Apparatus, method and system for improved planning and guidance in laser windowing applications

Abstract

A system for windowing within a body lumen is provided. The system includes an intraluminal device and a processor. The processor is configured to obtain, from the imaging system, a planning image comprising a lumen and a branch lumen extending from the lumen, and in the planning image: identify a treatment device; identifying a centerline of the branch lumen extending from the branch lumen to a desired puncture point on the treatment device; and identifying a desired trajectory of the intraluminal device relative to the puncture point. The processor is further configured to obtain a real-time process image comprising the lumen and the branch lumen from the second imaging system; and identifying the treatment device, the centerline of the branch lumen, the desired puncture point, the desired trajectory of the intraluminal device, and the actual trajectory of the intraluminal device in the real-time process image.

Description

Technical Field

[0001] The subject matter described herein relates to devices, systems, and methods for intraluminal therapeutic fenestration (eg, puncture) of vascular stent grafts. The technology has particular, but not exclusive, utility for improving the speed and quality of aortic aneurysm repair. Background Art

[0002] The aorta is the main artery that carries blood from the heart to the rest of the body. Blood leaves the heart through the aortic valve and then flows through the aorta, branching arteries that carry blood from the aorta to the limbs and organs. An aortic aneurysm is a balloon-like bulge in the aorta, which can occur due to disease or injury. An aortic aneurysm can dissect or rupture, for example, where the pressure inside can split the layers of the artery wall, allowing blood to leak between the layers or into the chest or abdominal cavity.

[0003] Complex endovascular aneurysm repair (EVAR) techniques (designed to exclude aortic aneurysms while maintaining blood flow to critical vessels anatomically contained within the seal zone) are ideally performed using custom-made custom devices (CMDs). This ideal is often compromised by clinical exigencies (e.g., emergency surgery after an accident), which has spawned a range of alternative technical options, including complex "off-the-shelf" branching devices, chimney / periscope / ventilator EVAR (CHIMPS), and physician-modified endografts (PMEGs). Modifications to the latter can be done on the bench prior to implantation or in vivo. In situ laser fenestration (LfEVAR, e.g., using an intravascular laser catheter to puncture a stent graft from the inside) is an example of the latter. In situ laser fenestration uses laser energy to create intentionally prepared holes in the graft fabric of the host device after deployment of the host device, which can be expanded and used as windows for emergency fenestration EVAR and similar procedures.

[0004] The principle is to create a small starting hole (for dilation and stenting) in the fabric of the deployed endograft using a contact laser fiber that is precisely positioned over the center of the target vessel ostium. Depending on the anatomy, there are two possible approaches for performing in situ fenestration: antegrade (e.g., from the aorta to the target vessel) and retrograde (e.g., from the target vessel to the aorta). Each of these approaches has its own technical challenges and ancillary tools.

[0005] The retrograde approach can utilize vascular access downstream of the target arterial ostium. The laser probe is introduced in a retrograde manner, and once in contact with the graft, its end is positioned at right angles or flush with the endograft fabric to transfer the maximum amount of energy to the smallest surface area, thereby attempting to form a circular, non-elliptical hole. The antegrade approach may be more challenging. For example, precise positioning and high stability of the laser fiber are desired, but difficult to achieve using existing approaches. In some cases, a steerable sheath can be used to guide the positioning of the laser fiber. The radiopaque end of the steerable sheath can be positioned at the level of the ostium of the target artery and confirmed by fluoroscopy (e.g., two orthogonal fluoroscopy views).

[0006] Once the laser fiber is in contact with the polyester fabric of the stent graft and is properly positioned and stabilized by the steerable sheath, the laser generator is activated (e.g., for 3 seconds). A guidewire (e.g., 0.014-inch diameter) can then be inserted through the monorail laser fiber and advanced through the window into the target vessel. Serial balloon dilatations of the graft window may be required to gradually enlarge it. For the visceral arteries, a 2- or 2.5-mm diameter cutting balloon can be used, and for the superior aorta, a 6-mm diameter cutting balloon can be used for the first dilatation, followed by a semi-compliant 4-mm diameter coronary balloon. The 0.014-inch guidewire can be replaced with a 0.035-inch Rosen guidewire and a 6-F sheath can be advanced into the target vessel to facilitate positioning and deployment of a bridging (covered) balloon-expandable stent that can be expanded and protrude 3 to 4 mm into the aortic lumen for final dilatation (e.g., using a 9- or 10-mm diameter balloon).

[0007] In situ laser fenestration is a useful adjunct to EVAR when the proximal landing zone includes the origins of visceral (abdomen) or large (arch) vessels. Use of a CMD remains the preferred option when delayed treatment is safe. Laser fenestration is recommended in an emergency setting for fragile patients who are not considered good candidates for open surgical repair. Laser fenestration may also be used to treat chronic aortic dissections. A laser fiber can be used to fenestrate the dissecting flap to allow navigation from one lumen to the other. This can be a rapid procedure and may be less invasive or risky than alternative solutions using a transseptal needle or rigid guidewire tip.

[0008] The median time reported for performing four fenestrations is <1 hour. A potential advantage of in situ fenestration over the PMEG technique is rapid exclusion of the aneurysm, which may be advantageous in the presence of a rupture. For example, laser fenestration may be indicated for the treatment of painful or ruptured juxtarenal artery aneurysms and symptomatic patients with early EVAR complicated by type Ia endoleak. It is also sometimes used to treat thoracoabdominal aneurysms, aortic arch aneurysms, and preserved large renal polar arteries using laser fenestration. In addition, this principle has been used to convert a previously implanted aortic single iliac stent-graft to an aortic bi-iliac stent-graft.

[0009] Once the beginning of the side branch vessel has been covered by the fabric of the endograft, it may be difficult to locate by angiography. Pre-stenting of the target branch artery and / or image fusion techniques can be used to overcome this problem. In order to pre-stent the target branch vessel, a balloon-expandable stent can be positioned in the target branch vessel at the beginning of the operation before the aortic endograft is inserted. These stents can be deployed with their proximal extensions at the vessel ostium. If deployed too far in the target branch artery, the stent may not be used for accurate positioning of the beginning of the target branch vessel and subsequent positioning of the end of the steerable sheath; if deployed too close to the inside and protrudes into the aortic lumen, there is a risk of crushing the target branch vessel stent and disrupting the seal of the main aortic device.

[0010] There may be a risk of dissection during pre-stent placement, as well as the risk of collision of the 0.014-inch guidewire with the stent struts and the risk of stent displacement when advancing the guide sheath. The laser fiber diameter for antegrade visceral artery laser fenestration can be 0.9 mm, while an optical fiber with a diameter of 2.3 mm can be used for retrograde fenestration of the supra-aortic trunk, but devices of other sizes can be used for both antegrade and retrograde surgery. Accurate and stable positioning of the laser fiber can be challenging. The radiopaque end of the steerable sheath (or a general laser catheter) can be positioned at the level of the mouth of the target artery and confirmed, for example, on two orthogonal fluoroscopic views. In addition, the laser catheter cannot be bent beyond a certain radius of curvature and still function properly.

[0011] Type II endoleaks may also occur after endovascular abdominal aortic aneurysm repair (e.g., due to retrograde blood flow from arterial collaterals to the aorta that refills the aneurysm sac). Type II endoleaks are complex vascular structures that may contain an endoleak lumen or lesion with several feeding and draining vessels, similar to an arteriovenous malformation. Some type II endoleaks are transient and resolve spontaneously or remain benign within a few months. However, persistent type II endoleaks may be related to sac dilation and may require secondary intervention to avoid rupture. Currently, it can be difficult to judge the ideal amount of glue for embolization that should be used to seal an endoleak.

[0012] A C-arm is an x-ray imaging system that can rotate about multiple different axes. During surgery, it may be desirable to set the C-arm angle so that the scanner can image the target vessel with minimal obstruction from other body structures. However, it is difficult to know in advance which C-arm angle or angles will optimize the view of the target vessel, which may interfere with the registration and / or landmark identification between the planning CT image and the real-time fluoroscopic image.

[0013] Therefore, it should be appreciated that existing intravascular stent graft fenestration techniques may have a number of disadvantages, including difficulty identifying the correct location for piercing the stent graft material, difficulty aligning the laser catheter at the correct location, difficulty forming a circular (rather than an elliptical or irregularly shaped) opening, difficulty aligning the laser catheter without excessive bending, etc. Therefore, there is a need for improved stent graft fenestration devices, systems, and methods that address one or more of the aforementioned problems and / or other problems.

[0014] The information contained in the background section of this specification (including any documents cited herein and any description or discussion thereof) is included for technical reference purposes only and should not be regarded as subject matter by which the scope of the present disclosure is limited. Summary of the invention

[0015] Disclosed are devices, systems, and methods for improving navigation of catheters and guidewires during laser fEVAR techniques, endoleak repair, or other endovascular fenestration procedures. Specifically, improved navigation can be provided by pre-planning puncture points on a stent graft in 3D; defining the catheter laser path in 3D during surgical planning; adjusting the pre-planning after the main stent graft is positioned to avoid stent struts and improve blood flow during laser perforation; and performing image segmentation on fluoroscopy of the laser catheter to assess whether the catheter follows the 3D planned trajectory. In the case of laser fEVAR surgery, improved navigation and results can be provided by enlarging the opening to a size that correctly matches the diameter of the arterial branch shown in the surgical plan by a cutting balloon or other tool. In the case of endoleak repair, improved navigation and results can be provided by planning and marking the area of ​​the branch artery to be occluded with glue; calculating the volume of glue to be injected; and once the glue catheter is in the appropriate position at the distal end of the glue injection area, injecting the calculated amount of glue while withdrawing the glue catheter.

[0016] A system consisting of one or more computers may be configured to perform a specific operation or action because software, firmware, hardware, or a combination thereof is installed on the system, which, when in operation, causes or causes the system to perform an action. One or more computer programs may be configured to perform a specific operation or action because it includes instructions that, when executed by a data processing device, cause the device to perform an action. One general aspect includes a system for performing an intraluminal fenestration in a body lumen. The system includes a first intraluminal device, which includes a flexible, elongated member; and a processor in communication with the first intraluminal device, wherein the processor is configured to: obtain a planning image from a first imaging system, the planning image including a body lumen and a branch lumen extending from the body lumen; in the planning image: identify the contour of a treatment device; identify the centerline of the branch lumen, the centerline of the branch lumen extending from the branch lumen to a desired puncture point at a boundary of the contour of the treatment device; and identify a desired trajectory of the first intraluminal device relative to the desired puncture point. The processor is further configured to obtain a real-time process image from a second imaging system, the real-time process image comprising a body lumen and a branch lumen extending from the body lumen; and in the real-time process image, identify the contour of the treatment device, the centerline of the branch lumen, the desired puncture point, the desired trajectory of the first intraluminal device, and the actual trajectory of the first intraluminal device. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of the method.

[0017] Embodiments may include one or more of the following features. In some aspects, the processor is further configured to: activate a functional portion of the first intraluminal device to puncture the treatment device when the first intraluminal device is within a desired proximity and angle of the desired puncture point. In some aspects, the processor is further configured to: identify the lumen wall of the branch lumen extending from the branch lumen to the outline of the treatment device in the planning image; and identify the lumen wall of the branch lumen extending from the branch lumen to the outline of the treatment device in the real-time process image. In some aspects, the processor is further configured to: adjust the identified desired puncture point and the identified desired trajectory of the first intraluminal device based on the position of the treatment device in the real-time process image after the treatment device is placed in the body lumen. In some aspects, the processor is further configured to: display an indication of the difference between the desired trajectory of the first intraluminal device and the actual trajectory of the first intraluminal device on the real-time process image. In some aspects, the guide catheter or guidewire is configured to affect the actual trajectory of the first intraluminal device. In some aspects, the guidewire is a fiber true shape (FORS) guidewire, and the processor is further configured to identify the 3D trajectory of the FORS guidewire on a real-time process image as the FORS guidewire moves through a body lumen. In some aspects, the processor is further configured to: identify the actual trajectory of the second intraluminal device on a real-time process image as the second intraluminal device moves through a body lumen. In some aspects, the guide catheter or guidewire is configured to affect the actual trajectory of the second intraluminal device. In some aspects, the second intraluminal device is a cutting device configured to increase the diameter of the puncture hole in the treatment device. In some aspects, the second intraluminal device is an intravascular imaging device. In some aspects, the second intraluminal device is an injection catheter configured to inject a therapeutic material. In some aspects, the processor is further configured to: in a planning image, identify an injection volume in a branch lumen, wherein the injection volume will be injected with a therapeutic material; and in a real-time process image, identify the injection volume in the branch lumen. In some aspects, the contour of the therapeutic device is a desired contour of a therapeutic device to be implanted or an actual contour of an implanted therapeutic device. The first intraluminal device is a laser catheter device. In some aspects, the processor is further configured to identify a desired trajectory of the first intraluminal device so that a bending radius of the first intraluminal device is not less than a specified bending radius. In some aspects, the processor is further configured to identify a desired trajectory of the first intraluminal device so that a functional portion of the first intraluminal device approaches a desired puncture point within a desired angular range. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0018] One general aspect includes a method for performing an intraluminal fenestration in a body lumen. The method includes, using a processor in communication with a first intraluminal device including a flexible, elongated member: acquiring a planning image from a first imaging system, the planning image including a body lumen and a branch lumen extending from the body lumen; in the planning image, identifying a contour of a treatment device; in the planning image, identifying a centerline of the branch lumen, the centerline of the branch lumen extending from the branch lumen to a desired puncture point at a boundary of the contour of the treatment device; in the planning image, identifying a desired trajectory of the first intraluminal device relative to the desired puncture point; acquiring a real-time procedural image from a second imaging system, the real-time procedural image including the body lumen and the branch lumen extending from the body lumen; and in the real-time procedural image, identifying the contour of the treatment device, the centerline of the branch lumen, the desired puncture point, the desired trajectory of the first intraluminal device, and the actual trajectory of the first intraluminal device. Other embodiments of this aspect include corresponding computer systems, apparatuses, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of the method.

[0019] The Summary of the Invention section introduces some selected concepts in a simplified form, which will be further described in the Detailed Description section below. The Summary of the Invention section is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive introduction to the features, details, utilities, and advantages of the laser windowing systems, devices, and methods, as defined in the claims, will be provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, in which:

[0021] Figure 1A is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0022] Figure 1B is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0023] Figure 2 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0024] Figure 3 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0025] Figure 4is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0026] Figure 5 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0027] Figure 6 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0028] Figure 7 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0029] Figure 8 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0030] Fig. 9 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0031] Fig.10 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0032] Fig.11 is a schematic diagram showing a CT planning image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0033] Fig.12 is a schematic diagram showing a CT planning image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0034] Fig.13 is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0035] Fig.14 is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0036] Fig.15 is a schematic diagram showing a fluoroscopic image and a magnified portion of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0037] Fig.16 is a fluoroscopic image of an aortic stent-graft in accordance with aspects of the present disclosure, wherein an endoleak is formed in an aortic side branch artery outside the aortic stent-graft.

[0038] Fig.17 is a fluoroscopic image of an aortic stent-graft in accordance with aspects of the present disclosure, wherein an endoleak is formed in an aortic side branch artery outside the aortic stent-graft.

[0039] Fig.18 is a fluoroscopic image of an aortic stent-graft in accordance with aspects of the present disclosure, wherein an endoleak is formed in an aortic side branch artery outside the aortic stent-graft.

[0040] Fig.19 is a fluoroscopic image of an aortic stent-graft in accordance with aspects of the present disclosure, wherein an endoleak is formed in an aortic side branch artery outside the aortic stent-graft.

[0041] Fig. 20 is a fluoroscopic image of an aortic stent-graft in accordance with aspects of the present disclosure, wherein an endoleak is formed in an aortic side branch artery outside the aortic stent-graft.

[0042] Fig.21 is a schematic diagram showing a CT planning image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0043] Fig. 22 is a schematic diagram showing a CT planning image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0044] Fig.23 is a schematic diagram showing a CT planning image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0045] Fig.24 is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0046] Fig.25 is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0047] Fig.26A is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0048] Fig.26B is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0049] Fig.27Ais a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0050] Fig.27B is a schematic diagram showing a fluoroscopic image of at least a portion of an intraluminal stent graft fenestration system according to aspects of the present disclosure.

[0051] Fig.28 A flow chart is shown of an example stent graft fenestration method according to aspects of the present disclosure.

[0052] Fig.29 A flow chart is shown of an example stent graft fenestration method according to aspects of the present disclosure.

[0053] Fig.30 is a schematic diagram of a processor circuit 3050 according to aspects of the present disclosure. DETAILED DESCRIPTION

[0054] Apparatus, systems and methods for improving navigation of catheters and guidewires during laser fEVAR techniques or other endovascular fenestration procedures are disclosed. Specifically, improved navigation is provided by pre-planning puncture points on a stent graft in 3D; defining the catheter laser path in 3D during surgical planning; adjusting the pre-planning after the main stent graft is positioned to avoid stent struts and improve blood flow during laser perforation; and performing image segmentation on fluoroscopy of the laser catheter to assess whether the catheter follows the 3D planned trajectory. In the case of laser fEVAR surgery, improved navigation and results can be provided by enlarging the opening to a size that correctly matches the diameter of the arterial branch shown in the surgical plan by a cutting balloon or other tool. In the case of endoleak repair, improved navigation and results can be provided by planning and marking the area of ​​the branch artery to be occluded with glue; calculating the volume of glue to be injected; and once the glue catheter is in the appropriate position at the distal end of the glue injection area, injecting the calculated amount of glue while withdrawing the glue catheter.

[0055] During pre-planning, a preoperative CT angiogram (or similar 3D images of the patient) can be used to plan the surgery. The vessels can be segmented from the preoperative CT image and used as a roadmap for planning. The optimal C-arm angle for each arterial branch that needs to be fenestrated can then be calculated and marked on the preoperative CT image. The virtual main stent graft is positioned corresponding to the aortic aneurysm for planning the location of the laser puncture and also for guiding the placement of the stent graft during surgery. The optimal puncture location can be determined by evaluating multiple options using computational modeling. The optimization can be aimed at achieving a certain amount of blood flow into the side branch.

[0056] Then, the arterial branches that need to be fenestrated are segmented, and the trajectory of the vessel diameter and the vessel center axis can be calculated and marked on the CT image. Then, the target vessel trajectory is extended until it reaches the virtual main stent graft, and its intersection with the virtual stent graft defines the 3D position of the puncture point of the main stent graft. In some aspects, instead of extending the arterial trajectory, another method can be used to achieve intersection with the main stent graft, for example, by orthogonally projecting the arterial start onto the axis of the main stent graft.

[0057] Define the laser catheter path in 3D during surgical planning:

[0058] The optimal 3D path of the laser catheter can be calculated so that the path is contained within the 3D vascular roadmap segmented from the preoperative CT image. Moreover, the path should prevent the laser catheter from bending beyond a certain bending angle so that the laser catheter operates properly. The limiting angle depends on the specific circumstances of the laser plaque removal device used for laser windowing. In addition, considering the above constraints, the path can be selected to approach the wall of the stent graft as orthogonally as possible (e.g., within the desired angle range) so that the resulting window is as circular as possible. The trajectory of the laser catheter can be calculated for each arterial branch to be windowed.

[0059] Adjusting preplanning after primary stent-graft placement:

[0060] When the surgical procedure begins, the 3D surgical plan made on the preoperative CT images is registered to the patient. A 2D projection of the surgical plan can be superimposed on the 2D fluoroscopic image. The plan can then be used to position the main stent graft over the aortic aneurysm. After deployment of the main stent graft, the C-arm angle for the target arterial branch is selected and the surgical plan is projected in 2D on the new C-arm angle. On fluoroscopy, the position of the stent graft and its stent struts are visible.

[0061] At this point, the difference between the planned landing point and the actual landing point of the stent is visible, and the plan can be adjusted accordingly. For example, the puncture location and the laser catheter path can be adjusted. In one specific example, the stent struts may interfere with the desired puncture location of the laser catheter because it is not easy to open a hole through the strut material. Therefore, the 3D puncture location can be shifted, such as above or below the stent struts, in order to reduce interference. Subsequently, the corresponding arterial branch trajectory and the planned laser catheter path are also shifted or adjusted, and the desired trajectory of the laser catheter can be recalculated based on the updated path to ensure that it remains within its operating specifications (bending radius, etc.).

[0062] If the stent struts are not exactly at the planned puncture location of the laser, but are still in the vicinity within the projected diameter of the target vessel to be fenestrated, once the branch stent graft is deployed, the stent struts may exert some pressure on it and cause it to close (or partially close). In this case, the planned puncture location may also be shifted.

[0063] Assessment of laser catheter path on fluoroscopy:

[0064] A laser catheter (e.g., used with a steerable sheath or guided by a guidewire placed along its end against a desired puncture site) is advanced within the main stent graft until the planned puncture site is reached. The laser catheter may be guided by a 3D planning trajectory that is projected on a fluoroscopic image in 2D. The catheter is segmented from the fluoroscopic image (e.g., by image-based segmentation) and matched with the projected planning path in 2D, so that the catheter position can be adjusted in real time or near real time to match the projected planning. In some aspects, the average distance between the planned path and the segmented catheter position is calculated and reported to the user in order to assess the degree of overlap of the laser catheter with the planned 3D path. If the catheter needs to be adjusted, or, for example, the angle of the catheter exceeds a limit bending angle, the system can notify the surgeon (e.g., by a message on a display). In other aspects, the range of the optimal path can be displayed so that the surgeon is guided to position the catheter within the range. After the laser catheter is placed in the correct position, the main stent graft can be punctured.

[0065] Enlarging the holes in stent grafts

[0066] Depending on the size of the arterial branch, the hole can be enlarged by a balloon (e.g., a cutting balloon) to match the diameter of the arterial branch projected on the main stent-graft in the fluoroscopic image. Thereafter, a guidewire can be advanced through the hole in the main stent-graft to reach the arterial branch, after which the stent-graft branch can be advanced over the guidewire, through the window, and deployed into the arterial branch, as shown below.

[0067] The present disclosure greatly facilitates the placement of arterial stent grafts with fenestrated branches by improving the planning and execution of laser fenestration of main stent grafts. When implemented in conjunction with imaging systems such as CAT and fluoroscopic x-ray on a catheterization laboratory workstation, the laser fenestration system disclosed herein provides practical guidance to the surgeon in a preoperative manner and in a real-time or near real-time manner during the stent graft placement procedure, particularly during the fenestration of the main stent graft, to enable the placement of branch stent grafts. This improved situational awareness transforms a surgical procedure based on subjective judgment and guesswork into one guided by evidence-based planning without the conventional need to perform the procedure on an ad hoc basis based on real-time fluoroscopic imaging. By annotating the fluoroscopic images with the desired catheter trajectory and window geometry, this unconventional approach improves the functionality of the systems and processors used during the stent graft placement procedure.

[0068] The laser windowing system can be implemented at least in part as an annotation process viewable on a display and operated by a control process executed on a processor that accepts user input from a keyboard, mouse, or touch screen interface and communicates with one or more imaging systems. In this regard, the control process performs some specific operations in response to different inputs or selections made at different times or under different circumstances. Some of the structure, functions, and operations of the processor, display, sensor, and user input system are known in the art, while other structures, functions, and operations are described herein to enable novel features or aspects of the present disclosure.

[0069] These descriptions are for exemplary purposes only and should not be considered as limiting the scope of the present disclosure. Some features may be added, removed or modified without departing from the spirit of the claimed subject matter.

[0070] For the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the various aspects shown in the accompanying drawings, and specific language will be used to describe the various aspects. However, it should be understood that there is no limitation on the scope of the present disclosure. Any changes and further modifications to the described devices, systems and methods, as well as any further applications of the principles of the present disclosure, are fully contemplated and included within the scope of the present disclosure, as would normally occur to a person skilled in the art to which the present disclosure relates. Specifically, it is fully contemplated that the features, components and / or steps described in relation to one aspect may be combined with the features, components and / or steps described in relation to other aspects of the present invention. However, for the purpose of brevity, multiple repetitions of these combinations will no longer be described separately.

[0071] Figure 1Ais a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. The intraluminal stent graft fenestration system 100 may include an intraluminal device 402, such as a catheter, a guidewire, or a guide catheter (see Figure 1B ), interface 415, processor, processing system or controller 170, and display device 105. At a high level, the intraluminal device 402 emits light longitudinally outward from a distal portion of the intraluminal device and into tissue or an implanted therapeutic device. In this regard, the intraluminal device 402 can be sized, shaped, or otherwise configured to be positioned within a body lumen 110 of a patient. In some aspects, the intraluminal device 402 can include a soft, non-invasive tip to facilitate movement of the intraluminal device 402 into the body lumen 110. The body lumen 120 can be a blood vessel (e.g., an artery or vein of a patient's vascular system, including cardiac, peripheral, neural, renal vessels) and / or any other suitable lumen within the body. For example, the intraluminal device 402 may be used to direct light into any number of anatomical locations and tissue types, including, but not limited to: organs including the liver, heart, kidneys, gallbladder, pancreas, lungs; ducts; the intestines; nervous system structures including the brain, thecal sac, spinal cord, and peripheral nerves; the urinary tract; and valves, chambers of the heart or other parts of the blood and / or other systems of the body. In addition to natural structures, the intraluminal device 402 may also be used to inspect or modify artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, grafts, stent grafts, and other devices.

[0072] In some aspects, the intraluminal device 402 may include a flexible elongated member 421 that includes an optical fiber 510. In some aspects, the optical fiber 510 is a single optical fiber. In some aspects, the optical fiber 510 includes a plurality of optical fibers. The optical fiber 510 includes a proximal portion and a distal portion. The proximal portion of the optical fiber 510 may be coupled to a light source 520. The proximal portion of the optical fiber 510 may be coupled to the light source 520, for example, via an interface 415, as further described below. For example, in some cases, the intraluminal device 402 may include and / or be coupled to a connector 414. The connector 414 may be configured to directly or indirectly couple the intraluminal device 402 to the interface 415. The interface 415 may couple the intraluminal device 402 and / or one or more components of the intraluminal device 402 to the light source 520 and / or the processing system 170. In some cases, when optical fiber 510 is a plurality of optical fibers, each of the plurality of optical fibers can simultaneously illuminate multiple areas of tissue or artificial structures in body lumen 110. The proximal portion of optical fiber 510 is configured to receive light from light source 520. In some cases, when optical fiber 510 is a plurality of optical fibers, each of the plurality of optical fibers can be coupled to the same light source 520. In some cases, when optical fiber 510 is a plurality of optical fibers, one or more of the plurality of optical fibers can be coupled to different light sources, such as a plurality of light sources 520. In some cases, when a plurality of light sources 520 are used, light sources 520 can be configured to emit the same or different wavelengths of light.

[0073] In some aspects, the light emitted from the light source 520 can be a wavelength in the ultraviolet spectrum, the visible spectrum, or the infrared spectrum. In some aspects, the light emitted from the light source can be a wavelength between about 300 nanometers (nm) and about 700nm. In some aspects, the light emitted from the light source can be a UV wavelength of about 300nm. The distal portion of the optical fiber 510 is configured to be positioned close to the tissue or artificial structure (i.e., the area of ​​interest), and the light from the light source 520 is longitudinally emitted outward from the distal end of the optical fiber 510 into the tissue or artificial structure in the patient's body lumen 110. Therefore, in some aspects, the distal portion of the optical fiber 510 can extend longitudinally outward from the end of the flexible elongated member 421. In some aspects, the intraluminal device 402 can be a balloon delivery intraluminal device, an injection catheter, an intravascular imaging device (e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), a combination thereof, etc.) or other device.

[0074] The optical fiber 510 may include a core and a cladding positioned around the core. As previously described, the distal portion of the optical fiber 510 may be configured to emit light from the light source 520 longitudinally outward from the distal end of the optical fiber 510 into tissue or an artificial structure within the patient's body lumen 110. In some aspects, the optical fiber 510 includes one or more scattering elements. The one or more scattering elements may include one or more of bubbles, nanospheres, or microspheres.

[0075] In the example shown in FIG. 1 , the intraluminal device 402 includes a guidewire port 416 and a guidewire lumen 417. In this regard, the intraluminal device 402 can be a rapid-exchange catheter. The guidewire port 416 and the guidewire lumen can allow the intraluminal device 402 to be introduced into the patient's body lumen 110 over the guidewire 140. In some aspects, the intraluminal device 402 includes a guidewire lumen 417 extending along most or all of the length of the intraluminal device 402. In this regard, the intraluminal device 402 can be an over-the-wire catheter. In some cases, the intraluminal device 402 includes one or more optical fiber lumens 419 that receive an optical fiber 510 to be positioned within the flexible elongated member 421.

[0076] The interface 415 can facilitate signal communication between the processing system or controller 170, the intraluminal device 402, and / or the light source 520. That is, the interface 415 can have appropriate connectors / components for optical, electrical, and / or wireless communication with the processing system or controller 170, the intraluminal device 402, and / or the light source 520. In some aspects, the interface 415 and the light source 520 can be one and the same. That is, the intraluminal device 402 can be directly coupled to the light source 520, which serves as an interface to the processing system 170, the controller, or other components of the intraluminal stent graft fenestration system 100.

[0077] In some aspects, the intraluminal device 402 may also include a thermal monitoring device 423 that provides an indication of the intensity of illumination of the length of the emitted light of the optical fiber 510. For example, the processing system or controller 170 (which communicates with the thermal monitoring device 423 and the light source 520 via the interface 415) may be configured to control one or more properties of the light source 520 based on feedback received from the thermal monitoring device 423. For example, if the thermal monitoring device 423 detects that the temperature of the tissue or structure exposed to the emitted light may be damaging the tissue or structure, the processing system or controller 170 may change one or more properties of the light source such that the intensity of the light emitted by the light source is reduced. As an alternative example, if the thermal monitoring device 423 detects that the temperature of the tissue or structure exposed to the emitted light may not produce the desired amount of heat or damage, the processing system or controller 170 may change one or more properties of the light source such that the intensity of the light emitted by the light source is increased. In some aspects, the interface 415 transmits signals including feedback received from the thermal monitoring device 423 in the intraluminal device 402 to the processing system or controller 170 , where the signals may be displayed on the display device 105 .

[0078] In some aspects, the intraluminal stent graft fenestration system 100 may include a computer-assisted tomography (CAT or CT) scanner or imaging system 150 and / or a fluoroscopic x-ray system 160 under the control of one or more processors 170. In one example, the CAT scanner 150 or the fluoroscopic x-ray system may capture images upon command by the processing system 170, and / or the CAT scanner 150 or the fluoroscopic x-ray system may transmit images to the processing system 170 for display on the display device 105. In some cases, the processing system 170 may modify the image before displaying it. For example, the processing system 170 may process, enhance, annotate, split, combine, overlay, label, segment, highlight, or otherwise modify the entire image or specific features of the image (e.g., anatomical features or artificial devices within the image). In some cases, the light source 520 may be part of the processing system 170, vice versa, or the light source 520 may be controlled by the processing system 170 (whether directly or indirectly).

[0079] Any of the CAT scan system 150 or the fluoroscopy system 160, or other related imaging systems capable of imaging anatomical structures and devices within the body, may be referred to as an imaging system. The CAT scan system 150, the fluoroscopy system 160, the processing system 170, the light source 520, and other operations of the intraluminal device 402 will be described in more detail below.

[0080] Figure 1Bis a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. The intraluminal stent graft fenestration system 100 includes a functional catheter 120 (e.g., a laser catheter, a balloon catheter, a glue-injected catheter, an intravascular ultrasound (IVUS) catheter, etc.), which can be inserted into a blood vessel or other body lumen 110 and advanced therethrough. According to an embodiment, the catheter 120 can be guided by a steerable sheath or guide catheter 130, or by a guidewire 140. The guidewire 140 can be, for example, a fiber optic true shape (FORS) guidewire, a sensing guidewire, or other type of guidewire. Any of the catheter 120, the guide catheter 130, or the guidewire 140 can be radiopaque, or can include radiopaque features so that they can be clearly imaged by a CAT scan system 150 and / or a fluoroscopic x-ray system 160 under the control of one or more processors of a processing system 170. Any of the catheter 120 , guide catheter 130 , or guidewire 140 may be considered an intravascular or intraluminal device 402 (see FIG. 1 ) that includes a flexible, elongated member 421 .

[0081] Before continuing, it should be noted that the above examples are provided for illustrative purposes only and are not intended to be limiting. Other devices and / or device configurations may be used to perform the operations described herein.

[0082] Figure 2 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible is the aorta 210, which (at Figure 2 ) includes an aneurysm 220. An aneurysm 220 may be a dangerous pathological condition, such as may be caused by disease or injury. A plurality of sacrificial branch arteries 230 extend from the aorta 210. The sacrificial branch arteries 230 will be covered by stent grafts and therefore will be prevented from delivering blood to other parts of the body. Also extending from the aorta 210 are a number of critical branch arteries 240, including the renal arteries 240 that supply blood to the kidneys 250. The blood supply through the critical branch arteries 240 may be considered important to the patient's health, and therefore these critical branch arteries 240 will be provided with stent graft branches.

[0083] In some aspects, primary stenting of the key branch arteries 240 can be performed prior to placement of the aortic stent graft. Thus, a stent 270 can be placed at the end of each key branch artery 240. The stents 270 can, for example, be radiopaque so that they can effectively mark both the location and diameter of the key branch arteries 249 within the aortic aneurysm 220 on both planning images (e.g., 3D CAT scan images) and real-time surgical images (e.g., fluoroscopic x-ray images).

[0084] Figure 3is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 in accordance with aspects of the present disclosure. The endovascular exclusion step occurs when the main stent graft 310 is positioned within the aorta 210 in order to relieve pressure on the aneurysm 220. At this stage, the main stent graft 310 occludes blood flow to the sacrifice branch artery 230 and the critical branch artery 240. In order to limit the potential for ischemic damage to body tissue (e.g., kidney 250), the surgeon may need to limit the amount of time that the critical branch artery 240 remains occluded.

[0085] Figure 4 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. To assist in fenestration, a guidewire 140 or a steerable sheath or guide catheter 130 may be advanced into a main stent graft 310 located within an aneurysm 220 of an aorta 210 until the distal end of the guidewire 140 or steerable sheath 130 approaches a desired puncture site. The functional catheter 120 may then be advanced over the guidewire 140 or within the guide catheter 130 until it also reaches the desired puncture site. In some aspects (e.g., where the functional catheter 120 itself is steerable), the functional catheter 120 may be advanced into the main stent graft 310 without the guidewire 140 or steerable sheath 130.

[0086] Figure 5 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. The functional catheter 120 may be, for example, a laser catheter 120u, which includes a plurality of optical fibers 510 and is capable of piercing the sidewall material of the main stent graft. In one example, the light source 520 of the laser catheter 120u is a commercially available medical excimer laser from Philips, and the laser catheter 120u is a commercially available Turbo-Elite laser atherectomy catheter, or other atherectomy lasers from Philips. Excimer is an abbreviation for "excited dimer" and describes a laser technology that relies on the use of a combination of a rare inert gas (helium or xenon) and a halide (bromine or chlorine). For example, the generated laser light may be in the ultraviolet range (approximately 300 nm), with high energy and a maximum absorption depth of 50 μm. This specificity allows the target material to be vaporized to a limited depth without the risk of causing damage to structures beyond the range.

[0087] Excimer lasers have found widespread use in fields including ophthalmic surgery (particularly refractive surgery), interventional cardiology (to facilitate extraction of pacemaker leads and recanalization of fibrotic and atherosclerotic occlusive lesions in the coronary arteries), and vascular surgery. Vascular surgeons have used the laser catheter 120u at the level of the femoropopliteal arteries to treat chronic stenoses and occlusions and to treat in-stent restenosis. However, the laser catheter 120u can also be used to puncture (fenestrate) aortic stent grafts to facilitate placement of branch stent grafts into critical branch arteries.

[0088] Figure 6 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. After a brief pulse of a current fluence (e.g., 60 fluence, 45 Hz, for 3 seconds) from a laser catheter 120u, the material of the stent graft 310 may be fenestrated to form a hole 610. Depending on the embodiment, the hole 610 may then be rounded and / or enlarged.

[0089] Figure 7 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Figure 7 A bench test experiment of laser fenestration is shown. Visible is the main stent graft 310 and its supporting struts 710. The struts 710 may be, for example, metal or polymer wires attached to the fabric of the main stent graft 310. Figure 7 In the example shown, the hole or window 610 is positioned so that it does not overlap with the stent strut 710 and is not interfered with by the stent strut 710. Then, the branch artery stent graft 720 can be placed through the hole or window 610 to provide a connection between the main stent graft 310 and the key branch artery to ensure blood flow to tissues such as the kidney. In one example, the branch artery stent graft 720 is held in place by friction in the hole or window 610. Therefore, it may be desirable that the size of the hole or window 610 closely matches the diameter of the branch artery stent graft 720.

[0090] Figure 8is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. The main stent graft 310 is pierced by the laser catheter 120u so that the hole or window 610 is well spaced from the stent struts 710 and so that the hole or window 610 is aligned with the key branch artery 240, which can be marked with a radiopaque key branch artery stent 270. The aneurysm 220 is also visible. In current LfEVAR procedures, the placement and alignment of the hole or window 610 with the key branch artery 240 may rely heavily on the surgeon's judgment and dexterity, and is accompanied by risks as described above. The present disclosure provides the surgeon with clear guidance for this step, as described below.

[0091] Fig. 9 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Fig. 9 In the example shown, a guidewire (e.g., a 0.014 inch diameter wire) is advanced through a hole or window 610 in main stent graft 310 so that it enters a critical arterial branch 240 at the location of the marked stent 270 and can thus be used to guide additional stents or catheters into branch arteries 240.

[0092] Fig.10 is a schematic diagram of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Fig.10 In the example shown, a branch artery stent graft 720 is deployed through hole or window 610, through marker stent 270, and into branch artery 240, thereby ensuring blood flow through branch artery 240 to other tissues in the body. Stent struts 710 and aneurysm 220 are also visible.

[0093] Figures 11 to 15 The steps used to improve planning and laser catheter guidance during laser fEVAR procedures will now be shown.

[0094] Fig.111 is a schematic diagram showing a CT or CAT scan planning image 1200 and a magnified portion 1205 of the planning image 1200 of at least a portion of the intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Once the CT planning image 1200 is captured (e.g., by the CAT scan imaging system 150 of FIG. 1 ), the planning image 1200 may, for example, display the aorta 210, the aortic aneurysm 220, and at least one key branch artery 240. However, the present disclosure provides useful annotations of the planning image 1200. These annotations may, for example, include a virtual stent graft 1210 indicating the size and desired positioning of the main stent graft 310 within the aorta 210 in order to occlude the aneurysm 220. In addition, an annotation may be displayed that extends a virtual sidewall 1215 of diameter D of the branch artery 240 and a virtual centerline or branch artery trajectory 1230 from the actual sidewall and centerline of the branch artery 240 until they intersect the virtual stent graft 1210. The point where the virtual centerline 1230 intersects the virtual stent graft 1210 then becomes the desired puncture point 1220 where it is most favorable for the laser catheter 120u to puncture the main stent graft 310 (e.g., as shown in FIG. Figure 8 ). Such annotations of the planning CT image 1200 are very useful for the surgeon in planning and performing the laser fEVAR procedure, especially when the branch artery 240 is not marked with a stent.

[0095] Fig.12 1 is a schematic diagram of a CT planning image 1200 and a magnified portion 1205 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. An optimal 3D path 1310 for a laser catheter can be calculated so that the path is contained within the aorta 210 and the virtual stent graft 1210 and approaches the desired puncture point 1220 as orthogonally as possible without bending beyond a specified bending radius (depending on the specific type of catheter used). According to an embodiment, the trajectory of the laser catheter can be calculated for each arterial branch that the surgeon intends to fenestrate.

[0096] Fig.13 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. A 2D projection of surgical planning annotations from a planning CT image 1200 can be registered to the fluoroscopic image 1400 in real time or near real time such that, for example, the annotations move with associated anatomical features in response to heartbeat, respiration, etc. The annotations can include, for example, a virtual stent graft 1210, a virtual sidewall 1215, a virtual centerline 1230, a desired puncture point 1220, and a desired catheter path 1310.

[0097] During this process, the main stent graft 310 is placed in the aorta 210, aligned with the virtual stent graft 1210, so as to occlude the aneurysm 220. Afterwards, the main stent graft 310 is deployed, the C-arm angle of the target arterial branch is selected, and the surgical plan is projected in 2D on the new C-arm angle. On fluoroscopy, the position of the stent graft 310 and its stent struts 1210 are visible.

[0098] At this point, the difference between the planned landing point and the actual landing point of the main stent graft 310, as well as the final position of the stent struts, can be seen, and the planning can be adjusted accordingly. For example, the puncture position and the laser catheter path can be adjusted to avoid the stent struts 710. As described above, the stent struts may interfere with the desired puncture position of the laser catheter because the hole cannot be opened corresponding to the struts. Therefore, the 3D puncture position 1220 can be shifted, such as above or below the stent struts, to reduce interference. This shift can occur automatically, for example, and the surgeon can choose to override the position and select a different adjustment. Once the puncture point 1220 is moved, the corresponding arterial branch trajectory 1230 and the planned laser catheter path 1310 can be moved or adjusted, and the bending radius of the laser catheter can be recalculated (e.g., in real time or near real time) based on the updated path to ensure that it remains within its operating specifications, and the resulting catheter path annotation can be updated on the fluoroscopic image 1400.

[0099] If the stent struts are not completely located at the planned puncture location of the laser, but are still located in the vicinity within the projected diameter of the target vessel to be fenestrated, once the branch stent graft is deployed, the stent struts may exert some pressure on it and cause it to close (or partially close). In this case, the planned puncture location can also be shifted.

[0100] Fig.14 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. In one example, the system segments the actual path of the laser catheter 120u on the fluoroscopic image 1400 and compares it to the 2D projection of the 3D laser planned path 1310.

[0101] The laser catheter 120u (e.g., used with a steerable sheath) is advanced within the main stent graft 310 until the planned puncture point 1220 is reached. The laser catheter 120u is guided by a 3D planning trajectory 1310, which is projected on the fluoroscopic image in 2D. The catheter 120u is segmented from the fluoroscopic image (e.g., by image-based segmentation) and matched with the projected planning path in 2D, so that the surgeon can adjust the catheter position to match the projected plan. In some aspects, the average distance between the planned path 1310 and the segmented position of the catheter 120u is calculated and displayed to assess the degree of overlap of the laser catheter 120u with the 3D planning path 1310. Then, if the catheter 120u needs to be adjusted, or if, for example, the angle of the catheter 120u exceeds the maximum specified bending radius of the catheter type, the system can notify the surgeon (e.g., through a message on a display). In other aspects, a range of acceptable paths 1310 can be displayed, and the surgeon can then position the catheter 120u within the range. Once the surgeon has placed the laser catheter 120u in the correct position, the laser may be activated for a period of time (eg, 3 seconds) to puncture the main stent graft 310 at the desired puncture point.

[0102] Fig.15 is a schematic diagram showing at least a portion of an intraluminal stent graft fenestration system 100 and a magnified portion 1510 according to aspects of the present disclosure. Enlargement of hole 610 (e.g., by balloon catheter 120b equipped with a cutting balloon, scoring balloon, or other type of balloon 122b) can match the diameter of enlarged hole 1520 to the diameter D of the branch artery, as shown on fluoroscopic image 1400 by virtual vessel wall 1215 intersecting main stent graft 310. Thereafter, a guidewire can be advanced through enlarged hole 1520 in main stent graft 310 to reach arterial branch 240 so that a branch stent graft can be placed in arterial branch 240, as described above.

[0103] IVUS for intravascular guidance

[0104] In other aspects, IVUS catheter 120i (or OCT catheter, or combination thereof, or other intravascular imaging device) may be advanced along with laser catheter 120u and may be used to better locate stent struts 710 prior to laser puncturing main stent graft 310. Also, after laser fenestration of the graft, IVUS catheter 120i may be advanced within holes 610 or 1520 in main stent graft 310 to visualize the origin of arterial branches 240 and guide the deployment of branch stent grafts into arterial branches 240.

[0105] FORS for improved laser catheter guidance

[0106] In other aspects, the laser catheter 140u can be guided by a FORS guidewire 140f, which can be registered on the fluoroscopic image 1400 and used to track the path of the laser catheter 120u in 3D and in real time or near real time as the laser catheter 120u moves toward the desired puncture point 1220. In some aspects, the 3D planned path 1310 of the laser catheter 120u is projected on the fluoroscopic image 1400 in 2D, and the path of the laser catheter 120u is segmented from the fluoroscopy (i.e., the segmented path is in 2D). By using the FORS guidewire 140f, the path of the laser catheter 120u can be visualized in 3D on the fluoroscopic image 1400, and can be adjusted to match the 3D planned path 1310, thereby potentially improving navigation accuracy.

[0107] When the FORS Guidewire 140f is used in conjunction with a laser catheter, the FORS device can track the location of the laser pulses in 3D. This can help prevent laser damage to tissue near the stent graft and can be used to create a 3D map of the laser fenestration locations.

[0108] Improved visualization of arterial branches and main stent grafts

[0109] In other aspects, the arterial branch 240 is pre-stented to improve the visualization of the artery 240 during fluoroscopy. The stent 270 of the arterial branch 240 can be segmented from the fluoroscopic image 1400 (see Figure 2 ) (e.g., by image-based segmentation), and used to update the planned trajectory 1310 of the laser catheter 120u based on the location of the arterial branches 240 on each new fluoroscopic image 1400. In addition, once the main stent-graft 310 is deployed, the same method can be used to update the surgical plan and correctly position the main stent-graft 310. This allows the 3D puncture point 1220 to be updated based on the new location of the arterial branches 240 and the deployed main stent-graft 310. This method can be used, for example, to compensate for deformation of the artery that may occur during the procedure, as well as misalignment of the surgical planning annotations on top of the fluoroscopic image 1400.

[0110] In addition to stents, other fiducials (eg, radiopaque markers) may be placed in arterial branches 240 for improving their positioning in fluoroscopic image 1400. In another instance, arterial branches may be cannulated prior to deployment of main stent-graft 310.

[0111] Fig.161 is a fluoroscopic image 1600 of an aortic stent graft 310 according to aspects of the present disclosure, wherein an endoleak has formed outside the aortic stent graft within an aortic side branch artery. The approximate location of the side branch artery has been marked with a dashed line 230. It is shown here for explanation purposes only; in a conventional endoleak repair procedure, such annotation of the fluoroscopic image 1600 may not be available. Also visible are the glue catheter, injection catheter, or glue injection catheter 120g, the stent struts 710, and the mammary duct, guide catheter, or steerable sheath 130.

[0112] After endovascular repair of an abdominal aortic aneurysm, a type II endoleak may form in a sacrificial branch artery (e.g., an artery blocked by the main stent graft 310). For example, an endoleak may be caused by retrograde blood flow through the sacrificial branch artery, thereby refilling the aneurysm sac. Such an endoleak may be a complex vascular structure containing an endoleak cavity or lesion with multiple feeding and draining vessels, similar to an arteriovenous malformation. Most of these endoleaks are temporary and resolve spontaneously within a few months or remain benign. However, persistent type II endoleaks may be associated with dilation of the aortic aneurysm sac and may require secondary intervention to avoid rupture. Although open and laparoscopic techniques have been described to eliminate side branch perfusion, an endovascular approach may be preferred given its minimally invasive nature.

[0113] Endovascular approaches include transarterial embolization (TAE), translumbar embolization (TLE), and, more recently, transcaval embolization (TCE). TAE is perhaps the most commonly used approach, and its technical success may require catheter and guidewire maneuvers through small and tortuous arteries, which can be technically challenging. TLE may not always be feasible due to the location of the endoleak relative to the inferior vena cava, bowel, or kidneys, or its location in the pelvis, where safe needle access may be blocked by surrounding bony structures. TCE has been reported to be effective, especially in patients who do not have transarterial access and are not good candidates for TLE. As an alternative to transarterial, translumbar, and transcaval approaches, the transgraft embolization (TGE) technique can be used.

[0114] Transgraft embolization (TGE) uses laser energy to micropuncture the endograft via a transfemoral approach to gain access to the aneurysmal sac at the precise location of the type II endoleak lesion, regardless of its anatomical location.

[0115] Techniques used for laser transgraft embolization

[0116] The primary goal may be to use a laser device to open a small hole in the fabric of the deployed stent graft 310 so that a catheter can be advanced into the aneurysm sac to eliminate the Type II endoleak at the level of the lesion.

[0117] A planning computed tomography (CT) angiography may be performed to assess the diameter of the aneurysm sac and the presence of a type II endoleak, such as retrograde blood flow from one or more arterial branches. The CT angiogram may be analyzed to determine from which limb (e.g., which leg) the endoprosthesis may be accessed. Following percutaneous catheterization of the femoral artery, a sheath may be advanced over a selected standard guidewire. Through the sheath, a guide catheter may be advanced to the level of the endoleak.

[0118] exist Fig.16 In the example shown, a 6-F internal mammary duct 130 is positioned so that it is directed toward a known Type II endoleak.

[0119] Fig.17 FIG. 1 is a fluoroscopic image 1600 of an aortic stent graft 310 in which an endoleak (marked by dashed line 230 ) has formed outside the aortic stent graft within an aortic side branch artery in accordance with aspects of the present disclosure. Fig.17 In the example shown, the stent graft 310 is pierced using a 0.9 mm coronary laser probe (e.g., Philips Turbo-Elite laser plaque removal catheter) directed to the site of the endoleak. For example, the laser can be activated at a frequency of 60 pulses / second and a fluence of 60 mJ / mm2. In some cases, a Turbo-Elite catheter can be used. A radiopaque marker 1710 is located on the distal end of the laser catheter, which can now be seen through the endograft, located within the abdominal aortic aneurysm sac (arrow). The guide catheter 130 or guidewire 140 can then be advanced into the side branch artery 230.

[0120] Fig.18 16 is a fluoroscopic image 1600 of an aortic stent graft 310 in accordance with aspects of the present disclosure, wherein an endoleak has formed outside the aortic stent graft within an aortic side branch artery (marked by dashed line 230). A guidewire (e.g., a 0.014 inch guidewire) 140 has been advanced into the aneurysm sac and then replaced with a gel-injected microcatheter 120g.

[0121] Fig.19 FIG. 1 is a fluoroscopic image 1600 of an aortic stent graft 310 in which an endoleak (marked by dashed line 230 ) has formed outside the aortic stent graft within an aortic side branch artery in accordance with aspects of the present disclosure. Fig.19 In the example shown, a selective digital subtraction angiogram has been performed to demonstrate the endoleak. For example, the digital subtraction angiogram can be obtained by entering the aneurysm sac over a guidewire with an exchanged 2.4-F microcatheter (e.g., Philips Echelon). Note the focus of a type II endoleak 1910 and the vascular structure 1920, most likely representing the lumbar artery.

[0122] Fig. 201 is a fluoroscopic image 1600 of an aortic stent graft 310 according to aspects of the present disclosure, wherein an endoleak has formed outside the aortic stent graft within an aortic side branch artery. Through the glue injection microcatheter 120g, a therapeutic material 2010 (e.g., Onyx glue from Medtronic or a similar medical adhesive compound) may be administered to occlude a Type II endoleak at the level of the lesion. The x-ray fluoroscopic image is obtained after the therapeutic material 2010 is administered through the glue injection microcatheter 120g. The precise positioning of the glue catheter 120g and the precise amount of therapeutic material 2010 to be injected are generally subjective to the surgeon. Therefore, the present process and system may include some safeguards to prevent injection of too much or too little glue.

[0123] In some embodiments, therapeutic material 2010 can be or include a medical adhesive as described above, but can also be or include a solvent, a drug, a contrast material, a cell solution (e.g., platelets), or other materials deemed important or desirable by the surgeon.

[0124] Figure 21 to Figure 2 7 will now be shown steps for improving planning, laser catheter guidance, glue catheter guidance, and glue injection during laser endoleak repair. The present disclosure describes a method for improving navigation during laser transgraft embolization techniques (Type II endoleak repair). Specifically, improved navigation is provided by:

[0125] Pre-planning of puncture points on the stent graft in 3D;

[0126] Planning the minimum length of the vessel with retrograde blood flow that needs to be filled and the volume of glue that needs to be injected;

[0127] Define the catheter laser path in 3D during surgical planning;

[0128] Adjust preplanning before puncture to avoid stent struts during laser perforation;

[0129] On fluoroscopic images, the laser catheter is segmented to assess whether the catheter follows the 3D planned trajectory;

[0130] advancing the gel catheter in the blood vessel until it passes the smallest portion of the blood vessel to be filled; and

[0131] Inject glue until the entire section of the vessel is filled while the glue catheter is retracted.

[0132] Fig.211 is a schematic diagram of a CT planning image 1200 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible are the aorta 210, aneurysm 220, stent graft 310, stent struts 710, and an occluded (sacrificed) branch artery 230. Retrograde blood flow 2110 through the branch artery 230 creates an endoleak condition. However, the present disclosure provides annotations for the CT planning image 310, including a virtual centerline 1230 extending from the centerline of the branch artery 230 until it intersects the stent graft 310, where it designates a desired puncture point 1220.

[0133] During pre-planning, the surgery can be planned using the pre-operative CT angiogram 1200 (or similar 3D images of the patient). The blood vessels 210, 230 and stent graft 310 in the pre-operative CT image can be segmented and used as a roadmap for planning. The optimal C-arm angle can be defined for each artery with retrograde blood flow on the pre-operative CT image. These angles can be acquired pre-operatively by examining the anatomy or simulating a fluoroscopic view through the CT volume (e.g., using digitally reconstructed radiographs).

[0134] Arterial branches 230 with retrograde blood flow 2110 may be segmented, and a trajectory 1230 of the central axis of branch arteries 230 may be defined. Then, target vessel trajectory 1230 may be extended until it intersects with main stent graft 310, and their intersection defines the 3D location of the desired puncture point 1220 of the main stent graft. Alternatively, instead of extending the arterial trajectory, the intersection with the main stent graft may also be achieved by other related methods, such as orthogonally projecting the start of branch arteries 230 to the axis of main stent graft 310.

[0135] In another case, when multiple arteries with retrograde blood flow require embolization, one puncture point may be used for more than one artery to minimize the number of holes in the fabric of the stent graft. As an example, the puncture point for the multiple arteries may be selected as: one of the defined points that minimizes the distance between the stent graft 310 and the origin of the selected artery 230 that requires embolization, or: a new point that minimizes the distance between the stent graft and the origin of the selected artery 230 that requires embolization. In addition to the previously described methods, other indicators may be used to select the desired puncture point 1220 on the stent graft 310.

[0136] Fig. 22is a schematic diagram of a CT planning image 1200 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible are the aorta 210, aneurysm 220, stent graft 310, stent struts 710, occluded (sacrificed) branch arteries 230, retrograde blood flow 2110, and desired puncture points 1220. In this step, as described above, an optimal 3D path 1310 for the laser catheter can be calculated so that the path is contained within the 3D vessel roadmap segmented from the preoperative CT image 1200, so that the laser burns a fairly circular (rather than elliptical) hole, and so that the path prevents the laser catheter from bending beyond its specified minimum bend radius. The specified minimum value depends on the type of catheter used. According to an embodiment, a trajectory of the laser catheter is calculated for each desired puncture point 1220 previously identified.

[0137] Fig.23 1 is a schematic diagram showing a CT planning image 1200 and a magnified area 2310 of at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible are the aorta 210, the aneurysm 220, the stent graft 310, the stent struts 710, the blocked (sacrificed) branch artery 230, the retrograde blood flow 2110, and the desired puncture point 1220. In this step, the portion 2340 of the arterial branch 230 to be filled with glue can be planned on the preoperative CT image 1200. The portion 2340 to be filled can be defined, for example, by the surgeon (e.g., a 5 cm length of the arterial branch 230) and starts from the origin of the arterial branch 230 (located at the aneurysm sac) and moves distally therefrom. Then, a distal position 2320 on the arterial branch 230 representing the smallest portion to be filled and a proximal position 2310 at the origin of the arterial branch 230 can be marked on the surgical planning image 1200. The volume V of the portion 2340 of the arterial branch 230 represents the required volume of glue to be used. A variety of methods can be used to calculate the volume of glue. The volume V can be easily calculated by looking at the length of the portion to be filled and its diameter D or its known cross-sectional area. In another case, the volume V can be calculated by counting the number of voxels in the preoperative CT image that represent the arterial portion 2340 that needs to be filled.

[0138] In other aspects, the volume of glue to be injected into the artery can be predefined, and given a preoperative CT image or an anatomical model, the spatial portion of the artery to be filled can be calculated. For example, the length of the arterial portion 2340 to be filled can be calculated by dividing the volume of glue by the cross-sectional area of ​​the artery. In another case, the arterial portion 2340 can be calculated by counting the number of voxels of the segmented arterial branches, starting from the beginning of the arterial branch 230 at the aneurysm sac, until the defined volume of glue is reached.

[0139] The portion 2340 of the artery branch only represents the minimum length of the artery to be filled. If necessary, the surgeon can fill a larger portion.

[0140] Fig.24 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible are aorta 210, aneurysm 220, stent graft 310, stent struts 710, occluded (sacrificed) branch artery 230, retrograde blood flow 2110, desired puncture point 1220, and distal volume marker 2320 and proximal volume marker 2340 defining a portion 2340 or volume V of branch artery 230 to be filled with adhesive.

[0141] When the surgical procedure begins, the 3D surgical planning annotations made on the preoperative CT image 1200 are registered to the patient. A 2D projection of the surgical planning annotations can be superimposed on the 2D fluoroscopic image so that the surgeon can see the branch artery centerline 1230, the desired puncture point 1220, the desired path 1310 of the laser catheter, and the distal volume marker 2320 and the proximal volume marker 2340 that define the portion 2340 or volume V. On the fluoroscopic image 1400, the location of the stent graft 310 and its stent struts 710 will also typically be visible to some extent.

[0142] As described above, the stent struts may interfere with the desired puncture location 1220 of the laser catheter because a location opening through the struts 710 may not be feasible or desirable. Therefore, the 3D puncture location 1220 can be shifted, such as above or below the stent struts, to reduce interference. This shifting can occur automatically, for example, and the surgeon can choose to overrule the location and select a different adjustment. The change in the location of the desired puncture point 1220 can result in an automatic recalculation of the desired catheter path 1310, as described above.

[0143] Fig.25 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Visible are aorta 210, aneurysm 220, stent graft 310, stent struts 710, occluded (sacrificed) branch artery 230, retrograde blood flow 2110, desired puncture point 1220, and distal volume marker 2320 and proximal volume marker 2340 defining a portion 2340 or volume V of branch artery 230 to be filled with adhesive.

[0144] The laser catheter 120u (e.g., used with a steerable sheath or guidewire) can be advanced within the main stent graft 310 until the planned puncture point 1220 is reached. The laser catheter 120u can be guided by the 3D planned trajectory 1310 and projected in 2D on the fluoroscopic image 1400. The catheter 120u can be segmented from the fluoroscopic image 1400 (e.g., by image-based segmentation) and matched to the projected planned path in 2D, so that the catheter position can be adjusted (e.g., by the surgeon) to match the planned path 1310. In some aspects, the average distance between the planned path 1310 and the segmented position of the catheter 120u is calculated to assess the degree of overlap of the laser catheter 120u with the planned or optimized 3D path 1310. If the catheter needs to be adjusted, or if, for example, the angle of the catheter is less than the minimum bend radius, the system can notify the surgeon (e.g., through a message on a display). In other aspects, a range of acceptable paths can be displayed, and the surgeon can position the catheter 120u within the range. After the laser catheter 120u is placed in the correct position, the laser may be used to pierce the main stent graft 310, thereby forming a hole or window.

[0145] Fig.26A 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Through the hole or window 610 in the stent graft 310, the glue catheter 120g can be inserted into the branch artery 230 until the distal end of the glue catheter 120g passes the distal marker 2320, which marks the smallest portion of the vessel to be filled. Then, glue can be injected while the glue catheter 120g is withdrawn.

[0146] Fig.26B 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. The glue injection catheter 120g can be inserted into the branch artery 230 until it passes the smallest portion of the vessel to be filled as marked on the surgical plan. Once there, the therapeutic material 2010 (e.g., glue) can be injected until the entire filling portion 2340 of the branch artery 230 is filled, and the glue catheter is retracted. When the therapeutic material 2010 is glue, for example, it can be selected to remain liquid in the glue injection catheter 210g, but quickly solidify, harden, gel, or increase in viscosity when in contact with blood, so that the glue 2010 forms a plug 2610, mostly or completely blocking the branch artery 230, so that retrograde blood flow through the branch artery does not produce endoleak.

[0147] Fig.27A is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 in accordance with aspects of the present disclosure. Fig.27Aand Fig.27B Demonstrated another method for planning the minimum length to be filled of the artery. In these aspects, the minimum filling length 2410 of the branch artery 230 can be marked on the surgical planning CT image 1200. Subsequently, when the glue tube 120g is segmented out from the fluoroscopic image 1400 (e.g., by image-based segmentation), then the minimum filling length 2410 can be marked or annotated on the image of the glue tube 120g itself, starting from the distal end of the glue tube 120g and moving distally until the minimum filling length 2410 is crossed. Such marking or annotation can take the form of a colored line along the outline of the glue tube 120g, or take the form of a distal mark at the distal end of the glue tube 120g plus a proximal mark positioned at the minimum filling length 2410 along the glue tube. Other markings or annotations can be used alternatively or in addition. In this way, the marked or annotated image of the glue tube provides a direct reminder about how far the glue tube needs to be inserted into the branch artery 230 in order to inject the desired volume of glue.

[0148] Fig.27B 1 is a schematic diagram of a fluoroscopic image 1400 showing at least a portion of an intraluminal stent graft fenestration system 100 according to aspects of the present disclosure. Fig.27B In the example shown, the glue catheter 120g is advanced within the arterial branch 230 until the marked length 2410 on the glue catheter matches the start of the arterial branch 230. Because fluoroscopy displays a 2D projection of the glue catheter 120g, the length segmented from the fluoroscopy image 1400 may not represent the true 3D length of the catheter. In some aspects, a FORS guidewire can be used to visualize the glue catheter 120g in 3D during fluoroscopy, as described above for the laser catheter 120u.

[0149] In other aspects, the IVUS catheter can be advanced with the laser catheter and used to better locate the stent struts before puncturing with the laser. In addition, after puncturing the graft with the laser, the IVUS catheter can be advanced within the hole in the main graft to visualize the beginning of the arterial branch 230 and guide the insertion of the glue catheter 120g into the arterial branch.

[0150] Fig.28 2800 is a flowchart of an exemplary stent graft fenestration method 2800 according to aspects of the present disclosure. It is understood that the steps of the method 2800 may be performed in the same manner as described above. Fig.28, additional steps may be provided before, during, and after the steps, and / or some of the steps described may be replaced or eliminated in other aspects. One or more steps of method 2800 may be performed by one or more devices and / or systems described herein, such as components of system 100, processing system 170, and / or processor circuit 3050.

[0151] In step 2810 , method 2800 includes capturing a 2D or 3D planning image using a CAT scanner or other imaging technology. Execution then proceeds to step 2820 .

[0152] In step 2820, method 2800 includes identifying and marking arterial branches in the planning image. For example, such identification can be accomplished by a segmentation algorithm, such as described in U.S. Pat. No. 9,842,401 (issued to Perval et al., with a priority date of August 8, 2013) and / or U.S. Pat. No. 10,417,765 (issued to Saalbach et al., with a priority date of January 14, 2015), both of which are incorporated herein by reference as if fully set forth herein. Marking can, for example, include extending a virtual vessel wall and a virtual vessel centerline from the arterial branch until they intersect with a real or virtual stent graft in the planning image. Execution then proceeds to step 2830.

[0153] In step 2830, method 2800 includes calculating a desired location for puncturing the stent graft and marking the location on the planning image. In some aspects, the desired puncture location is the intersection of the branch artery centerline and the stent graft. Execution then proceeds to step 2840.

[0154] In step 2840, method 2800 includes calculating and marking a desired path for the laser catheter. For example, the desired path may pass through the stent graft so that it meets the desired puncture point at the most perpendicular angle possible without exceeding a minimum bend radius. Execution then proceeds to step 2850.

[0155] In step 2850, method 2800 includes calculating and marking a desired diameter of the window. In some aspects, the diameter is approximately equal to the diameter of the arterial branch and equal to the virtual sidewall of the arterial branch that is extended to meet the stent graft. Execution then proceeds to step 2860.

[0156] At step 2860 , method 2800 includes capturing one or more fluoroscopic images of the patient. Execution then proceeds to step 2870 .

[0157] In step 2870, method 2800 includes registering the markers from the planning image to the fluoroscopic image. Such registration may use anatomical landmarks and other information, such as described in U.S. Pat. No. 8,620,050 (issued to Liao et al., with a priority date of September 23, 2010) and / or U.S. Pat. No. 9,295,435 (issued to Florent et al., with a priority date of February 7, 2011), both of which are incorporated herein by reference as if fully set forth herein. Execution then proceeds to step 2880.

[0158] In step 2880, method 2800 includes segmenting the laser catheter on the fluoroscopic image and marking it with the expected catheter path. In some cases, the difference between the actual catheter path and the expected catheter path can be numerically calculated and reported to the surgeon. Execution then proceeds to step 2890.

[0159] In step 2890, method 2800 includes advancing the laser catheter into the stent graft until it reaches the desired puncture location. In some aspects, this advancement is performed by the surgeon under the guidance of the actual catheter path and the desired catheter path displayed on the fluoroscopic image. Execution then proceeds to step 2895.

[0160] In step 2895, method 2800 includes activating the laser to pierce or fenestrate the stent graft. In some aspects, the method is now complete. In other aspects, execution then proceeds to step 2897.

[0161] In step 2897, the laser catheter is exchanged for a cutting instrument, such as a balloon catheter equipped with a cutting balloon, which can enlarge the hole until it reaches the desired window diameter. The method is now complete.

[0162] Fig.29 2900 is a flowchart of an exemplary stent graft opening method 2900 according to various aspects of the present disclosure. It is understood that the steps of the method 2900 may be performed in the same manner as described above. Fig.29 , additional steps may be provided before, during, and after the steps, and / or some of the steps described may be replaced or eliminated in other aspects. One or more steps of method 2900 may be performed by one or more devices and / or systems described herein, such as components of system 100, processing system 170, and / or processor circuit 3050. In some aspects, method 2900 may follow or be a continuation of method 2800 described above.

[0163] In step 2910 , method 2900 includes capturing a 2D or 3D planning image using a CAT scanner or other imaging technology. Execution then proceeds to step 2920 .

[0164] In step 2920, method 2900 includes identifying and marking arterial branches in the planning image. Such identification can be accomplished, for example, by a segmentation algorithm as described above. Marking can, for example, include extending a virtual vessel wall and a virtual vessel centerline from the arterial branch until they intersect a real or virtual stent graft in the planning image. Execution then proceeds to step 2930.

[0165] In step 2930, method 2900 includes calculating a desired location for puncturing the stent graft and marking the location on the planning image. In some aspects, the desired puncture location is the intersection of the branch artery centerline and the stent graft. Execution then proceeds to step 2940.

[0166] In step 2940, method 2900 includes calculating and marking a desired path for the adhesive catheter. For example, the desired path may pass through the stent graft and the stent graft window to enter the branch artery. Execution then proceeds to step 2950.

[0167] In step 2950, ​​method 2900 includes calculating and marking the volume of the arterial branch to be filled with glue. Such volume can be automatically calculated and marked on the planning image as described above, or can be calculated based on the location marked by the surgeon on the planning image. Execution then proceeds to step 2960.

[0168] At step 2960 , method 2900 includes capturing one or more fluoroscopic images of the patient. Execution then proceeds to step 2970 .

[0169] In step 2970, method 2900 includes registering the markers from the planning image to the fluoroscopic image. Such registration may use anatomical landmarks and other information, as described above. Execution then proceeds to step 2980.

[0170] In step 2980, method 2900 includes segmenting the glue catheter on the fluoroscopic image and marking it with the expected catheter path. In some cases, the difference between the actual catheter path and the expected catheter path can be numerically calculated and reported to the surgeon. Execution then proceeds to step 2990.

[0171] In step 2990, method 2900 includes advancing the adhesive catheter into the arterial branch until the distal end of the filling volume. In some aspects, this advancement is performed by the surgeon under the guidance of the actual catheter path and the desired catheter path displayed on the fluoroscopic image. Execution then proceeds to step 2995.

[0172] In step 2995, method 2900 includes injecting a minimal volume of glue into the arterial branch while withdrawing the glue catheter. In some aspects, this injection is performed by the surgeon under the guidance of glue volume markings from the fluoroscopic image. The method is now complete.

[0173] Flowcharts and block diagrams are provided herein for exemplary purposes; those of ordinary skill in the art will recognize numerous variations, but these variations are still within the scope of the present disclosure. For example, a block diagram may show a specific arrangement of components, modules, services, steps, processes, or layers, thereby generating a specific data flow. It is understood that some aspects of the systems disclosed herein may include additional components, some components shown may not be present for some aspects, and the arrangement of components may be different from that shown, thereby generating different data flows, while still performing the methods described herein.

[0174] Similarly, the logic of the flow chart can be shown as sequential. However, similar logic can be parallel, massively parallel, object-oriented, real-time, event-driven, cellular automaton or other, while achieving the same or similar functions. In order to perform the method described herein, the processor can be divided into multiple machine instructions for each step described herein, and these instructions can be executed in a single processor or across multiple processors at a rate of hundreds, thousands, millions or billions per second. This fast execution can be utilized to perform the method described herein in real time or near real time. For example, when repositioning the ideal fenestration point to avoid the stent strut, the ideal catheter path can be recalculated in real time to prevent the delay that may increase the risk of ischemic injury of the patient.

[0175] Fig.30 3060 , memory 3064 , and communication module 3068 . These elements can communicate directly with each other or indirectly, for example, via one or more buses.

[0176] The processor 3060 may include any combination of a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller or a general purpose computing device, a reduced instruction set computing (RISC) device, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other related logic devices (including mechanical and quantum computers). The processor 3060 may also include another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 3060 may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in cooperation with a DSP core, or any other such configuration.

[0177] Memory 3064 may include cache memory (e.g., cache memory of processor 3060), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash disk, solid-state storage device, hard disk drive, other forms of volatile and non-volatile memory, or a combination of different types of memory. In one aspect, memory 3064 includes a non-transitory computer-readable medium. Memory 3064 may store instructions 3066. Instructions 3066 may include instructions that, when executed by processor 3060, cause processor 3060 to perform the operations described herein. Instructions 3066 may also be referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of computer-readable statements. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, processes, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0178] The communication module 3068 may include any electronic circuit and / or logic circuit to facilitate direct or indirect communication of data between the processor circuit 3050 and / or other processors or devices. In this regard, the communication module 3068 may be an input / output (I / O) device. In some examples, the communication module 3068 facilitates direct or indirect communication between the processor circuit 3050 and / or various elements of the stent graft fenestration system 100. The communication module 3068 may communicate within the processor circuit 3050 via a variety of methods or protocols. Serial communication protocols may include, but are not limited to, United States Serial Protocol Interface (USSPI), Inter-Integrated Circuit Bus (I2C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio Equipment Corporation 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol. Parallel protocols include, but are not limited to, Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged via a Universal Asynchronous Receiver Transmitter (UART), a Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystems.

[0179] External communications (including but not limited to software updates, firmware updates, preset sharing between the processor and the central server, or readings from a CAT scan device or a fluoroscopic imaging device) can be accomplished using any suitable wireless or wired communication technology, such as a cable interface (such as a Universal Serial Bus (USB), micro USB, Lightning, or FireWire interface), Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection (e.g., 2G / GSM (Global System for Mobile Communications), 3G / UMTS (Universal Mobile Telecommunications System), 4G, Long Term Evolution (LTE), WiMax, or 5G). For example, a Bluetooth Low Energy (BLE) radio can be used to establish a connection with a cloud service, transfer data, and receive software patches. The controller can be configured to communicate with a remote server or a local device (e.g., a laptop, tablet, or handheld device), or can include a display capable of displaying state variables and other information.

[0180] Therefore, it can be seen that the systems, methods and devices disclosed herein advantageously improve the surgeon's ability to plan and perform stent graft fenestration while eliminating the risks and difficulties associated with such surgery. There may be many variations to the above examples and aspects. For example, puncture instruments other than laser catheters may be used to achieve fenestration, including, for example, cutting catheters, deployable needles, and the like. The adhesive catheter may be replaced with any type of injection catheter configured for injecting therapeutic materials. The technology described herein may be applied to blood vessels or body lumens other than the aorta, to fenestration of objects within lumens other than stent grafts, to the treatment of diseases other than aneurysms, to fenestration of stent grafts not contained within a blood vessel (e.g., bypass grafts), and to the placement of implantable sensors within blood vessels or other organs.

[0181] The logical operations constituting the various aspects of the technology described herein are variously referred to as operations, steps, objects, elements, components, or modules. In addition, it should be understood that these operations can be performed in any order unless explicitly required otherwise or a specific order is inherently required by the required language.

[0182] All directional references, such as up, down, inside, outside, upward, downward, left, right, side, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal and distal, are used for identification purposes only to assist the reader in understanding the claimed subject matter and do not create limitations, especially with respect to the location, orientation or use of the laser windowing system. References to connection, such as attachment, coupling, connection, engagement or "communication with..." should be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements, unless otherwise stated. Thus, references to connection do not necessarily mean that two elements are directly connected and in a fixed relationship to each other. The term "or" should be interpreted as "and / or", not "exclusively or". Unless otherwise stated in the claims, the numerical values ​​stated should be interpreted as merely illustrative and should not be regarded as limiting. The word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. Unless otherwise stated in the claims, the stated numerical values ​​should be interpreted as illustrative only and should not be regarded as limiting.

[0183] The above specification, examples, and data provide a complete description of the structure and use of exemplary aspects of the laser windowing system as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of specificity, or with reference to one or more individual aspects, those skilled in the art may make numerous modifications to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0184] Other aspects are also contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Modifications may be made in detail or structure without departing from the essential elements of the subject matter as defined in the following claims.

Claims

1. A system for performing intraluminal fenestration in a body lumen, the system comprising: a first intraluminal device comprising a flexible elongated member; and a processor in communication with the first intraluminal device, wherein the processor is configured to: obtaining a planning image from a first imaging system, the planning image including the body lumen and branch lumens extending from the body lumen; identifying, in the planning image, a contour of a treatment device; In the planning image, identifying a centerline of the branch lumen, the centerline of the branch lumen extending from the branch lumen to a desired puncture point at a boundary of a contour of the treatment device; identifying, in the planning image, a desired trajectory of the first intraluminal device relative to the desired puncture point; obtaining a real-time procedural image from a second imaging system, the real-time procedural image including the body lumen and the branch lumens extending from the body lumen; as well as In the real-time procedure image, the outline of the treatment device, the centerline of the branch lumen, the desired puncture point, the desired trajectory of the first intraluminal device, and the actual trajectory of the first intraluminal device are identified.

2. The system according to claim 1, wherein: The processor is further configured to: When the first intraluminal device is within a desired proximity and angle of the desired puncture point, a functional portion of the first intraluminal device is activated to puncture the therapeutic device.

3. The system according to claim 1, wherein: The processor is further configured to: In the planning image, identifying a lumen wall of the branch lumen extending from the branch lumen to a contour of the treatment device; and In the real-time procedural image, a lumen wall of the branch lumen is identified that outlines the lumen extending from the branch lumen to the treatment device.

4. The system according to claim 1, wherein: The processor is further configured to: After the treatment device is placed within the body lumen, the identified desired puncture point and the identified desired trajectory of the first intraluminal device are adjusted based on the position of the treatment device within the real-time procedural image.

5. The system according to claim 1, wherein: The processor is further configured to: An indication of a difference between the desired trajectory of the first intraluminal device and the actual trajectory of the first intraluminal device is displayed on the real-time procedural image.

6. The system according to claim 1, wherein: The system further includes at least one of a guide catheter or a guidewire, wherein the guide catheter or guidewire is configured to affect the actual trajectory of the first intraluminal device.

7. The system according to claim 6, wherein: The guidewire is a fiber optic true shape (FORS) guidewire, and the processor is further configured to identify a 3D trajectory of the FORS guidewire on the real-time procedural image as the FORS guidewire moves through the body lumen.

8. The system according to claim 1, wherein: The processor is further configured to: As the second intraluminal device traverses the body lumen, an actual trajectory of the second intraluminal device is identified on the real-time procedural image.

9. The system according to claim 8, wherein: The system also includes at least one of a guide catheter or a guidewire, wherein the guide catheter or guidewire is configured to affect an actual trajectory of the second intraluminal device.

10. The system according to claim 9, wherein: The guidewire is a fiber optic true shape (FORS) guidewire, and the processor is further configured to display a 3D trajectory of the FORS guidewire on the real-time procedural image stream as the FORS guidewire moves through the body lumen.

11. The system according to claim 8, wherein: The second intraluminal device is a cutting device configured to increase the diameter of a perforation in the treatment device.

12. The system according to claim 8, wherein: The second intraluminal device is an intravascular imaging device.

13. The system according to claim 8, wherein: The second intraluminal device is an injection catheter configured for injecting a therapeutic material.

14. The system according to claim 13, wherein: The processor is further configured to: identifying, in the planning image, an injection volume within the branch lumen, wherein the injection volume is to be injected with the therapeutic material; and In the real-time procedure image, the injection volume within the branch lumen is identified.

15. The system of claim 1, wherein: The contour of the therapeutic device is a desired contour of a therapeutic device to be implanted or an actual contour of an implanted therapeutic device.

16. The system of claim 1, wherein: The first intraluminal device is a laser catheter device.

17. The system of claim 1, wherein: The processor is further configured to identify a desired trajectory of the first intraluminal device such that a bend radius of the first intraluminal device is no less than a specified bend radius.

18. The system of claim 17, wherein: The processor is further configured to identify a desired trajectory of the first intraluminal device such that a functional portion of the first intraluminal device approaches the desired puncture point within a desired angular range.

19. A method for performing intraluminal fenestration in a body lumen, the method comprising: Using a processor in communication with a first intraluminal device comprising a flexible elongated member: obtaining a planning image from a first imaging system, the planning image including the body lumen and branch lumens extending from the body lumen; In the planning image, identifying a contour of a treatment device; In the planning image, identifying a centerline of the branch lumen, the centerline of the branch lumen extending from the branch lumen to a desired puncture point at a boundary of a contour of the treatment device; identifying, in the planning image, a desired trajectory of the first intraluminal device relative to the desired puncture point; obtaining a real-time procedural image from a second imaging system, the real-time procedural image including the body lumen and the branch lumens extending from the body lumen; as well as In the real-time procedure image, the outline of the treatment device, the centerline of the branch lumen, the desired puncture point, the desired trajectory of the first intraluminal device, and the actual trajectory of the first intraluminal device are identified.

Images