Systems and methods for introducing stent-grafts through vessels located above the diaphragm - Patents.com

Abstract

Systems and methods are provided for repairing aneurysms (e.g., abdominal aortic aneurysms). The systems and methods provide a stent-graft system having a first stent and a primary graft body, the primary graft body configured to be inserted into a target vessel through a blood vessel located above the diaphragm of a patient. In some embodiments, the first stent and primary graft body can be in a substantially end-to-end configuration. In some cases, the stent-graft systems and methods are configured for use in a single arterial puncture or dissection, for example, in a blood vessel having a diameter smaller than or equivalent to that of a femoral artery from the same patient or subject.

Description

[Technical Field]

[0001] All documents cited herein, including but not limited to patents and patent applications, are incorporated by reference in their entirety. [Background technology]

[0002] An aneurysm is an abnormal enlargement or dilation of a blood vessel. Aortic aneurysms can lead to embolism in branch vessels, aortic thrombosis, and aortic rupture. Damaged blood vessels are treated or repaired by surgery or placement of a vascular endograft.

[0003] The aorta is the largest artery in the body, originating from the left ventricle of the heart and extending into the abdomen. It branches into two iliac arteries. Aortic aneurysms (AA) can occur anywhere in the aorta and its branches. (Sabiston Textbook of Townsend, et al., Surgery: The Biological Basis of Modern Surgical Practice, 20th Edition, pp. 1722-1753 (2017))

[0004] AAs are typically repaired through open surgery or endovascular aneurysm repair (EVAR), which is touted as a minimally invasive procedure that utilizes a stent-graft device to repair AAs. A stent-graft device is a combination device that includes a stent portion and a graft portion that are connected to each other so that they can be deployed together to repair the vascular injury.

[0005] A stent is typically an expandable metal lattice device that is inserted into a blood vessel and expanded to open a constricted, damaged, or blocked vessel. In addition to opening the vessel, a stent can provide rigid structural support to prevent the vessel from reopening. Stents are often used in conjunction with balloon angioplasty.

[0006] Artificial grafts are medical devices that can be used to replace or repair diseased blood vessels. They are made of synthetic materials (e.g., ePTFE, polyester) and can be expanded to approximate the diameter of the blood vessel needing repair. The graft material provides a blood seal so that it can support normal blood flow without leaking.

[0007] Stent-graft devices can provide a combination of a substantial blood seal from the graft and the support structure of the stent to prevent dislodgement of the stent-graft device under the pressure of normal blood flow. A stent and prosthetic graft combination can be used to hydraulically isolate an aneurysm when placed across the neck of the aneurysm. However, coupling and deployment of the components of a stent-graft device can prove challenging because the delivery system profile (i.e., the outer diameter of the delivery sheath) of a stent-graft device is quite large, which can make it more difficult to insert, navigate through, and deploy the device in the target anatomy. To address these challenges, several thin stent-graft devices have been developed by the present inventors, such as those described in U.S. Pat. Nos. 10,105,209, 9,050,182, 8,257,423, 7,105,017, 7,175,651, 6,981,982, 6,015,422, 6,102,918, and 6,168,620.

[0008] AA is often asymptomatic and occurs frequently in people older than 65 years. Untreated, AA has a high mortality rate; therefore, early detection and repair are important. EVAR is preferable to open surgery as a less invasive option for patients with aortic aneurysms who are appropriate candidates. Although EVAR is safer, faster, and less invasive than open surgery, it is more difficult, takes longer, and may result in higher postoperative morbidity.

[0009] An EVAR procedure for an infrarenal aortic aneurysm typically requires one puncture or incision in each femoral artery, followed by maneuvering a constrained stent-graft device in a superior cranial direction (femoral approach) and moving it into position below the renal arteries over a guidewire constrained within an introducer sheath. A portion of the stent-graft device is deployed below the renal arteries. The stent-graft device is then positioned and deployed in one iliac artery. Another stent-graft device is then positioned and deployed in the second iliac artery through the other femoral artery puncture or incision. Such a procedure relies on the insertion and deployment of the stent-graft device from below the subject's or patient's diaphragm.

[0010] In summary, a standard EVAR procedure requires bilateral femoral punctures (i.e., one puncture or incision in each femoral artery) for arterial access, in addition to delicate positioning maneuvers for the stent-graft device from a femoral approach (below the diaphragm). While EVAR is superior to open surgery, as noted above, it requires patient recovery from the bilateral femoral punctures used for access. Patients often require several days of bed rest and pain medication, which incur additional costs (e.g., hospitalization, medication, and lost work time).

[0011] The delivery system profiles of currently available stent-graft devices limit the vessels that can be targeted for introduction of these devices: Such devices have wide diameters due in part to how the components of the stent-graft device are positioned and / or connected to each other in the catheter-based systems used for their delivery.

[0012] What is needed are improved, thinner stent-graft systems and methods for repairing aneurysms that are thinner than currently available stent-graft devices and therefore easier to deploy in smaller diameter vessels, with less post-procedural morbidity and patient discomfort. Summary of the Invention [Means for solving the problem]

[0013] The stent-graft systems and methods described herein, in some embodiments, provide a thin stent-graft device that is configured to be introduced / inserted into a blood vessel located above a patient's diaphragm and deployed in a "top-down" approach. Exemplary systems and methods are also provided for adjusting the placement of the stent-graft device within a target vessel (e.g., infrarenal, pararenal, perirenal, thoracic aorta, or suprarenal) after initial deployment. Further embodiments provide for adjusting the deployed location of the stent-graft device within the target vessel by adjusting the position of the stent-graft device. centering For use in centering Describe the device.

[0014] One embodiment described herein is directed to a first stent-graft system for repair of an aneurysm in a target vessel having a first stent and a main graft body, the stent-graft system being configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm.

[0015] Another aspect provides a first method of repairing an abdominal aortic aneurysm in a patient by puncturing an entry site vessel located above the patient's diaphragm and forming a passage in the entry site vessel. A stent-graft system can be inserted into the passage in the entry site vessel. The stent-graft system can include a main graft body bifurcating into a first limb gate and a second limb gate. The main graft body of the stent-graft system can be positioned and deployed, for example, within the patient's target vessel.

[0016] A further aspect provides a second stent-graft system (e.g., an endograft deployment system) for deploying an endograft in a target vessel of a patient or subject. In some embodiments of the second stent-graft system, the endograft can be deployed from below the diaphragm of the patient or subject. The endograft deployment system can have an outer tube including a central inner member containing the endograft and a carrier tube containing a tether wire. The tether wire can have a caudal end and a more cranial end (i.e., an end closest to the top of the head or body). The endograft deployment system can have a top stent surrounding the central inner member, the top stent including a plurality of hooks with a plurality of receptacles and a plurality of sutures.

[0017] In some embodiments of the second stent-graft system, a first end of at least a first suture can be placed through one of a plurality of receptacles to hold the top stent in a constrained configuration. A second end of the first suture can be attached to a more cranial portion of a tether wire. Movement of the tether wire can control removal of the plurality of sutures from the plurality of receptacles, releasing the top stent from the constrained configuration to an unconstrained configuration and removing the plurality of sutures from the patient's or subject's vessel.

[0018] One aspect described herein provides a second method of deploying the stent-graft in a patient or subject with a stent-graft deployment system including an outer tube including a central inner member containing the endograft and a carrier tube including a tether wire, puncturing a first femoral artery and a second femoral artery, forming a passage in each of the femoral arteries, and inserting a stent-graft into the passage in either the first femoral artery or the second femoral artery. In some embodiments of the second method, the endograft can be deployed from above or below the diaphragm of the patient or subject.

[0019] In some embodiments of the second method, the tether wire has a caudal end and a more cranial portion. The top stent can surround the central inner member, the top stent including a plurality of hooks having a plurality of receptacles. Some embodiments of the second method can further include a plurality of sutures, a first end of at least a first suture being disposed through one of the plurality of receptacles to hold the top stent in a constrained configuration, and a second end of the first suture being affixed to the more cranial portion of the tether wire.

[0020] The tether wire can be moved to remove the sutures from the receptacles, release the top stent from a constrained configuration to an unconstrained configuration, and remove the sutures from the patient's or subject's vessel. In some embodiments, the tether wire can be removed and the sutures can be left in the patient.

[0021] Embodiments described herein provide a third stent-graft system for repair of an aneurysm in a target vessel, the stent-graft system including a primary graft body including a sealing stent at least partially disposed within the primary graft body, the stent-graft system may be configured to be inserted through a single arterial puncture or incision in an entry site vessel located above the patient's diaphragm. The primary graft body is configured to be inserted through a single arterial puncture or incision in an entry site vessel located above the patient's diaphragm.

[0022] Further aspects described herein provide a third method of positioning a main graft body of a stent-graft system within a target vessel of interest (e.g., infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal) by advancing a main graft body delivery system to a target location within the target vessel. The main graft body delivery system may include a main graft body and a centering device. The main graft body may be positioned within the target vessel at a first position at the target location, and it may be determined whether the first position of the main graft body is centered within the target vessel at the target location. In some examples, the third method is directed to inserting the main graft body through a single arterial puncture or incision in an entry vessel located above the patient's diaphragm.

[0023] The centering device can be deployed within the target vessel at a centering position if the first position of the main graft body is not centered within the target vessel at the target location. The main graft body can be repositioned within the target vessel at a second position determined from the center position if the first position of the main graft body is not centered within the target vessel at the target location.

[0024]

[0006] Aspects described herein provide a fourth stent-graft system for repairing an aneurysm in a target vessel, the system including a top stent having multiple positioning receptacles and a main graft body, the top stent and main graft body being in a substantially end-to-end configuration. The top stent and main graft body may be disposed around an inner member. The stent-graft system includes a snare tube including a snare loop. A first end of the snare loop may be disposed within the snare tube. A second end of the snare loop may be disposed from the snare tube, through the positioning receptacles, around the inner member, and within the snare tube. The snare tube may be parallel to the inner member, and the first end of the snare loop may be adjacent to the second end of the snare loop. The stent-graft system may be configured to be inserted through a single arterial puncture or incision in a blood vessel at an insertion site located above the patient's diaphragm.

[0025] A further aspect provides a fifth stent-graft system for repairing an aneurysm in a target vessel, comprising a top stent having a plurality of positioning receptacles and a main graft body, wherein the top stent and main graft body are in a substantially end-connected configuration, and the top stent and main graft body are disposed about an inner member. The stent-graft system may include a snare loop disposed through the positioning receptacles at a rotational angle greater than 360 degrees around the top stent. A first end of the snare loop may be disposed substantially symmetrically relative to the inner member. The stent-graft system may be configured to be inserted through a single arterial puncture or incision in an entry site vessel located above the patient's diaphragm. In another aspect, the main graft body is configured to be inserted through a single arterial puncture or incision in an entry site vessel located above the patient's diaphragm. [Brief explanation of the drawings]

[0026] [Figure 1] 1 is an exemplary drawing of the descending thoracic aorta, the abdominal aorta above the renal arteries, the renal arteries, the infrarenal arteries, and the ipsilateral and contralateral iliac arteries. [Figure 2A] 1 is a front view of an exemplary stent-graft device according to embodiments described herein; FIG. 2 shows a flattened side view. [Figure 2B] 1 shows a flattened side view of an exemplary stent-graft device according to aspects described herein. [Figure 3A] 1 shows an exemplary top stent portion of an exemplary stent-graft device, including a connector and a receptacle. [Figure 3B] 10 shows an enlarged view of an exemplary connector and receptacle portion connecting a top stent to a connecting ring in an exemplary stent-graft device. [Figure 3C] 1 illustrates alternative configurations of exemplary connectors and receptacles. [Figure 3D] 1 illustrates alternative configurations of exemplary connectors and receptacles. [Figure 4] 10 illustrates alternative configurations of the arms of an exemplary connecting ring. [Figure 5] 1 illustrates an exemplary configuration of an iliac leg component. [Figure 6A] 1 illustrates femoral positioning and deployment of a stent-graft device in a typical EVAR procedure. [Figure 6B] 1 illustrates femoral positioning and deployment of a stent-graft device in a typical EVAR procedure. [Figure 7A] 1 illustrates an exemplary deployment of a stent-graft device according to embodiments described herein, where the device is inserted / introduced from an access point above the diaphragm (eg, the axillary or brachial artery). [Figure 7B] 1 illustrates an exemplary deployment of a stent-graft device according to embodiments described herein, where the device is inserted / introduced from an access point above the diaphragm (eg, the axillary or brachial artery). [Figure 7C] 1 illustrates an exemplary deployment of a stent-graft device according to embodiments described herein, where the device is inserted / introduced from an access point above the diaphragm (eg, the axillary or brachial artery). [Figure 7D] 1 illustrates an exemplary deployment of a stent-graft device according to embodiments described herein, where the device is inserted / introduced from an access point above the diaphragm (eg, the axillary or brachial artery). [Figure 8A] 10 illustrates an exemplary fine positioning of the body of a stent-graft device according to embodiments described herein. [Figure 8B] 8B shows an enlarged view of the embodiment of FIG. 8A. [Figure 9] 10 illustrates an alternative stent-graft deployment system that ensures the removal of sutures used to guide the introduction and positioning of an exemplary stent-graft. [Figure 10] FIG. 10 shows a top view of an optional shelf for use with the alternative stent-graft deployment system shown in FIG. 9. [Figure 11]1 shows an exemplary stent-graft device having snare loops within a snare tube asymmetrically positioned around an inner member to adjust the axial position of the stent-graft system within a vessel. [Figure 12A] 12 shows an exemplary stent-graft device in FIG. 11, with an optional centering device shown. [Figure 12B] 12B shows an alternative embodiment of the device of FIG. 12A. [Figure 13] 1 shows an exemplary stent-graft device having a snare loop placed through an eyelet on a top stent with 540 degrees of rotation and snare loop ends symmetrically positioned around the inner member. [Figure 14] 12B shows a cross-sectional view of the exemplary device of FIGS. 11 and 12A. FIG. [Figure 15] 14 shows a cross-sectional view of the exemplary device of FIG. 13. DETAILED DESCRIPTION OF THE INVENTION

[0027] Stent-graft systems and methods are provided herein for improving the introduction, positioning, and deployment of stent-graft devices for the repair of aneurysms. It is understood that stent-graft devices according to aspects described herein may be used to repair aneurysms in any suitable blood vessel where vascular access is through an artery located below the diaphragm.

[0028] Modern stent-graft systems, with an outer diameter of 14–24F (French), are used in EVAR procedures via insertion of the stent-graft system below the diaphragm. A typical EVAR procedure today involves two punctures or incisions, one in each femoral artery. Cannulation of each puncture, followed by placement and deployment of a guidewire through each puncture, adds time and increases the potential risk of variability and error. Furthermore, closure of the punctures in both femoral arteries can be painful, increasing the morbidity associated with EVAR procedures and thereby prolonging patient recovery.

[0029] Thus, according to embodiments described herein, a stent-graft device (or component thereof) is configured to be inserted through a single puncture or incision above the diaphragm of a patient or subject (e.g., in a smaller caliber artery). As described herein, these exemplary stent-graft devices have smaller diameters (e.g., outer diameter profiles ranging from about 6 to about 13 French or about 13 to about 22 French) and can be positioned below the renal arteries in a "top-down" orientation for easier and faster positioning and deployment, for example, in the below-renal arteries and left and right iliac arteries. The term "top-down," as described herein, refers to introducing or inserting the stent-graft device into an insertion vessel located above the patient's diaphragm.

[0030] The "top-down" approach is expected to significantly reduce the access time and challenges posed by the typical bilateral femoral artery approach, because a bilateral approach requires device access and placement in both of the patient's legs, and the leg arteries of patients suffering from abdominal aneurysms (for example) are often highly angulated and diseased, significantly complicating the setup of an EVAR procedure for the interventionalist. In this embodiment, the procedure is quick, less prone to error, and provides for patient recovery from puncture or dissection of an artery located above the patient's diaphragm. The access location (above the diaphragm) overcomes many of the anatomical challenges of a typical EVAR procedure. The embodiments described herein offer less tortuosity and a lower risk of disease associated with cannulation and placement of the necessary access devices / instruments to enable the EVAR procedure. Using the embodiments described herein, patients will also experience less discomfort and a faster recovery, as "top-down" access can be achieved using the single puncture (above the diaphragm access) technique contemplated herein.

[0031] One aspect described herein provides a first stent-graft system for repair of an aneurysm in a target vessel of a patient, the first stent-graft system including a first stent and a main graft body. In some embodiments of the first stent-graft system, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an entry site vessel located above the diaphragm of a subject or patient. In one aspect, the entry site vessel has a diameter less than or equal to the diameter of the patient's femoral artery.

[0032] The term "insertion site vessel" refers to the vessel into which a stent-graft device is initially inserted during a procedure for repair of a vessel (eg, an EVAR procedure).

[0033] The term "target vessel" refers to a vessel that is the site of repair for a disease or condition (e.g., an aortic aneurysm). Target vessels can include, but are not limited to, the infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal.

[0034] The term "stent" refers to a mesh or lattice tube structure, e.g., laser cut from superelastic nitinol thin wires or tubes (or any other suitable material, e.g., titanium, or chromium-cobalt alloy), that can be inserted into a blood vessel in a constrained state and deployed in an unconstrained state.

[0035] The term "constrained" refers to a configuration of a stent-graft system or a component of a stent-graft system that has a minimum or smaller diameter compared to the fully expanded or "unconstrained" configuration of the stent-graft system. The constrained configuration of the stent-graft system may be of a diameter small enough to be introduced into an insertion site vessel located above the diaphragm and / or may have a diameter that is smaller than or equal to the diameter of the patient's femoral artery.

[0036] In some embodiments of the first stent-graft system, the target vessel is selected from the group consisting of infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal.

[0037] In some embodiments of the first stent-graft system, the first stent and main graft body are in a substantially end-to-end configuration. In some embodiments of the first stent-graft system, the insertion site vessel is located above the patient's diaphragm. In other embodiments of the first stent-graft device, the diameter of the stent-graft system in the constrained configuration can be about 13 French to about 22 French. In other embodiments, the diameter of the stent-graft system in the constrained configuration can be about 6 French to about 13 French.

[0038] In further embodiments of the first stent-graft device, the main graft body comprises a densified material. In some embodiments, the first stent is encapsulated within the densified material (e.g., at least one or two layers of polytetrafluoroethylene or ePTFE). In some examples, the ePTFE is substantially free of pores.

[0039] The term "densified material" refers to a material (e.g., ePTFE) that has been modified to increase its density compared to the same material without modification. For example, a densified material can have an increased density of at least 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 95 percent. As an example, ePTFE may be densified by the application of a mechanical compressive force.

[0040] The densified material has the same or greater tensile strength as the non-densified material and can be thinner than the non-densified material. As described herein, the densified material can be used to make a graft material that can be compressed to a diameter suitable for insertion into a vessel location above the diaphragm of a patient or subject or into a vessel of a diameter smaller than or equal to the diameter of the femoral artery from the same patient or subject.

[0041] In some embodiments, the entry site vessel (i.e., a vessel located above the patient's diaphragm, a small vessel) is selected from the group consisting of the brachial artery, radial artery, ulnar artery, axillary artery, and carotid artery. In some embodiments, the entry site vessel is the axillary artery. In one aspect, the diameter of the entry site vessel or small vessel is 2-8 mm. In another embodiment, the entry site vessel is the subclavian artery.

[0042] In an alternative embodiment, a guidewire may be introduced into an insertion site vessel located above the subject's or patient's diaphragm and introduced into a target vessel, such as below the renal arteries. Catheters and / or wires can be inserted into branch vessels (e.g., the superior mesenteric artery, celiac artery, renal arteries, and inferior mesenteric artery), and the fenestrated graft can be advanced over the catheters and / or wires with each wire exiting the palisade and entering one of the branches into the target vessel, such as the aorta.

[0043] Alternatively, the fenestrated graft can be introduced into an entry site vessel located above the diaphragm of a subject or patient to a target vessel, such as below the renal arteries, without wires passing through the fenestrations of the fenestrated graft. Branch vessels can optionally be catheterized.

[0044] Another alternative is to have wires protruding from each fenestration in the sheath when the device is loaded, but not catheterize the branch vessels until after the main device is deployed.

[0045] Some embodiments of the first stent-graft system include a connection ring including a plurality of connectors adapted to receive a plurality of receptacles. The connection ring can be disposed within the primary graft body. The plurality of connectors and the plurality of receptacles can be integral with the stent (e.g., spot welded in place).

[0046] A further embodiment of the first stent-graft system includes a plurality of sutures disposed about the plurality of connectors and the plurality of receptacles. The expansion angle of the coupling ring can be greater than about 90 degrees.

[0047] The term "connection ring" refers to a structure (e.g., a ring) that is adapted to connect to a first stent and that is disposed within the primary graft body. The connection ring may also be referred to as an annular ring. The connection ring connects the first stent to the primary graft body, provides a primary seal, and helps form a thin stent-graft device in which the first stent and primary graft body are in a substantially end-to-end configuration.

[0048] The term "connector" refers to a structure adapted to connect two components, for example. For example, a connector (e.g., a zigzag or other structure) disposed on a connecting ring can be adapted to fit into a hole on a receptacle disposed on a first stent, as shown, for example, in Figures 3A-3D.

[0049] It will be appreciated that any suitable connector-receptacle system may be employed to carry the majority of the axial load force between the first stent and the connection ring. For example, the connector may be shaped as a hook, semicircle, triangle, etc., and the receptacle may be a hole adapted to receive the hook, semicircle, triangle, etc. If desired, an optional suture may be provided to provide stability in place of or in addition to the exemplary connector-receptacle system.

[0050] The term "end-connected configuration" refers to connecting a stent-graft component to another component at its edge (e.g., side-by-side or end-to-end). An end-connected configuration can avoid overlapping (i.e., coaxial) components in the stent-graft introducer sheath. For example, a thick, strong top stent can be combined with an ePTFE graft or a densified ePTFE graft. In one aspect, the components are arranged in series rather than coaxially. A coaxial configuration of components requires a larger diameter introducer sheath, a larger hole in the vessel, and potentially a larger vessel for introducing the stent-graft. As described herein, this exemplary configuration results in a smaller diameter stent-graft device that can be used, for example, in arteries and / or small arteries located above the diaphragm. In this aspect, the first stent can be thicker and more robust because it is not oriented to overlap the main graft body.

[0051] The term "end-connected configuration" with respect to the stent-graft systems and devices described herein can also refer to a situation in which the wall thickness of a connecting ring disposed on the main graft body is less than the wall thickness at the connection between the first stent and the graft, or in some embodiments, a connecting ring when multiple connectors receive multiple receptacles.

[0052] In some embodiments of the first stent-graft system, the connections between the multiple connectors on the connection ring and the multiple receptacles on the first stent provide a stable configuration without increasing the overall diameter of the device. Furthermore, this configuration supports an expansion angle of the connection ring greater than about 90 degrees. For example, this configuration is very stable during crimping in the delivery sheath, allowing for stabilization of the connection ring (due to the end-connected attachment). If the connection ring were not stabilized by the top stent, it would be less stable during crimping, potentially causing damage and / or not achieving the expected or desired crimped diameter.

[0053] In another embodiment of the first stent-graft system, the main graft body bifurcates into two branches including a first limb gate and a second limb gate. In this aspect, the first limb gate and the second limb gate can be adapted for placement in the ipsilateral iliac artery 18, for example, as shown in FIG. 1. In another aspect, the main graft branch does not bifurcate and can be configured for placement in a vessel other than the aorta that does not extend to the thoracic aorta or iliac bifurcation or an intrarenal aneurysm, or for placement of an aorto-iliac tube endograft in the aorta and one iliac artery.

[0054] The first stent-graft system embodiment further includes at least a first iliac leg component. The stent-graft system can include at least a second iliac leg component. The iliac leg component can be adapted for constrained positioning, for example, through an insertion site vessel located above the diaphragm or a small artery, through the main graft body, and through either an unconstrained deployable first limb gate or a second limb gate into either the ipsilateral or contralateral iliac artery.

[0055] In some embodiments of the first stent-graft system, the overlap of the first iliac leg component with the first limb gate is no larger in diameter than the overlap of the second iliac component with the second limb gate.

[0056] Another embodiment of the first stent-graft system includes barbs disposed on one or more of the first and second iliac leg components to secure the one or more of the first and second iliac leg components to a blood vessel.

[0057] In some embodiments of the first stent-graft system, the first iliac component and the second iliac component comprise a densified material (eg, densified ePTFE).

[0058] Yet another embodiment of the first stent-graft system includes a second stent coupled to the caudal end (i.e., the end closest to the tail or bottom of the body) of the first limb gate and a third stent coupled to the caudal end of the second limb gate. This embodiment may further include tethers disposed at the caudal ends of each of the main graft body, the second stent, and the third stent for coupling to a caudal (i.e., toward the end or rear of the body) positioning system.

[0059] The term "caudal positioning system" can refer to a tool (e.g., a catheter, guidewire, trigger or tether wire, etc.) configured to engage the caudal end of a stent-graft system to allow an operator (i.e., physician) to control and adjust the position of the stent-graft system within a target vessel.

[0060] Yet another embodiment of the first stent-graft system further includes a plurality of sutures disposed about the plurality of connectors and the plurality of receptacles, it being understood that the sutures may be disposed in alternative or additional locations.

[0061] The first stent-graft system may further include barbs disposed on one or more of the first iliac leg component and the second iliac leg component for anchoring the one or more of the first iliac leg component and the second iliac leg component to a blood vessel.

[0062] The term "barb" refers to a sharp protrusion configured to attach, associate, or secure a stent-graft device or components of a stent-graft device to one another within a blood vessel. In this embodiment, the multiple barbs may function to prevent unintended movement of the stent-graft device from a desired location. The barbs can be integral to the design (i.e., not made separately and then attached) or spot welded into place. The multiple barbs can be configured to have alternating heights relative to one another. In another embodiment, each of the multiple barbs can be oriented in a different direction relative to one another.

[0063] In another embodiment of the first stent-graft system, the overlap of the first iliac leg component with the first limb gate and the overlap of the second iliac component with the second limb gate are not larger in diameter (e.g., not excessively large).

[0064] The optional tether can be used, for example, to allow manipulation by a positioning system (e.g., a guidewire, catheter, trigger wire) to steer the stent-graft device within the vessel and help more precisely position the stent-graft system at a desired location. In this embodiment, the tether can be removably attached to the positioning system to push or pull the stent-graft system through the vessel.

[0065] The term "tether" refers to a loop(s) or similar structure that can be removably attached to a portion of a positioning system and used to assist in the positioning and deployment of a stent-graft device, for example. Tethers can be made from any suitable suture material or thin metal wire and can be rigid or flexible.

[0066] In some embodiments of the first stent-graft device, the stent-graft system further includes an optional annular element disposed within the main graft body and a plurality of connecting members associated with a plurality of locations on the annular element. In this aspect, the first stent has a first axial stent end and a second axial stent end, and the main graft has a first axial graft end and a second axial graft end. The annular element can be made of any suitable material or can be integral to the graft. The annular element can be continuous or discontinuous and can be disposed around the circumference of the graft or a portion of the circumference of the graft.

[0067] The annular element can be positioned substantially adjacent to the first axial graft end. The plurality of connecting members can be configured to connect to the first axial stent end and maintain a substantially end-to-end axial connection between the first stent and the main graft body. The annular element can be made of any suitable material (e.g., the graft material, a biocompatible metal, ePTFE) and can be a separate annular element having different properties (e.g., a different density) compared to the graft material.

[0068] In one aspect, the connecting members can be attached at locations within the main graft body without the need for annular elements. These locations can be arranged in any desired pattern, including in a circumferential manner around the interior of the main graft body.

[0069] The term "connecting member configured to couple" refers to a feature of the connecting member that engages and is retained by a stent end in a substantially end-to-end arrangement. Examples of connecting members configured to couple to a first axial stent end are shown, for example, in Figures 3A, 3B, 3C, and 3D.

[0070] In some embodiments, the plurality of connectors protrude beyond the first axial graft end. In some embodiments, the plurality of connectors are circumferentially spaced apart. In further embodiments, the plurality of connectors are curved. In yet other embodiments, each of the plurality of connectors can differ (e.g., in length, curvature, material) from another connector.

[0071] In one embodiment, the substantially end-connected configuration includes a gap between the first stent and the first axial graft end. In some embodiments, the gap is 0-2 mm. In other embodiments, at least one of the plurality of connectors extends across the gap.

[0072] The first stent-graft device embodiment further includes a centering device adapted to be positioned above the renal arteries and expanded, such that the main graft body can be repositioned within the below-renal arteries after the centering device is expanded.

[0073] The term "centering device" refers to a structure that can be removably or temporarily deployed and expanded in an artery or blood vessel (e.g., above the renal arteries) to allow another device (e.g., a stent-graft device) to be centered in another portion of the blood vessel relative to the centering device.

[0074] In one embodiment, the centering device can be a device with multiple arms, each of which can expand radially to contact the wall of the vessel, hi another embodiment, the centering device can be a balloon, which can be expanded to contact the wall of the vessel.

[0075] The centering device (e.g., basket, balloon) can be used to assist an operator (e.g., physician) in positioning a stent-graft device within a target vessel, for example, by expanding the centering device to engage the vessel wall. The operator can adjust the position of a second device (e.g., a stent-graft device) relative to the midpoint of the centering device when the centering device is expanded within the vessel.

[0076] Centering devices can be used, for example, in situations where there is a bend or angle in the vascular anatomy (e.g., angulation above the renal artery; see, e.g., Mathlouthi et al., Clinical research study Abdominal aortic and iliac artery aneurysms, Impact of suprarenal neck angulation on endovascular aneurysm repair outcomes, Journal of Vascular Surgery, Volume 71, Issue 6, P1900-1906, June 01, 2020). In this situation, the centering device can be connected to a second device by a tether, suture, or other connection to further aid in centering the second device relative to the centering device.

[0077] In some embodiments, the centering device can surround the central member for symmetric expansion of the centering device, or can be attached to only one point around the circumference of the central member to allow for eccentric expansion of the centering device. In this embodiment, the centering device is configured to push the central member away from one side of the aorta to counteract the effects of aortic angulation.

[0078] In some embodiments, the centering device is selected from the group consisting of a centering basket and a centering balloon. In some embodiments, the centering basket is inflatable such that at least a portion of the centering basket engages the arterial wall above the renal arteries. In some embodiments, the centering balloon is inflatable such that at least a portion of the centering balloon engages the arterial wall above the renal arteries.

[0079] A further aspect provides a first method including repairing an abdominal aortic aneurysm in a patient by puncturing an entry site vessel above the diaphragm and forming a passage in the entry site vessel. A stent-graft system can then be inserted into the passage in the entry site vessel. The stent-graft system can include a main graft body, a first limb gate, and a second limb gate. The main graft body of the stent-graft system can be positioned and deployed within the patient's target vessel (e.g., infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal).

[0080] The first method described herein may be used, for example, to insert a straight tubular stent-graft into an insertion site vessel located above the diaphragm. In some embodiments, the insertion site vessel is, for example, a smaller vessel (i.e., a vessel with a diameter smaller than or equal to the femoral artery of the same patient), artery (e.g., the common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, axillary artery, and iliac artery), or vein (e.g., the superior vena cava, inferior vena cava, femoral vein, and popliteal vein, radial vein, cephalic vein, cephalic vein, and basilic vein). In some embodiments, the insertion site vessel is the subclavian artery. In some embodiments, the methods described herein may be used to insert hemodialysis grafts and / or other artificial vascular grafts.

[0081] In some embodiments of the first method, the stent-graft system is adapted to be inserted through a single arterial puncture or incision located above the diaphragm of the subject or patient. Use of such a stent-graft system avoids the disadvantages of prior systems that require multiple arterial punctures or incisions. In some embodiments of the first method, the first stent and the main graft body are in a substantially end-to-end configuration.

[0082] The vessel insertion site for the stent-graft system described herein can be the second or proximal third portion of the axillary artery. This insertion site is the axillary artery proximal to the origin of the subscapular artery (e.g., closer to the heart). Use of this insertion site can avoid, for example, damaging branches of the brachial plexus.

[0083] In another embodiment of the first method, the femoral artery is not used to insert the stent-graft device. Instead, the stent-graft device may be inserted through a single puncture or incision in an insertion site vessel (e.g., a "small artery" as described herein) located above the diaphragm that is not located in the leg. Such a procedure allows the patient to immediately ambulate, avoiding the recovery time and discomfort associated with a femoral artery puncture or incision.

[0084] Furthermore, as discussed above, stent-graft devices can be more easily adjusted and positioned from a "top-down" orientation within the aorta down to both legs, for example, for repair of abdominal aortic aneurysms, thereby shortening the procedure time, reducing the likelihood of errors, and providing the patient with a shorter, less painful recovery period.

[0085] In some embodiments of the first method, a single arterial puncture or incision is made in a small artery (e.g., an artery smaller in diameter than or equivalent to the femoral artery from the same patient). The small artery can be located above the diaphragm. The artery can be selected from the group consisting of the brachial artery, radial artery, ulnar artery, femoral artery, iliac artery, axillary artery, and carotid artery. In yet another embodiment, the artery is the brachial artery. In a further embodiment, the artery is the femoral artery or the subclavian artery. In another embodiment, the artery is the second or proximal third portion of the axillary artery.

[0086] In yet another aspect, a stent-graft system can be deployed in the suprarenal abdominal aorta to treat infrarenal abdominal aortic aneurysms, for example, to provide side graft branches for the renal, celiac, and superior mesenteric arteries.

[0087] The term "positioning" refers to moving a stent-graft device (e.g., in a constrained or partially constrained configuration) through a blood vessel to a desired location (e.g., axial position) within the blood vessel using any suitable mechanism (e.g., a positioning system). The positioning system may include a guidewire, a sheath over the guidewire, one or more catheters, trigger wires, and other components that can push, pull, and deploy the stent-graft device. A physician can visualize the progress of the positioning system and stent-graft device via appropriately placed radiopaque markers with angiography, fluoroscopy, or other visualization systems.

[0088] In some embodiments of the first method, the main graft body stent-graft system can be positioned below the lowest renal artery in an orientation adapted to access the contralateral limb gate. A marker (e.g., a radiopaque marker) can be used for orientation of the contralateral gate under fluoroscopic guidance. In another embodiment, the device can be deployed above the renal arteries.

[0089] In some embodiments of the first method, the main graft body of the stent-graft system may be deployed within the infrarenal arteries, wherein the main graft body of the stent-graft system is substantially blood-tight against the arterial wall below the renal arteries. The terms "deployed" or "deploying" refer to the transformation of a stent-graft device from a constrained configuration to an unconstrained or released configuration capable of treating an aneurysm or other condition.

[0090] The stent-graft system may also include a first iliac leg component and a second iliac leg component. The first iliac leg component may be positioned and deployed in a first branch of the iliac artery. The second iliac leg component may then be positioned and deployed in a second branch of the iliac artery. In this embodiment, the first and second iliac leg components may be substantially blood-sealed to the main graft body (e.g., via the graft branch).

[0091] The first iliac leg component can be substantially blood-sealed to a first branch of the iliac artery, and the second iliac leg component can also be substantially blood-sealed to a second branch of the iliac artery.

[0092] The term "substantially blood-sealing" means limiting (eg, 95, 90, 85, or 80%) or eliminating endoleak (eg, blood leaking back into the aneurysm sac after an EVAR procedure).

[0093] In another embodiment of the first method, the main graft body is positioned within the target vessel (e.g., infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal) in a constrained state using a guidewire. The main graft body can be further positioned within the target vessel (e.g., infrarenal, pararenal, subrenal, thoracic aorta, or suprarenal) by partially unsheathing the main graft body. In one aspect, the main graft body is unconstrained after the main graft body is deployed infrarenal.

[0094] In some embodiments of the first method, a sealing stent can be deployed in the main graft body. The term "sealing stent" refers to a stent configured to limit or prevent endoleaks.

[0095] The first iliac leg component can be positioned within the first branch of the iliac artery while being constrained through the main graft body using a guidewire. The first iliac leg component can also be further positioned within the first branch of the iliac artery by partially unsheathing the first iliac leg component. In this embodiment, the first iliac leg component is unconstrained after, for example, being fully unsheathed and positioned within the first branch of the iliac artery.

[0096] The second iliac leg component can be positioned within the second branch of the iliac artery while being constrained through the main graft body using a guidewire. The second iliac leg component can also be further positioned within the second branch of the iliac artery by partially unsheathing the second iliac leg component. In this embodiment, the second iliac leg component is unconstrained after, for example, being fully unsheathed and positioned within the second branch of the iliac artery.

[0097] In some embodiments of the first method, the stent-graft system further includes a first stent and a connection ring. The first stent can have a plurality of receptacles, and the connection ring can have a plurality of connectors adapted to receive the plurality of receptacles. In this embodiment, the connection ring can be disposed on the primary graft body, and the first stent and the primary graft body are in a substantially end-connected configuration.

[0098] In some embodiments of the first method, an optional annular element is disposed within the main body graft, and multiple connecting members are associated with multiple locations on the annular element. In this embodiment, the first stent has a first axial stent end and a second axial stent end, and the main body graft has a first axial graft end and a second axial graft end. The annular element can be disposed substantially adjacent to the first axial graft end. The annular element can be made of any suitable material or can be integrated into the graft. The annular element can be continuous or discontinuous and can be disposed around the circumference of the graft or a portion of the circumference of the graft.

[0099] The annular element can be positioned substantially adjacent to the first axial graft end. A plurality of connecting members can be configured to connect to the first axial stent end to maintain a substantially end-to-end axial connection between the first stent and the main graft body. The annular element can be made of any suitable material (e.g., the graft material, a biocompatible metal, ePTFE) and can be a separate annular element having different properties (e.g., a different density) compared to the graft material.

[0100] In a further embodiment of the first method, the connecting members can be attached at locations within the main graft body without the need for annular elements. These locations can be arranged in any desired pattern, including in a circumferential manner around the interior of the main graft body.

[0101] The connecting member may be configured to connect to the first axial stent end to maintain a substantially end-to-end axial connection between the first stent and the main graft body.

[0102] In some embodiments of the first method, the plurality of connectors protrude beyond the first axial graft end, hi some embodiments, the plurality of connectors and the plurality of receptacles are circumferentially spaced apart.

[0103] A substantially end-connected configuration can include a gap (e.g., greater than 0 to 2 mm) between the first stent and the graft. In some embodiments, multiple connectors extend across the gap.

[0104] A further aspect provides a second stent-graft system having an endograft deployment system for deploying an endograft in a target vessel (e.g., infrarenal, pararenal, renal, thoracic aorta, or suprarenal) of a patient or subject. The endograft deployment system includes an outer tube having a central inner member including the endograft, a carrier tube including a tether wire having a caudal end and a more cranial portion, a top stent surrounding the central inner member, the top stent including a plurality of hooks with a plurality of receptacles, and a plurality of sutures, wherein a first end of at least a first suture is disposed through one of the plurality of receptacles to hold the top stent in a constrained configuration, and a second end of the first suture is affixed to the more cranial portion of the tether wire. The first end of at least a first suture can be attached, for example, to the tether wire. Movement of the tether wire may control removal of the sutures from the receptacles, releasing the top stent from a constrained configuration to an unconstrained configuration and removing the sutures from the target vessel. In some embodiments, the tether wire may be removed while leaving the sutures in the patient.

[0105] Aspects described herein provide stent-graft systems and methods that substantially remove sutures from a subject's vessel after deployment of the stent-graft system. In some embodiments, a first end of at least a first suture is formed into a loop, and the loop is disposed around a caudal end of a tether wire.

[0106] Sutures can be important or essential components of many surgical procedures, including EVAR. However, the presence of sutures or parts of sutures after cardiovascular surgery can cause serious side effects, including embolism, adverse effects on vascular healing, and coronary artery injury. For example, Lee et al.Suture knot embolism-a rare complication of percutaneous arterial closure device,Cardiovascular Pathology Volume 19,Issue 1,January-February 2010, Pages 63-64,Osama Hazim Al Hayini,Effect of different suture materials on healing of blood vessels in dogs,Iraqi Journal of Veterinary Sciences 26:77-82(January 2012), Annuloplasty Rings 510(k) Submissions-Final Guidance for Industry and FDA (Food and Drug Administration) Staff, US FDA Guidance January 31, 2001.

[0107] In some embodiments, the endograft deployment system further includes a shelf disposed below the first end of the at least first suture to initially retain the first end of the at least first suture on the shelf. In some embodiments, the shelf further includes a first opening for receiving the central inner member. The endograft deployment system may include a second opening for receiving the carrier tube. The endograft deployment system may include a third opening for receiving at least one of the plurality of sutures. In some embodiments, the third opening includes three partial openings.

[0108] Embodiments described herein provide a second method including puncturing the femoral artery to form a passage in the femoral artery, and inserting a stent-graft into the passage in the femoral artery using a stent-graft deployment system having an outer tube including a central inner member including an endograft, and a carrier tube including a tether wire.

[0109] In this aspect, the tether wire can have a caudal end and a more cranial portion. The stent-graft deployment system can further include a top stent surrounding the central inner member, the top stent including a plurality of hooks with a plurality of receptacles and a plurality of sutures. In this aspect, a first end of at least a first suture is disposed through one of the plurality of receptacles to hold the top stent in a constrained configuration, and a second end of the first suture is affixed to the more cranial portion of the tether wire. The first end of the at least first suture can be attached to the tether wire, for example.

[0110] The tether wire can be moved to remove the sutures from the receptacles, release the top stent from a constrained state to an unconstrained state, and remove the sutures from the target vessel.

[0111] A first end of at least the first suture can be formed into a loop, and the loop can be placed around the caudal end of the tether wire.

[0112] A first limb gate of the stent-graft device may be positioned and deployed in a first branch of the iliac artery, the first limb gate of the stent-graft device being substantially blood-sealed against the wall of the first branch of the iliac artery and the main graft body.

[0113] A second limb gate of the stent-graft device can be positioned and deployed in a second branch of the iliac artery. As described herein, positioning and deployment of the second limb gate in the second branch of the iliac artery can be accomplished without requiring a second puncture or incision in the corresponding femoral artery. In this embodiment, the stent-graft device can be substantially blood-sealed against the wall of the second branch of the iliac artery.

[0114] The embodiments described herein also provide an alternative method for repairing an abdominal aortic aneurysm in a patient by puncturing or cutting through the femoral artery and creating a passageway in the femoral artery. In this embodiment, a stent-graft system (e.g., a main graft body, a first limb gate, and a second limb gate) can be inserted into the passageway in the femoral artery. The main graft body of the stent-graft system can be positioned below the patient's renal arteries and deployed.

[0115] The main graft body of the stent-graft system can be substantially blood-sealed against the arterial wall below the renal arteries. In this embodiment, the stent-graft system can have a first iliac leg component and a second iliac leg component. The first iliac leg component can be positioned and deployed in a first branch of the iliac artery, and the second iliac leg component can be positioned in a second branch of the iliac artery and the main graft.

[0116] In this embodiment, the first iliac leg component can be substantially blood-sealed to a first branch of the iliac artery, and the second iliac leg component can be substantially blood-sealed to a second branch of the iliac artery.

[0117] In another embodiment, the contralateral limb gate (i.e., the exit point of the second limb gate) can be cannulated from a "top-down" approach using a steerable guidewire and steerable catheter, with access from an entry site vessel (e.g., the axillary artery) located above the patient's or subject's diaphragm. Alternatively, instead of using a catheter and guidewire combination, a guidewire with a bend near the nosecone can be used. In some embodiments, a retrograde femoral artery approach can be used.

[0118] In another aspect, the main graft body is positioned within the infrarenal arteries in a constrained state using a guidewire. In another aspect, the main graft body is further positioned within the infrarenal arteries by partially unsheathing the main graft body. In yet another aspect, the main graft body is unconstrained after the main graft body is deployed within the infrarenal arteries.

[0119] An embodiment provides a further alternative method of repairing an abdominal aortic aneurysm in a patient by puncturing a femoral artery and forming a passage in the femoral artery. A stent-graft device can be inserted into the passage in the femoral artery. In this embodiment, the stent-graft device can include a main graft body, a first limb gate, and a second limb gate. The main graft body of the stent-graft device can be positioned and deployed within a target vessel (e.g., below the renal arteries, pararenal arteries, at the renal arteries, the thoracic aorta, or above the renal arteries) of the patient. In this embodiment, the main graft body of the stent-graft device is substantially blood-tight against the arterial wall below the renal arteries. The main graft body of the stent-graft device can be substantially blood-tight against the wall of the target vessel. In another embodiment, only one femoral artery is punctured.

[0120] Aspects described herein provide a third stent-graft system for repairing an aneurysm in a target vessel having a main graft body including a sealing stent at least partially disposed within the main graft body. In this aspect, the stent-graft system can be configured to be inserted through a single arterial puncture or incision at an insertion site vessel located above the patient's diaphragm. In some embodiments, the diameter of the stent-graft system in the constrained configuration is adapted for insertion into a small artery (e.g., an artery smaller in diameter than or equivalent to the femoral artery from the same patient). In some examples, the diameter of the stent-graft system in the constrained configuration is about 13 to about 22 French or 6 to about 13 French.

[0121] In one embodiment, the sealing stent has a plurality of struts. The plurality of struts can have a strut width of about 0.013 to about 0.016 inches. In some embodiments, the sealing stent has a plurality of struts, and the plurality of struts can have a strut wall thickness of about 0.016 to about 0.020 inches.

[0122] In some embodiments, the main graft body has a first axial end and a second axial end. The sealing stent can be disposed adjacent the first axial end. The sealing stent can further include a plurality of hooks.

[0123] In some embodiments, the plurality of hooks extend beyond the first axial end of the main graft body. In some embodiments, each of the plurality of hooks further comprises a radiopaque marker.

[0124] In further aspects, each of the plurality of hooks can be oriented in a right-handed or left-handed orientation. In yet other embodiments, the orientation of each of the plurality of hooks is different from adjacent hooks. In some aspects, the plurality of hooks are adapted to be reversibly retained by looped wires for repositioning of the main graft body below the renal arteries.

[0125] In some embodiments, the looped wire is inserted into the target vessel through a recapture sheath. The recapture sheath can be approximately 2-4 French. In one aspect, recapture of the stent-graft device and repositioning of the stent-graft device can occur solely from an insertion site vessel located above the diaphragm of the patient or subject.

[0126] The plurality of hooks may further include a plurality of hook eyelets. The looped wire may be removably inserted through at least one of the plurality of hook eyelets.

[0127] In some embodiments, for example, a 10 French sheath can be used to recapture the entire stent-graft device (e.g., endograft) in the event that the procedure needs to be aborted. In other embodiments, the sheath can be exchanged for a larger size sheath during the procedure, allowing the entire stent-graft device to be recaptured in the event that the entire procedure needs to be aborted.

[0128] Embodiments described herein provide an alternative method of repairing an abdominal aortic aneurysm in a patient by (a) inserting a first guidewire into a small artery with a first access profile of approximately 3 French, (b) inserting a catheter into the ipsilateral iliac artery with a second access profile of approximately 5 French, (c) deploying a main graft body from a main graft body deployment system below the patient's renal arteries with a third access profile of approximately 10 French, (d) removing internal components of the main graft body deployment system, leaving a first sheath and a first guidewire below the renal arteries, (e) deploying a first limb gate in the ipsilateral iliac artery using the first sheath and the first guidewire, (f) moving the first guidewire from the ipsilateral iliac artery to the contralateral iliac artery, and (g) deploying a limb gate in the contralateral iliac artery using the first sheath and the first guidewire.

[0129] A further aspect provides an alternative method of repairing an abdominal aortic aneurysm in a patient by (a) inserting a first guidewire into a small artery in the patient's ipsilateral iliac artery, (b) inserting a main body graft and a first sheath over the first guidewire below the renal arteries, (c) deploying the main body graft below the patient's renal arteries, (d) inserting a first limb gate into the patient's ipsilateral iliac artery and deploying the first limb gate, (e) removing the first guidewire from the ipsilateral iliac artery, (f) inserting a 4-5 French directional catheter through the first sheath, (g) cannulating the contralateral iliac gate and the contralateral iliac artery with the first guidewire, (h) inserting a second limb gate into the contralateral iliac artery, and (i) deploying the second limb gate in the contralateral iliac artery.

[0130] In some embodiments, the method further comprises deploying one or more sealing stents below the renal arteries. The sealing stents can prevent or minimize endoleaks.

[0131] Aspects described herein provide a third method that includes positioning a main graft body of a stent-graft system within the infrarenal arteries of a subject by advancing a main graft body delivery system to a target location, the main graft body delivery system including the main graft body and a centering device. The main graft body can then be positioned within the infrarenal arteries at a first position at the target location, and a determination can be made as to whether the first position of the main graft body is centered within the infrarenal arteries at the target location. If the first position of the main graft body is not centered within the infrarenal arteries at the target location, the centering device can be deployed above the renal arteries to a centered position. If the first position of the main graft body is not centered within the infrarenal arteries at the target, the main graft body can be repositioned within the infrarenal arteries at a second position determined from the centered position.

[0132] In some embodiments of the third method, the insertion site vessel of the stent-graft device is located above the patient's diaphragm.

[0133] In some embodiments of the third method, the centering device is selected from the group consisting of a centering basket and a centering balloon. In some embodiments, the centering basket can be inflated so that at least a portion of the centering basket engages the arterial wall above the renal arteries. In some embodiments, the centering balloon can be inflated so that at least a portion of the centering balloon engages the arterial wall above the renal arteries. In some embodiments, the outward force exerted by the outer surface of the centering basket or centering balloon is greater than the longitudinal force exerted by the sheath or other delivery device as it conforms to the curvature of the vessel.

[0134] In some embodiments of the third method, the main graft body delivery system further includes a sheath that defines the main graft body, and the sheath is retracted to expose the main graft body below the renal arteries before positioning the main graft body below the renal arteries.

[0135] In some embodiments of the third method, the sheath further includes a centering device, and further retraction of the sheath exposes the centering device above the renal arteries before deploying the centering device.

[0136] In some embodiments of the third method, the main graft body delivery system further includes a main graft body restraining device and a main graft body release device. The main graft body restraining device can maintain the main graft body cranial end in a constrained configuration. The main graft body release device can induce release of the main graft body to an unconstrained configuration.

[0137] For example, the restraining device can include main graft body restraining wires adapted to control the main graft body position. The term "adapted to control" refers, for example, to the ability of an operator (e.g., a physician) to move the restraining wires to change the main graft body position within the artery (e.g., move the main graft body in a caudal or cranial direction).

[0138] In some embodiments of the third method, the main graft body release device includes a snare loop adapted to release the main graft body within the infrarenal arteries. The term "snare loop" refers to a material (e.g., wire, suture) configured into a loop or circular shape that allows the diameter of the loop to be reduced around a target. See, e.g., U.S. Patent No. 8,628,540. In the context of surgery, the loop can be placed around or through a target and closed to remove or manipulate the target (e.g., a snare loop placed through an eyelet attached to a stent).

[0139] In some embodiments, the snare loop can re-constrain the cranial end of the main graft body after expansion of the cranial end, controlling repositioning of the axial position of the main graft body below the renal arteries. In this manner, the operator can position and reposition the main graft body within the below the renal arteries. In one embodiment, the snare loop can be detached from the subject. In another embodiment, the caudal end of the main graft body can be secured to the delivery system shaft by a trigger wire.

[0140] In further embodiments of the third method, the main graft body has a caudal end and a cranial end, and the location of the first location is determined by the location of a marker (e.g., a radiopaque marker) on the cranial end of the main graft body. In some embodiments, the location of the marker is caudal to the renal arteries. In some embodiments, the method further includes securing the caudal end of the main graft body to the main graft body restraining device with a trigger wire.

[0141] In some embodiments, repositioning of the stent-graft device may occur only from an insertion site vessel located above the diaphragm of the patient or subject.

[0142] Aspects described herein provide a fourth stent-graft system for repairing an aneurysm in a target vessel (e.g., infrarenal, pararenal, renal, thoracic aorta, or suprarenal), comprising: a top stent having a plurality of positioning receptacles; a main graft body, wherein the top stent and main graft body are in a substantially end-connected configuration, and wherein the top stent and main graft body are disposed around an inner member; and a snare tube including a snare loop, wherein a first end of the snare loop is disposed within the snare tube and a second end of the snare loop is disposed from the snare tube, through the positioning receptacles, around the inner member, and within the snare tube, the snare tube being parallel to the inner member, and the first end of the snare loop being adjacent to the second end of the snare loop.

[0143] In one embodiment of the fourth stent-graft system, the stent-graft system can optionally be configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm. One example of this stent-graft system is shown in FIG.

[0144] In another embodiment of the fourth stent-graft system, each of the plurality of positioning receptacles further includes an eyelet, and the second end of the snare loop is disposed through at least one eyelet. In some embodiments, the stent-graft system further includes an outer sheath disposed about the inner member.

[0145] The insertion site vessel can have a diameter less than or equal to the diameter of the patient's femoral artery. The diameter of the stent-graft system in the constrained configuration can be about 13 to about 22 French, or about 6 to about 13 French. The main graft body can be comprised of a densified material.

[0146] In a fourth stent-graft system embodiment, the main graft body is bifurcated and further includes a first limb gate and a second limb gate. The first limb gate can include a first iliac leg component. The second limb gate can include a second iliac leg component. The top stent and main graft body are in a substantially end-to-end configuration.

[0147] In a further embodiment of the fourth stent-graft system, the stent-graft system further includes a trigger or tether wire for positioning the first limb gate and the second limb gate. The positioning system may further include a first limb gate tether and a second limb gate tether. The first limb gate tether and the second limb gate tether may be held by a trigger wire.

[0148] The fourth stent-graft system may further include a centering device for centering the main graft body within the infrarenal arteries, as illustrated, for example, in FIG. 12A.

[0149] The main graft body, top stent, and centering device may initially be housed within an outer sheath. Once the outer sheath is removed from the main graft body and top stent, the top stent is deployed and the centering device may be pushed caudally axially into the aortic neck (e.g., the non-dilated region above the aneurysm) and into the main graft body. The centering device may be deployed within the graft at the portion of the main graft body closest to the heart. The centering device may then be retracted, releasing the snare loop and allowing the top stent to be deployed.

[0150] An alternative embodiment provides a method of positioning a stent-graft system within a target vessel described herein (e.g., FIG. 11 ) by shortening the length of the snare loop, where the top stent is collapsed from a deployed configuration to a constrained configuration and moved into an outer sheath, shortening the length of the snare loop, adjusting the location of the stent-graft system within the infrarenal artery, and lengthening the snare loop, where the top stent is moved out of the outer sheath, and expanding the top stent from a constrained configuration to a deployed configuration within the target vessel. In some embodiments, repositioning of the stent-graft device can occur only from an insertion site vessel located above the diaphragm of the patient or subject.

[0151] In situations where a high angle above the kidney results in suboptimal deployment (e.g., an angle originating from the renal artery), the snare loop can be opened and the centering device can be moved caudally into the inferior renal artery to the most cranial portion of the graft. The snare loop can be closed to re-constrain the hook and allow the centering device to center the endograft within the inferior renal artery. The snare loop can be opened to retract the centering device. The centering device can help evenly open the top end of the endograft.

[0152] In some embodiments (e.g., FIG. 12A), the snare loop and snare tube are positioned outside the circumference of the centering device and inside the circumference of the outer sheath. In this embodiment, when the centering basket is depressed, the snare loop passes through the center of the top stent and into the inner member.

[0153] Aspects described herein provide a fifth stent-graft system for repairing an aneurysm in a target vessel (e.g., infrarenal, pararenal, para-aortic, thoracic aorta, or suprarenal) having a top stent including a plurality of positioning receptacles; a main graft body, wherein the top stent and main graft body are in a substantially end-to-end configuration and the top stent and main graft body are disposed about an inner member; and a snare loop, wherein the snare loop rotates greater than 360 degrees (e.g., 300-800 degrees, 540 degrees) about the top stent, the snare loop being positioned through the positioning receptacles, and wherein a first end of the snare loop is positioned substantially symmetrically (e.g., concentrically) relative to the inner member. In one embodiment of the fifth stent-graft system, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm.

[0154] In a further embodiment of the fifth stent-graft system, each of the plurality of positioning receptacles further includes an eyelet, and the second end of the snare loop is positioned through at least one eyelet. The stent-graft system may include an outer sheath disposed around the inner member. The insertion site vessel may have a diameter less than or equal to the diameter of the patient's femoral artery. The diameter of the stent-graft system in the constrained configuration may be about 13 to about 22 French, or about 6 to about 13 French. The main graft body comprises a densified material.

[0155] In one embodiment of the fifth stent-graft system, the main graft body is bifurcated and further includes a first limb gate and a second limb gate. The first limb gate may include a first iliac leg component. The second limb gate may include a second iliac leg component.

[0156] In some embodiments of the fifth stent-graft system, the top stent and main graft body are in a substantially end-connected configuration. The stent-graft system further includes a trigger or tether wire for positioning the first and second limb gates. The stent-graft system further includes a first and second limb gate tether. The first and second limb gate tethers may be retained by a trigger wire.

[0157] Embodiments described herein provide a method of positioning a stent-graft system within a target vessel described herein (e.g., FIG. 13 ) by shortening the length of the snare loop, whereby the top stent collapses from a deployed configuration to a constrained configuration and moves into an outer sheath, adjusting the location of the stent-graft system within the target vessel, and lengthening the snare loop, whereby the top stent moves out of the outer sheath and expands from the constrained configuration within the target vessel. In this embodiment, repositioning of the stent-graft device can be performed from an insertion site vessel located above the diaphragm of the patient or subject.

[0158] FIG. 1 shows the anatomy of a portion of the aorta, including the descending thoracic aorta 10, the suprarenal abdominal aorta 12, the renal arteries 14, the infrarenal aneurysmal aorta 16, and the ipsilateral iliac artery 18 and the contralateral iliac artery 19.

[0159] 2A shows an exemplary stent-graft device 20 according to some embodiments of the first stent-graft system described herein. In this embodiment, stent-graft device 20 includes a graft 21, a first stent 22, a connecting ring 24, a main graft body 26, a connecting bar 28, a first limb gate 30, a second limb gate 32, a second stent 34, a third stent 36, a first tether 38, and a second tether 40. Connecting ring 24 and stents (22, 34, and 36) can be completely encapsulated in graft body material 26, partially encapsulated in graft body material 26, or not encapsulated at all in graft body material 26.

[0160] FIG. 2B is a flattened side view of the exemplary stent-graft device of FIG. 2A according to embodiments described herein.

[0161] 3A shows an exemplary portion of a first stent 22 having lower and upper barbs 42, 44 and a receptacle 46. A connector 48 is shown on a connecting ring 24 embedded within the graft 21.

[0162] 3B shows enlarged front and side views of receptacle 46 and connector 48, with the angled zigzag configuration of receptacle 46 adapted to engage and mate with connector 48. An optional suture 50 is shown wrapped around connector 48 within receptacle 46. An optional receptacle stabilizer 52 is shown adjacent connector 48 to provide additional axial support.

[0163] FIG. 3C shows an enlarged front view of an alternative configuration of receptacle stabilizer 52 having a portion of first stent 22, a portion of connecting ring 24, receptacle 46, connector 48, suture 50, and optional connector stabilizer 54 adapted to fit receptacle stabilizer 52.

[0164] FIG. 3D shows an enlarged front view of an alternative configuration of a portion of the first stent 22, a portion of the connecting ring 24, a receptacle 46, and a connector 48, where the connector 48 has a triangular shape adapted to fit into the triangular-shaped receptacle 46.

[0165] 4 shows an alternative embodiment in which the arms 56 of the connecting ring or first stent 24 are angled at a 110 degree angle relative to one another. Conventional stent-graft devices can become unstable if the angle between the arms of the connecting ring or stent is greater than 60 degrees.

[0166] Conventional stent-graft devices in end-connected configurations using angles between stent arms greater than about 60 degrees can be unstable. Figure 4 shows a connecting ring 24 in which adjacent arms 56 are at angles greater than 90 degrees. Standalone z-stents are typically unstable at angles greater than 60 degrees. In this embodiment, attachment of the connecting ring to a robust and stable first stent (such as first stent 22 shown in Figure 3A) via a connector / receptacle results in an increased angle of the connecting ring. The increased angle results in a shortened stent length and therefore a shorter sealing length. Without being bound by theory, it is believed that the sealing length is coupled with the length from the cranial edge of the graft to the first full ring of stent engagement. Short-neck aneurysms cannot be treated based on some designs with long stents in the sealing zone. In some embodiments, the connecting ring and stent can be encapsulated in the graft, unencapsulated, or partially encapsulated in the graft.

[0167] 5 shows an exemplary configuration of an iliac leg component 58 having a leg component tether 60, a leg component top stent 62, leg component modular joining barbs 64, a leg component connecting ring 66, a leg component connector 68, a leg component receptacle 70 on a leg component outer stent 72 having a lower barb 74 and an upper barb 76. The iliac leg component 58 can be steered and positioned using the leg component tether 60.

[0168] Deployment of the iliac leg component 58 expands the leg component top stent 62 and the leg component outer stent 72 as the iliac leg component 58 moves from a constrained configuration to an unconstrained configuration. In the unconstrained configuration, the iliac leg component 58 can substantially form a blood seal with the iliac artery. The leg component barbs 64 can provide additional stability with respect to positioning the iliac leg component 58 within the body branch. The leg component connection ring 66 can be configured similarly to the connection ring 24, including having the leg component 68 adapted to fit into the leg component receptacle 70 on the leg component outer stent 72. The iliac leg component 58 can be deployed into the contralateral iliac artery, the ipsilateral iliac artery, or both, depending on the patient's needs.

[0169] FIG. 6A illustrates an example of positioning and deploying a contemporary (currently typical) main graft body using a typical EVAR technique for repairing abdominal aortic aneurysms. In panel 1, a guidewire 78 is inserted via a femoral puncture or incision in a "bottom-up" approach, past the iliac arteries 18, the infrarenal aneurysmal aorta 16, the renal arteries 14, and into the suprarenal aneurysmal aorta 12. In panel 2, a delivery system sheath 80 containing a main graft body 82 is inserted over the guidewire 78 and tracked over the guidewire into the suprarenal abdominal aorta 12. In panel 3, the main graft body 82 is positioned and partially desheathed, allowing its position to be adjusted before final release. In panel 4, the main body 82 is fully desheathed and deployed into the suprarenal abdominal aorta 12, as shown just below the renal arteries 14.

[0170] FIG. 6B shows an example of positioning and deploying a currently typical iliac leg component using a currently typical EVAR method for repairing an abdominal aortic aneurysm. The delivery system sheath 80 is left in place. As shown in panel 1, the leg component 84 is inserted into the delivery system sheath 80 and inserted into the graft branch of the main graft body 82 over the guidewire 78 through a puncture or incision in the femoral artery in a "bottom-up" approach. The iliac leg component sheath 84 is positioned and partially retracted, allowing the iliac leg component to expand in the overlap zone. In panel 2, the leg component 84 is fully unsheathed and deployed into one leg of the iliac artery 18.

[0171] In panel 3, a guidewire 78 is inserted into a second femoral artery puncture or incision in a "bottom-up" approach to position (referred to as cannulation) the other leg branch of the main graft body 82. Accurate positioning of the leg component 84 via cannulation in a "bottom-up" approach can be very difficult. In panel 4, once cannulation is achieved with the guidewire, the leg component 84 is positioned and deployed in the other leg of the iliac artery 18.

[0172] In contrast to the EVAR approach shown in Figures 6A and 6B, panels 1-4 of Figure 7A show an exemplary insertion and deployment of a main body graft module from an insertion vessel located above the patient's diaphragm.

[0173] In panel 1, a "top-down" approach is used to make a puncture or incision in a blood vessel above the patient's diaphragm, and after removal of the directional catheter (not shown) a delivery sheath 80 is inserted. With the contralateral iliac artery 19 uninstrumented, a guidewire 78 is inserted through the inner member 79, past the renal arteries 14, down the suprarenal abdominal aorta 12, across the infrarenal aneurysmal aorta 16 and into the ipsilateral iliac artery 18.

[0174] In panel 2, a delivery sheath 80 containing / restraining the main graft 26 (not shown) within its lumen is threaded over the indwelling guidewire 78 through the lumen of the first nosecone 86 and then introduced / inserted through the small arterial puncture (vascular access point) and advanced past the renal arteries 14 and down the abdominal aorta 12 suprarenal. Subsequently, the first nosecone 86 is positioned just above the ipsilateral iliac artery 18, substantially across the aneurysmal aorta 16 subrenal, leaving the contralateral iliac artery 19 uninstrumented.

[0175] Panels 3 and 4 of FIG. 7A show the deployment of the delivery sheath 80 in the infrarenal aneurysmal aorta 16 and the initial delivery / release of the main graft 26.

[0176] In panel 3 of Figure 7A, the main graft body 26, first limb gate 30, and second limb gate 32 with radiopaque markers 88 are shown partially deployed and oriented both axially and rotationally as desired in the target anatomy. The radiopaque markers 88 serve as an aid in orienting the device under fluoroscopy. Partial deployment can be achieved by partially retracting the delivery sheath 80 relative to the renal arteries 14 in a direction toward the abdominal aorta 12 superior to the renal arteries while generally maintaining a stationary position of the main graft body 26 and inner member (not shown) with the first nosecone 86 in the infrarenal aorta 16. The position of the guidewire 78 within the ipsilateral iliac artery 18 is also maintained.

[0177] First tether 38 and second tether 40 substantially secure the distal end of main graft body 26 to first nosecone 86 to allow traction and secure the distal end of main graft body 26 during deployment. Crumpling Or "run up" (riding up) As previously described, panel 3 depicts partial deployment of the endograft by withdrawal (or proximal) retraction of the delivery sheath 80.

[0178] 7A, panel 4 shows when the delivery sheath 80 is fully retracted, releasing the main graft body 26 to self-expand, except that the proximal and distal ends of the main graft body 26 remain constrained. This is accomplished by fixedly constraining the first tether 38 and the second tether 40 at the distal end to the first nosecone 86 using tether wires (not shown), and using a similar system or arrangement (not shown) for the first stent 22 at the proximal end. In this manner, the length of the main graft body 26 is reduced. Crushed ( Clamp ring , crumpling) are avoided during positioning and deployment.

[0179] Figure 7B shows the deployment sequence of the right iliac limb component in a manner similar to the deployment of the main graft body. Panel 1 of Figure 7B shows the main graft body, including the top stent, fully released. Panel 2 of Figure 7B shows the sheath advanced into the right external iliac artery. Panel 3 of Figure 7C shows the sheath partially withdrawn, partially releasing the right iliac limb gate. Panel 4 of Figure 7B shows the right iliac limb gate fully released.

[0180] In panel 1 of Figure 7B, the main graft body 26, first limb gate 30, and second limb gate 32 are fully deployed (i.e., the first tether 38, second tether 40, and first stent 22 are no longer constrained) by releasing the first tether 38 and second tether 40 from the distal first nosecone 86 and proximal anchoring system at both the proximal and distal ends of the main graft body 26. As shown in this panel, the main graft body 26 is released from the delivery sheath 80 completely unconstrained, with the stent-graft now implanted within the vessel.

[0181] Panel 1 of Figure 7B further depicts the main graft body 26 in a position to form a substantial blood seal (not shown) with the infrarenal aneurysmal aorta 16. The first stent 22 in panel 1 of Figure 7B is shown spanning the renal arteries 14 without the covered portions of the main graft body 26 interfering with perfusion or obstructing blood flow to these critical vessels. Furthermore, the position of the guidewire 78 is generally maintained within the ipsilateral iliac artery 18 throughout the deployment procedures depicted in panels 1-4 of Figure 7B.

[0182] Upon completion of full deployment of the main graft body 26 in panel 1 of FIG. 7B, the delivery system is carefully retracted and removed, ensuring that the first nosecone 86 crosses the edge of the ipsilateral leg component 98 during this procedure. The first nosecone 86 is attached to the inner member 79. It is envisioned that the first nosecone 86 may also be made radiopaque to ensure safe retraction of the delivery system from the main graft body 26 through observation of the nosecone retraction by fluoroscopy during this procedure.

[0183] Figures 7B (starting with panel 2) and 7C illustrate exemplary positioning and deployment of ipsilateral leg component 98 and contralateral leg component 106 (not shown) in a manner similar to that described for deployment of main graft body 26 in Figure 7A, in which delivery sheath 80 is withdrawn proximally while generally maintaining the relative stationary positions of the leg components during their respective deployment within main graft body 26.

[0184] In panel 2 of Figure 7B, the delivery sheath 80 is left in place and the ipsilateral leg component 98 is loaded in a constrained manner through the puncture or incision at the location of the entry site vessel above the diaphragm via the delivery sheath 80 and positioned for desheathment over the guidewire 78 from a "top-down" direction through the main graft body 26 and first limb gate 30. The guidewire 78 is shown inserted through the second nosecone 96.

[0185] In panel 3 of Figure 7B, the ipsilateral leg component 98 is partially desheathed and finely positioned within the ipsilateral iliac artery 18. The distal end of the ipsilateral leg component 98 is constrained in a manner similar to that described in Figure 7A, for example, by fixedly constraining a tether (not shown) on the distal end of the ipsilateral leg component 98 to the second nosecone 96 using a tether wire (not shown). At this stage, the proximal end of the ipsilateral leg component 98 is still constrained within the delivery sheath 80.

[0186] As shown in panel 4 of FIG. 7B, the ipsilateral leg component 98 is fully desheathed and deployed into the ipsilateral iliac artery 18.

[0187] Panels 1 and 2 of Figure 7C show equivalent full deployment (i.e., implantation) of the contralateral leg component 99 in the contralateral iliac artery 19 in the same manner as described in Figure 7B. Panel 1 of Figure 7C shows the guidewire 78 advanced into the left external iliac artery 19. Panel 2 of Figure 7C shows the fully deployed contralateral leg component 99.

[0188] FIG. 7D shows an alternative in which a self-expanding additional stent 105 may be deployed in the sealing zone spanning the cranial graft margin, for example, to further enhance the substantial blood seal.

[0189] 8A and 8B show an alternative deployment system in cross section (FIG. 8A) and close-up (FIG. 8B). In this embodiment, first and second tethers 38, 40 are looped around tether wire 107 and to ledge 103 to control first and second limb gates 30, 32. First and second tethers 38, 40 may be positioned anywhere around the circumference of first and second limb gates 30, 32, respectively. Shelf 103 is fixedly coupled to inner member 79. Retracting the distal end of tether wire 107 into a carrier catheter (not shown) from inside first nosecone 86 to a position at or proximal to shelf 103 releases first and second tethers 38, 40 prior to deployment of main graft body 26.

[0190] 9 illustrates an exemplary stent-graft deployment system 108 in accordance with a second stent-graft system for deploying a stent-graft 118 within a target vessel of a subject. The second stent-graft system described herein may be configured for insertion into the femoral artery. The system includes an outer tube 110 surrounding a central inner member 112 and a carrier tube 114. The central inner member 112 has a caudal end 115 with a distal tip and a cranial end 116, and is surrounded by a stent-graft 118. The carrier tube 114 includes a tether wire 117. The tether wire 117 has a caudal end and a more cranial portion.

[0191] A top stent 119 is shown surrounding the central inner member 112. The top stent 119 includes a plurality of hooks 120 with a plurality of receptacles 122. In this embodiment, the receptacles 122 are integral with the hooks 120. The receptacles 122 can be spot welded to the hooks 120, for example. The hooks 120 can also be bent or positioned to function as receptacles. A plurality of sutures 124, where a first end of at least a first suture is placed through one of the plurality of receptacles 122 to hold the top stent 119 in a constrained configuration, and a second end of the first suture is affixed to a more cephalad portion of the tether wire 117. An optional shelf 126 can be placed around the inner member 112 and the carrier tube 114 to hold the carrier tube 114 and the inner member 112 together.

[0192] 10 , inner member 112 can be placed through inner member aperture 128 in ledge 126, and carrier tube 114 can be placed through carrier tube aperture 130 in ledge 126. Ledge 126 can function as a support for threading suture 124 through receptacle 122 and to substantially hold inner member 112 and carrier tube 114 together, adding further radial stability to the system. Receptacle aperture 132 can receive a portion of receptacle 122, for example, with suture 124 placed therethrough.

[0193] Movement of the tether wire 117 can control the removal of the sutures from the receptacles, releasing the top stent 117 from a constrained configuration to an unconstrained configuration. The sutures 124 can be removed from the subject's vessel. In some embodiments, all of the sutures are removed from the vessel, for example, to protect the subject from negative side effects of having the sutures or portions of the sutures remain in the subject for a period of time.

[0194] 11 illustrates an embodiment of a fourth stent-graft device including an exemplary snare loop positioner for adjusting the axial location of the main graft body within the target vessel. An outer sheath 134 encompasses an inner member 164 and a snare tube 136. A centering device (not shown) is also encompassed by the outer sheath 134. A snare loop 138 is positioned within and through the snare tube 136, with ends that can be controlled by the operator. The snare loop 138 is shown threaded through a plurality of eyelets 140. A top stent 142 is shown including a plurality of hooks 144 disposed within the eyelets 140. In the configuration shown, the top stent 142 is in a constrained or closed configuration. A guidewire 160 is shown positioned through the third nosecone 158.

[0195] Top stent 142 is shown in a substantially terminally connected configuration with main graft body 144. Main graft body 144 may be made of a densified material (e.g., densified ePTFE). Tether wire 146 is shown disposed through outer sheath 124 and main graft body 144, and ipsilateral limb gate 148 is shown coupled to trigger wire holder 156. Contralateral tether 152 is shown disposed through contralateral limb gate 150 and coupled to tether wire 146. Ipsilateral tether 154 is shown disposed through ipsilateral limb gate 148 and attached to tether wire 146. In this embodiment, tether wire 146 may be used to adjust the position of contralateral limb gate 150 and ipsilateral limb gate 148 using contralateral tether 152 and ipsilateral tether 154.

[0196] Using the example of FIG. 11 , an operator can insert the stent-graft device through a single puncture of a small artery located above the diaphragm, for example, with the third nosecone 158 of the stent-graft device "top down" below the renal arteries. In use, the snare loop 138 is retracted, and the top stent 142 can be retracted into the outer sheath 134 using the hook 144. The stent-graft can optionally be axially repositioned within the vessel as desired by the operator. Once the stent-graft is positioned in the desired location by the operator, the top stent 142 can be released in the deployed configuration by releasing the snare loop 138. In this exemplary manner, the position of the stent-graft can be adjusted and readjusted as needed. As shown in FIG. 11 , the snare loop 138 is retracted, and the top stent 142 is in a constrained configuration, and the top stent 142 can be retracted into the outer sheath 134. The position of the stent-graft device can then be adjusted.

[0197] FIG. 12A illustrates one embodiment of a fourth stent-graft system. In this example, retraction of the outer sheath 134 reveals the centering basket 162. The snare loop 138 is not retracted, and the top stent 142 is deployed in an unconstrained configuration. The centering basket 162 can facilitate centering and positioning of the main graft body 144, for example, below the renal arteries. The arms of the centering basket 162 engage the arterial wall above the renal arteries when the centering basket 162 is deployed by retracting the outer sheath 134. In this manner, the location of the entire stent-graft device can be adjusted so that the main graft body 144 is centered below the renal arteries, for example. It is understood that the centering basket 162 can be a centering device (e.g., a basket, balloon, or the like) as described herein.

[0198] 12A depicts snare loop 138 in an unconstrained or released configuration, deploying top stent 142. If the operator desires to adjust the position of main graft body 144, snare loop 138 can be tightened to effect re-constraint of top stent 142. Main graft body 144 can then be repositioned axially (in a cranial or caudal direction) until a more desired location below the renal arteries is reached. Snare loop 138 can then be loosened or released, resulting in redeployment of top stent 142 in the new location. The exemplary device of FIGS. 11 and 12A shows snare tube 136 in an asymmetric configuration relative to inner member 164.

[0199] In the embodiment of Figures 11 and 12A, the contralateral tether 152 and the ipsilateral tether 154 are shown secured to the tether wire 146 so that the tethers 152 and 154 are not pushed upward. Alternatively, the contralateral tether 152 and the ipsilateral tether 154 can be placed within the catheter. The tether wire can exit the catheter just above the tethers. The tether wire can be placed through the center of the tether and back into the catheter through a hole in the catheter just below the contralateral tether 152 and the ipsilateral tether 154. In this way, the contralateral tether 152 and the ipsilateral tether 154 can be pinned to a small length of wire outside the catheter. The contralateral tether 152 and the ipsilateral tether 154 can be released when the tether wire 146 is removed.

[0200] In a further alternative, the main graft body 144, top stent 142, and centering basket 162 are initially housed within the outer sheath 134. In this embodiment, once the outer sheath 134 is removed from the main graft body 144, the top stent 142 is deployed and the centering basket 162 can be pushed axially caudal to the aortic neck and into the main graft body 144. The centering basket 162 can be deployed within the main graft body 144 in the portion of the main graft body 144 closest to the heart. The centering basket 162 can then be retracted and the snare loop 138 can be released to deploy the top stent 142.

[0201] A fourth alternative embodiment of the stent-graft device is shown in Figure 12B, which illustrates an exemplary alternative to the stent-graft device of Figure 12A in which snare loop 138 and snare tube 136 are positioned outside the outer circumference of centering basket 162 but inside the outer circumference of outer sheath 134. In this example, when centering basket 162 is depressed, it passes through the center of snare loop 135, top stent 142, and inner member 164.

[0202] Without being bound by theory, it is believed that sheaths used within blood vessels naturally tend to straighten along a straight line. When a sheath is inserted into a curved blood vessel, the sheath may press against the vessel wall in an attempt to straighten itself. The force of the sheath against the vessel wall may depend on the material and its thickness. In one aspect, the wire or outer wall of an exemplary centering device (e.g., basket, balloon) has a greater outward "straightening" force than the sheath, so that the centering device does not collapse against the side of the blood vessel. In this manner, a stent-graft device may be centered within a blood vessel using an exemplary centering device.

[0203] In one embodiment, the pressure exerted by the centering basket wire or the outer wall of the centering balloon exerts sufficient force to hold the top stent in the center of the vessel against the force of the sheath. In another embodiment, the force exerted longitudinally by the sheath is sufficient to prevent the sheath from collapsing on itself (e.g., this may be useful for advancing the sheath and releasing the endograft). At the same time, the sheath can be flexible for "side-to-side" movement but more rigid longitudinally to minimize sheath straightening forces. The additional flexibility for "side-to-side" movement can avoid situations where the stent-graft device is pushed against the vessel wall and does not deploy symmetrically. In this embodiment, endoleaks can be minimized.

[0204] FIG. 13 shows a fifth stent-graft device embodiment having a symmetrical configuration of snare loops 138 relative to inner member 164. In this embodiment, FIG. 13 illustrates a stent-graft device having a top stent 142 with snare loops 138 threaded through eyelets 140 affixed over hooks 144, such that snare loops 138 have a degree of rotation about top stent 142 of greater than 360 degrees. In one embodiment, the degree of rotation can be between 360 degrees and 800 degrees, or approximately 540 degrees. In this manner, snare loops 138 can be symmetrically positioned relative to inner member 164, as shown in FIG. 13.

[0205] When snare loop 138 is used by an operator to draw top stent 142 into outer sheath 134 or to deploy top stent 142 to a desired location from outer sheath 134, top stent 142 is pulled symmetrically inward rather than pulled to one side. In this way, the stent-graft device can be maintained in a more central configuration relative to the target vessel.

[0206] In some embodiments, the bottom of the legs of the stent-graft device can be secured to the introducer by trigger wires that can be used to move the entire endograft up and down within the aorta without collapsing the stent-graft device. The stent-graft device can be secured at both its top and bottom between an upper lasso and a lower trigger wire (both of which can be released for final deployment).

[0207] 11 and 12A showing the snare loop 138 positioned within the snare tube 136 asymmetrically relative to the inner member 164. As shown in the right panel of FIG. 14, the snare tube 136 is shown to one side of the inner member 164.

[0208] Figure 15 provides an exemplary cross-sectional view of the embodiment shown in Figure 13 in which the ends of snare loop 138 are positioned symmetrically relative to inner member 164. As shown in Figure 15, the two strings of snare loop 138 are positioned on either side of concentric inner member 164 in a substantially symmetrical configuration.

[0209] In one embodiment, the main graft body, first limb gate, and second branch graft comprise ePTFE (polytetrafluoroethylene). In another embodiment, the ePTFE is an ultra-thin composite consisting of up to 10 or more ply layers, with layers as thin as about 0.00015 inches. Sintering can be performed at elevated temperatures with compression to adhere all ePTFE layers. In this embodiment, the ePTFE has unidirectional strength with layer orientation that prevents creep. In this embodiment, creep or migration of the ePTFE should be avoided or minimized, allowing for continuous expansion of the graft. In another embodiment, the ePTFE can be configured to be substantially impermeable to blood serum, for example, by the addition of FEP (fluorinated ethylene propylene) layer(s) to provide a blood seal. In a further embodiment, the total thickness of the sintered ePTFE is about 0.0015 inches.

[0210] In some embodiments, the main graft body, first limb gate, and second limb gate can be made of human or animal tissue or artificial tissue. See, e.g., Deeken et al., Differentiation of Biologic Scaffold Materials Through Physicomechanical, Thermal, and Enzymatic Degradation Techniques. Annals of Surgery, March 2012; U.S. Patent Application Publication No. US20180326120.

[0211] While the aspects described herein have been disclosed with reference to certain specific embodiments, numerous modifications, substitutions, and variations to the described aspects are possible without departing from the scope of the disclosure as defined in the appended claims. Accordingly, it is intended that the disclosure not be limited to the described aspects, but rather have the full scope defined by the language of the following claims, and equivalents thereof. The present invention includes the following inventions. [Invention 1] 1. A stent-graft system for repairing an aneurysm in a target vessel of a patient, comprising: a first stent; and a primary graft body, the primary graft body configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm. [Invention 2] 2. The stent-graft system according to claim 1, wherein the target vessel is selected from the group consisting of an infrarenal artery, a pararenal artery, a renal artery, a thoracic aorta, or a suprarenal artery. [Invention 3] 2. The stent-graft system of claim 1, wherein the first stent and the main graft body are in a substantially end-connected configuration. [Invention 4] 2. A stent-graft system according to claim 1, wherein the insertion site vessel has a diameter smaller than or equal to the diameter of the patient's femoral artery. [Invention 5] 2. The stent-graft system of claim 1, wherein the diameter of the stent-graft system in the constrained configuration is about 13 to about 22 French. [Invention 6] 2. The stent-graft system of claim 1, wherein the main graft body comprises a densified material. [Invention 7] 2. The stent-graft system of claim 1, wherein the first stent is encapsulated within a densified material. [Invention 8] 8. The stent-graft system according to claim 7, wherein the densified material is ePTFE. [Invention 9] 9. The stent-graft system according to claim 8, wherein the ePTFE is substantially free of pores. [Invention 10] 8. The stent-graft system of claim 7, wherein the first stent is encapsulated within at least two layers of ePTFE. [Invention 11] 2. The stent-graft system according to claim 1, wherein the insertion site blood vessel is selected from the group consisting of the brachial artery, the radial artery, the ulnar artery, the axillary artery, and the carotid artery. [Invention 12] 12. The stent-graft system according to claim 11, wherein the insertion site vessel is the axillary artery. [Invention 13] 13. The stent-graft system according to claim 12, wherein the insertion site vessel is the second or proximal third portion of the axillary artery. [Invention 14] 2. The stent-graft system according to claim 1, wherein the insertion site blood vessel is the subclavian artery. [Invention 15] 2. The stent-graft system of claim 1, further comprising a connection ring including a plurality of connectors adapted to receive a plurality of receptacles, said connection ring being disposed on said main graft body. [Invention 16] 16. The stent-graft system of claim 15, wherein the plurality of connectors and the plurality of receptacles are either integrally formed with the stent or spot welded into place. [Invention 17] 16. The stent-graft system of claim 15, further comprising a plurality of sutures disposed around the plurality of connectors and the plurality of receptacles. [Invention 18] 16. The stent-graft system of claim 15, wherein the expansion angle of the connecting rings is greater than about 90 degrees. [Invention 19] The stent-graft system according to claim 1, further comprising a first limb gate and a second limb gate. [Invention 20] 20. The stent-graft system of claim 19, wherein the first limb gate further comprises a first iliac leg component. [Invention 21] 21. The stent-graft system of claim 20, wherein the second limb gate includes a second iliac leg component. [Invention 22] A stent-graft system as described in invention 21, wherein the overlap of the first iliac leg component with the first limb gate is no larger in diameter than the overlap of the second iliac component with the second limb gate. [Invention 23] 22. The stent-graft system of claim 21, further comprising barbs disposed on one or more of the first iliac leg component and the second iliac leg component for securing the one or more of the first iliac leg component and the second iliac leg component to a blood vessel. [Invention 24] 22. The stent-graft system of claim 21, wherein the first iliac component and the second iliac component comprise a densified material. [Invention 25] 25. The stent-graft system of claim 24, wherein the densified material is ePTFE. [Invention 26] 20. The stent-graft system of claim 19, further comprising a second stent coupled to the caudal end of the first limb gate and a third stent coupled to the caudal end of the second limb gate. [Invention 27] 27. The stent graft system of claim 26, further comprising a tether disposed at the caudal end of each of the main graft body, the second stent, and the third stent for connection to a caudal positioning system. [Invention 28] 10. The stent-graft system of claim 1, further comprising: an annular element disposed within the main graft body; and a plurality of connecting members associated with a plurality of locations on the annular element, wherein the first stent has a first axial stent end and a second axial stent end, the main graft body has a first axial graft end and a second axial graft end, the annular element is located substantially adjacent to the first axial graft end, and the plurality of connecting members are configured to connect to the first axial stent end to maintain a substantially end-connected axial connection between the first stent and the main graft body. [Invention 29] 29. The stent-graft system of claim 28, wherein the plurality of connecting members protrude beyond the first axial graft end. [Invention 30] 30. The stent-graft system of claim 29, wherein the plurality of connecting members are circumferentially spaced apart. [Invention 31] 29. The stent-graft system of claim 28, wherein the substantially end-connected configuration includes a gap between the first stent and the first axial graft end. [Invention 32] 32. The stent-graft system according to claim 31, wherein the gap is about 0 to 2 mm. [Invention 33] 33. The stent-graft system of claim 32, wherein at least one of said plurality of connecting members extends across said gap. [Invention 34] A stent-graft system as described in Invention 1, further comprising a centering device adapted to be positioned and expanded within the inferior renal artery, wherein the main graft body can be repositioned within the inferior renal artery after the centering device is expanded. [Invention 35] 35. The stent-graft system of claim 34, wherein the centering device is selected from the group consisting of a centering basket and a centering balloon. [Invention 36] 36. The stent-graft system of claim 35, wherein the centering basket is expandable and at least a portion of the centering basket engages with the arterial wall above the renal arteries. [Invention 37] 36. The stent-graft system of claim 35, wherein the centering balloon is inflatable and at least a portion of the centering balloon engages the arterial wall above the renal arteries. [Invention 38] 1. A method of repairing an abdominal aortic aneurysm in a patient, comprising: puncturing a blood vessel at an entry site located above the patient's diaphragm to form a passageway in the entry site blood vessel; inserting a stent-graft system into the vascular passage at the insertion site, the stent-graft system including a first stent, a main graft body, a first limb gate, and a second limb gate; positioning the primary graft body of the stent-graft system within a target vessel of the patient; and deploying the main graft body of the stent-graft system into a target vessel of the patient. [Invention 39] 39. The method of claim 38, wherein the target vessel is selected from the group consisting of an infrarenal artery, a pararenal artery, a renal artery, a thoracic aorta, or a suprarenal artery. [Invention 40] 39. The method of claim 38, wherein the first stent and the main graft body are in a substantially end-to-end configuration. [Invention 41] 39. The method of claim 38, wherein said insertion site vessel has a diameter less than or equal to the diameter of a femoral artery from said patient. [Invention 42] 39. The method of claim 38, wherein the main graft body of the stent-graft system is substantially blood-sealed against the wall of the target vessel. [Invention 43] the stent-graft system further includes a first iliac leg component and a second iliac leg component, and the method positioning and deploying the first iliac leg component in a first branch of the iliac artery; and 39. The method of claim 38, further comprising positioning and deploying the second iliac leg component in a second branch of the iliac artery. [Invention 44] 44. The method of claim 43, wherein the first iliac leg component is substantially blood-sealed to the first branch of the iliac artery and the main body graft. [Invention 45] 44. The method of claim 43, wherein the second iliac leg component is substantially blood-sealed to the second branch of the iliac artery and the main body graft. [Invention 46] 39. The method of claim 38, wherein the main graft body is positioned within the target vessel in a constrained state using a guidewire. [Invention 47] 47. The method of claim 46, further positioning the primary graft body within the target vessel by partially unsheathing the primary graft body. [Invention 48] 48. The method of claim 47, wherein the main graft body is unconstrained after it is deployed within the target vessel. [Invention 49] 49. The method of claim 48, further comprising deploying a sealing stent within said main graft body. [Invention 50] 44. The method of claim 43, wherein the first iliac leg component is positioned in the first branch of the iliac artery using a guidewire constrained through the main graft body. [Invention 51] 51. The method of claim 50, further positioning the first iliac leg component in the first branch of the first iliac artery by partially unsheathing it. [Invention 52] 52. The method of claim 51, wherein the first iliac leg component is unconstrained after the first iliac leg component is deployed in the first branch of the iliac artery. [Invention 53] 53. The method of claim 52, wherein the second iliac leg component is positioned in the second branch of the iliac artery using a guidewire constrained through the main graft body. [Invention 54] 54. The method of claim 53, further positioning the second iliac leg component in the second branch of the second iliac artery by partially unsheathing it. [Invention 55] 55. The method of claim 54, wherein the second iliac leg component is unconstrained after the second iliac leg component is deployed in the second branch of the iliac artery. [Invention 56] 39. The method of claim 38, wherein the stent-graft system further comprises a connecting ring, the first stent comprises a plurality of receptacles, the connecting ring comprises a plurality of connectors adapted to receive the plurality of receptacles, the connecting ring is disposed on the main graft body, and the first stent and the main graft body are in a substantially end-connected configuration. [Invention 57] 57. The method of claim 56, wherein the plurality of connectors are angled relative to the plurality of receptacles. [Invention 58] 58. The method of claim 57, further comprising a plurality of sutures disposed around the plurality of connectors and the plurality of receptacles. [Invention 59] 44. The method of claim 43, further comprising barbs disposed on one or more of the first iliac leg component and the second iliac leg component for securing the one or more of the first iliac leg component and the second iliac leg component to a blood vessel. [Invention 60] 39. The method of claim 38, wherein the stent-graft system further comprises a second stent coupled to the caudal end of the first limb gate and a third stent coupled to the caudal end of the second limb gate. [Invention 61] 61. The method of claim 60, wherein the stent-graft system further comprises a tether disposed at the caudal end of each of the main graft body, the second stent, and the third stent for connecting to a positioning system. [Invention 62] 39. The method of claim 38, wherein the insertion site vessel is selected from the group consisting of the brachial artery, radial artery, ulnar artery, axillary artery, and carotid artery. [Invention 63] 63. The method of claim 62, wherein the insertion site vessel is the axillary artery. [Invention 64] 64. The method of claim 63, wherein the insertion site vessel is the second or proximal third portion of the axillary artery. [Invention 65] 39. The method of claim 38, wherein the insertion site vessel is the subclavian artery. [Invention 66] 39. The method of claim 38, wherein the annular element is disposed within the main graft body, a plurality of connecting members are associated with a plurality of locations on the annular element, the first stent has a first axial stent end and a second axial stent end, the main graft has a first axial graft end and a second axial graft end, the annular element is disposed at a position substantially adjacent to the first axial graft end, and the plurality of connecting members are configured to connect to the first axial stent end to maintain a substantially end-connected axial connection between the first stent and the main graft body. [Invention 67] 67. The method of claim 66, wherein the plurality of connecting members protrude beyond the first axial graft end. [Invention 68] 68. The method of claim 67, wherein the plurality of connecting members are circumferentially spaced apart. [Invention 69] 67. The method of claim 66, wherein the substantially end-connected configuration includes a gap between the first stent and the first axial graft end. [Invention 70] 69. The method of claim 69, wherein the gap is about 0 to 2 mm. [Invention 71] 70. The method of claim 69, wherein at least one of the plurality of connecting members extends across the gap. [Invention 72] 1. An endograft deployment system for deploying an endograft in a target vessel of a subject, comprising: the outer tube comprising a central inner member comprising an endograft, and a carrier tube comprising a tether wire, the tether wire having a caudal end and a more cranial portion; a top stent surrounding the central inner member, the top stent including a plurality of hooks having a plurality of receptacles; and a plurality of sutures, wherein a first end of at least a first suture is disposed through one of the plurality of receptacles for holding the top stent in a constrained configuration, and a second end of the first suture is attached to the more cranial portion of the tether wire; An endograft deployment system, wherein movement of the tether wire controls removal of the plurality of sutures from the plurality of receptacles, releases the top stent from a constrained configuration to an unconstrained configuration, and removes the plurality of sutures from the blood vessel of the subject. [Invention 73] 73. The endograft deployment system of claim 72, wherein the first end of the at least first suture is formed into a loop, and the loop is positioned around the caudal end of the tether wire. [Invention 74] 73. The endograft deployment system of claim 72, further comprising a shelf positioned below the first end of the at least first suture to initially retain the first end of the at least first suture above the shelf and to retain the second end of the at least first suture below the shelf. [Invention 75] 75. The endograft deployment system of claim 74, wherein the shelf portion further comprises a first opening for receiving the central inner member. [Invention 76] 76. The endograft deployment system of claim 75, further comprising a second opening for receiving the carrier tube. [Invention 77] 77. The endograft deployment system of claim 76, further comprising a third opening for receiving at least one of the plurality of sutures. [Invention 78] 1. A method of deploying a stent-graft in a patient, comprising: puncturing a first femoral artery and a second femoral artery and forming a passageway in each of said femoral arteries; inserting a stent-graft into a passageway of either the first femoral artery or the second femoral artery with a stent-graft deployment system, the stent-graft deployment system including: an outer tube including a central inner member including an endograft; a carrier tube including a tether wire, the tether wire having a caudal end and a more cranial portion; a top stent surrounding the central inner member, the top stent including a plurality of hooks having a plurality of receptacles; and a plurality of sutures, wherein a first end of at least the first suture is disposed through one of the plurality of receptacles to hold the top stent in a constrained configuration and a second end of the first suture is attached to the more cranial portion of the tether wire; Actuating the tether wire to remove the plurality of sutures from the plurality of receptacles and release the top stent from a constrained configuration to an unconstrained configuration; and removing the plurality of sutures from the subject's blood vessel. [Invention 79] 79. The method of claim 78, wherein the first end of the at least first suture is formed into a loop, and the loop is placed around the caudal end of the tether wire. [Invention 80] 79. The method of claim 78, further comprising a shelf positioned below said first end of said at least first suture for initially retaining said first end of said at least first suture on said shelf. [Invention 81] 81. The method of claim 80, wherein the shelf further comprises a first opening for receiving the central inner member. [Invention 82] 82. The method of claim 81, further comprising a second opening for receiving said carrier tube. [Invention 83] 83. The method of claim 82, further comprising a third opening for receiving at least one of said plurality of sutures. [Invention 84] 1. A stent-graft system for repair of an aneurysm in a target vessel comprising a primary graft body including a sealing stent at least partially disposed therein, the primary graft body being configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm. [Invention 85] 85. The stent-graft system of claim 84, wherein the sealing stent has a plurality of struts, the plurality of struts having a strut width of about 0.013 to 0.016 inches. [Invention 86] 85. The stent-graft system of claim 84, wherein the sealing stent has a plurality of struts, the plurality of struts having a strut wall thickness of about 0.016 to about 0.020 inches. [Invention 87] 85. The stent-graft system of claim 84, wherein the main graft body has a first axial end and a second axial end, the sealing stent is disposed adjacent the first axial end, and the sealing stent further comprises a plurality of hooks. [Invention 88] 88. The stent-graft system of claim 87, wherein each of said plurality of hooks extends beyond said first axial end of said main graft body. [Invention 89] 88. The stent-graft system of claim 87, wherein each of the plurality of hooks further comprises a radiopaque marker. [Invention 90] 88. The stent-graft system of claim 87, wherein each of said plurality of hooks can be oriented in a right-handed or left-handed orientation. [Invention 91] 91. The stent-graft system of claim 90, wherein the orientation of each of the plurality of hooks is different from that of adjacent hooks. [Invention 92] 88. The stent-graft system of claim 87, wherein the plurality of hooks are adapted to be reversibly retained by looped wires for repositioning of the main graft body below the renal arteries. [Invention 93] 93. The stent-graft system of claim 92, wherein the looped wire is inserted into the target vessel through a recapture sheath. [Invention 94] 94. The stent-graft system of claim 93, wherein the recapture sheath is about 2 to 4 French. [Invention 95] 93. The stent-graft system of claim 92, wherein the plurality of hooks further comprises a plurality of hook eyelets. [Invention 96] 96. The stent-graft system of claim 95, wherein the looped wire is removably inserted through at least one of the plurality of hook eyelets. [Invention 97] 1. A method of positioning a main graft body of a stent-graft system within a target vessel of a subject, comprising: advancing a main graft body delivery system to a target location in the target vessel, the main graft body delivery system including the main graft body and a centering device; positioning the primary graft body within the target vessel at a first position at the target location; determining whether the first position of the main graft body is at the center of the target location within the target vessel; if the first position of the main graft body is not centered at the target location within the target vessel, deploying the centering device within the target vessel to a centered position; and If the first position of the main graft body is not at the center of the target location within the target vessel, repositioning the main graft body within the target vessel from the center position to a determined second position. [Invention 98] 98. The method of claim 97, wherein the centering device is selected from the group consisting of a centering basket and a centering balloon. [Invention 99] 99. The method of claim 98, wherein the centering basket is expandable and at least a portion of the centering basket engages the wall of the target vessel. [Invention 100] 99. The method of claim 98, wherein the centering balloon is inflatable and at least a portion of the centering balloon engages the wall of the target vessel. [Invention 101] 98. The method of claim 97, wherein the main graft body delivery system further includes a sheath containing the main graft body, and the sheath is retracted to expose the main graft body below the renal arteries before positioning the main graft in the target vessel. [Invention 102] 99. The method of claim 98, wherein the sheath further comprises the centering device, and further retracting the sheath exposes the centering device within the target vessel prior to deploying the centering device. [Invention 103] The method of invention 97, wherein the main graft delivery system further comprises a main graft body restraining device and a main graft body release device, the main graft body restraining device maintaining the head end of the main graft body in a restrained configuration and the main graft body release device inducing release of the main graft body to an unrestrained configuration. [Invention 104] 104. The method of claim 103, wherein the restraining device comprises a main graft body restraining wire adapted to control the position of the main graft body. [Invention 105] 104. The method of claim 103, wherein the main graft body release device comprises a snare loop adapted to release the main graft within the target vessel. [Invention 106] The method of invention 105, wherein the snare loop can re-restrain the head end of the main graft body after expansion of the head end of the main graft body and control repositioning of the main graft body within the target vessel. [Invention 107] 106. The method of claim 105, further comprising removing the snare loop from the subject. [Invention 108] 98. The method of claim 97, wherein the main graft body has a caudal end and a cranial end, and the location of the first position is determined by the location of a marker on the cranial end of the main graft body. [Invention 109] 109. The method of claim 108, wherein the marker is located caudal to the renal artery. [Invention 110] 104. The method of claim 103, further comprising securing the caudal end of the main graft body to the main graft body restraining device with a trigger wire. [Invention 111] 1. A stent-graft system for repairing an aneurysm in a target vessel, comprising: a top stent having a plurality of positioning receptacles; a primary graft body, wherein the top stent and the primary graft body are in a substantially end-to-end configuration, and the top stent and the primary graft body are disposed about an inner member; and a snare tube including a snare loop, wherein a first end of the snare loop is disposed within the snare tube, and a second end of the snare loop passes from the snare tube through the positioning receptacle and is disposed within the snare tube around the inner member, the snare tube being parallel to the inner member, and the first end of the snare loop being adjacent to the second end of the snare loop; The stent-graft system is configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm. [Invention 112] 112. A stent-graft system as described in claim 111, wherein each of the plurality of positioning receptacles further includes an eyelet, and wherein the second end of the snare loop is positioned through at least one eyelet. [Invention 113] 112. The stent-graft system of claim 111, further comprising an outer sheath disposed about the inner member. [Invention 114] 112. A stent-graft system according to claim 111, wherein the insertion site vessel has a diameter less than or equal to the diameter of the patient's femoral artery. [Invention 115] 112. The stent-graft system of claim 111, wherein the diameter of said stent-graft system in the constrained configuration is from about 13 to about 22 French. [Invention 116] 112. The stent-graft system of claim 111, wherein the main graft body comprises a densified material. [Invention 117] 112. The stent-graft system of claim 111, wherein the main graft body is bifurcated and further comprises a first limb gate and a second limb gate. [Invention 118] 118. The stent-graft system of claim 117, wherein the first limb gate includes a first iliac leg component. [Invention 119] 119. The stent-graft system of claim 118, wherein the second limb gate includes a second iliac leg component. [Invention 120] 112. The stent-graft system of claim 111, wherein the top stent and the main graft body are in a substantially end-to-end configuration. [Invention 121] 118. The stent-graft system of claim 117, further comprising a trigger wire for positioning the first limb gate and the second limb gate. [Invention 122] 122. The stent-graft system of claim 121, further comprising a first limb gated tether and a second limb gated tether. [Invention 123] 123. The stent-graft system of claim 122, wherein the first limb gate tether and the second limb gate tether can be held by the trigger wire. [Invention 124] 112. The stent-graft system of claim 111, further comprising a centering device for centering the main graft body within the infrarenal arteries. [Invention 125] A method for positioning a stent-graft system according to invention 113 in a target vessel, comprising: shortening the length of the snare loop, wherein the top stent is collapsed from a deployed configuration to a constrained configuration and the top stent is moved into an outer sheath; adjusting the location of the stent-graft system in the target vessel; and The method includes lengthening the snare loop, wherein the top stent is moved from the outer sheath and the top stent is expanded from a constrained configuration to a deployed configuration in the target vessel. [Invention 126] 1. A stent-graft system for repairing an aneurysm in a target vessel, comprising: a top stent having a plurality of positioning receptacles; a primary graft body, wherein the top stent and the primary graft body are in a substantially end-to-end configuration, and the top stent and the primary graft body are disposed about an inner member; and a snare loop positioned through the positioning receptacle at a rotational angle about the top stent greater than 360 degrees, the first end of the snare loop being positioned substantially symmetrically relative to the inner member; The stent-graft system, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm. [Invention 127] 127. A stent-graft system as described in claim 126, wherein each of the plurality of positioning receptacles further includes an eyelet, and the second end of the snare loop is positioned through at least one eyelet. [Invention 128] 127. The stent-graft system of claim 126, further comprising an outer sheath disposed about the inner member. [Invention 129] 127. A stent graft system as described in claim 126, wherein the insertion site vessel has a diameter smaller than or equal to the diameter of the patient's femoral artery. [Invention 130] 127. The stent-graft system of claim 126, wherein the diameter of said stent-graft system in the constrained configuration is from about 13 to about 22 French. [Invention 131] 127. The stent-graft system of claim 126, wherein the main graft body comprises a densified material. [Invention 132] 127. The stent-graft system of claim 126, wherein the main graft body is bifurcated and further comprises a first limb gate and a second limb gate. [Invention 133] 133. The stent-graft system of claim 132, wherein the first limb gate comprises a first iliac leg component. [Invention 134] 134. The stent-graft system of claim 133, wherein the second limb gate includes a second iliac leg component. [Invention 135] 127. The stent-graft system of claim 126, wherein the top stent and the main graft body are in a substantially end-connected configuration. [Invention 136] 133. The stent-graft system of claim 132, further comprising a trigger wire for positioning the first limb gate and the second limb gate. [Invention 137] 137. The stent-graft system of claim 136, further comprising a first limb gated tether and a second limb gated tether. [Invention 138] 138. The stent-graft system of claim 137, wherein the first limb gate tether and the second limb gate tether can be held by the trigger wire. [Invention 139] A method for positioning a stent-graft system according to claim 128 in a target vessel, comprising: shortening the length of the snare loop, wherein the top stent is collapsed from a deployed configuration to a constrained configuration and the top stent is moved into the outer sheath; adjusting the location of the stent-graft system in the target vessel; and The method includes lengthening the snare loop, wherein the top stent is moved from the outer sheath and the top stent is expanded from a constrained configuration to a deployed configuration in the target vessel.

Claims

1. 1. A stent-graft system for repair of an aneurysm in a target vessel of a patient, comprising: a primary graft body including a bifurcated second end and a first end including a first limb gate and a second limb gate; at least one stent constrained to the main graft body; a delivery sheath positioned to constrain a primary graft body, the delivery sheath being retracted to first expose the bifurcated second end of the primary graft body and thereafter expose the first end of the primary graft body; a leg component protruding beyond each of the first limb gate and the second limb gate; Equipped with the primary graft body is configured to be inserted through a single arterial puncture or incision in an insertion site vessel located above the patient's diaphragm; The stent-graft system.

2. The stent-graft system of claim 1 further comprising a centering device that facilitates centering and positioning of the main graft body.

3. 2. The stent-graft system of claim 1, wherein the at least one stent comprises a first stent adjacent a first end of the main graft body, and comprises first and second tethers configured to substantially secure a distal end of the main graft body to a first nosecone to allow traction and prevent collapse of the main graft body during deployment.

4. 10. The stent-graft system of claim 1, wherein the at least one stent comprises a first stent adjacent a first end of the main graft body, the stent-graft system further comprising a connecting ring connecting the first stent to the main graft body.

5. 2. The stent-graft system of claim 1, wherein the at least one stent includes a first stent adjacent a first end of the main graft body, and the stent-graft system further includes a snare loop disposed through a snare tube, the first stent including an eyelet, and the snare loop being threaded through the eyelet.

6. 10. The stent-graft system of claim 1, further comprising a second stent coupled to the caudal end of the first limb gate and a third stent coupled to the caudal (i.e., the end closest to the tail or bottom of the body) end of the second limb gate.

7. 7. The stent-graft system of claim 6, further comprising an inner member passing from the delivery sheath through the main graft body to a location beyond the first and second limb gates, a wire holder coupled to the inner member at a location beyond the first and second limb gates, and first and second limb tethers coupled to the second and third stents, respectively.

8. The stent-graft system of claim 1 wherein the main graft body comprises a densified material.

9. The stent-graft system of claim 1, wherein the at least one stent is encapsulated within a densified material.

10. The stent-graft system of claim 8 or 9, wherein the densified material is ePTFE.

11. The stent-graft system of claim 1 further comprising another stent disposed on the main graft body between the first end and the bifurcated second end.

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