to map one or more damaged cardiac tissues in a defined area;
a center electrode (106) positioned at the distal end (102A) of the catheter shaft (102), configured to ablate the one or more damaged cardiac tissues via Radio Frequency Ablation (RFA) when in operation;
an expandable basket structure (108) arranged near the distal end (102A) of the catheter shaft (102), wherein the expandable basket structure (108) comprises a plurality of ring electrodes (110) configured to ablate the one or more damaged cardiac tissues via Pulse Field Ablation (PFA) when in operation; and
a handle (112) attached to the proximal end (102B) of the catheter shaft (102), the handle (112) is configured to control an expansion and contraction of the expandable basket structure (108) and transmit a controlled amount of energy to the center electrode (106) and the expandable basket structure (108) for RFA and PFA, respectively, of the one or more damaged cardiac tissues.

2. The cardiac ablation device (100A) as claimed in claim 1, wherein the handle (112) comprises:
a push-pull switch (114) configured to expand and compress the expandable basket structure (108);
a rotating switch (116) configured for bidirectional deflection of the catheter shaft (102); and
an energy delivery switch (118) with multiple functional levels configured to selectively generate and transmit RFA energy and PFA energy to the center electrode (106) and the plurality of ring electrodes (110), respectively.
3. The cardiac ablation device (100A) as claimed in claim 2, wherein the push-pull switch (114) is configured to provide at least two stages of expansion of the expandable basket structure (108) to cover additional tissues surrounding the one or more damaged cardiac tissues for the PFA.

4. The cardiac ablation device (100A) as claimed in claim 2, wherein the energy delivery switch (118) comprises at least three functional level controls, wherein:
a first functional level control (118A) is configured to transmit the PFA energy to a first set of ring electrodes from the plurality of ring electrodes (110), wherein the first set of ring electrodes is arranged on a front surface of the expandable basket structure (108);
a second functional level control (118B) is configured to transmit the PFA energy to a second set of ring electrodes from the plurality of ring electrodes (110), wherein the second set of ring electrodes is arranged on side surfaces of the expandable basket structure (108); and
a third functional level control (118C) is configured to transmit the RFA energy to the center electrode (106) for RF ablation of the one or more damaged cardiac tissues.

5. The cardiac ablation device (100A) as claimed in claim 1, wherein the center electrode (106) comprises a temperature sensor (302) configured to measure temperature of a surgical site during RF ablation of the one or more damaged cardiac tissues, wherein the surgical site corresponds to the defined area comprising the one or more damaged cardiac tissues.

6. The cardiac ablation device (100A) as claimed in claim 1, wherein the center electrode (106) comprises an irrigation port (304) configured to supply an irrigation fluid to the surgical site during RF ablation of the one or more damaged cardiac tissues.

7. A cardiac ablation device (400A) comprising:
a catheter shaft (402) with a distal end (402A) and a proximal end (402B);
a plurality of mapping electrodes (404) arranged on the catheter shaft (402), wherein each of the plurality of mapping electrodes (404) is configured to map one or more damaged cardiac tissues in a defined area;
a center electrode (406) positioned at the distal end (402A) of the catheter shaft (402), configured to map the one or more damaged cardiac tissues;
an expandable basket structure (408) arranged near the distal end (402A) of the catheter shaft (402), wherein the expandable basket structure (408) comprises a plurality of ring electrodes (602) configured to ablate the one or more damaged cardiac tissues via Pulse Field Ablation (PFA); and
a handle (412) attached to the proximal end (402B) of the catheter shaft (402), the handle (412) is configured to control an expansion and contraction of the expandable basket structure (408) and transmit a controlled amount of energy to the expandable basket structure (408) for the PFA of the one or more damaged cardiac tissues.

8. The cardiac ablation device (400A) as claimed in claim 7, wherein the handle (412) comprises:
a push-pull switch (414) configured to expand and compress the expandable basket structure (408);
a rotating switch (416) configured for bidirectional deflection of the catheter shaft (402); and
an energy delivery switch (418) with multiple functional levels configured to selectively generate and transmit PFA energy to the plurality of ring electrodes (602).

9. The cardiac ablation device (400A) as claimed in claim 7, wherein the energy delivery switch (418) comprises at least two functional level controls, wherein:
a first functional level control (418A) is configured to transmit the PFA energy to a first set of ring electrodes from the plurality of ring electrodes (602), wherein the first set of ring electrodes is arranged on a front surface of the expandable basket structure (408); and
a second functional level control (418B) is configured to transmit the PFA energy to a second set of ring electrodes from the plurality of ring electrodes (602), wherein the second set of ring electrodes is arranged on side surfaces of the expandable basket structure (408).

10. The cardiac ablation device (400A) as claimed in claim 7, wherein the catheter shaft (402) has a diameter ranging from 7.5 French gauge (Fr) to 9 Fr.