Devices and methods for generating ablation lesion patterns in blood vessels

Abstract

Devices and methods for cardiac ablation are described herein. In some embodiments, a device can include a catheter having a plurality of splines that generate helicoidal or spiral-shaped ablation lesions. By translating the catheter proximally or distally to an ablation site, multiple helicoidal or spiral-shaped lesions can intersect, forming a cross-hatch pattern of lesions that surround and isolated clusters of non-ablated tissue. The apparatus can further include a basket that is expanded or collapsed using a handle. The handle can pull or push a central shaft coupled to the plurality of splines, which causes a portion of the ablation device to abut an inner wall of the blood vessel. The position of the central shaft can be locked via a knob and grooves mechanism, with each groove being associated with an intensity of an ablation treatment needed to adjust for variations in the diameter of the blood vessel.

Description

Attorney File Ref. SPRL-001 / 02WO 358804-2002DEVICESAND METHODS FOR GENERATING ABLATION LESION PATTERNS IN BLOOD VESSELSCross-Reference To Related Applications

[0001] This application claims priority to and the benefit of Canadian Patent Application No. 3260436, filed on December 22, 2024, and titled “Transcatheter Device For The Treatment Of Vascular Aneurysms And Methods Of Using The Same;” and Canadian Patent Application No. 3270946, filed on April 15, 2025, and titled “Device For The Treatment Of Aneurysms And Methods Of Using The Same,” disclosure of each of which is incorporated by reference herein in their entireties.Technical Field

[0002] The present disclosure relates to devices and methods for assisting physicians in performing surgical procedures on patients, and more specifically, this disclosure describes devices and methods for navigating the vasculature of a patient and generating ablation lesions patterns to treat vascular aneurysms.Background

[0003] Vascular aneurysms are rounded (e.g., bulging) protuberances present in the wall of a blood vessel such as the aorta or a brain artery of a subject and / or patient. Aortic aneurysms increase the risk of aortic dissection, e.g., a tear in an inner layer of the wall of the aorta which can cause massive internal bleeding, resulting in life-threatening conditions for the patient. Common approaches for treating aortic aneurysms in patients include the insertion via a catheter of endovascular stent grafts. Despite their widespread use, the use of endovascular stent grafts is oftentimes limited by the aneurysm’ location, size, or morphology. Therefore, aortic aneurysms, especially those situated in complex or anatomically challenging regions, remains a formidable clinical challenge. In instances in which insertion of endovascular stent grafts is challenging, an alternative approach for treating the aneurysm may include standard surgical open procedures. These procedures are fraught with significant risks and a high rate of complications, particularly for patients with comorbid conditions, which may ultimately render the procedure unsuitable for certain patients. Consequently, there is a need in the fieldAttorney File Ref. SPRL-001 / 02WO 358804-2002 for devices and methods for the treatment of aortic aneurysms that cannot be effectively prevented, managed, and / or treated with conventional endovascular stent grafts or standard surgical open procedures.Summary

[0004] Systems, devices, and methods for navigating the vascular system of a patient to generate ablation lesion patterns to treat vascular aneurysms are described herein. In some embodiments, a method comprises advancing an ablation device disposed in a first configuration into a blood vessel of a patient. The first configuration of the ablation device is characterized by having a first cross-sectional area. With the ablation device located in the blood vessel, the method further comprises transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel. With the ablation device in the second configuration and at a first location within the blood vessel, the method further comprises ablating during a first time period, the inner wall of the blood vessel to create a first set of parallel ablation lesions. The method further comprises axially translating the ablation device from the first location to a second location within the blood vessel; and with the ablation device at the second location, ablating during a second time period after the first time period, the inner wall of the blood vessel, to create a second set of parallel ablation lesions that intersect the first set of parallel ablation lines to form a crosshatch pattern of lesions.

[0005] In some embodiments, a method comprises advancing an ablation device to a first location within a blood vessel of a patient; measuring a first parameter associated with tissue composition at the first location; and ablating, with the ablation device and using a first amount of energy, an inner wall of the blood vessel at the first location based on the first parameter. The method further comprises moving the ablation device to a second location within the blood vessel; measuring a second parameter associated with tissue composition at the second location; and ablating, using a second amount of energy with the ablation device the inner wall of the blood vessel at the second location based on the second parameter. The first parameter being different than the second parameter and the first amount of energy being different than the second amount of energy.

[0006] In some embodiments, a method comprises advancing an ablation device disposed a first configuration into a target vessel of a patient. The first configuration of the ablationAttorney File Ref. SPRL-001 / 02WO 358804-2002 device is characterized by having a first cross-sectional area. The ablation device includes a catheter and a plurality of splines. The catheter defines a longitudinal axis and a shaft lumen therethrough. The plurality of splines are coupled to the catheter. Each spline from the plurality of splines includes electrodes configured to deliver ablation energy. With the ablation device located in the target vessel, the method further comprises transitioning the ablation device from the first configuration to a second configuration such that a portion of the ablation device contacts an inner wall of the target vessel at the first location. The second configuration of the ablation device is characterized by having a second cross-sectional area greater than the first cross-sectional area. With the ablation device in the second configuration and at a first location within the target vessel, the method further comprises ablating the inner wall of the target vessel with a first amount of energy. The first amount of energy is selected based on the ablation device being in the second configuration. The method further comprises axially translating the ablation device from the first location to a second location within the target vessel; and transitioning the ablation device from the second configuration to a third configuration such that a portion of the ablation device contacts the inner wall at the second location. The third configuration of the ablation device is characterized by having a third cross- sectional area greater than the second cross-sectional area. With the ablation device at the second location and disposed in the third configuration, the method further comprises ablating the inner wall of the target vessel with a second amount of energy greater than the first amount of energy. The second amount of energy is selected based on the ablation device being in the third configuration.

[0007] In some embodiments, an apparatus comprises a catheter, a plurality of splines, and a handle. The catheter defines a longitudinal axis and a shaft lumen therethrough. The plurality of splines is coupled to the catheter and extends from a distal end of the shaft lumen. Each spline from the plurality of splines includes electrodes configured to deliver ablation energy. The plurality of splines are configured to transition between a first configuration and a second configuration. The first configuration has a first cross-sectional area and a first distance between splines. The second configuration has a second cross-sectional area and a second distance between splines. The second cross-sectional area is greater than the first cross- sectional area, and the second distance is greater than the first distance. The handle is configured to be actuated to transition the plurality of splines between the first and second configurations. The handle includes a first indicator representative of a first ablation intensity level and corresponding to the plurality of splines being in the first configuration. The handleAttorney File Ref. SPRL-001 / 02WO 358804-2002 also includes a second indicator representative of a second ablation intensity level corresponding to the plurality of splines being in the second configuration. The second ablation intensity level is greater than the first ablation intensity level.

[0008] In some embodiments, an apparatus comprises a catheter, a plurality of splines, and a handle. The catheter defines a longitudinal axis and a shaft lumen therethrough. The plurality of splines is coupled to the catheter and extends from a distal end of the shaft lumen, with each spline from the plurality of splines including electrodes configured to deliver ablation energy. The plurality of splines is configured to transition between a first configuration and a second configuration. The first configuration has a first cross-sectional area and a first distance between splines. The second configuration has a second cross-sectional area and a second distance between splines. The second cross-sectional area is greater than the first cross- sectional area, and the second distance is greater than the first distance. The handle is configured to be actuated to transition the plurality of splines between the first and second configuration. The handle includes one or more sensors configured to send to an ablation generator a signal representative of the plurality of splines being in the first or second configuration

[0009] In some embodiments, a method comprises advancing an ablation device disposed in a first configuration into a blood vessel of a patient. The first configuration is characterized by a first cross sectional area. The method further comprises transitioning the ablation device from the first configuration to a second configuration with the ablation device located in the blood vessel. The second configuration is characterized by a second cross sectional area greater than the first cross sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel. With the ablation device in the second configuration and at a location within the blood vessel, the method further comprises ablating during a first time period the inner wall of the blood vessel to create a first set of parallel ablation lesions. The method further comprises transitioning the ablation device from the second configuration to a third configuration without axially translating the ablation device from the location within the blood vessel. The third configuration is characterized by a third cross sectional area greater than the second cross sectional area. With the ablation device at the location and in the third configuration, the method further comprises ablating, during a second time period after the first time period, the inner wall of the blood vessel to create a second set of parallel ablation lesions that intersect the first set of parallel ablation lines to form a crosshatch pattern of lesions.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0010] In some embodiments, an apparatus comprises a catheter, a shaft and a plurality of splines. The shaft defines a lumen and is slidably disposable relative to the catheter. Each spline from the plurality of splines has a proximal end fixedly coupled to the catheter and a distal end fixedly coupled to the shaft. Each spline includes an electrode configured to deliver ablation energy.

[0011] In some embodiments, a method comprises advancing an ablation device in a first configuration into a blood vessel. The first configuration is characterized by a first cross- sectional area. With the ablation device located in the blood vessel, the method further comprises transitioning the ablation device from the first configuration to a second configuration. The second configuration is characterized by a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel. With the ablation device in the second configuration and at a first location within the blood vessel, the method further comprises ablating during a first time period, the inner wall of the blood vessel to create a first set of parallel ablation lesions. The method further comprises, axially translating the ablation device from the first location to a second location within the blood vessel. With the ablation device at the second location, the method further comprises ablating during a second time period after the first time period, the inner wall of the blood vessel, to create a second set of parallel ablation lesions.

[0012] In some embodiments, a method comprises advancing an ablation device in a contracted configuration into a blood vessel of a patient. With the ablation device located in the blood vessel, the method further comprises transitioning the ablation device from the contracted configuration to an expanded configuration. With the ablation device in the expanded configuration within the blood vessel, the method further comprises ablating smooth muscle cells of the blood vessel.Brief Description Of The Drawings[00131 FIG. 1A shows a schematic illustration of a device for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0014] FIGS. 1B-1C show schematic illustrations of example orientations of splines of an ablation device, according to some embodiments.

[0015] FIG. ID shows a histology image of a cross-section of an untreated blood vessel of a patient.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0016] FIGS. IE- IF show histology images of cross-sections of target blood vessels after generating lesions using an ablation device, according to some embodiments.

[0017] FIG. 1G illustrates proportion of collagen and elastin for various aortic segments, according to an embodiment.

[0018] FIGS. 2A-2E illustrate a device including multiple splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0019] FIG. 3 illustrates a perspective view of a device including four splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0020] FIG. 4 illustrates a perspective view of a device including three splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0021] FIGS. 5A-5B show a schematic illustration of a device including a single spline for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0022] FIG. 5C schematically illustrates a pattern of lesions on a vascular wall of a patient generated with the device shown in FIGS. 5A-5B.

[0023] FIG. 6 shows a schematic illustration of a device including three loop-shaped splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0024] FIG. 7 shows a schematic illustration of a device including an expandable structure for generating cryoablation lesions on a vascular wall of a patient, according to an embodiment.

[0025] FIG. 8 shows a schematic illustration of a device including a collapsable mesh spline for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0026] FIG. 9 shows a schematic illustration of a device including a circular shape spline and an embolic protection element for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0027] FIG. 10 shows a schematic illustration of a device for generating ablation lesions on a vascular wall of a patient operably coupled to an endovascular graft, according to an embodiment.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0028] FIG. 11 shows a schematic illustration of a device including three open-ended splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0029] FIG. 12 shows a schematic illustration of a device including splines of different length for generating ablation lesions on a vascular wall of a patient, according to an embodiment.

[0030] FIG. 13 illustrates a method for generating ablation lesions on a vascular wall of a patient, according to embodiment of the present disclosure

[0031] FIG. 14A-14F show example lesion patterns generated with an ablation device, according an embodiment.

[0032] FIGS. 15A-15C show example lesion patterns generated with an ablation device, according to an embodiment.

[0033] FIGS. 16A-16C show example lesion patterns generated with an ablation device, according to an embodiment.Detailed Description|0034] Disclosed herein are devices and methods for treating aortic aneurysms that cannot be effectively managed with either conventional endovascular stent grafts or standard surgical open procedures. The devices and methods disclosed herein are particularly relevant for the treatment of ascending aortic aneurysms, which can currently only be treated using surgical open techniques due to the proximity of the aneurysm to the carotid and coronary arteries, as well as the aortic valve. The devices disclosed herein can be inserted via small incisions in the body of a subject and / or patient; advanced through the vasculature of the patient to specific locations on the anatomy of the patient which are otherwise inaccessible without the use of a more invasive procedure; and delivering ablation therapy to a target site to treat an aortic aneurysm. The devices may be implanted directly into a target vessel, or alternatively, be guided to the target vessel from another vessel in communication with the target vessel. For example, in some instances the devices disclosed herein can be inserted from the femoral artery or the radial artery of a patient and be guided into the aorta of the patient.

[0035] The devices disclosed herein can include an ablation element or component that induces changes at the cellular level in the wall of a diseased target vessel. For example, inAttorney File Ref. SPRL-001 / 02WO 358804-2002 some embodiments the devices disclosed herein can induce cell death or apoptosis, tissue inflammation, or damage to a specific subset of cells such as myocytes or vascular smooth muscle cells of a diseased target vessel. The vessel wall ablation can potentially lead to scar formation (e.g., tissue scarring), and results in strengthening of the vessel wall without the need for a permanent implant such as a stent graft. In some embodiments, the devices disclosed herein can include an ablation element configured to deliver different types of ablation including radiofrequency ablation, microwave ablation, laser ablation, cryoablation, and / or pulsed field ablation (PF A) which induces and / or generates lesions in tissue of a target vessel. For example, PFA involves the application of brief high direct current (DC) voltages to a target tissue to generate locally high electric fields that disrupt cell membranes by generating pores in the cell membrane. Without wishing to be bound by any particular theory, it is thought that the application of relatively brief and large electric fields generates instabilities in the lipid bilayers in cell membranes, causing the occurrence of a distribution of local gaps or pores in the cell membrane. This electroporation may be irreversible if the applied electric field at the cell membrane is larger than a threshold value such that the pores do not close and remain open, thereby permitting exchange of biomolecular material across the membrane leading to necrosis and / or apoptosis (cell death), while surrounding tissue may heal naturally.

[0036] The devices disclosed herein can be used to treat aneurysmal or pre-aneurysmal vessels. In use, the devices can be configured to assume a first configuration in which a contact assembly of the devices (e.g., a structure containing an ablation element) is contracted to allow the devices to be inserted and navigated through the vasculature of a patient until reaching a target vessel. The devices can then be configured to transition from the first configuration to a second configuration in order to deliver ablation. In the second configuration, the contact assembly of the device can be expanded to make physical contact with tissue of an inner surface of the target vessel and deliver ablation to generate lesions on an inner wall of the target vessel. The device is configured such that the transition from the first configuration to the second configuration exerts minimal pressure upon the vessel wall to reduce and / or limit the risk of arterial dissection. In some embodiments, the contact assembly of the devices disclosed herein can be configured to generate ablation (scar) lines that intersect one another, generating patterns that include areas of unaltered tissue (e.g., islands) surrounded by scar tissue. The generation of these islands of unaltered tissue facilitates containing and / or limiting dissection of the arterial wall. More specifically, in instances where aortic dissection takes place, the scar tissue can limit and / or restrict dissection of the wall vessel to the islands of unaltered tissue.Attorney File Ref. SPRL-001 / 02WO 358804-2002Alternatively, in some embodiments the devices disclosed herein can allow complete circumferential ablation of a vessel length, such that the entirety of the target vessel wall region is ablated.

[0037] In some embodiments, the devices disclosed herein can incorporate multiple ablation elements that can be positioned across a commissure of the aortic valve. In such embodiments, the energy can be delivered from the ventriculo-aortic junction or the aortic annulus to more distal aortic zones. In such embodiments, the multiple ablation elements may be able to mitigate some potential complications resulting from aortic dissection such as aortic perforation into the pericardial space leading to tamponade. Alternatively, in some embodiments aortic perforation may be mitigated using a circular catheter shape position just above, below, or at the level of the aortic annulus to deliver ablation to the aortic annulus.

[0038] In some embodiments, the devices disclosed herein can be actively controlled to reversibly transition between the first and the second configuration disclosed above via a handle operably coupled to the device. In some embodiments, the handle can be configured to deliver a feedback signal (e.g., an electronic feedback signal) to an energy generator or a device controller to modulate an amount of energy to be delivered to the ablation target vessel. For example, in some instances in which the contact assembly is partially expanded, a feedback signal can be sent to a device controller to reduce the energy delivered to the target vessel compared to the energy that is delivered when the contact assembly is fully expanded. The reduction in the amount and / or intensity of energy delivered to the target vessel by the devices disclosed herein stem from the desire in some instances to supply a constant (or substantially constant) voltage per centimeter to the tissue of the target vessel. As the contact assembly of the devices expands, the dimensions of the contact assembly change and thus there is a need or desire to adjust and / or correct the voltage and / or current delivered by the devices. In such instances, the reduction in the energy delivered to the target vessel is proportional to the degree of expansion of the contact assembly. In some embodiments, the handle of the device may include a user interface that can be configured to deliver feedback (e.g., visual, audio, haptic, etc.) to an operator of the device to indicate a measured voltage and / or current of the contact assembly, or a measured diameter of the contact assembly such that the operator of the device can derive and / or determine, based on the measured voltage / current or diameter, a level of energy (e.g., an intensity) that needs to be delivered to the target vessel via the contact assembly.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0039] In some embodiments, the devices disclosed herein can be operably coupled to other device implants. For example, in some embodiments the devices disclosed herein can be coupled and / or connected to a transcatheter aortic valve replacement device or an endovascular graft. In use, the contact assembly of the device can be configured to deliver ablation energy via a portion of the transcatheter aortic valve replacement device or the endovascular graft, or via a combination of the contact assembly and the portion of the transcatheter aortic valve replacement device or the endovascular graft. For example, the device may be operably connected to an endovascular graft and deliver at least partially pulse-field-ablation energy via a nitinol frame of the endovascular graft once it is expanded at the target implant location.

[0040] In some embodiments, the device may incorporate an embolic protection device. In some embodiments, the embolic protection device is a self-expandable nitinol mesh located between the contact assembly and an externalized portion of the device.

[0041] Now referring to the drawings, FIG 1. shows a schematic illustration of a device 100 for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 100 can be used to generate ablation lesions in any suitable vessel or blood vessel of a patient. For example, in some embodiments the device 100 can be used to generate ablation lesions on an aorta of a patient. In some embodiments the device 100 can be used to generate ablation lesions on a peripheral artery, e.g., that may be subject and / or at risk of peripheral artery disease. In some instances, stent restenosis or restenosis after balloon angioplasty may occur because of smooth muscle cell (SMC) hyperplasia. In such instances, the device 100 can be used to generate lesions to ablate SMC, limiting and / or preventing restenosis. In some embodiments, the device 100 can be used to generate ablation lesions on a pulmonary vessel that may be subject to and / or at risk of pulmonary hypertension. In some instances, SMC hyperplasia can drive a reduction in a caliber and / or thickness of small arterioles, which results in higher pulmonary pressure and right heart failure. In such instances, the device 100 can be used to ablate such pulmonary vessels to limit and / or prevent an undesirable increase in pulmonary pressure. In some embodiments, the device 100 can be used to generate ablation lesions on a coronary artery that may be subject and / or at risk of coronary artery disease or that has had or is at risk of having spontaneous artery dissection. In some instances, stent restenosis or restenosis after balloon angioplasty may also occur (just as described above with reference to the treatment of peripheral arteries. In such instances, the device 100 can be used to generate lesions to ablate SMC, limiting and / or preventing restenosis.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0042] The device 100, which can also be referred to herein as the “vascular wall ablation device 100” and / or the “ablation device 100”, includes a handle 110, a catheter 120, a central shaft 130, and a contact assembly 140 including a plurality of electrode(s) 150 disposed on one or more supporting tubes and / or splines 160. In use, the device 100 can be inserted via a small incision in the body of a patient while the contact assembly 140 is disposed in a first configuration. In the first configuration, which can also be referred to as a contracted configuration, a shape of the contact assembly 140 may be characterized by a first cross- sectional area that is smaller than an inner cross-sectional area of a vessel of the patient through which the device 100 is being introduced. Said in other words, in the first and / or contracted configuration, the distances between each spline 160 and a longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A), is smaller than a radius of the inner wall of the vessel of the patient through which the device 100 is introduced. When the device is advanced in the first and / or contracted configuration the contact assembly 140 may assume an elongated shape. Consequently, the device 100 can be advanced through the vasculature of the patient while the contact assembly 140 remains in the first and / or contracted configuration until reaching a target vessel of the patient, such as an aneurysmal or a pre-aneurysmal vessel.

[0043] In some embodiments, the contact assembly 140 may assume an elongated shape while the device 100 is advanced through the vasculature of the patient. When the device 100 is positioned within a target vessel, the handle 110 of the device 100 can be actuated to transition the contact assembly 140 from the first and / or contracted configuration to a second configuration. In the second configuration, which can also be referred to as an expanded configuration, the contact assembly 140 may be characterized by a second cross-sectional area that is greater than the first cross-sectional area. Also in the second configuration, the contact assembly 140 may assume a relatively shortened shape, i.e., less elongated than in the first configuration. Said in other words, in the second and / or expanded configuration, the distances between the splines 160 and a longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1A and 2 A) are greater than the corresponding distances observed between the splines 160 and the longitudinal axis when the contact assembly is in the first configuration. The magnitude and / or size of the second cross-sectional area allows and / or enables at least a portion of the plurality of electrode(s) 150 and the one more splines 160 to physically contact, touch, and / or abut the inner wall of the target vessel.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0044] With the device 100 positioned within the target vessel and the contact assembly 140 disposed in the second and / or expanded configuration, the handle 110 of the device 100 can be further actuated to deliver ablation for a period of time to the inner wall of the target vessel via the one or more electrodes 150. In some embodiments, the device 100 can be configured to deliver any suitable type of ablation, including, for example, thermal ablation, radiofrequency ablation, microwave ablation, chemical ablation, laser ablation, cryoablation, and / or pulsed field ablation (PF A). The delivery of ablation for a period of time can generate ablation lesions on tissue disposed on the inner wall of the target vessel. In some instances, the device 100 can be operated by delivering successive amounts and / or intensities of ablation while the contact assembly 140 is disposed within the target vessel in different positions and / or orientations, thus generating a pattern of lesions on tissue disposed on the inner surface of the wall of the target vessel. For example, in some instances the device 100 can be used to deliver a first amount and / or intensity of ablation energy (e.g., an ablation intensity level) to tissue of the target vessel while the device 100 is disposed in a first position and / or orientation within the target vessel and the contact assembly 140 is disposed in an expanded configuration. The device 100 can then be successively translated and / or rotated to move the contact assembly 140 into different positions and / or orientations within the target vessel. In some instances, the contact assembly 140 can be transitioned from the second and / or expanded configuration to the first and / or contracted configuration prior to translating and / or rotating the device 100 within the target vessel. In other instances, the device 100 can be translated and / or rotated within the target vessel without transitioning the contact assembly 140 from the second configuration to the first configuration. Said in other words, in some instances the device 100 can be translated and / or rotated within the target vessel while the contact assembly 140 remains in the second and / or expanded configuration. In some such instances, the device 100 can be translated such that the contact assembly 140 is dragged across (while in contact with) the vessel wall without actively collapsing the contact assembly 140, in part because the contact assembly may be sufficiently atraumatic. That said, to avoid any challenges with plaque in the vessel, in some instances, the contact assembly 140 may be transitioned (e.g., collapsed) from the second configuration towards the first configuration; in some such instances, the contact assembly 140 may not be transitioned completely to the first configuration, but instead somewhere between the first and second configurations, e.g., just enough to reduce or avoid contact with the vessel wall during translation and / or rotation of the contact assembly 140.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0045] With the device 100 disposed in each one of the different positions and / or orientations within the target vessel, the contact assembly 140 can then be transitioned to new expanded configurations such that at least a portion of the plurality of electrode(s) 150 and the one more supporting tubes and / or splines 160 physically contact, touch, and / or abut the inner wall of the target vessel. The device 100 can be used to deliver ablation in each one of the different positions and / or orientations within the target vessel and generate one or more patterns of ablation lesions on the tissue of the inner wall of the target vessel, as further disclosed herein. In some embodiments, the device 100 can include one or more sensor(s) (not shown in FIG. 1A) that can be used to measure a property and / or a parameter associated with tissue composition of the inner wall of the target vessel. The measured property can be used to determine an amount and / or intensity of ablation energy (e.g., an ablation intensity level) that needs to be delivered to the target tissue. For example, in some embodiments the sensor(s) can be used to measure a property and / or a parameter such as a voltage at the surface of the inner wall of the target vessel, or an impedance of tissue disposed at the inner wall of the target vessel. The measured property can then be used to determine and / or adjust an amount and / or intensity of ablation energy (e.g., an ablation intensity level) required to produce sufficient ablation lesions on the target vessel. Once the device 100 has generated ablation lesions on the tissue of the inner wall of the target vessel, the handle 110 can be actuated to transition the contact assembly 140 from the second and / or expanded configuration to the first and / or contracted configuration. In the first and / or contracted configuration, the device 100 can be moved through the vasculature of the patient to a different target vessel, and / or be removed from the vasculature of the patient.[0046j The handle 100 can be any suitable structure disposed on a proximal end of the device 100 and configured to facilitate an operator to control the device 100 and deliver ablation to a target vessel. In some embodiments, the handle 100 can be an elongate member that has any suitable cross-sectional shape, including, for example, a circle, a square, rectangular, and / or other polygonal cross-sectional shape. In some embodiments, the handle 110 can have a shape, surface features, and / or surface material or finishes that can be configured to increase the ergonomics of the device 100, which can, for example, allow an operator to control the device 100 with one hand (i.e., single-handed use). In some embodiments, the handle 110 can be shaped and / or configured to facilitate achieving a desired positioning and / or orientation of the catheter 120, the central shaft 130, and / or the contact assembly 140 within the vasculature of a patient.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0047] The handle 110 can be operably coupled to the catheter 120, the central shaft 130, and the contact assembly 140. In some embodiments, the handle 110 can include one or more actuators that can be operated to cause the contact assembly 140 to transition between a first and / or contracted configuration and a second and / or expanded configuration to deliver ablation to tissue of a target vessel. In some embodiments, the actuator of the handle can be configured to operate the device 100 such that the contact assembly assumes a first and / or contracted configuration in which the contact assembly 140 and the device 100 can be introduced and navigated through the vasculature of a patient. As disclosed above, in the first and / or contracted configuration, a cross-sectional area of the contact assembly 140 can be smaller than a cross-sectional area of the inner wall of a vessel of a patient such that the device 100 can be advanced through the vessel of the patient until reaching a target region. The actuator of the handle 110 can be configured to transition the contact assembly 140, and thus the supporting tubes and / or splines 160 containing the electrode(s) 150, between the first configuration and a second and / or expanded configuration. In the second and / or expanded configuration, the cross- sectional area of the contact assembly 140 may be greater than the cross-sectional area of the contact assembly 140 assumed in the first and / or contracted configuration, to allow and / or enable at least a portion of the electrode(s) 150 and the splines 160 to physically contact, touch, and / or abut the inner wall of the target vessel. In some instances, the actuator of the handle 110 can be configured to transition the contact assembly between different expanded configurations to adjust to the specific size and / or morphology of the target vessel when the device 100 is moved (e.g., translated, angulated, and / or rotated) within the target vessel. For example, in some embodiments the actuator of the handle 110 can be actuated to transition the contact assembly between the first configuration and a second, third, fourth, fifth, or more configurations, with the second, third, fourth, fifth, or more configurations being characterized by cross-sectional areas of the contact assembly 140 that are larger than the first and / or contracted configuration, allowing contact between the tissue of the inner wall of the target vessel and at least a portion of the electrode(s) 150 and the splines 160 for delivering ablation. Furthermore, in some embodiments the handle 110 can include one or more sensors (not shown in FIG. 1A) configured to generate and / or send signals to an ablation generator operably coupled to the device 100, with the signals being representative of the device 100, or a state or characteristic state of the device, e.g., representative of the contact assembly 140 being disposed in the second, third, fourth, fifth, or other configuration. In some embodiments, the handle 110 can display and / or issue an alert to an operator if the electrodes 150 are adequately contacting the inner wall of a target vessel when the contact assembly 140 is transitioned to anAttorney File Ref. SPRL-001 / 02WO 358804-2002 expanded configuration. In some embodiments, for example, one or more signals generated from one or more of the electrodes 150 can be evaluated to determine adequate contact. In some embodiments, instead of or in addition to using the electrodes 150 for this purpose, additional contact sensor(s) (not shown) can be included in or on the contact assembly 150 to determine adequate contact.

[0048] In some embodiments, the handle 110 can include a knob disposed and / or mounted on a track having multiple grooves (not shown in FIG. 1A). The knob can be actuated (manually) to transition the contact assembly 140 between the first and / or contracted configuration and one or more expanded configurations. In such embodiments, the knob can be mechanically coupled to the central shaft 130. In some embodiments, the central shaft 130 can include a coupler (not shown in FIG. 1A), that can be coupled to the splines 160 (e.g., to the distal end of the splines). In use, the knob can be positioned in a first groove. When the knob is positioned in the first grove, the coupler of the central shaft 130 can cause the splines 160 to be positioned such that the contact assembly 140 assumes the contracted configuration described above. When an operator moves the knob from the first groove to a second groove, the coupler of the central shaft 130 is moved along longitudinal axis defined by the catheter 120 in a proximal direction (e.g., towards the handle 110) causing the splines 160 to move and change their position and / or orientation such that the contact assembly 140 assumes a second and / or expanded configuration. The operator can further move the knob to a third, fourth, or more grove, to cause the coupler of the central shaft 130 to move closer to the handle 110 and cause the splines 160 to transition to a third, fourth, fifth, or more configurations, as described above. In some embodiments, the coupler of the central shaft 130 can be configured to rotate along an axial axis of the central shaft 130 such that the splines 160 may be able to move and assume different orientations. For example, in some embodiments an operator can move a knob of the handle 110 to cause the coupler of the central shaft 130 to rotate clockwise along the axial axis of the central shaft 130. Alternatively, in some embodiments the knob of the handle 110 can cause the coupler of the central shaft 130 to rotate anticlockwise along the axial axis of the central shaft 130. The rotation of the coupler clockwise or anticlockwise can cause the splines 160 to change their orientation since an end portion of each spline 160 is coupled the coupler of the central shaft 130. Consequently, the handle 110 can facilitate moving the splines 160 and changing an orientation of the splines 160 and thus transitioning the contact assembly 140 from a first configuration to a second, third, fourth, or more configurations, as further disclosed herein. In some embodiments, the central shaft 130 can be configured toAttorney File Ref. SPRL-001 / 02WO 358804-2002 rotate with respect to the catheter 120. Said in other words, in some embodiments, the central shaft 130 can be configured to be rotated along an axial axis of the central shaft 130 (while the catheter 120 remains relatively stationary) such that the splines 160, which are coupled to the central shaft 130 may be able to move and assume different orientations. For example, in some embodiments an operator can move a knob of the handle 110 to cause the coupler of the central shaft 130 to rotate clockwise along the axial axis of the central shaft 130. Alternatively, in some embodiments the knob of the handle 110 can cause the coupler of the central shaft 130 to rotate anticlockwise along the axial axis of the central shaft 130.

[0049] In some embodiments, the handle 110 can include multiple indicators that allow an operator determine a characteristic of the contact assembly 140 (e.g., a cross-sectional area, a distance between splines 160, a diameter of the contact area 140, or any other suitable parameter associated with the configuration of the contact assembly 140), depending on the groove on which the knob of the handle 110 is positioned. In that way, the handle 110 of the device 100 can be configured to facilitate sequentially transitioning the contact assembly 140 between multiple configurations starting from a first and / or contracted configuration and various successive expanded configurations, with each expanded configurations having incrementally a large cross-sectional area, diameter, distance between the splines 160 and / or other suitable parameter describing the position and / orientation of the splines 160 of the contact assembly 140. In some embodiments, the handle 110 can include multiple indicators representative of amounts or intensities of energy the operator should select at the ablation generator. For example, a first indicator may correspond to a first energy or intensity setting of the ablation generator, and a second indicator different from the first indicator may correspond to a second energy or intensity setting of the ablation generator that is different from the first second energy or intensity setting. In some embodiments, there is a non-linear relationship between transition of the contact assembly 140 between configurations and change of energy or intensity from the ablation generator.

[0050] The ablation generator (not shown in FIG. 1A) may be any suitable device configured to generate pulse waveforms for delivery energy of a desired amount and / or intensity of ablation energy (e.g., an ablation intensity level) to generate ablation lesions on tissue of a target vessel, such as, for example, an aneurysmal or pre-aneurysmal vessel. In some embodiments, the ablation generator may be a voltage pulse waveform generator configured to deliver a pulse waveform to tissue of a target vessel via the one or more electrode(s) 150. In some embodiments, a processor (not shown in FIG. 1A) can be operablyAttorney File Ref. SPRL-001 / 02WO 358804-2002 coupled to the handle 110 of the device 100 and the ablation generator, and configured to incorporate data received from a memory, an external device such as a cardiac stimulator, a pacing device, or a sensor disposed on the handle 110, to determine parameters (e.g., amplitude, width, duty cycle, energy intensity, etc.) of the pulse waveform to be generated by the ablation generator. For example, as disclosed above, in some embodiments the handle 110 can include one or more sensors (e.g., movement and / or position sensors) that can generate and / or send signals to the ablation generator representative of the contact assembly 140 being disposed in a first, second, third, fourth fifth, or more configuration(s). The signals sent to the ablation generator can be used to estimate (e.g., via the processor) a relative size and / or cross-sectional area of the contact assembly 140, and then automatically determine, based on the relative size and / or cross-sectional area of the contact assembly 140, a suitable amount and / or intensity of ablation energy (e.g., an ablation intensity level) that needs to be delivered to the tissue of the target vessel to generate lesions.[0051 | The processor can be any suitable processing device configured to run and / or execute a set of instructions or code. The processor may be, for example, a general-purpose processor, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and / or the like. The processor may be configured to run and / or execute application processes and / or other modules, processes and / or functions associated with the device 100. The processor may include a variety of component types, e.g., metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like emitter- coupled logic (ECL), polymer technologies (e.g., silicon-conjugated polymer and metal- conjugated polymer-metal structures), mixed analog and digital, and / or the like.[0052| The memory can be and / or include a database, a random access memory (RAM), a memory buffer, a hard drive, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), a read-only memory (ROM), Flash memory, etc. The memory may store instructions to cause the processor to execute modules, processes and / or functions associated with the device 100, such as pulse waveform generation for generating ablation tissue lesions.

[0053] In some embodiments, the handle 110 can include multiple indicators representative of an ablation intensity level (e.g., an ablation energy intensity level) corresponding to a particular configuration of the contact assembly 140. In some embodiments the handle 110 can include a first indicator representative of and / or corresponding to a first ablation energyAttorney File Ref. SPRL-001 / 02WO 358804-2002 intensity level associated with the contact assembly 140, and more specifically, the spline(s) 160 being disposed in a first configuration (e.g., assuming a first cross-sectional area). The handle 110 can also include a second indicator representative of and / or corresponding to a second ablation energy intensity level associated with the contact assembly 140, and more specifically, the spline(s) 160 being disposed in a second configuration (e.g., assuming a second cross-sectional area greater than the first cross-sectional area), with the second ablation energy intensity level being greater than the first ablation energy intensity level. Since in some embodiments the device 100 is configured to deliver ablation to a target vessel by flowing an electric current between electrodes 150 disposed on adjacent splines 160 (as opposed to, in some implementations or other devices, run an electric current on electrodes disposed on the same splines), the distance that separates adjacent splines 160 determines a voltage per centimeter (V / cm) between the splines 160 when the splines 160 are in any particular configuration. In some embodiments, it may be desirable to operate the device 100 such that the electrodes 150 deliver the same voltage per centimeter (V / cm) regardless of the specific configuration that the contact assembly assumes. Therefore, when the contact assembly 140 is transitioned from a first configuration having a first cross-sectional area (and thus a first distance between adjacent splines 160) to a second configuration having a second cross- sectional area (and this a second distance between adjacent splines 160, the second distance being greater than the first distance) the device 100 is configured to send a signal to the ablation generator to increase a voltage between the adjacent splines 160 such that the voltage per centimeter (V / cm) between the adjacent splines 160 is kept constant, substantially constant, and / or within a suitable range or tolerance. In some embodiments, the handle 110 can include multiple indicators which are representative of a diameter of the contact assembly 140 when the contact assembly assume a specific configuration. In use, the indicators can provide information of the diameter (and / or other suitable measurement or suitable characteristic) of the contact assembly 140, such that an operator can input the diameter of the contact assembly 140 into the processor. The processor can receive the diameter data of the contact assembly 140, and determine, in response to receiving the diameter data of the contact assembly 140, a voltage, current, and / or other electrical signal required to deliver to the electrodes 150 to generate the ablation lesions.10054] The catheter 120 can be any suitable structure defining an interior volume, cavity, lumen, shaft, or the like, that can be used to accommodate one or more components of the device 100 including, for example, lead wires that electrically connect the electrode(s) 150 withAttorney File Ref. SPRL-001 / 02WO 358804-2002 the handle 110 and / or with external devices such as a power source and / or an ablation generator. The catheter 120 can be constructed of any suitable material including, for example, metals, metal alloys, polymeric materials, and / or ceramic materials. In some embodiments the catheter 120 can be an elongated structure having a proximal end and a distal end and defining a longitudinal axis from the proximal end to the distal end. The catheter 120 can define one or more interior volumes, cavities, and / or lumens, oriented along the longitudinal axis of the catheter 120 from the proximal end (or proximal end portion) to the distal end (or distal end portion). In some embodiments, the interior volume(s) of the catheter 120 can accommodate lead wires electrically coupled to the electrode(s) 150. In some embodiments, the catheter 120 may be slidably advanced over the central shaft 130 so as to be disposed over the central shaft 130 during use.

[0055] The catheter 120 may have any suitable dimensions. For example, in some embodiments the catheter 120 can be an elongated structure with longitude of at least about 30 cm, at least about 40 cm, at least about 50 cm, at least about 60 cm, at least about 70 cm, at least about 80 cm, at least about 90 cm, at least about 100 cm, at least about 110 cm, at least about 120 cm, at least about 130 cm, at least about 140 cm, or at least about 150 cm, inclusive of all values and ranges therebetween. In some embodiments the catheter 120 can be an elongated structure with longitude of no more than about 150 cm, no more than about 145 cm, no more than about 135 cm, no more than about 125 cm, no more than about 105 cm, no more than about 95 cm, no more than about 85 cm, no more than about 75 cm, no more than about 65 cm, no more than about 55 cm, no more than about 45 cm, or no more than about 40 cm, inclusive of all values and ranges therebetween. In some embodiments, the catheter 120 can be configured to accommodate an irrigation and / or flushing system to prevent ingress of blood inside the shaft defined by the catheter 120. In such embodiments, the catheter 120 may be constructed of a material capable of withstanding power injection pressures or reinforced in order to endure high pressure.

[0056] The central shaft 130 can be any suitable catheter, rod, wire, post, tube, pipe, conduit, and / or the like that defines an interior volume, cavity, and / or lumen. The central shaft 130 can have a cylindrical wall that surrounds the interior volume. In some embodiments, the interior volume defined by the central shaft 130 can be sized and configured to accommodate one or more components of the device 100 such as, for example, a guidewire, an irrigation system, an imaging system, and / or one or more sensors that can be used while the device 100 is navigated through the vasculature of a patient. The central shaft 130 can have any suitableAttorney File Ref. SPRL-001 / 02WO 358804-2002 construction, e.g., stainless-steel, nitinol, and / or composite, etc.) and be slidably disposed within the lumen defined by the catheter 120. The central shaft 130 can be configured to guide and navigate the device 100 through the vasculature of the patient. In some embodiments, a portion of the central shaft 130 may be shaped to aid placement of the device 100 in a lumen of the patient. For example, in some embodiments, the shape of a distal portion of the central shaft 130 may be configured for placement in a lumen of a vessel of a patient to facilitate navigating the device 100 to a target region. The distal portion of the central shaft 130 may include and / or be formed in an atraumatic shape that reduces trauma to tissue (e.g., prevents and / or reduces the possibility of tissue puncture). For example, in some embodiments the distal portion of the central shaft 130 may include a nonlinear shape such as a circle, loop (not shown in FIG. 1 A), ellipsoid, or any other geometric shape. In some embodiments, the central shaft 130 may be configured to be resilient such that the nonlinear shape of the central shaft 130 may conform to a lumen of the catheter 120 when disposed in the catheter 120; and re- form / otherwise regain the nonlinear shape when advanced out of the catheter 120. In other embodiments, the shaft catheter 120 may similarly be configured to be resilient, such as for aiding advancement of the shaft catheter 120 through a sheath (not shown). In some embodiments, the shaped distal portion of the central shaft 130 may be angled relative to the other portions of the central shaft 130 and the shaft catheter 120. In some embodiments, the central shaft 130 can serve as a spline 160 of the device 100. In such embodiments, the central shaft 130 can include a plurality of electrodes 150 configured to deliver ablation for generating lesions on tissue of a target vessel. As disclosed above, in some embodiments the central shaft 130 can include a coupler (not shown in FIG. 1A). In some embodiments, the coupler can be mounted and / or disposed on an exterior surface of the central shaft 130. The coupler can be configured to couple an end portion of each one of the splines 160 (e.g., a distal end portion of the splines 160) such that the coupler can be actuated (via the handle 110) to move the splines 160 and transition the contact assembly 140 between the contracted configuration and one or more expanded configurations, as further disclosed herein. Alternatively, in some embodiments the shaft 130 can be configured to be directly coupled to the splines 160 at one or more points, locations, and / or regions along the length of the central shaft 130. For example, in some embodiments the central shaft 130 can be configured to be directly coupled, at a specific point, location, and / or region along the length of the central shaft 130, to a distal end of each spline 160. In some embodiments, this specific point, location, and / or region can be a distal end portion (e.g., a terminal end) of the shaft 130. In some embodiments, this specific point, location, and / or region can be proximal with respect to the distal end portion (e.g., theAttorney File Ref. SPRL-001 / 02WO 358804-2002 terminal end) of the shaft 130. In some embodiment, the shaft 130 can be configured to be directly coupled to the splines 160 at multiple points, locations, and / or regions along the length of the central shaft 130. For example, in some embodiments a first portion of the splines 160 can be coupled to the central shaft 130 at a first point, location, and / or region along the length of the central shaft 130, and a second portion of the splines 160 can be coupled to the central shaft 130 at a second point, location and / or region different form the first point, location and / or region, as shown, for example, in FIG. 12. In such embodiments, the splines 160 can have different lengths, and may be configured to assume different orientations when the splines 160 are transitioned to an expanded configuration, as further disclosed herein.[0057| In some embodiments, the central shaft 130 can extend beyond the coupler that is used to couple the splines 160, and / or can extend distally beyond the distal ends of the splines 160. Said in other words, in some embodiments the central shaft 130 can include a coupler for coupling the splines 160, with the coupler disposed on a central region of the central shaft 130, at a non-zero distance from a distal end of the central shaft 130. In such embodiments, the device 100 can have a tapered and / or profiled coupler that facilitates navigations through the vasculature of a patient, particularly when tracking the device 100 (or a guidewire disposed within the central shaft 130) in smaller vessels. Furthermore, in such embodiments, the central shaft 130 can be used to inject contrast to perform an angiography to facilitate determining and / or confirming apposition of the splines to the vessel wall. The use of a central shaft 130 that extends beyond the distal end of the splines allows the contrast to diffuse into the entire cross-sectional area of the vessel before reaching the splines 160, facilitating the generation of higher resolution data. FIGS. 2B, 2C, 2D, 3 and 4 shown example devices 200, 400 and 500 in which a central shaft extends beyond a coupler that couples a distal end of the splines.[0058| As disclosed above, in some embodiments, the central shaft 130 can be configured to be rotatably coupled to the catheter 120. In such embodiments, the central shaft 130 can be configured to be rotated along an axial axis of the central shaft 130 while the catheter 120 remains stationary. The rotation of the central shaft 130 can cause the splines 160 which are coupled to the central shaft 130 to move and assume different orientations, as further disclosed herein. In some embodiments, rotating the central shaft 130 along an axial axis of the central shaft 130 can cause the splines 160 to wrap around the central shaft 130 and assume different orientations with respect to the central shaft 130. In such embodiments, an actuator disposed in the handle 110 can be used to rotate the central shaft 130 clockwise or anticlockwise toAttorney File Ref. SPRL-001 / 02WO 358804-2002 change the orientation of the splines 160, facilitating transitioning the contact assembly 140 to transition between a contracted configuration and multiple expanded configurations.

[0059] The contact assembly 140 is a structure formed by the plurality of electrodes 150 and the one or more splines 160. Said in other way, the plurality of electrode(s) 150 and the one or more splines 160 collectively form the contact assembly 140. In some embodiments, the contact assembly 140 can also be referred to as a basket 140. As disclosed above, the contact assembly 140 can be a structure capable of transitioning between a first configuration (also referred to herein as a contracted configuration) and a second configuration (also referred to a herein as an expanded configuration). As disclosed above, in the first configuration, a shape of the contact assembly 140 may be characterized by a first cross-sectional area that is smaller than an inner cross-sectional area of the vessel of the patient though which the device 100 is introduced. Consequently, the device 100 can be advanced through the vasculature of the patient while the contact assembly 140 remains in the first and / or contracted configuration. In the second configuration the contact assembly 140 may be characterized a second cross- sectional area that is greater than the first cross-sectional area. The magnitude and / or size of the second cross-sectional area allows and / or enables at least a portion of the plurality of electrode(s) 150 and the one more supporting tubes and / or splines 160 to physically contact, touch, and / or abut the inner wall of the target vessel, allowing delivery of ablation to generate lesions in tissue of the inner wall of the target vessel.]0060| The plurality of electrode(s) 150 can be a series of metallic bands or rings disposed along the one or more splines 160 and electrically connected together. The plurality of electrode(s) 150 can be used to deliver a voltage and current to deliver ablation energy and generate lesions in tissue of an inner wall of a target vessel, as further disclosed hereon. In some embodiments, a single electrode 150 from the plurality of electrodes 150 can have multiple metallic bands disposed on a spline 160. In some embodiments, an electrode 150 can have a single metallic band disposed on a spline 160. In some embodiments, the electrode(s) 150 may be disposed along the central shaft 130. In such embodiments, device 100 may not include one or more splines 160 and / or a contact assembly 140 configured to transition between a contracted and an expanded configuration. Instead, the central shaft 130 can be made of a shape-memory metal or metal alloy material including, for example, Nickel-Titanium (e.g., Nitinol), Copper-Aluminium-Nickel, Copper-Zinc-Aluminium, Iron - Manganese - Silicon, or the like, capable of expand within a target vessel to facilitate contacting at least a portion of the electrodes 150 with the inner wall of the target vessel, as further disclosed herein. TheAttorney File Ref. SPRL-001 / 02WO 358804-2002 plurality of electrodes 150 can be made of metals such as platinum, or platinum alloys. In some embodiments, each electrode from the electrodes 150 may be connected to an insulated electrical lead (not shown in FIG. 1 A) leading to the handle. The electrical leads can be made of a conductive metal such as copper, silver, nickel, aluminum, or alloys thereof. The insulation on each of the electrical leads may sustain an electrical potential difference across its thickness without dielectric breakdown. For example, in some embodiments, the insulation on each of the electrical leads may sustain an electrical potential difference of between about 200V to about 2500 V across its thickness without dielectric breakdown, including all values and subranges in between.[00611 In some embodiments the device 100 can include any suitable number of electrodes 150 disposed on each spline 160 of the contact assembly 140, as further disclosed herein. For example, in some embodiments each spline 160 can be configured to accommodate at least 1 electrode, at least 2 electrodes, at least 3 electrodes, at least 4 electrodes, at least 5 electrodes, at least 6 electrodes, at least 7 electrodes, at least 8 electrodes, at least 9 electrodes, or at least 10 electrodes. In some embodiments, each spline 160 can include the same number of electrodes 150. Said in other words, in some embodiments the device 100 can include / / number of splines 160, with each spline 160 including m electrodes. For example, FIG. 11 shows a device 1100 which includes three (3) splines 1160, with each spline 1160 including four (4) electrodes 1150. In some embodiments the spline 160 can each have any suitable number of electrodes. In some embodiments, the device 100 can have multiple electrodes 150 disposed on a spline 160 and spaced at a constant and / or fixed distance from each other (e.g., a constant distance separating adjacent electrodes 150). In some embodiments, the device 100 can have multiple electrodes disposed on a spline 160, with the electrodes 150 disposed at different distances from each other (e.g., difference spacings between adjacent electrodes 150).

[0062] In some embodiments, each electrode 150 from the plurality of electrodes 150 can include one electrical lead configured to electrically couple each electrode 150 with the handle 110 and / or with an ablation generator. In some embodiments, an electrical lead disposed within a spline 160 may couple multiple electrodes 150. For example, in some embodiments the contact assembly 140 may include 2 splines 160, with each spline 160 having 6 electrodes 150 disposed thereon. In such embodiments, each spline 160 may include two insulated electrical lead: a first insulated electrical lead coupling 3 of the 6 electrodes 150 disposed on the spline 160, and a second electrical lead coupling the other 3 electrodes 150 disposed on the spline 160.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0063] The one or more splines 160 can be and / or include a plurality of elongated structures that provide an external surface that can be used to couple, mount, attach, and or integrate the plurality of electrode(s) 150, and one or more interior lumens, volumes, passages, and / or cavities, that can accommodate insulated electrical leads that electrically couple and / or connect each electrode 150 to the handle 110 and / or to an ablation generator operably coupled to the device 100. In some embodiments, each spline may include two, three, or more lumens configured to house a wire or lead from the electrodes. In some implementations, there may be one wire per multiple (e.g., 2, 3, 4, or more) electrodes, and each wire may be routed through a separate lumen. For example, a spline with 8 electrodes may define two lumens, with a first lumen housing a first wire coupled to four electrodes, and a second lumen housing a second wire coupled to four other electrodes. In some embodiments, the contact assembly 140 can include at least 1 spline 160, at least 2 splines 160, at least 3 splines 160, at least 4 splines 160, at least 5 splines 160, at least 6 splines 160, at least 8 splines 160, at least 9 splines 160, or at least 10 splines 160. The splines 160 can have any suitable shape and / or form. For example, in some embodiments the splines 180 can be an elongated shape defined by a length and a suitable cross-sectional area, including, for example, a triangular, circular, elliptical, square, pentagonal, hexagonal, or polygonal cross-sectional area. The splines 160 can have any suitable length. For example, in some embodiments the splines 160 can have a single length. In some embodiments, the splines 160 can have different length. For example, in some embodiments a first portion of the splines 160 can have a first length, and a second portion of the splines 160 can have a second length. In some embodiments the splines 160 can have multiple lengths. For example, in some embodiments a first portion of the splines 160 have a first length, a second portion of the splines 160 have a second length, a third portion of the splines have a third length, and so on. In some embodiments, the length of the splines 160 can be at least about 2 mm, at least about 3 mm, at least about 4 mm, at least about 6 mm, at least about 8 mm, at least about 10 mm, at least about 12 mm, at least about 14 mm, at least about 16 mm, at least about 20 mm, at least about 24 mm, at least about 28 mm, at least about 30 mm, at least about 40 mm, at least about 50 mm, at least about 60 mm, at least about 70 mm, at least about 80 mm, inclusive of all ranges, sub-ranges, and values therebetween. In some embodiments, the length of the splines 160 can be no more than about 80 mm, no more than about 70 mm, no more than about 60 mm, no more than about 50 mm, no more than about 40 mm, no mor than about 30 mm, no more than about 20 mm, no more than about 17.5 mm, no more than about 15 mm, no more than about 13.5 mm, no more than about 10 mm, no more than about 9 mm, no more than about 8 mm, no more than about 7 mm, no more than about 6Attorney File Ref. SPRL-001 / 02WO 358804-2002 mm, no more than about 5 mm, no more than about 4 mm, no more than about 3 mm, or no more than about 2 mm, inclusive of all ranges and values therebetween.

[0064] Combinations of the above referenced ranges for the length of the splines 160 are also possible (e.g., a length of at least about 2.0 mm to no more than about 20 mm, or at least about 6 mm to more than about 14 mm).[0065| The splines 160 can be disposed on the device 100 according to specific orientations. For example, in some embodiments the splines 160 can be coupled to and / or partially disposed within a lumen defined by the catheter 120. More specifically, the splines 160 can be coupled to the catheter 120 and disposed extending from a distal end of the catheter 120. In some embodiments, the splines 160 can be disposed according to a rectilinear arrangement, as schematically shown in FIG. IB. In such embodiments, each one of the splines 160 can be an elongated shape with a first end portion 160a disposed adjacent to (or coupled to) the catheter 120, a central portion that extends linearly (e.g., substantially parallel to the central shaft 130) from the first end portion 160a, and a second end portion 160b that can be coupled to the central shaft 130. It is worth noticing that in the rectilinear arrangement, the first end portion 160a and the second end portion 160b of the splines 160 are aligned with respect to a radial axis BB of the central shaft 130, as shown in FIG IB. In some embodiments, the splines 160 can be disposed according to a spiral and / or helical arrangement, as schematically shown in FIG. 1C. In such embodiments, each one of the splines 160 can be an elongated shape with a first end portion 160a disposed adjacent to (or coupled to) the catheter 120 and aligned with a radial axis BB of the central shaft 130. Each spline 160 also include second end portion 160b that can be coupled the central shaft 130. FIG. 1C shows the second end portion 160b is not aligned with the radial axis BB, but instead it is aligned with the radial axis CC. Each spline 160 also includes a central portion that extends around the central shaft 130 from the first end portion 160a to the second end portion 160b describing a helical and / or spiral arrangement defined by an angle a formed between the radial axis aligned with the first end portion 160a (e.g., the radial axis BB) and the radial axis aligned with the second end portion 160b (e.g., the radial axis CC). In some embodiments, the angle a can be at least about 10 degrees, at least about 20 degrees, at least about 40 degrees, at least about 60 degrees, at least about 80 degrees, at least about 100 degrees, at least about 120 degrees, at least about 140 degrees, at least about 160 degrees, at least about 180 degrees, at least about 200 degrees, at least about 220 degrees, at least about 240 degrees, at least about 260 degrees, at least about 280 degrees, or at least about 360 degrees, inclusive of all values and ranges therebetween. InAttorney File Ref. SPRL-001 / 02WO 358804-2002 some embodiments, the angle a can be no more than about 360 degrees, no more than about 330 degrees, no more than about 300 degrees, no more than about 270 degrees, no more than about 240 degrees, no more than about 210 degrees, no more than about 180 degrees, no more than about 150 degrees, no more than about 120 degrees, no more than about 90 degrees, no more than about 60 degrees, no more than about 30 degrees, or no more than about 10 degrees, inclusive of all values and ranges therebetween. In some embodiments, when the splines 160 are transitioned from an elongated and / or contracted configuration to a shortened and / or expanded configuration, a distance d between the first end portion 160a and the second end portion 160b (shown in FIG. 1C) can be decreased. The decrease in the distance t / between the first end portion 160a and the second end portion 160b is accompanied by an increased spacing between the splines 160. Said in other words, when the device 100 is transitioned from a contracted configuration to an expanded configuration the distance d is decreased and a distance between adjacent splines 160 is increased, and thus a cross-sectional area of the contact assembly 140 is also increased. In some embodiments, when the device 100 is disposed in a contracted configuration, the distance d assumes a maximum value and the splines 160 become oriented straight adjacent to the central shaft 130. As the device 100 is transitioned from the contracted configuration to an expanded configuration, the distance d is reduced, and the splines 160 assume an arched orientation in which a spacing between adjacent splines 160 (a distance measured at a reference point along the splines 160 such as a mid-point of each spline 160) is increased. In some embodiments, when the device 100 is transitioned to a most extended configuration, the distance d becomes zero, and the splines 160 assume a flower-like orientation similar to the flower-like orientation shown in FIG. 2C. In some embodiments, the handle 110 can display to an operator the magnitude of the distance d as the operator transitions the contact assembly 140 from the contracted configuration to multiple expanded configurations.

[0066] In some embodiments, the splines 160 can be coupled to the catheter 120 (or the central shaft 130) and extend forming closed loops that extend from a distal end of the shaft lumen defined by the catheter 120 of from a distal end of the catheterl20 (or the central shaft 130). In some embodiments, the splines 160 can be and / or form a mesh (e.g., a network of wires or threads) coupled to the catheter 120 or the central shaft 130 and configured to expand (and shorten) and contract (and elongate) when the contact assembly is transitioned between a contracted configuration and an expanded configuration, as further disclosed herein. In some embodiments the splines 160 can be coupled to the catheter 120 or the central shaft 130 andAttorney File Ref. SPRL-001 / 02WO 358804-2002 extend radially from the central shaft 130 to form a circular shape. In some embodiments, the splines 160 can be coupled to the catheter 120 and extend away from the distal end of the catheter 120 in multiple directions. Said in other words, the splines 160 extended away from a distal end of the shaft lumen defined by the catheter 120 in multiple directions (e.g., following non-parallel directions). In some embodiments, the splines 160 can be coupled to the catheter 120 and extend in a random direction from a distal end of the shaft lumen defined by the catheter 120, or from a distal end of the central shaft 130.

[0067] The distal ends of the splines 160 can be coupled to the central shaft 130 in any suitable manner. In some embodiments, for example, the splines 160 can be coupled directly to the central shaft 130. In some embodiments, for example, the distal ends of the splines 160 can be coupled to the central shaft 130 via a coupler (not shown). The central shaft 130 may terminate at or near, or extend distally beyond, where the distal ends of the splines 160 meet the central shaft 130.

[0068] With a proximal end of the splines 160 coupled to the catheter 120, and the central shaft 130 slidable relative to the catheter 120, and the distal ends of the splines 160 coupled to the central shaft 130, movement of the central shaft 130 relative to the catheter 120 causes the contact assembly 140 to transition between configurations (e.g., expand and elongate, or contract and shorten). The central shaft 130 may extend proximally through the catheter 120, and be manipulated (e.g., axially advanced or pushed, and axially withdrawn or pulled) by an operator relative to the catheter 120, to transition the contact assembly 140 between configurations. Similarly, in some instances, the catheter 120 may be manipulated (e.g., axially advanced or pushed, and axially withdrawn or pulled) by an operator relative to the central shaft 130) to transition the contact assembly 140 between configurations.

[0069] The splines 160 can be made of a flexible material that is able to deform to accommodate small changes in the topography of the vasculature of the patient. For example, in some embodiments, one or more splines 160 can include a first portion and / or segment made of a relatively strong material (e.g., a material having mechanical high strength, hardness, impact resistances and / or fracture toughness) and at least one second portion and / or segment made of a material having relatively weaker mechanical properties with respect to the material in the first portion. The portions and / or sections having weaker mechanical properties can enable deforming the spline 160 to facilitate flexing the spline 160 as needed. As disclosed above, the splines 160 can be actuated with the aid of an actuator of the handle 110 to flex, move, and orient the splines 160 such that the contact assembly 140 transitions between aAttorney File Ref. SPRL-001 / 02WO 358804-2002 contracted configuration and expanded configuration. In the contracted configuration, the splines 160 can be moved, flexed, rotated, translated, or a combination thereof to collapse and / or elongate the splines 160 along a longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A). As disclosed above, when the splines 160 are disposed in the contracted configuration, the contact assembly 140 can be characterized by a cross-sectional area that is smaller than a cross-sectional area of the vessel through which the device 100 is being inserted. In the expanded configuration, the splines 160 can be moved, flexed, rotated, translated, or a combination thereof to inflate, rise, swell and / or spread the contact assembly 140 and cause at least a portion of the electrodes 150 and the splines 160 to become in direct physical contact with the inner wall of a target vessel. In some embodiments, when the contact assembly 140 is disposed in an expanded configuration, the splines 160 can assume different positions and / or orientations with respect to a longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A). For example, in some embodiments, when the contact assembly 140 is disposed in an expanded configuration, the splines 160 can be moved to orient each spline 160 substantially parallel to the axial axis defined by the catheter 120 and at a relatively constant distance from the axial axis defined by the catheter 120. In some embodiments, when the contact assembly 140 is disposed in an expanded configuration, the splines 160 can be moved to orient each spline 160 substantially perpendicular to the longitudinal axis defined by the catheter 120, forming a flower-like structure, as further disclosed herein. As disclosed above, in some embodiments the handle 110 of the device 100 can be configured to facilitate sequentially transitioning the contact assembly 140 between multiple configurations (effectively infinite configurations between maximum expansion and maximum contraction) starting from a first and / or contracted configuration and various successive expanded configurations, with each expanded configurations having incrementally a large cross-sectional area, diameter, distance between the splines 160 and / or other suitable parameter describing the position and / orientation of the splines 160 of the contact assembly 140.[007(>| In some embodiments, the splines 160 can be configured to be moved by rotating the central shaft 130 along the axial axis of the central shaft 130 such that the orientation of the splines 160 is changed. For example, as disclosed above, in some embodiments the splines 160 can be an elongated shape with a first end portion disposed adjacent to (or coupled to) the catheter 120, and a second end portion that can be coupled to the central shaft 130. When the central shaft 130 is rotated (via an actuator included in the handle 110) clockwise orAttorney File Ref. SPRL-001 / 02WO 358804-2002 anticlockwise, the second end portion of the splines 160 (which is coupled to the central shaft 130) is also moved (rotated) along axial axis of the central shaft 130. The rotation of the second end portion of the splines 160 changes the orientation of the splines 160, facilitating transitioning the contact assembly 140 between different configurations (e.g., a contacted configuration and multiple expanded configurations). In some embodiments, the rotation of the central shaft 130 can cause the splines 160 to be moved and become wrapped or partially entangled along the length of the splines along the central shaft 130. These changes in the orientation of the splines 160 may facilitate transitioning the contact assembly 140 between a contracted configuration and multiple expanded configurations.[00711 In some embodiments, the splines 160 can be made from a flexible or spring-like material including polymers such as Polyether Ether Ketone (PEEK), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), or the like. In some embodiments, the splines 160 can be made of and / or include a shape-memory metal or metal alloy materials including, for example, Nickel - Titanium (e.g., Nitinol), Copper - Aluminum - Nickel, Copper-Zinc-Aluminum, Iron - Manganese - Silicon, or the like or the like. The dimensions of spline 160 (e.g., the length and / or diameter) can be selected to impart a specific property to the spline 160, or at least portions thereof, including for example, a resiliency, a flexibility, a stiffness, a foldability, and / or a conformability. In particular, the foldability of materials such as Nitinol facilitates transitioning the contact assembly 140 between the contracted and the expanded configurations, enabling inserting the device 100 into the vascularity of a patient, delivering ablation, and / or removing the device 100 from the body of the patient after completing a procedure.

[0072] In use, the contact assembly 140 of the apparatus 100 can be disposed in a first and / or contracted configuration with the aid of an actuator disposed on the handle 110. As disclosed above, in first and / or contracted configuration a shape of the contact assembly 140 may be characterized by a first cross-sectional area that is smaller than an inner cross-sectional area of a vessel of a patient through which the device 100 is being introduced. In the first and / or contracted configuration, the distances between each spline 160 of the device 100 and a longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A) is smaller than a radius of the inner wall of the vessel of the patient through which the device 100 is being introduced. The device 100 can then be advanced through the vasculature of the patient while the contact assembly 140 remains in the first and / or contracted configuration until reaching a target vessel of the patient, such as an aneurysmal or a preAttorney File Ref. SPRL-001 / 02WO 358804-2002 aneurysmal vessel. Once the device 100 is disposed within a target vessel of the patient, the actuator of the handle 110 can be actuated to transition the contact assembly 140 from the first and / or contracted configuration to a second and / or expanded configuration. In the second and / or expanded configuration the contact assembly 140 may be characterized by a second cross-sectional area that is greater than the first cross-sectional area. Said in other words, in the second and / or expanded configuration, the distances between the splines 160 and the longitudinal axis defined by the catheter 120 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A) are greater than those same distances observed between the splines 160 and the longitudinal axis, when the contact assembly is in the first configuration. The magnitude and / or size of the second cross-sectional area allows and / or enables at least a portion of the plurality of electrode(s) 150 and the one more splines 160 to physically contact, touch, and / or abut the inner wall of the target vessel. With the device 100 positioned within the target vessel and the contact assembly 140 disposed in the second and / or expanded configuration, the handle 110 of the device 100 can be further actuated to deliver ablation for a period of time to the inner wall of the target vessel via the one or more electrodes 150. In some embodiments, a current can be passed from one or more positive electrodes 150 disposed on a first spline 160 to one or more negative electrodes 150 disposed on a second spline 160 adjacent to the first spline 160. For example, in some embodiments the device 100 can include two splines 160: a first spline 160 having 8 electrodes 150 disposed thereon, and a second spline 160 adjacent to the first spline 160 and separated by a distance d (when the contact assembly assumes the second and / or expanded configuration); and having another 8 different electrodes disposed thereon. The 8 electrodes 150 disposed on the first spline 160 can act a positive pole while the 8 electrodes 150 disposed on the second spline 160 can act as a negative pole. In use, an ablation generator operably coupled to the device 100 can pass a current from the positive pole to the negative pole. The current can establish a potential and / or voltage between the 8 electrodes 150 in the first spline 160, and the 8 electrodes 150 in the second spline 160. Since the first spline 160 and the second spline 160 are separated by a distance d when the contact assembly assumes the second and / or expanded configuration, the device 100 will deliver a specific voltage per centimeter to the tissue of the target vessel. In some instances, the electrodes 150 that are disposed adjacent to and in direct physical contact with tissue of the wall of the target vessel will experience more intense lesions than tissue which is not in direct physical contact with the electrodes 150. Said in other words, there is a larger effect of the established voltage for the regions of the vessel wall in direct contact with the splines 160 and a less pronounced effect for regions not in contact with the splines 160.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0073] In some instances, when the device 100 is disposed on a target vessel having a relatively high density (e.g., beyond a predetermined threshold) of smooth muscle cells, the device 100 can be operated at a preferred or predetermined corresponding voltage per centimeter parameter to generate transmural tissue lesions (e.g., lesions that completely penetrate through the thickness of the vessel wall). Alternatively, in other instances, when the device 100 is disposed on a target vessel having a relatively low density of muscle cells, such as in the ascending aorta, elastin can act as a shield and cause lesions produced by the device 100 to not sufficiently penetrate inside the inner wall of the target vessel and instead produce non-transmural lesions.[00741 In some embodiments, the device 100 can include one or more sensors configured to measure a property and / or parameter of the tissue of the inner wall of the target vessel associated with a composition of the tissue, a density of muscle cells, an amount and / or percentage of collagen, an amount and / or percentage of smooth muscle cells (SMC), a wall thickness of the vessel, and / or an amount and / or a percentage of elastin. For example, in some embodiments the device 100 can include one or more sensors and / or alternatively a group of electrodes 150 which can be used to measure an impedance of the tissue which can be correlated with the density of muscle cells, and / or a percentage of elastin present in the tissue. The one or more sensors can send signals indicative of the measured property and / or parameter to the processor. The processor, in response to receiving the signals, can determine and / or adjust an ablation intensity level (a voltage, current, and / or voltage per centimeter) needed to generate transmural (or non-transmural) lesions on the tissue of the target vessel.

[0075] In some embodiments, the device 100 can include and / or be configured to accommodate an imaging modality, such as, for example, intravascular ultrasound (IVUS). In some embodiments, the IVUS can disposed within the central shaft 130 and be navigated through the vasculature of a patient to one or more target vessels. Alternatively, in some embodiments the IVUS can be disposed on a separate catheter and be navigated through the vasculature of a patient to the one or more target vessels. The IVUS can be used to analyze tissue of the target vessel using, for example, speckle-tracking to estimate a strain from the vessel wall. In some embodiments, the IVUS can be used to record anatomic data of the target vessel as a function of the position of the device 100 within the target vessel. The device 100 can send signals to a processor operably coupled to the device 100 to recreate the three- dimensional (3-D) anatomy of the target vessel based on the IVUS data. In some embodiments, the device 100 can include and / or be configured to accommodate an optical coherenceAttorney File Ref. SPRL-001 / 02WO 358804-2002 tomography (OCT) device. In some embodiments, the OCT device can be disposed within the central shaft 130 and be navigated through the vasculature of a patient to one or more target vessels. Alternatively, in some embodiments the OCT can be disposed on a separate catheter and be navigated through the vasculature of a patient to the one or more target vessels. The OCT can be used to analyze tissue of the target vessel. In some embodiments, the OCT can be used to record anatomic data of the target vessel as a function of the position of the device 100 within the target vessel. The device 100 can send signals to a processor operably coupled to the device 100 to recreate the three-dimensional (3-D) anatomy of the target vessel based on the IVUS data. In some embodiments, the device 100 can integrate multiple devices including an IVUS, and OCT, and / or other intra-procedural mapping tools accommodated within the central shaft 130. The multiple devices can be navigated through the vasculature of a patient to generate 3-D maps of the anatomy of the patient. These maps can be used to inform a user the collagen and / or elastin content in the vessel wall as a function of the position or length of the vessel, similar to and / or substantially the same as the map shown in FIG. 1 G.[0076| In some embodiments, ablation energy and / or intensity can be selected and / or adjusted based on the particular anatomical section, segment, or region in which the device 100 is delivering the ablation, since nominal or relative tissue composition, property, and / or parameters may be known. Such anatomical sections or regions can include, for example, the ascending aorta, descending aorta, thoracic aorta, abdominal aorta, infra-renal aorta, and / or the like. FIG. 1G illustrates proportion of collagen and elastin for various aortic segments, for example.

[0077] In some instances, the device 100 can be moved (e.g., translated, rotated, and / or angled) to change, alter and / or modify an orientation of the contact assembly 140 within the target vessel and generate a specific pattern of lesions on the inner wall of the target vessel. For example, in some instances the device 100 can be advanced in a first configuration (e.g., a contracted configuration) through the vasculature of a patient to be positioned within a target vessel. As disclosed above, in the first and / or contracted configuration a shape of the contact assembly 140 may be characterized by a first cross-sectional area that is smaller than an inner cross-sectional area of the vessel or group of vessels of the patient through which the device 100 is being introduced. At the target vessel, the contact assembly 100 of the device 100 can be transitioned (with the aid of the actuator included in the handle 110) from the first configuration to a second configuration (e.g., an expanded configuration) such that at least a portion of the electrodes 150 and the splines 160 are in direct physical contact with the innerAttorney File Ref. SPRL-001 / 02WO 358804-2002 wall of the target vessel. As disclosed above, in the second configuration the contact assembly 140 may be characterized by a second cross-sectional area that is greater than the first cross- sectional area.

[0078] In some instances, a sensor operably coupled to the handle 110 can be configured to sense and / or measure a parameter associated with the second configuration of the contact assembly (e.g., a position, an orientation, a diameter and / or a distance between one or more splines 160), and send a signal to an ablation generator operably coupled to the device 100 representative of the measured parameter of the second configuration of the contact assembly 140. The ablation generator (or a processor operably coupled to the ablation generator and the device 100) can receive the signal, and determine, based on the measured parameter associated with the signal, a voltage, current, and / or voltage per centimeter that needs to be delivered to the inner wall of the target vessel via the electrodes 150 to generate ablation lesions on the target vessel. Alternatively, and / or additionally, in some embodiments the handle 110 can include multiple indicators representative of a parameter of the second configuration of the contact assembly 140 (e.g., a position, an orientation, a diameter and / or a distance between one or more splines 160). The indicators can provide information of the parameter associated with the second configuration of the contact assembly 140 such that an operator can input the parameter of the contact assembly 140 into the processor. The processor can receive the input parameter, and determine, based on the input parameter, an ablation intensity level (a voltage, current, and / or voltage per centimeter) that needs to be delivered to the inner wall of the target vessel via the electrodes 150 to generate ablation lesions on the target vessel when the contact assembly is in the second configuration.

[0079] The electrodes 150 can deliver the ablation intensity level to generate multiple sets of lesions. The lesions on the target vessel can be disposed and / or arranged in any particular arrangement, as determined by the contact points between the tissue and the spines 160 and electrodes 150 of the device 100 in the second configuration. In some embodiments, the device 100 can be used to selectively generate complex patterns of lesions which include islands of unaltered tissue (e.g., non-ablated tissue) surrounded by scar and / or lesion tissue, as further disclosed herein. FIGS. 14-16 show in further detail example lesion patterns that can be generated with the ablation devices disclosed herein.

[0080] In some embodiments, the contact assembly 140 can be moved by rotating, translating, and / or angling, the device 100 to generate a set of lesions (e.g., continuous lesions) that cover an entire circumference (e.g., 360 degrees) of the inner wall of a target vessel. SaidAttorney File Ref. SPRL-001 / 02WO 358804-2002 in other words, in some embodiments the device 100 can be moved in different ways (rotated, translated, angled or a combination thereof) to ensure that for a section of the target vessel all the inner wall of the vessel is exposed to ablation energy to generate lesions without having islands of untreated tissue (e.g., the entire circumference of a portion of the vessel is covered with lesions). For example, in some embodiments the device 100 can be actuated via the handle 110 to transition the contact assembly 140 to an expanded configuration in which the splines 160 are moved to orient each spline 160 substantially perpendicular to a longitudinal axis defined by the catheter 120, forming a flower-like structure similar to and / or the same as the flower-like structure shown in FIG. 2C. When the splines 160 are disposed in this flower-like structure, the device 100 can be rotated while simultaneously delivering ablation energy to ablate an entire circumference of a portion of the vessel covering it with a continuous 360 lesion. Optionally and / or additionally, in some embodiments, the device 100 can also be axially translated a short distance along the length of the vessel while the splines 160 are kept in the flower-like structure to ablate an entire segment of the vessel. In some embodiments, the device 100 can be disposed in an expanded configuration and then used to ablate the inner wall of the vessel to generate a first set of parallel lesions. The device 100 can be rotated a small amount without axially translating the device 100 and then be used to generate a second set of parallel lesions adjacent to the first set of lesions. Further rotations of the device 100 can facilitate generating multiple sets of parallel lesions that collectively create a continuous 360 degrees circumference lesion. In some embodiments, the device 100 can be disposed in an expanded configuration and used to ablate the inner wall of a target vessel. Increasing the amount of ablation energy delivered to the tissue can facilitate generating larger lesions which collectively create a continuous 360 degrees circumference lesion. In some embodiments, the device 100 can include a collapsable mesh spline similar and / or the same as the collapsable mesh spline 840 shown in FIG. 8. In such embodiments, the collapsable mesh spline can be transitioned to an expanded configuration and used to deliver ablation energy to create a continuous 360 degrees circumference lesion. In some embodiments, ablating the entire circumference of the vessel can facilitate enriching the tissue of the walls of the vessel (where the smooth muscle cells are) with collagen in the entire circumference of the vessel wall. Said in other words, in some embodiments, the device 100 can be used to generate continuous lesions disposed around a circumference (e.g., 360 degrees) of the vessel to ablate SMC only and have that region being replaced and / or repopulated with collagen to preserve endothelial cells or have endothelial cells repopulate the inner section of the ablation zone. TheAttorney File Ref. SPRL-001 / 02WO 358804-2002 repopulation of endothelial cells can be desirable effect to prevent formation of thrombus on the inside of the vessel wall.

[0081] In some embodiments, the contact assembly 140 can be moved by rotating, translating, and / or angling with the purpose of generating a wide range of lesion patterns. In some instances the pattern of lesions can include transmural lesions, non-transmural, or a combination thereof. For example, in some instances the device 100 can be moved (e.g., translated, rotated, or angled) to generate a first set of transmural lesions. The device 100 can be moved (e.g., translated, rotated, or angled) once again to generate a second set of non- transmural lesions. As described above, the ablation generator (or a processor operably coupled to the ablation generator and the device 100) can receive signals from one or more sensors configured to measure a property and / or parameter of the tissue of the inner wall of the target vessel associated with a composition of the tissue, a density of muscle cells, an amount and / or percentage of collagen, an amount and / or percentage of SMC, a wall thickness of the vessel, and / or an amount and / or a percentage of elastin. The one or more sensors can send signals indicative of the measured property and / or parameter to the processor. The processor, in response to receiving the signals, can determine and / or adjust an ablation intensity level (a voltage, current, and / or voltage per centimeter) needed to generate the transmural (or non- transmural) lesions on the tissue of the target vessel. In some instances, the one or more sensors can be used to measure multiple properties and / or parameters of the tissue of the inner wall of the target vessel associated with a composition of the tissue, a density of muscle cells, an amount and / or percentage of collagen, an amount and / or percentage of SMC, a wall thickness of the vessel, and / or an amount and / or a percentage of elastin. For example, in some instances the one or more sensors can be used to measure a first parameter associated with tissue composition at a first location on the target vessel (e.g., a first parameter measured when the contact assembly is transitioned to a first expanded configuration). The one or more sensors can then be used to measure a second parameter associated with tissue composition at a second location on the target vessel after the contact assembly has been moved (e.g., rotated, translated, and / or angled) and the contact assembly has assumed a second expanded configuration. In some embodiments, the device 100 can be configured to measure parameters associated with tissue composition at different locations within the vessel to generate a map of the vessel. For example, in some embodiments the one or more sensors can measure a property and / or parameter of the tissue (e.g., collagen, SMS, wall thickness, elastin, and / or the like) at multiple locations within a vessel of a patient as the device 100 is navigated through the vessel of theAttorney File Ref. SPRL-001 / 02WO 358804-2002 patient. The device can send signals associated with each measured property and / or parameter recorded at every position such that a processor can receive the signals and generate a map of the vessel of the patient displaying the distribution of the measured property and / or parameter along the vessel of the patient.[00821 In some embodiments, the vessels treated with the aid of the device 100 can be characterized after the generation of ablation lesions with the purpose of evaluating the extent of the ablation treatment, the type of lesions generated, the content of collagen, and / or any other suitable metric that allows an operator to determine if additional ablation lesions are needed. In some embodiments, the extent, quantity, and / or morphology of the ablation lesions generated with the device 100 can be estimated and / or quantified by Magnetic Resonance Imaging (MRI), and mores specifically using MRI with gadolinium to visualize, via late gadolinium enhancement (LGE), the areas where scar tissue has been formed in the vessel wall. The use of MRI imaging can help confirm the results of the vessel treatment using the device 100, and whether repeated procedures are necessary. In some embodiments, the extent, quantity, and / or morphology of the ablation lesions generated with the device 100 can be estimated and / or quantified by endovascular ultrasound. In some embodiments the device 100 can be used to inject a contrast agent to facilitate imaging the treated vessel. For example, in some embodiments the catheter 120 can accommodate an irrigation system which can be used to direct a contrasting solution to facilitate imaging the target vessel after generating a pattern of lesions using the device 100. In some embodiments, the device 100 can include one or sensors configured to measure an impedance of tissue on the inner wall of the target vessel. In some embodiments, the one or more sensors can include one or more electrodes 150 configured to contact tissue of the inner wall of the vessel and collect and / or measure an impedance. The impedance can then be used to estimate and / or determine whether a scar tissue has been formed, the extent of the lesions created, a content of collagen, and / or any other suitable metric that allows an operator to determine if additional ablation lesions are needed.

[0083] FIG. ID shows a histology image of a cross section of a vessel of a patient (e.g., an untreated vessel) while FIGS. IE and IF show similar images of target vessels of patients after generating lesions using an ablation device similar to and / or the same as the ablation device 100. FIGS. ID, IE and IF show the distribution, relative content, and / or concentration of collagen and smooth muscle cells (SMC) on the cross sections of the untreated and treated vessel (e.g., the vessel receiving the ablation lesions). FIG. ID shows the untreated vessel includes an external and / or outer layer 10 that includes a relatively high content of collagen.Attorney File Ref. SPRL-001 / 02WO 358804-2002This outer layer 10 corresponds to the adventitia (e.g., the outermost layer of fibrous connective tissue that covers and / or surrounds a blood vessel). FIG. ID also shows the adventitia surrounds an interior layer 12 (e.g., a layer disposed inside the outer layer 10) that includes a relatively high content of SMC. This inner layer 12 corresponds to the media and intima layers of the blood vessel.

[0084] FIG. IE shows a schematic representation of a histology image of a cross section of a target vessel of a patient after generating non-transmural lesions using the ablation device 100. As disclosed above, in some instances, when the device 100 is disposed on a target vessel having a relatively low density of muscle cells, such as in the ascending aorta, elastin can act as a shield and cause lesions produced by the device 100 to not sufficiently penetrate inside the inner wall of the target vessel and instead produce the non-transmural lesions. Interestingly, although the current applied through the electrodes 150 travels from a first spline 160 to a second spline 160 different form the first spline 160 (as discussed above), the effect of the ablation energy delivered by the device 100 in some instances is not homogeneous between the splines 160. As shown in FIG. IE, there may be a larger effect around the areas that the splines 160 contact the vessel wall (e.g., regions 10A in FIG. IE) and a lesser pronounced effect in the regions between the splines 160. The formation of regions of higher collagen content (e.g., regions 10A) disposed adjacent to regions of lower collagen content (with respect to the regions 10) can result in a hybrid-type of tissue which preserves some of the desirable properties of the native vessel wall (SMC having some endocrine-paracrine functions and give elasticity to the vessel) with a strengthened crisscross scaffold of more collagenous tissue.

[0085] In some embodiments, the device 100 can be used to kill bacteria in vessel wall infections and / or endovascular material infection. For example, in patients with endovascular aneurysm repair (EVAR) where the endograft becomes infected. In these cases, the bacteria can produce a biofilm which antibiotics are typically not able to kill and / or remove all the bacteria. In such instances, the device 100 can be used to lyse the bacteria locally by generating ablation lesions as disclosed herein. Additionally, for patients having infected aneurysms (i.e., syphilis), or aortitis (i.e., infamously salmonella infections after food poisoning which is associated with significant mortality).

[0086] FIG. IE shows that after delivering ablation energy, the regions of the target vessel that were in direct physical contact with the splines 160 show an increase in the content of collagen in the vessel with even some degree of subendothelial collagen deposition in the sections where the splines 160 were touching the inner wall of the vessel, as shown by theAttorney File Ref. SPRL-001 / 02WO 358804-2002 contact regions 10 A. Further inspection of FIG. IE shows these regions 10A are restricted to the immediate vicinity of the inner surface of the vessel (e.g., within the inner layer 12 which corresponds to the media an intima layers of the blood vessel), confirming the formation of non-transmural lesions. In contrast, FIG. IF shows a schematic representation of a histology image of a cross section of a target vessel of a patient after generating transmural lesions using the ablation device 100. FIG. IF shows treating the target vessel with the device 100, resulted in an overall thickening of the vessel and an increase in the content of collagen in the vessel with even some degree of subendothelial collagen deposition starting in the sections where the splines 160 were touching the inner wall of the vessel, and extending radially towards the external and / or outer layer 10, as highlighted by the regions 10B in FIG. IF.. The results shown by the histology images in FIGS. IE and IF provide experimental evidence that treatment of the inner wall of a vessel and / or artery with the device 100 results in a reduction in the content of SMC and overall strengthening of the vessel.[0087| FIGS. 2A-2E illustrate a device 200 including multiple splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 200 can be structurally and / or functionally similar to the device 100 disclosed above with reference to FIG. 1. The device 200, which can also be referred to herein as the “vascular wall ablation device 200” and / or the “ablation device 200”, includes handle 210, a catheter 220, a central shaft 230, and a contact assembly 240 including a plurality of electrode(s) 250 disposed on one or more splines 260 (e.g., splines 260A, 260B, 260C, and 260D). In some implementations, portions, and / or aspects of the device 200 can be similar to and / or substantially the same as portions and / or aspects of the device 100 described above with reference to FIG. 1. Accordingly, such similar portions and / or aspects may not be described in further detail herein.[0088| FIG. 2 A shows the device 200 includes a handle 210 having an elongated shape that allow an operator to control the device 200 with one hand (i.e., single-handed use). The handle 210 can be sized and configured to accommodate an irrigation and / or flushing system to prevent ingress of blood inside the shaft defined by the catheter 220. The irrigation and / or flushing system can include one or more inlet ports 212 that can be used to flow a fluid within an interior volume of the handle 210 and the shaft lumen defined by the catheter 220. As disclosed above, the use of an irrigation and / or flushing system to prevent ingress of blood inside the shaft defined by the catheter 220, requires that the catheter 220 be made of a reinforced material capable of withstanding the high pressures required to flow the fluid. FIG. 2A shows in some embodiments the handle 210 can include a knob 212 disposed and / orAttorney File Ref. SPRL-001 / 02WO 358804-2002 mounted on a track having multiple grooves (not shown in FIG. 2 A). The knob 212 can be actuated (e.g., manually) to transition the contact assembly 240 between a first and / or contracted configuration and multiple expanded configurations. The knob 212 can be mechanically coupled to the central shaft 230. The central shaft 230 includes a coupler 262 that can be coupled to the splines 160. In use, the knob 212 can be placed in a first groove. When the knob 212 is positioned in the first grove, the coupler 262 of the central shaft 230 can cause the splines 260 to move and become positioned and / or oriented such that contact assembly 240 assumes a first and / or contracted configuration, as shown in FIG.2D. When an operator moves the knob 212 from the first groove to a second groove, the coupler 262 of the central shaft 230 is moved along a longitudinal axis defined by the catheter 220 in a proximal direction (e.g., towards the handle 210) causing the splines 260 to move and change their position and / or orientation such that the contact assembly 240 assumes a second and / or expanded configuration, as shown in FIG.2B. The operator can further move the knob 212 to a third, fourth, or more grove, to cause the coupler 262 of the central shaft 230 to move closer towards the handle 210 and cause the splines 260 to transition to a third, fourth, fifth, or more configurations. FIG. 2C shows the contact assembly 240 disposed in an expanded configuration achieved when the coupler 262 is moved at close proximity with a distal end of the catheter 220 such that the splines 260 form a flower-like structure.[0()89| FIG. 2B illustrates a side view of the device 200 displaying the contact assembly 240 disposed in an expanded configuration. FIG. 2B shows the device 200 includes four (4) splines 260 coupled to the catheter 220 and extending away from a distal end of a shaft lumen defined by the catheter 220 according to a spiral and / or helical arrangement. FIG. 2B shows each spline 260 includes a first end portion disposed adjacent to (or coupled to) the catheter 220 and in close contact with the central shaft 230, a second end portion coupled to the central shaft 230 (via the coupler 262), and a central portion that extends from the first end portion to the second end portion. Furthermore, FIG. 2B shows that for each spline 160 the first end portion of the spline 260 is disposed at a first location relative to the central shaft 230, and the second end portion of the spline 160 is disposed at a second location relative to the central shaft 230 with the first and second locations being related by an offset angle a similar to and / or the same as described above with reference to FIG. 1C. The different locations between the first and second end portion of the splines 260 facilitate the splines 160 to assume different orientations depending on the magnitude of offset angle a. In some embodiments, the splines 260 can assume an orientation in which the splines 260 include a portion or segment disposedAttorney File Ref. SPRL-001 / 02WO 358804-2002 at a maximum radial distance and / or separation from the central shaft 230 (e.g., describing a half wave and / or one loop trajectory). In some embodiments, the splines 160 assume an orientation in which the splines 260 include two or more portions or segments disposed at a local maximum radial distance and / or separation from the central shaft 230 (e.g., describing a wave-like or two loop trajectory). For example, FIG. 2B shows the spline 260B and 260C can assume an orientation in which the splines 260B and 260C each include a portion or segment disposed at a maximum radial distance and / or separation from the central shaft 230 (e.g., describing a half wave and / or one loop trajectory). Similarly, FIG. 2B shows the spline 260A and 260D can assume an orientation in which the splines 260A and 260D each include two portions or segments disposed at a local maximum radial distance and / or separation from the central shaft 230 (e.g., describing a wave-like or two loop trajectory).

[0090] FIG. 2B shows two or more splines 160 can assume an expanded configuration in which the splines 160 are characterized by a radially aligned distance and / or separation from the central shaft 230 and offset from each other by a length along the axial axis of the central shaft 230. For example, as shown in FIG. 2B, the apparatus 200 includes a first spline 260A and a second spline 260B which are characterized by a portion or segment radially aligned a distance and / or separation e from the central shaft 230 and offset by a length L. FIG. 2B also shows each spline 260 comprises eight (8) electrodes 250 mounted and / or disposed on each spline 260. The splines 260 are also distally coupled to a coupler 262 formed in an atraumatic shape that reduces trauma to tissue (e.g., prevents and / or reduces the possibility of tissue puncture). In some embodiments, the coupler 262 can be mechanically coupled to an actuator of the handle 210 to transition the contact assembly between a contracted configuration and an expanded configuration. The actuator of the handle 210 can be used to move the coupler 262 along the longitudinal axis defined by the catheter 220 (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2 A) from a first position close to the proximal end of the device 200 and a second position close to the distal end of the device 200. When the coupler 262 is moved to the first position, the splines 260 are moved such that each spline 260 assumes an orientation substantially perpendicular to the axial axis defined by the catheter 220, forming the flowerlike structure shown in FIG. 2C. FIG 2C shows that when the contact assembly 240 assumes the flower-like structure, the splines 260 can form one or more petals of the flower. That is to say, the splines 260 assume a loop shape, with each loop orientated perpendicular to the axis AA. In the flower-like structure, the contact assembly 240 can be characterized by the largestAttorney File Ref. SPRL-001 / 02WO 358804-2002 possible cross-sectional area (e.g., a cross-sectional area defined by the distance e between the axis AA and the outer end of each petal, as shown in FIG. 2C).

[0091] FIG. 2D illustrates a side view of the device 200 displaying the contact assembly 240 disposed in a contracted configuration. FIG. 2D shows when the coupler 262 is moved to the second position (e.g., a position close to the distal end of the device 200), the splines 260 are moved such that each spline 160 collapses and assumes an orientation substantially parallel to the longitudinal axis defined by the catheter 220, (e.g., an axis similar to the axis AA shown in FIGS. 1 A and 2A) and at very short distance to the longitudinal axis. FIG. 2D illustrates that at the contracted configuration the contact assembly 240 can be characterized by the smallest possible cross-sectional area (e.g., a cross-sectional area defined between the axial axis and the splines 260.

[0092] FIG. 2E illustrates a perspective view of the device 200 displaying the device 200 assuming an expanded configuration within a simulated vessel (e.g., a plastic tubing). FIG 2E shows when the when the coupler 262 is moved to an intermediate position between the first position (e.g., a position close to the distal end of the device 200) and the second position (e.g., a position close to the distal end of the device 200) the splines 260 are moved such that each spline 260 assumes spiral and / or helical arrangement. Furthermore, FIG. 2E shows that in the expanded configuration shown in FIG. 2E, at least a portion of the splines 260 are disposed in direct physical contact with the inner wall of the vessel, as shown schematically in FIG. 2E by the region labeled A.

[0093] FIG. 3 illustrates a perspective view of a device 300 including four (4) splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 300 can be structurally and / or functionally similar to the device 100 and 200 disclosed above with reference to FIGS. 1 A and 2A-2E. The device 300, which can also be referred to herein as the “vascular wall ablation device 300” and / or the “ablation device 300”, includes a catheter 320, a central shaft 330, and a contact assembly 340 including a plurality of electrodes (not shown in FIG. 3) and four (4) splines 360. In some implementations, portions and / or aspects of the device 300 can be similar to and / or substantially the same as portions and / or aspects of the device 100 and 200 described above with reference to FIGS. 1A and 2A-2E. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0094] FIG. 3 shows the contact assembly 340 of the device 300 disposed in an expanded configuration. In the expanded configuration, the contact assembly 340 of the device 300Attorney File Ref. SPRL-001 / 02WO 358804-2002 includes the four (4) splines 360 coupled to the catheter 320 and disposed extending away from a distal end of a shaft lumen defined by the catheter 320 linearly (e.g., substantially parallel to a longitudinal axis defined by the catheter 320). FIG. 3 further shows that the splines 360 are disposed at a 90 degrees angle with respect to adjacent splines 360. Said in other words, the splines 360 form a cross-like shape when the device 100 is displayed from a top view (e.g., a view oriented parallel to the longitudinal axis defined by the catheter 320, or point of view P shown in FIG. 3).

[0095] FIG. 4 illustrates a perspective view of a device 400 including three (3) splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 400 can be structurally and / or functionally similar to the device 100, 200, and 300 disclosed above with reference to FIGS. 1-3. The device 400, which can also be referred to herein as the “vascular wall ablation device 400” and / or the “ablation device 400”, includes a catheter 420, a central shaft 430, and a contact assembly 440 including a plurality of electrodes 450 and three (3) splines 460. In some implementations, portions and / or aspects of the device 400 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, and 300 described above with reference to FIGS. 1-3. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0096] FIG. 4 shows the contact assembly 440 of the device 300 disposed in an expanded configuration. In the expanded configuration, the contact assembly 440 of the device 400 includes the three (3) splines 460 coupled to the catheter 420 and disposed extending away from a distal end of a shaft lumen defined by the catheter 420 linearly (e.g., substantially parallel to a longitudinal axis defined by the catheter 420). FIG. 4 further shows the splines 460 are disposed at a 120 degrees angle with respect to adjacent splines 460.

[0097] FIGS. 5A-5B show a schematic illustration of a device 500 including a single (1) spline for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 500 can be structurally and / or functionally similar to the device 100, 200, 300, and 400 disclosed above with reference to FIGS. 1-4. The device 500, which can also be referred to herein as the “vascular wall ablation device 500” and / or the “ablation device 500”, includes a central shaft 530, and a plurality of electrodes 550 disposed on the central shaft 530. In some implementations, portions and / or aspects of the device 500 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, and 300 described above with reference to FIGS. 1-4. Accordingly, such similar portions and / or aspects may not be described in further detail herein.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0098] FIG. 5A shows the central shaft 530 can be coupled to a catheter and extend according to a spiral and / or helical arrangement. Unlike other devices disclosed herein, the device 500 does not include a contact assembly made of a plurality of electrodes and one or more splines. Instead, the central shaft 530 can include a plurality of electrodes 550 disposed on a helically and / or spirally-shaped portion of the central shaft 530 distal to the device 500. The central shaft 530 can be made of a flexible material that is able to deform to accommodate small changes in the topography of the vasculature of the patient. For example, in some embodiments, the central shaft 530 can include a first portion and / or segment made of a relatively strong material (e.g., a material having mechanical high strength, hardness, impact resistances and / or fracture toughness) and at least one second portion and / or segment made of a material having relatively weaker mechanical properties with respect to the material in the first portion. The portions and / or sections having weaker mechanical properties can enable deforming and / or flexing the central shaft 530 such that the central shaft 530 can be transitioned from a compacted configuration to an expanded configuration. More specifically, the helically and / or spirally-shaped portion of the central shaft 530 can have the flexibility to adjust and expand and / or contract to accommodate its dimensions to the dimensions of the vessel through which the device 500 is being navigated. In some embodiments, the helically and / or spirally- shaped portion of the central shaft 530 can be made from a flexible or spring-like material including polymers such as Polyether Ether Ketone (PEEK), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), or the like. In some embodiments, the helically and / or spirally-shaped portion of the central shaft 530 can be made of and / or include a shape-memory metal or metal alloy materials including, for example, Nickel - Titanium (e.g., Nitinol), Copper - Aluminum - Nickel, Copper-Zinc-Aluminum, Iron - Manganese - Silicon, or the like or the like.

[0099] FIG. 5B shows a schematic illustration of the central shaft 530 while disposed within a target vessel V. FIG. 5B shows that when the central shaft 530 is introduced into the target vessel V, the helically and / or spirally-shaped portion of the central shaft 530 transitions on its own to an expanded configuration such that at least a portion of the electrodes 550 and the central shaft 530 is in direct physical contact with the inner wall of the target vessel V. Said in other words, the central shaft 530 can have a spring-like behavior which allows the helically and / or spirally-shaped portion of the central shaft 530 containing the electrodes 550 to expand or contract, adjusting a cross-sectional area of the helically and / or spirally-shaped portion to the inner area of the vessel V. Consequently, the helically and / or spirally-shaped portion ofAttorney File Ref. SPRL-001 / 02WO 358804-2002 the central shaft 530 can be automatically transitioned from a contracted configuration (when the device 500 is being introduced into the vasculature of a patient) to an expanded configuration (when the device 500 is positioned within a target vessel such as the vessel V shown in FIG. 5B).[01001 FIG. 5C schematically illustrates a set of lesions 550A and 550B produced by the device 500 when the device 500 is used on a target vascular wall V of a patient. The lesions 550A and 550B shown in FIG. 5C collectively from a pattern that includes a plurality of islands 550D surrounded by scar and / or lesion tissue, similar to the plurality of islands 150D described with reference to FIG. ID. In some instances, the pattern of lesions produced by the device 500 can be generated by positioning the device 500 in multiple positions and delivering ablation energy to the tissue of the inner wall of the target vessel V when the device 500 is in each position. For example, in some instances the device 500 can be advanced to a target vessel V with the device 500 disposed in a first configuration (a contracted configuration) in which the device 500 is characterized by a first cross sectional area. With the device 500 positioned within the target vessel V, the helically and / or spirally-shaped portion of the central shaft 530 can be transitioned from the first and / or contracted configuration to a second configuration (e.g., an expanded configuration) in which the device 500 is characterized by a second cross- sectional area greater than the first cross-sectional area. In the second and / or expanded configuration, at least a portion of the helically and / or spirally-shaped portion of the central shaft 530 makes physical contact and / or abuts the inner wall of the target vessel V. The device 500 can then be operated to ablate the inner wall of the target vessel V, delivering a desired amount and / or intensity of ablation energy (e.g., an ablation intensity level) while the device 500 is at a first location and / or position within the target vessel V and in the second configuration. In some instances, the desired amount and / or intensity of ablation energy can be determined based on the location and configuration of the device 500 (e.g., the first location within the target vessel V and in the second configuration). Ablation of tissue of the inner wall of the vessel V produces the first set of lesions 550A.

[0101] The device 500 can then be axially translated from the first location and / or position to a second location and / or position within the target vessel V. In some instances, the axial translation of the device 500 from the first to the second position can be between about 15% to 90% of the average length of the length of the first set of lesions. The device 500 can be transitioned from the second and / or expanded configuration to a third configuration in which the device 500 is characterized by a third cross-sectional area greater than the second crossAttorney File Ref. SPRL-001 / 02WO 358804-2002 sectional area. Alternatively, in some instances the third cross-sectional area can be smaller than the second cross-sectional area. In the third configuration, at least a portion of the helically and / or spirally-shaped portion of the central shaft 530 makes physical contact and / or abuts the inner wall of the target vessel V. The device 500 can then be operated to ablate the inner wall of the target vessel V, delivering a desired amount and / or intensity of ablation energy (e.g., an ablation intensity level) while the device 500 is at the second location within the target vessel V and in the third configuration. In some instances, the desired amount and / or intensity of ablation energy can be determined based on the location and the configuration of the device 500 (e.g., the second location within the target vessel V and in the third configuration). Ablation of tissue of the inner wall of the vessel V produces a second set of lesions 550B. In some embodiments the device 500 can be subsequently moved one, two, three, or more times by axially translating, axially rotating, or angling the device 500 to obtain any suitable pattern of lesions.[0102| FIG. 6 show a schematic illustration of a device 600 including three loop-shaped splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 600 can be structurally and / or functionally similar to the device 100, 200, 300, 400, and 500 disclosed above with reference to FIGS. 1-5. The device 600, which can also be referred to herein as the “vascular wall ablation device 600” and / or the “ablation device 600”, includes a central shaft 630, and a contact assembly 640 including a plurality of electrodes 650, and three (3) loop-shaped splines 660. In some implementations, portions and / or aspects of the device 600 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, and 500 described above with reference to FIGS. 1-5. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0103] FIG. 6 shows the plurality of electrodes 650 is disposed on the three (3) loop-shaped splines 660. FIG. 6 also shows the three (3) loop-shaped splines 660 are located on a distal end of the central shaft 630. Similar to the central shaft 530 disclosed above with reference to FIGS. 5A and 5B, the splines 660 can be made of a flexible material that is able to deform to accommodate small changes in the topography of the vasculature of the patient. For example, in some embodiments, the splines 660 can include a first portion and / or segment made of a relatively strong material (e.g., a material having mechanical high strength, hardness, impact resistances and / or fracture toughness) and at least one second portion and / or segment made of a material having relatively weaker mechanical properties with respect to the material in theAttorney File Ref. SPRL-001 / 02WO 358804-2002 first portion. The portions and / or sections having weaker mechanical properties can enable deforming and / or flexing the splines 660 such that the contact assembly 640 can be transitioned from a compacted configuration to an expanded configuration. More specifically, the splines 660 can have the flexibility to adjust and expand and / or contract to accommodate its dimensions to the dimensions of the vessel through which the device 600 is being navigated. FIG. 6 shows the splines 660 while disposed within a target vessel V. When the splines 660 are introduced into the target vessel V, the splines 660 (and thus the contact assembly 640) transition on their own to an expanded configuration such that at least a portion of the electrodes 650 and the splines 660 are in direct physical contact with the inner wall of the target vessel V. Said in other words, the splines 660 can have a spring-like behavior which allows the splines 660 containing the electrodes 650 to expand or contract, adjusting a cross-sectional area of the contact assembly 640 to the inner area of the vessel V. Consequently, the contact assembly 640 can be automatically transitioned from a contracted configuration (when the device 600 is introduced into the vasculature of a patient) to an expanded configuration (when the device 500 is positioned within a target vessel such as the vessel V shown in FIG. 6). In some embodiments, the splines 660 can be made from a flexible or spring-like material including polymers such as Polyether Ether Ketone (PEEK), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), or the like. In some embodiments, the splines 660 can be made of and / or include a shape-memory metal or metal alloy materials including, for example, Nickel - Titanium (e.g., Nitinol), Copper - Aluminum - Nickel, Copper-Zinc- Aluminum, Iron - Manganese - Silicon, or the like or the like.

[0104] FIG. 7 shows a schematic illustration of a device 700 including an expandable structure 770 for generating cryoablation lesions on a vascular wall of a patient, according to an embodiment. The device 700 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, and 600 disclosed above with reference to FIGS. 1-6. The device 700, which can also be referred to herein as the “vascular wall ablation device 700” and / or the “ablation device 700”, includes a central shaft 730, and an expandable structure 770 for generating cryoablation. In some implementations, portions and / or aspects of the device 700 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, and 600 described above with reference to FIGS. 1-6. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0105] FIG. 7 shows the device 700 can be configured to deliver ablation in the form of cryoablation. FIG. 7 shows the expandable structure 770 can be couped to the central shaftAttorney File Ref. SPRL-001 / 02WO 358804-2002730. Similar to the contact assembly 640 disclosed above with reference to FIG.6, the expandable structure 770 can be configured to transition from a contracted configuration to an expanded configuration on its own, according the relative dimensions of the target vessel V through which the device 700 is being inserted and / or being positioned.[0106| FIG. 8 shows a schematic illustration of a device 800 including a collapsable mesh spline for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 800 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, 600, and 700 disclosed above with reference to FIGS. 1-7. The device 800, which can also be referred to herein as the “vascular wall ablation device 800” and / or the “ablation device 800”, includes a central shaft 830, and a contact assembly 840 including a plurality of electrodes 850, and a collapsable mesh spline 860. In some implementations, portions and / or aspects of the device 800 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, 600, and 700 described above with reference to FIGS. 1-7. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0107] FIG. 8 shows the contact assembly 840 includes a collapsable mesh spline 860 formed from a material made of a flexible material that is able to deform to accommodate small changes in the topography of the vasculature of the patient. For example, in some embodiments, the collapsable mesh 860 can include a plurality of splines connected to produce a reticulated structure that can be transitioned between a contracted and an expanded configuration. In some embodiments portions and segments of the collapsable mesh 860 can be made of a relatively strong material (e.g., a material having mechanical high strength, hardness, impact resistances, and / or fracture toughness) and other portions and / or segments made of a material having relatively weaker mechanical properties with respect to the material in the first portions. The portions and / or sections having weaker mechanical properties can enable deforming and / or flexing the collapsable mesh 860 such that collapsable mesh 860 can be transitioned from a compacted configuration to an expanded configuration. In some embodiments, the collapsable mesh 860 can be made from a flexible or spring-like material including polymers such as Polyether Ether Ketone (PEEK), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), or the like. In some embodiments, the collapsable mesh 860 can be made of and / or include a shape-memory metal or metal alloy materials including, for example, Nickel - Titanium (e.g., Nitinol), Copper - Aluminum - Nickel, Copper-Zinc- Aluminum, Iron - Manganese - Silicon, or the like or the like.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0108] FIG. 9 shows a schematic illustration of a device 900 including a circular shape spline and an embolic protection element for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 900 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, 600, 700, and 800 disclosed above with reference to FIGS. 1-8. The device 900, which can also be referred to herein as the “vascular wall ablation device 900” and / or the “ablation device 900”, includes a catheter 920, a central shaft|0109] 930, an embolic protection element 980, and a plurality of electrodes 950. In some implementations, portions and / or aspects of the device 900 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, 600, 700, and 800 described above with reference to FIGS. 1-8. Accordingly, such similar portions and / or aspects may not be described in further detail herein.

[0110] FIG. 9 shows the central shaft 930 can be coupled to the catheter 920 and extend according to a circular shape arrangement. Unlike other devices disclosed herein, the device 900 does not include a contact assembly made of a plurality of electrodes and one or more splines. Instead, the central shaft 930 can include a plurality of electrodes 950 disposed on a circularly-shaped portion of the central shaft 930 distal to the device 500. The central shaft 930 can be made of a flexible material that is able to deform to accommodate small changes in the topography of the vasculature of the patient. For example, in some embodiments, the central shaft 930 can include a first portion and / or segment made of a relatively strong material (e.g., a material having mechanical high strength, hardness, impact resistances and / or fracture toughness) and at least one second portion and / or segment made of a material having relatively weaker mechanical properties with respect to the material in the first portion. The portions and / or sections having weaker mechanical properties can enable deforming and / or flexing the central shaft 930 such that the central shaft 930 can be transitioned from a compacted configuration to an expanded configuration. More specifically, the circularly-shaped portion of the central shaft 930 can have the flexibility to adjust and expand and / or contract to accommodate its dimensions to the dimensions of the vessel through which the device 900 is being navigated. In some embodiments, the circularly-shaped portion of the central shaft 930 can be made from a flexible or spring-like material including polymers such as Poly ether Ether Ketone (PEEK), Polypropylene (PP), Polystyrene (PS), Polycarbonate (PC), polyethylene terephthalate (PET), or the like. In some embodiments, the circularly-shaped portion of the central shaft 930 can be made of and / or include a shape-memory metal or metal alloy materials including, for example, Nickel - Titanium (e.g., Nitinol), Copper - Aluminium - Nickel,Attorney File Ref. SPRL-001 / 02WO 358804-2002Copper-Zinc-Aluminum, Iron - Manganese - Silicon, or the like or the like. The embolic protection element 980 can be a mesh (e.g., a fine mesh) designed to capture thrombus (e.g., small thrombus) that could form during ablation. In some embodiments, the embolic protection element 980 can be used to catch or aspirate small air bubbles that commonly form when delivering ablation energy such as PF A, preventing the formation of an embolus which could block vessels, such as small capillary vessels.|(M ll] FIG. 10 shows a schematic illustration of a device 1000 for generating ablation lesions on a vascular wall of a patient operably coupled to an endovascular graft, according to an embodiment. The device 1000 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, 600, 700, 800, and 900 disclosed above with reference to FIGS. 1-9. The device 1000, which can also be referred to herein as the “vascular wall ablation device 1000” and / or the “ablation device 1000”, includes a catheter 1020, two (2) splines 1060, and two (2) electrodes 1050. In some implementations, portions and / or aspects of the device 900 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, 600, 700, 800, and 900 described above with reference to FIGS. 1-9. Accordingly, such similar portions and / or aspects may not be described in further detail herein.10112] FIG. 10 shows that the device 1000 can be operably and mechanically coupled to an endovascular graft G. More specifically, the device 1000 can be coupled via a distal end of the splines 1060 to a nitinol frame of the endovascular graft G. FIG 10 shows the electrodes 1050 can be positioned at the junction between the splines 1060 and the nitinol frame of the endovascular graft G. In use, the device 1000 can be navigated through the vasculature of a patient to a target vessel to deliver ablation energy to the target vessel. In some embodiments, the nitinol mesh of the endovascular graft G can be used to deliver the ablation energy to a target vessel such as, for example, an aortic wall.

[0113] FIG. 11 shows a schematic illustration of a device 1100 including three (3) open- ended splines 1160 for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 1100 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, 600, 700, 800, 900, and 1000 disclosed above with reference to FIGS. 1-10. The device 1100, which can also be referred to herein as the “vascular wall ablation device 1100” and / or the “ablation device 1100”, includes a catheter 1120, three (3) splines 1160, and a plurality of electrodes 1150 disposed on each spline 1160. In some implementations, portions and / or aspects of the device 900 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, 600, 700,Attorney File Ref. SPRL-001 / 02WO 358804-2002800, 900, and 1000 described above with reference to FIGS. 1-10. Accordingly, such similar portions and / or aspects may not be described in further detail herein.10114] FIG. 11 shows the device 1100 includes three (3) splines 1160 coupled to the catheter 1120 and extending away from a distal end of the catheter 1120 in multiple directions. Said in other words, splines 1160 extended away from a distal end of the shaft lumen defined by the catheter 1120 in multiple directions (e.g., following non-parallel directions). FIG. 11 shows each spline 1160 can include four (4) electrodes 1150 disposed on a surface of the splines 1160.

[0115] FIG. 12 shows a schematic illustration of a device 1200 including six (6) splines for generating ablation lesions on a vascular wall of a patient, according to an embodiment. The device 1200 can be structurally and / or functionally similar to the device 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, and 1000 disclosed above with reference to FIGS. 1-11. The device 1200, which can also be referred to herein as the “vascular wall ablation device 1200” and / or the “ablation device 1200”, includes a catheter 1220, two (2) splines 1260A, four (4) splines 1260B, and a plurality of electrodes 1250 disposed on the splines 1260A and 1260B. In some implementations, portions and / or aspects of the device 900 can be similar to and / or substantially the same as portions and / or aspects of the device 100. 200, 400, 500, 600, 700, 800, 900, 1000, and 1100 described above with reference to FIGS. 1-11. Accordingly, such similar portions and / or aspects may not be described in further detail herein.]0116| FIG. 12 shows each one of the splines 1260 A can be an elongated shape with a first end portion disposed coupled to a distal end of the catheter 1220, a central portion that extends linearly (e.g., substantially parallel to a central shaft 1230), and a second end portion that can be coupled to a contact point C along the central shaft 1230. In some embodiments, the contact point C can be any suitable point along the length of the central shaft 1230. Unlike the splines 1260A, each one of the splines 1260B can be elongated shape with a first end portion disposed coupled to a distal end of the catheter 1220, a central portion that extends linearly (e.g., substantially parallel to central shaft 1230), and a second end portion that is coupled to the distal end of the central shaft 1230 (e.g., point C’ in FIG. 12). In this way, the device 100 can be characterized by splines 1260 of different lengths. More specifically, in some embodiments the device 1200 can include a first group and / or subset of splines 1260 having a relatively short length (e.g., splines 1260A) and a second group and / or subset of splines 1260 having a relatively longer length (e.g., splines 1260B). In some embodiments, the device 1200 can haveAttorney File Ref. SPRL-001 / 02WO 358804-2002 multiple splines 1260 with each spline 1260 having a different length. FIG. 12 also shows the central shaft 1230 can be sized and configured to accommodate a guidewire 1232.10117] FIG. 13 illustrates a method for generating ablation lesions on a vascular wall of a patient, according to embodiment of the present disclosure. At step 1301, the method 1300 includes advancing an ablation device disposed in a first configuration having a first cross- sectional area into vessel of a patient. In some embodiments, the vessel of the patient can be an aorta. In some embodiments, the vessel of the patient can be an aneurysmal or a pre- aneurysmal vessel. In some embodiments the ablation device can include a handle, a catheter, a central shaft, and a contact assembly that includes a plurality of electrodes disposed on one or more splines. In some embodiments, the ablation device can be substantially similar to and / or the same as the ablation device 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, or 1200, disclosed above with reference to FIGS. 1-11. In some embodiments, the ablation device can be advanced into the vessel of the patient by inserting, via a small incision in the body of the patient, the ablation device while the ablation device is disposed in the first configuration. In some embodiments, when the ablation device is disposed in the first configuration, the contact assembly of the ablation device is characterized by the first cross- sectional area, with the first cross-sectional area being smaller than an inner cross-sectional area of the vessel of the patient through which the ablation device is being introduced and / or advanced. In some embodiments, when the ablation device is disposed in the first configuration, the distances between each spline from the one or more splines and a longitudinal axis defined by the catheter is smaller than a radius of the inner wall of the vessel through which the ablation device is introduced and / or advanced.

[0118] At step 1302, the method 1300 includes transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device abuts an inner wall of the vessel, with the ablation device located in the vessel. In some embodiments, the ablation device can be transitioned from the first configuration to the second configuration with the aid of an actuator included in the handle of the ablation device. The actuator can be operably coupled to the contact assembly, and more specifically to the one or more splines. In some embodiments the actuator can cause the plurality of splines to move and / or change their orientation with respect to the longitudinal axis defined by the catheter. In some embodiments, when the ablation device is disposed in the second configuration, the contact assembly of the ablation device is characterized by the second cross-sectional area, with the second crossAttorney File Ref. SPRL-001 / 02WO 358804-2002 sectional area being greater than the first cross-sectional area. In some embodiments, when the ablation device is disposed in the second configuration, the distances between each spline from the one or more splines and the longitudinal axis defined by the catheter is greater than the corresponding distances (e.g., the distances between the one or more splines and the longitudinal axis) when the ablation device is disposed in the first configuration. In some embodiments, when the contact assembly of the ablation device is disposed in the second configuration, at least a portion of the plurality of electrodes and the splines physically contact, touch, and / or abut the inner wall of the vessel.[0119J In some embodiments, the handle of the ablation device can include one or more sensors configured to send signals to an ablation generator and / or a processor operably coupled to the ablation device, with the signals being representative of the contact assembly being disposed in the second configuration. In some embodiments, the one or more sensors can include movement and / or position sensors. In some embodiments, the signals can be received at the ablation generator and / or the processor and be used to estimate a relative size and / or magnitude of the second cross-sectional area of the contact assembly. In some embodiments, the processor can be any suitable processing device configured to run and / or execute a set of instructions or code. In some embodiments, the processor may be, for example, a general- purpose processor, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and / or the like. In some embodiments, the processor may be configured to run and / or execute application processes and / or other modules, processes and / or functions associated with the ablation device. In some embodiments, the processor may include a variety of component types, e.g., metal-oxide semiconductor field-effect transistor (MOSFET) technologies like complementary metal-oxide semiconductor (CMOS), bipolar technologies like emitter-coupled logic (ECL), polymer technologies (e.g., silicon-conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and / or the like.

[0120] At step 1303 the method 1300 includes ablating at a first time, the inner wall of the vessel to create a first set of parallel ablation lesions, with the ablation device in the second configuration and at a first location within the vessel. In some embodiments, the handle of the ablation device can be actuated to deliver thermal ablation for a period of time to the inner wall of the target vessel via the plurality of electrodes. In some embodiments, the actuator can cause the plurality of electrodes to delivery thermal ablation for a period of time to generate the first set of parallel ablation lesions on tissue disposed on the inner wall of the target vessel. In someAttorney File Ref. SPRL-001 / 02WO 358804-2002 embodiments, the ablation device can be operated to deliver (with the aid of the actuator) successive amounts and / or intensities of thermal ablation while the contact assembly is disposed within the target vessel in the second configuration. The successive amounts and / or intensities of thermal ablation can generate the first set of parallel ablation lesions.[0121 | In some embodiments, the ablation device can include one or more sensors that can be used to measure a property and / or a parameter associated with tissue composition of the inner wall of the target vessel, a density of muscle cells, and / or a percentage of elastin at the first location. In some embodiments, the measured property can be used to determine an amount and / or intensity of thermal ablation energy (e.g., an ablation intensity level) that needs to be delivered to the target tissue at the first location. In some embodiments the sensor(s) can be used to measure a property and / or a parameter such as a voltage at the surface of the inner wall of the target vessel, an impedance of tissue disposed on the inner wall of the target vessel. The measured property can then be used to determine and / or adjust an amount and / or intensity of thermal ablation energy (e.g., an ablation intensity level) required to produce the first set of parallel ablation lesions on the vessel.

[0122] As disclosed above, in some embodiments the handle of the ablation device can include one or more sensors configured to send signals to the ablation generator and / or a processor operably coupled to the ablation device, with the signals being representative of the contact assembly being disposed in the second configuration. In such embodiments, the signals can be received at the ablation generator and / or the processor and be used to estimate a relative size and / or magnitude of the second cross-sectional area of the contact assembly, and determine, based on the relative size and / or magnitude of the second cross-sectional area of the contact assembly, a suitable amount and / or intensity of thermal ablation energy (e.g., an ablation intensity level) that needs to be delivered to the tissue of the vessel to generate the first set of parallel ablation lesions.

[0123] In some embodiments, the handle of the ablation device can include multiple indicators representative of an ablation intensity level (e.g., an ablation energy intensity level) corresponding to a particular configuration of the contact assembly. For example, in some embodiments the handle can include a first indicator representative of a first ablation energy intensity level associated with the contact assembly, and more specifically, the one or more spindles being disposed in the second configuration. In some embodiments, the indicators can provide information of the magnitude of the second cross-sectional area of the contact assembly, such that an operator can input the magnitude of the second cross-sectional area ofAttorney File Ref. SPRL-001 / 02WO 358804-2002 the contact assembly into the processor. The processor can receive the second cross-sectional area data of the contact assembly, and determine, in response to receiving the second cross- sectional area data, a voltage, current, and / or other electrical signal required to deliver to the plurality of electrodes to generate the first set of parallel ablation lesions.[0124| In some embodiments, when the vessel has a high density of smooth muscle cells at the first location, the ablation device can be operated at a preferred voltage per centimeter parameter to generate transmural tissue lesions (e.g., parallel ablation lesions that completely penetrate through the thickness of the vessel wall) at the first location. In some embodiments, when the vessel has a low density of muscle cells, such as in the ascending aorta, elastin can act as a shield and cause lesions produced by the ablation device to not penetrate much inside the inner wall of the vessel and instead produce non-transmural lesions (e.g., parallel ablation lesions) at the first location.

[0125] At step 1304, the method 1300 includes axially translating the ablation device from the first location to a second location within the vessel. In some embodiments, an operator can translate, with the aid of the handle, to position the ablation device at the second location within the vessel. In some embodiments, the ablation device can be axially translated a short distance along the length of the vessel. In some embodiments, the ablation device can be translated a short distance of no more than about 15%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, or 90%, of an average length of the first set of parallel ablation lesions.]0126| At step 1305, the method 1300 includes creating a second set of parallel ablation lesions that intersect the first set of parallel ablation lines to form a crosshatch pattern of lesions, with the ablation device at the second location. In some embodiments, the ablation device can include one or more sensors that can be used to measure a property and / or a parameter associated with tissue composition of the inner wall of the target vessel, a density of muscle cells, and / or a percentage of elastin at the second location. In some embodiments, the measured property can be used to determine an amount and / or intensity of thermal ablation energy (e.g., an ablation intensity level) that needs to be delivered to the target tissue at the second location. In some embodiments the sensor(s) can be used to measure a property and / or a parameter such as a voltage at the surface of the inner wall of the target vessel, an impedance of tissue disposed on the inner wall of the target vessel. The measured property can then be used to determine and / or adjust an amount and / or intensity of thermal ablation energy (e.g., an ablation intensity level) required to produce the second set of parallel ablation lesions on the vessel.Attorney File Ref. SPRL-001 / 02WO 358804-2002

[0127] In some embodiments, when the vessel has a high density of smooth muscle cells, the ablation device can be operated at a preferred voltage per centimeter parameter to generate transmural tissue lesions (e.g., parallel ablation lesions that completely penetrate through the thickness of the vessel wall) at the second location. In some embodiments, when the vessel has a low density of muscle cells, such as in the ascending aorta, elastin can act as a shield and cause lesions produced by the ablation device to not penetrate much inside the inner wall of the vessel and instead produce non-transmural lesions (e.g., parallel ablation lesion) at the second location. In some embodiments, the first set of parallel ablation lesions and the second set of parallel ablation lesions form a crosshatch pattern of lesions.[0128| FIGS. 14A-14F show example lesion patterns that can be generated with an ablation device 1400 similar to and / or substantially the same as the devices 100-1200 described above. FIG. 14A shows a schematic representation of a first set of parallel lesions 1450A generated by a plurality of electrodes after a contact assembly of the device 1400 is transitioned from a first configuration (e.g., a contracted configuration) to a second configuration (e.g., an expanded configuration) within a target vessel of a patient, and then used to ablate (by delivering ablating energy via the plurality of electrodes) the tissue of the inner wall of the target vessel. After generating the first set of parallel lesions 1450A, the device 1400 can be moved, for example by rotating the device 1400 about a longitudinal axis (e.g., an axis similar to and / or the same as the axis AA shown in FIGS. 1 A and 2A) an angle smaller than about 360 degrees. After rotating the device 1400, the contact assembly may be transitioned from the second configuration to a third configuration such that at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel. In the third configuration new contact points between the tissue and the spines and electrodes are generated (different from the contact points generated in the second configuration of the contact assembly). The new contact points between the tissue and the spines and the electrodes (in the third configuration) allow ablating the target vessel and generating a second set of parallel lesions 1450B that are also parallel to the first set of lesions 1450A, as shown in FIG. 14B.]0129] In some embodiments, the device 1400 can then be axially translated (e.g., a short distance) along the length of the target vessel. In some embodiments, the device 1400 can be axially translated a short distance of no more than about 15%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, or 90%, of the length of the first set of parallel lesions 1450A and / or 150B. After axially translating the device 1400, the contact assembly may be transitioned from the third configuration to a fourth configuration such that at least a portion of the electrodesAttorney File Ref. SPRL-001 / 02WO 358804-2002 and the splines are in direct physical contact with tissue of the inner wall of the target vessel. In the fourth configuration new contact points between the tissue and the spines and electrodes are generated (different from the contact points generated in the second and the third configuration of the contact assembly described above). The new contact points between the tissue and the spines and the electrodes (in the fourth configuration) allow ablating the target vessel and generating a third set of parallel lesions 1450C, shown in FIG. 14C. The parallel lesions 1450A, 1450B, and 1450C collectively form and / or define a crosshatch pattern of lesions comprising a plurality of islands 1450D of unaltered tissue surrounded by scar and / or lesion tissue, as shown in FIG. 14C. The scar and / or lesion tissue surrounding the islands 1450D can isolate each island 1450D such that if dissection of the target vessel occurs within one of the islands 1450D that island 1450D remains isolated from all the other islands 1450D from the plurality of islands 1450D.

[0130] In some embodiments, the target vessel can be further treated to generate a more complex pattern of lesions. For example, FIG. 14D shows a set of parallel lesions 1450E generated after producing the set of lesions 1450C shown in FIG. 14C. The set of parallel lesions 1450E can be generated after rotating the device 1400 (a second time) along the longitudinal axis (e.g., the axis AA shown in FIGS. 1 A and 2A) an angle smaller than about 360 degrees. After rotating the device 1400, the contact assembly can be transitioned from the fourth configuration to a fifth configuration such that at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel. In the fifth configuration new contact points between the tissue and the spines and the electrodes are generated. The new contact points between the tissue and the spines and the electrodes (in the fifth configuration) allow generating the set of parallel lesions 1450E, which are also parallel to the set of lesions 1450C. In some embodiments, the target vessel can be further treated by axially translating the device 1400 a short distance along the length of the target vessel, transitioning the contact assembly from the fifth configuration to a sixth configuration, and then ablating the tissue of the target vessel to generate the set of parallel lesions 1450F shown in FIG. 14E. As disclosed above, in some embodiments, the device 1400 can be axially translated a short distance of no more than about 15%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, or 90%, of the length of the first set of lesions 1450A. In some embodiments, a further rotation of the device 1400 along the longitudinal axis can facilitate generating the set of parallel lesions 1450G shown in FIG. 14F. The lesions 1450A, 1450B, 1450C, 1450E, 1450F, and 1450G collectively form and / or define a crosshatch pattern of lesions comprisingAttorney File Ref. SPRL-001 / 02WO 358804-2002 a plurality of islands 1450D of unaltered tissue surrounded by scar and / or lesion tissue, as shown in FIG. 14C and 14F. The scar and / or lesion tissue surrounding the islands 1450D can isolate each island 1450D such that if dissection of the target vessel occurs within one of the islands 1450D that island 1450D remains isolated from all the other islands 1450D from the plurality of islands 1450D.

[0131] FIGS. 15A-15C show example lesion patterns that can be generated with an ablation device 1500 similar to and / or substantially the same as the devices 100-1200 and 1400 described above. FIG. 15A shows a schematic representation of a first set of parallel lesions 1550A and a second set of parallel lesions 1550B generated by a plurality of electrodes after a contact assembly of the device 1500 is used to ablate a target vessel of a patient similar to and / or substantially the same as described above with reference to the set of parallel lesions 1450A and 1450B in FIG. 14A. After generating the set of parallel lesions 1550A and 1550B, the device 1500 can be axially translated (e.g., a short distance) along the length of the target vessel. In some embodiments, the device 1500 can be axially translated a short distance of no more than about 15%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, or 90%, of the length of the set of lesions 1550A and / or 1550B. After axially translating the device 1500, the contact assembly can be transitioned to a first expanded configuration such that at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel. In this expanded first configuration, new contact points between the tissue and the spines and electrodes are generated. The new contact points between the tissue and the spines and the electrodes allow generating (via ablation) the set of parallel lesions 1550C shown in FIG. 15 A. It is worth noting that the axial translation of the device 1500 along the length of the target vessel was deliberately set to a very short distance to ensure that each lesion from the generated set of parallel lesions 1550C intersect a lesion from the set of parallel lesions 1550A, as shown in FIG. 15 A. The intersection of the lesions 1550A and 1550C collectively form and / or define a crosshatch pattern of lesions comprising a plurality of islands 1550D of unaltered tissue surrounded by scar and / or lesion tissue, as shown in FIG. 15 A. As disclosed above, the scar and / or lesion tissue surrounding the islands 1550D can isolate each island 1550D such that if dissection of the target vessel occurs within one of the islands 1550D that island 1550D remains isolated from all the other islands 1550D from the plurality of islands 1550D.

[0132] In some embodiments, the device 1500 can be further moved by rotating the device 1500 along a longitudinal axis (e.g., an axis similar to and / or the same as the axis AA shownAttorney File Ref. SPRL-001 / 02WO 358804-2002 in FIGS. 1 A and 2A) an angle smaller than about 360 degrees. After rotating the device 1500, the contact assembly may be transitioned from the first configuration to second configuration such that at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel. In the second configuration new contact points between the tissue and the spines and electrodes are generated (different from the contact points generated in the first configuration of the contact assembly). The new contact points between the tissue and the spines and the electrodes (in the second configuration) allow generating a set of parallel lesions 1550E that are also parallel to the set of parallel lesions 1550C, as shown in FIG. 15B.[0133 | In some embodiments, the target vessel can be further treated to generate a more complex pattern of lesions. For example, FIG. 15C shows a set of parallel lesions 1550F and 1550G generated after producing the set of parallel lesions 1550A, 1550B, 1550C, and 1550E. The set of parallel lesions 1550F can be generated by axially translating the device 1500 along the length of the target vessel for a short distance, transitioning the contact assembly to an expanded configuration in which at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel, and then ablating the tissue of the inner wall of the target vessel. The set of parallel lesions 1550G can then be generated by rotating the device 1500 along the longitudinal axis (e.g., the axis AA shown in FIGS. 1A and 2 A) by an angle smaller than about 360 degrees, transitioning the contact assembly into a new expanded configuration in which at least a portion of the electrodes and the splines are in direct physical contact with tissue of the inner wall of the target vessel, and then ablating the tissue of the inner wall of the target vessel one more time. The set of parallel lesions 1550A, 1550B, 1550C, 1550E, 1550F and 1550G collectively form and / or define a more complex crosshatch pattern of lesions comprising a plurality of islands 1550D of unaltered tissue surrounded by scar and / or lesion tissue. FIG. 15C shows the crosshatch pattern of lesions includes a large population of small islands 1550D. As disclosed above, the scar and / or lesion tissue surrounding the islands 1550D can isolate each island 1550D such that if dissection of the target vessel occurs within one of the islands 1550D that island 1550D remains isolated from all the other islands 1550D from the plurality of islands 1550D.

[0134] FIGS. 16A- 16C show example lesion patterns that can be generated with an ablation device 1600 similar to and / or substantially the same as the devices 100-1200, 1400 and 1500 described above. FIG. 16A shows a schematic representation of a first set of parallel lesions 1650A generated with the device 1600 by ablating tissue of the inner wall of a target vesselAttorney File Ref. SPRL-001 / 02WO 358804-2002 while the contact assembly of the device 1600 is kept in an expanded configuration. FIG. 16A also shows a second set of parallel lesions 1650B generated after the first set of parallel lesions 1650A by axially translating the device 1600 along the length of the target vessel a specific and / or predetermined distance, transitioning the contact assembly of the device 1600 to a new expanded configuration, and then ablating tissue of the inner wall of the target vessel. The specific and / or predetermined distance is selected such that the second set of parallel lesions 1650B start at the end points 1650a of each lesion 1650A, as shown in FIG. 16A. In this way, the device 1600 can be used to generate a long set of parallel lesions formed by small consecutive lesions aligned along the length of the target vessel.[0135| In some embodiments, the target vessel can be further treated to generate a more complex pattern of lesions. For example, FIG. 16B shows the device 1600 can be moved by tilting and / or displacing angularly the contact assembly of the device 1600 with respect to the axial axis of the target vessel, transitioned the contact assembly into expanded configuration, and then ablating tissue of the inner wall of the target vessel, forming the set of parallel lesions 1650C. In some embodiments, the device 1600 can be further axially translated a short distance along the length of the target vessel while keeping the contact assembly at the same tilting angle with respect to the axial axis of the target vessel, transitioning the contact assembly into an expanded configuration, and then ablating tissue of the inner wall of the target vessel, forming the set of parallel lesions 1650E. The set of parallel lesions 1650A, 1650B, 1650C, and 1650E, collectively form and / or define a complex crosshatch pattern of lesions comprising a plurality of islands 1650D of unaltered tissue surrounded by scar and / or lesion tissue, as shown in FIG. 16C. As disclosed above, the scar and / or lesion tissue surrounding the islands 1650D can isolate each island 1650D such that if dissection of the target vessel occurs within one of the islands 1650D that island 1650D remains isolated from all the other islands 1650D from the plurality of islands 1650D.|(>136] In some embodiments, the ablation devices disclosed herein can be configured to generate lesions that do not include parallel sets and / or that do not intersect. That is to say, in some embodiments, the ablation devices disclosed herein can generate complex patterns of lesions in which each individual lesion may not necessarily be parallel to other lesions in the set of lesions, and / or may not necessarily intersect other lesions. For example, in some embodiments an ablation device similar to and / or substantially the same as the ablation device 500 can be used to generate multiple non-parallel and / or non-intersecting lesions by movingAttorney File Ref. SPRL-001 / 02WO 358804-2002 the central shaft 530 (rotating, translating and / or tilting), and ablating tissue of the inner wall of a target vessel.10137] In some embodiments, a target vessel of a patient can be treated to generate ablation lesions using multiple devices similar to and / or the same as the ablation devices disclosed herein. For example, in some embodiments a first device can be navigated through the vasculature of a patient to a target vessel. The first device can be transitioned from a contracted configuration to an expanded configuration and then used to ablate an inner wall of the target vessel. The first device can include a plurality of splines that deliver ablation energy and generate a first set of lesions (e.g., parallel). The splines of the first device can be oriented according to a helical orientation in a first direction, similar to and / or the same as the splines show in FIG. 1C. After generating the first set of lesions, the first device can be removed from vasculature of the patient. A second device different from the first device can then be navigated through the vasculature of the patient to the target vessel. The second can be transitioned from a contracted configuration to an expanded configuration and then used to ablate the inner wall of the target vessel at the same location (or general vicinity) as the first device. The second device can include a plurality of splines that deliver ablation energy and generate a second set of lesions (e.g., parallel lesions). The splines of the second device can be oriented according to a helical orientation in a second direction different from and / or opposite the first direction such that each lesion (or a portion of lesions) from the first set of lesions intersects a lesion from the second set of lesions. Said in other words, the first and second device can include splines disposed in different and / or opposite orientations such that the splines generate ablation lesions that intersect forming a crisscross pattern.

[0138] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those of skill in the art.10139] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the function and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / orAttorney File Ref. SPRL-001 / 02WO 358804-2002 configurations will depend upon the specific application or applications for which the inventive teachings is / are used. Those skilled in the art will recognize many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.[0140J All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0141] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” Any ranges cited herein are inclusive.

[0142] The terms “substantially,” “approximately,” and “about” used throughout this Specification and the claims generally mean plus or minus 10% of the value stated, e.g., about 100 would include 90 to 110.

[0143] The phrase “and / or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and / or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and / or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and / or B”, when used in conjunction with open-ended language such as “comprising” may refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.

[0144] As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items inAttorney File Ref. SPRL-001 / 02WO 358804-2002 a list, “or” or “and / or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of’ or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e., “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.[01451 In the claims, as well as in the specification above, all transitional phrases such as“comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of’ and “consisting essentially of’ shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0146] As used herein, the term “about” and “approximately” generally mean plus or minus 10% of the value slated, e.g., about 250 pm would include 225 pm to 275 pm, about 1,000 pm would include 900 pm to 1,100 pm. As used herein in the specification and in the claims, the term “aspect ratio” can be defined as a ratio of an in-plane lateral dimension to the thickness of the final product.

[0147] The claims should not be read as limited to the described order or elements unless stated to that effect. It should be understood that various changes in form and detail may be made by one of ordinary skill in the art without departing from the spirit and scope of the appended claims. All embodiments that come within the spirit and scope of the following claims and equivalents thereto are claimed.

Claims

Attorney File Ref. SPRL-001 / 02WO 358804-2002CLAIMS1. A method, comprising: advancing an ablation device in a first configuration into a blood vessel of a patient, the ablation device in the first configuration having a first cross-sectional area; with the ablation device located in the blood vessel, transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel; with the ablation device in the second configuration and at a first location within the blood vessel, ablating during a first time period, the inner wall of the blood vessel to create a first set of parallel ablation lesions; axially translating the ablation device from the first location to a second location within the blood vessel; and with the ablation device at the second location, ablating during a second time period after the first time period, the inner wall of the blood vessel, to create a second set of parallel ablation lesions that intersect the first set of parallel ablation lines to form a crosshatch pattern of lesions.

2. The method of claim 1, wherein the blood vessel is an aorta and the first set of lesions and the second set of lesions are transmural lesions.

3. The method of claim 1 or 2, wherein the crosshatch pattern is formed without rotating the ablation device between the first time period and the second time period.

4. The method of any one of claims 1-3, wherein the ablation device includes: a catheter defining a longitudinal axis and a shaft lumen therethrough; and a plurality of splines coupled to the catheter, each spline from the plurality of splines including electrodes configured to deliver ablation energy.

5. The method of any one of claims 1-4, wherein the ablating during the first time period and during the second time period includes pulse-field ablation.Attorney File Ref. SPRL-001 / 02WO 358804-20026. The method of any one of the claims 1-5, wherein the ablation device includes a plurality of splines, each spline from the plurality of splines including electrodes configured to deliver ablation energy, and wherein the ablating during the first time period and during the second time period includes ablating across a spline from the plurality of splines.

7. The method of any one of claims 1-6, wherein the crosshatch pattern of lesions define a plurality of islands of unaltered tissue surrounded by scar tissue such that dissection of the blood vessel within a first island of the plurality is isolated from remaining islands from the plurality of islands.

8. The method of any one of claims 1-7, wherein at least one of the first location or the second location within the blood vessel includes an aneurysm.

9. The method of any one of claims 1-8, further comprising: before the axially translating and with the ablation device at the first location, rotating the ablation device without axially translating the ablation device; and ablating the inner wall of the blood vessel to create a third set of parallel ablation lesions that are axially aligned with and circumferentially offset with the first set of parallel ablation lesions.

10. The method of claim 9, further comprising: after the ablating during the second time period, and with the ablation device at the second location, rotating the ablation device without axially translating the ablation device to dispose the ablation device at a third location; and with the ablation device at the third location, ablating the inner wall of the blood vessel to create a fourth set of parallel ablation lesions that are axially aligned with and circumferentially offset with the second set of parallel ablation lesions.

11. The method of any one of claims 1-10, wherein the axially translating is limited to no more than about 50% a length of the first set of parallel ablation lesions.

12. The method of any one of claims 1-11, wherein the crosshatch pattern of lesions define a plurality of islands of unaltered tissue surrounded by scar tissue such that dissectionAttorney File Ref. SPRL-001 / 02WO 358804-2002 of the blood vessel within a first island of the plurality is isolated from remaining islands from the plurality of islands, the method further comprising: ablating continuously along a 360 degree circumference of the blood vessel to limit repopulation of endothelial cells between the plurality of islands.

13. The method of any one of claims 1-12, wherein the ablating continuously includes causing a layer of thrombus to form between the plurality of islands.

14. The method of any one of claims 1-13, further comprising: measuring a first parameter associated with tissue composition at the first location; and measuring a second parameter associated with tissue composition at the second location, the ablating during the first time period including ablating using a first amount of energy based on the first parameter, the ablating during the second time period including ablating using a second amount of energy based on the second parameter, the first parameter being different than the second parameter and the first amount of energy being different than the second amount of energy.

15. The method of claim 14, wherein: the first parameter is representative of a first amount of elastin, the second parameter is representative of a second amount of elastin greater than the first amount of elastin, and the second amount of energy being greater than the first amount of energy.

16. The method of claim 14 or 15, wherein the measuring the first parameter and the second parameter includes measuring impedance at the first location and the second location, respectively.

17. The method of claim 14, wherein: the first parameter is representative of a first amount of collagen, the second parameter is representative of a second amount of collagen greater than the first amount of collagen, and the second amount of energy being greater than the first amount of energy.Attorney File Ref. SPRL-001 / 02WO 358804-200218. The method of claim 14, wherein: the first parameter is representative of a first amount of smooth muscle cells, the second parameter is representative of a second amount of smooth muscle cells greater than the first amount of smooth muscle cells, the second amount of energy being less than the first amount of energy.

19. The method of claim 14, wherein: the first parameter is representative of a first anatomical region of the blood vessel, the second parameter is representative of a second anatomical region of the blood vessel different from the first anatomical region of the blood vessel, the second amount of energy being different than the first amount of energy.

20. The method of any one of claims 14-19, further comprising: generating a map of the blood vessel to visually display the first parameter and the second parameter along the length of the blood vessel.

21. The method of any one of claims 1-14, further comprising transitioning the ablation device from the second configuration to a third configuration having a third cross-sectional area greater than the second cross-sectional area, and with the ablation device in the third configuration, ablating during a third time period the inner wall of the blood vessel, and wherein: the ablating during the first time period including ablating with a first amount of energy, the first amount of energy being selected based on the ablation device being in the second configuration, the ablating during the third time period including ablating with a second amount of energy, the second amount of energy being selected based on the ablation device being in the third configuration, the first amount of energy being different than the second amount of energy.

22. The method of claim 21, wherein the ablation device includes a plurality of splines, with each spline from the plurality of splines including electrodes configured to deliver ablation energy,Attorney File Ref. SPRL-001 / 02WO 358804-2002 the first amount of energy being based on a distance between the plurality of splines when the ablation device is in the second configuration, and the second amount of energy being based on a distance between the plurality of splines when the ablation device is in the third configuration.

23. The method of claim 21 or 22, wherein the ablation device further includes a handle operably coupled to the plurality of splines, and includes an actuator configured to be actuated to cause the ablation device to transition between first, second, and third configurations, the handle including one or more sensors configured to send to an ablation generator a signal representative of the ablation device being in the first, second, or third configuration, the ablation generator configured to deliver ablation energy based on the signal.

24. An apparatus, comprising: a catheter; a shaft defining a lumen and slidably disposable relative to the catheter; and a plurality of splines, with each spline from the plurality of splines having a proximal end fixedly coupled to the catheter and a distal end fixedly coupled to the shaft, each spline including an electrode configured to deliver ablation energy.

25. The apparatus of claim 24, wherein a distal end of the shaft is spaced distally from the distal end of each spline.

26. The apparatus of claim 24, wherein the shaft includes a coupler, the coupler configured to couple the distal end of the plurality of splines to the shaft.

27. The apparatus of claim 24, wherein the shaft is configured to be axially rotatable with respect to the catheter.

28. The apparatus of claim 24, wherein the lumen of the central shaft is configured to slidably receive a guidewire.Attorney File Ref. SPRL-001 / 02WO 358804-200229. The apparatus of claim 24, wherein the plurality of splines are disposed according to a helical orientation, and the proximal end of each spline is radially offset from the distal end of each spline.

30. The apparatus of claim 24, wherein the plurality of splines includes a first spline and a second spline, the first spline having a portion radially aligned relative to the shaft with a portion of the second spline, the portion of the first spline being axially offset relative to the portion of the second spline.

31. The apparatus of claim 24, wherein the shaft is configured to accommodate a plurality of sensors.

32. The apparatus of claim 31, wherein the plurality of sensors include at least one of an intravascular ultrasound (IVUS) or an optical coherence tomography (OCT).

33. The apparatus of claim 24, further comprising: a handle configured to be actuated to transition the plurality of splines between first and second configurations, the handle including a first indicator representative of a first ablation intensity level and corresponding to the plurality of splines being in the first configuration, and a second indicator representative of a second ablation intensity level corresponding to the plurality of splines being in the second configuration, the second ablation intensity level being greater than the first ablation intensity level.

34. The apparatus of claim 24, wherein the lumen of the shaft includes an irrigation system.

35. The apparatus of claim 24, wherein the shaft is a central shaft.

36. The apparatus of claim 24, wherein the shaft is slidably disposable within a lumen of the catheter.

37. The apparatus of claim 24, wherein the plurality of splines includes a first spline and a second spline, the first spline defining only one apex between its proximal and distal ends, and the second spline defining only two apices between its proximal and distal ends.Attorney File Ref. SPRL-001 / 02WO 358804-200238. A method, comprising: advancing an ablation device to a first location within a blood vessel of a patient; measuring a first parameter associated with tissue composition at the first location; ablating using a first amount of energy with the ablation device an inner wall of the blood vessel at the first location based on the first parameter; moving the ablation device to a second location within the blood vessel; measuring a second parameter associated with tissue composition at the second location; and ablating using a second amount of energy with the ablation device the inner wall of the blood vessel at the second location based on the second parameter, the first parameter being different than the second parameter and the first amount of energy being different than the second amount of energy.

39. The method of claim 38, wherein: the first parameter is representative of a first amount of elastin, the second parameter is representative of a second amount of elastin greater than the first amount of elastin, and the second amount of energy being greater than the first amount of energy.

40. The method of claim 39, wherein the measuring the first parameter and the second parameter includes measuring impedance at the first location and the second location, respectively.

41. The method of claim 38, wherein: the first parameter is representative of a first amount of collagen, the second parameter is representative of a second amount of collagen greater than the first amount of collagen, the second amount of energy being greater than the first amount of energy.

42. The method of claim 38, wherein: the first parameter is representative of a first amount of smooth muscle cells, the second parameter is representative of a second amount of smooth muscle cells greater than the first amount of smooth muscle cells,Attorney File Ref. SPRL-001 / 02WO 358804-2002 the second amount of energy being less than the first amount of energy.

43. The method of claim 38, wherein: the first parameter is representative of a first thickness of the blood vessel, the second parameter is representative of a second thickness of the blood vessel greater than the first thickness of the blood vessel, the second amount of energy being greater than the first amount of energy.

44. The method of claim 38, wherein: the first parameter is representative of a first anatomical region of the blood vessel, the second parameter is representative of a second anatomical region of the blood vessel different from the first anatomical region of the blood vessel, the second amount of energy being different than the first amount of energy.

45. The method of any one of claims 38-44, further comprising: generating a map of the blood vessel to visually display the first parameter and the second parameter along the length of the blood vessel.

46. A method, comprising: advancing an ablation device disposed a first configuration having a first cross- sectional area into a target vessel of a patient, the ablation device including: a catheter defining a longitudinal axis and a shaft lumen therethrough, and a plurality of splines coupled to the catheter, with each spline from the plurality of splines including electrodes configured to deliver ablation energy; with the ablation device located in the target vessel, transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the target vessel at the first location; with the ablation device in the second configuration and at a first location within the target vessel, ablating the inner wall of the target vessel with a first amount of energy, the first amount of energy being selected based on the ablation device being in the second configuration; axially translating the ablation device from the first location to a second location within the target vessel;Attorney File Ref. SPRL-001 / 02WO 358804-2002 transitioning the ablation device from the second configuration to a third configuration having a third cross-sectional area greater than the second cross-sectional area such that a portion of the ablation device contacts the inner wall at the second location; and with the ablation device at the second location and disposed in the third configuration, ablating the inner wall of the target vessel with a second amount of energy greater than the first amount of energy, the second amount of energy being selected based on the ablation device being in the third configuration.

47. The method of claim 46, wherein the first amount of energy is based on a distance between the plurality of splines when the ablation device is in the second configuration, and the second amount of energy is based on a distance between the plurality of splines when the ablation device is in the third configuration.

48. The method of claim 46 or 47, wherein the ablation device further includes a handle operably coupled to the shaft and the plurality of splines, and includes an actuator configured to be actuated to cause the ablation device to transition between first, second, and third configurations, the handle including one or more sensors configured to send to an ablation generator a signal representative of the ablation device being in the first, second, or third configuration, the ablation generator configured to deliver ablation energy based on the signal.

49. An apparatus, comprising: a catheter defining a longitudinal axis and a shaft lumen therethrough; a plurality of splines coupled to the catheter and extending from a distal end of the shaft lumen, with each spline from the plurality of splines including electrodes configured to deliver ablation energy, the plurality of splines configured to transition between a first configuration having a first cross-sectional area and a first distance between splines and a second configuration having a second cross-sectional area and a second distance between splines, the second cross- sectional area being greater than the first cross-sectional area and the second distance being greater than the first distance; and a handle configured to be actuated to transition the plurality of splines between the first and second configurations, the handle including a first indicator representative of a first ablation intensity level and corresponding to the plurality of splines being in the firstAttorney File Ref. SPRL-001 / 02WO 358804-2002 configuration, and a second indicator representative of a second ablation intensity level corresponding to the plurality of splines being in the second configuration, the second ablation intensity level being greater than the first ablation intensity level.

50. An apparatus, comprising: a catheter defining a longitudinal axis and a shaft lumen therethrough; a plurality of splines coupled to the catheter and extending from a distal end of the shaft lumen, with each spline from the plurality of splines including electrodes configured to deliver ablation energy, the plurality of splines configured to transition between a first configuration having a first cross-sectional area and a first distance between splines and a second configuration having a second cross-sectional area and a second distance between splines, the second cross- sectional area being greater than the first cross-sectional area and the second distance being greater than the first distance; and a handle configured to be actuated to transition the plurality of splines between the first and second configurations, the handle including one or more sensors configured to send to an ablation generator a signal representative of the plurality of splines being in the first or second configuration.

51. The apparatus of claim 50, wherein the ablation generator is configured to deliver ablation energy based on the signal.

52. A method, comprising: advancing an ablation device disposed a first configuration having a first cross- sectional area into a blood vessel of a patient; with the ablation device located in the blood vessel, transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel; with the ablation device in the second configuration and at a location within the blood vessel, ablating during a first time period, the inner wall of the blood vessel to create a first set of parallel ablation lesions; without axially translating the ablation device from the location within the blood vessel, transitioning the ablation device from the second configuration to a thirdAttorney File Ref. SPRL-001 / 02WO 358804-2002 configuration having a third cross-sectional area greater than the second cross-sectional area; and with the ablation device at the location and in the third configuration, ablating during a second time period after the first time period, the inner wall of the blood vessel, to create a second set of parallel ablation lesions that intersect the first set of parallel ablation lines to form a crosshatch pattern of lesions.

53. The method of claim 52, wherein the transitioning the ablation device from the second configuration to the third configuration includes adjusting a pitch or angle of the ablation device relative to the inner wall of the blood vessel.

54. The method of claim 53, wherein the ablation device includes a plurality of spines configured in a spiral pattern, and the transitioning the ablation device from the second configuration to the third configuration includes adjusting a pitch or angle of the spines relative to the inner wall of the blood vessel.

55. A method, comprising: advancing an ablation device in a first configuration into a blood vessel, the ablation device in the first configuration having a first cross-sectional area; with the ablation device located in the blood vessel, transitioning the ablation device from the first configuration to a second configuration having a second cross-sectional area greater than the first cross-sectional area such that a portion of the ablation device contacts an inner wall of the blood vessel; with the ablation device in the second configuration and at a first location within the blood vessel, ablating during a first time period, the inner wall of the blood vessel to create a first set of ablation lesions; axially translating the ablation device from the first location to a second location within the blood vessel; and with the ablation device at the second location, ablating during a second time period after the first time period, the inner wall of the blood vessel, to create a second set of ablation lesions.

56. The method of claim 55, wherein the first set of lesions and the second set of lesions are transmural lesions.Attorney File Ref. SPRL-001 / 02WO 358804-200257. The method of claim 55, wherein the ablation device includes: a catheter defining a longitudinal axis and a shaft lumen therethrough; and a plurality of splines coupled to the catheter, each spline from the plurality of splines including electrodes configured to deliver ablation energy.

58. A method, comprising: advancing an ablation device in a contracted configuration into a blood vessel of a patient; with the ablation device located in the blood vessel, transitioning the ablation device from the contracted configuration to an expanded configuration; and with the ablation device in the expanded configuration within the blood vessel, ablating smooth muscle cells of the blood vessel.

59. The method of claim 58, wherein the ablating the smooth muscle cells causes fibroblasts to replace the smooth muscle cells with deposits of neo-collagen.

60. The method of claim 58, wherein the ablating the smooth muscle cells enriches a wall of the blood vessel with collagen.

61. The method of claim 60, wherein the collagen enrichment limits or prevents smooth muscle cell hyperplasia.

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