Inflatable sheath multi-electrode catheter

Abstract

The invention is entitled "Inflatable sheath multi-electrode catheter". The invention discloses an apparatus comprising a shaft and an inflatable sheath catheter. The shaft is configured for insertion through a sheath into a lumen of an organ of a patient. The inflatable sheath catheter is secured to a distal end of the shaft, wherein the inflatable sheath catheter comprises: (i) a resilient inner end section secured to the distal end of the shaft and shaped so as to assume a predefined shape when unconstrained; (ii) an inflatable sheath enclosing the inner end section; and a plurality of electrodes disposed on the inflatable sheath and configured to contact tissue.

Description

[0001] Cross Reference to Related Applications

[0002] This patent application claims the benefit of U.S. Provisional Patent Application 62 / 924,394, filed October 22, 2019, the disclosure of which is incorporated by reference herein as if set forth in its entirety. TECHNICAL FIELD

[0003] The present invention relates generally to medical probes, and in particular to cardiac electroanatomic mapping and ablation catheters. BACKGROUND

[0004] Multi-electrode cardiac catheters have been previously proposed in the patent literature. For example, U.S. Patent 9,289,606 describes a catheter system including a directionally sensitive multi-pole tip electrode assembly including configurations for producing narrow linear ablation lesions as well as distributed wide area ablation lesions. In one embodiment, the electrode elements are distributed continuously in a linear fashion or in an arcuate fashion on an outermost surface of a tubular base structure. The tubular base structure includes a non-conductive material.

[0005] As another example, U.S. Patent 8,600,472 describes a cardiac catheter in a system for electrical mapping and ablation of a heart, including a lasso catheter. The lasso catheter has a series of raised circumferential ring hump electrodes, where each circumferential electrode has a plurality of perforations in fluid communication with a cavity or chamber formed below the surface of the circumferential ring. The cavities are formed in a manner that surrounds 360 degrees of the outer surface of the lasso section of the catheter or the collar lumen, in fluid communication with one or more fenestrations drilled through the collar lumen and in fluid communication with a flush lumen.

[0006] To eliminate unwanted electrical pathways that can cause arrhythmias, a pulmonary vein (PV) isolation procedure typically applies ablation to create a circumferential ablation lesion at the ostium of the PV. For example, U.S. Patent Application Publication 2016 / 0175041 describes cardiac ablation by introducing a catheter into the left atrium, extending a lasso guide through a lumen of the catheter to engage a wall of the PV, and deploying a balloon via the lasso guide. The balloon has an electrode assembly disposed on its exterior. The electrode assembly includes a plurality of ablation electrodes arranged circumferentially around a longitudinal axis of the catheter. The inflated balloon is positioned against the PV ostium such that the ablation electrodes are in electrical contact with the PV, and electrical energy is conducted through the ablation electrodes to create a circumferential ablation lesion around the PV. SUMMARY

[0007] Embodiments of the present invention described below provide an apparatus comprising a shaft and an inflatable sheath catheter. The shaft is configured for insertion through a sheath into a lumen of an organ of a patient. The inflatable sheath catheter is fixed to a distal end of the shaft, wherein the inflatable sheath catheter comprises: (i) a resilient inner end segment fixed to the distal end of the shaft and shaped so as to assume a predefined shape when unconstrained; (ii) an inflatable sheath enclosing the inner end segment; and a plurality of electrodes disposed on the inflatable sheath and configured to contact tissue.

[0008] In some embodiments, the resilient inner end segment is straight. In other embodiments, the inflatable sheath catheter is flexible.

[0009] In some embodiments, the electrodes have a cylindrical shape. In other embodiments, the electrodes have a semi-cylindrical shape.

[0010] In one embodiment, the inflatable sheath catheter is a lasso catheter, and the resilient inner end segment is shaped so as to assume an arcuate shape when unconstrained, and wherein the plurality of electrodes are disposed circumferentially on the inflatable sheath.

[0011] In another embodiment, the inner end segment is at least partially made of a shape memory alloy having a self-configurable pre-shaped shape comprising a straight base segment portion and an arcuate segment portion. In another embodiment, the inflatable sheath encloses the inner end segment along the straight base segment portion and the arcuate segment portion of the inner end segment by passing through the inner end segment.

[0012] In some embodiments, the inner end segment becomes unconstrained upon exiting the sheath.

[0013] In some embodiments, the inflatable sheath is configured to be inflated using a saline solution.

[0014] In one embodiment, the apparatus further comprises a flexible PCB sheet having the plurality of electrodes disposed thereon.

[0015] In another embodiment, the flexible PCB sheet is glued to the inflatable sheath.

[0016] According to another embodiment of the present application, there is additionally provided a method comprising inserting an inflatable sheath catheter fixed to a distal end of a shaft into a lumen of an organ of a patient through a sheath, the inflatable sheath catheter comprising: (i) a resilient inner end segment fixed to the distal end of the shaft and shaped so as to assume a predefined shape when unconstrained; (ii) an inflatable sheath enclosing the inner end segment; and (iii) a plurality of electrodes disposed on the inflatable sheath and configured to contact tissue. After the inflatable sheath catheter exits the sheath in the lumen and the resilient inner end segment assumes the predefined shape, the inflatable sheath is inflated; contact is formed between the plurality of electrodes and the tissue; and a medical procedure is performed using the electrodes.

[0017] According to another embodiment of the present application, there is additionally provided a method of manufacturing an inflatable sheath catheter, the method comprising fixing a resilient inner end segment to a distal end of a shaft, the resilient inner end segment being shaped so as to assume a predefined shape when unconstrained. The inner end segment is enclosed with an inflatable sheath. A plurality of electrodes configured to contact tissue are disposed on an outer circumference of the inflatable sheath.

[0018] The present application will be more fully understood from the following detailed description of the embodiments thereof, taken together with the drawings in which: BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a schematic illustration of a system for electroanatomical mapping and ablation according to embodiments of the present application;

[0020] Figure 2 is a schematic illustration of a sheath catheter in an operational position for electroanatomical sensing and ablation according to embodiments of the present application Figure 1 is a schematic illustration of a distal portion of an inflatable sheath lasso catheter shown;

[0021] Figure 3 is a schematic illustration of a sheath catheter in an operational position for electroanatomical sensing and ablation according to embodiments of the present application Figure 2 is a schematic cross-section of an inflatable sheath lasso catheter of

[0022] Figure 4 is a flowchart schematically illustrating a method of pulmonary vein (PV) isolation using an inflatable sheath lasso catheter according to embodiments of the present application; and Figure 2

[0023] Figure 5 is a schematic cross-section of an inflatable sheath flexible linear catheter according to embodiments of the present application. DETAILED DESCRIPTION

[0024] SUMMARY ​

[0025] The distal end of a diagnostic and / or therapeutic catheter for cardiac applications, such as a curved distal end or a distal end having a shape that can be flexed (e.g., a segmented linear shape) or having a rigid linear shape, typically assumes its shape by an elastic end segment that is fixed to the distal end of the shaft and is shaped such that it assumes a predefined (e.g., curved or straight) shape when unconstrained. In the case of a curved shape, the curved shape should in principle be such that electrodes disposed on the curved end segment are able to engage some or all of the circumference of an opening in the heart, such as the ostium of a pulmonary vein (PV). In the case of a linear distal end, the distal end can be flexed to adapt to a variable anatomy (e.g., a septum) such that some or all of the electrodes disposed on the flexibly distal end are able to engage the target cardiac tissue.

[0026] However, an elastic distal segment made of a rigid material such as plastic-coated metal having a sufficiently large cross-section to support the electrodes, such as a curved distal segment or a linear distal segment, can not readily adapt to the variable shape of the opening. Thus, only a fraction of the electrodes disposed on the circumference of the curved end segment, for example, actually come into contact with the tissue, leaving the electrodes that do not contact the tissue in the blood pool. Thus, when the electrodes are used to pick up electrophysiological signals from the tissue, unwanted electrophysiological signals from the blood create interference. When the electrodes are used for tissue ablation, electrical power is injected into the blood, which can create side effects such as blood clots.

[0027] Similarly, a linear rigid distal end as well as even a flexibly distal end can not readily adapt to the variable shape of the anatomy (e.g., the wall tissue of a lumen).

[0028] Furthermore, even the electrodes that do contact the tissue can only partially contact the tissue due to the rigidity of the curved end segment, for example, a substantial fraction of the electrode area still contacts the blood pool. Such electrodes can also pick up unwanted electrophysiological signals and can cause side effects of ablation.

[0029] Embodiments of the present invention described below provide catheters comprising an inflatable sleeve that encloses a thin inner end segment that assumes a predefined shape, such as an arcuate shape, when unconstrained. The disclosed inner end segment (hereinafter also referred to as "wireform") passes through the inflatable sleeve over the entire length of the sleeve. The disclosed wireform imparts its predefined (e.g., arcuate, linear) shape to the sleeve and serves as a rigid "backbone", while the inflatable sleeve imparts the desired balance between additional structural rigidity and tissue conformability to the catheter. For example, the stiffness of the inflatable sleeve can be adjusted by adjusting the rate of saline solution pumped into the sleeve to maintain inflation of the sleeve. As another example, the thickness of the sleeve and / or the type of plastic used for the sleeve construction can be selected to impart an optimized balance.

[0030] In some embodiments, the plurality of electrodes are disposed circumferentially and equidistantly over the entire outer circumference or elongated surface of the inflatable sleeve. Due to its inherent ability to accept the shape of the anatomy while remaining sufficiently elastic, the cross-sectional diameter of the disclosed inflatable sleeve catheter can be made large enough to support a large area electrode that can still be in full contact with the tissue.

[0031] In a typical procedure, a physician advances the inflatable catheter, which is fixed to the distal end of the shaft, through a sheath to a desired body location, such as within the left atrium, with the wireform being straightened by the sheath. In the case of an inflatable lasso catheter, once the lasso emerges from the sheath and enters the left atrium, the wireform resumes its unconstrained arcuate form. The physician then inflates the sleeve and manipulates the catheter to establish contact between the electrodes disposed on the sleeve and the tissue, such as the tissue of the ostium. When the diagnostic and / or therapeutic procedure is complete, the physician deflates the lasso and withdraws the deflated lasso catheter through the sheath. The withdrawal process is typically made easier by using a thin wireform.

[0032] In some embodiments, the electrodes (and their electrical connections) are formed on an electrode support, which is typically a flexible PCB sheet, and the support is glued to the inflatable sleeve. In some embodiments of the inflatable lasso catheter, the electrodes are disposed on the outer (tissue-facing) circumference of the inflatable sleeve, and are not fully cylindrical, i.e., do not fully surround the inflatable sleeve to reach the inner circumference facing away from the tissue. This configuration helps to minimize unwanted exposure of the electrodes to blood. The conformability of the inflatable sleeve, together with the electrode shape and location, thus helps to minimize unwanted interference from stray electrophysiological signals and power injection into the blood.

[0033] As noted above, the inflatable sheath disclosed herein can support a large area electrode, which can be, for example, glued to the sheath. Large area electrodes can be clinically advantageous over small electrodes, for example, by creating larger ablation lesions. Moreover, large electrodes have more resiliency when pushed against tissue walls of the ostium so that the electrodes can make firm contact with the tissue without being shaved off.

[0034] The inflatable sheath catheter disclosed herein can have superior diagnostic and therapeutic capabilities (e.g., relative to other types of catheters such as balloon catheters), and its use can increase the rate of successful and safe ablation therapy of serious cardiac conditions such as drug-resistant arrhythmias.

[0035] System Description

[0036] Figure 1 A schematic illustration of a system 20 for electroanatomical mapping and ablation according to an embodiment of the present application. As shown, an inflatable sheath lasso catheter 40 is fitted at the distal end of a shaft 22, which is inserted through a shaft 23 into the heart 26 of a patient 28 on an operating table 29. Figure 1 A physician 30 is shown using the inflatable sheath lasso catheter 40 to perform electroanatomical mapping of a cardiac chamber, such as the left atrium 45 of the heart 26. The inset 25 also shows the inflatable sheath lasso catheter 40 provided with a plurality of electrodes 53.

[0037] Once the distal end of the shaft 22 has reached the target location (e.g., the left atrium 45), the physician 30 retracts the sheath 23, and the catheter 40 expands to its preformed curved shape. Figure 3 The wire-formed object is shown self-expanding into its preformed curved shape in the shape of a lasso. Next, the physician 30 inflates the sheath 50 by pumping a saline solution into the sheath 50. The physician 30 also manipulates the shaft 22 to arrange the electrodes 53 disposed on the circumference of the sheath 50 in contact with tissue, such as in contact with the ostium of the PV, as shown. Figure 2

[0038] During the mapping procedure, the electrodes 53 gather and / or inject signals from and / or to the tissue of the left atrium 45. The processor 38 in the console 24 receives these signals via the electrical interface 35 and uses the information contained in these signals to construct an electroanatomical map 31. During and / or after the procedure, the processor 38 can display the electroanatomical map 31 on the display 26. Typically, the processor 38 stores the electroanatomical map 31 in the memory 41.

[0039] ​The physician 30 navigates the distal end of the shaft 22 to a target location within the left atrium 45 of the heart 26 by manipulating the flexing of the shaft 22 and / or the sheath 23 using a manipulator 32 proximate to the proximal end of the catheter. The inflatable sleeve lasso catheter 40 is held in a collapsed configuration by the sheath 23 during the insertion of the shaft 22. By containing the catheter 40 in the collapsed configuration, the sheath 23 also serves to minimize vascular trauma along the way to the target location.

[0040] During the procedure, a tracking system is used to track the respective locations of the electrodes 53 so that each of the diagnostic signals can be associated with the location at which the diagnostic signal was acquired. A suitable tracking system is the Advanced Catheter Location (ACL) system manufactured by Biosense-Webster (Irvine, California) described in U.S. Patent 8456182, the disclosure of which is incorporated herein by reference. In the ACL system, a processor estimates the respective locations of the electrodes 53 based on impedance measured between each of the electrodes 53 and a plurality of surface electrodes 49 coupled to the skin of the patient 28.

[0041] Figure 1 The exemplary illustrations shown are chosen purely for conceptual clarity. Other tracking methods can be used, such as methods based on measuring voltage signals. In an optional embodiment, the processor 38 is further configured to indicate the quality of physical contact between the inflatable sleeve lasso catheter 40 and the inner surface of the left atrium 45 during the measurement and / or during the ablation.

[0042] The processor 38 typically comprises a general purpose computer having software programmed to perform the functions described herein. The software can be downloaded to the computer in electronic form, over a network, for instance, or it can alternatively or additionally be provided and / or stored on non-transitory tangible media, such as magnetic or optical storage media or an electronic memory.

[0043] Inflatable lasso catheter

[0044] Figure 2 Exemplary illustration of the distal portion of the inflatable sleeve lasso catheter 40 shown in an operational position for radiofrequency ablation according to an embodiment of the present application. Figure 1 Exemplary illustration of the distal portion of the inflatable sleeve lasso catheter 40 shown. The inflatable sleeve lasso catheter 40 is shown fully inflated and secured to the distal end of the shaft 22. The distal end of the shaft 22 defines a longitudinal axis 70 along and parallel to the distal end of the shaft 22. The arcuate inner end segment (visible in Figure 3 The arcuate inner end segment (visible in

[0045] As used herein, the term "arc" or "arc shape" refers to the shape of an arc segment extending around a longitudinal axis, and this arc segment may be bent into a semi-circular segment or an elliptical segment, as observed by an observer facing the longitudinal axis 70 (e.g. Figure 3 (As shown). The flexible sleeve can be defined as having an arcuate shape with a substantially constant radius (as measured from axis 70), which can be seen in Figure 2 In the middle. Alternatively, in... Figure 3 In this process, the flexible sleeve can be defined as an arcuate shape extending in the form of an outward spiral, the outward spiral having radii (r1, r2, r3, r4, r5…r) increasing from the axis 70. n As observed by an observer above axis 70. In some embodiments, the arc segment may extend less than 90 degrees to more than 180 degrees relative to the longitudinal axis 70. Figure 3 The arc segment can be 70 degrees, and in some cases up to 720 degrees. The arc segment can also be translated along axis 70 to simulate a portion of a spiral or helix around axis 70.

[0046] As shown in the figure, the fully inflatable cannula 50 of the inflatable cannula-cuff catheter 40 contacts the orifice 60 of the PV 61 across its entire circumference. The inflatable cannula 50 has multiple ablation electrodes 53 disposed on a flexible PCB 55 located on the outer surface of the cannula 50. During the PV isolation procedure, electrical energy is transmitted through the electrodes 53 to form a circumferential ablation focus 59 at the orifice 60, which blocks electrical propagation and isolates the PV from the heart. The electrodes 53 can also be used to obtain an electrogram to confirm the electrical isolation of the PV after ablation.

[0047] Illustration 48 shows the inflatable sheath 40 from the perspective of emphasizing the inherent capabilities of the combined structure of the wire-formed material and the inflatable sheath 50, which can both accept the shape of the anatomical structure and push the tissue forcefully enough to make the semi-cylindrical electrode 53 firmly contact the oral cavity 60 tissue over most or all of the area of ​​the electrode 53, i.e., minimal (if any) electrode area is exposed to blood.

[0048] Figure 2 The exemplary illustrations shown are chosen solely for clarity of concept. Other geometries for electrode 53, such as elliptical patches, are also possible.

[0049] Figure 3 According to an embodiment of the present invention Figure 2 A schematic cross-section of the inflatable sheath 50 is shown. As seen, the sheath 50 is traversed by a wire forming 57, which occupies a circumferential space 58 defined by the sheath 50. Electrodes 53 are disposed on a flexible PCB 55, which itself is disposed on the outer surface of the sheath 50.

[0050] The sleeve 50 is shown fully inflated, for example, by a saline solution 66 pumped through a lumen (not shown) within the shaft 22 and in fluid connection with the sleeve 50.

[0051] In one embodiment, the wire form 57 is at least partially made from a shape memory alloy having a pre-shaped shape that is self-configurable including a straight base section 62 portion and an arcuate section 63 portion. Thus, when the physician 30 advances the catheter 40 beyond the distal edge of the sheath 23, the wire form 57 becomes unconstrained and thus self-configures from a collapsed straight configuration to an expanded configuration having the straight base section 62 portion and the arcuate section 63 portion.

[0052] Figure 3 The exemplary illustrations shown are chosen for conceptual clarity only. Figure 3 Only components relevant to the embodiments of the present application are shown. Other details, such as irrigation holes, temperature sensors, and electrical wiring, are omitted for simplicity of presentation.

[0053] Figure 4 To illustrate a flowchart of a method for pulmonary vein (PV) isolation according to embodiments of the present application. The procedure can begin at an insertion step 83 where the physician 30 inserts the inflatable sleeve lasso catheter 40 into the left atrium of the heart.

[0054] Next, at a deployment step 85, the physician 30 deploys the catheter 40 out of the sheath 23 near the inner wall of the ostium 60, causing the wire form 57 to assume its pre-shaped shape. Next, at an inflation step 87, the physician 30 inflates the sleeve 50. At a positioning step 89, the physician 30 brings the inflatable lasso catheter into circumferential contact with the ostium 60 of the PV 61, causing the electrode 53 to make firm contact with the ostium 60 wall tissue. At a measurement step 91, once the inflatable lasso catheter 40 is in place, the physician 30 acquires a pre-ablation electrocardiogram.

[0055] The method now proceeds to a decision step 93 where the physician 30 determines whether the electrode 53 is properly positioned based on the electrogram. If the determination at the decision step 93 is negative, the method returns to step 89 and the physician 30 can reattempt to optimally position the inflatable lasso catheter 40.

[0056] If the decision at decision step 93 is positive, the method proceeds to an ablation step 95 during which the physician 30 performs ablation using the electrode 53. The ablation operation creates a circumferential ablation lesion 59 in the tissue region of the outer interface 60. The ablation lesion 59 should block electrical propagation and effectively electrically isolate the PV 61 from the heart. To confirm the functional isolation of the PV 61, at a measurement step 100, the physician 30 obtains a post-ablation electrogram from the electrode 53 of the inflatable lasso catheter 40.

[0057] If the analysis of the electrogram at decision step 102 shows that the ablation lesion 59 did not completely electrically isolate the PV 61 from the heart, the physician 30 can perform another attempt by looping back to the positioning step 89.

[0058] After completion of the ablation, the procedure can be repeated to treat another PV ostium by withdrawing the distal end of the shaft 22 and thereby the deflated lasso catheter 40. The method can then return to step 85. Alternatively, at a retraction step 104, the physician 30 can end the procedure and retract the catheter from the heart.

[0059] Figure 4 The exemplary flowchart shown in FIG. 6 is chosen for conceptual clarity only. In alternative embodiments, additional steps can be performed, such as applying irrigation to cool the ostial 60 tissue.

[0060] Inflatable linear catheter

[0061] By a straight analogue of the lasso catheter, a sleeve catheter can be implemented for various types of catheter geometries, including catheters carrying a linear electrode array, where the catheter can be rigid or flexible. While the illustrated embodiment has a flexible distal end, the same description applies to a straight linear distal end.

[0062] Figure 5 Schematic cross-sectional view of a flexible linear catheter 44 of the inflatable sleeve according to embodiments of the present application.

[0063] As seen, the sleeve 500 of the catheter 44 is traversed by a flexible wire form 570, which occupies a space 580 defined by the sleeve 500. The wire form 570 can be made of separate links, and can include elements that flex the wire. Alternatively, the wire form 570 is at least partially made of a shape memory alloy having a self-configurable pre-shaped shape, such as a straight linear shape. The electrode 530, which is a cylindrical electrode, is disposed on a flexible PCB 550, which itself is disposed on an outer exterior surface of the sleeve 500.

[0064] Cannula 500 is shown fully inflated, for example, by a saline solution 66 pumped through a lumen (not shown) within the shaft of the access catheter and in fluid connection with the cannula 500.

[0065] Figure 5 The example illustrations shown are chosen for conceptual clarity only. Figure 5 Only components relevant to embodiments of the application are shown. Other details, such as flex elements, irrigation holes, temperature sensors, and electrical wiring, are omitted for simplicity of presentation.

[0066] The above-described lasso, straight, and deflectable catheter embodiments are presented by way of example. The inflatable cannula disclosed herein can be used with any shape of inner end segment, such as, for example, a multi-armed catheter.

[0067] While the embodiments described herein primarily relate to the inflatable cannula disclosed herein in connection with cardiac diagnostic and therapeutic applications, the methods and systems described herein can also be used in other applications, such as neurology and otolaryngology.

[0068] It should therefore be understood that the embodiments described above are cited by way of example, and that the present application is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present application includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons of skill in the art upon reading the foregoing description and which are not disclosed in the prior art. Documents incorporated by reference in the present patent application are to be considered an integral part of the application except that to the extent any terms are defined in such incorporated documents in a manner inconsistent with the definitions expressly set forth in the present specification, the terms as expressly used in the present specification take precedence.

Claims

1. An apparatus for electroanatomical sensing and ablation, comprising: a shaft configured for insertion through a sheath into a lumen of an organ of a patient; and an inflatable sleeve catheter fixed to a distal end of the shaft, the inflatable sleeve catheter comprising: a resilient inner end segment fixed to the distal end of the shaft and shaped so as to assume a predefined shape when unconstrained, the predefined shape comprising a straight base segment and an arcuate segment; an inflatable sleeve, wherein the inner end segment is enclosed within a circumferential space defined by the inflatable sleeve along the straight base segment and along the arcuate segment; and a plurality of electrodes disposed on the inflatable sleeve and configured to contact tissue.

2. The apparatus of claim 1, wherein, The resilient inner end segment is straight.

3. The apparatus of claim 1, wherein, The inflatable sleeve catheter is flexible.

4. The apparatus of claim 1, wherein, The electrodes have a cylindrical shape.

5. The apparatus of claim 1, wherein, The electrodes have a semi-cylindrical shape.

6. The apparatus of claim 1, wherein, The inflatable sleeve catheter is a lasso catheter, wherein the resilient inner end segment is shaped so as to assume an arcuate shape when unconstrained, and wherein the plurality of electrodes are disposed circumferentially on the inflatable sleeve.

7. The apparatus of claim 6, wherein, The inner end segment is at least partially made of a shape memory alloy having a self-configurable pre-shaped form comprising a straight base segment portion and an arcuate segment portion.

8. The apparatus of claim 7, wherein, The inflatable sleeve encloses the inner end segment along the straight base segment portion and arcuate segment portion of the inner end segment by passing through by the inner end segment.

9. The apparatus of claim 1, wherein, The inner end segment becomes unconstrained upon exiting the sheath.

10. The apparatus of claim 1, wherein, The inflatable sleeve is configured to be inflated using a saline solution.

11. The apparatus of claim 1, wherein, Further comprising a flexible PCB sheet having the plurality of electrodes disposed thereon.

12. The apparatus of claim 11, wherein, The flexible PCB sheet is glued to the inflatable sleeve.

13. A method of manufacturing an inflatable sleeve catheter, the method comprising: fixing a resilient inner end segment to a distal end of a shaft, the resilient inner end segment shaped so as to assume a predefined shape when unconstrained, the predefined shape comprising a straight base segment and an arcuate segment; enclosing the inner end segment within a circumferential space defined by the inflatable sleeve along the straight base segment and along the arcuate segment; and disposing a plurality of electrodes configured to contact tissue on an outer circumference of the inflatable sleeve. The resilient inner end segment is straight. The inflatable sleeve catheter is flexible. The electrodes have a cylindrical shape. The electrodes have a semi-cylindrical shape. The inflatable sleeve catheter is a lasso catheter, wherein the resilient inner end segment is shaped so as to assume an arcuate shape when unconstrained, and wherein the plurality of electrodes are disposed circumferentially on the inflatable sleeve. The inner end segment is at least partially made of a shape memory alloy having a self-configurable pre-shaped form comprising a straight base segment portion and an arcuate segment portion. The inflatable sleeve encloses the inner end segment along the straight base segment portion and arcuate segment portion of the inner end segment by passing through by the inner end segment. The inner end segment becomes unconstrained upon exiting the sheath. The inflatable sleeve is configured to be inflated using a saline solution. Further comprising a flexible PCB sheet having the plurality of electrodes disposed thereon. The flexible PCB sheet is glued to the inflatable sleeve.

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