Methods and systems for robotic transcaval treatment of aneurysms

Abstract

Embodiments described herein relate to a shunt for treating an aortic aneurysm and a robotic insertion system for implanting the shunt. In some embodiments, the shunt may include a central portion, an arterial sealing structure, and a venous sealing. In some embodiments, the venous sealing structure may have a lateral length in its deployed configuration, and the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure. The shunt may be advanced robotically in a delivery configuration through a venous puncture site of a vein to access an arterial puncture site of the artery, and then deployed, thereby enabling blood flow through the shunt from the artery to the vein.

Description

METHODS AND SYSTEMS FOR ROBOTIC TRANSCAVAL TREATMENT OFANEURYSMSRELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. Patent Application No. 19 / 186,418, filed April 22, 2025, entitled “METHODS AND SYSTEMS FOR TRANSCAVAL TREATMENT OF ANEURYSMS,” which is a division of U.S. Application No. 18 / 792,233, filed August 1, 2024, entitled “METHODS AND SYSTEMS FOR TRANSCAVAL TREATMENT OF ANEURYSMS,” which is a continuation-in-part of U.S. Patent Application No. 18 / 419,262, filed January 22, 2024, entitled “METHODS AND SYSTEMS FOR TRANSCAVAL TREATMENT OF ANEURYSMS,” and this application claims priority to International Application No. PCT / US2025 / 012472 filed January 21, 2025, and to U.S. Provisional Application No. 63 / 675,046, filed July 24, 2024 entitled “METHODS AND SYSTEMS FOR ROBOTIC TRANSCAVAL TREATMENT OF ANEURYSMS,” and to U.S. Provisional Application No. 63 / 675,198, filed July 24, 2024 entitled “SELF- ADJUSTING SHUNTS AND METHODS AND SYSTEMS FOR USING THE SAME,” the contents of each of which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Embodiments described herein relate to methods and systems for robotic transcaval treatment of aortic aneurysms.BACKGROUND

[0003] Tissue defects within blood vessels, such as aneurysms (e.g., aortic aneurysms and brain aneurysms) can lead to pain, stroke, and / or eventual ruptures in the vessel. Aneurysms occur when there is a weakening in the wall of the blood vessel leading to a widening, opening or formation of a cavity within the vessel wall. The opening of such a cavity can be further exasperated by the continual pooling of blood in the cavity, thereby pressurizing the already weakened vessel wall. Such a damaged vessel, which can be age-related, drug or tobacco-induced, resulting from atherosclerosis or in some instances, caused by infection, can result in a vessel rupture, which can lead to life-threatening internal bleeding. Shunts can be used to treat a variety of conditions including cardiac conditions (e.g., heart failure), peripheralvascular disease (PVD), portal hypertension, traumatic injuries, and aneurysms, for example. Tissue defects within blood vessels, such as aneurysms (e.g., aortic aneurysms and brain aneurysms) can lead to pain, stroke, and / or eventual ruptures in the vessel. Existing shunts have drawbacks associated with treating different conditions such as, for example, lack of adaptability and flexibility, difficult deployment, issues with anchoring (e.g., thereby causing leaks), and invasiveness.SUMMARY

[0004] In some embodiments, a method of preventing or relieving endotension in an aortic aneurysm in a subject includes puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; after the puncturing the artery, delivering an endograft to the aortic aneurysm; and after the puncturing the artery, creating a fluid passageway between the venous puncture site and the arterial puncture site to permit blood flow therethrough from the artery to the vein.

[0005] In some embodiments, a method of treating an aortic aneurysm of an artery in a subject having an endograft implanted within the aortic aneurysm, includes puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; and after the puncturing the artery, delivering a shunt through the venous puncture site towards and through the arterial puncture site, thereby enabling blood flow from the endoleak through a lumen defined by the shunt from the artery to the vein

[0006] In some embodiments, a method of treating an endoleak associated with an endograft implanted within an aortic aneurysm of an artery in a subject, includes selecting a shunt based on a lateral thickness of a thrombus formed in an aortic aneurysm determined by imaging of the aortic aneurysm, the shunt defining a body and having an arterial sealing structure at a first end of the body and a venous sealing structure at a second, opposite end of the body, a lateral length of the arterial sealing structure being greater than or equal to the lateral thickness of the thrombus; advancing the shunt in a delivery configuration through a venous puncture site of a vein to access an arterial puncture site of the artery; and transitioning the shunt from the delivery configuration to a deployed configuration to secure the shunt to the artery and the vein, thereby enabling blood flow through the body of the shunt from the artery to the vein.

[0007] In some embodiments, an apparatus for treating an endoleak includes a shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure.

[0008] In some embodiments, a cutting apparatus includes a proximal member and a distal member movably coupled to the proximal member to allow for relative axial movement between a first configuration in which the proximal member and the distal member are spaced a distance sufficient to span across a venous wall of a vein and an arterial wall of an artery, and a second configuration in which the proximal member and the distal member are spaced less than a thickness of at least one of the venous wall or the arterial wall, one of the proximal member or the distal member having a cutting edge configured to cut through the venous wall and the arterial wall.

[0009] In some embodiments, an apparatus for treating an endoleak includes a shunt defining a body and having an arterial sealing structure at a first end of the body and a venous sealing structure at a second, opposite end of the body, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration, the body having a fluid porosity that is less than a fluid porosity of both the arterial sealing structure and the venous sealing structure.

[0010] In some embodiments, a method of treating an aortic aneurysm in a subject, includes: puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; after puncturing the artery, delivering an endograft to the aortic aneurysm; and after puncturing the artery, delivering a shunt including a proximal flaring element and a distal flaring element such that the proximal flaring element is disposed within the vein and the distal flaring element is disposed within the artery, the distal flaring element having a lateral length greater than that of the proximal flaring element, wherein one or more instruments configured to puncture the vein, puncture the artery, deliver the endograft, and / or deliver the shunt are controlled by a robotic insertion system.

[0011] In some embodiments, a method of treating an aortic aneurysm in a subject having an endograft implanted within the aortic aneurysm, includes: puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; and after puncturing the artery, delivering a shunt through the venous puncture site towards and through the arterial puncture site, thereby enabling blood flow through a lumen defined by the shunt from the artery to the vein, the shunt including an arterial sealing structure and a venous sealing structure, the arterial sealing structure having a lateral length greater than that of the venous sealing structure, wherein one or more instruments configured to puncture the vein, puncture the artery, and / or deliver the shunt are controlled by a robotic insertion system.

[0012] In some embodiments, a method of treating an endoleak, includes: selecting, a shunt based on a lateral thickness of a thrombus formed in an aortic aneurysm determined by imaging of the aortic aneurysm, the shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, a lateral length of the arterial sealing structure being greater than or equal to the lateral thickness of the thrombus; advancing, via a robotic insertion system, the shunt in a delivery configuration through a venous puncture site of a vein to access an arterial puncture site of the artery; and transitioning, via a robotic insertion system, the shunt from the delivery configuration to a deployed configuration to secure the shunt to the artery and the vein, thereby enabling blood flow through the central portion of the shunt from the artery to the vein, wherein an imaging modality of a robotic insertion system is configured to image the aortic aneurysm.

[0013] In some embodiments, an apparatus, includes: a shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure, wherein the shunt is configured to be inserted via a robotic insertion system.

[0014] In some embodiments, a cutting apparatus, includes: a proximal member and a distal member movably coupled to the proximal member to allow for relative axial movement between a first configuration in which the proximal member and the distal member are spaced a distance sufficient to span across a venous wall of a vein and an arterial wall of an artery, and a second configuration in which the proximal member and the distal member are spaced less than a thickness of at least one of the venous wall or the arterial wall, one of the proximal member or the distal member having a cutting edge configured to cut through the venous wall and the arterial wall, wherein the cutting apparatus is configured to be controlled by a robotic insertion system.

[0015] In some embodiments, an apparatus is disclosed, including: a shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration by a robotic insertion system, the arterial sealing structure having a fluid porosity that is greater than a fluid porosity of the central portion.

[0016] In some embodiments, a method for performing a transcaval access procedure using a robotically steerable catheter, includes: inserting a steerable catheter into the inferior vena cava using a robotically controlled system, wherein the steerable catheter is advanced along the inferior vena cava until the distal end is adjacent a target transcaval puncture location; manipulating the catheter using the robotically controlled system; imaging at least a portion of the inferior vena cava and the aorta using an imaging device to obtain an image; locating an anatomical landmark using the image of at least a portion of the inferior vena cava and the aorta, and storing a position and orientation of the robotically steerable catheter to arrive at the anatomical landmark; and advancing a transcaval puncture device through the steerable catheter via a central lumen to puncture through the inferior vena cava and the aorta.

[0017] In some embodiments, a robotic system configured for transcaval access, includes: a medical instrument having an elongate body and at least one sensor; a display; a processor; and a memory storing computer-executable instructions to cause the processor to: access a three-dimensional model of at least a portion of the vena cava and at least a portion of the aorta, the model based on a preoperative mapping of at least a portion of the vena cava andat least a portion of the aorta, determine a position of a target transcaval puncture location with respect to the model, determine, based on data from the at least one sensor, a position and orientation of a distal end of the medical instrument with respect to the model, cause, on at least a portion of the display, a rendering of the model, the position of the target transcaval puncture location with respect to the model, and the position and orientation of the distal end of the medical instrument with respect to the model, wherein the rendering includes a virtual viewpoint directed at the target transcaval puncture location, the rendering being simulated from a virtual viewpoint perspective at a virtual location with respect to the model, and cause within the portion of the display a rendering of a modified view of the model, the modified view being rendered from a modified virtual viewpoint in which the virtual viewpoint perspective is rotated around the target transcaval puncture location with the target transcaval puncture location as a center of the rotation.

[0018] In some embodiments, a non-transitory computer readable storage medium having stored thereon instructions that, when executed, cause at least one computing device to: access a three-dimensional model of at least a portion of the vena cava and at least a portion of the aorta, the model based on a preoperative mapping of at least a portion of the vena cava and at least a portion of the aorta, determine a position of a target transcaval puncture location with respect to the model; determine, based on data from at least one sensor of a medical instrument, a position and orientation of a distal end of the medical instrument with respect to the model; cause, on at least a portion of a display, a rendering of the model, a position of the target transcaval puncture location with respect to the model, and the position and orientation of the distal end of the medical instrument with respect to the model, wherein the rendering includes a virtual viewpoint directed at the target transcaval puncture location, the rendering being simulated from a virtual viewpoint perspective at a virtual location with respect to the model.

[0019] In some embodiments, a method of providing transcaval access to the aorta using a robotic system, includes: inserting a steerable catheter into the inferior vena cava using a robotically controlled system; routing the steerable catheter to a target transcaval puncture location via the inferior vena cava; positioning a distal portion of the steerable catheter against tissue adjacent the target transcaval puncture location; and routing a piercing instrumentthrough a central lumen of the steerable catheter to puncture through the inferior vena cava and the aorta to access the endovascular space of the aorta.

[0020] In some embodiments, a method for deploying a transcaval stent is disclosed, the method including: introducing robotically controlled steerable catheter into the inferior vena cava; articulating the distal end of the steerable catheter towards a target transcaval puncture location; advancing a guidewire through the target transcaval puncture location into the sac of an aortic aneurysm, wherein the guidewire is advanced via a central lumen of the steerable catheter, advancing a stent delivery catheter over the guidewire, wherein the stent delivery catheter includes a transcaval stent disposed within an outer sheath; positioning the stent delivery catheter proximal the target transcaval puncture location; deploying a first distal end of the transcaval stent within the sac of the aortic aneurysm, wherein the distal end of the transcaval stent is expanded from a small profile, undeployed configuration to a large profile, deployed configuration by sliding the outer sheath from a first position to a second position; and deploying a second proximal end of the transcaval stent within the inferior vena cava, wherein the transcaval stent is expanded from a small profile, undeployed configuration to a large profile, deployed configuration by sliding an outer sheath from the second position to a third position.

[0021] In some embodiments, a method of performing a medical procedure on a patient, includes: introducing a first medical instrument into the venous system of a patient, the first medical instrument configured for robotic endovascular navigation and including an elongate, flexible body with at least one central lumen extending therethrough; introducing a second medical instrument via a central lumen of the first medical instrument, a distal end of the second medical instrument including a piercing element configured to pierce at least one anatomical vessel; positioning the piercing element proximal to a target transcaval puncture site; advancing the piercing element through the target transcaval puncture site into the sac of an aortic aneurysm; introducing a third medical instrument via a central lumen of the first medical instrument, the third medical instrument including at least one expandable element configured for creating a fluid conduit between the sac of an aortic aneurysm and the inferior vena cava; and expanding the third medical instrument to create a fluid conduit between the sac of the aortic aneurysm and the inferior vena cava.

[0022] In some embodiments, a method for performing transcaval embolization is disclosed, the method performed by a robotic medical system and including: acquiring an anatomical image to identify at least one target embolization location and at least one target transcaval puncture location; introducing a first instrument into a blood vessel, the first medical instrument configured for robotic endovascular navigation and including an elongate, flexible body with at least one central lumen extending therethrough; introducing a second instrument via a central lumen of the first medical instrument, the second instrument including: an elongate, flexible body with at least one central lumen extending therethrough; and a piercing element configured to pierce at least one anatomical vessel, the piercing element disposed at a distal end of the second instrument; acquiring localization information for at least one instrument from at least one tracking sensor integrated in the instrument; registering at least one instrument to the anatomical image; overlaying a representation of at least a portion of at least one instrument on the anatomical image for display to a user; receiving a user command to drive the first instrument, the user command received from the user via a user input device; identifying, based on the localization information of at least one instrument and at least one identified target, a suitable position and suitable orientation of a distal end of the first instrument; overlaying a representation of a virtual trajectory extending from the first instrument on the display, the trajectory being defined by the position and orientation of the distal end of the first instrument; advancing the piercing element of the second instrument such that the piercing element substantially follows over the virtual trajectory defined by the position and orientation of the first instrument; and delivering a flowable material via a central lumen of at least one instrument.

[0023] In some embodiments, a stent delivery apparatus includes an outer sheath, comprising an elongated tubular member having distal and proximal ends. An inner shaft is located coaxially within said outer sheath, said inner shaft having a distal end and a proximal end. A stop is releasably affixed on an exterior surface of the inner shaft adjacent its proximal end, said stop being configured to allow said outer sheath to move a predetermined distance, thereby enabling at least partial deployment of a self-expanding stent. A self-expanding stent is configured for creating a fluid conduit between an aortic aneurysm and a venous vessel, said stent located within said outer sheath. In some embodiments, the stent comprises a central portion; an arterial sealing structure at a first end of the central portion; and a venous sealingstructure at a second, opposite end of the central portion. In some embodiments, the arterial sealing structure and the venous sealing structure are both expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, and the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure. In some embodiments, the stent delivery apparatus is configured and adapted for use with a robotic insertion system for robotic delivery of the stent.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 A is a schematic block diagram of a shunt for treating or alleviating an aortic aneurysm in a delivery configuration, according to an embodiment.

[0025] FIG. IB is a schematic block diagram of the shunt for treating or alleviating an aortic aneurysm in a deployed configuration, according to an embodiment.

[0026] FIGS. 2A-2C are schematic block diagrams depicting placement of the shunt of FIGS. 1A- IB to connect a vena cava and an aorta of a patient to treat an endoleak, according to an embodiment.

[0027] FIGS. 3A-3B are a flow diagrams of an example method of using the shunt of FIGS. 1 A-1B to treat an aortic aneurysm, according to an embodiment.

[0028] FIG. 4 is a schematic block diagram of a distal end of a delivery system of the shunt, according to an embodiment.

[0029] FIG. 4A is a schematic block diagram of a distal end of another delivery system of the shunt, according to an embodiment.

[0030] FIG. 5A shows a side view of a shunt for treating or alleviating an aortic aneurysm in a delivery configuration, according to an embodiment.

[0031] FIGS. 5B-5C show a front view and a side view, respectively, of the shunt in a deployed configuration, according to an embodiment.

[0032] FIGS. 6A-6D are side views of a shunt in the deployed configuration forming an hourglass shape, according to an embodiment.

[0033] FIG. 6E is a side view of a shunt in the deployed configuration in which the arterial sealing structure forms a conical bulb shape, according to an embodiment.

[0034] FIG. 7 is an illustration of the shunt in the deployed configuration illustrating positioning of a venous sealing structure relative to a wall of a vein and an arterialsealing structure relative to a wall of an artery including thrombus, according to an embodiment.

[0035] FIG. 8 is a side view of a shunt in the deployed configuration with a flow controller including a valve and a filter disposed therein, according to an embodiment.

[0036] FIGS. 9A-9G are illustrations of the shunt disposed between an artery and a vein to place the artery in fluid communication with the vein to treat an aortic aneurysm, according to an embodiment.

[0037] FIGS. 10A-10B show the delivery system including a guidewire, dilator, sliding sheath, catheter, and handle for delivering the shunt to treat or alleviate an aortic aneurysm, according to an embodiment.

[0038] FIG. 11 is an illustration of a distal tip for cutting an opening in the vasculature such that the shunt may be disposed therethrough, according to an embodiment.

[0039] FIG. 12 is an illustration of an abdominal aortic aneurysm showing the aneurysm sac, the right kidney, the left kidney, and arterial vessels that branch out from the aorta.

[0040] FIG. 13 A is a schematic of the abdominal aortic aneurysm showing the aneurysm sac.

[0041] FIG. 13B is a schematic of an endograft implanted in the aneurysm sac to treat or alleviate the abdominal aortic aneurysm, according to an embodiment.

[0042] FIG. 13C is a schematic of a distal end of a delivery system puncturing the vena cava and the aorta to treat an aortic aneurysm, according to an embodiment.

[0043] FIG. 13D is a schematic of the shunt being deployed transcavally to place the aorta in fluid communication with the vena cava, according to an embodiment.

[0044] FIG. 13E is a schematic of the shunt in a deployed configuration implanted transcavally between the aorta and the vena cava, according to an embodiment.

[0045] FIG. 13F is a schematic of the shunt in the deployed configuration implanted transcavally to allow blood to flow from the aorta to the vena cava, according to an embodiment.

[0046] FIGS. 14A-14B are illustrations of the shunt in the deployed configuration implanted transcavally to allow blood to flow from the aorta to the vena cava, according to an embodiment

[0047] FIG. 15 is a diagram of a distal end of a delivery system disposed through a venous puncture site and an arterial puncture site with the a in a delivery configuration disposed therein, according to an embodiment.

[0048] FIG. 16 is a diagram of the distal end of a delivery system of FIG. 15 extending toward a target puncture site on a wall of the vena cava, according to an embodiment.

[0049] FIG. 17 is a diagram of the distal end of the delivery system of FIGS. 15- 16 puncturing the vena cava and the aorta with a guidewire, according to an embodiment.

[0050] FIG. 18 is a diagram of a dilator tip of the distal end of the delivery system of FIGS. 15- 17 dilating a venous puncture site and arterial puncture site created by the guidewire, according to an embodiment.

[0051] FIG. 19 is a diagram of the dilator body including the shunt being disposed through the venous puncture site and the arterial puncture site to position the shunt between the vena cava and the aorta, according to an embodiment.

[0052] FIG. 20 is a diagram of a distal end of the shunt being deployed to seal the arterial puncture site, according to an embodiment.

[0053] FIG. 21 is a diagram of the proximal end of the shunt being deployed to seal the venous puncture site, according to an embodiment.

[0054] FIGS. 22-24 are diagrams of the dilator body being retracted such that the shunt is disposed between the aorta and the vena cava in the deployed configuration, according to an embodiment.

[0055] FIG. 25 is a diagram illustrating blood flow through the shunt deployed between the aorta and the vena cava, according to an embodiment.

[0056] FIG. 26 is a diagram illustrating the arterial sealing structure of the deployed shunt conforming to a curvature of the aorta, according to an embodiment.

[0057] FIG. 27 is a diagram illustrating flexibility of the body of the shunt such that a fluid tight seal around the arterial puncture site is maintained, according to an embodiment.

[0058] FIG. 28 is a diagram illustrating the venous sealing structure and the arterial sealing structure of the shunt pivoting relative to a central portion of the shunt to maintain the fluid tight seal, according to an embodiment.

[0059] FIGS. 29-38 are diagrams illustrating implantation of a shunt using a snare wire, according to an embodiment.

[0060] FIG. 39 is a diagram showing a decrease in size of the aneurysm sac and tissue ingrowth into the shunt after implantation of the shunt.

[0061] FIGS. 40A-40E are diagrams of implantation of a bypass graft connecting a portion of the aorta above the aneurysm sac to a portion of the aorta below the aneurysm sac to treat or alleviate the aneurysm, according to an embodiment.

[0062] FIG. 41 A shows a shunt including a self-rolling mechanism, according to embodiments.

[0063] FIG. 4 IB shows dimensions of the shunt, according to embodiments.

[0064] FIGS. 42A-42B show a self-rolling shunt including a braided metal alloy, according to embodiments.

[0065] FIGS. 43A-43G are images of a self-rolling shunt transitioning from a delivery configuration to a deployed configuration, according to embodiments.

[0066] FIGS. 44A-44C show a handle for a delivery system for delivering a shunt, according to embodiments.

[0067] FIG. 45 is a schematic diagram of a robotic insertion system, according to an embodiment.

[0068] FIG. 46 illustrates a robotic insertion device of the robotic insertion system of FIG. 41, according to an embodiment.

[0069] FIG. 47 illustrates an operation assembly with the robotic insertion system of FIG. 41, according to an embodiment.

[0070] FIG. 48 illustrates a block diagram of a method for performing transcaval embolization with a robotic insertion system, according to an embodiment.

[0071] FIG. 49 illustrates a block diagram illustrating an embodiment of a computer hardware system configured to run software for implementing one or more embodiments of the system, methods, and devices disclosed herein.DETAILED DESCRIPTION

[0072] Aneurysms occur when there is a weakening in the wall of the blood vessel leading to a widening, opening or formation of a cavity within the vessel wall. The opening of such a cavity can be further exasperated by the continual pooling of blood in the cavity, therebypressurizing the already weakened vessel wall. Such a damaged vessel, which can be age- related, drug or tobacco-induced, resulting from atherosclerosis or in some instances, caused by infection, can result in a vessel rupture, which can lead to life-threatening internal bleeding.

[0073] An abdominal aortic aneurysm is an aneurysm in the abdominal portion of the aorta usually located in or near one or both of the two iliac arteries or near the renal arteries. The aneurysm often arises in the infrarenal portion of the diseased aorta, for example, below the kidneys. The occurrence of aneurysms is not confined to the abdominal region. While abdominal aortic aneurysms are generally the most common, aneurysms in other regions of the aorta or one of its branches are possible. For example, a thoracic aortic aneurysm is an aneurysm in the thoracic portion of the aorta. When left untreated, the aneurysm may rupture, usually causing rapid fatal hemorrhaging. A ruptured abdominal aortic aneurysm is presently the thirteenth leading cause of death in the United States. Aortic aneurysms often cause an enlarged area in portion of the aorta in which they are located (e.g., aneurysm sac).

[0074] Endovascular Aortic Aneurysm Repair (EVAR) is a procedure in which a stent-graft prosthesis (hereinafter, 'endograft') is deployed endovascularly to treat an aneurysm, while leaving the aneurysm sac in place. Endografts have been developed to place exclusion devices within or across an opening or cavity associated with the subject tissue defect to preserve blood flow through the damaged blood vessel (e.g., where the aneurysm sac is located) and prevent blood from further pressurizing the damaged vascular tissue. EVAR may be favored over open surgical repair of aneurysms in order to, for example, shorten operation, intensive care, and total hospital times and lower postoperative morbidity. Although EVAR has become a viable alternative to open repair for a significant percentage of abdominal aortic aneurysm patients, the varying shapes, locations, sizes, and other features associated with an abnormal or unhealthy aorta can prevent proper alignment and / or sealing of the endograft with the vessel wall / tissue. As a result, EVAR requires long-term postoperative surveillance to detect complications such as endoleaks, endograft migration, endograft fracture, and aortic neck dilation. Endoleak remains the most severe complication of EVAR and may result in lifethreatening sac enlargement and aneurysm rupture if a patient does not receive imaging on a regular basis to detect possible complications. Endoleak occurs in up to 50% of all EVAR cases. Almost 30% of patients require reintervention within 5 years after EVAR due to endoleaks causing aneurysm sac enlargement.

[0075] Endoleaks, of which there are 5 different types, involve blood flow within the aneurysm sac and outside the endograft lumen and can lead to an increased risk of aneurysmal expansion and rupture. A Type I endoleak occurs when blood flows between the endograft and the blood vessel wall; typically at the proximal (often renal) or distal (often iliac) end of the endograft. This complication may also occur as a result of movement of the endograft away from the desired location, sometimes called migration. Type II endoleaks occur when blood flows backwards (retrograde) into the aneurysm sac from arteries originating from the aneurysm sac itself (typically the lumbar, testicular or inferior mesenteric arteries). Type III endoleaks occur when blood leaks between the junction sites of "articulated" or "segmented" endografts; these multi-component endografts are inserted as separate segments which are then assembled inside the artery into their final configuration. Detecting and confirming accurate assembly and fluid-tight contact between the different segments is difficult and current verification methods of correct assembly are suboptimal. Type IV endoleaks occur when cracks or defects develop in the endograft fabric and blood is able to leak directly through the graft material. Lastly, Type V endoleaks are leakage of blood into the aneurysm sac of an unknown origin. Regardless of their cause, endoleaks are frequently a medical emergency and early detection, characterization and monitoring of them is an important unmet medical need. Incidence rates vary from 15% to 52%, and most patients require either a surgical or endovascular intervention.

[0076] The origin of the leak defines the type of endoleak, but all or most types of endoleaks are typically monitored with long term surveillance or addressed with subsequent surgical procedures. New endoleaks may develop as long as several years post-procedure, which necessitates long term patient screening. As more patients are opting for EVAR, there is a strain on healthcare systems to cover the cost. Long-term surveillance, imaging studies, and reintervention have been shown to increase the global cost of EVAR by nearly 50%. According to recent meta-analyses, EVAR has a 56% greater intermediate reintervention rate and 243% greater long-term reintervention rate when compared to open surgical repair. Despite more compliant stent-graft technology and more surgical experience, EVAR remains less durable than open repair. Long-term durability of EVAR suffers due to endoleak development, graft migration, and continued sac pressurization, all of which may result in sac rupture. Despite new technology for stent-grafts, the amount of people who develop endoleaks has notsignificantly decreased, partly as a result of endografts being implanted outside of their instructions for use (IFU) and the inability to effectively prevent type II endoleaks.

[0077] Embodiments described herein help prevent or mitigate endoleaks and may liberalize the IFU for stent-grafts, reduce EVAR complications related to endoleak, and reduce the amount of stringent post-EVAR imaging. The embodiments described herein may have a positive impact economically, physically, and mentally on patients due to increased EVAR durability and reduced monitoring. Accordingly, embodiments that reduce the development and severity of endoleaks will improve cost effectiveness and durability of EVAR.

[0078] Type I (Tl) and type III (T3) endoleaks have been treated by coil embolization, angioplasty, additional endografts, or glue embolization. However, management for type II (T2) endoleaks remains controversial despite being the most common type of endoleak. Unlike Tl and T3 endoleaks, T2 endoleaks can spontaneously resolve and their relationship to aneurysm sac enlargement and pressurization are uncertain. There is a consensus, however, that persistent T2 endoleaks (>6 months) are associated with aneurysm sac growth, reintervention, conversion to open repair, and rupture. Furthermore, the detection and embolization of T2 endoleaks is difficult due to the size of feeding vessels. As a result of inadequate detection of endoleaks and the ability of endoleaks to resolve then reappear, patients are monitored yearly. Regardless of the type of endoleak, embodiments address a clinical need to make EVAR more durable and to exclude the aneurysm from systemic circulation. Prophylactic embodiments may reduce the need for long- term surveillance, prevent endograft migration via biological fixation, and mitigate endoleak formation.

[0079] The risk of aneurysm rupture is related to aneurysm size, with large aneurysms more likely to rupture than small aneurysms. Due to the risks of early repair, most patients with abdominal aortic aneurysms (AAAs) are only eligible for treatment when their aneurysms have progressed to the point of imminent rupture. There is no solution to prevent disease progression when AAAs are at a relatively harmless stage (smaller than -5cm). These patients are under "active surveillance" (annual or semi-annual imaging protocols), tracking their aneurysm's growth until it reaches a large enough threshold for treatment. In the meantime, these patients are living their lives knowing they have up to an 8% risk of rupture.

[0080] There are an estimated 13 million people worldwide currently living with an abdominal aortic aneurysm. When left untreated, all AAAs will eventually rupture if apatient lives long enough. A ruptured AAA is associated with up to a 90% mortality rate and is a contributing factor for 2% of all deaths. AAAs are estimated to cause over 200,000 deaths every year worldwide. With a rapidly growing worldwide population of elderly patients with a significantly higher risk of developing aortic aneurysms, there is a need for solutions to improve the standard of care of endovascular aortic aneurysm repair.

[0081] In some embodiments, the methods and systems disclosed and described herein are useful to treat aneurysms after a patient has undergone an EVAR procedure and requires additional treatment to alleviate the aneurysm and / or reduce endotension. In some embodiments, the methods and systems disclosed and described herein are useful to treat, repair, and / or prevent endoleaks and / or endotension after, during, and / or before a patient has undergone an EVAR procedure. In some embodiments, the methods and systems disclosed and described herein are useful to treat aneurysms by alleviating blood pressure at a target vascular site. In some embodiments, the methods and systems disclosed and described herein are useful to reduce the severity, frequency, and / or duration of adverse events related to the treatment of aortic aneurysms.

[0082] In some embodiments, treating aortic aneurysms helps prevent an aneurysm rupture, reduce an aneurysm size (e.g., aneurysm sac size), alleviates hypertension within the aneurysm, or any combination thereof.

[0083] There have been several case studies showing the presence of an aortocaval fistula providing immediate benefit to patients after EVAR by shunting blood from the aneurysm sac to the inferior vena cava, resulting in rapid shrinkage of AAAs despite persistent endoleaks. Accordingly, a device configured for creating a fluid connection between the inferior vena cava and the sac of an abdominal aortic aneurysm would provide a safe and effective alternate means of improving post-procedural outcomes following endovascular aortic aneurysm repair. Transcaval access provides an improved access route for endovascular aortic interventions in aortic interventions, particularly for patients unsuitable for traditional access routes including femoral, subclavian, transapical, and aortic. This approach involves percutaneous advancement of a guidewire into the abdominal aorta via initial access from the femoral vein through the adjoining inferior vena cava.

[0084] In some embodiments, treating aortic aneurysms comprises relieving pressure build-up and / or reducing blood flow through the impacted region experiencing theaneurysm. In some embodiments, a shunt (e.g., transcaval shunt) is implanted from an adjacent vein (e.g., vena cava) and passed through an aortic wall so as to allow blood to flow from the artery (e.g., abdominal aorta) to the vein (e.g., vena cava). In some embodiments, the shunt is used to help alleviate, reduce, eliminate, and / or prevent fluid build-up resulting from one or more endoleaks. In alternate or additional embodiments, a bypass graft may be implanted so as to bypass all or some of the blood flow around the aneurysm (e.g., aneurysm sac). In some embodiments, systems and methods described herein are used to treat an aortic aneurysm after a subject has undergone an EVAR procedure to implant a stent-graft prosthesis (e.g., endograft).

[0085] According to some embodiments, systems, methods, and procedures, a catheter is manipulated through a patient's vasculature to, for example, the site of an aortic aneurysm. Once at the intended site, treatment may include the delivery of a shunt to create a fluid conduit between an aortic aneurysm and a venous vessel, which may be desirable to prevent pressure build-up within the sac of an aortic aneurysm due to one or more endoleaks, alleviate or otherwise reduce pressure within the sac of an aortic aneurysm due to one or more endoleaks, facilitate aneurysm shrinkage, facilitate the transfer of oxygenated blood into the venous system, promote thrombus reabsorption, and / or prevent thrombus formation.

[0086] Such systems and treatments can require precise control of the catheter during manipulation to and at the treatment site, which can invariably be a function of a user's skill level. There is a need for a system and method for precise and dynamic automated control of a catheter and its related components, for example, to treat aortic aneurysms, that will minimize and / or eliminate procedural variability due to a user's skill level. Additionally, it may be desirable to minimize and / or eliminate radiation exposure from fluoroscopy by enabling separation of a physician from the patient, with the procedures being optionally performed at the patient site or from a remote location.

[0087] Robotic surgical systems and devices are well suited for use in performing minimally invasive medical procedures, as opposed to conventional techniques wherein the patient's body cavity is open to permit the surgeon's hands access to internal organs.

[0088] Disclosed herein, in some aspects, is a stent delivery apparatus including an outer sheath, comprising an elongated tubular member having distal and proximal ends. An inner shaft is located coaxially within said outer sheath, said inner shaft having a distal end anda proximal end. A stop is releasably affixed on an exterior surface of the inner shaft adjacent its proximal end, said stop being configured to allow said outer sheath to move a predetermined distance, thereby enabling at least partial deployment of a self-expanding stent. A selfexpanding stent is configured for creating a fluid conduit between an aortic aneurysm and a venous vessel, said stent located within said outer sheath. In some embodiments, the stent comprises a central portion; an arterial sealing structure at a first end of the central portion; and a venous sealing structure at a second, opposite end of the central portion. In some embodiments, the arterial sealing structure and the venous sealing structure are both expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, and the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure. In some embodiments, the stent delivery apparatus is configured for use with a robotic insertion system for robotic delivery of the stent.

[0089] Disclosed herein, in some aspects, is a method of treating or alleviating an aortic aneurysm in a subject and a robotic insertion system configured to perform one or more steps of the method. The method may include advancing a shunt through a venous puncture site of a vein to access an arterial puncture site of an artery, the arterial puncture site disposed within the aortic aneurysm or upstream of the aortic aneurysm; and securing the shunt to the artery and vein by deploying i) an arterial sealing structure coupled to a distal end of the shunt, and ii) deploying a venous sealing structure coupled to a proximal end of the shunt, thereby enabling fluid to flow from the artery to the vein. In some embodiments, advancing the shunt occurs contemporaneous or substantially contemporaneous with an implantation of an endograft within the aortic aneurysm. In some embodiments, advancing the shunt occurs after an implantation of an endograft within the aortic aneurysm. In some embodiments, advancing the shunt includes inserting a catheter within the vein, the catheter being steerable via a catheter handle coupled thereto; and extending a sliding sheath from the catheter, the sliding sheath detachably coupled to the shunt.

[0090] In some embodiments, securing one or both of the arterial sealing structure and the venous sealing structure comprises withdrawing the sliding sheath away from the artery. In some embodiments, one or both of the arterial sealing structure and the venous sealing structure are self expandable. In some embodiments, the aortic aneurysm is anabdominal aortic aneurysm. In some embodiments, one or both of the arterial and venous sealing structures are pivotally attached to the shunt. In some embodiments, the shunt comprises a shunt body made of a compliant material capable of stretching and shrinking. In some embodiments, the shunt body includes a lumen therein so as to enable the fluid to flow from the artery to the vein.

[0091] Disclosed herein, in some aspects, is a method of treating an aortic aneurysm in a subject, the method including implanting a graft within a subject to at least partially bypass a fluid flow through an artery around the aortic aneurysm, the graft having a lumen therein. In some embodiments, the graft is fluidly coupled to the artery at i) a first location upstream of the aortic aneurysm to receive the fluid, and ii) a second location downstream of the aortic aneurysm to deliver the fluid back to the artery. In some embodiments, the graft passes through a portion of a vein. In some embodiments, implanting the graft includes inserting a catheter within the artery; passing the artery through the second location of the artery to exit the artery; advancing the catheter to the first location of the artery; passing the catheter through the first location; advancing the graft over the catheter; deploying a first sealing structure to secure and seal the graft at the first location; deploying a second sealing structure to secure and seal the graft at the second location; and withdrawing the catheter. In some embodiments, one or both of the first and second sealing structures are selfexpandable.

[0092] Disclosed herein, is a shunt that includes a self-adjusting mechanism (e.g., a self-sizing, self-rolling, etc.). In some embodiments, a distal end and / or a proximal end of the shunt may be configured to roll and / or unroll during and / or after deployment of the shunt such that a total length of the shunt is adjustable during and / or after deployment. Therefore, the total length of the shunt may be adjusted to accommodate changes in anatomy (e.g., a space between vessels increasing and / or decreasing after deployment). In some embodiments, the distal end of the shunt may roll to form a toroidal structure, and the toroidal structure may act as an anchor to stabilize the shunt. In some embodiments, one end (e.g., proximal end) of the shunt maybe roll to form a toroidal structure and another end (e.g., distal end) of the shunt may form a different structure, e.g., a sealing structure (e.g., a bulb-like shape, a cone, a disc-like shape, a flared structure, etc.) to seal any openings around the shunt in the vessel (or other anatomy) to prevent leakage of blood into the extravascular space after deployment.

[0093] In some embodiments, a shunt may include a first end, a second end, and a central portion therebetween, and the shunt can be configured to transition between a delivery configuration in which the shunt is cylindrical and a deployed configuration in which the second end of the shunt has rolled to form a toroidal structure and to decrease a total length of the shunt. In some embodiments, the first end of the shunt may be the proximal end and the second end of the shunt may be the distal end. In some embodiments, the second end of the shunt may form a toroidal structure when the second end rolls towards the central portion, and the toroidal structure may be configured to anchor the shunt relative to a vessel. In some embodiments, the first end may expand radially to form a disc shape when the shunt transitions from the delivery configuration to the deployed configuration. In some embodiments, the shunt may be configured to dynamically adjust the total length of the shunt by further rolling or unrolling the toroidal structure based on changes in anatomic structure or pressure conditions. In some embodiments, the shunt may be coupled to a delivery catheter configured to constrain the shunt in the delivery configuration and to release the shunt to transition the shunt to the deployed configuration. In some embodiments, the shunt can include at least one radiopaque marker.

[0094] In some embodiments, a shunt may include a first end, a second end, and a central portion therebetween, and the shunt may be configured to transition between a delivery configuration in which the shunt is cylindrical and a deployed configuration in which the second end of the shunt has rolled to form a ring-like structure and to decrease a total length of the shunt. In some embodiments, a shunt may include a first end, a second end, and a central portion therebetween, and the shunt may be configured to, upon expansion, invert at least a portion of the second end outwardly so that at least a portion of the second end is directed towards the first end.

[0095] In some embodiments, a stent may include a proximal end, a distal end, and a central portion extending therebetween, and the stent may be configured to transition from a compressed delivery configuration to a deployed configuration. The distal end of the stent may be configured to invert towards the proximal end upon deployment such that the inner surface of the distal end faces outwardly to create an anchoring structure. In some embodiments, a vascular stent may include inversion capabilities. In some embodiments, a tubular stent body may include a proximal end, a distal end, and a central portion, and at least a portion of thedistal end may be configured to invert outwardly towards the central portion upon deployment, resulting in an outwardly facing inner surface.

[0096] The self-adjusting shunt may be used for a variety of applications including, for example, interatrial shunts, hemodialysis access, peripheral vascular disease, congenital heart defects, portal hypertension, traumatic injuries, cerebral arteriovenous malformations, coronary artery disease, pulmonary hypertension, cancer treatment, venous insufficiency, transcaval shunting for abdominal aortic aneurysm, research and experimental therapies, etc. For these applications, the self-adjusting shunt may provide an adaptable, versatile, minimally invasive, and durable solution.

[0097] FIGS. 1A-1B are schematic block diagrams of an implantable device (e.g., a shunt) 100 for treating or aiding in the treatment of an aortic aneurysm in a delivery configuration and a deployed configuration, respectively, according to an embodiment. The shunt 100 may include a central portion 102 defining a central lumen, a proximal end 101, and a distal end 103. The proximal end 101 of the shunt 100 may include a venous sealing structure 104, and the distal end 103 of the shunt 100 may include an arterial sealing structure 106. The shunt 100 may optionally include (1) a coating or cover 108 disposed around the central portion 102 and / or (2) a flow controller 105 disposed in the central lumen. In the delivery configuration (e.g., the biased or compressed configuration), the shunt 100 may form a substantially cylindrical shape (e.g., a uniform cylindrical shape) such that the shunt 100 may move through a catheter of a delivery system (not shown) and / or a blood vessel. In some embodiments, the central lumen of the shunt 100 may have a diameter (inner diameter of the central portion 102 corresponding to a cross- sectional area of the central portion 102) DB, the venous sealing structure may have a diameter (inner diameter corresponding to a cross-sectional area of the venous sealing structure) Dv, and the arterial sealing structure may have a diameter (inner diameter corresponding to a cross- sectional area of the arterial sealing structure) DA. In some embodiments, in the delivery configuration, a diameter of the shunt 100 may be constant across a length of the shunt 100 (e.g., DB, Dv, and DA may all be equivalent or substantially equivalent) or the diameter of the shunt 100 may have little variation (e.g., less than 5%) across the length of the shunt 100. In some embodiments, the central portion 102 of the shunt 100 is attached to the arterial sealing structure 106 and venous sealing structure 104 via an arterial sealing structure attachment and venous sealing structure attachment, respectively.

[0098] In some embodiments, the diameters of the central lumen DB, the arterial sealing structure DA, and the venous sealing structure Dv in the delivery configuration may be in a range of about 1 mm to about 5 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the length LB of the central portion 102 (and therefore the central lumen) in the delivery configuration may be in a range of about 1 mm to about 50 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the length LA of the arterial sealing structure 106 in the delivery configuration may be in a range of about 1 mm to about 50 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the length Lv of the venous sealing structure 104 in the delivery configuration may be in a range of about 1 mm to about 50 mm, inclusive of all ranges and subranges therebetween.

[0099] In some embodiments, the shunt 100 may be implanted in a body of the patient to place the sac of an aortic aneurysm in fluid communication with a region of lower pressure. For example, the shunt 100 may be implanted to place an aorta of the patient in fluid communication with the vena cava of the patient. The lower pressure passage (e.g., the vena cava) may decrease the arterial resistance and reduce pressure within the aneurysm because blood may preferentially flow down the pressure gradient to the lower pressure passage. In this way, the shunt 100 may be implanted to alleviate pressure within an aortic aneurysm, prevent progression of an aortic aneurysm, and / or drain or remove fluid within the aneurysm sac (e.g., build-up fluid resulting from an endoleak). Treating aortic aneurysms may help prevent an aneurysm rupture, reduce an aneurysm size (e.g., aneurysm sac size), alleviate hypertension within the aneurysm, or any combination thereof.

[0100] In order to implant the shunt 100, a delivery system including a guidewire and a catheter may be navigated through the vena cava until a target location corresponding to the aortic aneurysm is reached, described in further detail with respect to FIG. 4 and FIGS. 10A-10B. Then a distal end of the delivery system may be positioned perpendicular (or nearly perpendicular) to a wall of the vena cava. The distal end of the delivery system may include a needle configured to create a venous puncture site in the wall of the vena cava and to create an arterial puncture site in a wall of the aorta. Additionally or alternatively, the guidewire may be used to perform vessel puncture. In some embodiments, electrocautery may be applied while puncturing the vessels to seal the tissue near and / or at the puncture site. The delivery system may then advance the distal end 103 of the shunt 100 distally through the venous puncture site,across an extravascular space, and through the arterial puncture site while the proximal end 101 of the shunt 100 is positioned on an inner wall of the vena cava.

[0101] In some embodiments, a robotic insertion system, such as robotic insertion system 490 as shown in FIG. 4A, and / or such as robotic insertion system 4100 described in further detail with respect to FIGS. 41-44, may be configured to control the delivery system. The robotic insertion system may be configured to automatically navigate the delivery system through the vena cava to the target location. The robotic insertion system may include a robotic insertion device. The delivery system may be coupled to the robotic insertion device. The robotic insertion device may be configured to control the guidewire and / or the catheter of the delivery system in order to navigate the guidewire and / or the catheter through the vena cava. The robotic insertion device may be configured to control the distal end of the delivery system to create the venous puncture site in the wall of the vena cava and / or the arterial puncture site in the wall of the aorta with the needle positioned at the distal end of the delivery system. In some embodiments, the robotic insertion device may be configured to control the guidewire to perform vessel puncture. In some embodiments, the robotic insertion system may be configured to control an electrocautery device to seal the tissue near and / or at the puncture site. The robotic insertion system may be configured to advance the distal end 103 of the shunt 100 distally through the venous puncture site, across the extravascular space, and through the arterial puncture site while the proximal end 101 of the shunt 100 is positioned on the inner wall of the vena cava.

[0102] In cases where thrombus is located along the wall of the arterial puncture site (e.g., in some instances in response to an implanted endograft), the distal end 103 of the shunt 100 may be advanced through at least a portion of the thrombus until the distal end 103 reaches an inner lumen of the aorta. In some embodiments, the distal end of the delivery system may be moved proximally (e.g., out of the aorta, through the venous puncture site, and into the vena cava) to help deploy the shunt 100. The robotic insertion system may advance the distal end 103 of the shunt 100 through at least the portion of the thrombus until the distal end 103 reaches the inner lumen of the aorta. In some embodiments, the robotic insertion system may move the distal end of the delivery system proximally to facilitate deployment of the shunt 100. The robotic insertion system may implant the shunt 100 at any suitable location relative to the aneurysm. In some cases, the puncture site for the aorta may be located upstream (e.g.,superior) of the aneurysmal sac (with respect to blood flow therethrough). The robotic insertion system may implant the shunt 100 before, during, and / or after implantation of an endograft in the aorta of the patient to prevent and / or alleviate the occurrence of endoleaks. In some embodiments, the shunt 100 and the endograft may be implanted in one procedure. For example, the endograft may be positioned in the aorta after the venous puncture site and the arterial puncture site are formed (e.g., after transcaval access is established) to avoid the possibility of the distal end of the delivery system damaging the endograft. The robotic insertion system may control the delivery system to perform a transcaval puncture to establish access to the aorta preferably prior to endograft delivery to reduce possibility of complications during implantation. In some embodiments, the robotic insertion system may control the delivery system to perform a transcaval puncture to establish access to the aorta after placement of a previously placed endograft. Difficulties may arise from the following scenarios, for example, (1) The aorta may have calcification, scarring, fibrosis, or some combination thereof that stiffens the tissue, which can increase the force required to puncture the tissue and cause "jumping" or jerking of the needle or guide wire after puncture. Therefore, accidental perforation of the aorta may occur due to difficulty controlling movement of the guidewire or needle after puncture; (2) the geometry of the abdominal aortic aneurysm may bias the endograft towards / against the endovascular surface of the aorta, leaving little to no space for transcaval puncture, as can occur with a "left-sided" aneurysm).

[0103] In some embodiments, the shunt 100 may transition from the delivery configuration to the deployed configuration as the shunt 100 is advanced out of an opening defined by the distal end of the delivery system. For example, while inside the catheter, the shunt 100 may be in the delivery configuration in which the shunt 100 is constrained (e.g., to allow advancement through the catheter), and as the shunt 100 exits the catheter, the shunt 100 may transition to the deployed configuration in which at least a portion of the shunt 100 is expanded. In some embodiments, the venous sealing structure 104 and the arterial sealing structure 106 may expand or flare out (e.g., the diameter Dv, DA of the sealing structures 104, 106 may increase). In some embodiments, one or both of the arterial sealing structure 104 and venous sealing structure 106 may be self- expandable. Accordingly, in some embodiments, the shunt 100, via the deployed arterial sealing structure 106 and venous sealing structure 104 may help form a circumferential fluid seal around the vascular puncture sites, creating a fluidpassageway between the venous puncture site and the arterial puncture site to permit blood flow from the aorta to the vena cava. The robotic insertion system may be configured to control the shunt 100 and / or the delivery system in order to deploy the shunt 100.

[0104] In some embodiments, the venous sealing structure 104 and the arterial sealing structure 106 may have a starting diameter in the delivery configuration and may expand to an expanded diameter larger than the starting diameter in the deployed configuration. As shown in FIG. IB, the diameter of the venous sealing structure Dv and the diameter of the arterial sealing structure DA are larger than in the delivery configuration. Additionally or alternatively, the central portion 102 of the shunt 100 may narrow when the shunt transitions to the deployed configuration to form an hourglass or dumbbell shape, as shown in FIGS. 5A- C and FIGS. 6A-6E and described in further detail below. For example, the diameter of the central lumen DB may decrease from the delivery configuration to the deployed configuration. In some embodiments, when the shunt 100 is in the deployed configuration, the central lumen of the central portion 102 may have a diameter (inner diameter) DB in a range between about 0.5 mm to about 100 mm, about 1 mm to about 50 mm, about 2 mm to about 25 mm, about 3 mm to about 15 mm, about 4 mm to about 10 mm, or about 3 mm to about 8 mm, inclusive of all ranges and subranges therebetween. In some embodiments, as the shunt 100 transitions from the delivery configuration to the deployed configuration, the length LB of the central lumen (and therefore the central portion 102) may increase. In some embodiments, in the deployed configuration, the central portion 102 and the central lumen have a length LB in a range of about 10 mm to about 10 cm, inclusive of all ranges and subranges therebetween.

[0105] In some embodiments, the deployed arterial sealing structure 106 and / or deployed venous sealing structure 104 may have a diameter (inner diameter) Dv, DA in a range of about 0.5 mm to about 200 mm, about 1 mm to about 100 mm, about 5 mm to about 75 mm, about 8 mm to about 50 mm, about 10 mm to about 30 mm, or about 10 mm to about 20 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the diameter DA of the deployed arterial sealing structure 106 may be equivalent to the diameter Dv of the deployed venous sealing structure 104. In some embodiments, the diameter DA of the deployed arterial sealing structure 106 may not be equivalent to the diameter Dv of the deployed venous sealing structure 104. In some embodiments, an inner diameter of the sealing structures 104, 106 and an outer diameter of the sealing structure 104, 106 may differ by a thickness of thematerial of the shunt 100. In some embodiments, one or both of the sealing structure(s) 104, 106 may include an inflatable balloon coupled thereto. Therefore, the inner diameters Dv, DA of the sealing structures 104, 106 (e.g., the diameter of the fluid passageway) may be substantially smaller than the outer diameters of the sealing structures 104, 106. In such embodiments, the inner diameters Dv, DA of the sealing structures 104, 106 may be equivalent or nearly equivalent to the diameter DB of the central lumen in the deployed configuration, while the outer diameters of the sealing structure 104, 106 expand larger than the inner diameters to seal the vessels.

[0106] In some embodiments, in the deployed configuration, the venous sealing structure 104 may have a length Lv in a range of about 1 mm to about 10 mm, inclusive of all ranges and subranges therebetween. In some embodiments, in the deployed configuration, the arterial sealing structure 106 may have a length LA in a range of about 1 mm to about 50 mm, inclusive of all ranges and subranges therebetween. In some embodiments, as the shunt 100 is deployed or expanded, a total length of the shunt 100 may decrease. For example, the length Lv, LA of the venous sealing structure 104 and arterial sealing structure 106, respectively, may decrease such that the total length of the shunt 100 decreases.

[0107] The shunt 100 may include a material such as a shape-memory alloy that allows the shunt 100 to conform to different configurations (e.g., the compressed configuration and the expanded configuration). In some embodiments, the shunt 100 may include a flexible, compliant stretchy tube that can lengthen as the aneurysmal sac shrinks, and as the distance between the puncture sites of the aorta and vena cava increases. Additionally, the material may enable the sealing structures 104, 106 to pivot or bend. In some embodiments, the central portion 102 and / or the sealing structures 104, 106 may include braided or laser cut metal and / or alloy, a bioabsorbable material, a polymer, a compliant balloon, or any combination and / or variant thereof. In some embodiments, the shunt 100 may include a material (e.g., a metal alloy) that promotes endothelialization. In some embodiments, at least a portion of the shunt 100 may be laser cut from super-elastic metal and / or braided from super-elastic wires to have a heat set shape. The material may be any suitable material including, but not limited to, copper-aluminum-nickel, nickel- titanium (Nitinol), copper-zinc-aluminum, iron-manganese- silicon, brass, steel or a suitable combination thereof. In some embodiments, the material includes Nitinol. Nitinol is a super-elastic material with shape-memory properties, andimplementation of Nitinol in the shunt 100 allows the shunt 100 to adapt to dynamic vascular environments. The compliance of the material of the shunt 100 may also ensure that the shunt 100 remains functional and effective even as the anatomy of the vessels changes over time.

[0108] In some embodiments, the central portion 102 of the shunt can stretch from about 1% to about 300% of its original length (e.g., such as when the aneurysm shrinks and thereby causes increased separation between the vena cava and the aorta), inclusive of all ranges and subranges therebetween. In some embodiments, the central portion 102 can compress from about 100% to about 25% of its original length (e.g., when transitioning into the deployed configuration from the delivery configuration), inclusive of all ranges and subranges therebetween. In some embodiments, the sealing structures 104, 106 may be configured to compress from about 100% to about 25% of their original length, inclusive of all ranges and subranges therebetween. In some embodiments, the sealing structures 104, 106 are identical in shape, size, and / or material to each other. In some embodiments, the arterial sealing structure 106 is not identical in shape, size, and / or material as the venous sealing structure 104, to account for differences in mechanical and fluid properties found between the vein and the artery.

[0109] In an endovascular procedure, the ability of the shunt 100 to expand from a substantially uniform cylindrical shape to one with a narrowed middle section is beneficial for several reasons. First, this allows for targeted pressure distribution: the narrowed central portion 102 can help focus and control the flow of blood through the shunt 100, which may reduce the risk of turbulent flow and promote a laminar flow pattern, lessening stress on the vessel walls. Second, having a shape with a narrow central portion 102 may be important in some instances for stability and / or anchoring. In particular, the wider ends of the shunt 100 can anchor the shunt 100 securely within the vessels, preventing migration, while the narrowed section reduces contact of the material of the shunt with the blood vessels, potentially minimizing the risk of thrombosis. Third, with regards to delivery and deployment, starting in a compressed, compact configuration allows the shunt 100 to be introduced through a low- profile catheter. This minimizes vessel trauma during introduction and transcaval positioning, as the reduced diameter of the catheter and shunt assembly lessens the force required to penetrate the vessel walls, thus reducing the risk of arterial or venous injury. Additionally, thisallows the shunt 100 to be delivered and / or deployed at the target site by the robotic insertion system and / or the delivery system.

[0110] The sealing structures 104, 106 when the shunt 100 is in the deployed configuration may be configured to form a seal between an outer surface of the shunt 100 and the puncture sites to permit blood flow through the shunt 100 and / or prevent leakage of blood. When the shunt 100 is in the deployed configuration, the venous sealing structure 104 may be configured to conform to an inner surface (e.g., the endovascular surface) of the vena cava to seal the venous puncture site and prevent blood from flowing out of the vena cava and into the extravascular space. Similarly, the arterial sealing structure 106 in the deployed configuration may be configured to conform to an inner surface (e.g., the endovascular surface) of the aorta and / or a surface of the thrombus to prevent blood from flowing out of the aorta and into the extravascular space. In some embodiments, the sealing structure 104, 106 when expanded may help secure the shunt 100 in position and / or prevent movement of the shunt 100. In some embodiments, the sealing structures 104, 106 may further include a balloon-expandable component that, once positioned, can be inflated to press against the vessel walls, adapting to the shape of the vessel walls and securing the shunt 100 in place. This technique allows for a customized fit to unique vascular anatomy of the patient, further enhancing the efficacy of the seal.[OHl] In some embodiments, the shunt 100 may be configured to include or assume an asymmetrical shape such as a "shuttlecock" shape when in the deployed configuration, as shown in FIG. 6E and FIG. 7. For example, the venous sealing structure 104 may form a disc shape (or saddle shape) configured to conform to the endovascular saddle shaped profile of the vena cava, and the distal sealing structure 106 may form a conical bulb shape (e.g., conical shape, elliptical cone, parabolic cone, oblate spheroid, or the like). One advantage of the shuttlecock shape is that the venous sealing structure 104 may lay flush against the endovascular surface of the vena cava to minimize disruption to venous blood flow through the vena cava. This helps prevent clot formation as well as promote tissue ingrowth over a larger surface area to provide structural stability to the arteriovenous connection. When in the deployed configuration, the venous sealing structure may be disc shaped (or saddle shape) and under tension due to the expansion of the arterial sealing structure 104, which enables the venous sealing structure 104 to lay flush against the vessel wall regardless ofwhether the vessel wall has concavities. The conical bulb of the arterial sealing structure 106 allows for robust functionality of the shunt (e.g., enabling drainage of blood) regardless of thrombus thickness as described herein. This shape also serves to gently displace the thrombus away from the endoleak drainage pathway (e.g., the central lumen) to permit arteriovenous blood flow. Additionally, through the displacement of thrombus, this shape facilitates the creation of a tensile force between the venous sealing structure 104 and the arterial sealing structure 106 to support a fluid tight seal around the outer surface of the shunt 100. The rounded bulb protects an endograft from damage due to contact with the endoleak shunt in the case of aneurysm shrinkage. In some embodiments, the bulb of the arterial sealing structure 106 can include an open distal end, as shown in FIG. 6E and FIG. 7. In some embodiments, the bulb of the arterial sealing structure 106 can be closed at the distal end (like the head of a microphone) to prevent large clots from passing through or clogging the shunt.

[0112] In some embodiments, the shunt includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) radiopaque markers. In some embodiments, the radiopaque markers are disposed at the proximal end 101 of the shunt 100. In some embodiments, the radiopaque markers are disposed at the distal end 103 of the shunt 100. In some embodiments, the radiopaque markers are disposed at both the proximal and distal ends 101, 103 of the shunt 100. The radiopaque markers may allow an imaging modality of the robotic insertion system to identify a position of the shunt 100 during insertion and / or implantation of the shunt 100 via the robotic insertion system.

[0113] In some embodiments, the venous sealing structure 104 and the arterial sealing structure 106 may pivot (hinge, bend, curve, deform, etc.) relative to the central portion 102 of the shunt 100 to accommodate movement and / or variations in alignment between attachment points (e.g., the locations on the vessel walls to which the sealing structure 104, 106 are coupled). For example, the shunt 100 may include a flexible material (e.g., Nitinol) that allows the sealing structures 104, 106 to pivot or hinge to ensure a fluid tight seal regardless of puncture angle. The pivotable design of the sealing structures 104, 106 relative to the central portion 102 of the shunt 100 further ensures a secure and adaptable connection within the vascular system. For example, if an angle between the aorta and the vena cava may change due to body movements or alterations in the vascular anatomy over time, the sealingstructures can adjust accordingly, maintaining a secure, leak-proof seal around the central portion 102 of the shunt 100 that ensure proper blood flow through the shunt 100.

[0114] In some embodiments, the shunt 100 may be wholly formed of and / or include a bioabsorbable material designed to degrade over time to correspond with a change in size of the aneurysm sac (e.g., due to shrinkage of the aneurysm sac). In other words, once the aneurysm sac has remodeled itself and endoleaks are closed off, the shunt 100 may no longer be needed and can be absorbed by the body. Additionally, one or more structures of the shunt 100 may be coated or covered with or formed from a compliant material such as silicone, hydrogel, or another biocompatible polymer that can fill in the irregularities of the vessel walls, ensuring that even in areas where the vessel surface is not smooth or uniform, the seal remains intact and effective. In some embodiments, the shunt 100 may include polylactic acid (PLA) or polygly colic acid (PGA) to support tissue ingrowth such that the shunt 100 degrades and is replaced by natural tissue (e.g., endothelial tissue) over time. In some embodiments, the cover 108 may span along at least a portion of the length of the shunt 100. The cover 108 may aid in anchoring the shunt 100 to the vascular puncture sites and / or prevent the leakage of fluids around the shunt 100. In some embodiments, the cover 108 may span at least a portion of the central portion 102 of the shunt 100 can offer localized support and maintain patency in the narrowed region, reduce turbulent flow, minimize retroperitoneal bleeding or leakage, and allow for flexibility and ease of access at the ends of the shunt. The cover 108 over the narrowed central portion 102 of the shunt 100 can provide structural support, preventing collapse or excessive narrowing which could impede blood flow. Turbulent flow, often a concern in areas of narrowing, can lead to endothelial damage and increased risk of thrombosis. The cover 108 can help smooth the transition of blood flow through the narrowed section, reducing turbulence and associated risks. By concentrating the cover 108 on the central portion 102, the flexibility of the ends 101, 103 of the shunt 100 may be maintained. This is important for accommodating movement and reducing the stress on the vascular anastomoses (junctions).

[0115] In some embodiments, the shunt 100 may be configured to adapt to changes in geometry as the aortic aneurysm begins to shrink. For example, the superelastic material of the shunt 100 may allow the shunt 100 to comply to changing vessel geometry while still maintaining a level of firmness to prevent the shunt 100 from collapsing. The sealing structures 104, 106, particularly for interfacing with the endovascular surface of the inferior vena cavaand the aortic aneurysm, may be configured to adapt to the internal contours of these vessels. The shunt 100 may be configured to allow for a degree of expansion or contraction to accommodate variations in vessel diameter and surface irregularities. For instance, sealing structures 104, 106 may each include a self-expanding mechanism, which may exert a continuous outward force (e.g., radial force) against the vessel walls. This ensures contact with the endovascular surface, conforming to the shape and providing a secure seal to prevent blood leakage. As the aneurysm shrinks as facilitated be the implantation of an endograft and / or the creation of an arteriovenous connection between the abdominal aortic aneurysm and the vena cava, the distance between the vena cava and the abdominal aorta may increase or otherwise change in some manner. The shunt 100 can accommodate this change through its superelastic property, which allows the shunt 100 to maintain apposition against the vessel walls despite changes in spatial geometry. This elongation can lead to a reduction in the diameter of the shunt's central portion 102 and central lumen. As the aneurysm shrinks, the flow rate of an endoleak through the shunt 100 correspondingly diminishes because the driving pressure behind the endoleak decreases. In some embodiments, if the aneurysm heals to the point where an endoleak no longer exists, the blood flow through the shunt 100 may cease, and the shunt 100 may close off This closure would occur due to the lack of pressure differential needed to maintain the patency of the shunt 100. The gradual nature of this transition allows the patient's vascular system to adjust slowly, enhancing overall circulatory stability and reducing the risk of complications.

[0116] The radial force of the shunt 100 is defined as the force generated in a direction outward (e.g., radially) from the surface of the shunt 100. In some embodiments, the shunt 100 can elongate or shorten without a decrease in the radial force of the outer surface of the sealing structure 104, 106 on the vessel walls, ensuring that the seal remains intact, and the stent continues to provide fluid communication between the two vessels with little to no leakage. In some embodiments, the sealing structures 104, 106 may maintain the radial force above a predetermined threshold to prevent deterioration of the seal and / or leaking of blood into the extravascular space.

[0117] In some embodiments, the shunt may optionally include a flow controller 105 disposed in the central lumen of the shunt 100. In some embodiments, the flow controller 105 may be integrated into an inner surface of the central portion 102 of the shunt 100. In someembodiments, the flow controller 105 may be coupled to a portion of the central portion 102 of the shunt 100. In some embodiments, the flow controller 105 may be a one-way valve mechanism positioned centrally along the total length of the shunt 100. The flow controller 105 may be configured to allow blood to flow in a first direction through the central lumen while preventing blood from flowing in a second direction opposite the first direction through the central lumen. For example, the flow controller 105 may allow normal antegrade blood flow through the vena cava while preventing retrograde flow into the aneurysm sac. In some embodiments, the flow controller 105 may only let blood flow when certain parameters are met (e.g., a pressure, pressure gradient, absolute flow, flow gradient, etc.). In some embodiments, the parameters that allow blood to flow in the first direction may be the same or different than the parameters to allow blood to flow in the second direction. In some embodiments, the flow controller 105 may include biocompatible and / or flexible material that responds to changes in blood pressure and flow dynamics. In the presence of an endoleak, the flow controller 105 may remain open, allowing unimpeded blood flow. However, in the presence of reversed flow pressure, the flow controller 105 closes, thus preventing blood from entering the aneurysm sac. The shunt 100 may additionally or alternatively include a filter or filter-like structure configured to capture and contain clots or embolic debris originating from the aneurysm sac, thereby preventing migration of debris into the systemic circulation. In some embodiments, the filter may include a fine, biocompatible mesh material. In some embodiments, a pore size of the mesh of the filter may be calibrated to trap clots while allowing normal blood flow. In some embodiments, the pore size of the mesh of the filter may be in a range of about 100 pm to about 10000 pm. In some embodiments, the filter may be affixed to the inner wall of the central portion 102 of the shunt 100 (e.g., the nitinol frame).

[0118] In some embodiments, the shunt 100 may be configured to allow blood flow or cease blood flow in response to predetermined local conditions. For example, pressure or flow may act to change the effective shunt lumen size (open, close, other). In some embodiments, when one or more parameters (e.g., a pressure, pressure gradient, absolute flow, flow gradient, etc.) reach an 'onset' threshold, the shunt 100 may increase in diameter, whereas when the one or more parameters reach an 'offset' threshold, the shunt 100 may decrease in diameter. A purpose of adaptive shunting is to protect organs or biologic tissues from pressure or flow damage. This protection may be conferred by limiting pressures at either the source orreceiving end of the connection. For example, a "bleed off shunt could be used to drop pressures which are approaching or exceeding a specified threshold value.

[0119] The thrombus within an abdominal aortic aneurysm presents unique challenges in the context of creating an endoleak drainage pathway, particularly due to its variable nature and the risks associated with disturbing it. Abdominal aortic aneurysm thrombi are typically composed of layers of blood components, including fibrin, red blood cells, and platelets. The structure can vary from soft, friable material to more organized, harder deposits. The location and extent of the thrombus can vary widely; it may line the aneurysm wall partially or entirely. Thrombus formation is a dynamic process, evolving over time. Initially, it may be more unstable and prone to fragmentation, whereas older thrombi tend to be more organized and stable. In placing a shunt 100 to create a drainage pathway for endoleaks, for example, pre-procedural imaging may be done to measure the thickness of the thrombus and to determine a suitable length LA of the arterial sealing structure 106. The length LA of the arterial sealing structure 106 in the deployed configuration may be at least as long as the thickness of thrombus. Additionally, a size (e.g., a cross-sectional area) of each cell (gap, opening) defined by the braided filaments of the shunt (or the openings between struts of a laser cut shunt) may be below an upper threshold such that the filaments do not cut into the thrombus (e.g., cause fragmentation of the thrombus) upon deployment of the shunt 100, but above a lower threshold to permit sufficient endoleak drainage rate without clots forming inside the shunt 100 and blocking blood flow. In some embodiments, the area (e.g., the cross- sectional area) of each cell defined by the shunt 100 may be in a range of about 1 mm2to about 10 mm2, inclusive of all ranges and subranges therebetween. In some embodiments, the size or area the cells may vary across the total length of the shunt 100 and / or around a circumference of the shunt 100. The average size or area (cross-sectional area) of the cells in a portion of the shunt 100 may be directly proportional to a fluid porosity of the portion of the shunt 100. In some embodiments, the central portion 102 of the shunt 100 may have a fluid porosity that is less than a fluid porosity of both the arterial sealing structure 106 and venous sealing structure 104.

[0120] In some embodiments, the shunt 100 may be resized during and / or after delivery. For example, after initial delivery, a diameter of the central lumen DB of the shunt 100 may be increased or decreased depending on the anatomy of the patient and the state ofthe aneurysm. In some embodiments, the diameter of the central lumen DB may be increased (or expanded) by disposing an inflatable balloon in the central lumen and inflating the balloon until the target diameter of the central lumen is reached. To reduce the diameter of the central lumen DB, a separate delivery catheter may be used to deliver a spacer (e.g., a tubular spacer) having a thickness that reduces the diameter DB of the central lumen. In some embodiments, the thickness of the spacer corresponds to an amount to reduce the shunt 100 diameter. In some embodiments, the spacer may include a shunt structure subsequently deployed inside of the original shunt 100. In some embodiments, the robotic insertion system may be configured to control the delivery system in order to increase the diameter of the central lumen DB of the shunt 100. The robotic insertion system may be configured to advance or facilitate advancement of the inflatable balloon into the central lumen of the shunt. The robotic insertion system may be configured to automatically inflate the inflatable balloon. The robotic insertion system may be configured to inflate the inflatable balloon when the imaging modality determines that the inflatable balloon is positioned in the central lumen. In some embodiments, the robotic insertion system may be configured to control the delivery system in order to decrease the diameter of the central lumen DB. The robotic insertion system may be configured to advance or facilitate advancement of the spacer through the delivery catheter. The robotic insertion system may be configured to insert the spacer into the shunt 100. The ability to resize the shunt 100 after delivery allows for customization of the amount of fluid for each patient. Furthermore, the size of the shut 100 may be modified in a similar manner as described above at a later time if the hemodynamic needs of the patient change.

[0121] In some embodiments, flow and / or pressure changes intra-procedure may be measured when and / or to help inform resizing the shunt 100. In some embodiments, for example, Doppler ultrasound may be used to non-invasively measure blood flow velocity (in real-time or near real-time) by placing a Doppler ultrasound probe near the shunt site. In some embodiments, the imaging modality of the robotic insertion system may include the Doppler ultrasound probe. Changes in flow velocity after resizing the shunt 100 can indicate the effectiveness of the resizing procedure. In some embodiments, the shunt 100 may be resized until the flow velocity reaches a predetermined flow velocity range. In some embodiments, the robotic insertion system may be configured to display the measured blood flow velocity to the user. In some embodiments, the robotic insertion system may be configured to automaticallyresize the shunt 100 based on the measured blood flow velocity. In some embodiments, thermal dilution may be used during the resizing procedure. Thermal dilution involves injecting a known amount of cold saline into the bloodstream and measuring the temperature change of the blood downstream. This technique may provide accurate flow measurements and can be used to assess the change in flow rate through the shunt 100 before and / or after resizing. In some embodiments, the robotic insertion system may be configured to inject the cold saline into the blood stream and / or measure the temperature change of the blood downstream. Manometry is a pressure measurement technique that involves using a pressure transducer inserted via a catheter to directly measure the blood pressure within the shunt 100. This technique is helpful for assessing whether the resized shunt 100 is functioning within the desired pressure parameters. In some embodiments, a pressure-sensing guidewire may be used during the procedure. The pressure-sensing guidewire may be advanced through the shunt 100, allowing for precise measurement of pressure gradients across the shunt 100 before and / or after resizing. In some embodiments, the robotic insertion system may be configured to insert the pressure-sensing guidewire through the catheter and / or advance the pressure-sensing guidewire through the shunt 100. In some embodiments, a combination of flow and pressure assessment can be used. For example, Angiography with Quantitative Flow Ratio (QFR) Analysis can be used in which visual imaging, such as the imaging modality of the robotic insertion system, and computational analysis are used to assess both flow and pressure. After resizing the shunt 100, angiographic images are taken, and software is used to calculate the QFR, which gives a quantitative assessment of blood flow. In some embodiments, Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT) can be used during the procedure. In some embodiments, the imaging modality of the robotic insertion system may include Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT). These imaging techniques provide high-resolution images of the vessel and shunt 100 can be used to verify the position of the shunt 100, its expansion, and indirectly infer flow dynamics based on anatomical changes. The robotic insertion system may be configured to use the high- resolution images of the vessel and / or the sunt 100 in order to determine and / or verify the position of the shunt 100, its expansion, and indirectly infer flow dynamics based on anatomical changes.

[0122] Tissue ingrowth can play a crucial role in ensuring the long-term success and stability of the shunt 100. In some embodiments, the shunt 100 may include one or more materials configured to promote endothelialization and / or tissue ingrowth. For example, the shunt may include metal alloys such as Nitinol and / or biodegradable polymers such as polylactic acid (PLA) and / or polyglycolic acid (PGA). The shunt may include PLA and / or PGA such that the shunt 100 degrades and is replaced by natural tissue over time. Additionally, the shunt may include porous or micro- structured surfaces that enable migration of endothelial cells into the shunt 100, promoting tissue encapsulation and integration. In some embodiments, the shunt 100 may include a combination of biodegradable materials and non-degradable materials: the biodegradable materials may create spaces or openings for tissue to grow while the non-degradable material may provide structural support for the shunt 100. Tissue ingrowth can provide the following benefits: (1) enhanced stability and anchoring; (2) reduced complication rates; (3) improved hemocompatibility; and (4) facilitate healing. Tissue ingrowth into the shunt 100 and / or shunt cover 108 helps secure the shunt 100 in place, reducing the likelihood of shunt 100 migration or dislodgement. This is particularly important in an aortocaval shunt, which involve the largest artery and vein in the body. Proper integration of the shunt 100 with the surrounding tissue can decrease the risk of complications such as infection or irritation at the site of the shunt 100 because a well-integrated shunt 100 is less likely to provide a pathway for bacterial ingress. Tissue ingrowth can lead to a more natural interface between the shunt 100 and the blood vessel, potentially reducing the risk of thrombosis (blood clotting) and improving the overall hemocompatibility of the shunt. This is critical in maintaining patency (openness) and functionality of the shunt 100. Lastly, in the initial post-surgical period, tissue ingrowth can aid in the healing process by promoting the integration of the shunt 100 with the body's natural tissue, leading to a reduction in inflammatory responses and better overall healing.

[0123] The shunt 100 may include a self-adjusting mechanism (e.g., selfsizing, self-rolling, self-deployment, adjustable sizing mechanism, etc.) such that the shunt 100 can adjust a total length of the shunt 100 during and after deployment. The self-adjusting mechanism can include any mechanism configured to adjust a dimension of the shunt 100 during and / or after deployment. In some embodiments, the self-adjusting mechanism can include a self-rolling mechanism, in which a portion of the shunt 100 rolls onto itself to adjust(e.g., increase and / or decrease) at least one of a diameter along a length of the shunt 100 or a length of the shunt 100. The shunt 100 may include a first end, a second end, and a central portion defined therebetween. In some embodiments, during deployment of the shunt 100 and / or after deployment of the shunt 100, the shunt 100 may be configured to perform at least one of (1) roll toward the central portion to decrease a total length of the shunt 100 or (2) roll away from the central portion to increase a total length of the shunt 100. In some embodiments, when the shunt 100 transitions from the delivery configuration to deployed configuration, the first end of the shunt 100 may be configured to expand radially and the second end of the shunt 100 may be configured to transition from a first configuration in which the second end of the shunt 100 has a first diameter and a first length to a second configuration in which the second end of the shunt 100 has a second diameter greater than the first diameter and a second length smaller than the first length. In some embodiments, the first end of the shunt 100 may be the proximal end 101 and the second end of the shunt 100 may be the distal end 103. In some embodiments, the first end of the shunt 100 may be the distal end 103 and the second end of the shunt 100 may be the proximal end 101. In some embodiments, the second end in the first configuration forms a substantially cylindrical shape, and the second end in the second configuration includes a toroidal shape. In some embodiments, the distal end of the shunt 100 may roll proximally to transition the shunt 100 from the first configuration to the second configuration. In some embodiments, the proximal end of the shunt 100 may roll distally to transition the shunt from the first configuration to the second configuration.

[0124] The arterial sealing structure 106 may include a self-rolling mechanism. For example, the shunt 100 in the delivery configuration may form a substantially cylindrical shape, and the second end of the shunt 100 (e.g., the distal end 103 of the shunt 100) may be configured to roll proximally along a length of the shunt 100 as the shunt 100 transitions from the delivery configuration to the deployed configuration and / or after deployment of the shunt 100. In some embodiments, after deployment, the shunt 100 may roll proximally and / or unroll distally to accommodate changes to the anatomy (e.g., the vein and artery moving closer together or further apart). The distal end 103 of the shunt 100 may roll into a toroidal or ringlike structure to anchor the shunt 100 and / or form the arterial sealing structure 106. In some embodiments, the toroidal structure may be configured to engage the vessel wall to anchor the shunt 100 and / or to engage thrombus after deployment. In some embodiments, afterdeployment, the second end of the shunt 100 (e.g., the distal end 103) may be configured to transition towards the second configuration in response to a distance between vessels decreasing and transition towards the first configuration in response to the distance between the artery and vein increasing.

[0125] When the shunt 100 transitions from the delivery configuration to the deployed configuration, the proximal end 101 (e.g., the venous sealing structure 104) of the shunt 100 may be configured to expand (e.g., self-expand). The venous sealing structure 104 may include any suitable shape such as, for example, a bulb shape, a disc-shape, a flared shape, a cone shape. In some embodiments, the venous sealing structure 104 of the shunt 100 may form the disc-shape. In some embodiments, both the distal end 103 and the proximal end 101 may be configured to roll into the toroidal structure such that the length of the distal end 103 and / or the proximal end 101 may be adjustable. In some embodiments, at least one of the distal end 103 and the proximal end 101 of the shunt 100 may be configured to roll (e.g., into the toroidal structure) and / or unroll during and / or after deployment.

[0126] As the distal end 103 of the shunt 100 rolls proximally, a total length of the shunt 100 may decrease, and an outer diameter Dv, DA of the venous sealing structure 104 and the arterial sealing structure 106 may each increase to anchor the shunt 100 and / or form a seal with the vessel wall. For example, as the shunt 100 transitions from the delivery configuration to the deployed configuration, the distal end 103 of the shunt 100 may roll proximally such that the length LA of the distal end 103 decreases and the outer diameter DA of the arterial sealing structure 106 increases from the delivery configuration. During and after deployment, the length LA of the distal end 103 may be variable or adjustable depending on the vessel geometry. As the shunt 100 transitions from the delivery configuration to the deployed configuration, the length Lv of the venous sealing structure 104 may decrease and the outer diameter Dv of the venous sealing structure 104 may increase, as described previously. In some embodiments, the length Lv of the venous sealing structure may remain constant after deployment, and the length LA of the distal end 103 of the shunt 100 may vary to accommodate vessel geometry.

[0127] The inner and outer diameter of the central portion 102 in the delivery configuration may be equivalent (or substantially equivalent) to the inner and outer diameter, respectively in the fully deployed configuration. In some embodiments, the length LB of thecentral portion 102 may remain, increase, and / or decrease based on rolling of the distal end 103 of the shunt 100 such that the total length of the shunt 100 is adjusted. In some embodiments, both the length LB of the central portion 102 and the length LA of the arterial sealing structure 106 may vary.

[0128] When the shunt transitions from the delivery configuration to the deployed configuration, the diameter of the distal end (e.g., the toroidal structure) may increase while the length of the central portion may decrease. In some embodiments, after deployment and in response to a distance between two vessels increasing, a total length of the shunt 100 may increase while a diameter of the distal end (e.g., an outer diameter of the toroidal structure) may decrease. Conversely, in response to a distance between two vessels decreasing, the total length of the shunt 100 may decrease while the diameter of the distal end may increase. Dimensions and applications of the shunt 100 including the self-rolling mechanism are further described in FIGS. 41 A-43G.

[0129] FIG. 2A-2C are schematic block diagrams depicting placement of the shunt of FIGS. 1A-1B to connect a vena cava and an aorta of a patient to treat an aortic aneurysm (e.g., an abdominal aortic aneurysm), according to an embodiment. As shown in FIG. 2A, the shunt 100 may be moved through the venous puncture site 151 and the arterial puncture site 152 via a catheter of the delivery system 150. A robotic insertion system, such as robotic insertion system 4100, may be configured to control the catheter of delivery system 150 in order to move the shunt 100 through the venous puncture site 151 and the arterial puncture site 152. In some embodiments, an endograft 120 may be disposed in the aorta before or during implantation of the shunt 100, as shown. In some embodiments, the robotic insertion system may be configured to insert and / or dispose the endograft 120 in the aorta. The robotic insertion system may be configured to insert and / or dispose the endograft 120 in the aorta via a second delivery system. As shown, the shunt 100 has a uniform cylindrical shape. The central portion 102 of the shunt 100 (e.g., the central lumen) has a diameter DB, and the venous sealing structure 104 and the arterial sealing structure 106 each have a diameter equivalent to the diameter DB. The central portion 102 of the shunt has a length LB, the arterial sealing structure has a length LA, and the venous sealing structure has a length Lv. The thrombus T is shown in grey and has a length LT. AS shown, the thrombus T causes the arterial wall to deform. The extravascular space (e.g., the space between the vena cava and the aorta) has a length denotedas LES. AS shown in FIG. 2B, the shunt 100 is transitioned to the deployed configuration such that the venous sealing structure 104 seals the venous puncture site 151 and the arterial sealing structure 106 seals the arterial puncture site 152 to allow blood flow through the shunt 100 toward the vena cava. The robotic insertion system may be configured to control the position of the catheter of the delivery system 150, the guidewire of the delivery system 150 and / or the shunt 100 in order to transition the shunt 100 from the delivery configuration to the deployed configuration. In some embodiments, the robotic insertion system may advance the shunt 100 past the distal end of the catheter of the delivery system 150 and the shunt 100 may transition to the deployed configuration. In some embodiments, the robotic insertion system may retract the catheter of the delivery system 150 when the distal end of the catheter and / or the shunt 100 are positioned at a target position. Accordingly, when the robotic insertion system retracts the catheter, the shunt 100 may remain positioned at the target position and / or the shunt 100 may transition to the deployed configuration.

[0130] In the deployed configuration, the diameter DB of the central lumen decreases, and the diameters of the sealing structure 104, 106 increase in size in the deployed configuration. The length Lv of the venous sealing structure and the length LA of the arterial sealing structure 106 decrease, while the length LB of the central portion 102 (and central lumen) increases. Therefore, the shunt 100 may form an hourglass (e.g., a dumbbell, a hyperboloid of one sheet, or the like) in the deployed configuration. In some embodiments, the shunt 100 may form an asymmetrical shape such as a "shuttlecock" shape in the deployed configuration. In some embodiments, the central portion 102 may remain cylindrical while one or both of the sealing structures 104, 106 form a conical shape, an elliptical cone, a parabolic cone, a conical bulb, an oblate spheroid, or the like. The length Lv of the venous sealing structure 104 may be configured to be smaller than the length LA of the arterial sealing structure such that the venous sealing structure 104 lays substantially flat against the inner wall of the vena cava such that the venous sealing structure 104 does not obstruct or is limited in obstructing blood flow through the vena cava. In other words, the venous sealing structure 104 is configured to anchor and seal the shunt 100 relative to the vena cava while minimizing blood flow disruptions through the vena cava. As shown, the length LA of the arterial sealing structure 106 in the deployed configuration may be configured to be at least as long as the thickness LT of the thrombus T. Therefore, the arterial sealing structure 106 may be configured to span atleast the thickness LT of the thrombus T to improve blood flow through the shunt 100 and to avoid clotting and / or blockage of the shunt 100. For example, with the shunt 100 in the deployed configuration, the arterial sealing structure extends laterally beyond the thrombus such that the thrombus is disposed between a distal end of the arterial sealing structure and an inner wall surface of the artery proximal to the distal end of the arterial sealing structure. In some embodiments, the increased diameter DA of the arterial sealing structure 106 may be operable to push the thrombus away from the inner lumen of the shunt to further prevent clotting and / or blockage near or in the shunt. In some embodiments, the shunt 100 may be configured to automatically transition from the delivery configuration to the deployed configuration. In some embodiments, the robotic insertion system may be configured to transition the shunt 100 from the delivery configuration to the deployed configuration.

[0131] FIG. 2C shows the shunt 100 implanted between the aorta and the vena cava after the thrombus T has decreased in size (e.g., due to improvement of the aneurysm). As shown, the thickness LT of the thrombus T has decreased, and therefore the length LES of the extravascular space has increased. As shown, the shunt 100 is configured to accommodate this change: the length LB of the central portion 102 has increased, and the diameter DB of the central lumen has decreased.

[0132] FIG. 3A is a flowchart of an example method of using a shunt to treat or alleviate an aortic aneurysm, according to an embodiment. In some embodiments, the implantation site may be imaged to determine one or more characteristics of the shunt. In some embodiments, a size of the shunt may be determined based on imaging data collected during imaging. For example, CT angiography imaging may be performed to determine a lateral thickness of the thrombus. In some embodiments, an imaging modality of a robotic insertion system, such as imaging modality 4106 of the robotic insertion system 4100, may be configured to image the implantation site. The shunt to be used may be selected based on the lateral thickness of the thrombus, at 201. In some embodiments, the arterial sealing structure of the shunt may have a thickness at least as wide as the thickness of the thrombus. In some embodiments, imaging (e.g., CT angiography) may also be used to determine one or more characteristics of the thrombus and / or to identify target punctures sites in the vena cava. In some embodiments, the imaging modality of the robotic insertion system may be configured to determine one or more characteristic of the thrombus and / or identify target puncture sites inthe vena cava. The robotic insertion system may be configured to display the one or more characteristics of the thrombus and / or the target puncture sites on a user interface. The robotic insertion system may be configured to use the one or more characteristics of the thrombus and / or the target puncture cites as inputs to control insertion of the delivery system and / or insertion and / or implantation of the shunt. In some embodiments, the robotic insertion system may be configured to generate a 3-D model of the patient’s anatomy based on the imaging data collected during imaging.

[0133] In some embodiments, the method includes puncturing a vein to define a venous puncture site, at step 202 In some embodiments, the distal end of a delivery system may be used to puncture a target puncture site on a wall of the vena cava to define the venous puncture site. The robotic insertion system may be configured to control the delivery system to puncture the target puncture site on the wall of the vena cava to define the venous puncture site. In order to access the target puncture site, the distal end of the delivery system housing may be inserted into the femoral vein of the patient percutaneously or via a small incision. The robotic insertion system may insert the distal end of the delivery system housing into the femoral vein of the patient. In some embodiments, a delivery system for an endograft may be inserted into the femoral artery percutaneously or via a small incision. The robotic insertion system may insert the delivery system for the endograft into the femoral artery. In some embodiments, a sheath may be inserted into the vein and / or artery to facilitate introduction of the delivery system. The robotic insertion system may insert the sheath into the vein and / or artery to facilitate introduction of the delivery system. In some embodiments, a guidewire at a distal end of the shunt delivery system may be moved through the vena cava toward the puncture site using a medical imaging technique (e.g., fluoroscopic guidance). The robotic insertion system may move the distal end of the shunt delivery system through the vena cava. The robotic insertion system may use the imaging modality in order to identify a position of the distal end of the shunt delivery system and / or the catheter shaft. The robotic delivery system may display the position of the distal end of the shunt delivery system to a user. In some embodiments, the robotic delivery system may use image data from the imaging modality to automatically advance the distal end of the shunt delivery system through the vena cava toward the puncture site. In some embodiments, the distal end of the delivery system may be aligned with the venous puncture site (e.g., perpendicularly). The robotic insertion system may beconfigured to control the delivery system in order to position the distal end of the delivery system. In some embodiments, a catheter radiopaque marker disposed at the distal end of the catheter shaft may provide a signal useful to determining the location of the distal end of the catheter shaft in relation with venous puncture site and the arterial puncture site. The imaging modality of the robotic insertion system may use the catheter radiopaque marker to determine the location of the distal end of the catheter shaft in relation with the venous puncture site and the arterial puncture site. In some embodiments, the distal end of the catheter shaft may include a localization sensor. The robotic insertion system may use the localization sensor to determine the location of the distal end. In some embodiments, the robotic insertion system may use the localization sensor and the catheter radiopaque marker to determine the location of the distal end of the catheter shaft.

[0134] As described above, the robotic insertion system may be configured to control the delivery system in order to position the distal end of the shunt delivery system and / or the catheter shaft. The robotic insertion system may be configured to control the shunt delivery system and / or the catheter shaft in order to position the distal end of the shunt delivery system and / or the catheter shaft at the venous puncture site and / or the arterial puncture site. The robotic insertion system may be configured to alert a user if the identified position of the distal end of the shunt delivery system and / or the catheter shaft is moving away from (e.g., not towards) the venous puncture site and / or the arterial puncture site. In some embodiments, the robotic insertion system may be configured to display insertion directions to a user via the user interface. The insertion directions may include one or more steps for the user to perform in order to position the shunt delivery system and / or the catheter shaft at the venous puncture site and / or the arterial puncture site. Then, a needle may be advanced through a venous puncture site. The robotic insertion system may be configured to advance the needle through the venous puncture site. The robotic insertion system may be configured to automatically advance the needle through the venous puncture site. In some embodiments, a user may use a user interface of the robotic insertion system to control the robotic insertion system in order to advance the needle through the venous puncture site. Additionally and / or alternatively, the guidewire may be used to perform vessel puncture. In some embodiments, electrocautery may be applied when puncturing the vessels to seal an edge of the puncture site. The robotic insertion system mayautomatically apply electrocautery to seal an edge of the puncture site. The user may control the robotic insertion system to apply electrocautery.

[0135] At step 203, an artery may be punctured via the venous puncture site to define an arterial puncture site. For example, the guidewire and / or needle may be advanced through the venous puncture site, across the extravascular space, and toward the wall of the artery. Then, the guidewire and / or needle may be used to puncture the artery to define the arterial puncture site. The robotic insertion system may be configured to control the guidewire and / or needle to automatically advance the guidewire and / or needle through the venous puncture site. The robotic insertion system may be configured to control the guidewire and / or needle to automatically puncture the artery. The user may use a user interface of the robotic insertion system to control the guidewire and / or needle in order to advance the guidewire and / or needle through the venous puncture site and / or to puncture the artery. In some embodiments, access by the guidewire and / or needle to the aneurysm sac is then confirmed using fluoroscopy. In some embodiments, contrast may be injected to confirm entry into the aortic lumen. In some embodiments, the imaging modality may be configured to confirm access by the guidewire and / or needle to the aneurysm sac. In some embodiments, a dilator coupled to the delivery system may be advanced over the guidewire and used to increase a size of the opening of the venous puncture site and / or the arterial puncture site. The robotic insertion system may be configured to control the delivery system to automatically advance the dilator over the guidewire. A user may control the robotic insertion system via the user interface in order to advance the dilator over the guidewire. In some embodiments, the robotic insertion system may facilitate manual advancement of the dilator over the guidewire. In some embodiments, the dilator may be rotated via the catheter handle to advance the dilator into the aneurysm sac. In some embodiments, the dilator may act as a support member for the shunt. The robotic system may control the delivery system to rotate the catheter handle to advance the dilator into the aneurysm sac. A user may control the robotic insertion system via the user interface in order to rotate the dilator. In some embodiments, the robotic insertion system may facilitate manual rotation of the catheter handle.

[0136] At step 204, the endograft may optionally be delivered to the aortic aneurysm such that blood flows through the endograft. A guidewire of an endograft delivery system may be advanced through a sheath of the endograft delivery system into the vascularsystem under fluoroscopic guidance. The robotic insertion system may control the endograft delivery system to advance the guidewire of the endograft delivery system through the sheath of the endograft delivery system. The robotic insertion system may use the imaging modality and / or a localization sensor positioned at a distal end of the guidewire to automatically determine the position of the guidewire. The guidewire may be navigated to the aneurysm site in the aorta. The endograft delivery system may be introduced over the guidewire. Precise positioning is confirmed via imaging before deployment. The endograft is deployed, creating a new path for blood flow that excludes the aneurysm. The robotic insertion system may navigate the guidewire to the aneurysm site in the aorta. The robotic insertion system may introduce the endograft delivery system over the guidewire. The position of the guidewire and / or the endograft delivery system may be confirmed via the imaging modality before the endograft is deployed. The robotic insertion system may deploy the endograft.

[0137] At step 205, the shunt may be advanced in the delivery configuration through the venous puncture site of the vein to access the arterial puncture site of the artery. The shunt device may be introduced over the previously established transcaval guidewire (e.g., including the dilator) and navigated to the implantation site. The robotic insertion system may advance the shunt in the delivery configuration and navigate the shunt to the implantation site over the transcaval guidewire. In some embodiments, a sliding sheath may be disposed in the catheter and coupled to the shunt. In some embodiments, the shunt and the sliding sheath may be detachably attached, the shunt being initially held in an undeployed configuration, and the sliding sheath being disposed within the inner diameter of the shunt. The robotic insertion system may dispose the sliding sheath in the catheter and couple the sliding sheath to the shunt. The shunt may preferably be positioned so that about half of its length is positioned in the aneurysm sac and the vena cava, respectively. In some embodiments, the sliding sheath may be advanced until at least the arterial sealing structure is located within the aorta (e.g., the aneurysm sac). The robotic insertion system may advance the sliding sheath.

[0138] At step 206, the shunt may be transitioned from the delivery configuration to the deployed configuration, to allow blood to flow through the central portion of the shunt from the artery to the vein. The robotic insertion system may transition the shunt from the delivery configuration to the deployed configuration. Once in position, the sliding sheath and the dilator may be withdrawn (e.g., proximally). The robotic insertion system may withdrawthe sliding sheath and the dilator. In some embodiments, when the sliding sheath is withdrawn (e.g., by the robotic insertion system) from the aorta, the arterial sealing structure is deployed. Then, the sliding sheath may be withdrawn (e.g., moved proximally) to deploy the venous sealing structure, thereby positioning the shunt lumen between the aorta and the vena cava. In some embodiments, the dilator may remain in the shunt lumen and act as a support member. For example, the dilator may be kept in the shunt when at least some extravascular space exists and / or when a length of the extravascular space between the aorta and the vena cava is above a threshold. In some embodiments, the dilator may be withdrawn (e.g., by the robotic insertion system) when the sliding sheath is withdrawn. In some embodiments, when in the deployed configuration, blood may flow through the shunt during occurrence of leaking from the implanted endograft. In this way, the shunt can prevent endoleaks from occurring, which may in turn damage the aorta. In some embodiments, the implanted shunt serves to continuously drain fluid (e.g., blood) from the aneurysmal sac into the vena cava. Accordingly, in some embodiments, the shunt, via the deployed arterial sealing structure and venous sealing structure may form a circumferential fluid seal around the vascular puncture sites permitting fluid flow from the aorta to the vena cava. In some embodiments, a snare wire may be used to position and deploy the shunt, as described in further detail with respect to FIGS. 29-39. The robotic insertion system may be configured to manipulate the snare wire to position and deploy the shunt.

[0139] In some embodiments, after placement of the shunt, a final assessment may be completed to ensure the shunt and / or endograft have been placed in the correct location and are stable. Angiography may be performed to confirm the correct position of the endograft and the endoleak shunt. Further angiography checks for the adequacy of the shunt placement and function. In some embodiments, the imaging modality of the robotic insertion system may be configured to perform angiography. The robotic insertion system may display angiography image data to a user via the user interface of the robotic insertion system. The robotic insertion system may be configured to automatically analyze the image data to confirm the correct position of the endograft and the endoleak shunt. The robotic insertion system may be configured to automatically analyze the image data to confirm the adequacy of the shunt placement and function. The robotic insertion system may be configured to compare the image data with location data from a localization system in order to confirm the position of theendograft and / or the endoleak shunt. Once satisfactory, all wires, catheters, and sheaths are removed. In some embodiments, the robotic insertion system may be configured to automatically remove the wires, catheters, and sheaths. Establishing transcaval access prior to endograft delivery may be desired to avoid the risk of damaging a deployed endograft during transcaval puncture. In some embodiments, the method may include resizing the shunt after delivery. Specifically, the shunt can be delivered as previously described, but the shunt lumen may be expanded to an initial diameter that is smaller than the shunt lumen is capable of expanding to. This may be achieved, for example, by further expanding the shunt lumen diameter by inflatable balloon that inflates to a desired diameter. Alternately, if it is desirable to reduce the diameter of the shunt lumen, a separate delivery catheter may be used to deliver a tubular spacer having a thickness that reduces the size of the shunt lumen. In one example, the tubular spacer may be a secondary shunt structure subsequently deployed inside of the first shunt. The ability to resize the shunt after delivery allows for customization of the amount of shunted fluid for each individual subject. The robotic insertion system may be configured to inflate the inflatable ballon. The robotic insertion system may be configured to deliver the tubular spacer via the separate delivery catheter.

[0140] In some embodiments, the method may include implanting a bypass graft so as to divert some or all of the fluid (e.g., blood) flow around an aneurysmal sac, thereby alleviating the pressure against the aneurysmal sac, as described in further detail below with respect to FIGS. 40A-40E. The robotic insertion system may be configured to facilitate implantation of the bypass graft.

[0141] FIG. 3B is a flowchart of an example method of delivering the shunt using a delivery system, such as the robotic insertion system, according to an embodiment. In some embodiments, the method may include performing an abdominal computed tomography (CT) scan to measure a relationship between an inferior vena cava and an aorta of a patient, at step 301. The imaging modality of the robotic insertion system may be configured to perform the abdominal computed tomography (CT) scan. In some embodiments, the robotic insertion system may be configured to receive image data from the abdominal computed tomography (CT) scan. At step 302, target puncture locations in an inferior vena cava and an aorta may be determined as well as (optionally in some instances) an ideal puncture trajectory (e.g., of the distal tip of the delivery device). The robotic insertion system may be configured to displaythe image data via the user interface. A user may select the target puncture locations and / or the ideal puncture trajectory via the user interface. In some embodiments, the robotic insertion system may be configured to analyze the image data to automatically determine the target puncture locations and / or the ideal puncture trajectory. The robotic insertion system may be configured to analyze the image data to determine a path to the target puncture location. At step 303, a steerable access catheter may be introduced into a femoral vein of the patient. Then, the steerable access catheter may be navigated to a target puncture location within the inferior vena cava of the patient, at 304. The robotic insertion system may be configured to introduce the steerable access catheter into the femoral vein of the patient and / or navigate the steerable access catheter to the target puncture location. In some embodiments, the robotic insertion system may be configured to generate and / or display navigation instructions to the user via the user interface. The navigation instructions may include a trajectory of the steerable access catheter. The robotic insertion system may be configured to display alerts or notifications to the user. The alerts or notifications may inform the user when the steerable access catheter moves away from the path to the target puncture location. In some embodiments, the robotic insertion system may be configured to automatically navigate the steerable access catheter along the path to the target puncture location. The steerable access catheter may be used to align a distal tip (e.g., a guidewire and / or a dilator tip) of the delivery device with the target puncture location in the inferior vena cava. The robotic insertion system may be configured to position the steerable access catheter so the steerable access catheter may align the distal tip of the delivery device with the target puncture location. The robotic insertion system may be configured to manipulate the delivery device to align the distal tip of the delivery device with the target puncture location. In some embodiments, the robotic insertion system may be configured to steer or manipulate the distal tip of the delivery device. The guidewire may be advanced through the target puncture location in the inferior vena cava, at step 306, thereby defining a venous puncture site. The robotic insertion system may be configured to advance the guidewire through the target puncture location in the inferior vena cava. At step 307, the guidewire may be further advanced through the target puncture location within the aorta. The robotic insertion system may be configured to further advance the guidewire through the target puncture location within the aorta. The robotic insertion system may use image data from the imaging modality to determine the position of the delivery device and / or the distal tip of thedelivery device. The robotic insertion system may use a localization system to determine the position of the delivery device and / or the distal tip of the delivery device. The localization system may include a localization sensor positioned on the delivery device and / or the distal tip of the delivery device. The robotic insertion system may be configured to display the position of the delivery device and / or the distal tip of the delivery device to the user via the user interface. In some embodiments, the robotic insertion system may overlay a graphical representation of the position of the delivery device and / or the distal tip of the delivery device on the image data from the imaging modality. At step 308, access to the aorta may be confirmed. In some embodiments, access may be confirmed by imaging (with or without injecting contrast into the blood, and using any suitable imaging modality, such as the imaging modality of the robotic insertion system). The robotic insertion system may be configured to display image data from the imaging modality and the user may confirm access to the aorta. In some embodiments, the robotic insertion system may be configured to automatically analyze the image data from the imaging modality to confirm access to the aorta. At step 309, the dilator may be advanced over the guidewire to increase a size of the openings in the inferior vena cava and the aorta created by the guidewire. The robotic insertion system may be configured to advance the dilator over the guidewire. The dilator may include a localization sensor. The robotic insertion system may be configured to determine a position of the dilator via the localization sensor. The robotic insertion system may be configured to determine the position of the dilator via image data from the imaging modality. At step 310, the steerable sheath may be advanced over the dilator. The robotic insertion system may be configured to advance the steerable sheath over the dilator. Then, the dilator and the guidewire may be withdrawn from the steerable sheath, at 311. The robotic insertion system may be configured to withdraw the dilator and the guidewire from the steerable sheath. The steerable sheath may be advanced to deploy a distal end of the shunt, at step 312. The robotic insertion system may be configured to advance the steerable sheath to deploy the distal end of the shunt. The steerable sheath may include a localization sensor positioned at a distal end of the steerable sheath. The robotic insertion system may be configured to determine a position of steerable sheath via the localization sensor at the distal end of the steerable sheath. The robotic insertion system may be configured to determine the position of the steerable sheath and / or the shunt via image data from the imaging modality. Then, the steerable sheath may be retracted (e.g.,proximally) to deploy the proximal end of the shunt. In some embodiments, the shunt may be self-expanding. The robotic insertion system may be configured to retract the steerable sheath and / or deploy the shunt. The delivery system is further described with respect to FIGS. 4 and FIGS. 10A-10B. In some embodiments, the robotic insertion system may be configured to automatically perform one or more of the steps 301-313 of method 300. In some embodiments, the robotic insertion system may be configured to perform one or more of the steps 301-313 of method 300 in response to the user interface receiving confirmation from the user to proceed with the one or more of the steps 301-313. In some embodiments, a user may perform one or more of the steps 301-313 of method 300 via the robotic insertion system. The user may control the robotic insertion system via a user input of the user interface. The robotic insertion system 4100 is described further with respect to FIGS. 41-44.

[0142] FIGS. 4-4A are schematic block diagrams of a distal end of a delivery system 450 configured to deliver a shunt 400, according to some embodiments. A robotic system, such as robotic insertion systems 490 and / or 4100 may be configured to control or manipulate the delivery system 450 to deliver the shunt 400. The robotic insertion system 4100 is further described with respect to FIGS. 41-44. As shown, the delivery system 450 includes a catheter 460 (e.g., a steerable catheter) defining a catheter lumen. A sliding sheath 466 may extend through the catheter lumen and the shunt 400 may be detachably coupled thereto. The sliding sheath 466 may define a sheath lumen and be configured to slide over a dilator 464 including a dilator tip 465. The dilator 464 may define a dilator lumen through which a guidewire 462 may extend. During implantation of the shunt 400, once the distal end of the delivery system 450 is positioned near a target puncture site in the vein (e.g., the vena cava), the guidewire 462 may be configured to extend through an opening defined by the dilator tip 465 to puncture the vein. The guidewire 462 may be further extended through the venous puncture site toward the artery to puncture the artery. The dilator tip 465 may then be moved through the venous puncture site and / or the arterial puncture site to widen openings to accommodate a diameter of the shunt 400. For example, the dilator tip 465 may gradually increase in diameter from a distal end to a proximal end such that the distal end can be easily disposed through an opening defined by the guidewire, and as the dilator tip 465 is moved distally, the dilator tip 465 may gradually increase a size of the opening.

[0143] In some embodiments, the dilator 464 may include a cutting mechanism configured to cut through the vessels (e.g., the aorta and the vena cava) to create an anastomosis or aortocaval fistula (e.g., a fluid path between the vessels). In some embodiments, the cutting edge 476 may be disposed around a periphery of and / or and protruding from at least of a proximal end of the distal end 465 of the dilator 464 (e.g., a distal member) or a distal end of a body of the dilator 464 (e.g., a proximal member). In some embodiments, the distal member and the proximal member may be movably coupled to one another to allow for relative axial movement between a first configuration in which the proximal member and the distal member are spaced a distance sufficient to span across a venous wall of a vein and an arterial wall of an artery, and a second configuration in which the proximal member and the distal member are spaced less than a thickness of at least one of the venous wall or the arterial wall. In some embodiments, one of the proximal member or the distal member having a cutting edge configured to cut through the venous wall and the arterial wall. In some embodiments, a portion of the dilator 464 proximal to the dilating tip 465 may have a reduced diameter and form a cutting edge 476. The cutting edge may include a tapered surface with a blade. The dilator 464 may include a blunt surface 475 proximal to the first cutting edge 476. In some embodiments, the cross-section of the cutting edge and / or the blunt surface may form an oval or a circle. In some embodiments, the cutting edge 476 and the blunt surface 475 may have matching profiles and be configured to oppose one another. In some embodiments, the cutting edge 476 and the blunt surface 475 may be parallel to one another. In some embodiments, once the distal end of the dilator 464 including the first cutting edge is disposed through a puncture site, the distal end of the dilator 464 may be retracted (e.g., proximally) such that the cutting edge 476 contacts the blunt surface 475, capturing the vessel therebetween, thereby cutting a portion of the vessel wall. In some embodiments, the dilator 464 may be retracted (e.g., transitioned from an extended configuration to a retracted configuration) after the dilator tip 465 and first cutting edge have been disposed through both a venous puncture site and an arterial vessel site, such that both the vein and the artery are captured between the cutting edge 476 and the blunt surface 474 and cut simultaneously. In some embodiments, a shaft may be coupled to the dilator 464 (e.g., extend at least partially through a lumen of the dilator 464) and configured to extend and / or retract to move the distal end of the dilator 464 between a first configuration (extended configuration) in which the cutting edge 476 and the blunt surface 475 are separated by adistance and second configuration (retracted configuration) in which the cutting edge 476 and the blunt surface 475 oppose one another. In some embodiments, the shaft may not extend entirely through the dilator 464. For example, the shaft may move the distal end of the dilator 464 in a proximal direction to transition the cutting apparatus from the first configuration to the second configuration. In some embodiments, the dilator 464 may be configured such that the cutting edge 476 and the blunt surface 475 in the extended configuration may define a distance therebetween corresponding to at least a distance of the extravascular space. In some embodiments, the cutting edge 476 may cut the vessel wall to have a shape of the cutting edge 476 (e.g., an oval or a circle with a desired diameter).

[0144] In some embodiments, a predetermined pressure may be applied between the cutting edge 476 and the blunt surface 475 to cut out a small circular and / or oval section of the target vessel (e.g., the aorta and / or the vena cava). In some embodiments, the pressure applied between the cutting edge 476 and the blunt surface 475 may be controlled internally in the catheter. In some embodiments, the pressure may be controlled by a handle attached to a proximal end of the catheter. In some embodiments, the cutting edge 476 and / or the blunt surface 475 may be configured to apply heat (e.g., electrocautery) during the cutting.

[0145] In some embodiments, the sliding sheath 466 of the delivery system 450 may be configured to slide over the dilator 464 to position the shunt 400 between the venous and arterial puncture sites. In some embodiments, the sliding sheath 466 may be disposed in an inner diameter of the shunt 400. The shunt 400 may be coupled to the sliding sheath 466 such that the shunt 400 is constrained to the delivery configuration until the sliding sheath 466 is withdrawn (e.g., moved proximally). For example, the proximal and distal ends of the shunt 400 may be temporarily attached to the sliding sheath 466 such that when the sliding sheath 466 is moved proximally, the ends of the shunt 400 detach, allowing the sealing structures to expand. In some embodiments, once the shunt 400 is in position with the distal end of the shunt positioned in the aorta, and the proximal end of the shunt 400 positioned in the vena cava, the sliding sheath may be retracted proximally such that the arterial sealing structure and the venous sealing structure expand.

[0146] In some embodiments, the sliding sheath 466 of the delivery system 450 may include one or more bias members (e.g., inflatable devices) disposed along the length of the shunt 400. For example, slidable sheath 466 may include two or three inflatable balloonsthat may be inflated to different diameters to deform the shunt 400 into an hourglass or shuttlecock shape, for example. In some embodiments, the slidable sheath 466 may include one balloon that when inflated has an hourglass or shuttlecock shape. Use of inflatable balloons allows the central portion of the shunt 400 to expand to a desired diameter while ensuring the sealing structures to expand to a diameter independent of the diameter of the central portion 102 to engage the surrounding tissue.

[0147] In some embodiments, one or more portions of the distal end of the delivery system may include one or more radiopaque markers to guide navigation of the distal end and delivery of the shunt 400. For example, the catheter 460, the sliding sheath 466, the dilator 464, the dilator tip 465, the guidewire 462, the distal end of the shunt 400, and / or the proximal end of the shunt 400 may include one or more radiopaque markers. The delivery system is described in further detail with respect to FIGS. 10A-10B.

[0148] As shown in FIG. 4A, delivery system 450 may include a localization system 480. The localization system 480 may be configured to determine and / or monitor the position of one or more components of the delivery system 450 and / or the sheath 400. The localization system 480 may be configured to determine the position of the one or more components of the delivery system 450 in real time or substantially real time. In some embodiments, the localization system 480 may include an electromagnetic localization system, an ultrasound localization system, an optical shape sensor localization system, a shape sensing fiber localization system, and / or any other localization system.

[0149] The localization system 480 may include a transmitter 481 and a plurality of localization sensors. The catheter 460 may include a catheter localization sensor 460A, the guidewire 462 may include a guidewire localization sensor 462A, the dilator 464 may include a dilator localization sensor 464A, and / or the sliding sheath 466 may include a sheath localization sensor 466A. The shunt 400 may include a first shunt localization sensor 400A and / or a second localization sensor 400B. The first localization sensor 400A may be positioned at the distal end of the shunt 400. The second localization sensor 400B may be positioned at the proximal end of the shunt 400.

[0150] For example, the transmitter 481 may be configured to generate and / or emit a magnetic field. The localization sensors 400A, 400B, 462A, 464A, 466A may include sets of coils configured to sense the magnetic field emitted by the transmitter 481. A roboticinsertion system, such as robotic insertion system 4100 may be communicatively coupled to the transmitter 481 and the localization sensors 400A, 400B, 462A, 464A, 466A. The robotic insertion system may be coupled to the localization sensors 400A, 400B, 462A, 464A, 466A via one or more leads 482. The leads 482 may be embedded in the components of the delivery systems 450. The robotic insertion system may be configured to receive localization data or information from the transmitter 481 and the localization sensors 400A, 400B, 462A, 464A, 466A. The robotic insertion system may be configured to determine the position of the localization sensors 400A, 400B, 462A, 464A, 466A based on the localization data or information received from the transmitter 481 and the localization sensors 400A, 400B, 462A, 464A, 466A.

[0151] In another example, the localization sensors 400A, 400B, 462A, 464A, 466A may include one or more conductive rings positioned in the one or more components of the delivery system 450. The localization sensors 400A, 400B, 462A, 464A, 466A may be positioned at various locations along the length of each of the one or more components of the delivery system 450. The transmitter 481 may include a plurality of conductive skin patches. The transmitter 481 may be configured to generate current. The localization sensors 400A, 400B, 462A, 464A, 466A may be configured to sense the current generated by the transmitter 481. The robotic insertion system 490 may be configured to determine the position of the localization sensors 400A, 400B, 462A, 464A, 466A based on the data or information received from the transmitter 481 and the localization sensors 400A, 400B, 462A, 464A, 466A.

[0152] FIG. 5A shows a side view of a shunt 500 for treating aortic aneurysm in a delivery configuration, according to an embodiment. As shown, the shunt 500 includes a central portion 502, a venous sealing structure 504, and an arterial sealing structure 506. The shunt 500 further includes a cover 508 disposed around the central portion 502 at or near a center point of the shunt 500. The shunt 500 may be structurally and / or functionally similar to the shunt 100, and therefore certain details of the shunt 500 may not be described herein with respect to FIGS. 5A-5C. As shown, the shunt 500 in the delivery configuration forms a cylindrical shape such that a diameter of along the length of the shunt 500 is constant or has little (less than 5%) fluctuation. The distal and proximal ends of the shunt 500 may include radiopaque markers to provide visual aid during placement of the shunt 500.

[0153] FIGS. 5B-5C show a front view and a side view, respectively, of the shunt in a deployed configuration. As shown in FIG. 5B, in the deployed configuration, the diameter DB of a center lumen 512 defined by the central portion 502 is smaller than the maximum diameters DA, Dv of the arterial sealing structure 506 and the venous sealing structure (not shown). The arterial sealing structure 506 and the venous sealing structure 504 in the deployed configuration each form a conical shape, as shown in FIG. 5C. In some embodiments, an apex of the conical shape may point away from the central portion 502 and a base of the conical shape may be proximate to the central portion 502. For example, an outer surface of the venous sealing structure 504 proximate to the central portion 502 and an outer surface of the arterial sealing structure 506 proximate to the central portion 502 may each include a flat surface (e.g., a bottom surface of the conical shape) configured to lay against an inner wall of the vein and artery, respectively, to seal the puncture sites. In some embodiments, the flat surface may be configured to curve or conform if the vasculature curves or changes shape. The central portion 502 of the shunt remains cylindrical in the deployed configuration such that the shunt 500 forms a dumbbell shape (e.g., a cylindrical shape disposed between two conical shape ends). In some embodiments, a length of the central portion 502 and / or the sealing structure 504, 506 may decrease as the shunt 500 transitions to the deployed configuration. In some embodiments, the length of the central portion 502 may increase when the shunt 500 transitions to the deployed configuration. In some embodiments, the cover 508, when the shunt 500 is in the deployed configuration, may be configured to span at least a portion of the length of the central portion (e.g., the length between the flat surface of the sealing structures 504, 506). In some embodiments, the cover 508 may be configured to span an entire length of the central portion 502 (e.g., the entire length between the flat surface of the sealing structures 504, 506) to provide support to the central portion 502 and prevent collapse and / or closing of the central lumen defined by the central portion.

[0154] FIGS. 6A-6D are side views of a shunt 600 in the deployed configuration including a super-elastic material formed in an hourglass shape, according to an embodiment. As shown, the shunt 600 includes a central portion 602, a venous sealing structure 604, and an arterial sealing structure 606. The shunt 600 may be structurally and / or functionally similar to the shunt 100, 500, and therefore certain details of the shunt 600 may not be described with respect to FIGS. 6A-6D. In the deployed configuration, a diameter of the venous sealingstructure 604 increases proximally and a diameter of the arterial sealing structure 606 increases distally such that the sealing structures 604, 606 each form an elliptical cone shape. In some embodiments, the shunt 600 in the deployed configuration forms an hourglass shape (e.g., a hyperboloid of one sheet). For example, a maximum diameter of the venous sealing structure 600 may be at a proximal end of the shunt 600 and a maximum diameter of the arterial sealing structure 600 may be at a distal end of the shunt 600. In some embodiments, the cells defined by the shunt may vary in size across a length of the shunt. For example, the cells corresponding to the central portion 602 may be smaller in size (e.g., have a smaller cross-sectional area) than the cells corresponding to the sealing structures 604, 606 due to a higher degree of compression at the central portion 602 of the shunt 600. In other words, the central portion 602 may have a fluid porosity that is less than a fluid porosity of the sealing structure 604, 606. The shunt 600 may be configured to stretch (e.g., stretch, bend, flex, conform, deform, etc.) to accommodate changing anatomy of the vasculature, as shown in FIGS. 6B-6D. As shown in FIG. 6B, the shunt 600 may be stretched longitudinally such that a total length of the shunt 600 increases, and the diameter of the central portion 602 may decrease. The shunt 600 may enter the longitudinally stretched configuration as an aneurysm sac begins to decrease in size and a length of the extravascular space increases, for example. The shunt 600 may be configured to accommodate changes in a horizontal alignment of the venous puncture site and the arterial puncture site. The decrease in the diameter of the central portion 602 (e.g., the central lumen of the central portion) may be operable to control blood flow (e.g., to decrease blood flow) through the shunt 600.

[0155] In some embodiments, the venous sealing structure 604 and the arterial sealing structure 606 may be configured to pivot (hinge, bend, rotate, twist) relative to the central portion 602 allowing the shunt 600 to conform to changes in vessel anatomy. For example, the shunt 600 may be configured to accommodate changes in a vertical alignment of the venous puncture site and the arterial puncture site, as shown in FIG. 6C. In some embodiments, the shunt 600 may be able to accommodate curvature of at least one of the vein or the artery (e.g., curvature of a wall of the vein or the artery closest to the extravascular space between the vein and the artery), as shown in FIG. 6D.

[0156] FIGS. 6E is a side view of a shunt 700 in the deployed configuration including a super- elastic material formed in asymmetrical shape, according to an embodiment.The shunt 700 may include a central portion 702, a venous sealing structure 704, and an arterial sealing structure 706. In some embodiments, the venous sealing structure 704 and the arterial sealing structure 706 may be configured to form different shapes in the deployed configuration such that the shunt 700 is asymmetrical in the deployed configuration. The venous sealing structure 704 may be configured to form a disc shape, as shown. In some embodiments, a diameter of the venous sealing structure increases in the proximal direction such that a maximum diameter of the venous sealing structure is at a proximal end of the shunt 700. In some embodiments, the venous sealing structure 704 may include a flat or substantially flat portion configured to seal the venous puncture site and secure the shunt 100 in place. As shown, the arterial sealing structure 706 may be configured to form a bulb (e.g., a conical bulb, an oblate spheroid, etc.) in the deployed configuration. Along a distal direction, a diameter of the arterial sealing structure 706 may increase until the arterial sealing structure 706 reaches a maximum diameter, then decrease such that a maximum diameter of the arterial sealing structure 706 is between the central portion 702 and the distal end of the shunt 700. In some embodiments, the bulb shape of the arterial sealing structure may be operable to displace the thrombus away from the lumen of the shunt 700 and therefore the endoleak drainage pathway to prevent blockage and / or to promote blood flow through the shunt 700. The bulb shape of the arterial sealing structure 706 through displacement of thrombus may also generate a tensile force between the venous sealing structure 704 and the arterial sealing structure to improve the seal at the venous and arterial puncture sites. Furthermore, the rounded edges of the bulb (and the absence of sharp edges) may prevent damage to the endograft by reducing likelihood the arterial sealing structure 706 punctures the endograft. Damage to the endograft may otherwise occur when the aneurysm sac shrinks and a volume between the endograft and the shunt 700 decreases.

[0157] In some embodiments, the distal end of the arterial sealing structure 706 may be open, as shown in FIG. 6E to allow blood to flow therethrough unobstructed. In some embodiments, the distal end of the arterial sealing structure 706 may be at least partially closed to prevent large clots from passing through or clogging the shunt 700. In some embodiments, a size of the opening at the distal end of the arterial sealing structure 706 may prevent clots from passing therethrough. In some embodiments, the size of the opening at the distal end of the arterial sealing structure 706 may be in a range of about 10 mm2to about 40 mm2, inclusiveof all ranges and subranges therebetween. In some embodiments, a length of the arterial sealing structure 706 may be greater than a length of the venous sealing structure 704, as shown for example in FIG. 6E. In some embodiments, the length of the arterial sealing structure 706 may be at least as long as a thickness of the thrombus being treated. In some embodiments, the venous sealing structure 704 may have a length that is about 10% of the length of the arterial sealing structure 706. In some embodiments, the length of the venous sealing structure may be about 5% to about 100% of the length of the arterial sealing structure 706, inclusive of all ranges and subranges therebetween. In some embodiments, the venous sealing structure 704 may be shorter in length to reduce likelihood the venous sealing structure 704 impedes blood flow in the vein (e.g., vena cava). In some embodiments, an area of the cell defined by the shunt 700 may be larger in the arterial sealing structure 706 than the central portion 702 and / or venous sealing structure, as shown in FIG. 6E. For example, the central portion 702 may be more compressed (or less expanded) meaning the area of each of the cells is smaller (e.g., the fluid porosity is lower) than the area of each of the cells (or some of the cells) in the venous sealing structure and / or the each of the cells (or some of the cells) in the arterial sealing structure 706. The central portion 702 may be more compressed such that (1) leakage of fluid through the cells in the central portion 702 is reduced; (2) the central portion 702 has more structural support and / or rigidity to aid with tissue dilation during deployment; and / or (3) there is higher surface area of material in the central portion 702 for tissue integration. In some embodiments, at least some of the cells at a terminal end of the venous sealing structure 704 may not be closed cells. In some embodiments, the cells at a terminal end of the arterial sealing structure 706 may be closed cells (as shown). In some embodiments, the shunt 100 may have open cells with large cell sizes at a proximal end (e.g., the Nitinol braids or struts may have sharp, unclosed terminal ends). The shunt 100 at the central portion 702 may include closed cells with cell sizes smaller than those at the proximal end. The shunt 700 at a maximum diameter of the bulb may further include closed cells with cell sizes equal to or larger than those at the proximal end. The shunt 700 at a distal end may include cells that converge to a common point with cell sizes smaller than those at the maximum diameter of the bulb. Therefore, a fluid porosity of the shunt 700 may vary along the length of the shunt. For example, the fluid porosity in the central portion 702 of the shunt may be less than the fluid porosity at each of the sealing structure 704, 706.

[0158] FIG. 7 is an illustration of the shunt 800 in the deployed configuration illustrating positioning of a venous sealing structure 804 relative to a wall of a vein 823 and an arterial sealing structure 806 relative to a wall of an artery 821 including thrombus T. As shown, the bulb shape of the arterial sealing structure 806 enables thrombus engagement regardless of the thickness of the thrombus T. This allows for the shunt 800 to serve as an adequate solution across a ranges of thrombus thicknesses and geometries.

[0159] FIG. 8 shows a side view of a shunt 900 in the deployed configuration including a flow controller including a valve 907 and a filter 909, according to an embodiment. The valve 907 may be a one-way valve configured to enable blood to flow in a first direction (e.g., from the artery to the vein) but to prevent blood from flowing in a second direction (e.g., from the vein to the artery). In some embodiments, the valve may include a flexible material configured to respond to changes in blood pressure and flow dynamics. For example, the valve may open (or remain open) in response to blood pressure and / or blood flow in a first direction, whereas the valve may close (or remain closed) in response to a reverse in blood pressure and / or blood flow to prevent blood from flowing into the aneurysm sac. In some embodiments, in response to an increase in blood pressure and / or blood flow in the first direction, the valve may open to increase a flow rate and / or volume of blood therethrough. In some embodiments, in response to a decrease in blood pressure and / or blood flow as the aneurysm sac decreases in size and / or the endoleak decreases in severity, the valve may close to decrease a flow rate and / or volume of blood flow therethrough. As shown, the valve 907 may be disposed in a central portion 902 of the shunt 900 at or near a center point along a length of the shunt 900. The valve 907 may include a tubular member, and a proximal end of the tubular member may taper laterally such that a cross-sectional area defined by the tubular member decreases. In some embodiments, the tubular member may taper such that the proximal end of the tubular member defines a flat opening or slit. In some embodiments, the filter 909 of the flow controller may be cylindrical member including a plurality of walls disposed configured to catch blood clots and / or debris (e.g., from the thrombus) from flowing through the shunt 900 and toward the vein and into the systemic circulation. Alternatively or additionally, the filter 909 may include a mesh, net, a porous membrane, a semipermeable membrane, lattice, screen, etc. to prevent flow of solid matter through the filter 909.

[0160] FIG. 9A-9G are illustrations of the shunt 1000 disposed between an artery 1011 and a vein 1013 to place the artery 1011 in fluid communication with the vein 1013 to treat an aneurysm, according to an embodiment. The shunt 1000 may be implanted in a portion of a wall of the artery 1011 that defines an aneurysm sac. As shown, the shunt 1000 is laser cut from a super-elastic material and defines a plurality of cells. The arterial sealing structure 1006 includes an elliptical cone shape having an open distal end that extends toward a lumen of the artery 1011.

[0161] The central portion 1002 forms a cylindrical shape defining an inner lumen. As shown, the venous sealing structure 1004 includes one or more stability members coupled to the central portion 1002 and configured to conform to a curvature of an inner surface of a wall of the vein (e.g., the vena cava) 1013. In some embodiments, a first stability member may include a compliant projection configured to extend along at least a portion of a circumference of the inner surface of the vein wall 1013. A second stability member may include a compliant projection configured to extend along a length of the vein 1013 (e.g., extend straight or flat along the length of the vein 1013). In some embodiments, the compliant projection may include a biocompatible material, including but not limited to, a metal, a polymer, a plastic, an alloy, a fabric, etc. The one or more stability members may help secure the shunt 1000 in place and / or prevent movement of the shunt 1000.

[0162] The arterial sealing structure 1006 (e.g., the elliptical cone shape) is configured to be positioned within the aorta, providing a stable anchor that prevents migration of the shunt 1000. In some embodiments, the arterial sealing structure 1006 may be expandable such that a distal end of the shunt 1000 remains securely positioned within the aorta under varying vein-to-artery geometries (for example, varying thrombus thicknesses), thus maintaining the integrity of the placement of the shunt 1000. For example, the arterial sealing structure 1006 may be configured to expand after the shunt 100 is robotically placed by control of delivery system 1150 via robotic insertion system 4100. As the arterial sealing structure 1006 expands within the aorta, it can push away any thrombus that may be present, thereby creating a clear drainage pathway for an endoleak. Furthermore, the arterial sealing structure 1006 includes a wide aperture or opening (e.g., at least 5 mm) to capture endoleaks from various intrasac locations such that the blood leaking into the aneurysm sac can be effectively drained into the inferior vena cava. The drainage pathway from a distal end of the shunt 1000through the central portion 1002 can reduce the risk of aneurysm sac pressurization and potential rupture. The expansion of the arterial sealing structure 1006 may also generate an opposing force directed towards the proximal stability members 1004 A, 1004B, 1004C, 1004D (e.g., the petaloids). This opposing force may compress the puncture sites (e.g., move the puncture sites toward one another) in the walls of both the vena cava and the aorta. By exerting pressure in the direction opposite to the proximal stability members 1004A, 1004B, 1004C, 1004D, the arterial sealing structure 1006 can help create an effective arteriovenous seal, which can help direct blood to flow through the shunt 1000 and can prevent leakage through the puncture sites to an extravascular space. When the aneurysm shrinks and causes the arterial sealing structure 1006 to contact the endograft, the shape of the arterial sealing structure 1006 promotes or ensures protection of the endograft. For example, the elliptical cone shape of the arterial sealing structure 1006 may distribute a force applied by the shunt 1000 to the endograft to be evenly distributed and may prevent localized stress on the endograft. This protection can promote or maintain the integrity of the endograft and limit or prevent complications related to endograft damage.

[0163] The shunt 1000 may enable secure anchoring within the vascular system. This secure anchoring may facilitate robotic insertion of the shunt 1000. The stability members 1004 A, 1004B, 1004C, 1004D of the venous sealing structure 1004 are configured to lay flush against the interior surface of the vena cava. In some embodiments, the stability members 1004 A, 1004B, 1004C, 1004D and can be heat-set in a curved form to create a saddle-shaped deployed configuration. The deployed configuration may comply with an inner geometry of the vessel, providing a secure fit. For example, in the deployed configuration the petaloids to lay flush against the interior surface of the vena cava, ensuring a secure and stable anchoring mechanism, as shown in FIG. 9E. Dimensions of the saddle-shaped configuration of the petaloids can be specifically tailored to conform to the inner geometry of the vessel, providing a customized fit that enhances the stability of the shunt 1000.

[0164] The shunt 1000 and any other shunt described herein may be formed from a single tube of a material, such as nitinol, spring steel, glass or carbon composites or polymers, or pseudoelastic (at body temperature) material such as nitinol or comparable alloys and polymers, by laser cutting several closed-ended slots along the length of the tube (leaving theextreme distal and proximal edges of the tube intact) and cutting open-ended slots from the longitudinal center of the tube through the distal and proximal edges of the tube.

[0165] During deployment, the stability members 1004A, 1004B, 1004C, 1004D may be oriented such that at least a first pair of stability members 1004 A, 1004C align with a curved surface of the vein and at least a second pair of stability members 1004B, 1004D align parallel or substantially parallel to a longitudinal axis of the vein. The pre-set curved petaloids expand and lay flush against the interior surface of the vena cava, forming a saddle-shaped configuration.

[0166] Advantages of the shunt 1000 may include providing a secure anchoring mechanism, being adaptable, improving patient outcomes, and being biocompatible and / or durable. For example, the combined use of the arterial sealing structure 1006 and proximal stability members 1004A, 1004B, 1004C, 1004D ensures a stable and secure anchoring mechanism. The saddle-shaped configuration of the stability members 1004A, 1004B, 1004C, 1004D provides a customized fit within the vena cava, enhancing the stability of the shunt 1000 and preventing migration. The ability of the central portion 1002 to expand and / or shorten upon release from the catheter allows the shunt 1000 to adapt to varying vessel diameters. This adaptability ensures a secure fit, accommodating the dynamic nature of the vascular system, and may facilitate robotic insertion of the shunt 1000, for example by control of a delivery system 1150 via robotic insertion system 4100. By reducing pressure and providing a drainage pathway for endoleaks within the aneurysm sac, the shunt 1000 effectively prevents rupture, improving patient outcomes and reducing the need for long-term surveillance and potential reinterventions associated with traditional EVAR procedures. The use of biocompatible materials and precise laser-cutting techniques allow the shunt 1000 to be safe for long-term implantation, and the durable construction minimizes the risk of adverse reactions and complications, promoting better long-term patient outcomes.

[0167] In some embodiments, the shunt 1000 can be implanted in locations other than between vein and artery, and although referred to as the arterial sealing structure 1006 and the venous sealing structure 1004A-1004D, it should be appreciated the arterial sealing structure 1006 and venous sealing structure 1004A-1004D can be configured for other parts of the anatomy (e.g., other than the aorta).

[0168] FIGS. 10A-10B show a delivery system 1150 including a catheter 1160 for delivering a shunt 1100 to treat an aortic aneurysm, according to an embodiment. The delivery system 1150 may be configured to be controlled by a robotic insertion system, such as robotic insertion system 4100. The robotic insertion system may be configured to control the delivery system 1150 in order to deliver the shunt 1100 to treat an aortic aneurysm. The robotic insertion system may be configured to control, insert, advance, and / or retract components of the delivery system 1150 in order to deliver the shunt 1100 to treat the aortic aneurysm. The robotic insertion system may be configured to control or manipulate components of the delivery system 1150 in order to perform any of the functions or features of the components of the delivery system 1150 described herein. In some embodiments, the delivery system 1150 includes a catheter handle 1168 and a catheter shaft 1160, extending therefrom, and having a catheter lumen therein. A sliding sheath 1166 may be disposed in the catheter lumen, and the shunt 1100 may be detachably coupled to the sliding sheath 1166. The sliding sheath 1166 may be configured to slide over a dilator 1164 including a dilator tip 1165. A guidewire 1162 may be disposed through a lumen defined by the dilator 1164 and configured to guide navigation of a distal end of the delivery system 1150. In some embodiments, the catheter shaft 1160 is steerable (e.g., a steerable sheath). As shown in FIG. 10A, a distal portion of the steerable catheter shaft 1160 may be configured to move through multiple positions. The robotic insertion system may be configured to control the catheter shaft 1160 and / or the distal portion of the steerable catheter shaft 1160. In some embodiments, the catheter handle 1168 includes a hemostatic valve 1172 at a proximal end of the catheter handle 1168. In some embodiments, the catheter handle 1168 includes a rotation collar 1174 for steering the catheter shaft 1160. The robotic insertion system may be configured to steer the catheter shaft 1160 via the rotation collar 1174. In some embodiments, the robotic insertion system may be configured to control the catheter shaft 1160 via control elements, such as tension cables, as described further with respect to FIG. 42. In some embodiments, the delivery system 1150 comprises a contrast port 1171 coupled to the catheter handle 1168. In some embodiments, the catheter handle 1168 includes a tip rotation indicator 1173 to determine a rotation of the dilator tip 1165.

[0169] In some embodiments, the catheter 1160 includes one or more catheter radiopaque markers 1161. In some embodiments, the catheter 1160 includes between about 1 radiopaque marker and 10 radiopaque markers, inclusive of all ranges and subrangestherebetween. In some embodiments, one or more radiopaque markers are disposed at the distal end of the catheter shaft 1160. In some embodiments, the one or more catheter radiopaque markers 1161 include a radiopaque band disposed around the catheter shaft 1160. In some embodiments, the catheter shaft 1160 has a length in a range of about 10 cm to about 100 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the catheter shaft 1160 includes a catheter wall forming an inner diameter and an outer diameter. In some embodiments, the inner diameter of the catheter shaft 1160 is in a range of about 0.5 cm to about 2 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the outer diameter of the catheter is in a range of about 0.5 cm to about 2 cm, inclusive of all ranges and subranges therebetween.

[0170] In some embodiments, the delivery system 1150 may include a localization system. The localization system may include any of the features of the localization system 480. The localization system may be configured to determine and / or monitor the position of one or more components of the delivery system 1150 and / or the sheath 1100.

[0171] In some embodiments, the proximal end of the catheter shaft 1160 is operably connected to the catheter handle 1168. In some embodiments, the position of the catheter shaft 1160 inside the blood vessel (e.g., artery or vein) may be controlled by a user (e.g., a surgeon, a medical specialist, a doctor, or similar) or by a machine (e.g., a robotic arm or the robotic insertion system 4100). In some embodiments, the position of the catheter shaft 1160 inside the blood vessel is controlled using the catheter handle 1168. In some embodiments, a robotic insertion system (e.g., robotic insertion system 4100) may control the position of the catheter shaft 1160 via control elements. In some embodiments, the catheter handle 1168 includes a release mechanism operably linked to any one or more of the guidewire 1162, dilator 1164 the sealing structures (1104, 1106), the shunt 1100, the sliding sheath 1166, or the catheter shaft 1160. In some embodiments, the catheter handle 1168 is configured to orient the direction of any one or more of the guidewire 1162, the dilator 1164, the sliding sheath 1166, or the shunt 1100.

[0172] In some embodiments, the guidewire 1162 is configured to pass through a dilator 1164. In some embodiments, the guidewire 1162 includes a proximal end and a distal end. The guidewire 1162 may additionally include a guidewire lumen traversing the length of the guidewire 1162 from the proximal end to the distal end. In some embodiments, theguidewire 1162 (and the guidewire lumen) has a length in a range of about 10 cm to about 250 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the guidewire may have a guidewire wall forming an inner diameter and an outer diameter. In some embodiments, the inner diameter of the guidewire is in a range of about 0.1 mm to about 3 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the outer diameter of the guidewire outer diameter is in a range of about 0.1 mm to about 3 mm, inclusive of all ranges and subranges therebetween. The robotic insertion system may be configured to advance and / or retract the guidewire 1162 through the dilator 1164.

[0173] In some embodiments, the guidewire 1162 is introduced within the dilator 1164 via a guidewire introduction port 1163. In some embodiments, the dilator 1164 includes one or more depth markings 1167, configured to indicate a distance the dilator 1164 extends from a point of reference (e.g., a distal end of the catheter handle 1168). In some embodiments, the dilator 1164 body serves as a support member. In some embodiments, the dilator tip 1164 is configured to be rotated (bent, deflected, etc.) to dilate an opening at the venous and / or arterial puncture site. In some embodiments, the dilator tip 1165 is configured to be rotated via the catheter handle 1168 and / or by the robotic insertion system via the control elements. In some embodiments, the shunt 1110 and the dilator 1164 are detachably attached.

[0174] In some embodiments, the dilator 1164 includes one or more dilator radiopaque markers. In some embodiments, the dilator 1164 includes between about 1 radiopaque marker and 10 radiopaque markers, inclusive of all ranges and subranges therebetween. In some embodiments, the radiopaque markers on the dilator 1164 are disposed at the distal end of the dilator 1164, proximal to the dilator tip 1165. In some embodiments, the dilator 1164 has a length in a range of about 10 cm to about 100 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the dilator 1164 includes a wall forming an inner diameter and an outer diameter. In some embodiments, the inner diameter of the dilator 1164 is in a range of about 0.1 mm to about 5 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the outer diameter of the dilator 1164 is in a range of about 1 mm to about 5 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the dilator includes a localization sensor, such as localization sensor 464A described with reference to FIG. 4A.

[0175] In some embodiments, the sliding sheath 1166 is configured to slide over the dilator 1164. In some embodiments, the sliding sheath 1166 is configured to be detachably coupled to the shunt 1100 at a distal end portion of the sliding sheath 1166. The robotic insertion system may be configured to slide the sliding sheath 1166 over the dilator 1164 and / or detachably couple the sliding sheath 1166 to the shunt 1100. In some embodiments, the sliding sheath 1166 may include be disposed in an inner diameter of the shunt 1100. In some embodiments, the sliding sheath 1166 includes a braided shaft (e.g., includes a plurality of filaments braided into a shaft). In some embodiments, the sliding sheath 1166 is configured to maintain the sealing structures 1104, 1106 in a non-deploy ed state (e.g., the delivery configuration) until the sliding sheath 1166 is withdrawn, for example, by the robotic insertion system 4100. In some embodiments, the sliding sheath 1166 is moved (e.g., by the robotic insertion system 4100) proximally to transition the sealing structures 1104, 1106 to the deployed configuration. In some embodiments the sliding sheath 1166 may include one or more bias members (e.g., an inflatable balloon) disposed at or near a distal end of the sliding sheath 1166. In some embodiments, the sliding sheath 1166 may include an inflation port at a proximal end of the sliding sheath 1166 configured to supply a medium (e.g., gas or liquid) to the inflatable balloon to inflate the balloon. In some embodiments, inflating the balloon may expand the shunt 1100 from the delivery configuration (e.g., compressed configuration) to the deployed configuration and / or to controllable decouple the shunt 1100 from the sliding sheath 1166.

[0176] In some embodiments, the delivery system 1150 described herein may include one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) steerable access catheters, one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) guidewires, one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) dilators, one or more sliding sheaths, and one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) shunts. The robotic insertion system may be configured to control the one or more steerable access catheters, the one or more guidewires, the one or more dilators, the one or more sliding sheaths, and / or the one or more shunts.

[0177] FIG. 11 is an illustration of a distal tip for cutting an opening in the vasculature (e.g., the vein and / or artery) such that the shunt (e.g., any of the shunts described herein) may be disposed therethrough, according to an embodiment. The delivery system may include a cutting mechanism configured to cut through two vessel walls to create ananastomosis (e.g., to place the two vessels in fluid communication). In some embodiments, the cutting mechanism may be structurally and / or functionally similar to the cutting mechanism described in FIG. 4, therefore, certain aspects of the cutting mechanism are not described herein with respect to FIG. 11. A robotic insertion system, such as robotic insertion system 4100, may be configured to control the cutting mechanism. The catheter (e.g., the dilator 1264) may track over a guidewire (not shown) which has been positioned through a first vessel, such as the inferior vena cava (IVC), and into a second vessel, such as the aorta, or more broadly between any two vascular structures. The robotic insertion system may be configured to advance the catheter 1264 over the guidewire. The distal tip of the catheter 1264 has a dilating tip 1265, which allows the catheter 1264 to advance easily through the vessel walls. At a proximal end of the distal tip, the catheter 1264 reduces in diameter (e.g., tapers) to a bladed edge (e.g., the first cutting edge). As shown, the first cutting edge 1276 may form an oval shape, meaning the edge tapers at a diagonal. The catheter 1264 further may include a blunt surface (and / or a second cutting edge) corresponding to the first cutting edge positioned along the catheter 1264 proximal to the first cutting edge 1276. As the catheter 1264 is tracked over the guidewire (e.g., by the robotic insertion system), the tapered distal tip 1265 easily passes into an adjacent vessel. The distal tip 1265 may be configured to retract, capturing the walls of the two vessels between the bladed surface and the blunt surface. The robotic insertion system may be configured to control the catheter 1264 to retract the distal tip 1265. The distal tip 1265 and the body of the dilator 1264 may each be coupled to a shaft 1262 configured to move the distal tip distally and / or proximally such that the first cutting edge 1276 moves toward the blunt surface 1275. The robotic insertion system may be configured to control the shaft 1262 to move the shaft 1262 distally and / or proximally. A predetermined pressure may be applied between the two surfaces to cut out a small circular section of the aorta and the IVC.

[0178] FIG. 12 is an illustration of an abdominal aortic aneurysm showing the aneurysm sac 1318, the right kidney 1341, the left kidney 1342, and arterial vessels that branch out from the aorta 1311. FIG. 13A-13E are illustrations of an example method for implanting the shunt 1400, according to an embodiment. As shown in FIG. 13A the aneurysm sac 1418 is located along the aorta 1411, and the vena cava 1413 is adjacent to the aorta 1411. As shown in FIG. 13B, an endograft 1420 may be implanted in the aneurysm sac 1418 to treat the abdominal aortic aneurysm. A robotic insertion system, such as robotic insertion system 4100,may be configured to implant the endograft 1420. The endograft 1420 may be placed as an initial treatment for an aortic aneurysm (e.g., abdominal aortic aneurysm), wherein the fluid (e.g., blood) flows entirely through the endograft 1420, thereby alleviating pressure build-up and stress against the aortic wall at the aneurysm. In some cases, however, one or more leaks may form about the endograft 1420, such that fluid (e.g., blood) builds up at the aneurysm site (e.g., aneurysm sac 1418), and potentially resulting in further stress and / or rupture of the aortic wall. For example, type 2 endoleaks are the most common type of endoleak and are described as a refilling of the aortic sac 1418 via branches such as lumbar arteries (LAS), inferior mesenteric artery (IMA), median sacral artery, or accessory renal arteries. Accordingly, in some cases, providing a shunt (e.g., via the robotic insertion system) between the artery (e.g., aorta 1411) and vein (e.g., vena cava 1413) will help to drain fluid (e.g., blood) being collected within the aneurysm sac 1418 to alleviate further progression of the aneurysm and potential rupture. As shown in FIG. 13C, a delivery system 1450 including a dilator with a dilator tip 1465 at a distal end of the delivery system 1450 is navigated (e.g., via the robotic insertion system) through the vena cava 1413 toward the aneurysm sac 1418. In some embodiments, a guidewire of the delivery system 1450 may be configured to puncture the vena cava 1413 and then puncture the aorta 1411 to create a path through which the dilator may be disposed. The robotic insertion system may be configured to control the guidewire to puncture the vena cava 1413 and / or the aorta 1413. In some embodiments, the dilator tip 1465 may be used to expand a size of a puncture site at the vena cava 1413 and a puncture site at the aorta 1411. The robotic insertion system may be configured to control the dilator tip 1465 to expand the size of the puncture sites. As shown in FIG. 13D-13E, the shunt 1400 is deployed transcavally (e.g. via the robotic insertion system) such that a venous sealing structure 1404 is positioned in the vena cava 1413, an arterial sealing structure 1406 is positioned in the aneurysm sac 1418, and a central portion 1402 of the shunt 1400 spans across the extravascular space between the vena cava 1413 and the aorta 1411. The catheter may be removed (e.g., via the robotic insertion system) such that blood can flow out of the aorta. The shunt 1400 places the aorta (e.g., the aneurysm sac 1418) in fluid communication with the vena cava 1413 such that blood may flow from the aneurysm sac 1418, through the shunt 1400, and into the vena cava 1413, as shown in FIG. 13F. The robotic insertion system (e.g., robotic insertion system 4100) may beconfigured to control the delivery system 1450 to perform any of the functions and / or steps of the methods described above with reference to FIGS. 13A-13E.

[0179] FIGS. 14A-14B are illustrations of the shunt 1500 in the deployed configuration implanted transcavally to allow blood to flow from the aorta 1511 to the vena cava 1513, according to an embodiment. As shown, the shunt 1500 is implanted transcavally such that blood may flow out of the aneurysm sac 1518, wherein the aorta wall at the aneurysm site 1418 abuts the wall of the vena cava.

[0180] FIG. 15 is an illustration of a distal end of a delivery system 1650 disposed transcavally during implantation of a shunt 1600, according to an embodiment. A robotic insertion system, such as robotic insertion system 4100, may be configured to position the delivery system 1650 transcavally to facilitate implantation of the shunt 1600. As shown, the delivery system 1650 includes a catheter 1660 (e.g., robotically steerable catheter) including a radiopaque marker 1661a on a distal end of the catheter 1660. In some embodiments, the catheter 1160 may include a localization sensor on the distal end of the catheter 1160 instead of or in addition to the radiopaque marker 1661a. A dilator 1664 is disposed (e.g. via the robotic insertion system) in a lumen of the catheter 1660 and configured to extend from the distal end of the catheter 1660. The dilator 1664 defines a lumen in which a guidewire 1662 may be disposed (e.g., via the robotic insertion system) and further includes a distal tip 1665 through which the guidewire 1662 may extend. The shunt 1600 may be disposed around the dilator 1664 (e.g., via the robotic insertion system) and coupled to the dilator 1664 (e.g., via the robotic insertion system) via a proximal attachment point 1169a and a distal attachment point 1669b. As shown, the dilator 1664 is moved (e.g., via the robotic insertion system) through a venous puncture site 1651 and an arterial puncture site 1652 such that a venous sealing structure 1604 of the shunt is positioned in the vena cava, an arterial venous sealing structure 1606 of the shunt is positioned in the aorta, and a central portion 1602 of the shunt spans the extravascular space. In some embodiments, the arterial sealing structure 1606 (e.g., the distal end of the shunt) may include one or more radiopaque markers 1661b. In some embodiments, the arterial sealing structure 1606 may include one or more localization sensors instead of or in addition to the one or more radiopaque markers 1661b.

[0181] FIGS. 16-28 shows an example method of deploying a shunt transcavally to place the aorta in fluid communication with the vena cava, according to an embodiment. Insome embodiments, said method for implanting the shunt may occur contemporaneous or substantially contemporaneous with when an endograft is implanted to treat an aneurysm, as a preventive care means in the event a leak occurs across the endograft. In some embodiments, said method for implanting the shunt occurs after the endograft has been implanted, as a preventive care means or as a remedial response to the leakage of fluid into the sac of an aortic aneurysm. Said method may be performed by a robotic insertion system, such as robotic insertion system 4100. As shown in FIG. 16, the distal end of the delivery system 1650 is positioned near a target venous puncture site (e.g., via the robotic insertion system). Then, the guidewire 1662 is moved distally (e.g., via the robotic insertion system) to define the venous puncture site 1651 and the arterial puncture site 1652, as shown in FIG. 17. After the initial puncture sites 1651, 1652 are defined, the dilator 1664 may be moved (e.g., via the robotic insertion system) through the venous puncture site 1651 to expand the venous puncture site1651, as shown in FIG. 18. Subsequently, the dilator 1664 may be moved (e.g., via the robotic insertion system) through the arterial puncture site 1652 to expand the arterial puncture site1652, as shown in FIG. 19.

[0182] As shown in FIGS. 20-21, once the shunt is in position, the dilator 1664 may be retracted (e.g., moved in a proximal direction), for example, via the robotic insertion system, such that the arterial sealing structure 1606 transitions from the delivery configuration to the deployed configuration and then subsequently the venous sealing structure 1604 transitions to the deployed configuration. After the shunt is deployed (e.g., via the robotic insertion system), the dilator 1664 may be further retracted proximally (e.g., via the robotic insertion system) through the central portion 1602 of the shunt, as shown in FIGS. 22-24. FIG. 25 illustrates blood flow through the shunt deployed between the aorta and the vena cava.

[0183] FIG. 26 is a diagram illustrating the arterial sealing structure of the deployed shunt conforming to a curvature of the aorta. FIG. 27 is a diagram illustrating flexibility of the central portion 1602 of the shunt (e.g., to expand, extend, lengthen) such that a fluid tight seal around the arterial puncture site 1652 is maintained as the aortic aneurysm shrinks, and the aortic wall moves from position A to position B. FIG. 28 is a diagram illustrating the arterial sealing structure 1606 of the shunt pivoting relative to the central portion 1602 of the shunt to maintain the fluid tight seal at the arterial puncture site 1652.

[0184] FIGS. 29-38 are diagrams illustrating implantation of a shunt using by puncturing the vena cava and the aorta using a guidewire of the delivery system and a snare wire, according to an embodiment. A robotic insertion system, such as robotic insertion system 4100, may be configured to implant the shunt as described with reference to FIGS. 29-38. In some embodiments, the robotic insertion system may implant the shunt without the use of the snare wire. In some embodiments, a steerable catheter 1760 is inserted (e.g., via the robotic insertion system) through the vena cava, as shown in FIG. 29. In some cases, the catheter 1760 is advanced (e.g., via the robotic insertion system) to a puncture site at the vena cava using a similar method as described herein with reference to FIGS. 15-28. In some embodiments, a snare wire 1790 may be advanced through the artery, through the aneurysm sac 1718, and to a location proximate to a targeted puncture site of the aorta, as shown in FIG. 30. In some embodiments, the targeted puncture site of the artery is disposed upstream (e.g., with respect to blood flow) of the aneurysmal sac 1718. The snare wire 1790 may be advanced to the location proximate the targeted puncture site of the aorta manually and / or via the robotic insertion system. In some embodiments, a first robotic insertion device of the robotic insertion system may be configured to control the steerable catheter 1760 and / or any other component inserted through the vena cava and a second robotic insertion device of the robotic insertion system may be configured to control the snare wire 1790 and / or any other component inserted through the aorta.

[0185] In some embodiments, the snare wire 1790 includes a proximal end and a distal end. In some embodiments, the snare wire has a length of from about 10 cm to about 100 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the snare wire has a thickness of from about 0.1 mm to about 3 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the snare wire 1790 includes a snare wire loop 1791 disposed at the distal end of the snare wire. In some embodiments, the snare wire loop 1791 is configured to be tightened and / or loosened (e.g., via the robotic insertion system). In some embodiments, tightening the snare wire loop 1791 decreases a diameter of the snare wire loop 1791.

[0186] In some embodiments, a guidewire 1762 is then advanced (e.g., via the robotic insertion system) from the catheter 1760 to puncture through the vena cava and access the aorta via the puncture site at the aorta, as shown in FIG. 31. In some embodiments, theguidewire 1762 may be advanced (e.g., via the robotic insertion system) until it is located within the snare wire loop 1791. In some embodiments, radiopaque markers or localization sensors on the guidewire 1762 and / or the snare wire 1790 (e.g., snare wire loop 1791) may be used to determine the location of the guidewire 1762 relative to the snare wire loop 1791. In some embodiments, the snare wire 1790 is tightened (e.g., via the robotic insertion system), so as to shorten the snare wire loop 1791, as shown in FIG. 32, and to secure the snare wire loop 1791 about the guidewire 1762, thereby securing the snare wire to the guidewire, as shown in FIG. 33. In some embodiments, the snare wire is then pulled (e.g., via the robotic insertion system), so as to advance the catheter 1760 through the aorta puncture site, as shown in FIG. 34. In some embodiments, the guidewire 1762 is then cut and removed (e.g., via the robotic insertion system). In some embodiments, a shunt 1700 is then advanced (e.g., via the robotic insertion system) through the catheter 1760 to the aorta, as shown in FIGS. 35-36. In some embodiments, a distal sealing structure 1706 is then deployed (e.g., via the robotic insertion system), as shown in FIG. 37, so as to seal the arterial puncture site. In some embodiments, the distal sealing structure is deployed (e.g., via the robotic insertion system) similar to as described herein for the distal sealing structure 1706, using a sliding sheath. Accordingly, withdrawing the catheter and a corresponding sliding sheath enables a proximal sliding structure for the shunt 1700 to be deployed, thereby providing a sealed fluid (e.g., blow) flow path between the aorta and vena cava, as shown in FIG. 38. FIG. 39 illustrates tissue ingrowth into the shunt to form a permanent (or semi-permanent) flow path between the aorta and the vena cava. Additionally, FIG. 39 depicts a reduction in the size of the aneurysm sac due to implantation of the shunt to alleviate pressure in the aneurysm sac.

[0187] As described herein, in some aspects, systems and methods disclose treating an aortic aneurysm by implanting a bypass graft (e.g., via a robotic insertion system, such as robotic insertion system 4100) so as to divert some or all of the fluid (e.g., blood) flow around an aneurysmal sac, thereby alleviating the pressure against the aneurysmal sac, and reducing the risk of an aneurysm rupture. FIGS. 40A-40E are diagrams of implantation of a bypass graft 1880 connecting a portion of the aorta 1811a above the aneurysm sac 1818 to a portion of the aorta 1811b below the aneurysm sac 1818 to treat the aneurysm, according to an embodiment. A robotic insertion system, such as robotic insertion system 4100 may be configured to implant the bypass graft 1880, as described herein. In some embodiments, the bypass graft 1880accesses the aorta 1811 through an arterial puncture site. In some embodiments, the bypass graft 1880 passes within a vena cava 1813, and then rejoins the aorta 1811 downstream of an aneurysm sac 1818. In some embodiments, the system includes one or more (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) bypass grafts 1880. In some embodiments, the bypass graft 1880 includes a proximal end, a distal end, and a bypass graft lumen traversing the length of the bypass graft 1880 from the proximal end to the distal end. In some embodiments, the bypass graft 1880 has a length of from about 20 mm to about 20 cm, inclusive of all ranges and subranges therebetween. In some embodiments, the bypass graft 1880 has a bypass graft wall forming an inner diameter of the bypass graft and an outer diameter of the bypass graft. In some embodiments, the inner diameter of the bypass graft 1880 is in a range of about 5 mm to about 30 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the outer diameter of the bypass graft 1880 is in a range of about 5 mm to about 30 mm, inclusive of all ranges and subranges therebetween.

[0188] The bypass graft 1880 may be manufactured from any biologically acceptable material that possesses the ability to be shaped into a tubular structure having the required compliance. In some embodiments, the bypass graft 1880 may include a material including expanded polytetrafluoroethylene (e-PTFE); woven, knitted, or velour design polyethylene terephthalate (PET); or Dacron. In some embodiments, the bypass graft 1880 may include polymeric fibers such as, for example, polyurethanes, polyethylene terephthalate, polypropylene, and polytetrafluoroethylene. In some embodiments, the polymeric fibers may include elastomeric polymers, e.g. polyurethane elastomers or composite fibers that act in an elastic fashion. In some embodiments, polymeric fibers may be "shrinking" polymers (e.g., pressure-sensitive polymers) where the shrinkage may be controlled. In some embodiments, the bypass graft 1880 may include wires of one or more metals such as, for example, stainless steel and cobalt-chromium alloys. In some embodiments, the bypass graft 1880 may include wires made of shape memory alloys such as Nitinol. In some embodiments, the bypass graft 1880 may be at least partially coated with a polymer for improved biocompatibility. In some embodiments, the coating may be the same or similar to the cover / coating used on the shunt 100, as described with respect to FIG. 1.

[0189] In some embodiments, implanting a bypass graft includes introducing a catheter 3702 (e.g., via the robotic insertion system), as herein described, into an artery (e.g.,femoral artery) of a subject. In some embodiments, after introducing the catheter into the artery, the method includes navigating the catheter 3702 (e.g., via the robotic insertion system) within the artery to a first arterial puncture site 3704 disposed substantially near a first venous puncture site 3706 (FIG. 37). In some embodiments, the catheter 3702 is then advanced (e.g., via the robotic insertion system) through the first arterial puncture site 3704 and through the first venous puncture site 3706 and into the femoral vein (e.g., vena cava). In some embodiments, the catheter 3702 is then advanced (e.g., via the robotic insertion system) to a second venous puncture site 3802 and through a second arterial puncture site 3804 (FIG. 38). In some embodiments, the aneurysm sac 3602 is located between the first and second arterial puncture sites. In some embodiments, the first and second venous and arterial puncture sites are penetrated by a guidewire before the catheter is driven through each puncture site. In some embodiments, a graft is then advanced via the catheter through the first arterial puncture site 3704, the first and second venous puncture sites 3706, 3802, and the second arterial puncture site 3804 (e.g., via the robotic insertion system). In some embodiments, a sealing structure is deployed (e.g., via the robotic insertion system) at the first and second arterial puncture sites, thereby sealing fluid (e.g., blood) to flow through the graft and not pass into the vena cava. In some embodiments, the sealing structures are similar to the distal sealing structure 502 and proximal sealing structure 504 described herein. Accordingly, in some embodiments, fluid is able to flow through both the bypass graft and the aneurysm sac, whereas such reduction in pressure and / or flow through the aneurysm sac will alleviate the tension imposed thereto.

[0190] FIGS. 41 A-41B show a shunt 2000 including a self-rolling mechanism 2006 (e.g., a self-deployment, a self-adjusting, a self-sizing, an adjustable sizing mechanism), according to embodiments. The self-rolling mechanism 2006 of shunt 2000 may enhance performance, stability, and adaptability during and after deployment of the shunt 2000. The shunt 2000 may include a proximal end 2001 and a distal end 2003 and a central portion 2002 therebetween. The central portion 2002 may define a central lumen that serves as the conduit for blood flow, maintaining the patency of the vessel. The shunt 2000 may form a cylindrical shape in a delivery configuration and transition to an expanded, asymmetrical shape in the deployed configuration. For example, the shunt 2000 may be robotically inserted by robotic insertion system 4100, and the shunt 2000 form a cylindrical shape when a sheath is positionedover the shunt 200 and an expanded, asymmetrical shape after the sheath is withdrawn by the robotic insertion system 4100.

[0191] The proximal end 2001 of the shunt 2000 may include a venous sealing structure 2004 that forms a disc-like shape in the deployed configuration. For example, the proximal end 2001 may flare outward to help seal the proximal end 2001 of the shunt 2000 against the vessel wall. The proximal end 2001 of the shunt 2000 may create a broad surface area that forms a backstop against the vessel wall. This feature ensures a secure seal and prevents migration, and may facilitate robotic insertion of the shunt 2000.

[0192] The distal end 2003 of the shunt 2000 may be configured to roll proximally such that the distal end 2003 forms a toroidal structure 2006 (e.g., torus, ring-like structure, etc.) as the shunt 2000 transitions from the delivery to the deployed configuration. In some embodiments, the distal end 2003 may curl outward and roll proximally such that the toroidal structure 2006 is positioned about an outer surface of the distal end 2003 of the shunt 2000. After the shunt 2000 is deployed, the distal end 2003 of the shunt 2000 may be configured to roll proximally and / or unroll distally to accommodate changing anatomy of the vessels and / or other anatomical or related forces. The toroidal structure 2006, which forms during deployment, acts as an anchor, securing the shunt 2000 in place and preventing it from migrating within the vessel. In some embodiments, as the shunt 2000 is deployed from the catheter, the distal end 2003 may roll proximally until the distal end 2003 abuts an inner surface of an arterial wall. In some embodiments, the toroidal structure 2006 may be configured to engage a thrombus in the artery (e.g., the aorta).

[0193] The shunt 2000 may be structurally and / or functionally similar to the shunt 100 or any other shunts described herein, and therefore, certain details of the shunt 2000 are not described in FIGS. 41A-41B.

[0194] FIG. 4 IB shows dimensions of the self-rolling stent 2000 in the deployed configuration. As shown, the shunt 2000 in the deployed configuration has a total deployed length L, a deployed diameter (e.g., a maximum outer diameter in the deployed configuration) DA of the distal end 2003, a deployed diameter (e.g., a maximum outer diameter in the deployed configuration) Dv of the proximal end 2001, and a radius Rx of the toroidal structure 2006. In some embodiments, as the distal end 2003 of the shunt 2000 rolls proximally, the total length of the shunt 2000 may decrease. In some embodiments, a delivery length (or a starting length)of the shunt 2000 (e.g., a total length of the shunt 2000 before rolling) may be in a range of about 10 mm to about 100 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the total deployed length L of the shunt 2000 after rolling may decrease by up to 5%, up to 10%, up to 20%, up to 30%, up to 40%, up to 50%, up to 60%, up to 70%, or up to 80% after maximum rolling. For example, the shunt 2000 may have a delivery length of about 30 mm and a fully deployed length L (e.g., after maximum rolling) of about 5 mm. In some embodiments, the total deployed length L of the stent 2000 after deployment may be adjustable (e.g., may vary over time) between 5% of the total delivery length to 100% of the total delivery length. The diameter of the distal end 2003 may increase in a range of about 1% to about 500% from the delivery configuration to the deployed configuration, inclusive of all ranges and subranges therebetween. In some embodiments, when the distal end 2003 rolls proximally and / or unrolls distally, a diameter DB of the central portion 2002 may be equivalent or substantially equivalent before deployment and after deployment is completed. In some embodiments, the diameter DB of the central portion 2002 may be at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, in the deployed configuration. In some embodiments, the diameter DB of the central portion 2002 may decrease as the distal end 2003 rolls and / or unrolls and then increase to the starting diameter of the central portion 2002 once the shunt 2000 is deployed. In some embodiments, the deployed diameter Dv of the proximal end 2001 may be in a range of about 3 mm to about 20 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the deployed diameter DA of the distal end 2003 is in a range of about 3 mm to about 25 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the radius Rx of the toroidal structure may be in a range of about 0.25 mm to about 10 mm, inclusive of all ranges and subranges therebetween. In some embodiments, the radius Rx may be large enough to engage thrombus as the distal end 2001 rolls proximally.

[0195] The toroidal structure 2006 may provide the following benefits: adaptive self-sizing capability, enhanced anchoring and stability, proximal disc sealing, atraumatic ends, resheathability and / or retrievability, better thrombus engagement than traditional stents, and / or insensitivity to delivery orientation. The toroidal structure 2006 may also facilitate robotic insertion of the shunt 2000. The self-rolling mechanism and toroidal structure 2006 can allow the shunt to 2000 (i) self-size (e.g., adjust a total length L of the shunt 2000, e.g., withoutuser intervention) to different fluid pathway lengths between the arterial anchoring site and the venous anchoring site, and (ii) adapt to varying vessel geometries and anatomical changes over time. This mechanism is distinct from the expansion methods employed by some selfexpanding shunts, for example, which typically expand radially without forming complex and functional shapes. An advantage of the toroidal structure 2006 in some use cases and implementations is its ability to accommodate a wide range of deployment configurations, geometry changes of the vessels, and / or system or methods of insertion, such as robotic insertion. For example, the shunt 2000 can shorten (e.g., the distal end 2003 and proximal ends 2001 are close together), allowing the shunt 2000 to adapt to short vessel segments (e.g., less than 10 mm) or tight anatomical spaces. As another example, as the aneurysm sac or vessel diameter changes, the torus can continue to roll or unroll along the length of the shunt 2000, maintaining a secure and stable position. This adaptability is particularly beneficial in ensuring long-term stability and performance, and may facilitate robotic insertion, for example, by robotic insertion system 4100. This level of configurability is unparalleled in some traditional stent designs, which lack the ability to dynamically adjust their deployed length.

[0196] The deployed diameter DA (e.g., the maximum outer diameter) of the distal end 2003 (or the toroidal structure 2006), may be larger than the diameter DB of the central portion 2002, thereby creating a rivet-like anchoring effect. This feature, for example, may significantly reduce the risk of migration. The flared shape of the proximal end 2001 can provide a customized seal against the vessel wall, enhancing the shunt’s 2000 sealing capabilities. The proximal end 2001 can deform and match the vessel’s concavity ensuring a secure and effective seal. The distal end 2003 and proximal end 2001 of the shunt 2000 are configured to maintain atraumatic surfaces within the lumen of the vessels they are anchored in. The toroidal mechanism 2006 in particular continues to provide an atraumatic surface as it adjusts during the life of the shunt 2000. This is advantageous in reducing risks of interference with other implants in the same vessel (e.g., an endograft).

[0197] In some embodiments, at least one of the distal end 2003 and proximal end 2001 of the shunt 2000 can be configured to be resheathed, allowing precise deployment at the time of implantation. For example, the shunt 2000 can be repositioned such that a tight seal is formed between the shunt 2000 and the vessels. By design, the toroidal shape 2006 may be resheathed without compromising the anchoring mechanism. Similarly, in the event that the-n-implant needs to be removed, the toroidal design allows for a safe removal from the vessel as the distal end 2001 may “unroll” and be moved back into the catheter, and the toroidal design may facilitate robotic removal of the shunt 200, for example, by robotic insertion system 4100.

[0198] The deployment of the shunt 2000 in some implementations involves the use of a retractable outer catheter sheath. The shunt 2000 may be initially compressed within the sheath, allowing it to be navigated through the vascular system to the target site. The shunt 2000 may be navigated through the vascular system to the target site robotically. For example, the shunt 2000 may be navigated through the vascular system by the robotic insertion system 4100. Once the shunt 2000 is in position (e.g., across the puncture sites), the outer sheath can be gradually withdrawn (e.g., robotically via control of the delivery system 1150) proximally, allowing the shunt 2000 to deploy. In some embodiments, deployment of shunt 2000 may include the distal end 2003 rolling proximally as the outer sheath exposes the distal end 2003 and then the proximal end 2001 expanding radially to form the disc-like shape as the outer sheath exposes the proximal end 2001. The flared disc provides a backstop against the vessel wall, applying a sealing force that enhances the stability and sealing capabilities of the shunt 2000.

[0199] FIGS. 42A-42B show a self-rolling shunt 2100 including braided metal alloy, according to embodiments. As shown, the distal end 2103 of the shunt 2100 includes a toroidal structure 2106, a proximal end 2101 of the shunt 2000 forms a disc-like sealing structure 2104, and a central portion 2102 of the shunt 2000 defines a lumen between the distal end 2103 and the proximal end 2101. In some embodiments, the shunt 2200 may include braided nitinol, which enables the shunt 2200 to form the toroidal structure 2206 during deployment. In some implementations, a heat-setting process can be used in manufacturing the shunt 2200 to ensure that it retains flexibility and durability, allowing it to function effectively in clinical settings. The heat-setting process involves shaping the nitinol braid into the desired configuration (e.g., the toroidal structure 2206) and heating the shunt 2200 to a specific temperature to set the shape. The braided design of the nitinol also allows the stent to be highly flexible, enabling it to conform to the natural curves and variations in the vessel (or other) anatomy, which may facilitate robotic insertion of the shunt 2200, for example, by robotic insertion system 4100. The flexible braided nitinol allows the proximal end 2201 to deform and match the concavity of the vessel, providing a customized fit and enhancing the sealingeffect. The shunt 2100 may be structurally and / or functionally similar to the shunts 100, 2000, or any other shunts described herein, and therefore, certain details of the shunt 2100 are not described in FIGS. 42A-42B.

[0200] FIGS. 43A-43G are images of a self-rolling shunt 2200 transitioning from a delivery configuration to a deployed configuration, according to embodiments. As shown in FIG. 43 A, the distal end 2203 of the shunt 2200 begins to extend distally from a distal end of the catheter 2260. In FIGS. 43B-43D, the distal end 2203 of the shunt begins to roll proximally. In FIG. 43E, the central portion 2202 is deployed and a proximal end 2201 of the shunt 2200 begins to be deployed from the distal end of the catheter 2260. As shown, the proximal end 2201 begins to expand radially as it is deployed from the catheter 2260. FIGS. 43F-43G show the proximal end 2201 of the shunt 2200 forming the disc-like shape, and a diameter of the central portion 2202 widens. As shown in FIG. 43 G, the shunt 2200 when deployed includes the toroidal structure at the distal end 2203, the central portion 2202, and the disc-like proximal end 2201. The shunt 2200 may be structurally and / or functionally similar to the shunt 100, 2000, 2100, or any other shunts described herein, and therefore, certain details of the shunt 2200 are not described in FIGS. 43A-43G.

[0201] In some embodiments, the shunts 2000, 2100, 2200 can be implanted in locations other than between vein and artery, and although referred to as the arterial sealing structure 2006, 2106, 2206 and the venous sealing structure 2004, 2104, 2204, it should be appreciated the arterial sealing structure 2006, 2106, 2206 and venous sealing structure 2004, 2104, 2204 can be configured for other parts of the anatomy (e.g., other than the aorta).

[0202] In some embodiments, the shunts 2000, 2100, 2200 can be implanted and / or removed robotically. The shunts 2000, 2100, 2200 can be implanted and / or removed via the robotic insertion system 4100. The shunts 2000, 2100, 2200 can be implanted via method 4400.Applications and Treatments using Shunts

[0203] Several applications and treatments using shunts are described in more detail below. In particular, applications and treatments using a self-rolling shunt are specifically described. While self-rolling shunts are presented, other shunts described herein can also be used in advantageous applications and treatments. The descriptions regarding selfrolling shunts are representative examples and the disclosure is not limiting with respect to other shunt systems and devices described herein, which may also be implemented, roboticallyor manually in other implementations for use with applications, treatments, systems, and / or methods disclosed herein. Various shunts can be implanted in locations other than between vein and artery as described further herein. Various shunts can be implanted and / or removed robotically according to one or more of the methods disclosed herein.1. Interatrial Shunting

[0204] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) may be used as an interatrial shunt for management of various cardiac conditions, such as heart failure. In patients with heart failure, creating an interatrial shunt can help decompress the left atrium and reduce pulmonary congestion. These shunts create a controlled communication between the left and right atria, allowing for the regulation of pressure and blood flow between the heart chambers, thereby improving hemodynamics and reducing symptoms such as shortness of breath and fluid retention. Traditional methods for creating interatrial shunts include surgical procedures and transcatheter device placements, each with its own set of challenges. Shortcomings of existing solutions for interatrial shunts are that they are highly invasive, requiring open-heart surgery and cardiopulmonary bypass, which carries significant risks including infection, prolonged recovery times, and complications related to the surgery itself. Transcatheter device placements, while less invasive, often face challenges such as device migration, incomplete closure, and difficulties in achieving a precise fit within the interatrial septum.

[0205] The self-rolling shunt deployed via a transcatheter approach is significantly less invasive than surgical procedures. This reduces procedural risks and recovery times, making it a safer option for patients with heart failure. The self-rolling shunt can be used to create a precise and adaptable interatrial shunt, and can facilitate robotic insertion of the shunt as an interatrial shunt. For example, the toroidal structure can provide a secure anchoring mechanism within the interatrial septum, thereby (1) creating stable and effective communication between the atria and / or (2) minimizing the risk of device migration or embolization. Furthermore, the self-sizing capability of the shunt allows it to adapt to variations in the thickness and / or shape of the interatrial septum. This adaptability promotes or ensures a precise and secure fit, which also can reduce the risk of migration and improve the overall efficacy of the shunt. This secure anchoring is a significant improvement over traditional transcatheter devices, which often face issues with stability. The adaptability and / orsecure anchoring of the self-rolling shunt can facilitate robotic insertion (e.g., by robotic insertions system 4100) of the self-rolling shunt as an interatrial shunt. In implementations in which the shunt includes a braided nitinol construction, such construction of the shunt can be highly biocompatible, reducing the risk of infection and thrombus formation. The smooth and flexible design, in some implementations, promotes optimal blood flow, further minimizing the likelihood of complications. By creating a stable and effective interatrial shunt, the selfrolling shunt may help regulate pressure and / or blood flow between the atria, improving symptoms and outcomes for patients with heart failure. This leads to better long-term management of these conditions and enhanced quality of life for patients. The shunt can be used in various anatomical configurations, making it suitable for a wide range of interatrial shunt applications. This versatility increases the success rate of the procedure and expands its applicability to different patient populations.2, Hemodialysis Access

[0206] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) may be used for hemodialysis access. Chronic kidney disease (CKD) affects millions worldwide, necessitating regular hemodialysis to filter waste and excess fluids from the blood. Effective hemodialysis requires reliable vascular access, which is typically achieved through arteriovenous (AY) fistulas or AV grafts. AV fistulas involve connecting an artery directly to a vein, usually in the arm, creating a robust access point that can withstand repeated needle insertions for dialysis sessions. AV grafts, on the other hand, use a synthetic tube to connect the artery and vein, providing an alternative when a fistula is not viable. Current AV fistulas and grafts have several limitations. For example, AV fistulas can take several weeks to months to mature before they are usable for dialysis, and the success of their creation is highly dependent on the patient's vascular anatomy. They also have a significant failure rate due to issues like thrombosis, stenosis, and infection. AV grafts, while usable sooner, have higher rates of complications, including infections and thrombosis, and typically have a shorter lifespan than fistulas.

[0207] The self-rolling shunt offers a solution for hemodialysis access by providing a secure anchoring mechanism within the vessel. The shunt's ability to roll and unroll allows it to adapt dynamically to varying vessel sizes and conditions, and can facilitate robotic insertion of the shunt for hemodialysis access for treatment of CKD. Advantages over traditional AV Fistulas and grafts include: (1) providing a secure anchoring effect and / or (2)preventing migration and / or minimizing the risk of thrombosis and / or stenosis. The self-rolling capability promotes or ensures the shunt fits effectively or snugly within the vessel, adapting to changes over time and reducing the likelihood of complications. The self-rolling shunt may also control infection, in some use cases. For example, the use of nitinol, known for its biocompatibility, reduces the risk of infection compared to synthetic grafts currently used. Additionally, the streamlined design of the shunt minimizes potential sites for bacterial colonization. The self-rolling feature allows the shunt to be used in a broader range of vascular anatomies, making it suitable for patients who may not be ideal candidates for traditional fistulas or grafts. This versatility increases the success rate of creating functional dialysis access. The nitinol material provides superior durability, ensuring the shunt remains functional for extended periods. This longevity reduces the need for repeated surgical interventions, improving patient quality of life and reducing healthcare costs.3, Peripheral Vascular Disease

[0208] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) may be used for treating Peripheral Vascular Disease. Peripheral vascular disease (PVD) is characterized by the narrowing orblockage of arteries outside the heart, most commonly affecting the legs. PVD can lead to critical limb ischemia (CLI), where the reduced blood flow causes severe pain, ulcers, and potentially limb loss. Traditional treatments for PVD include angioplasty, stenting, and bypass surgery, each with its own set of challenges and limitations. Angioplasty and stenting, while less invasive, often fail to provide long-term relief due to restenosis, where the artery narrows again. Bypass surgery, although more durable, is highly invasive and not suitable for all patients, particularly those with significant comorbidities. These treatments also face issues like graft occlusion and infection, impacting their overall effectiveness and patient outcomes.

[0209] The self-rolling shunt can be used to bypass occluded or stenotic segments of peripheral arteries, restoring adequate blood flow to ischemic tissues. The toroidal structure ensures a secure fit within the vessel, preventing migration and reducing the risk of occlusion, for example, when the shunt is robotically inserted for treating PVD. The toroidal structure of the shunt also provides a stable anchor, minimizing the likelihood of restenosis. The deployment of the self-rolling shunt is less invasive than traditional bypass surgery, reducing recovery times and procedural risks. This is particularly beneficial for high-risk patients whomay not tolerate extensive surgery. The self-rolling capability allows the shunt to adapt to changes in vessel diameter, maintaining patency and / or limiting or preventing re-narrowing. The durable braided nitinol construction, in some such implementations, ensures the shunt remains functional over extended periods, reducing the need for repeat interventions. This durability is a significant improvement over the shorter lifespan of angioplasty and stents. The smooth, flexible design of the shunt, in some such embodiments, promotes optimal blood flow, reducing turbulence and the associated risk of thrombus formation. This leads to better overall outcomes for patients with PVD. The self-rolling feature allows the shunt to be used in various anatomical configurations, making it suitable for a wide range of PVD cases. This adaptability ensures a higher success rate in restoring blood flow to ischemic limbs.4, Congenital Heart Defects

[0210] Congenital heart defects (CHDs) such as hypoplastic left heart syndrome (HLHS) and atrial septal defects (ASDs) require complex surgical interventions to manage abnormal blood flow between the heart's chambers and the systemic and pulmonary circulations. Traditional treatments involve multiple surgeries, often with significant risks and complications. Current surgical approaches for CHDs, such as the Norwood procedure for HLHS, are highly invasive and carry substantial risks, including infection, heart failure, and arrhythmias. These procedures often require multiple stages, each with its own recovery period and potential for complications. Additionally, there are limited options for less invasive treatments that can effectively manage these complex conditions.

[0211] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200), in some embodiments, can be used to create controlled communications between the atria or between the systemic and pulmonary circulations, helping to balance oxygenated and deoxygenated blood flow. This approach can be tailored to the specific anatomical and physiological needs of each patient and can provide a less invasive alternative to traditional surgeries. The deployment of the self-rolling shunt can be less invasive than traditional open-heart surgeries, thereby reducing procedural risks and recovery times. This can be beneficial for infants and young children with CHDs, who are more vulnerable to surgical complications. In some embodiments, the self-rolling capability of the shunt can allow the shunt to adapt to the unique anatomical structures of each patient, enabling a precise and effective fit, and facilitating robotic insertion of the shunt for treating CHDs. This customization improves the efficacy ofthe treatment and reduces the likelihood of complications. The toroidal structure of the shunt, in some embodiments, can provide a secure anchor, thereby minimizing the risk of dislodgement and migration. The shunt can include durable braided nitinol construction in some embodiments, which can reduce the risk of infection and enhances long-term performance. The shunt can be used as part of a staged surgical approach, providing immediate relief and stabilization while preparing for more complex interventions. This flexibility can enable the shunt to manage progressive conditions like HLHS. The shunt may improve patient outcomes by promoting optimal blood flow dynamics, thereby reducing the workload on the heart and improving overall cardiac function. This leads to better long-term outcomes and quality of life for patients with CHDs.5, Portosystemic Shunts

[0212] Portal hypertension, commonly resulting from liver cirrhosis, leads to elevated pressure in the portal vein. This condition can cause severe complications, such as variceal bleeding, ascites, and hepatic encephalopathy. Traditional treatments include medication, endoscopic interventions, and surgical shunts, but these methods have limitations and risks. Medications often provide only symptomatic relief and do not address the underlying pressure. Endoscopic interventions, such as variceal banding, require repeated procedures and do not prevent future bleeding. Surgical shunts, including the Transjugular Intrahepatic Portosystemic Shunt (TIPS), while effective, carry risks of shunt dysfunction, hepatic encephalopathy, and infection.

[0213] In some embodiments, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used to create a controlled portosystemic shunt, diverting blood from the high- pressure portal vein to a lower-pressure systemic vein. This approach can reduce portal pressure and mitigate the complications of portal hypertension. The deployment of the selfrolling shunt may be less invasive than traditional surgical shunts, reducing procedural risks and recovery times. Lower invasiveness can be advantageous for patients with advanced liver disease, who may not tolerate extensive surgery. In some embodiments, the self-rolling capability of the shunt enables the shunt to adapt to changes in portal pressure and vessel diameter, maintaining effective blood flow diversion over time. The adaptability of the shunt, in certain aspects, can provide advantages over fixed-diameter shunts, which may become less effective as conditions change. The toroidal structure of the shunt can provide a secure anchor,minimizing the risk of migration and dysfunction, and facilitating robotic insertion of the shunt as a portosystemic shunt for treatment of portal hypertension. In some embodiments, the shunt can include durable braided nitinol construction, which can reduce the risk of infection and enhances long-term patency. By reducing portal pressure, the self-rolling shunt can decrease the risk of variceal bleeding and other complications of portal hypertension, which can promote improved patient outcomes and quality of life. The shunt can be used in various anatomical configurations, making it suitable for a wide range of patients with portal hypertension. This versatility can increase the success rate of the procedure and expands its applicability.6, Traumatic Injuries

[0214] Severe trauma, such as that resulting from accidents or combat injuries, can cause vascular damage that requires immediate intervention to preserve limb function. Rapid revascularization is critical to prevent tissue ischemia and necrosis. Traditional methods for managing vascular trauma include surgical repair and temporary vascular shunts. Surgical repair is time-consuming and may not be feasible in unstable patients. Temporary vascular shunts, while effective for immediate revascularization, are often bulky, difficult to secure, and prone to dislodgement.

[0215] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can provide a rapid and reliable solution for revascularization in traumatic injuries. In some embodiments, the toroidal structure of the shunt can promote secure anchoring within the vessel, maintaining blood flow to injured limbs until definitive surgical repair can be performed. One advantage of traditional shunts is that the shunt may be rapidly deployed. For example, the self-rolling shunt can be quickly deployed (e.g., robotically) in emergency settings, restoring blood flow within minutes. This speed can prevent tissue damage and promote improvement in outcomes in trauma patients. In some embodiments, the toroidal structure can provide a stable anchor, preventing dislodgement even in the dynamic environment of trauma care. The stability provides improvements over traditional temporary shunts, which are prone to movement and failure. The self-rolling capability may allow the shunt to adapt to various vessel sizes and configurations, promoting a precise fit in diverse anatomical situations. This adaptability can enhance the effectiveness of the shunt in maintaining blood flow, and can facilitate robotic insertion of the shunt for revascularization in traumatic injuries. In some embodiments, the shunt can include a durable braided nitinol construction, which can minimize the risk ofinfection and thrombosis, which are common issues with traditional shunts. In some embodiments, the shunt may include a smooth, flexible design which can promote optimal blood flow, reducing the risk of further complications. By providing reliable and secure revascularization, the self-rolling shunt can improve likelihood of limb salvage and recovery. This can lead to better overall outcomes for trauma patients, reducing morbidity and mortality.7, Cerebral Arteriovenous Malformations

[0216] Cerebral arteriovenous malformations (AVMs) are abnormal connections between arteries and veins in the brain, which can lead to serious complications such as hemorrhage, seizures, and neurological deficits. Traditional treatments include surgical resection, embolization, and stereotactic radiosurgery, each with varying degrees of invasiveness and risk. Surgical resection is highly invasive and carries risks of significant neurological damage. Embolization, while less invasive, often requires multiple procedures and carries a risk of incomplete treatment and recanalization. Stereotactic radiosurgery has delayed effects and may not fully resolve the AVM, leaving a residual risk of hemorrhage.

[0217] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used as part of a treatment strategy for cerebral AVMs, helping to reroute blood flow and reduce pressure within the malformation. This approach can offer a less invasive alternative to traditional treatments. In some embodiments, the deployment of the self-rolling shunt can be less invasive than surgical resection, reducing procedural risks and recovery times. Reducing invasiveness and procedural risks can be beneficial for patients with AVMs located in critical or deep brain regions. The self-rolling capability, in some embodiments, can allow the shunt to adapt to changes in vessel diameter and blood flow dynamics, maintaining effective treatment over time. This adaptability provides an improvement over static embolization materials, which may not fully adapt to changing conditions. In some embodiments, the toroidal structure of the shunt can provide a secure anchor, minimizing the risk of dislodgement and migration, and facilitating robotic insertion of the shunt for treatment of cerebral AVMs. In some embodiments, the shunt can include a durable braided nitinol construction, which can reduce the risk of infection and enhance long-term performance. By rerouting blood flow and reducing pressure within the AVM, the self-rolling shunt can decrease the risk of hemorrhage and other complications, which can lead to improved patient outcomes and quality of life. The shunt can be used in various anatomical configurations, making it suitable for a wide range ofAVMs. This versatility can increase the success rate of the procedure and expand its applicability.8, Coronary Artery Disease

[0218] Coronary artery disease (CAD) is characterized by the narrowing or blockage of coronary arteries, leading to insufficient blood flow to the heart muscle. This condition can cause angina, heart attacks, and other serious cardiac events. Traditional treatments include medications, angioplasty with stenting, and coronary artery bypass grafting (CABG). Medications provide symptomatic relief but do not address the underlying arterial blockage. Angioplasty and stenting, while effective for opening blocked arteries, have limitations such as restenosis and stent thrombosis. CABG, though durable, is highly invasive and not suitable for all patients, especially those with comorbidities.

[0219] In some embodiments, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used to create controlled communications between coronary arteries and veins, improving myocardial perfusion. This approach can provide a potential new treatment for severe cases of CAD. The deployment of the self-rolling shunt can be less invasive than CABG, which can reduce procedural risks and recovery times. The reduced invasiveness can be advantageous for high-risk patients who may not tolerate extensive surgery. In some embodiments, the self-rolling capability can allow the shunt to adapt to changes in coronary artery diameter and blood flow dynamics, maintaining effective perfusion over time. This adaptability can provide improvements over fixed stents, which may become less effective as conditions change. In some embodiments, the toroidal structure of the shunt can provide a secure anchor, minimizing the risk of dislodgement and thrombosis, and facilitating robotic insertion of the shunt for treatment of CAD. In some embodiments, the shunt includes a durable braided nitinol construction, which can reduce the risk of restenosis and enhances long-term patency. By enhancing myocardial perfusion, the self-rolling shunt can reduce symptoms of angina and improve overall cardiac function, which can lead to better long-term outcomes and quality of life for patients with severe CAD. The shunt can be used in various anatomical configurations, making it suitable for a wide range of CAD cases.9, Pulmonary Hypertension

[0220] Pulmonary hypertension (PH) is characterized by elevated pressure in the pulmonary arteries, leading to right heart failure and significant morbidity. Traditionaltreatments include medications, oxygen therapy, and lung transplantation, each with varying degrees of effectiveness and risk. Medications often provide symptomatic relief but do not address the underlying elevated pressure in the pulmonary arteries. Oxygen therapy is supportive but not curative, and lung transplantation, while potentially curative, carries significant risks and is limited by donor availability. These treatments do not offer a comprehensive solution for managing pulmonary hypertension.

[0221] The self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used to create controlled shunts between systemic and pulmonary circulations, reducing pressure in the pulmonary arteries. This approach offers a new treatment option for managing pulmonary hypertension. The deployment of the self-rolling shunt can be less invasive than lung transplantation, reducing procedural risks and recovery times. The reduced invasiveness can be advantageous for patients with severe pulmonary hypertension who may not tolerate extensive surgery. The self-rolling capability may enable the shunt to adapt to changes in vessel diameter and pressure dynamics, maintaining effective pressure reduction over time This adaptability can provide improvements over fixed treatments, which may become less effective as conditions change. In some embodiments, the toroidal structure of the shunt can provide a secure anchor, minimizing the risk of dislodgement and dysfunction, and facilitating robotic insertion of the shunt for managing pulmonary hypertentsion. In some embodiments, the shunt may include a durable braided nitinol construction, which can reduce the risk of infection and enhances long-term performance. By reducing pressure in the pulmonary arteries, the selfrolling shunt can decrease the workload on the right heart and improves overall cardiac function, which can lead to better long-term outcomes and quality of life for patients with pulmonary hypertension. The shunt can be used in various anatomical configurations, making it suitable for a wide range of pulmonary hypertension cases.10. Cancer Treatment

[0222] Delivering high doses of chemotherapy directly to tumors while minimizing systemic exposure is crucial for effective cancer treatment. Traditional systemic chemotherapy often results in significant side effects due to the widespread distribution of the drugs throughout the body. Systemic chemotherapy, while effective in targeting cancer cells, also affects healthy cells, leading to severe side effects such as nausea, hair loss, andimmunosuppression. Localized delivery methods, such as intra-arterial chemotherapy, can be more effective but are technically challenging and have limited applicability.

[0223] In some embodiments, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used to deliver chemotherapy directly to the tumor site, enhancing drug concentration at the target while reducing systemic side effects. This approach can offer a new method for localized cancer treatment. In some embodiments, the self-rolling shunt can enable precise delivery of chemotherapy directly to the tumor, increasing drug concentration at the target site and improving treatment efficacy. This localization can reduce the impact on healthy tissues and minimizes systemic side effects. The self-rolling capability can allow the shunt to adapt to changes in vessel diameter and tumor growth, maintaining effective drug delivery over time,. This adaptability can provide improvements over fixed delivery methods, which may become less effective as conditions change. In some embodiments, the toroidal structure of the shunt can provide a secure anchor, minimizing the risk of dislodgement and dysfunction, and facilitating robotic insertion of the shunt for cancer treatment. In some embodiments, the shunt can include a durable braided nitinol construction, which can reduce the risk of infection and enhances long-term performance, in some use cases. By enhancing the concentration of chemotherapy at the tumor site, the self-rolling shunt can improve treatment efficacy and reduces the likelihood of tumor recurrence, which can lead to better long-term outcomes and quality of life for cancer patients. The shunt can be used in various anatomical configurations, making it suitable for a wide range of tumor locations.11. Venous Insufficiency

[0224] Chronic venous insufficiency (CVI) is characterized by poor blood flow in the veins, leading to symptoms such as swelling, pain, and ulceration. Traditional treatments include compression therapy, sclerotherapy, and surgical interventions. Compression therapy provides symptomatic relief but does not address the underlying venous insufficiency. Sclerotherapy and surgical interventions, while effective, carry risks of complications and may require repeated treatments. These methods do not offer a comprehensive solution for managing CVI.

[0225] In some embodiments, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used to improve blood flow in the affected veins, alleviating symptoms and promoting healing. This approach can offer a new treatment option for managing chronicvenous insufficiency. The deployment of the self-rolling shunt can be less invasive than surgical interventions, reducing procedural risks and recovery times. This can be advantageous for patients with severe venous insufficiency who may not tolerate extensive surgery. In some embodiments, the self-rolling capability allows the shunt to adapt to changes in vessel diameter and blood flow dynamics, maintaining effective treatment over time. This adaptability can provide improvements over static treatments, which may become less effective as conditions change. The toroidal structure of the shunt can provide a secure anchor, minimizing the risk of dislodgement and dysfunction, and facilitating robotic insertion of the shunt for treatment of CVI. In some embodiments, the shunt may include a durable braided nitinol construction, which can reduce the risk of infection and enhance long-term performance. By improving blood flow in the affected veins, the self-rolling shunt can alleviate symptoms and promotes healing. This can lead to better long-term outcomes and quality of life for patients with chronic venous insufficiency. The shunt can be used in various anatomical configurations, making it suitable for a wide range of venous insufficiency cases.12, Transcaval Shunt for Abdominal Aortic Aneurysm

[0226] Abdominal aortic aneurysms (AAAs) are a life-threatening condition characterized by the abnormal dilation of the abdominal aorta, which can lead to rupture and severe internal bleeding. Traditional treatments include open surgical repair and endovascular aneurysm repair (EVAR). Open surgical repair, while effective, is highly invasive and carries significant risks, including prolonged recovery times and complications such as infection and cardiovascular events. EVAR, although less invasive, is associated with issues such as endoleaks, stent migration, and the need for long-term surveillance and potential reinterventions.

[0227] The shunts described herein, for example, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200), can be used to create a transcaval shunt, providing a controlled communication between the aorta and the inferior vena cava. This approach can reduce pressure within the aneurysm sac, preventing rupture and offering a new method for managing AAAs. The deployment of the self-rolling shunt can be less invasive than open surgical repair, reducing procedural risks and recovery times. This can be advantageous for high-risk patients who may not tolerate extensive surgery. The self-rolling capability can allow the shunt to adapt to changes in vessel diameter and aneurysm dynamics, maintaining effective pressurereduction over time. This adaptability can provide improvements over fixed stents, which may become less effective as conditions change. In some embodiments, the toroidal structure of the shunt can provide a secure anchor, minimizing the risk of migration and endoleaks, and facilitating robotic insertion of the shunt for managing AAAs. In some embodiments, the shunt may include a durable braided nitinol construction, which can reduce the risk of infection and enhance long-term performance. By reducing pressure within the aneurysm sac, the self-rolling shunt can decrease the risk of rupture and improves overall patient outcomes. This can lead to better long-term outcomes and quality of life for patients with AAAs. The shunt can be used in various anatomical configurations, making it suitable for a wide range of AAA cases.13, Research and Experimental Therapies

[0228] Understanding blood flow dynamics, vascular biology, and the development of new therapeutic techniques are critical areas of medical research. Experimental models are essential for studying the physiological responses to different interventions and for developing innovative treatments. Traditional research models, including animal studies and in vitro simulations, have limitations in replicating human vascular conditions accurately. These models often lack the dynamic adaptability and physiological complexity needed to fully understand the effects of new treatments.

[0229] In some embodiments, the self-rolling shunt (e.g., shunts 100, 2000, 2100, 2200) can be used in research settings to study the effects of altered blood flow on vascular health, wound healing, and the development of new vascular devices and treatments. The shunt may include properties (e.g., adaptability, flexibility, self-rolling mechanism, biocompatibility, etc.) make it an ideal tool for experimental therapies. The self-rolling shunt can provide advantages over existing research tools such as realistic physiological modeling. For example, the self-rolling shunt can provide a more accurate replication of human vascular conditions, enhancing the validity of research findings. This realism can be useful for understanding the physiological responses to new treatments. The self-rolling capability can allow the shunt to adapt to changes in vessel diameter and blood flow dynamics, providing a flexible model for studying various conditions, and can facilitate robotic insertion of the shunt. This adaptability can provide improvements over static models, which cannot replicate dynamic physiological changes. In some embodiments, shunt can be used in a wide range of research applications, from studying blood flow dynamics to testing new vascular devices. This versatility canincrease the scope and applicability of research findings. By providing a more accurate and adaptable model, the self-rolling shunt enhances the quality of research data. This leads to better understanding and development of new therapies, ultimately improving patient outcomes. The use of the self-rolling shunt in research can reduce the reliance on animal models, addressing ethical concerns and improving the acceptance of research findings providing ethical advantages.

[0230] FIGS. 44A-44C show a handle 2368 for a shunt delivery system. As shown, the handle 2368 may be coupled to a catheter 2360 through which the shunt 2300 may be deployed. One or more functions or features of the handle 2368 and / or the catheter 2360 may be configured to be controlled by a robotic insertion system, such as robotic insertion system 4100. The catheter 2360 may include a guidewire lumen that runs longitudinally through the handle and catheter shaft. The guidewire lumen allows for the passage of a guidewire. The guidewire can be used to navigate the catheter to the target site within the vascular system. In some embodiments, the guidewire lumen may include a smooth inner surface to minimize friction and facilitate easy movement of the guidewire. The lumen can be sized to accommodate standard guidewires used in interventional procedures, promoting compatibility and ease of use. The material of the lumen may be selected for its low friction coefficient. In some embodiments, the material of the lumen may include, for example, fluoropolymers such as polytetrafluoroethylene (PTFE) to further reduce resistance and enhance guidewire maneuverability. The smooth inner surface may minimize the risk of guidewire kinking or snagging, promoting smooth and precise navigation.

[0231] A flush port (not shown) may be included in the catheter handle 2368 to allow for the flushing of the catheter system 2360. The flush port may be useful for maintaining the patency of the catheter 2360 and preventing the buildup of blood clots or other debris within the lumen of the catheter 2360. The handle 2360 and / or the flush port may include a connector 2369, enabling secure attachment to a syringe or infusion line. In some embodiments, the syringe can be coupled to the connector 2369 to deliver image contrast, saline, or any other fluid through the guide wire lumen. In some embodiments, the syringe may be robotically coupled to the connector 2369 by a robotic insertion system, such as robotic insertion system 4100. The connector (e.g., a Luer Lock connector, a Y connector, etc.) may further allow flushing to be performed efficiently and effectively, maintaining the integrity of the cathetersystem throughout the procedure. The connector 2369 may be configured to provide a leakproof connection such that the flushing fluid is directed through the catheter system and minimizing leakage. In some embodiments, the connector 2369 can provide an opening into the guidewire lumen through which the guidewire can be introduced (e.g., robotically). In some embodiments, the flush port can be coupled to the handle 2368 in a location provides easy access during the procedure, allowing for quick and convenient flushing as needed.

[0232] The handle 2368 may include a first actuator 2374, such as, for example, a rotating element, a rotation knob, a wheel, etc. The first actuator 2374 may be controlled or actuated robotically by a robotic insertion system, such as robotic insertion system 4100. As shown, the first actuator 2374 is a rotating conical structure coupled to the catheter 2360. The first actuator 2374 may provide control over the rotation of the catheter shaft 2360. For example, a degree of rotation of the first actuator 2374 may control a degree of rotation of the catheter shaft 2360. The first actuator 2374 may be ergonomically designed to be easily manipulated with one hand of the operator and / or by a robotic insertion system, such as robotic insertion system 4100, allowing the operator and / or the robotic insertion system to rotate the catheter 2360 smoothly and accurately. By actuating the first actuator 2374, the operator and / or the robotic insertion system can navigate the catheter through the vascular system and position the shunt (e.g., shunt 100, 2000, etc.) or any other interventional device at the target site. The first actuator 2374 may include a locking mechanism (e.g., grooves or detents to block rotation) to maintain the desired rotational position once it has been set. The locking mechanism is designed to provide secure and reliable engagement, preventing unintended rotation during critical phases of the procedure. The first actuator 2374 may include one or more features to provide tactile feedback to an operator such that the operator can feel the degree of rotation and make precise adjustments accordingly.

[0233] The handle 2368 may include a second actuator 2372 (e.g., a linear slider, a rack and pinion system, etc.) configured to facilitate deployment of the shunt. The second actuator 2372 may be controlled or actuated by a robotic insertion system, such as robotic insertion system 4100. As shown, the second actuator 2372 includes a linear slider including an engagement surface configured to be pushed proximally and / or distally. The second actuator 2372 may be connected to the catheter shaft 2360 and allow the operator and / or the robotic insertion system to advance or retract the shunt delivery system. The second actuator 2372 mayinclude a tactile feedback mechanism (e.g., one or more indents, detents, grooves, ridges, raised portions, etc. configured to temporarily engage a portion of the second actuator 2372 as it is actuated) to provide an operator with sensory feedback during deployment to help the operator accurately deployment of the shunt. The second actuator 2372 may also include a locking mechanism to secure the shunt in place (e.g., prevent movement of the shunt relative to the catheter 2360) until the shunt is ready to be deployed, thereby preventing accidental deployment during navigation. The tactile feedback mechanism may be configured to provide incremental feedback corresponding to the advancement or retraction of the shunt. In some embodiments, the tactile feedback mechanism may be configured such that the second actuator 2372 is encouraged or urged towards predefined positions along the length of the sliding path. For example, the tactile feedback mechanism may include a track including features (e.g., divets, cut outs, indentations, and / or ridges) to urge the second actuator 2372 to move into a predefined position. In some embodiments, the tactile feedback mechanism may be configured to provide tactile feedback (e.g., the user may feel a “click” or a vibration) when the second actuator 2372 moves or slides into each predefined position. The tactile feedback mechanism allows for secure shunt positioning and reliable deployment.

[0234] In some embodiments, the handle 2368 may be ergonomic such that the operator can comfortably hold and manipulate the handle 2368 for extended periods. For example, the handle 2368 may include a contoured grip that conforms to the natural shape of the hand, reducing operator fatigue and enhancing control. In some embodiments, a shape of the handle 2368 may correspond to a shape of an inner surface of the hand of the user. In some embodiments, the guidewire lumen, flush port, first actuator 2374, and second actuator 2372 are positioned on the handle 2368 for ease of access and operation such that the handle 2368 can be used efficiently during complex interventional procedures. In some embodiments, the handle 2368 can include materials with varying textures to enhance grip and comfort (e.g., a material or surface features to increase friction between the handle 2368 and the hand of the operator), reducing the likelihood of slippage even in a wet operating environment. A total weight of the handle 2368 and a weight distribution of the handle 2368 may be configured to minimize hand strain, allowing for precise and steady manipulation during prolonged procedures.

[0235] In some embodiments, the handle 2368 may be shaped in order to facilitate control of one or more functions or features of the handle 2368 by a robotic insertion system, such as robotic insertion system 4100. The guidewire lumen, flush port, first actuator 2374, and second actuator 2372 are positioned on the handle 2368 such that the handle 2368 can be controlled by a robotic insertion system, such as robotic insertion system. The handle 2368 can include materials with varying textures to increase friction between the handle 2368 and the robotic insertion system, and facilitate control of the handle 2368 by the robotic insertion system.

[0236] In some embodiments, the handle 2368 may include a biocompatible material such as, for example, medical-grade plastics, stainless steel, or a suitable combination thereof. These materials may provide durability, resistance to corrosion, and compatibility with sterilization processes. The handle 2368 may be configured to withstand the rigors of repeated use in a clinical setting while maintaining its functionality and safety. In some embodiments, medical-grade plastics, such as polycarbonate or polyether ether ketone (PEEK), can be included in a main body of the handle 2368 due to their strength and lightweight properties. In some embodiments, stainless steel components can be included in the handle 2368 for parts requiring high strength and precision, such as the first actuator and / or second actuators 2372. The material of the handle 2368 may be configured such that the handle can be sterilized using standard methods, such as autoclaving or ethylene oxide gas, without degrading its performance or structural integrity. The handle 2368 may be structurally and / or functionally similar to the handle 1168, and therefore, further details around the handle 2368 are not described herein with respect to FIGS. 44A-44C.Robotic Insertion Systems

[0237] FIGS. 45-49 illustrate a robotic insertion system 4100 and features thereof. The robotic insertion system 4100 may be configured to implant a shunt, an endograft, and / or a bypass graft, as described herein. The robotic insertion system 4100 may be configured to implant a shunt, an endograft, and / or a bypass graft for treatment of CVI, treatment of pulmonary hypertension, treatment of CAD, treatment of cerebral AVMs, revascularization in traumatic injuries, treatment of portal hypertension, treatment of CHDs, treatment of PCS, interatrial shunting for management of various cardiac conditions, and / or any other treatments described herein.

[0238] The robotic insertion system 4100 may be configured to control a delivery system, such as delivery systems 450, 1150, 1450, 1650, one or more components of the delivery system, such as handle 2368, and / or to perform any of the methods described with reference to FIGS. 3 A, 3B, 13A-13E, 16-28, 29-38, 40A-40E, and 41-45. The robotic insertion system 4100 may include any of the features of the robotic insertion system described herein, such as for example, robotic insertion system 490. The robotic insertion system 4100 may be configured to perform any of the functions of the robotic insertion systems described herein.

[0239] As shown in FIG. 45 A, the robotic insertion system 4100 may include a robotic insertion device 4102, an imaging modality 4106, and / or a computing system 4110. The robotic insertion device 4102 may be configured to control one or more components of a delivery system to implant a shunt, an endograft, and / or a bypass graft.

[0240] The computing system 4110 may include a robot controller 4104 and / or an imaging controller 4108. The robot controller 4104 may be configured to control components of the robotic insertion device 4102. The robot controller 4104 may be coupled to controls of the robotic insertion device 4102, such as controls 4202 (shown in FIG. 46). The robot controller 4104 may be configured to generate commands and / or instructions for the robotic insertion device 4102. The robot controller 4104 may be configured to transmit commands and / or instructions to the controls of the robotic insertion device 4102. The robot controller 4104 may be configured to receive control information from the robotic insertion device 4102. The control information may include localization data from a localization system, such as the localization system 480. The control information may include actuation data from the robotic insertion device 4102 (e.g., data indicative of axial translation and / or rotation of the controls and / or the delivery system, a force applied to the delivery system by the robotic insertion device 4102, etc.).

[0241] The imaging controller 4108 may be configured to control the imaging modality 4106. The imaging controller 4108 may be configured to generate commands and / or instructions for controlling the imaging modality 4106. The imaging controller 4108 may be configured to transmit commands and / or instructions to the imaging modality 4106. The imaging controller 4108 may be configured to receive image data from the imaging modality 4106. The imaging modality 4106 may include X-ray (fluoroscopy), computed tomography (CT), magnetic resonance imaging (MRI) or echocardiography, such as transesophagealechocardiography (TEE) or transthoracic echocardiography (TTE) an echo probe, intravascular echocardiography, and / or any other imaging modality.

[0242] The robot controller 4104 may be configured to generate commands and / or instructions for the robotic insertion device 4102 based on the control information from the robotic insertion device 4102 and / or imaging data from the imaging modality 4106. The imaging controller 4108 may be configured to generate commands and / or instructions for the imaging modality 4106 based on the control information from the robotic insertion device 4102 and / or imaging data from the imaging modality 4106. The computing system 4110 may include a user interface 4112. The user interface 4112 may include a display 4114 and / or a user input 4116. The display 4114 may include a touchscreen. The display 4114 may be configured to display pre-operative and / or intra-operative data to the user. The display 4114 may be configured to display image data, insertion directions, navigation instructions, control information (e.g., localization data, actuation data, etc.), pre-operative plans, notes from patient interviews, patient vitals, and / or any other information to a user. The computing system 4110 may be configured to overlay insertion directions, navigation instructions, control information, locations of target puncture sites, and / or an ideal puncture trajectory over the image data.

[0243] In some embodiments, the computing system 4110 may be configured to generate a 3-D model of a portion of the patient’s anatomy (e.g., the vena cava, the aorta, the aortic aneurysm, and / or any other portion of the patient). In some embodiments, the computing system 4110 may generate the 3-D model of the portion of the patient’s anatomy from the image data from the imaging modality 4106. In some embodiments, the imaging modality 4106 may include an anatomical mapping device. Prior to inserting a shunt, an endograft, and / or a bypass graft, the anatomical mapping device may be inserted into the patient. The anatomical mapping device may include an imaging device configured to collect imaging data of an interior of the patient’s anatomy. The anatomical mapping device may include a localization sensor. The computing system 4110 may use localization data from the localization sensor and the imaging data collected by the anatomical mapping device to generate a 3-D model of the portion of the patient’s anatomy. In some embodiments, the computing system 4110 may use the 3-D model and / or the imaging data collected by the anatomical mapping device to control the robotic insertion device 4102.

[0244] In some embodiments, the computing system 4110 may be configured to generate a trajectory of an instrument. The computing system 4110 may determine the trajectory of the instruments based on image data, localization information, user control inputs received by the user input 4116, and / or any other intra-operative or pre-operative data.

[0245] The display 4114 may be configured to display the 3-D model and / or any other pre-operative imaging to the user and real-time image data captured by the imaging modality 4106 during an operation. In some embodiments, the imaging modality 4106 may be configured to capture image data from multiple different views and / or multiple different imaging modalities. The display 4114 may be configured to display the image data from multiple different views and / or multiple different imaging modalities simultaneously. In some embodiments, the user may select which views and / or imaging modalities are displayed on the display 4114.

[0246] The user input 4116 may be configured to receive a selection of a location on the image data displayed to the user. The selection of the location on the image data may include a target puncture location and / or an ideal puncture trajectory. The robot controller 4104 may be configured to generate commands and / or instructions for the robotic insertion device 4102 based on the selection of the location on the image data. The user input 4116 may be configured to receive an input from the user indicative of confirmation from the user to proceed with a next step of inserting a shunt, an endograft, and / or a bypass graft. In response to receiving confirmation form the user, the robot controller 4104 may be configured to transmit commands and / or instructions to the robotic insertion device 4102. In some embodiments, the user input 4116 may include a user controller configured to receive user control inputs for controlling the robotic insertion device 4102. The user may actuate the user controller to control the robotic insertion device 4102 and / or the imaging modality 4106. For example, the user may actuate the user controller to advance a catheter through the vena cava. In response to the user actuation of the user controller, the robot controller 4104 may transmit commands and / or instructions to the robotic insertion device 4102 so the robotic insertion device 4102 advances the catheter through the vena cava.

[0247] In some embodiments, the computing system 4110 may be configured to automatically control the robotic insertion device 4102 and / or the imaging modality 4106 to insert a shunt, an endograft, and / or a bypass graft. In some embodiments, the user may instructthe robotic insertion device 4102 via the user input 4116 to insert the shunt, the endograft, and / or the bypass graft. In some embodiments, the computing system 4110 may be configured to automatically perform a portion of the steps to insert the shunt, the endograft, and / or the bypass graft, and a user may one or more of the steps. In some embodiments, the user may perform the one or more of the steps manually. In some embodiments, the user may perform the one or more of the steps by instructing the robotic insertion device 4102 to perform one or more of the steps via the user input 4116.

[0248] As shown in FIG. 46, the robotic insertion device 4102 may include a first controller (e.g., first instrument driver) 4202 and / or a second controller (e.g., second instrument driver) 4204. The first controller 4202 may be coupled to a first instrument 4206. The first instrument 4206 may include a catheter (e.g., a steerable catheter) and / or a handle configured to control one or more functions or features of the catheter. The first instrument 4206 may include the catheters 460, 1160, 1460, 1660, 1760, 3702, any other catheters described herein, the handle 2368, and / or any other components configured to control one or more functions of features of a catheter. The first controller 4202 may be configured to control (e.g., manipulate, steer, etc.) the first instrument 4206. The first controller 4202 may include actuators (e.g., drive inputs) 4208. The first controller 4202 may include one (1) actuator 4208, two (2) actuators 4208, three (3) actuators 4208, and / or four (4) actuators 4208. In some embodiments, the first controller 4202 may include more than four (4) actuators 4208. The actuators 4208 of the first controller 4202 may be actuated by the robot controller 4104 of the robotic insertion system 4100 (e.g., via commands and / or instructions). The actuators 4208 may control (e.g., manipulate, steer, etc.) the first instrument 4206 to steer the first instrument 4206 through the patient’s anatomy (e.g., vena cava, aorta, etc.) and / or otherwise position the first instrument 4206. The actuators 4208 may be coupled to control elements, such as tension cables, of the first instrument 4206. The control elements may control a steerable portion 4206A of the first instrument 4206. In some embodiments, the control elements may extend along the length of the first instrument 4206 to the steerable portion 4206A. The actuators 4208 may be configured to control the control elements in order to control (e.g., manipulate, steer, etc.) the steerable portion 4206A of the first instrument 4206.

[0249] The second controller 4204 may be coupled to a second instrument 4210. The second instrument may include a sheath. The second instrument 4210 may include thesliding sheaths 466, 1166 and / or any other sliding sheaths described herein. The second controller 4204 may be configured to control (e.g., manipulate, steer, etc.) the second instrument 4210. The second controller 4204 may include actuators (e.g., drive inputs) 4208. The second controller 4204 may include one (1) actuator 4208, two (2) actuators 4208, three (3) actuators 4208, and / or four (4) actuators 4208. In some embodiments, the second controller 4204 may include more than four (4) actuators 4208. The actuators 4208 of the second controller 4204 may be actuated by the robot controller 4104 of the robotic insertion system 4100 (e.g., via commands and / or instructions). The actuators 4208 may control (e.g., manipulate, steer, etc.) the second instrument 4210 to steer the second instrument 4210 through the patient’s anatomy (e.g., vena cava, aorta, etc.) and / or otherwise position the second instrument 4210. The actuators 4208 may be coupled to control elements, such as tension cables, of the second instrument 4210. The control elements may control a steerable portion 4210A of the second instrument 4210. In some embodiments, the control elements may extend along the length of the second instrument 4210 to the steerable portion 4210 A. The actuators 4208 may be configured to control the control elements in order to control (e.g., manipulate, steer, etc.) the steerable portion 4210A of the second instrument 4210.

[0250] The first controller 4202 and / or the second controller 4204 may be configured to telescopically control the first instrument 4206 and / or the second instrument 4210. The first controller 4202 and / or the second controller 4204 may be configured to extend and / or retract the first instrument 4206 and / or the second instrument 4210 through the patient’ s anatomy respectively. The first controller 4202 and / or the second controller 4204 may be configured to rotate the first instrument 4206 and / or the second instrument 4210. The first controller 4202 and the second controller 4204 may include drivers (not shown) configured to extend, retract, and / or rotate the first instrument 4206 and / or the second instrument 4210. The first controller 4202 and / or the second controller 4204 may include sterile adaptors positioned between the drivers of the controllers 4202, 4204 and the instruments 4206, 4210. In some embodiments, the sterile adaptors may be configured to transfer forces and / or motion from the drivers to the instruments 4206, 4210. The sterile adaptors may be configured to maintain physical separates and sterility between the instruments 4206, 4210 and the drives of the controllers 4202, 4204.

[0251] In some embodiments, additional instruments, such as a dilator (e.g., dilators 464, 1164, 1264, 1664), a guidewire (e.g., guidewires 462, 1162, 1662, 1762), and / or any other instruments described herein, may be inserted and / or advanced through into a lumen in second instrument 4210 via an instrument port 4212 in the second controller 4204. In some embodiments, the additional instruments may be manually inserted and / or advanced through the lumen in the second instrument 4210. In some embodiments, the additional instruments may be robotically inserted and / or advanced through the lumen in the second instrument 4210. For example, the robotic insertion device 4102 may include an additional controller configured to control the additional instruments.

[0252] In some embodiments, if a sheath, such as sliding sheaths 466, 1166, is not used during a procedure, the second instrument 4210 may include the dilator, such as dilators 464, 1164, 1264, 1664.

[0253] FIG. 47 illustrates an operation assembly. As shown in FIG. 47, the robotic insertion device 4102 may be coupled to robotic arm 4302. The robotic arm 4302 may be configured to position the robotic insertion device 4102 during an operation. The robotic arm 4302 may be configured to position the robotic insertion device 4102 so the robotic insertion device 4102 may insert one or more instruments to an access point. For example, the access point may be located in the femoral artery in the patient’s leg, and / or any other location on the patient. The robotic arm 4302 may be configured to position the robotic insertion device 4102 based on pre-operative data. The robotic arm 4302 may be configured to re-position the robotic insertion device 4102 intra-operatively based on pre-operative data and / or intra-operative data. In some embodiments, the robot controller 4104 may be configured to control the robotic arm 4302. In some embodiments, the user may control the robotic arm 4302 via the user input 4116 of the user interface 4112.

[0254] The computing system 4110 may be coupled to the robotic arm 4302, the robotic insertion device 4102, and / or the imaging modality 4106 via a connection 4304. The connection 4304 may include a wired connection and / or a wireless connection. The computing system 4110 may be positioned away from the patient or operating table 4310 to minimize and / or eliminate radiation exposure of the user.Methods for Robotic Endoleak Embolization

[0255] FIG. 48 illustrates one embodiment of a method for performing transcaval embolization with a robotic insertion system. An endoleak is one of the most common complications after EVAR. Specifically, type II endoleaks have been shown to occur in up to 50% of cases after EVAR. While many endoleaks will resolve spontaneously, those that remain after six months are described as persistent. There exists a need for an appropriate treatment of persistent type II endoleaks. When aortic sac size increases, intervention is warranted, particularly with a sac increase of >5 mm because of the risk of sac rupture. According to some embodiments, approaches to enlarging aortic sac size include the transarterial, the translumbar, and the transcaval approach to embolization of the offending vessels. Whereas transarterial and translumbar approaches have been the mainstay of type II endoleak repair, recurrence — with the need for subsequent reintervention — seems to be high. In addition, a translumbar approach is more invasive as it often necessitates general anesthesia in the prone or oblique position, computed tomography (CT) scanning, and careful navigation of periaortic structures. The transcaval approach, through the femoral vein, is relatively straightforward, involving an access site that is comfortable to all endovascular clinicians. Moreover, transcaval embolization (TCE) has been demonstrated to have a greater rate of technical success and a lower rate of endoleak recurrence.

[0256] Significant progress has been made in the development of hydrogel polymer compositions that are non-degradable, low-swelling and initially water soluble. Many hydrogel polymer compositions may be formed in situ and are useful for embolizing a body lumen such as a blood vessel or organ. Embolization, or the artificial blocking of fluid flow such as blood, may be used to treat a variety of maladies, including, by way of example only, controlling bleeding caused by trauma, preventing profuse blood loss during an operation requiring dissection of blood vessels, obliterating a portion of a whole organ having a tumor, blocking the blood flow into abnormal blood vessel structures such as aneurysms, arterio-venous malformations, arteriovenous fistulae, and blocking the passage of fluids or other materials through various body lumens. For such treatments, a variety of embolization technologies can be implemented, including for example mechanical means (including particulate technology), and liquid and semi-liquid technologies. The particular characteristics of such technologies (such as, e.g., the size of particles, radiopacity, viscosity, mechanism of occlusion, biological behavior and possible recanalization versus permanent occlusion, the means by which thematerial is delivered to the target body site, etc.), can be factors in determining the most suitable therapy for the indication to be treated.

[0257] According to some applications, mechanical and particulate embolization technologies can include detachable balloons, macro-coils and micro-coils, gelfoam, polyvinyl alcohol sponges, and microspheres. For example, one embolization technique uses platinum and stainless steel microcoils. Liquid and semi-liquid embolic compositions include viscous occlusion gels, collagen suspensions, and cyanoacrylate (n-butyl and iso-butyl cyanoacrylates).

[0258] Another class of liquid embolic compositions is precipitative materials. These materials employ a different mechanism in forming synthetic emboli than do the cyanoacrylate materials. Cyanoacrylate glues are monomeric and rapidly polymerize upon contact with blood. On the other hand, precipitative materials are pre-polymerized chains that precipitate into an aggregate upon contact with blood. Ethylene vinyl alcohol (EVOH) copolymer is an advantageous liquid embolic agent for use outside of neurovascular applications. Use of EVOH copolymer in specific peripheral applications has advantageous physical properties, which include its viscous nature, slow polymerization, ability to conform to vessel shape, and high fluoroscopic visibility.

[0259] According to some embodiments, embolic material formed in situ can be biocompatible, has a relatively short cure time from about a few seconds to a few minutes, exhibits minimal to moderate controllable swelling upon curing, exhibits long-term stability, and exhibits adequate mechanical properties, both in its pre- and post-cure state. For instance, such a material can have a relatively high viscosity before solidification or curing to facilitate safe and accurate delivery to the target site.

[0260] Accordingly, disclosed herein, in some aspects, is a method for performing transcaval embolization with a robotic insertion system. The method can include: Acquiring an anatomical image to identify at least one target embolization location and at least one target transcaval puncture location. Introducing a first instrument into a blood vessel, the first medical instrument configured for robotic endovascular navigation and comprising an elongate, flexible body with at least one central lumen extending therethrough. Introducing a second instrument via a central lumen of the first medical instrument, the second instrument comprising: an elongate, flexible body with at least one central lumen extending therethrough,and a piercing element configured to pierce at least one anatomical vessel, the piercing element disposed at a distal end of the second instrument. Acquiring localization information for at least one instrument from at least one tracking sensor integrated in the instrument. Registering at least one instrument to the anatomical image. Overlaying a representation of at least a portion of at least one instrument on the anatomical image for display to a user. Receiving a user command to drive the first instrument, the user command received from the user via a user input device. Identifying, based on the localization information of at least one instrument and at least one identified target, a suitable position and suitable orientation of a distal end of the first instrument. Overlaying a representation of a virtual trajectory extending from the first instrument on the display, the trajectory being defined by the position and orientation of the distal end of the first instrument. Advancing the piercing element of the second instrument such that the piercing element substantially follows over the virtual trajectory defined by the position and orientation of the first instrument, and delivering a flowable material via a central lumen of at least one instrument.

[0261] FIG. 48 illustrates a method 4400 for performing transcaval embolization with a robotic insertion system, such as robotic insertion system 4100. Method 4400 may include any of the steps of the methods previously described herein. The robotic insertion system may perform any of the steps of the method 4400. In some embodiments, the robotic insertion system may perform one or more of the steps of the method 4400 and the one or more of the steps of method 4400 may be performed manually.

[0262] At step 4402, an anatomical image may be acquired. The anatomical image may be acquired by an imaging modality of the robotic insertion system. At least one target embolization location and at least one target transcaval puncture location may be identified based on the anatomical image. In some embodiments, a user may identify the at least one target embolization location and / or the at least one target transcaval puncture location via a user interface of the robotic insertion system. In some embodiments, the robotic insertion system may be configured to analyze the anatomical image to automatically identify the at least one target embolization location and / or the at least one target transcaval puncture location. The anatomical image may be displayed to a user on a display of the robotic insertion system.

[0263] At step 4404, a first instrument may be inserted into a blood vessel. The first instrument may include a steerable instrument (e.g., a steerable catheter). The robotic insertion system may be configured to insert the first instrument into the blood vessel. For example, the first instrument may include the first instrument 4206, and the first controller 4202 may be configured to insert the first instrument 4206 into the blood vessel. The steerable instrument may include a lumen extending through an elongate body of the first instrument.

[0264] At step 4406, a second instrument may be inserted into the central lumen of the first instrument. The second instrument may include an elongate body and a central lumen extending through the elongate body. The second instrument may include one or more piercing elements at a distal end of the second instrument. A piercing element may be configured to pierce at least one anatomical vessel. The robotic insertion system may be configured to insert the second instrument into the central lumen of the first instrument. For example, the second instrument may include the second instrument 4210, and the second controller 4204 may be configured to insert the second instrument 4210 into the central lumen of the first instrument.

[0265] The first instrument and the second instrument may include any of the features of the instruments of the delivery systems described herein.

[0266] At step 4408, localization information may be received from a localization (e.g., tracking) sensor. The first instrument and the second instrument may each include localization sensors. The localization sensors may be positioned at distal ends of the first instrument and the second instrument. A localization system may use the localization information from the localization sensors to determine a position of the first instrument and / or the second instrument. The localization information may include a position and / or orientation of the first instrument and / or the second instrument.

[0267] At step 4410, the first instrument and / or the second instrument may be registered to the anatomical image. In some embodiments, the position and / or orientation of the first instrument and / or the second instrument may be overlaid on the anatomical image. The position of the first instrument and / or the second instrument may be displayed on the anatomical image on the display of the robotic insertion system. A graphical representation of the first instrument and / or the second instrument may be overlaid on the anatomical image.

[0268] At step 4412, a user command (e.g., control input) to drive the first instrument may be received. The user command may be received by a user interface of therobotic insertion system, such as the user interface 4112 of the robotic insertion system 4100. The user command may be received by a user input of the user interface.

[0269] At step 4414, a virtual trajectory of the first instrument may be displayed to the user. The virtual trajectory may be determined by a computing system of the robotic insertion system, such as computing system 4110 of the robotic insertion system 4100. The virtual trajectory may be determined based on at least the user command, the localization information, and / or the anatomical image. The virtual trajectory may be overlaid on the anatomical image displayed to the user by the display of the user interface. The virtual trajectory may include a determined path of the first instrument and / or the second instrument to the at least one target embolization location and / or the at least one target transcaval puncture location.

[0270] At step 4416, the second instrument may be advanced. The second instrument may be advanced along the virtual trajectory. The robotic insertion system may automatically advance the second instrument along the virtual trajectory in response to receiving the user command at step 4412.

[0271] At step 4418, a flowable material may be delivered to at least one target embolization location. The flowable material may include a viscous occlusion gel, collagen suspension, cyanoacrylate (n-butyl and iso-butyl cyanoacrylates), perceptive materials cyanoacrylate glues, ethylene vinyl alcohol (EVOH), and / or any other flowable material suitable for embolization. The flowable material may include a short cure time, minimal controllable swelling upon curing, stability, and suitable mechanical properties for embolization. For example, the flowable material may include a high-viscosity to facilitate accurate delivery to the at least one embolization location.Computer Systems

[0272] FIG. 49 is a block diagram depicting an embodiment of a computer hardware system configured to run software for implementing one or more embodiments disclosed herein.

[0273] In some embodiments, the systems, processes, and methods described herein are implemented using a computing system, such as the one illustrated in FIG. 49. The example computer system 4502 is in communication with one or more computing systems 4520 and / or one or more data sources 4522 via one or more networks 4518. While FIG. 49illustrates an embodiment of a computing system 4502, it is recognized that the functionality provided for in the components and modules of computer system 4502 may be combined into fewer components and modules, or further separated into additional components and modules.

[0274] The computer system 4502 can comprise a module 4514 that carries out the functions, methods, acts, and / or processes described herein. The module 4514 is executed on the computer system 4502 by a central processing unit 4506 discussed further below.

[0275] In general, the word “module,” as used herein, refers to logic embodied in hardware or firmware or to a collection of software instructions, having entry and exit points. Modules are written in a program language, such as JAVA, C or C++, Python, or the like. Software modules may be compiled or linked into an executable program, installed in a dynamic link library, or may be written in an interpreted language such as BASIC, PERL, LUA, or Python. Software modules may be called from other modules or from themselves, and / or may be invoked in response to detected events or interruptions. Modules implemented in hardware include connected logic units such as gates and flip-flops, and / or may include programmable units, such as programmable gate arrays or processors.

[0276] Generally, the modules described herein refer to logical modules that may be combined with other modules or divided into sub-modules despite their physical organization or storage. The modules are executed by one or more computing systems and may be stored on or within any suitable computer readable medium or implemented in-whole or inpart within special designed hardware or firmware. Not all calculations, analysis, and / or optimization require the use of computer systems, though any of the above-described methods, calculations, processes, or analyses may be facilitated through the use of computers. Further, in some embodiments, process blocks described herein may be altered, rearranged, combined, and / or omitted.

[0277] The computer system 4502 includes one or more processing units (CPU) 4506, which may comprise a microprocessor. The computer system 4502 further includes a physical memory 4510, such as random-access memory (RAM) for temporary storage of information, a read only memory (ROM) for permanent storage of information, and a mass storage device 4504, such as a backing store, hard drive, rotating magnetic disks, solid state disks (SSD), flash memory, phase-change memory (PCM), 3D XPoint memory, diskette, or optical media storage device. Alternatively, the mass storage device may be implemented inan array of servers. Typically, the components of the computer system 4502 are connected to the computer using a standards-based bus system. The bus system can be implemented using various protocols, such as Peripheral Component Interconnect (PCI), Micro Channel, SCSI, Industrial Standard Architecture (ISA) and Extended ISA (EISA) architectures.

[0278] The computer system 4502 includes one or more input / output (I / O) devices and interfaces 4512, such as a keyboard, mouse, touch pad, and printer. The VO devices and interfaces 4512 can include one or more display devices, such as a monitor, that allows the visual presentation of data to a user. More particularly, a display device provides for the presentation of GUIs as application software data, and multi-media presentations, for example. The I / O devices and interfaces 4512 can also provide a communications interface to various external devices. The computer system 4502 may comprise one or more multi-media devices 4508, such as speakers, video cards, graphics accelerators, and microphones, for example.

[0279] The computer system 4502 may run on a variety of computing devices, such as a server, a Windows server, a Structure Query Language server, a Unix Server, a personal computer, a laptop computer, and so forth. In other embodiments, the computer system 4502 may run on a cluster computer system, a mainframe computer system and / or other computing system suitable for controlling and / or communicating with large databases, performing high volume transaction processing, and generating reports from large databases. The computing system 4502 is generally controlled and coordinated by an operating system software, such as Windows XP, Windows Vista, Windows 7, Windows 8, Windows 10, Windows 11, Windows Server, Unix, Linux (and its variants such as Debian, Linux Mint, Fedora, and Red Hat), SunOS, Solaris, Blackberry OS, z / OS, iOS, macOS, or other operating systems, including proprietary operating systems. Operating systems control and schedule computer processes for execution, perform memory management, provide file system, networking, and I / O services, and provide a user interface, such as a graphical user interface (GUI), among other things.

[0280] The computer system 4502 illustrated in FIG. 49 is coupled to a network 4518, such as a LAN, WAN, or the Internet via a communication link 4516 (wired, wireless, or a combination thereof). Network 4518 communicates with various computing devices and / or other electronic devices. Network 4518 is communicating with one or more computing systems 4520 and one or more data sources 4522. The module 4514 may access or may be accessed by computing systems 4520 and / or data sources 4522 through a web-enabled useraccess point. Connections may be a direct physical connection, a virtual connection, and other connection type. The web-enabled user access point may comprise a browser module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network 4518.

[0281] Access to the module 4514 of the computer system 4502 by computing systems 4520 and / or by data sources 4522 may be through a web-enabled user access point such as the computing systems’ 4520 or data source’s 4522 personal computer, cellular phone, smartphone, laptop, tablet computer, e-reader device, audio player, or another device capable of connecting to the network 4518. Such a device may have a browser module that is implemented as a module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network 4518.

[0282] The output module may be implemented as a combination of an all-points addressable display such as a cathode ray tube (CRT), a liquid crystal display (LCD), a plasma display, or other types and / or combinations of displays. The output module may be implemented to communicate with input devices 4512 and they also include software with the appropriate interfaces which allow a user to access data through the use of stylized screen elements, such as menus, windows, dialogue boxes, tool bars, and controls (for example, radio buttons, check boxes, sliding scales, and so forth). Furthermore, the output module may communicate with a set of input and output devices to receive signals from the user.

[0283] The input device(s) may comprise a keyboard, roller ball, pen and stylus, mouse, trackball, voice recognition system, or pre-designated switches or buttons. The output device(s) may comprise a speaker, a display screen, a printer, or a voice synthesizer. In addition, a touch screen may act as a hybrid input / output device. In another embodiment, a user may interact with the system more directly such as through a system terminal connected to the score generator without communications over the Internet, a WAN, or LAN, or similar network.

[0284] In some embodiments, the system 4502 may comprise a physical or logical connection established between a remote microprocessor and a mainframe host computer for the express purpose of uploading, downloading, or viewing interactive data and databases online in real time. The remote microprocessor may be operated by an entity operating the computer system 4502, including the client server systems or the main server system, an / ormay be operated by one or more of the data sources 4522 and / or one or more of the computing systems 4520. In some embodiments, terminal emulation software may be used on the microprocessor for participating in the micro-mainframe link.

[0285] In some embodiments, computing systems 4520 who are internal to an entity operating the computer system 4502 may access the module 4514 internally as an application or process run by the CPU 4506.

[0286] In some embodiments, one or more features of the systems, methods, and devices described herein can utilize a URL and / or cookies, for example for storing and / or transmitting data or user information. A Uniform Resource Locator (URL) can include a web address and / or a reference to a web resource that is stored on a database and / or a server. The URL can specify the location of the resource on a computer and / or a computer network. The URL can include a mechanism to retrieve the network resource. The source of the network resource can receive a URL, identify the location of the web resource, and transmit the web resource back to the requestor. A URL can be converted to an IP address, and a Domain Name System (DNS) can look up the URL and its corresponding IP address. URLs can be references to web pages, file transfers, emails, database accesses, and other applications. The URLs can include a sequence of characters that identify a path, domain name, a file extension, a host name, a query, a fragment, scheme, a protocol identifier, a port number, a username, a password, a flag, an object, a resource name and / or the like. The systems disclosed herein can generate, receive, transmit, apply, parse, serialize, render, and / or perform an action on a URL.

[0287] A cookie, also referred to as an HTTP cookie, a web cookie, an internet cookie, and a browser cookie, can include data sent from a website and / or stored on a user’s computer. This data can be stored by a user’s web browser while the user is browsing. The cookies can include useful information for websites to remember prior browsing information, such as a shopping cart on an online store, clicking of buttons, login information, and / or records of web pages or network resources visited in the past. Cookies can also include information that the user enters, such as names, addresses, passwords, credit card information, etc. Cookies can also perform computer functions. For example, authentication cookies can be used by applications (for example, a web browser) to identify whether the user is already logged in (for example, to a web site). The cookie data can be encrypted to provide security for the consumer. Tracking cookies can be used to compile historical browsing histories of individuals. Systemsdisclosed herein can generate and use cookies to access data of an individual. Systems can also generate and use JSON web tokens to store authenticity information, HTTP authentication as authentication protocols, IP addresses to track session or identity information, URLs, and the like.

[0288] The computing system 4502 may include one or more internal and / or external data sources (for example, data sources 4522). In some embodiments, one or more of the data repositories and the data sources described above may be implemented using a relational database, such as Sybase, Oracle, CodeBase, DB2, PostgreSQL, and Microsoft® SQL Server as well as other types of databases such as, for example, a NoSQL database (for example, Couchbase, Cassandra, or MongoDB), a flat file database, an entity-relationship database, an object-oriented database (for example, InterSystems Cache), a cloud-based database (for example, Amazon RDS, Azure SQL, Microsoft Cosmos DB, Azure Database for MySQL, Azure Database for MariaDB, Azure Cache for Redis, Azure Managed Instance for Apache Cassandra, Google Bare Metal Solution for Oracle on Google Cloud, Google Cloud SQL, Google Cloud Spanner, Google Cloud Big Table, Google Firestore, Google Firebase Realtime Database, Google Memorystore, Google MongoDB Atlas, Amazon Aurora, Amazon DynamoDB, Amazon Redshift, Amazon ElastiCache, Amazon MemoryDB for Redis, Amazon DocumentDB, Amazon Keyspaces, Amazon Neptune, Amazon Timestream, or Amazon QLDB), a non-relational database, or a record-based database.

[0289] The computer system 4502 may also access one or more databases 4522. The databases 4522 may be stored in a database or data repository. The computer system 4502 may access the one or more databases 4522 through a network 4518 or may directly access the database or data repository through I / O devices and interfaces 4512. The data repository storing the one or more databases 4522 may reside within the computer system 4502.Robotic Tanscaval Access

[0290] According to some embodiments, the devices, systems, and methods disclosed herein can include additional components and features related to robotic systems and methods. For example, devices, systems, and methods disclosed herein can include components and features related to robotic transcaval access systems and methods as further disclosed herein.-I l l-

[0291] According to some procedures, complete percutaneous access into the arterial system is desired. Limiting factors to achieving this can include that some arteries may not facilitate use of access devices because of vessels that are atherosclerotic, tortuous, have a small diameter, are calcified, or have porcelain internal vascular walls. Anatomically parallel to the arterial system is the venous system, which does not typically have the same limiting properties. Percutaneous access into the venous system into the arterial system is advantageous and has been demonstrated and most impactful in caval-aortic procedures.

[0292] Transcaval access (TCA) is an advantageous catheter technique that enables non-surgical introduction of large devices into the abdominal aorta, or alternatively, to enable various catheter-based treatments of aortic aneurysms. TCA involves the creation of a conduit from the inferior vena cava (IVC) to the abdominal aorta (AA) by way of intravascular puncture and obturation of the resulting fistula. This fistula enables the introduction of catheter systems in a manner that bypasses existing arterial limitations.

[0293] However, in addition to closure limitations, some methods of caval-aortic crossing can be limited in accuracy. Patients undergoing TCA can be assessed via computed tomography (CT) for anatomical features, as well as the identification of an ideal crossing zone and angle. In some cases, this ideal crossing point can only be assessed from within the AA, and it can be defined as the least diseased, calcific, and obstructed portion of the AA. This ideal crossing point can also be associated with a radiological angle as a means of synchrony between the CT and the fluoroscopic imaging during the procedure.

[0294] In some procedures, the method of crossing can be as follows: Vascular access is gained in both the right femoral artery and right femoral vein. From within the artery a snare is advanced into the arterial side, up until the snare is located approximately at the site of ideal crossing. Through the venous side a steerable catheter is advanced until parallel to the snare, it is then articulated so the distal end of the catheter is direct...

Claims

WHAT IS CLAIMED IS:

1. A method of treating an aortic aneurysm in a subject, comprising: puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; after puncturing the artery, delivering an endograft to the aortic aneurysm; and after puncturing the artery, delivering a shunt including a proximal flaring element and a distal flaring element such that the proximal flaring element is disposed within the vein and the distal flaring element is disposed within the artery, the distal flaring element having a lateral length greater than that of the proximal flaring element, wherein one or more instruments configured to puncture the vein, puncture the artery, deliver the endograft, and / or deliver the shunt are controlled by a robotic insertion system.

2. The method of claim 1, wherein delivering the shunt includes moving the shunt through the venous puncture site towards and through the arterial puncture site to enable blood flow therethrough from the artery to the vein.

3. The method of claim 2, wherein delivering the shunt occurs after delivering the endograft.

4. The method of claim 1, wherein the aortic aneurysm is an abdominal aortic aneurysm.

5. The method of claim 1, wherein the arterial puncture site is disposed within the aortic aneurysm or upstream of the aortic aneurysm.

6. The method of claim 1, further comprising: rerouting at least a portion of arterial blood into the venous circulatory system.

7. The method of claim 2, further comprising: selecting a shunt based on a lateral thickness of a thrombus formed in the aortic aneurysm determined by imaging of the aortic aneurysm.

8. The method of claim 2, wherein the puncturing of the vein and the puncturing of the artery includes moving a guidewire through the venous puncture site and the arterial puncture site.

9. The method of claim 8, further comprising:dilating the venous puncture site and the arterial puncture site to a diameter corresponding to a diameter of the shunt.

10. The method of claim 2, further comprising: after delivering the shunt through the venous puncture site and the arterial puncture site, resizing a diameter of at least a portion of the shunt to modify an amount of blood flow therethrough.

11. A method of treating an aortic aneurysm in a subject having an endograft implanted within the aortic aneurysm, comprising: puncturing a vein to define a venous puncture site; puncturing an artery via the venous puncture site to define an arterial puncture site; and after puncturing the artery, delivering a shunt through the venous puncture site towards and through the arterial puncture site, thereby enabling blood flow through a lumen defined by the shunt from the artery to the vein, the shunt including an arterial sealing structure and a venous sealing structure, the arterial sealing structure having a lateral length greater than that of the venous sealing structure, wherein one or more instruments configured to puncture the vein, puncture the artery, and / or deliver the shunt are controlled by a robotic insertion system.

12. The method of claim 11, wherein the aortic aneurysm is an abdominal aortic aneurysm.

13. The method of claim 11, wherein the method of treating the aortic aneurysm is a method of treating an endoleak associated with the endograft implanted within the aortic aneurysm.

14. The method of claim 13, wherein delivering the shunt occurs after the implantation of the endograft.

15. The method of claim 11, further comprising: rerouting at least a portion of arterial blood into the venous circulatory system.

16. The method of claim 11, further comprising: selecting a shunt based on a lateral thickness of a thrombus formed in the aortic aneurysm determined by imaging of the aortic aneurysm.

17. The method of claim 11, wherein the puncturing of the vein and the puncturing of the artery includes moving a guidewire through the venous puncture site and the arterial puncture site.

18. The method of claim 17, further comprising: dilating the venous puncture site and the arterial puncture site to a diameter corresponding to a diameter of the shunt.

19. The method of claim 11, further comprising: after delivering the shunt through the venous puncture site and the arterial puncture site, resizing a diameter of at least a portion of the shunt to modify an amount of blood flow therethrough.

20. The method of claim 18, wherein dilating the venous puncture site and the arterial puncture site includes cutting a portion of tissue around the venous puncture site and the arterial puncture site, a size of the portion of tissue corresponding to the diameter of the shunt.

21. A method of treating an endoleak, comprising: selecting a shunt based on a lateral thickness of a thrombus formed in an aortic aneurysm determined by imaging of the aortic aneurysm, the shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, a lateral length of the arterial sealing structure being greater than or equal to the lateral thickness of the thrombus; advancing, via a robotic insertion system, the shunt in a delivery configuration through a venous puncture site of a vein to access an arterial puncture site of the artery; and transitioning, via a robotic insertion system, the shunt from the delivery configuration to a deployed configuration to secure the shunt to the artery and the vein, thereby enabling blood flow through the central portion of the shunt from the artery to the vein, wherein an imaging modality of a robotic insertion system is configured to image the aortic aneurysm.

22. The method of claim 21, wherein the arterial sealing structure and the venous sealing structure have a first cross-sectional area when the shunt is in the deliveryconfiguration, and a second cross-sectional area greater than the first cross-sectional area when the shunt is in the deployed configuration.

23. The method of claim 22, wherein the central portion has a first cross-sectional area when the shunt is in the delivery configuration, and a second cross-sectional area greater than the first cross-sectional area when the shunt is in the deployed configuration.

24. The method of claim 21, wherein with the shunt in the deployed configuration, the arterial sealing structure extends laterally beyond the thrombus such that the thrombus is disposed between a distal end of the arterial sealing structure and an inner wall surface of the artery proximal to the distal end of the arterial sealing structure.

25. The method of claim 21, wherein arterial sealing structure defines gaps sized (1) below a threshold to prevent fragmentation of the thrombus when the arterial sealing structure contacts the thrombus as the shunt is transitioned to its deployed configuration and (2) to permit sufficient flow therethrough.

26. The method of claim 21, wherein at least one of the arterial sealing structure or the venous sealing structure is configured to pivot relative to the central portion.

27. The method of claim 21, wherein a length of the shunt is configured to increase as a length of an extravascular space between the vein and the artery increases.

28. An apparatus, comprising: a shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure, wherein the shunt is configured to be inserted via a robotic insertion system.

29. The apparatus of claim 28, wherein the venous sealing structure is disc-shaped or saddle- shaped in its deployed configuration, and the arterial sealing structure is bulb-shaped in its deployed configuration.

30. The apparatus of claim 28, further comprising a cover coupled to at least the central portion, the cover configured to reduce a fluid porosity of at least the central portion.

31. The apparatus of claim 28, wherein at least a portion of the shunt is formed of bioabsorbable material.

32. The apparatus of claim 28, further comprising a one-way valve disposed within the central portion and configured to allow blood flow from the arterial sealing structure towards the venous sealing structure and prevent, limit, and / or restrict blood flow from the venous sealing structure to the arterial sealing structure.

33. The apparatus of claim 28, further comprising a filter disposed within the central portion, the filter configured to capture clots or embolic debris from the aorta while allowing blood to flow therethrough.

34. The apparatus of claim 28, wherein a fluid porosity of the central portion is less than a fluid porosity of at least one of the arterial sealing structure or the venous sealing structure.

35. A cutting apparatus, comprising: a proximal member and a distal member movably coupled to the proximal member to allow for relative axial movement between a first configuration in which the proximal member and the distal member are spaced a distance sufficient to span across a venous wall of a vein and an arterial wall of an artery, and a second configuration in which the proximal member and the distal member are spaced less than a thickness of at least one of the venous wall or the arterial wall, one of the proximal member or the distal member having a cutting edge configured to cut through the venous wall and the arterial wall, wherein the cutting apparatus is configured to be controlled by a robotic insertion system.

36. The cutting apparatus of claim 35, wherein the distal member includes the cutting edge and the proximal member includes a distal end having a blunt surface, the cutting edge and the blunt surface having matching profiles.

37. The cutting apparatus of claim 35, wherein in the first configuration the distance is sufficient to span across the venous wall, the arterial wall, and a thrombus disposed within the artery and abutting the arterial wall.

38. The cutting apparatus of claim 35, wherein a cross-sectional shape of the cutting edge is a circle or an oval.

39. The cutting apparatus of claim 38, wherein the cutting edge is configured to cut an opening in vessel tissue to have a diameter at least as large as a diameter of a shunt configured to be disposed through the opening.

40. The cutting apparatus of claim 36, further comprising: a shaft coupled to the proximal member and the distal member and configured to move the distal member in a proximal direction to transition the cutting apparatus from the first configuration to the second configuration.

41. An apparatus, comprising: a shunt defining a central portion and having an arterial sealing structure at a first end of the central portion and a venous sealing structure at a second, opposite end of the central portion, the arterial sealing structure and the venous sealing structure both being expandable from a delivery configuration to a deployed configuration by a robotic insertion system, the arterial sealing structure having a fluid porosity that is greater than a fluid porosity of the central portion.

42. The apparatus of claim 41, wherein the venous sealing structure is disc-shaped or saddle- shaped in its deployed configuration, and the arterial sealing structure is bulb-shaped in its deployed configuration.

43. The apparatus of claim 41, further comprising a cover coupled to the central portion to provide structural radial support, the arterial sealing structure and the venous sealing structing being more flexible than the central portion with the cover coupled thereto.

44. The apparatus of claim 43, wherein the cover includes a biocompatible polymer to fill in irregularities of a wall of at least one of the vein or the artery.

45. The apparatus of claim 41, wherein the shunt includes polylactic acid (PL A) or polyglycolic acid (PGA) to support tissue ingrowth.

46. The apparatus of claim 41, wherein at least a portion of the shunt is formed of bioabsorbable material.

47. The apparatus of claim 41, further comprising a one-way valve disposed within the central portion and configured to allow blood flow from the arterial sealing structure towards the venous sealing structure and prevent, limit, and / or restrict blood flow from the venous sealing structure to the arterial sealing structure.

48. The apparatus of claim 41, further comprising a filter disposed within the central portion, the filter configured to capture clots or embolic debris from the aorta while allowing blood to flow therethrough.

49. The apparatus of claim 41, further comprising: at least one inflatable device coupled to the shunt and configured to control a diameter along a length of the shunt when the shunt is in the deployed configuration.

50. The apparatus of claim 49, wherein a first inflatable device is coupled to the venous sealing structure and a second inflatable device is coupled to the arterial sealing structure, the first inflatable device configured to control a diameter of the venous sealing structure and the second inflatable device configured to control a diameter of the arterial sealing structure when the shunt is in the deployed configuration.

51. The apparatus of claim 41, wherein the shunt defines a plurality of openings, a cross- sectional area of each opening of the plurality of openings corresponding to the fluid porosity of the shunt at a location of the opening.

52. The apparatus of claim 51, wherein the cross-sectional area of the plurality of openings is configured to promote growth of tissue across a surface of the shunt.

53. A method for performing a transcaval access procedure using a robotically steerable catheter, comprising: inserting a steerable catheter into the inferior vena cava using a robotically controlled system, wherein the steerable catheter is advanced along the inferior vena cava until the distal end is adjacent a target transcaval puncture location; manipulating the catheter using the robotically controlled system; imaging at least a portion of the inferior vena cava and the aorta using an imaging device to obtain an image; locating an anatomical landmark using the image of at least a portion of the inferior vena cava and the aorta, and storing a position and orientation of the robotically steerable catheter to arrive at the anatomical landmark; and advancing a transcaval puncture device through the steerable catheter via a central lumen to puncture through the inferior vena cava and the aorta.

54. The method of claim 53, wherein advancing the steerable sheath along the inferior vena cava and advancing the transcaval puncture device comprises inputting user commandsinto an operator control station and transmitting corresponding signals to at least one drive unit coupled to the steerable sheath and transcaval puncture device.

55. A robotic system configured for transcaval access, comprising: a medical instrument having an elongate body and at least one sensor; a display; a processor; and a memory storing computer-executable instructions to cause the processor to: access a three-dimensional model of at least a portion of the vena cava and at least a portion of the aorta, the model based on a preoperative mapping of at least a portion of the vena cava and at least a portion of the aorta, determine a position of a target transcaval puncture location with respect to the model, determine, based on data from the at least one sensor, a position and orientation of a distal end of the medical instrument with respect to the model, cause, on at least a portion of the display, a rendering of the model, the position of the target transcaval puncture location with respect to the model, and the position and orientation of the distal end of the medical instrument with respect to the model, wherein the rendering comprises a virtual viewpoint directed at the target transcaval puncture location, the rendering being simulated from a virtual viewpoint perspective at a virtual location with respect to the model, and cause within the portion of the display a rendering of a modified view of the model, the modified view being rendered from a modified virtual viewpoint in which the virtual viewpoint perspective is rotated around the target transcaval puncture location with the target transcaval puncture location as a center of the rotation.

56. The system of claim 55, wherein the memory further stores computer-executable instructions to cause the processor to: cause, based on the position and orientation of the distal end of the medical instrument, a rendering of a graphical indicator extending from the distal end of the medical instrument in an insertion direction of the medical instrument,determine, based on the data from the at least one sensor, a change in at least one of the position and orientation of the distal end of the medical instrument, determine, in response to determining the change in at least one of the position and orientation of the distal end of the medical instrument, that the graphical indicator intersects the target transcaval puncture location, and cause a rendering of a change to the graphical indicator in response to determining that the line intersects the target transcaval puncture location.

57. The system of claim 55, wherein the memory further stores computer-executable instructions to cause the processor to: determine, based on the data from the at least one sensor, that the distal end of the medical instrument is within a threshold distance from the target transcaval puncture location; and cause a rendering of a graphical indicator in response to determining that the distal end of the medical instrument is within a threshold distance from the target transcaval puncture location, the graphical indicator extending from the distal end of the medical instrument in an insertion direction of the medical instrument.

58. A non-transitory computer readable storage medium having stored thereon instructions that, when executed, cause at least one computing device to: access a three-dimensional model of at least a portion of the vena cava and at least a portion of the aorta, the model based on a preoperative mapping of at least a portion of the vena cava and at least a portion of the aorta, determine a position of a target transcaval puncture location with respect to the model; determine, based on data from at least one sensor of a medical instrument, a position and orientation of a distal end of the medical instrument with respect to the model; cause, on at least a portion of a display, a rendering of the model, a position of the target transcaval puncture location with respect to the model, and the position and orientation of the distal end of the medical instrument with respect to the model, wherein the rendering comprises a virtual viewpoint directed at the target transcavalpuncture location, the rendering being simulated from a virtual viewpoint perspective at a virtual location with respect to the model.

59. The non-transitory computer readable storage medium of claim 58, further having stored thereon instructions that, when executed, cause at least one computing device to: cause, based on the position and orientation of the distal end of the medical instrument, a rendering of a graphical indicator extending from the distal end of the medical instrument in an insertion direction of the medical instrument; determine, based on the data from the at least one sensor, a change in at least one of the position and orientation of the distal end of the medical instrument; determine, in response to determining the change in at least one of the position and orientation of the distal end of the medical instrument, that the graphical indicator intersects the target transcaval puncture location; and cause a rendering of a change to the graphical indicator in response to determining that the line intersects the target transcaval puncture location.

60. The non-transitory computer readable storage medium of claim 58, further having stored thereon instructions that, when executed, cause at least one computing device to: determine, based on the data from the at least one sensor, that the distal end of the medical instrument is within a threshold distance from the target transcaval puncture location; and cause a rendering of a graphical indicator in response to determining that the distal end of the medical instrument is within a threshold distance from the target transcaval puncture location, the graphical indicator extending from the distal end of the medical instrument in an insertion direction of the medical instrument.

61. A method of providing transcaval access to the aorta using a robotic system, comprising: inserting a steerable catheter into the inferior vena cava using a robotically controlled system; routing the steerable catheter to a target transcaval puncture location via the inferior vena cava; positioning a distal portion of the steerable catheter against tissue adjacent the target transcaval puncture location; androuting a piercing instrument through a central lumen of the steerable catheter to puncture through the inferior vena cava and the aorta to access the endovascular space of the aorta.

62. The method of claim 61, further comprising routing a guidewire through the piercing instrument.

63. The method of claim 62, further comprising: routing a dilator over the guidewire to expand the transcaval puncture site; and advancing at least a portion of the steerable catheter into the aorta.

64. A method for deploying a transcaval stent, the method comprising: introducing robotically controlled steerable catheter into the inferior vena cava; articulating the distal end of the steerable catheter towards a target transcaval puncture location; advancing a guidewire through the target transcaval puncture location into the sac of an aortic aneurysm, wherein the guidewire is advanced via a central lumen of the steerable catheter; advancing a stent delivery catheter over the guidewire, wherein the stent delivery catheter comprises a transcaval stent disposed within an outer sheath; positioning the stent delivery catheter proximal the target transcaval puncture location; deploying a first distal end of the transcaval stent within the sac of the aortic aneurysm, wherein the distal end of the transcaval stent is expanded from a small profile, undeployed configuration to a large profile, deployed configuration by sliding the outer sheath from a first position to a second position; and deploying a second proximal end of the transcaval stent within the inferior vena cava, wherein the transcaval stent is expanded from a small profile, undeployed configuration to a large profile, deployed configuration by sliding an outer sheath from the second position to a third position.

65. A method of performing a medical procedure on a patient, comprising: introducing a first medical instrument into the venous system of a patient, the first medical instrument configured for robotic endovascular navigation andcomprising an elongate, flexible body with at least one central lumen extending therethrough; introducing a second medical instrument via a central lumen of the first medical instrument, a distal end of the second medical instrument comprising a piercing element configured to pierce at least one anatomical vessel; positioning the piercing element proximal to a target transcaval puncture site; advancing the piercing element through the target transcaval puncture site into the sac of an aortic aneurysm; introducing a third medical instrument via a central lumen of the first medical instrument, the third medical instrument comprising at least one expandable element configured for creating a fluid conduit between the sac of an aortic aneurysm and the inferior vena cava; and expanding the third medical instrument to create a fluid conduit between the sac of the aortic aneurysm and the inferior vena cava.

66. The method of claim 65, further comprising conveying control signals from a remote controller to a drive unit; and operating the drive unit in accordance with the control signals to actuate the piercing element to pierce a wall of the anatomical vessel.

67. The method of claim 66, wherein the control signals are conveyed from the remote controller to the drive unit in response to user commands.

68. The method of claim 67, wherein the user commands are movements made at a user interface that correspond to movements of at least one medical instrument.

69. The method of claim 66, wherein at least one medical instrument is introduced into the patient by operating the drive unit in accordance with the control signals.

70. The method of claim 65, further comprising conveying control signals from a remote controller to a drive unit; and operating the drive unit in accordance with the control signals to advance at least one medical instrument within the anatomical vessel.

71. A method for performing transcaval embolization, the method performed by a robotic medical system and comprising: acquiring an anatomical image to identify at least one target embolization location and at least one target transcaval puncture location;introducing a first instrument into a blood vessel, the first medical instrument configured for robotic endovascular navigation and comprising an elongate, flexible body with at least one central lumen extending therethrough; introducing a second instrument via a central lumen of the first medical instrument, the second instrument comprising: an elongate, flexible body with at least one central lumen extending therethrough; and a piercing element configured to pierce at least one anatomical vessel, the piercing element disposed at a distal end of the second instrument; acquiring localization information for at least one instrument from at least one tracking sensor integrated in the instrument; registering at least one instrument to the anatomical image; overlaying a representation of at least a portion of at least one instrument on the anatomical image for display to a user; receiving a user command to drive the first instrument, the user command received from the user via a user input device; identifying, based on the localization information of at least one instrument and at least one identified target, a suitable position and suitable orientation of a distal end of the first instrument; overlaying a representation of a virtual trajectory extending from the first instrument on the display, the trajectory being defined by the position and orientation of the distal end of the first instrument; advancing the piercing element of the second instrument such that the piercing element substantially follows over the virtual trajectory defined by the position and orientation of the first instrument; and delivering a flowable material via a central lumen of at least one instrument.

72. A stent delivery apparatus, comprising: an outer sheath, comprising an elongated tubular member having distal and proximal ends; an inner shaft located coaxially within said outer sheath, said inner shaft having a distal end and a proximal end;a stop releasably affixed on an exterior surface of the inner shaft adjacent its proximal end, said stop being configured to allow said outer sheath to move a predetermined distance, thereby enabling at least partial deployment of a selfexpanding stent; and a self-expanding stent configured for creating a fluid conduit between an aortic aneurysm and a venous vessel, said stent located within said outer sheath, wherein said stent comprises: a central portion; an arterial sealing structure at a first end of the central portion; and a venous sealing structure at a second, opposite end of the central portion; wherein the arterial sealing structure and the venous sealing structure are both expandable from a delivery configuration to a deployed configuration, the venous sealing structure having a lateral length in its deployed configuration, and the arterial sealing structure having a lateral length in its deployed configuration that is greater than the lateral length of the venous sealing structure.

73. The apparatus of Claim 72, wherein the stent delivery apparatus is configured and adapted for use with a robotic insertion system for robotic delivery of the stent.

74. A method of robotically implanting a shunt to treat a medical condition, comprising: introducing, via a robotic insertion system, a first medical instrument into a patient, the first medical instrument configured for robotic navigation and comprising an elongate, flexible body with at least one central lumen extending therethrough; introducing, via the robotic insertion system, a second medical instrument via a central lumen of the first medical instrument, a distal end of the second medical instrument comprising a piercing element; positioning, via the robotic insertion system, the piercing element proximal to a target puncture site; advancing, via the robotic insertion system, the piercing element through the target puncture site;introducing, via the robotic insertion system, a shunt via a central lumen of the first medical instrument; and transition the shunt from a delivery configuration to a deployed configuration to implant the shunt to treat the medical condition, wherein the shunt includes a first end, a second end, and a central portion therebetween, the shunt configured to transition between the delivery configuration in which the shunt is cylindrical and the deployed configuration in which the second end of the shunt has rolled to form a ring-like structure and to decrease a total length of the shunt.

75. The method of claim 74, further comprising conveying control signals from a remote controller to a drive unit; and operating the drive unit in accordance with the control signals to actuate the piercing element.

76. The method of claim 75, wherein the control signals are conveyed from the remote controller to the drive unit in response to user commands.

77. The method of claim 76, wherein the user commands are movements made at a user interface that correspond to movements of at least one medical instrument.

78. The method of claim 75, wherein at least one medical instrument is introduced into the patient by operating the drive unit in accordance with the control signals.

79. The method of claim 74, further comprising conveying control signals from a remote controller to a drive unit; and operating the drive unit in accordance with the control signals to advance at least one medical instrument80. The method of claim 74, wherein the first end of the shunt forms the ring-like structure when the first end rolls toward the central portion, the ring-like structure is configured to anchor the shunt relative to a vessel.

81. The method of claim 80, wherein the second end expands radially to form a disc shape when the shunt transitions from the delivery configuration to the deployed configuration.

82. The method of claim 74, wherein when the shunt is at least partially disposed in an anatomical structure, the shunt is configured to dynamically adjust the total length of the shunt by further rolling or unrolling the ring-like structure based on changes in the anatomical structure or pressure conditions in an environment around the shunt.

83. The method of claim 74, further comprising: a delivery catheter configured to constrain the shunt in the delivery configuration and to release the shunt to allow the shunt to transition to the deployed configuration.

84. The method of claim 74, wherein the shunt includes at least one radiopaque marker.

85. The method of claim 74, wherein the shunt is configured to, upon transition from the delivery configuration to the deployed configuration, invert at least a portion the first end outwardly so that at least a portion of the first end is directed towards the second end.

86. The method of claim 74, wherein the first end of the shunt is configured to invert towards the second end upon transition from the delivery configuration to the deployed configuration, such that an inner surface of the first end faces outwardly to create an anchoring structure.

87. The method of claim 74, wherein the first end of the shunt is configured to invert outwardly towards the central portion upon transition from the delivery configuration to the deployed configuration, resulting in an outwardly facing inner surface.

88. The method of claim 74, wherein at least a portion of the shunt is formed of bioabsorbable material.

89. The method of claim 74, further comprising a cover coupled to the central portion to provide structural radial support, the cover including polylactic acid (PLA) or polyglycolic acid (PGA) to support tissue ingrowth.

90. The method of claim 74, wherein the first end of the shunt is configured to be disposed in a first vessel, the second end of the shunt is configured to be disposed in a second vessel, and the central portion is configured to span a space between the first vessel and the second vessel and to convey fluid therebetween.

91. The method of claim 90, wherein the first end of the shunt is configured to unroll to transition the shunt from the deployed configuration back to the delivery configuration such that the shunt can be removed from the first vessel and the second vessel.

92. The method of claim 74, wherein the ring-like structure is a toroidal structure.

93. The method of claim 74, wherein the medical condition comprises heart failure.

94. The method of claim 74, wherein the medical condition comprises chronic kidney disease.

95. The method of claim 74, wherein the medical condition comprises peripheral vascular disease.

96. The method of claim 74, wherein the medical condition comprises a congenital heart defect.

97. The method of claim 74, wherein the medical condition comprises portal hypertension.

98. The method of claim 74, wherein the medical condition comprises a traumatic injury.

99. The method of claim 74, wherein the medical condition comprises pulmonary hypertension.

100. The method of claim 74, wherein the medical condition comprises cancer.

101. The method of claim 74, wherein the medical condition comprises chronic venous insufficiency.

102. The method of claim 74, wherein the medical condition comprises an abdominal aortic aneurysm.

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