Systems and methods for introducing a stent-graft device into a blood vessel

Abstract

Systems and methods for repairing aneurysms (e.g., abdominal aneurysm) are provided. The systems and methods provide stent-graft systems having a first stent and a main graft body wherein the main graft body is configured to be inserted through a blood vessel into a target blood vessel. In some instances, the first stent and the main graft body can be in a substantially end-to-end configuration. In some instances, the stent-graft systems and methods are configured for use in a single arterial puncture or incision in, for example, a blood vessel with a diameter less than or equal to the diameter of a femoral artery from the same patient or subject.

Description

SYSTEMS AND METHODS FOR INTRODUCI NG A STENT-GRAFT DEVICEI NTO A BLOOD VESSELInventors:Andrew KerrDavid MajercakAlan Schuster i

[0001] All references cited herein, including but not limited to patents and patent applications, are incorporated by reference in their entirety.CROSS-REFERENCE TO RELATED APPLICATION

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 516,943, filed August 1, 2023, the entirety of which is hereby incorporated by reference for all purposes.BACKGROU ND OF THE I NVENTION

[0003] An aneurysm is an abnormal enlargement or bulge in a blood vessel. Aortic aneurysms can cause embolization in to branch vessels, aortic thrombosis, and aortic rupture. Damaged blood vessels can be treated or repaired by surgery or by endovascular graft placement.

[0004] The aorta is the largest artery in the body originating from the left ventricle of the heart and extending into the abdomen. It bifurcates into the two iliac arteries. Arterial aneurysms (AA) occur in every part of 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).

[0005] AAs are typically repaired with open surgery or endovascular aneurysm repair (EVAR). EVAR is touted as a minimally invasive procedure that utilizes stent-graft devices to repair an AA. A stent-graft device is a combination device that includes a stent portion and a graft portion connected to each other such that they can be deployed together to repair damage to a blood vessel.

[0006] A stent is typically an expandable metal lattice device inserted into a blood vessel and expanded to open a constricted, damaged or occluded blood vessel. In addition to opening the blood vessel, a stent can provide a rigid structural support to prevent the blood vessel from re-closing. Stents are often used together with balloon angioplasty.

[0007] A prosthetic graft is a medical device that can be used to replace or repair a diseased blood vessel. The graft can be made of a synthetic material (e.g., ePTFE, polyester) that can be expanded to approximate the diameter of the blood vessel in need of repair. The graft material provides a blood-tight seal such that it can support normal blood flow without leakage.

[0008] A stent-graft device can provide a combination of substantially blood-tight seal from the graft with the support structure of a stent to prevent the stent-graft device from dislodgment under the pressure of normal blood flow. The combination of the stent with the prosthetic graft can be used to hydraulically isolate an aneurysm when positioned across the neck of the aneurysm. However, connecting and deploying components of stent-graft devices has proved to be challenging because the delivery system profile (i.e., outer diameter of the delivery sheath) of a stent-graft device can besignificant, making the device more difficult to insert, to navigate the target anatomy, and to deploy. In order to address these issues, several low-profile stent-graft devices have been developed by an inventor of the present application including, for example, as 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.

[0009] AAs are often asymptomatic and frequently occur in people over the age of 65 years. The mortality rate of AAs, if untreated, is high and as such, early detection and repair is important. EVAR is preferred to open surgery as a less invasive alternative for those aortic aneurysm patients who are appropriate candidates. Although safer, faster, and less invasive than open surgical repair, EVAR can still be difficult, lengthy, and produce post procedural morbidity.

[0010] The EVAR procedure for intrarenal aortic aneurysm typically requires one puncture or incision in each of the femoral arteries followed by maneuvering the constrained stent-graft device in an upward, cephalad direction (femoral approach) into position in the intrarenal aorta over a guidewire constrained in an introducer sheath. A portion of the stent-graft device is deployed in the intrarenal aorta. Next, the stent-graft device is positioned and deployed in one iliac artery. Another stent-graft device is then positioned and deployed in the other iliac artery second via the puncture or incision in the other femoral artery. Such procedures rely on inserting and deploying stent-graft devices from below the diaphragm of a subject or patient.

[0011] As summarized, the standard EVAR procedure requires bilateral femoral punctures (i.e., one puncture or incision in each femoral artery) for arterial access, in addition to making fine positioning movements for the stent-graft device from a femoral approach orientation (from below the diaphragm). While superior to open surgery, EVAR, as described above, requires patient recovery from the bilateral femoral punctures used for access. Patients often remain at bedrest for several days, require pain medication, and thereby incur additional costs (e.g., hospital stay, medication, loss of time at work).

[0012] The delivery system profile of currently available stent-graft devices restricts the blood vessels that can be a target for introduction of these devices. Such devices have a wide diameter due, in part, to how the components of the stent-graft device are arranged in catheter-based systems used for their delivery and / or connected to each other.

[0013] What is needed are improved low-profile stent-graft systems and methods of repairing aneurysms that are lower in profile and, as such, easier to deploy in lower diameter blood vessels and with less post procedure morbidity and patient discomfort than currently available stent-graft devices.SUMMARY

[0014] Stent-graft systems and methods described herein provide, in some aspects, low profile stentgraft devices configured to be introduced / inserted in a blood vessel located above the diaphragm of the patient and deployed in a "top down" approach. Additional aspects provide low profile stent-graft devices configured to be inserted / introduced in a blood vessel located below the diaphragm of the patient and deployed in a "top down" approach. Exemplary systems and methods for adjusting the placement of stent-graft devices in a target blood vessel (e.g., infrarenal aorta, juxtarenal aorta, pararenal aorta, thoracic aorta, or suprarenal aorta) after an initial deployment are also provided. Further aspects describe a centering device for use in centering the deployed location of stent-graft devices in a target blood vessel.

[0015] One aspect described herein is directed to a first stent-graft system for repair of an aneurysm in a target blood vessel having a first stent, and a main graft body wherein the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of a patient. In a further aspect described herein, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an assertion site blood vessel located below a diaphragm of the patient.

[0016] Another aspect provides a first method of repairing an abdominal aortic aneurysm in a patient, by puncturing an insertion site blood vessel located above a diaphragm of the patient and creating a passage in the insertion site blood vessel. The stent-graft system can be inserted in the passage of the insertion site blood vessel. The stent-graft system can comprise a main graft body that bifurcates 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, in a target blood vessel of the patient. A further aspect provides a method of repairing an abdominal aortic aneurysm in a patient, by puncturing an insertion site blood vessel located below a diaphragm of the patient and creating a passage in the insertion site blood vessel.

[0017] Further aspects provide a second stent-graft system (e.g., an endograft deployment system) for deploying an endograft in a target blood vessel of a patient or subject. In some instances of the second stent-graft system, the endograft can be deployed from below the diaphragm of a patient or subject. The endograft deployment system can have an outer tube comprising a central inner member comprising an endograft and a carrier tube comprising a tether wire. The tether wire can have a caudad end and a more cephalad portion (i.e., end closest to the head or top of the body). The endograft deployment system can have a top stent surrounding the central inner member, wherein the top stent comprises a plurality of hooks having a plurality of receptacles and a plurality of sutures.

[0018] In some instances of the second stent-graft system, a first end of at least a first suture can be disposed through one of the plurality of receptacles for retaining the top stent in a constrained configuration. A second end of the first suture can be affixed to the more cephalad portion of the tether wire. Movement of the tether wire can control removal of the plurality of sutures from the plurality of receptacles, release the top stent from a constrained to an unconstrained configuration, and remove the plurality of sutures from the blood vessel of the patient or subject.

[0019] One aspect described herein provides a second method of deploying a stent-graft in a patient or subject, by puncturing in a first femoral artery and a second femoral artery and creating a passage in each of the femoral arteries and inserting a stent-graft in a passage of either the first femoral artery or the second femoral artery with a stent-graft deployment system comprising an outer tube comprising a central inner member comprising an endograft and a carrier tube comprising a tether wire. In some instances of the second method, the endograft can be deployed from above the diaphragm or below the diaphragm of a patient or subject.

[0020] In some instances of the second method, the tether wire has a caudad end and a more cephalad portion. A top stent can surround the central inner member, wherein the top stent comprises a plurality of hooks having a plurality of receptacles. Some instances of the second method can further include a plurality of sutures, wherein a first end of at least a first suture is disposed through one of the plurality of receptacles for retaining the top stent in a constrained configuration, and a second end of the first suture is affixed to the more cephalad portion of the tether wire.

[0021] The tether wire can be moved to remove the plurality of sutures from the plurality of receptacles, release the top stent from a constrained to an unconstrained configuration, and remove the plurality of sutures from a blood vessel of the patient or subject. In some instances, the tether wire is removed, and the sutures can be left in the patient.

[0022] Aspects described herein provide a third stent-graft system for repair of an aneurysm in a target blood vessel comprising a main graft body comprising a sealing stent at least partially disposed in the main graft body, wherein the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of a patient. The main-graft body is configured to be inserted through a single arterial puncture or incision in an insertion blood vessel located above a diaphragm of a patient. In a further aspect, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an assertion site blood vessel located below a diaphragm of the patient.

[0023] Further aspects described herein provide a third method of positioning a main graft body of a stent-graft system in a target blood vessel (e.g., infrarenal aorta, juxtarenal aorta, pararenal aorta, thoracic aorta, or suprarenal aorta) of a subject by advancing a main graft body delivery system to a target location in the target blood vessel. The main graft body delivery system can include the main body graft and a centering device. The main graft body can be positioned in the target blood vessel in a first position at the target location and it can be determined if the first position of the main graft body is centered in the target blood vessel at the target location. In some instances, the third method can be directed to inserting the main graft body through a single arterial puncture or incision in an insertion blood vessel located above a diaphragm of a patient. In further instances, the third method can be directed to inserting the main graft body through a single puncture or incision in an insertion blood vessel located below a diaphragm of a patient.

[0024] The centering device can be deployed in the target blood vessel in a centered position if the first position of the main graft body is not centered in the target blood vessel at the target location. The main graft body can be repositioned in the target blood vessel in a second position determined from the centered position if the first position of the main graft body is not centered in the target blood vessel at the target location.

[0025] Aspects described herein provide a fourth stent-graft system for repair of an aneurysm in a target blood vessel, comprising a top stent having a plurality of positioning receptacles and a main graft body wherein the top stent and the main graft body are in a substantially end-to-end configuration. The top stent and the main graft body can be disposed around an inner member. The stent-graft system includes a snare tube comprising a snare loop. A first end of the snare loop can be disposed in the snare tube. A second end of the snare loop can be disposed from the snare tube, through the positioning receptacles, around the inner member, and into the snare tube. The snare tube can be parallel to the inner member and a first end of the snare loop can be adjacent to the second end of snare loop. The stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient. In a further aspect, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient.

[0026] Further aspects provide a fifth stent-graft system for repair of an aneurysm in a target blood vessel, comprising a top stent having a plurality of positioning receptacles and a main graft body wherein the top stent and the main graft body are in a substantially end-to-end configuration and wherein the top stent and the main graft body are disposed around an inner member. The stent-graftsystem can include a snare loop disposed through the positioning receptacles with a degree of rotation around the top stent of greater than 360 degrees. A first end of the snare loop can be disposed substantially symmetrically with respect to the inner member. The stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient. In another aspect, the main-graft body is configured to be inserted through a single arterial puncture or incision in an insertion blood vessel located above a diaphragm of a patient. In a further aspect, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient. In another aspect, the main-graft body is configured to be inserted through a single arterial puncture or incision in an insertion blood vessel located below a diaphragm of a patient.

[0027] Further aspects provide a stent-graft system for repair of an aneurysm in a target blood vessel of a patient. The stent-graft including: a main graft body having a first end (e.g., superior end, cephalad end) and a second end (e.g., inferior end, bifurcated end); and a stent connected to (e.g., disposed at least partly with and / or constrained on) the main graft body; where the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0028] Further aspects provide a stent-graft system for repair of an aneurysm in a target blood vessel of a patient. The stent-graft including: a main graft body having a first end (e.g., superior end, cephalad end) and a second end (e.g., inferior end, bifurcated end); and a stent connected to (e.g., disposed at least partly with and / or constrained on) the main graft body; where the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient.

[0029] Aspects described herein relate to a method of repairing an abdominal aortic aneurysm in a patient. The method including puncturing an insertion site blood vessel located above a diaphragm of the patient and creating a passage in the insertion site blood vessel; inserting a stent-graft system in a passage of the insertion site blood vessel, the stent-graft system including a top stent and a main graft body in a constrained circumferentially collapsed configuration; positioning the main graft body of the stent-graft system in a target blood vessel of the patient; and deploying the top stent and the main graft body of the stent-graft system in the target blood vessel of the patient.

[0030] Further aspects relate to a stent-graft system for repair of an aneurysm in a target blood vessel of a patient including: a main graft body having a first end and a second end; a stent connected to (e.g., disposed at least partly with and / or constrained on) the main graft body; a delivery sheath to positionthe main graft body and the stent at a location in the target blood vessel in proximity to the aneurysm, the delivery sheath being oriented relative to the main graft body and the at least one stent so that removal (and / or retraction) of the delivery sheath) from the target blood vessel initially exposes the second end (e.g., inferior end) of the main graft body and subsequently exposes the first end (e.g., superior end) of the main graft body, where the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0031] Some aspects relate to a graft system for repair of an aneurysm in a target blood vessel of a patient. The system including: a main graft body having a first end (e.g., superior end, cephalad end) and a second end (e.g., inferior end, bifurcated end); a coupling member (e.g., hook, barb, surface texture, suture, or any other coupling feature known in the art) for coupling the main graft body to a target blood vessel (e.g., coupling the main graft body to the interior wall surface of the target blood vessel); a constraining member (e.g., the constraining member may include a snare loop, and / or other device provided over and / or constraining the main graft body) for selectively adjusting the stent between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; and a catheter (e.g., inner member, delivery sheath, an outer sheath, a loading sheath, an outer layer) to position the main graft body at a location in the target blood vessel in proximity to the aneurysm, where the main graft body is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter, where the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0032] In some aspects, the present disclosure relates to a stent-graft system for repair of an aneurysm in a target blood vessel of a patient. The system including: (1) a first stent-graft device including: a main graft body having a superior end (e.g., cephalad end) and an inferior end, and a stent connected to (e.g., disposed at least partly with and / or constrained on) the main graft body adjacent the superior end; a first limb (e.g., ipsilateral limb) coupled to and extending distally from the inferior end of the main graft body; a second limb (e.g., contralateral limb) coupled to and extending distally from the inferior end of the main graft body; (2) a second stent-graft device including: a second main graft body having a superior end (e.g., cephalad end) and an inferior end, and a stent connected to (e.g., disposed at least partly with and / or constrained on) the second main graft body adjacent the superior end; a third limb (e.g., external iliac leg limb) coupled to and extending from an inferior end of the first limb, the third limb sized and configured to be received within the external iliac artery; a fourth limb (e.g., internal iliacleg limb) coupled to and extending from the inferior end of the first limb, the fourth limb sized and configured to be received within the internal iliac artery; (3) a first iliac stent device including: a graft body having a superior end (e.g., cephalad end) and an inferior end; and a stent connected to (e.g., disposed at least partly with and / or constrained on) the graft body; and (4) a second iliac stent device including: a graft body having a superior end and an inferior end; and a stent connected to the graft body of the second iliac stent, where first iliac stent device extends between a distal end of the first limb (e.g., ipsilateral limb) of the first stent-graft device and the superior end of the second main graft body of the second stent-graft device, where the second iliac stent device extends from a distal end of the second limb (e.g., contralateral limb) of the first stent-graft device, the second iliac stent device sized and configured to be received within a non-aneurysmal common iliac artery.BRI EF DESCRI PTION OF DRAWINGS

[0033] FIG. 1 is an exemplary drawing of the descending thoracic aorta, suprarenal abdominal aorta, renal arteries, infrarenal aorta, and the ipsilateral and contralateral iliac arteries;

[0034] FIG. 2A shows a front view and FIG. 2B shows a flattened side view of an exemplary stent-graft device in accordance with aspects described herein;

[0035] FIG. 3A shows an exemplary top stent portion of an exemplary stent-graft device, including connectors and receptacles;

[0036] FIG. 3B shows a close up of exemplary connector and receptacle portions connecting a top stent to a connecting ring in an exemplary stent-graft device;

[0037] FIGS. 3C and 3D show alternative configurations for the exemplary connectors and receptacles;

[0038] FIG. 4 shows an alternative configuration of the arms of an exemplary connecting ring;

[0039] FIG. 5 shows an exemplary configuration of an iliac leg component;

[0040] FIGS. 6A-6B show femoral positioning and deployment of a stent-graft device in a typical EVAR procedure;

[0041] FIGS. 7A-7D shows an exemplary deployment of a stent-graft device in accordance with aspects described herein wherein said device is inserted / introduced from an access point above the diaphragm (e.g., the axillary or brachial artery);

[0042] FIG. 8A shows an exemplary fine positioning of a main body of a stent-graft device in accordance with aspects described herein and FIG. 8B shows a close up view of the example of FIG. 8A;

[0043] FIG. 9 shows an alternative stent-graft deployment system that ensures removal of sutures used to guide the introduction and positioning of an exemplary stent-graft;

[0044] FIG. 10 shows a top-down view of an optional shelf for use with the alternative stent-graft deployment system shown in FIG. 9;

[0045] FIG. 11 shows an exemplary stent-graft device having a snare loop in a snare tube disposed asymmetrically around an inner member for adjusting the axial position of the stent-graft system in a blood vessel;

[0046] FIG. 12A shows the exemplary stent-graft device of FIG. 11 with a revealed optional centering device;

[0047] FIG. 12B illustrates an alternate embodiment of the device of FIG. 12A;

[0048] FIG. 13 shows an exemplary stent-graft device with a snare loop disposed through eyelets on a top stent with a degree of rotation of 540 degrees and snare loop ends disposed symmetrically around an inner member;

[0049] FIG. 14 shows cross sectional views of the exemplary devices of FIGS. 11 and 12A;

[0050] FIG. 15 shows cross sectional views of the exemplary device of FIG. 13;

[0051] FIG. 16 shows an exemplary stent-graft device having a snare loop selectively maintaining the stent in a constrained circumferentially collapsed configuration;

[0052] FIG. 17 shows the exemplary stent-graft device of FIG. 16 having a snare loop selectively maintaining the stent in an unconstrained circumferentially expanded configuration;

[0053] FIGS. 18A-18F show side views of the stent-graft device of FIG. 16 during deployment of the ipsilateral limb;

[0054] FIG. 19 shows an exemplary stent-graft device having a snare loop disposed through a plurality of eyelets positioned along a mid portion of the stent, the snare loop selectively maintaining the stent in an unconstrained circumferentially expanded configuration;

[0055] FIG. 20 shows the exemplary stent-graft device of FIG. 19 having a snare loop selectively maintaining the stent in a constrained circumferentially collapsed configuration;

[0056] FIG. 21 shows an exemplary stent-graft device having a first snare loop disposed through a plurality of eyelet positioned at a proximal end of the stent, and a second snare loop disposed through a plurality of eyelets positioned along a mid portion of the stent, the first and second snare loops selectively maintaining the stent in a constrained circumferentially collapsed configuration;

[0057] FIG. 22 shows the stent graft device of FIG. 21 within a target blood vessel;

[0058] FIG. 23 shows an exemplary stent-graft device having a main graft body provided adjacent a superior end of the stent and including a snare loop disposed through a plurality of eyelets positioned ata proximal end of the stent, the snare loop selectively maintaining the stent in a constrained circumferentially collapsed configuration;

[0059] FIG. 24 shows a side view of the exemplary stent-graft device of FIGS. 16-17 with a snare loop coupled to a trigger wire for selectively deploying the snare loop;

[0060] FIG. 25 shows a cross sectional view of the exemplary device of FIG. 24 along section line B-B of FIG. 17 in an unconstrained configuration;

[0061] FIG. 26 shows a cross sectional view of the exemplary device of FIG. 24 along section line C-C of FIG. 16 in a constrained configuration;

[0062] FIG. 27 shows a cross sectional view of the exemplary device of FIGS. 24 in a released configuration;

[0063] FIG. 28 shows an exemplary stent-graft device having a corset for selectively maintaining the top stent and the main graft body in a partially constrained / circumferentially collapsed configuration;

[0064] FIG. 29 is an enlarged view of a portion of the main graft body and corset of FIG. 28.

[0065] FIG. 30 shows a cross sectional view of FIG. 28 taken along section line A-A;

[0066] FIG. 31 shows a cross sectional view of FIG. 28 taken along section line A-A according to another example;

[0067] FIG. 32 shows a cross sectional view of FIG. 28 taken along section line A-A according to another example;

[0068] FIG. 33 shows an exemplary stent-graft device including a plurality of corsets for selectively maintaining the top stent and the main graft body in a constrained / circumferentially collapsed configuration;

[0069] FIG. 34 shows an enlarged partial view of the exemplary stent-graft device of FIG. 33;

[0070] FIG. 35 shows a cross sectional view of FIG. 34 taken along section line A-A;

[0071] FIG. 36 shows an enlarged partial view of the retaining member of FIG. 35;

[0072] FIG. 37 shows a partial side view of exemplary stent-graft device having a corset for selectively maintaining the top stent and the main graft body in a constrained / circumferentially collapsed configuration;

[0073] FIG. 38 shows a cross sectional view of FIG. 37 taken along section line A-A;

[0074] FIG. 39 shows an exemplary stent-graft device for use in repairing aortoiliac and iliac aneurysm;

[0075] FIGS. 40A-40F shows an exemplary deployment of a stent-graft device in accordance with aspects described herein wherein said device is inserted / introduced from an access point above the diaphragm (e.g., the axillary or brachial artery); and

[0076] FIGS. 41A-41B show an exemplary deployment of a stent-graft device in accordance with aspects described herein wherein said device is inserted / introduced from an access point below the diaphragm (e.g., the femoral artery).DETAI LED DESCRIPTION OF TH E I NVENTION

[0077] Stent-graft systems and methods are provided herein to improve the introduction, positioning, and deployment of stent-graft devices for repair of aneurysms. It is understood that stent-graft devices in accordance with aspects described herein can be used to repair aneurysms in any suitable blood vessel where access to the blood vessel is through arteries located above or below the diaphragm. Accordingly, it is understood that stent-graft devices in accordance with aspects described herein can be used to repair aneurysms in any suitable blood vessel from many different suitable insertion vessels, both above and below the diaphragm.

[0078] Contemporary stent-graft systems have an outer diameter of 14-24F (French) and are used in EVAR procedures via insertion of the stent-graft system from below the diaphragm. In current, typical EVAR procedures, two punctures or incisions are made - one in each femoral artery. Cannulation of each puncture is followed by positioning and deployment of a guidewire through each puncture, requiring additional time and increasing the potential risk of variation and error. In addition, closure of said punctures in both femoral arteries can be painful, increasing morbidity issues related to the EVAR procedure and thereby protracting a patient's recovery.

[0079] Thus, in accordance with some aspects described herein, stent-graft devices (or components thereof) are 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 can have a smaller diameter (e.g., ranging between about 6 to about 13 French or about 13 to about 22 French outer diameter profile) and can be positioned in, for example, the infrarenal aorta in a "top down" orientation for easier and faster positioning and deployment in the infrarenal aorta and the left and right iliac artery. The term "top down" refers to introducing or inserting a stent-graft device in an insertion blood vessel located above a diaphragm of a patient as described herein.

[0080] In some aspects, the "top down" approach is expected to substantively reduce the access time and challenges posed by the typical bilateral femoral artery approach since the bilateral approach requires access and instrumentation of devices in both legs of the patient and arteries in the legs of patient's suffering from abdominal aneurysms (for example) are often highly angulated and diseased making the set up of an EVAR procedure significantly more complex for interventionalists. In this aspect,the procedure is faster, less prone to error, and results in patient recovery from a puncture or incision in an artery located above the diaphragm of the patient. The access location (above the diaphragm) traverses many of the anatomical challenges of the typical EVAR procedure. Aspects described herein provide less tortuosity and lower risk of disease associated with the cannulation and placement of the necessary access devices / instruments that enable the EVAR procedure. Using the aspects described herein, the patient will also have less discomfort and a faster recovery, since "top down" access can be achieved using a single puncture (above the diaphragm access) technique contemplated herein.

[0081] In further examples, the exemplary stent-graft devices can be initially inserted into a femoral artery to provide access to an ipsilateral iliac artery or contralateral iliac artery. That is, for example, , the methods and devices disclosed herein can be used in alternate approaches, for example a "bottom up" approach, a "contra-ipsi" approach, or an "ipsi-contra" approach, to reduce or eliminate challenges posed by the typical bilateral femoral artery approach since the bilateral approach requires access and instrumentation of devices in both legs of the patient and arteries in the legs of patient's suffering from abdominal aneurysms (for example) are often highly angulated and diseased making the set up of an EVAR procedure significantly more complex for interventionalists. As a result, the procedure can be faster, less prone to error, and can result in faster patient recovery, for example by reducing the total number of incisions required to access patient physiology. In addition, the procedure according to the methods and devices disclosed herein can provide increased surgical access to patient physiology. Accordingly, using the aspects described herein, the patient will also have less discomfort, since surgical access can be achieved using a single puncture (below the diaphragm access) technique contemplated herein.

[0082] Aspects described herein provide a first stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising a first stent and a main graft body. In some instances 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 insertion site blood vessel located above or below the diaphragm of a subject or patient. In one aspect, the insertion site blood vessel has a diameter less than or equal to the diameter of a femoral artery of the patient.

[0083] The term "insertion site blood vessel" refers to a blood vessel into which a stent-graft device is initially inserted during a procedure for repair of a blood vessel (e.g., EVAR procedure).

[0084] The term "target blood vessel" refers to a blood vessel that is the site of repair for a disease or conditions (e.g., aortic aneurysm). The target blood vessel can include, but is not limited to, the infrarenal aorta, the juxtarenal aorta, the pararenal aorta, the thoracic aorta, or the suprarenal aorta. Insome implementations, the target blood vessel is a branch vessel selected from the group consisting of the superior mesenteric artery, celiac artery, renal arteries, and inferior mesenteric artery.

[0085] The term "stent" refers to a mesh or lattice tube structure made of, for example, super-elastic nitinol thin wire or laser cut from tubing (or any other suitable material, for example, titanium, or chromium cobalt alloy), that can be inserted into a blood vessel in a constrained state and deployed in an unconstrained state.

[0086] The term "constrained" refers to a configuration of the stent-graft system, or components of the stent-graft system, such that its diameter is at a minimum or smaller amount compared to a fully expanded or "unconstrained" configuration of the stent-graft system, or components thereof. The constrained configuration of the stent-graft system can be at a small enough diameter to be introduced into an insertion site blood vessel located above the diaphragm and / or having a diameter less than or equal to the diameter of a femoral artery of the patient.

[0087] In some embodiments of the first stent-graft system, the target blood vessel is selected from the group consisting of an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta.

[0088] In some embodiments of the first stent-graft system, the first stent and the main graft body are in a substantially end-to-end configuration. In some embodiments of the first stent-graft system, the insertion site blood vessel is located above a diaphragm of the patient. In further embodiments of the first stent-graft system as described herein, the insertion site blood vessel is located below the diaphragm of the patient. In another embodiment of the first stent-graft device, the diameter of the stent-graft system in a constrained configuration can be from about 13 to about 22 French. In another embodiment, the diameter of the stent-graft system in a constrained configuration can be from about 6 to about 13 French.

[0089] In a further embodiment of the first stent-graft device, the main graft body comprises a densified material. In some instances, the first stent is encapsulated within a densified material (e.g., at least one layer or two layers of polytetrafluoroethylene or ePTFE). In some instances, the ePTFE is substantially free of pores.

[0090] The term "densified material" refers to a material (e.g., ePTFE) that has been modified to increase its density in comparison to the same material that has not been modified. 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 mechanical, compressive force.

[0091] A densified material has same or greater tensile strength than a non-densified material and can be thinner than a material that has not been densified. As described herein, a densified material can be used to make graft material than can be compressed to a diameter suitable for insertion into an insertion site blood vessel location above or below a diaphragm of a patient or subject or in a blood vessel with a diameter less than or equal to the diameter of a femoral artery from the same patient or subject.

[0092] In some instances, the insertion site blood vessel (i.e., blood vessel located above a diaphragm of the patient, small blood vessel) is selected from the group consisting of the brachial, radial, ulnar, axillary, carotid, and subclavian arteries. In some instances, the insertion site blood vessel is an axillary artery. In further instances, the insertion site blood vessel is a blood vessel located below a diaphragm of the patient. In one aspect, the diameter of the insertion site blood vessel or small blood vessel is 2 to 8 mm. In another example, the insertion site blood vessel is the subclavian artery.

[0093] In an alternative embodiment, a guidewire can be introduced into an insertion site blood vessel located above a diaphragm of a subject or patient into a target blood vessel such as the infrarenal aorta, suprarenal aorta, or thoracic aorta. Catheters and / or wires can be inserted into branch vessels (e.g., superior mesenteric artery, celiac artery, renal arteries, and inferior mesenteric artery), and a fenestrated graft and / or a thoracic aortic graft can be advanced into a target blood vessel such as the aorta over the catheters and / or wires with each wire coming out of a fenestration and going into one of the branches.

[0094] Alternatively, a fenestrated graft or thoracic aortic graft can be introduced into an insertion site blood vessel located above a diaphragm of a subject or patient into a target blood vessel such as the infrarenal aorta with no wires going through the fenestrations of the fenestrated graft. The branch vessels can optionally be catheterized.

[0095] Another alternative, wires will protrude from each fenestration inside the sheath when the device is loaded, but the branch vessels may not be catheterized until after the main body device is deployed

[0096] Some implementations of the first stent-graft system include a connecting ring comprising a plurality of connectors adapted to receive the plurality of receptacles. The connecting ring can be disposed in the main graft body. The plurality of connectors and plurality of receptacles can be made integral with stent (e.g., spot welded into position).

[0097] Further implementations of the first stent-graft system include a plurality of sutures disposed around the plurality of connectors and plurality of receptacles. An angle of expansion of the connecting ring can be greater than about 90 degrees.

[0098] The term "connecting ring" refers to a structure (e.g., ring) adapted to connect to the first stent and to be disposed in the main graft body. The connecting ring can also be referred to as an annular ring. The connecting ring connects the first stent to the main graft body, provides for primary sealing and aids in forming a low profile stent-graft device wherein the first stent and main graft body are in a substantially end-to-end configuration.

[0099] The term "connector" refers to, for example, a structure adapted to connect two components. For example, a connector (e.g., zig zag 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 FIGS. 3A-3D.

[0100] It is to be understood that any suitable connector-receptacle system can be employed in order to bear a majority of the axial loading forces between the first stent and the connecting ring. For example, the connector can be shaped like a hook, half circle, triangle etc., and the receptacle can be a hole adapted to receive the hook, half circle, triangle, etc. Optional sutures can be provided to provide stability in place of or in addition to the exemplary connector-receptacle system, as needed.

[0101] The term "end-to-end configuration" refers to the connection of a component of the stent graft to another component at its margin (e.g., side by side, or end to end). An end-to-end configuration can avoid overlapping of components (i.e., coaxial) in the stent-graft introducer sheath. For example, a thick and strong top stent can be combined with an ePTFE graft or densified ePTFE graft, or other graft material known in the art. In one aspect, the components are arranged in series instead of coaxially. A coaxial configuration of components requires a larger diameter introducer sheath, a bigger hole in the blood vessel, and potentially a bigger 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 an artery located above the diaphragm and / or small arteries. In this aspect, the first stent can be thicker and more robust since it is not in an overlapping orientation with the main body graft.

[0102] The term "end-to-end configuration" with respect to the stent-graft systems and devices described herein, can also refer to a circumstance where the wall thickness of the connecting ring disposed in the main graft body is less than the wall thickness at a connection between the first stent and the graft or, in some instances, the connecting ring when the plurality of connectors receive the plurality of receptacles.

[0103] In some implementations of the first stent-graft system, the connection between the plurality of connectors on the connecting ring and the plurality of receptacles on the first stent provide a stable configuration without increasing the overall diameter of the device. In addition, this configuration supports an angle of expansion of the connecting ring which is greater than about 90 degrees. For example, this configuration is very stable upon crimping in the delivery sheath, which allows for the stabilization of the connecting ring (due to its end-to-end attachment). If the connecting ring is not stabilized by the top stent, it would not be as stable upon crimping, and potentially cause damage and / or would not achieve the anticipated or desired crimp diameter.

[0104] In another implementation of the first stent-graft system, the main graft body bifurcates into two branches comprising a first limb gate and a second limb gate. In this aspect, the first limb gate and second limb gate can be adapted to be disposed in ipsilateral iliac artery 18 as shown, for example, in FIG. 1. In another aspect, the main graft branch does not bifurcate and can be configured to be positioned and deployed in a thoracic aorta or a blood vessel other than the aorta or an infrarenal aneurysm that does not extend to the iliac bifurcation or an aorto-uni-iliac tube endograft for placement in the aorta and one iliac artery.

[0105] An implementation of the first stent-graft system further comprises 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 to be positioned in a constrained state through, for example, an insertion site blood vessel located above a diaphragm or small artery, through the main graft body, and through either the first limb gate or the second limb gate to either the ipsilateral or contralateral iliac artery where it can be deployed in an unconstrained state.

[0106] In some implementations of the first stent-graft system, an overlap of the first iliac leg component with the first limb gate is not larger in diameter than an overlap of the second iliac component with the second limb gate.

[0107] Another implementation of the first stent-graft system comprises barbs disposed on one or more of a first iliac leg component and a 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.

[0108] In some implementations of the first stent-graft system, the first iliac component and the second iliac component comprise a densified material (e.g., densified ePTFE).

[0109] Yet another implementation of the first stent-graft system includes a second stent connected to a caudal (i.e., end closest to the tail or bottom of the body) end of the first limb gate and a third stent connected to a caudal end of the second limb gate. This embodiment can further comprise tethersdisposed on a caudal end of each of the main graft body, the second stent, and the third stent for connecting to a caudad (i.e., toward the end or posterior of the body) positioning system.

[0110] The term "caudad positioning system" can refer to tools (e.g., catheter, guidewire, trigger or tether wire, etc.) that are configured to engage with the caudal end of the stent-graft system to allow an operator (i.e., doctor) to control and adjust the position of the stent-graft system in a target blood vessel.

[0111] Yet another implementation of the first stent-graft system further comprises a plurality of sutures disposed around the plurality of connectors and plurality of receptacles. It is understood that the sutures can be placed in alternative or additional locations.

[0112] The first stent-graft system can further comprise 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.

[0113] The term "barbs" refer to sharpened projections configured to attach, associate, or anchor the stent-graft system in a blood vessel or components of the stent-graft system to each other. In this aspect, the plurality of barbs can function to prevent unintentional migration of the stent-graft device from a desired location. Barbs can be integral to the design (i.e., not made separately and then attached) or spot welded into position. The plurality of barbs can be configured to have alternating heights with respect to each other. In another aspect, each of the plurality of barbs can be oriented in a different direction with respect to each other.

[0114] In another implementation 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 is not larger in diameter (e.g., oversized).

[0115] Optional tethers can be used, for example, to permit manipulation by a positioning system (e.g., guidewire, catheter, trigger wire) and aid in maneuvering the stent-graft device in the blood vessel and more precisely positioning the stent-graft system in a desired location. In this aspect, the tethers can be removably attached to the positioning system in order to push or pull the stent-graft system through the blood vessel.

[0116] The term "tether" refers to loop(s) or similar structures that can be used, for example, to removably attach to a portion of the positioning system and aid in positioning and deployment of the stent-graft device. A tether can be made from any suitable suture material or thin metallic wire and can be rigid or flexible.

[0117] In some implementations of the first stent-graft device, the stent-graft system further comprises an optional annular element disposed inside 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 body 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 integrated in 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.

[0118] The annular element can be located at a position substantially adjacent to the first axial graft end. The 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., graft material, biocompatible metal, ePTFE) and can be a discrete annular element that has different properties compared to the graft material (e.g., different density).

[0119] In one aspect, the connecting members can be attached to locations inside the main graft body without the need for an annular element. These locations can be arranged in any desired pattern including a circumferential manner around the inside of the main graft body.

[0120] The term "connecting members configured to connect" refers to a feature of a connecting member that engages with and is retained by a stent end in a substantially end-to-end arrangement. Examples of connecting members configured to connect to the first axial stent end are shown, for example, in FIGS. 3A, 3B, 3C, and 3D.

[0121] In some instances, the plurality of connectors project beyond the first axial graft end. In some instances, the plurality of connectors are circumferentially spaced apart. In a further aspect, the plurality of connectors are curved. In yet another aspect, each of the plurality of connectors can be different (e.g., length, curvature, material) from another connector.

[0122] In one aspect, the substantially end-to-end configuration comprises a gap between the first stent and the first axial graft end. In some instances, the gap is 0 to 2 mm. In other instances, the at least one of the plurality of connectors extends across the gap.

[0123] An implementation of the first stent-graft device further comprises a centering device adapted to be disposed and expanded in a suprarenal aorta wherein the main graft body can be repositioned in an intrarenal aorta after the centering device is expanded.

[0124] 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., suprarenal aorta) to permit another device(e.g., stent-graft device) to be centered in another portion of the blood vessel with reference to the centering device.

[0125] In one aspect, the centering device can be a device with a plurality of arms that can be expanded radially wherein each arm can contact a wall of a blood vessel. In another aspect, the centering device can be a balloon wherein the balloon can be expanded and contact a wall of a blood vessel.

[0126] The centering device (e.g., basket, balloon) can be used, for example, to assist an operator (e.g., doctor) in positioning a stent-graft device in a target blood vessel by expanding the centering device such that it engages with a wall of the blood vessel. The operator can adjust the position of a second device (e.g., stent-graft device) with reference to a midpoint of the centering device when the centering device is expanded in the blood vessel.

[0127] The centering device can be use, for example, in a circumstance where there is a bend or angle in the anatomy of the blood vessel (e.g., suprarenal aorta angulation, 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, Jun. 01, 2020). In this circumstance, the centering device can be connected to the second device by a tether, suture, or other connection to further assist in centering the second device in reference to the centering device.

[0128] In some instances, the centering device can surround the central member for symmetrical expansion of the centering device or can be attached to only one point on the circumference of the central member to allow for eccentric expansion of the centering device. In this instance, the centering device is configured to push the central member away from one side of the aorta in order to counteract the effect of aortic angulation.

[0129] In some instances, the centering device is selected from the group consisting of a centering basket and a centering balloon. In some instances, the centering basket can be expanded, wherein at least a portion of the centering basket engages with a wall of the suprarenal aorta. In some instances, the centering balloon can be inflated, wherein at least a portion of the centering balloon engages with a wall of the suprarenal aorta.

[0130] Further aspects provide a first method, comprising repairing an abdominal aortic aneurysm in a patient, by puncturing an insertion site blood vessel above a diaphragm and creating a passage in the insertion site blood vessel. Next, a stent-graft system can be inserted in a passage of the insertion site blood vessel. The stent-graft system can comprise a main graft body, a first limb gate and a second limbgate. The main graft body of the stent graft system can be positioned and deployed in a target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) of a patient. Further aspects provide a method comprising repairing an abdominal aortic aneurysm in a patient by puncturing an insertion site blood vessel below a diaphragm and creating a passage in the insertion site blood vessel.

[0131] The first method described herein can be used, for example to insert straight tubular stentgrafts in an insertion site blood vessel located above the diaphragm. In some instances, insertion site blood vessels can include, for example, smaller blood vessels (i.e., blood vessels smaller in or equal to the diameter than a femoral artery of the same patient), arteries (e.g., common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, axillary artery, and iliac artery) and veins (e.g., superior vena cava, inferior vena cava, femoral and popliteal veins, radial vein, cephalic vein, basilic vein, and axillary vein). In some instances, the insertion site blood vessel is the subclavian artery. In some instances, the methods described herein can be used to insert hemodialysis grafts and / or other man-made vascular grafts.

[0132] In some instances of the first method, the stent-graft system is adapted to be inserted through a single arterial puncture or incision located above a diaphragm of a subject or patient. In further instances, the stent-graft system is adapted to be inserted through a single arterial puncture or incision located below a diaphragm of a subject or patient. Use of such a stent-graft system avoids the disadvantages of prior systems which require multiple arterial punctures or incisions. In some instances of the first method, the first stent and the main graft body are in a substantially end-to-end configuration

[0133] The insertion site blood vessel for the stent-graft systems described herein can be the second or proximal third portion of the axillary artery. This insertion site is the axillary artery proximal (e.g., closer to the heart) to the origin of the sub scapular artery. Use of this insertion site can, for example, avoid damaging branches of the brachial plexus.

[0134] In another instance of the first method, the femoral arteries are not used for insertion of the stent-graft device. Instead, the stent-graft device can be inserted through a single puncture or incision in an insertion site blood vessel located above the diaphragm (e.g., a "small artery" as described herein) that is not located in the leg. Such a procedure avoids the recovery time and discomfort associated with femoral artery punctures or incisions since the patient is able to walk right away.

[0135] In addition, as described above, the stent-graft device can be manipulated and positioned more easily from a "top-down" orientation in the aorta into both legs for repair of, for example, an abdominalaortic aneurysm. Therefore, the procedure takes less time, is less prone to error, and offers the patient a shorter recovery period with less pain.

[0136] In some instances of the first method, the single arterial puncture or incision is made in a small artery (e.g., an artery smaller or equal in diameter to a 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 brachial, radial, ulnar, femoral, iliac, axillary, carotid, and subclavian arteries. In yet another aspect, the artery is the brachial artery. In a further aspect, the artery is a femoral artery or the subclavian artery. In another instance, the artery is the second or proximal third portion of the axillary artery.

[0137] In yet another aspect, stent-graft systems can be deployed in the supra renal abdominal aorta to treat intrarenal abdominal aortic aneurysms. For example, side graft branches can be provided for the renal arteries, the celiac artery, and the superior mesenteric artery.

[0138] The term "positioned" refers to moving the stent-graft device (e.g., in a constrained or partially constrained configuration) through blood vessels to the desired location in a blood vessel (e.g., axial position) using any suitable mechanism (e.g., a positioning system). The positioning system can comprise a guidewire, a sheath over the guidewire, one or more catheters, a trigger wire, and other components capable of pushing, pulling, and deploying the stent-graft device. A doctor can visualize the progress of the positioning system and stent-graft device with an angiogram, fluoroscope, or other visualization system via radio-opaque markers located as appropriate.

[0139] In some instances of the first method, the main graft body stent-graft system can be positioned inferior to the lowest renal artery and in an orientation adapted to access the contralateral limb gate. Markers (e.g., radiopaque markers) can be used for orientation of the contralateral gate under fluoroscopic guidance. In another aspect, the device may be deployed above the renal arteries.

[0140] In some instances of the first method, the main graft body of the stent-graft system can be deployed in the infrarenal aorta, wherein the main graft body of the stent-graft system is in a substantially blood-tight seal with respect to a wall of the infrarenal aorta. The term "deployed" or "deploying" refers to transforming the stent-graft device from a constrained to an unconstrained or open configuration where the stent-graft device can treat the aneurysm or other condition.

[0141] The stent-graft system can also include 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. Next, the second iliac leg component can be positioned and deployed in a second branch of the iliac artery. In this aspect, the first and second iliac leg components can be in a substantially blood-tight seal with respect to the main graft body (e.g., via the graft branches).

[0142] The first iliac leg component can be in a substantially blood-tight seal with respect to the first branch of the iliac artery. The second iliac leg component can also be in a substantially blood-tight seal with respect to the second branch of the iliac artery.

[0143] The term "substantially blood-tight seal" refers to limiting (e.g., by 95, 90, 85, or 80%) or eliminating an endoleak (e.g., a blood leak back into an aneurysm sac following an EVAR procedure).

[0144] In another instance of the first method, the main graft body is positioned in the target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) in a constrained state using a guidewire. The main graft body can be further positioned in the target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) by partially unsheathing the main graft body. In one aspect, the main graft body is unconstrained after the main graft body is deployed in the infrarenal aorta.

[0145] In some instances 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 an endoleak.

[0146] The first iliac leg component can be positioned in the first branch of the iliac artery in a constrained state through the main graft body using a guidewire. The first iliac leg component can also be further positioned in the first branch of the iliac artery by partially unsheathing the first iliac leg component. In this aspect, the first iliac leg component is unconstrained after the first iliac leg component is, for example, fully unsheathed and deployed in the first branch of the iliac artery.

[0147] The second iliac leg component can be positioned in the second branch of the iliac artery in a constrained state through the main graft body using a guidewire. The second iliac leg component can also be further positioned in the second branch of the iliac artery by partially unsheathing the second iliac leg component. In this aspect, the second iliac leg component is unconstrained after the second iliac leg component is, for example, fully unsheathed and deployed in the second branch of the iliac artery.

[0148] In some instances of the first method, the stent-graft system further comprises a first stent and a connecting ring. The first stent can have a plurality of receptacles and the connecting ring can have a plurality of connectors adapted to receive the plurality of receptacles. In this aspect, the connecting ring can be disposed in the main graft body, and the first stent and the main graft body are in a substantially end-to-end configuration.

[0149] In some instances of the first method, an optional annular element is disposed inside the main graft body, and a plurality of connecting members is 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 body graft had a first axial graft end and a second axial graft end. The annular element canbe located at a position substantially adjacent to the first axial graft end. The annular element can be made of any suitable material or can be integrated in 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.

[0150] The annular element can be located at a position substantially adjacent to the first axial graft end. The 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., graft material, biocompatible metal, ePTFE) and can be a discrete annular element that has different properties compared to the graft material (e.g., different density).

[0151] In further instances of the first method, the connecting members can be attached to locations inside the main graft body without the need for an annular element. These locations can be arranged in any desired pattern including a circumferential manner around the inside of the main graft body.

[0152] The 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.

[0153] In some instances of the first method, the plurality of connectors project beyond the first axial graft end. In some instances, the plurality of connectors and the plurality of receptacles are circumferentially spaced apart.

[0154] The substantially end-to-end configuration can include a gap (e.g., from greater than 0 to 2 mm) between the first stent and the graft. In some instances, the plurality of connectors extend across the gap.

[0155] Further aspects provide a second stent-graft system having an endograft deployment system for deploying an endograft in a target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) of a patient or subject. The endograft deployment system comprises an outer tube having a central inner member comprising an endograft and a carrier tube comprising a tether wire having a caudad end and a more cephalad portion, a top stent surrounding the central inner member, wherein the top stent comprises 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 retaining the top stent in a constrained configuration, and a second end of the first suture is affixed to the more cephalad portion of the tether wire. The first end of the at least a first suture can be attached to, for example, the tether wire. Movement of the tether wire can control removal of the plurality of sutures from the plurality of receptacles, release the top stentfrom a constrained to an unconstrained configuration, and remove the plurality of sutures from the blood vessel of the subject. In some instances, the tether wire may be removed while the sutures may be left in the patient.

[0156] Aspects described herein provide stent-graft systems and methods to substantially remove sutures from the blood vessel of a subject after deployment of a stent-graft system. In some instances, the first end of the at least a first suture is formed into a loop, and the loop is disposed around the caudad end of the tether wire.

[0157] Sutures can be an important or essential component for many surgical procedures, including EVAR. However, the presence of a suture or a portion of a suture after a cardiovascular surgical procedure can cause serious side effects, including embolism, negative impact on blood vessel healing, and injury to coronary arteries. See, e.g., 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.

[0158] In some instances, the endograft deployment system further comprises a shelf disposed below the first end of the at least a first suture for initially retaining the first end of the at least a first suture above the shelf. In some instances, the shelf further comprises a first opening for receiving the central inner member. The endograft deployment system can comprise a second opening for receiving the carrier tube. The endograft deployment system can comprise a third opening for receiving at least one of the plurality of sutures. In some instances, the third opening comprises three partial openings.

[0159] Aspects described herein provide a second method, comprising puncturing a femoral artery and creating a passage in the femoral artery, inserting a stent-graft in the passage of the femoral artery with a stent-graft deployment system having an outer tube comprising a central inner member comprising an endograft and a carrier tube comprising a tether wire.

[0160] In this aspect, the tether wire can have a caudad end and a more cephalad portion. The stentgraft deployment system can further comprise a top stent surrounding the central inner member, wherein the top stent comprises a plurality of hooks having 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 for retaining the top stent in a constrained configuration, and a second end of the firstsuture is affixed to the more cephalad portion of the tether wire. The first end of the at least a first suture can be attached to, for example, the tether wire.

[0161] The tether wire can be moved in order to remove the plurality of sutures from the plurality of receptacles, release the top stent from a constrained to an unconstrained configuration, and remove the plurality of sutures from the blood vessel of the subject.

[0162] The first end of the at least a first suture can be formed into a loop, and the loop can be disposed around the caudad end of the tether wire

[0163] The first limb gate of the stent-graft device can be positioned and deployed in a first branch of the iliac artery wherein the first limb gate of the stent-graft device is in a substantially blood-tight seal with respect to a wall of the first branch of the iliac artery and the main graft body.

[0164] The second limb gate of the stent-graft device can be positioned and deployed in a second branch of the iliac artery. As described herein, the positioning and deployment of the second limb gate in the second branch of the iliac artery can be accomplished without the need for a second puncture or incision in the corresponding femoral artery. In this aspect, the stent-graft device can be in a substantially blood-tight seal with respect to a wall of the second branch of the iliac artery.

[0165] Aspects described herein also provide alternative methods of repairing an abdominal aortic aneurysm in a patient by puncturing or making an incision in the femoral arteries and creating a passage in the femoral arteries. In this aspect, a stent-graft system (e.g., a main graft body, a first limb gate and a second limb gate) can be inserted in the passage of the femoral artery. The main graft body of the stentgraft system can be positioned and deployed in an infrarenal aorta of the patient.

[0166] The main graft body of the stent-graft system can be in a substantially blood-tight seal with respect to a wall of the infrarenal aorta. In this aspect, 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 body graft.

[0167] In this aspect, the first iliac leg component can be in a substantially blood-tight seal with respect to the first branch of the iliac artery and the second iliac leg component can be in a substantially blood- tight seal with respect to the second branch of the iliac artery

[0168] In another aspect, the contralateral limb gate (i.e., outlet of second limb gate) can be cannulated from a "top down" approach using access from an insertion site blood vessel located above a diaphragm of a patient or subject (e.g., axillary artery) using a maneuverable guidewire and steerable catheter. Alternatively, a guidewire with a bend near the distal end of the guidewire may be usedinstead of a catheter and guidewire in combination. In some instances, a retrograde femoral artery approach can be used.

[0169] In another aspect, the main graft body is positioned in the infrarenal aorta in a constrained state using a guidewire. In another aspect, the main graft body is further positioned in the infrarenal aorta by partially unsheathing the main graft body. In yet another aspect, the main graft body is unconstrained after the main graft body is deployed in the infrarenal aorta.

[0170] Aspects provide a further alternative method of repairing an abdominal aortic aneurysm in a patient by puncturing the femoral arteries and creating a passage in the femoral arteries. The stent-graft device can be inserted in a passage of the femoral artery. In this aspect, the stent-graft device can comprise a main graft body, a first limb gate and a second limb gate. The main graft body of the stentgraft device can be positioned and deployed in a target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) of the patient. In this aspect, the main graft body of the stent-graft device is in a substantially blood-tight seal with respect to a wall of the infrarenal aorta. The main graft body of the stent-graft device can have a substantially blood-tight seal with respect to a wall of the target blood vessel. In another aspect, only one femoral artery is punctured.

[0171] Aspects described herein provide a third stent-graft system for repair of an aneurysm in a target blood vessel having a main graft body comprising a sealing stent at least partially disposed in the main graft body. In some aspects, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of a patient. In further aspects, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of a patient. In some instances, the diameter of the stent-graft system in a constrained configuration is adapted to be inserted into a small artery (e.g., an artery smaller or equal in diameter to a femoral artery from the same patient). In some instances, the diameter of the stent-graft system in a constrained configuration is from about 13 to about 22 French or 6 to about 13 French.

[0172] In one aspect, the sealing stent has a plurality of struts. The plurality of struts can have a strut width of about 0.013 to 0.016 inches. In some instances, the sealing stent has a plurality of struts and the plurality of struts have a strut wall thickness of about 0.016 to about 0.020 inches.

[0173] In some instances, the main graft body has a first axial end and a second axial end. The sealing stent can be disposed adjacent to the first axial end. The sealing stent can further comprise a plurality of hooks.

[0174] In some instances, the plurality of hooks extend beyond the first axial end of the main graft body. In some instances, each of the plurality of hooks further comprises a radiopaque marker.

[0175] In further aspects, each of the plurality of hooks can be oriented in a right-hand orientation or a left-hand orientation. In yet another aspect, an orientation of each of the plurality of hooks is different from an adjacent hook. In some instances, the plurality of hooks are adapted to be reversibly retained by a looped wire for repositioning of the main graft body in the infrarenal aorta.

[0176] In some instances, the looped wire is inserted into the target blood vessel through a recapture sheath. The recapture sheath can be from about 2 to 4 French. In one aspect, recapture of the stentgraft device and repositioning of the stent-graft device can only occur from an insertion site blood vessel located above a diaphragm of a patient or subject. In a further aspect, recapture of the stent-graft device and repositioning of the stent-graft device can occur from an insertion site blood vessel located below a diaphragm of a patient or subject.

[0177] The plurality of hooks can further comprise a plurality of hook eyelets. The looped wire can be removably inserted through at least one of the plurality of hook eyelets.

[0178] In some instances, an entire stent-graft device (e.g., endograft) can be recaptured in a situation where the procedure needs to be aborted using, for example, a 10 French sheath. In another instance, the sheath can be exchanged for a higher size sheath during the procedure to recapture the entire stentgraft device if it is necessary to abort the entire procedure.

[0179] Aspects described herein provide alternative methods 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 about 3 French; (b) inserting a catheter into an ipsilateral iliac artery with a second access profile of about 5 French; (c) deploying a main graft body from a main graft body deployment system in an infrarenal aorta of the patient with a third access profile of about 10 French; (d) removing an inner component of the main graft body deployment system and leaving a first sheath and the first guidewire in the infrarenal aorta; (e) deploying a first limb gate in ipsilateral iliac artery using the first sheath and the first guidewire; (f) moving the first guidewire from the ipsilateral iliac artery to a contralateral iliac artery; and (g) deploying a second limb gate in the contralateral iliac artery using the first sheath and first guidewire.

[0180] Further aspects provide alternative methods of repairing an abdominal aortic aneurysm in a patient by (a) inserting a first guidewire into a small artery into an ipsilateral iliac artery of a patient; (b) insert a main body graft and a first sheath over the first guidewire into the infrarenal aorta; (c) deploying a main body graft in the infrarenal aorta of the patient; (d) inserting a first limb gate into an ipsilateraliliac artery of the patient and deploying the first limb gate; (e) removing the first guidewire from the ipsilateral artery; (f) inserting a 4-5 French directional catheter through the first sheath; (g) cannulating a contralateral iliac gate and a 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 into the contralateral iliac artery.

[0181] In some instances, the methods further comprise deploying one or more sealing stents in the infrarenal aorta. The sealing stents can prevent or minimize endoleaks.

[0182] Aspects described herein provide a third method, comprising positioning a main graft body of a stent-graft system in an infrarenal aorta of a subject by advancing a main graft body delivery system to a target location, the main graft body delivery system comprising the main body graft and a centering device. Next, the main body graft can be positioned in the infrarenal aorta in a first position at the target location and it can be determined if the first position of the main graft body is centered in the infrarenal aorta at the target location. The centering device can be deployed in a suprarenal aorta in a centered position if the first position of the main graft body is not centered in the infrarenal aorta at the target. The main graft body can be repositioned in the infrarenal aorta in a second position determined from the centered position if the first position of the main graft body is not centered in the infrarenal aorta at the target.

[0183] In some instances of the third method, the insertion site blood vessel for the stent-graft device is located above a diaphragm of the patient. In further instances of the third method, the insertion site blood vessel for the stent-graft device can be located below a diaphragm of the patient.

[0184] In some instances of the third method, the centering device is selected from the group consisting of a centering basket and a centering balloon. In some instances, the centering basket can be expanded, wherein at least a portion of the centering basket engages with a wall of the suprarenal aorta. In some instances, the centering balloon can be inflated, wherein at least a portion of the centering balloon engages with a wall of the suprarenal aorta. In some instances, the outward force exerted by a centering basket or the outer surface of a centering balloon is greater than a longitudinal force exerted by a sheath or other delivery device when conforming to the curvature of a blood vessel.

[0185] In some instances of the third method, the main graft body delivery system further comprises a sheath comprising the main graft body, wherein retracting the sheath exposes the main graft body in the infrarenal aorta prior to positioning the main graft body in the infrarenal aorta.

[0186] In some instances of the third method, the sheath further comprises the centering device, wherein further retraction of the sheath exposes the centering device in the suprarenal aorta prior to deploying the centering device.

[0187] In some instances of the third method, the main graft body delivery system further comprises a main graft body restraining device and a main graft body releasing device. The main graft body restraining device can maintain the main graft body cephalad end in a constrained configuration. The main graft body releasing device can induce release of the main graft body into an unconstrained configuration.

[0188] For example, the restraining device can comprise a main graft body restraining wire adapted to control the position of the main graft body. The term "adapted to control" refers to, for example, the ability of an operator (e.g., a doctor) to move the restraining wire in a manner that alters the position of the main graft body in an artery (e.g., moving the main graft body in a caudad or cephalad direction).

[0189] In some instances of the third method, the main graft body releasing device comprises a snare loop adapted to release the main graft in the infrarenal aorta. The term "snare loop" refers to a material (e.g., wire, suture) configured in a loop or circular shape where the diameter of the loop can be reduced around a target. See, e.g., U.S. Pat. 8,628,540. In the context of surgery, the loop can be disposed around or through a target and closed in order to remove or manipulate a target (e.g., snare loop disposed through eyelets attached to a stent).

[0190] In some instances, the snare loop can re-constrain the cephalad end of the main graft body after an expansion of the cephalad end of the main graft body and control repositioning of the axial position of the main graft body in the infrarenal aorta. In this aspect, the main graft body can be positioned and repositioned in the infrarenal aorta by the operator. In one aspect, the snare loop can be removed from the subject. In another aspect, the caudad end of the main graft body can be secured by a trigger wire to the delivery system shaft.

[0191] In a further instance of the third method, the main graft body has a caudad end and a cephalad end, and a location of the first position is determined by a location of markers on the cephalad end (e.g., radiopaque markers) of the main graft body. In some instances, the location of the markers is caudad to the renal arteries. In some instances, the method further includes securing the caudad end of the main graft body to the main graft body restraining device with a trigger wire.

[0192] In some instances, repositioning of the stent-graft device can only occur from an insertion site blood vessel located above a diaphragm of a patient or subject. In further instances, repositioning of thestent-graft device can occur from an insertion site blood vessel located below a diaphragm of a patient or subject.

[0193] Aspects described herein provide a fourth stent-graft system for repairing an aneurysm in a target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) having a top stent having a plurality of positioning receptacles; a main graft body wherein the top stent and the main graft body are in a substantially end-to-end configuration and wherein the top stent and the main graft body are disposed around an inner member; a snare tube comprising a snare loop, wherein a first end of the snare loop is disposed in 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 into the snare tube; wherein the snare tube is parallel to the inner member and first end of the snare loop is adjacent to the second end of the snare loop.

[0194] In one implementation 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 blood vessel located above a diaphragm of the patient. In another implementation of the fourth stent-graft system, the stent-graft system can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient. An example of this stent-graft system is illustrated in FIG. 11.

[0195] In another implementation of the fourth stent-graft system, each of the plurality of positioning receptacles further comprises an eyelet and the second end of the snare loop is disposed through at least one eyelet. In some instances, the stent-graft system further comprises an outer sheath disposed around the inner member.

[0196] The insertion site blood vessel can have a diameter less than or equal to the diameter of a femoral artery of the patient. The diameter of the stent-graft system in a constrained configuration can be from about 13 to about 22 French or about 6 to about 13 French. The main graft body can comprise a densified material.

[0197] In an implementation of the fourth stent-graft system, the main graft body bifurcates and further comprises a first limb gate and a second limb gate. The first limb gate can comprise a first iliac leg component. The second limb gate can comprise a second iliac leg component. The top stent and the main graft body can be in a substantially end-to-end configuration.

[0198] In a further implementation of the fourth stent-graft system, the stent-graft system further comprises a trigger or tether wire for positioning the first limb gate and second limb gate. Thepositioning system can further comprise a first limb gate tether and a second limb gate tether. The first limb gate tether and second limb gate tether can be retained by the trigger wire.

[0199] The fourth stent-graft system can further comprise a centering device for centering the main graft body in the infrarenal aorta as illustrated, for example, in FIG. 12A.

[0200] The main graft body, top stent, and centering device can initially be contained within an outer sheath. When the outer sheath is removed from the main graft body and the top stent, the top stent can be deployed, and the centering device can be pushed axially in a caudad direction to the aortic neck (e.g., non-dilated region above the aneurysm) and into the main graft body. The centering device can be deployed inside the graft in the portion of the main graft body nearest to the heart. The centering device can then be retracted, and the snare loop can be released to deploy the top stent.

[0201] Alternative aspects provide methods of positioning the stent-graft system in a target blood vessel described herein (e.g., FIG. 11 ), by 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 infrarenal aorta; and lengthening the snare loop wherein the top stent is moved out of the outer sheath and the top stent is expanded from a constrained configuration to a deployed configuration in the target blood vessel. In some instances, repositioning of the stent-graft device can only occur from an insertion site blood vessel located above a diaphragm of a patient or subject. In further instances, repositioning of the stent-graft device can occur from an insertion site blood vessel located below a diaphragm of a patient or subject.

[0202] In circumstances where high suprarenal angulation leads to a sub optimal deployment (e.g., angles that start at the renal arteries) the snare loop can be opened, and the centering device can be moved in a caudad direction into the infrarenal aorta to the most cephalad portion of the graft. The snare loop can be closed to re-constrain the hooks permitting the centering device to center the endograft in the infrarenal aorta. The snare loop can be opened in order to retract the centering device. The centering device can help to uniformly open the upper end of the endograft.

[0203] In some instances (e.g., FIG. 12A), snare loop and snare tube are disposed outside the perimeter of the centering device and inside the perimeter of the outer sheath. In this example, when centering basket is pushed down, it will pass through the center of the snare loop, top stent, and into the inner member.

[0204] Aspects described herein provide a fifth stent-graft system for repair of an aneurysm in a target blood vessel (e.g., an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta) having a top stent comprising a plurality of positioning receptacles; a main graft bodywherein the top stent and the main graft body are in a substantially end-to-end configuration and wherein the top stent and the main graft body are disposed around an inner member; a snare loop is disposed through the positioning receptacles with a degree of rotation around the top stent of greater than 360 degrees (e.g., 300 to 800 degrees, 540 degrees) wherein a first end of the snare loop is disposed substantially symmetrically (e.g., concentrically) with respect 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 blood vessel located above a diaphragm of the patient. In another 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 blood vessel located below a diaphragm of the patient.

[0205] In a further implementation of the fifth stent-graft system, each of the plurality of positioning receptacles further comprises an eyelet and the second end of the snare loop is disposed through at least one eyelet. The stent-graft system can comprise an outer sheath disposed around the inner member. The insertion site blood vessel can have a diameter less than or equal to the diameter of a femoral artery of the patient. The diameter of the stent-graft system in a constrained configuration can be from about 13 to about 22 French or about 6 to about 13 French. The main graft body can comprise a densified material.

[0206] In one implementation of the fifth stent-graft system, the main graft body bifurcates and further comprises a first limb gate and a second limb gate. The first limb gate can comprise a first iliac leg component. The second limb gate can comprise a second iliac leg component.

[0207] In some implementations of the fifth stent-graft system, the top stent and the main graft body are in a substantially end-to-end configuration. The stent-graft system can further comprise a trigger or tether wire for positioning the first limb gate and second limb gate. The stent-graft system can further comprise a first limb gate tether and a second limb gate tether. The first limb gate tether and second limb gate tether can be retained by the trigger wire.

[0208] Aspects described herein provide methods of positioning the stent-graft system in a target blood vessel described herein (e.g., FIG. 13 ) by 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 blood vessel; and lengthening the snare loop wherein the top stent is moved out of the outer sheath and the top stent is expanded from a constrained configuration to a deployed configuration in the target bloodvessel. In this aspect, repositioning of the stent-graft device can, in some examples, be performed from an insertion site blood vessel located above a diaphragm of a patient or subject.

[0209] FIG. 1 shows the anatomy of a portion of the aorta including descending thoracic aorta 10, suprarenal abdominal aorta 12, renal arteries 14, aneurysmal infrarenal aorta 16, and the ipsilateral iliac artery 18 and contralateral iliac artery 19.

[0210] FIG. 2A shows an exemplary stent-graft device 20 in accordance with some instances of the first stent-graft system described herein. In this example, stent-graft device 20 includes graft 21, first stent 22, connecting ring 24, main graft body 26, connecting bar 28, first limb gate 30, second limb gate 32, first limb stent 34, second limb stent 36, first tether 38, and second tether 40. Connecting ring 24 and stents (22, 34 and 36) can be fully encapsulated in main graft body 26 material, or partially encapsulated in main graft body 26 material or not encapsulated in the main graft body 26 material at all. In some implementations, the stent 22 can include an infrarenal top stent that is primarily covered by the main graft body 26 material, leaving only the barbs exposed.

[0211] FIG. 2B shows a flattened side view of the exemplary stent-graft device of FIG. 2A in accordance with aspects described herein.

[0212] FIG. 3A shows an exemplary portion of first stent 22 having lower barb 42 and higher barb 44 and receptacle 46. Connector 48 is shown on connecting ring 24 embedded in graft 21.

[0213] FIG. 3B shows close up front and side views of receptacle 46 and connector 48 with an angled zig-zag configuration of receptacle 46 adapted to engage with and fit into connector 48. Optional sutures 50 are shown wrapped around connector 48 inside receptacle 46. Optional receptacle stabilizer 52 is shown adjacent to connector 48 to provide additional axial support.

[0214] FIG. 3C shows close up front views of an alternate configuration of a portion of first stent 22, a portion of connecting ring 24, receptacle 46, connector 48, sutures 50, and receptacle stabilizer 52 with optional connector stabilizer 54 adapted to fit receptacle stabilizer 52.

[0215] FIG. 3D shows close up front views of an alternate configuration of a portion of first stent 22, a portion of connecting ring 24, receptacle 46, and connector 48 where connector 48 has a triangular shape adapted to fit into a triangular shaped receptacle 46.

[0216] FIG. 4 shows an alternative aspect where arms 56 of the connecting ring or first stent 24 are at angle of 110 degrees with respect to each other. Conventional stent-graft devices can be unstable if the angles between arms of the connecting ring or stent are greater than 60 degrees.

[0217] Prior stent-graft devices in an end-to-end configuration using angles between stent arms greater than about 60 degrees are susceptible to instability. FIG. 4 shows connecting ring 24 where adjacentarms 56 are at an angle greater than 90 degrees. Stand-alone z stents are typically unstable at angles greater than 60 degrees. In this aspect, the attachment of the connecting ring to a robust, stable first stent (e.g., such as first stent 22 seen in FIG. 3A) via the connectors / receptacles provides for an increased angle for the connecting ring. The increased angle provides for a shortened stent length and hence a shorter seal length. Without be bound by theory, it is believed that the seal length is coupled with the length from the cranial edge of the graft until the first full ring of stent apposition. Short neck aneurysms are not able to be treated based on some designs which have long stents in the seal zone. In some instances, the connecting ring and stents can be encapsulated in the graft, are not encapsulated in the graft, or can be partially encapsulated in the graft.

[0218] FIG. 5 shows an exemplary configuration of iliac leg component 58 having leg component tether 60, leg component top stent 62, leg component modular junction barb 64, leg component connecting ring 66, leg component connector 68, leg component receptacle 70 on leg component outer stent 72 having lower barb 74 and upper barb 76. Iliac leg component 58 can be maneuvered and positioned using leg component tether 60.

[0219] Deployment of iliac leg component 58 expands leg component top stent 62 and leg component outer stent 72 as iliac leg component 58 is moved from a constrained to an unconstrained configuration. In an unconstrained configuration, iliac leg component 58 can form a substantially blood tight seal against the iliac artery. Leg component barbs 64 can provide further stability with respect to positioning iliac leg component 58 within the main body branch. Leg component connecting ring 66 can be configured similarly to connecting ring 24 including having leg component 68 adapted to fit into leg component receptacle 70 on leg component outer stent 72. Iliac leg component 58 can be deployed in the contralateral iliac artery, the ipsilateral iliac artery, or both depending on the needs of the patient.

[0220] FIG. 6A shows an example of positioning and deploying a contemporary (currently typical) main graft body using the typical EVAR method of repairing an abdominal aortic aneurysm. In Panel 1, guidewire 78 is inserted through a femoral puncture or incision into iliac artery 18, aneurysmal infrarenal aorta 16, past renal arteries 14, into suprarenal abdominal aorta 12 in a "bottom up" approach. In Panel 2, delivery system sheath 80 containing a main graft body 82 is inserted over guidewire 78 and tracked over the guidewire into the suprarenal abdominal aorta 12. In Panel 3, the main graft body 82 is positioned, partially unsheathed, and can have its position adjusted before final release. In Panel 4, main graft body 82 is fully unsheathed and deployed in infrarenal abdominal aorta 12 as shown just below the renal arteries 14.

[0221] FIG. 6B shows an example of positioning and deploying typical currently available iliac leg components using the currently typical EVAR method of repairing an abdominal aortic aneurysm. The delivery system sheath 80 is left in place. As shown in Panel 1, leg component 84 is inserted into the delivery system sheath 80 and through the femoral artery puncture or incision in a "bottom up" approach over the guidewire 78 into a graft branch of main graft body 82. Iliac leg component sheath 84 is positioned and partially retracted exposing and allowing the iliac leg component to expand in the overlap zone. In Panel 2, leg component 84 is fully unsheathed and deployed into one leg of iliac artery 18.

[0222] In Panel 3, guidewire 78 is inserted into a second femoral puncture or incision in a "bottom up" approach to position it into another leg branch of main graft body 82, referred to as cannulation. Accurate positioning of leg component 84 by cannulation in a "bottom up approach" can be very difficult. In Panel 4, once cannulation is achieved with the guidewire, leg component 84 is positioned and deployed in the other leg of iliac artery 18.

[0223] In contrast to the EVAR approach illustrated in FIGS. 6A and 6B, Panels 1 to 4 in FIG. 7A shows an exemplary insertion and deployment of the main body graft module from an insertion blood vessel located above the diaphragm of a patient.

[0224] In Panel 1, a puncture or incision is made in a blood vessel located above a patient's diaphragm using a "top down" approach and delivery sheath 80 is inserted after removal of directional catheter (not shown). As described here, the delivery sheath 80 can also include a sleeve or other annular shaped structure positionable within the patient's vasculature to provide passage of the main graft body 26. Guidewire 78 is inserted through inner member 79 and is shown advancing down suprarenal abdominal aorta 12 past renal arteries 14, across the aneurysmal infrarenal aorta 16 and into ipsilateral iliac artery 18 while contralateral iliac artery 19 remains uninstrumented.

[0225] In Panel 2, delivery sheath 80 containing / constraining main graft body 26 (not shown) within its lumen is threaded over indwelling guidewire 78 via the lumen of the first nose cone 86 and subsequently introduced / inserted through said small artery puncture (vascular access point) and then advanced down the suprarenal abdominal aorta 12 past renal arteries 14, substantially across the aneurysmal infrarenal aorta 16 with first nose cone 86 positioned just above ipsilateral iliac artery 18 while contralateral iliac artery 19 continues to remain uninstrumented.

[0226] Panels 3 and 4 of FIG. 7A illustrate the deployment of delivery sheath 80 and initial delivery / release of main graft body 26 in aneurysmal infrarenal aorta 16.

[0227] In Panel 3 of FIG. 7A, main graft body 26, first limb gate 30 and second limb gate 32 having radiopaque marker 88 are shown partially deployed and oriented both axially and rotationally as desired in the target anatomy. Radiopaque marker 88 acts as an aid in orienting the device under fluoroscopy. The partial deployment can be accomplished by partial retraction of delivery sheath 80 in the direction towards renal arteries 14 up suprarenal aorta 12 while generally maintaining a stationary position of main graft body 26 and inner member (not shown) having first nose cone 86 in aneurysmal infrarenal aorta 16. The position of guidewire 78 in ipsilateral iliac artery 18 is also maintained. In some implementations, as described herein, the main graft body is delivered into the target blood vessel upon removal of the delivery sheath 80. In other implementations, for example using a sleeve or wrapper, the main graft body is delivered into the target blood vessel with the sleeve / wrapped remaining over at least a portion of the main graft body.

[0228] First tether 38 and second tether 40 are used to substantially fix the distal end of main graft body 26 to first nose cone 86 to permit traction and avoid crumpling or "riding up" of main graft body 26 during deployment. As previously noted, Panel 3 depicts partial deployment of the endograft by withdrawal (or proximal) retraction of delivery sheath 80.

[0229] As illustrated in Panel 4 of FIG. 7A, when delivery sheath 80 is fully retracted and main graft body 26 is released and self expands, with the exception that the proximal and distal ends of main graft body 26 remain constrained. This is achieved by fixedly constraining first tether 38 and second tether 40 on the distal end to first nose cone 86 using a tether wire (not shown) and using a similar system or arrangement (not shown) on first stent 22 on the proximal end. In this manner, crumpling of main graft body 26 is avoided during positioning and deployment.

[0230] FIG. 7B shows the deployment sequence for the right iliac limb component in a similar manner to the deployment of the main graft body. Panel 1 of FIG. 7B shows the main graft body fully released, including the top stent. Panel 2 of FIG. 7B shows the sheath / guide catheter 94 has been advanced through the first limb gate 30 into the right external iliac artery 18. Panel 3 of FIG. 7C shows that the sheath has been partly withdrawn, partially releasing the right iliac limb gate. Panel 4 of FIG. 7B shows the right iliac limb gate is completely released.

[0231] In Panel 1 of FIG. 7B, main graft body 26, first limb gate 30, and second limb gate 32 are fully deployed by releasing the first tether 38 and second tether 40 from first nose cone 86 on the distal end and the fixation system on the proximal end on both the proximal and distal ends of main graft body 26 (i.e., first tether 38, second tether 40 and first stent 22 are no longer constrained). As shown in thispanel, main graft body 26 is completely unconstrained and released from delivery sheath 80 with the stent graft now implanted in the vessel.

[0232] Panel 1 of FIG. 7B further depicts main graft body 26, in a state wherein it forms a substantially blood-tight seal (not shown) with aneurysmal infrarenal aorta 16. First stent 22 in Panel 1 of FIG. 7B is shown spanning renal arteries 14 without the covered portion of main graft body 26 blocking the perfusion or impeding the flow of blood into these important vessels. In addition, throughout the deployment maneuvers described in FIG. 7B Panels 1- 4, the position of guidewire 78 is generally maintained in ipsilateral iliac artery 18.

[0233] Upon completion of the full deployment of main graft body 26 in Panel 1 of FIG. 7B, the delivery system is carefully retracted and removed ensuring first nose cone 86 traverses the edge of ipsilateral leg component 98 during this maneuver. First nose cone 86 is attached to inner member 79. It is envisioned that first nose cone 86 may also be rendered radiopaque to ensure safe retraction of the delivery system from main graft body 26 via observation of the nose cone's retraction with fluoroscopy during this procedural maneuver.

[0234] FIG. 7B (starting with Panel 2) and 7C illustrates exemplary positioning and deploying ipsilateral leg component 98 and contralateral leg component 106 (not shown) in an analogous manner to that described for the main graft body 26 deployment in FIG. 7A wherein delivery sheath 80 is withdrawn proximally while generally maintaining the relative stationary position of leg components during each of their respective deployment within main graft body 26.

[0235] In FIG. 7B, Panel 2, delivery sheath 80 is left in place and loaded with ipsilateral leg component 98 in constrained form through the puncture or incision in an insertion site blood vessel location above the diaphragm via delivery sheath 80, over guidewire 78, and through main graft body 26 and first limb gate 30 from a "top down" orientation, and positioned for unsheathing. Guidewire 78 is shown inserted through second nose cone 96.

[0236] In FIG. 7B, Panel 3, ipsilateral leg component 98 is partially unsheathed and finely positioned in ipsilateral iliac artery 18. The distal end of ipsilateral leg component 98 are constrained in a manner similar to that described in FIG. 7A, for example, by fixedly constraining tethers (not shown) on the distal end of ipsilateral leg component 98 to second nose cone 96 using a tether wire (not shown). At this stage, the proximal end of ipsilateral leg component 98 is still constrained in delivery sheath 80. The directional / guide catheter 94 is advanced through the first limb gate 30 into the right external iliac artery 18. In some implementations, the end of the guide catheter 96 is manipulated under fluoroscopic guidance into the contralateral main graft body 26, through the first limb gate 30, and into the rightexternal iliac artery 18. Then a guidewire 78 can then be advanced into the contralateral iliac artery 19 (as described herein in reference to Panel 1 of FIG. 7C).

[0237] As shown in FIG. 7B, Panel 4, ipsilateral leg component 98 is fully unsheathed and deployed in ipsilateral iliac artery 18.

[0238] FIG. 7C, Panels 1 and 2 show the equivalent complete deployment (i.e., implantation) of contralateral leg component 99 in contralateral iliac artery 19 in the same manner as described in FIG. 7B. Panel 1 of FIG. 7C shows that guidewire 78 has been advanced into the left external iliac artery 19. For example, in some implementations, the directional / guide catheter 34 is withdrawn through the first limb gage 30 and advanced into / through the second limb gate 32 then into the left external iliac artery 19. Panel 2 of FIG. 7C shows a completely deployed contralateral leg component 99. In some implementations, placement of the guidewire 78 into the contralateral iliac artery 19 includes introducing the guide catheter 94 into the contralateral iliac artery 19 and advancing a snare through the delivery sheath 80. The distal end of the guidewire 78 is captured by the snare. The guidewire 78 is then pulled down through the delivery sheath 80 and into the contralateral iliac artery 19. The guidewire 78 enters the arterial system through the ipsilateral femoral sheath and exits the arterial sheath through the contralateral femoral sheath. As illustrated in Panel 2 of FIG. 7C, the contralateral leg component 99 is then deployed in the contralateral iliac artery 19.

[0239] FIG. 7D shows an alternative where self-expanding additional stent 105 can be deployed in the sealing zone spanning the cranial graft edge to, for example, to further strengthen the substantially blood-tight seal.

[0240] FIGS. 8A and 8B show an alternate deployment system in cross section (FIG. 8A) and close up (FIG. 8B). In this example, first tether 38 and second tether 40 are looped around and attached to tether wire 107 and around shelf 103 to control first limb gate 30, and second limb gate 32. First tether 38 and second tether 40 can be disposed anywhere around the circumference of first limb gate 30 and second limb gate 32, respectively. Shelf 103 is fixedly connected to the inner member 79. Retracting the tip of tether wire 107 from inside first nose cone 86 to a position up to or proximal to shelf 103 into the carrier catheter (not shown) releases first tether 38 and second tether 40 prior to deployment of main graft body 26.

[0241] FIG. 9 shows an exemplary stent-graft deployment system 108 in accordance with the second stent-graft system for deploying a stent-graft 118 in the target blood vessel of a subject. The second stent-graft system described herein can be configured to be inserted in a femoral artery. The system includes outer tube 110 around central inner member 112 and carrier tube 114. Central inner member112 has a caudad end with tip 115 and cephalad end 116 and is surrounded by stent-graft 118. Carrier tube 114 comprises tether wire 117. Tether wire 117 has a caudad end and a more cephalad portion.

[0242] Top stent 119 is shown surrounding the central inner member 112. Top stent 119 comprises a plurality of hooks 120 having a plurality of receptacles 122. In this example receptacles 122 are integral to hooks 120. Receptacles 122 can be, for example, spot welded to hooks 120. Hooks 120 can also be bent or arranged to function as receptacles. A plurality of sutures 124, wherein a first end of at least a first suture is disposed through one of the plurality of receptacles 122 for retaining the top stent 119 in a constrained configuration, and a second end of the first suture is affixed to the more cephalad portion of tether wire 117. An optional shelf 126 can be disposed around inner member 112 and carrier tube 114 for retaining carrier tube 114 and inner member 112 together.

[0243] As shown in FIG. 10, inner member 112 can be disposed through inner member hole 128 in shelf 126 and carrier tube 114 can be disposed through carrier tube hole 130 in shelf 126. Shelf 126 can function as a support for threading sutures 124 through receptacles 122 and for retaining inner member 112 and carrier tube 114 substantially together adding further radial stability to the system. Receptacle hole 132 can receive a portion of receptacles 122 with, for example, sutures 124 disposed through receptacles 122.

[0244] Movement of tether wire 117 can control removal of the plurality of sutures from the plurality of receptacles and release top stent 117 from a constrained to an unconstrained configuration. The plurality of sutures 124 can be removed from the blood vessel of the subject. In some instances, all of the sutures are removed from the blood vessel in order to, for example, protect the subject from negative side effects of sutures or portions of the sutures remaining in the subject for a period of time.

[0245] FIG. 11 illustrates an embodiment of the fourth stent-graft device including exemplary snare loop positioning features for adjusting the axial location of a main graft body in a target blood vessel. Outer sheath 134 encompasses an inner member 164 and snare tube 136, the inner member 164 including a guidewire lumen extending therethrough. A centering device (not shown) is also encompassed by outer sheath 134. Snare loop 138 is disposed in and through snare tube 136 with an end that can be controlled by an operator. Snare loop 138 is shown threaded through a plurality of eyelets 140. Top stent 142 is shown with a plurality of hooks 246 disposed in eyelets 140. In the configuration shown, top stent 142 is in a constrained or closed configuration. Guidewire 160 is shown disposed through third nose cone 158.

[0246] Top stent 142 is shown in a substantially end-to-end configuration with main graft body 144. Main graft body 144 can be made of a densified material (e.g., densified ePTFE). Tether wire 146 isshown disposed through outer sheath 124 and main graft body 144 and ipsilateral limb 148 is shown as being connected to trigger wire holder 156. Contralateral tether 152 is shown disposed through contralateral limb 150 and attached to tether wire 146. Ipsilateral tether 154 is shown disposed through ipsilateral limb 148 and attached to tether wire 146. In this example, tether wire 146 can be used to adjust the position of contralateral limb 150 and ipsilateral limb 148 using contralateral tether 152 and ipsilateral tether 154.

[0247] Using the example of FIG. 11, an operator can insert the stent-graft device in, for example, a single puncture of a small artery located above the diaphragm and third nose cone 158 of the stent-graft device "top down" into the infrarenal aorta. Similarly, as described herein, the operator can insert the stent-graft device of FIG. 11 through a single puncture of a small artery located below the diaphragm (e.g., a femoral artery) in a bottom up approach into the infrarenal aorta. In use, snare loop 138 can be retracted and pull top stent 142 into outer sheath 134 using hooks 246. The stent graft can optionally be repositioned axially in the blood vessel as desired by the operator. Releasing snare loop 138 can release top stent 142 in a deployed configuration once the stent-graft has been positioned in a desired location by the operator. In this exemplary manner, the position of the stent-graft can be adjusted and readjusted as needed. As shown in FIG. 11, snare loop 138 is retracted, top stent 142 is in a constrained configuration, and top stent 142 can be retracted into outer sheath 134. The position of the stent graft device can then be adjusted.

[0248] FIG. 12A illustrates an embodiment of the fourth stent-graft system. In this example, retraction of outer sheath 134 reveals centering basket 162. Snare loop 138 is not retracted and top stent 142 is deployed in an unconstrained configuration. Centering basket 162 can facilitate the centering and positioning of main graft body 144, for example, in the infrarenal aorta. The arms of centering basket 162 engage the walls of the suprarenal aorta when centering basket 162 is deployed by retracting outer sheath 134. In this manner, the location of the entire stent-graft apparatus can be adjusted with main graft body 144 centered, for example, in the infrarenal aorta. It is understood, as described herein, that centering basket 162 can be a centering device (e.g., basket, balloon or similar).

[0249] FIG. 12A depicts snare loop 138 in an unconstrained or released configuration which deploys top stent 142. If the operator wishes to adjust the position of main graft body 144, snare loop 138 can be tightened resulting in the re-constraining of top stent 142. Then, main graft body 144 can be repositioned axially (in a cephalad or caudad direction) until a more desirable location in the infrarenal aorta is reached. Then, snare loop 138 can be loosened or released resulting in re-deployment of topstent 142 in a new location. The exemplary devices of FIGS. 11 and 12A show snare tube 136 in an asymmetrical configuration with respect to inner member 164.

[0250] In the examples of FIGS. 11 and 12A, contralateral tether 152 and ipsilateral tether 154 are shown as fixed to tether wire 146 such that tether 152 and tether 154 are not pushed upwards. Alternatively, contralateral tether 152 and ipsilateral tether 154 can be disposed in a catheter. The tether wire can exit the catheter just above the tether. The tether wire can be disposed through the center of the tether, back into the catheter through a hole in the catheter just below contralateral tether 152 and ipsilateral tether 154. In this manner, contralateral tether 152 and ipsilateral tether 154 can be pinned to the small length of wire outside its catheter. Contralateral tether 152 and ipsilateral tether 154 can be released when tether wire 146 is removed.

[0251] In a further alternate example, main graft body 144, top stent 142, and centering basket 162 are initially contained within outer sheath 134. In this aspect, when outer sheath 134 is removed from main graft body 144, top stent 142 can be deployed and centering basket 162 can be pushed axially in a caudad direction to the aortic neck and into main graft body 144. Centering basket 162 can be deployed inside main graft body 144 in the portion of main graft body 144 nearest to the heart. Centering basket 162 can then be retracted and snare loop 138 can be released to deploy top stent 142.

[0252] An alternate embodiment of the fourth stent-graft system is shown in FIG. 12B. FIG. 12B illustrates an exemplary alternative to the stent-graft device of FIG. 12A where snare loop 138 and snare tube 136 are disposed outside the perimeter of centering basket 162 but inside the perimeter of outer sheath 134. In this example, when centering basket 162 is pushed down, it will pass through the center of the snare loop 135, top stent 142, and into inner member 164.

[0253] Without being bound by theory, it is believed that sheaths used in blood vessels naturally tend to straighten along a straight line. When a sheath is inserted into a curved blood vessel, it can push against the wall of the vessel in an attempt to straighten. The force of the sheath against the vessel wall can depend on the material and its thickness. In one aspect, the wires or outer wall of an exemplary centering device (e.g., basket, balloon) is greater than the outward "straightening" force of a sheath such that the centering device does not collapse against the side of the blood vessel. In this manner, the stent-graft device can be centered in the blood vessel using the exemplary centering device.

[0254] In one aspect, the wires of a centering basket or the pressure exerted by the outer wall of a centering balloon exert enough force to hold the top stent in the center of the blood vessel against the force of the sheath. In another aspect, the force exerted longitudinally by the sheath is sufficient so that the sheath will not collapse on itself (e.g., this can be useful for advancing the sheath and for releasingthe endograft). At the same time, the sheath can be flexible in terms of "side to side" movement but more rigid longitudinally to minimize the straightening force of the sheath. Additional flexibility for "side to side" movement can avoid a circumstance where the stent-graft device is pushed against the wall of the vessel and is not deployed symmetrically. In this aspect, endoleaks can be minimized.

[0255] FIG. 13 shows an instance of the fifth stent-graft system having a symmetrical configuration of snare loop 138 with respect to inner member 164. In this example, FIG. 13 illustrates a stent-graft device having top stent 142 with snare loop 138 threaded through eyelets 140 affixed above hooks 246 where snare loop 138 has a degree of rotation around top stent 142 of greater than 360 degrees. In one aspect, the degree of rotation can be from 360 to 800 degrees or a degree of rotation of about 540 degrees. In this manner, as shown in FIG. 13, snare loop 138 can disposed symmetrically with respect to inner member 164.

[0256] When snare loop 138 is used to retract top stent 142 into outer sheath 134 or deploy top stent 142 from outer sheath 134 in a desired location by an operator, top stent 142 is pulled inward symmetrically rather than being pulled to one side. In this manner, the stent-graft device can be maintained in a more centered configuration with respect to the target blood vessel.

[0257] In some instances, the bottom of the first and second limb gate (e.g., ipsilateral limb 148 and contralateral limb 150) of the stent-graft device can be fixed to the introducer by trigger wires. The trigger wires can be used to move the entire endograft up and down in the aorta without crumpling the stent-graft device. As described herein, the stent-graft device can be secured at both its top and its bottom between the lasso at the top and the trigger wires at the bottom (both can be released at final deployment).

[0258] FIG. 14 illustrates cross sectional views of the aspect shown in FIGS. 11 and 12A showing snare loop 138 disposed in snare tube 136 asymmetrically with respect to inner member 164. As shown in the right panel of FIG. 14, snare tube 136 is shown to one side of inner member 164.

[0259] FIG. 15 provides exemplary cross sectional views of the aspect shown in FIG. 13 where the ends of snare loop 138 are disposed symmetrically with respect to inner member 164. As shown in FIG. 15, two strands of snare loop 138 are disposed on either side of concentric inner member 164 in a substantially symmetrical configuration.

[0260] FIGS. 16-27 illustrate another example stent-graft device 200. The stent-graft device 200 of FIGS. 16-27 includes similar features, structure, and is constructed from similar materials as the stent-graft devices described here. Like reference numbers are used to identify like features.

[0261] The example stent-graft device 200 can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient. In some examples, the stent-graft device 200 can be configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient. The stent-graft device can be deployed in a "top down" and / or "bottom up" approach and the stent-graft can be provided oriented such that the bifurcated end of the main graft body is deployed first into the blood vessel. As described herein, the stent-graft device 200 includes snare loop positioning features operative for selectively adjusting the top portion of the graft body between a constrained circumferentially collapsed configuration and an unconstrained circumferentially expanded configuration, allowing the user to control the proximal diameter of the graft body. As a result, trauma to the blood vessel and procedure time are reduced as the stent-graft device 200 is positioned / repositioned within the target blood vessel.

[0262] As provided in FIGS. 16 and 17, the stent-graft device 200 includes a main graft body 144 having a first end 172 at the superior / cephalad end of the main graft body 144 and a second end 174 at the inferior end of the main graft body 144. When positioned within the patient's blood vessel, the first end 172 of the main graft body 144 is located in a superior (cephalad) position oriented toward the patient's head, and the second end 174 of the main graft body 144 is located at an inferior position oriented toward patient's feet. The main graft body 144 includes a first end portion 262 adjacent the first end 172 of the main graft body 144. In some implementations, the first end portion 262 has a cylindrical tubular shape. The second end portion 264 of the main graft body 144 is provided adjacent the second end 174 of the main graft body 144. The second end portion 264 is bifurcated and includes bifurcated leg components extending proximally from the second end 174 toward the first end 172 (superior / cephalad end).

[0263] In some implementations, the main graft body 144 includes a coupling mechanism for coupling the main graft body 144 to the target blood vessel. For example, the main graft body 144 can include a plurality of hooks, barbs, a surface texture / feature for coupling the main graft body 144 to an interior and / or exterior wall of the target blood vessel. In some implementations, the main graft body 144 is coupled by sutures or any other mechanical or chemical fastener known in the art for coupling graft material to the vessel wall.

[0264] Like other stent-graft devices described herein, a top stent 142 is connected to (e.g., disposed at least partly with and / or constrained on) the main graft body 144. For example, as illustrated in FIGS. 16 and 17, the top stent 142 is provided at the first end 172 of the main graft body 144 in a substantiallyend-to-end configuration with main graft body 144. In some examples, the main graft body 144 is coupled to the top stent 142 via spot welding. In some examples, a portion of the top stent 142 is ground down proximate the location of the main graft body 144.

[0265] The second end portion 264 of the main graft body 144 includes bifurcated leg components. For example, the bifurcated second end portion 264 includes a first iliac leg component (ipsilateral limb 148 and corresponding ipsilateral limb gate 149) and a second iliac leg component (contralateral limb 150 and corresponding contralateral limb gate 151), as described herein. A first limb stent 34 is disposed in the ipsilateral limb 148 adjacent the ipsilateral limb gate 149 and a second limb stent 36 is disposed in the contralateral limb 150 adjacent the contralateral limb gate 151.

[0266] In some examples, each of the ipsilateral limb 148 and the contralateral limb 150 include an anchor for coupling the graft material of each of the ipsilateral limb 148 and contralateral limb 150 to their respective first limb stent 34 and second limb stent 36. In some examples, the anchor comprises a series of low-profile loops (e.g., PTFE loops) that are used to couple (e.g., via suture) the graft material of the ipsilateral limb 148 and the contralateral limb 150 with the respective first limb stent 34 and second limb stent 36. In some examples, the graft material of the ipsilateral limb 148 and the contralateral limb 150 are adhered (e.g., via tape) to the first limb stent 34 and second limb stent 36.

[0267] Similarly, in some examples the ipsilateral limb 148 and contralateral limb 150 include an anchor for coupling the graft material of each of the limbs with the main graft body 144 and / or graft material of the main graft body 144. In some examples, the anchors couple with correspond anchors provided on the inner surface of the tubular portion of the main graft body 144 to prevent migration and leaks between the tubular portion of the main graft body 144 and the bifurcated limbs, ipsilateral limb 148 and contralateral limb 150. In some examples, the ipsilateral limb 148 and / or contralateral limb 150 can be coupled to the main graft body 144 via adhesive (e.g., via tape), pressure / interference coupling, friction, and / or any other mechanical or chemical fastener. For example, as described herein, the anchor can comprise a series of low-profile loops provided on the main graft body 144, ipsilateral limb 148 and / or contralateral limb 150 for coupling via suture with the corresponding opposing graft material. In some implementations, anchors are provided on the inner surface of the ipsilateral limb 148 and the contralateral limb 150 and include hooks that couple with corresponding anchors (e.g., suture loop) provided on the inner surface of the tubular portion of the main graft body 144 (and vise-a-versa). In some implementations, the superior and / or inferior apex of the stent wireframe of the ipsilateral limb 148 and / or contralateral limb 150 is exposed, providing the anchor point for coupling (e.g., via suture)with an adjacent stent provided on the tubular portion (e.g., first end portion 262) of the main graft body 144 and / or a portion of the graft material of the main graft body 144.

[0268] FIGS. 18A-18F provide side views of the stent-graft device 200 during deployment of the ipsilateral limb 148, showing anchors 180 for coupling the ipsilateral limb 148 with the main graft body 144. It is contemplated similar anchors 180 can be provided for coupling the contralateral limb 150 to the main graft body 144 and the structure and procedure described with respect to the ipsilateral limb 148 is similar structure and procedure for coupling the contralateral limb 150 to the main graft body 144.

[0269] FIG. 18A shows the main graft body 144 positioned with in the outer sheath 134. As described herein, and illustrated in FIG. 18B, the outer sheath 134 is removed from the main graft body 144, initially exposing the ipsilateral limb 148 and / or the contralateral limb 150. As provided in FIG. 18C, the trigger wire 230 is activated (moved proximally) and the first limb stent 34 of the ipsilateral limb 148 is released and positioned within the blood vessel. As illustrated in FIG. 18D, the ipsilateral limb 148 is appropriately centered and / or positioned with respect to the main graft body 144 and the outer sheath 134 is further removed. In some examples, the trigger wire 230 is further activated and the main graft body 144 and anchor 180 are released. The anchors 180 fix the position of the ipsilateral limb 148 with respect to the main graft body 144.

[0270] In some implementations, the stent-graft device 200 includes a catheter for positioning the main graft body 144 at a location in the target blood vessel in proximity to the aneurysm. As illustrated in FIGS. 16 and 17, the catheter includes the outer sheath 134. In some examples the catheter is provided by the inner member 164, the delivery sheath 80, a loading sheath and / or any other tubular layer for positioning the main graft body 144 in proximity to the aneurysm. The catheter / outer sheath 134 includes a central lumen sized and configured to receive the main graft body 144 therein. The outer sheath 134 is movable through the patient's blood vessel for positioning the main graft body 144 and the top stent 142 at a location in the target blood vessel in proximity to the aneurysm. During delivery and / or placement at the treatment site, the stent-graft / main graft body 144 is provided at a distal end portion of the outer sheath 134 and oriented such that the second end 174 (inferior end) of the main graft body 144 is adjacent the distal opening of the outer sheath 134. For example, the main graft body 144 and the top stent 142 are received within and oriented relative to the outer sheath 134 such that removal (and / or retraction) of the outer sheath 134 from the main graft body 144 (and / or the target blood vessel) initially exposes the ipsilateral limb 148 and the contralateral limb 150.

[0271] In some implementations, when the main graft body 144 is retained within the outer sheath 134, the first end 172 (superior end) of the main graft body 144 is oriented toward and / or adjacent the proximal end of the outer sheath 134, and the second end 174 (inferior end) of the main graft body 144 is oriented toward and / or adjacent the distal end of the outer sheath 134. The proximal end of the outer sheath 134 includes the portion of the outer sheath 134 located outside the patient and the distal end of the outer sheath 134 including the portion of the outer sheath 134 positioned inside the blood vessel, including the distal opening through which the main graft body 144 to the treatment site.

[0272] In some implementations, as illustrated in FIGS. 16 and 17, a contrast lumen 250 provided within the outer sheath 134 for providing a flow of contrast fluid to a site proximate the aneurysm. In some examples, the contrast lumen 250 is in fluid communication with a contrast port provided on the hub / handle coupled to a proximal end of the outer sheath 134. In some examples, when the main graft body 144 is retained / positioned within the outer sheath 134, the contrast lumen 250 terminates at a location proximal of the main graft body 144. That is, the distal end of the contrast lumen 250 is located between the proximal end of the outer sheath 134 and the first end 172 of the main graft body 144. Accordingly, in some examples, the contrast lumen 250 does not overlap main graft body 144 and / or pass next to the main graft body 144 when retained within the outer sheath 134. This provides a lower profile stent-graft device 200. Because the femoral puncture site is downstream of the main graft body 144, and the distal opening of the contrast lumen 250 is located upstream of the endograft / main graft body 144, contrast fluid is provided upstream of the main graft body 144. This simplifies current practice with a femoral approach where a separate pigtail angiographic catheter is used to deliver contrast fluid to the procedure site, also preventing the second access / opening in blood vessel for providing the second contrast catheter.

[0273] In some implementations, as illustrated for example in FIGS. 19-21, the stent-graft device 200 includes a pusher 280 received within the outer sheath 134 for engaging at least one of the top stent 142 or the main graft body 144. The pusher 280 is sized and configured to move axially (and / or rotationally) within the outer sheath 134 and maintain its position while the outer sheath 134 is moved axially (and / or rotationally) along the pusher 280. For example, when the outer sheath 134 is positioned within the target blood vessel at a location proximate the aneurysm, the outer sheath 134 is moved proximally to expose the main graft body 144. The pusher 280 engages the top stent 142 and / or first end 172 the main graft body 144, maintaining the position of the main graft body 144 within the blood vessel as the outer sheath 134 is removed. For example, when the main graft body 144 and the top stent 142 are received within the outer sheath 134, the distal end 282 of the pusher 280 is locatedadjacent and / or proximal of the first end of the top stent 142 and / or the first end 172 of the main graft body 144, such that removal (and / or retraction) of the outer sheath 134 from the main graft body 144 initially exposes the bifurcated second end 174 of the main graft body 144 (e.g., initially exposing the ipsilateral limb 148 and the contralateral limb 150).

[0274] In some examples, the pusher 280 is composed of the same or different material as the delivery sheath 134. For example, the pusher 280 is composed of HDPE and or PEEK. In some examples, the pusher 280 includes a lubricious coating for reducing friction between the pusher 280 and the outer sheath 134 as the pusher 280 moves axially (and / or rotationally) therein. In some examples, as illustrated in FIG. 23, the pusher 280 is comprised of a flexible metallic shaft or hypotube. The pusher 280 can include a hypotube spacer 281 at the distal end. The hypotube spacer 281 abuts the main graft body 144 / top stent 142 during delivery. In some examples, the hypotube spacer 281 is bonded to the inner member 164.

[0275] In some implementations, the stent-graft device 200 includes a constraining member provided over and / or constraining the main graft body 144 and / or the top stent 142 / superior apexes 244 of the top stent 142. The constraining member selectively adjusts the top stent 142 between a constrained circumferentially collapsed configuration as shown in FIG. 16 and an unconstrained circumferentially expanded configuration as shown in FIG. 17, and vis-a-versa.

[0276] In some examples, the outer sheath 134 is arranged to constrain the main graft body 144 and the top stent 142 while retained therein. For example, the outer sheath 134 provides an inwardly directed radial force that maintains the main graft body 144 and top stent 142 in a constrained circumferentially collapsed configuration.

[0277] In some examples, the constraining member includes a snare loop 138 or other device provided over and / or otherwise constraining the top stent 142 of the main graft body 144 and adapted to selectively release the main graft body 144 / top stent 142 in the target blood vessel. As provided in FIGS. 16 and 17, the snare loop 138 passes through a snare tube 136 and is releasably engaged with a plurality of circumferentially spaced positions on the top stent 142. The snare tube 136 extends within the central lumen the outer sheath 134.

[0278] The snare loop 138 is operative for selectively adjusting the top stent 142 between the constrained circumferentially collapsed configuration (FIG. 16) and the unconstrained circumferentially expanded configuration (FIG. 17). In some implementations, tightening of the snare loop 138 maintains the first end 172 / first end portion 262 of the main graft body 144 in the constrained configuration and loosening of the snare loop 138 induces release of the first end first end 172 / first end portion 262 of themain graft body 144 into the unconstrained configuration. In the constrained configuration, the top stent 142 and at least a portion of the first end portion 262 of the main graft body 144 are constrained circumferentially having a reduced diameter / profile, thereby reducing risk of damage to the blood vessel when the stent-graft device 200 is positioned or repositioned in the target blood vessel.

[0279] In some implementations, the snare loop 138 is used to re-constrain / collapse the main graft body 144 so that it can be repositioned within the blood vessel. For example, the snare loop 138 can be adjusted to re-constrain the first end 172 of the main graft body 144 after having been previously expanded, the position of the main graft body 144 within the target blood vessel can be adjusted and the main graft body 144 / top stent 142 can be re-expanded, thereby reducing trauma to blood vessel and allowing for the main graft body 144 to be repositioned.

[0280] As provided in FIGS. 16 and 17, the snare loop 138 is positioned through a plurality of positioning receptacles provided on the top stent 142. In some examples, the positioning receptacles comprise a plurality of eyelets 140. Snare loop 138 is shown threaded through a plurality of eyelets 140 and the top stent 142 is shown to include a plurality of hooks 143 disposed in / coupled to the eyelets 140. In some examples, the snare loop 138 is coupled to each of the eyelets 140 via a corresponding suture loop. The plurality of eyelets 140 are provided at a first end of the top stent 142, i.e., the superior / cephalad / cranial end of the top stent 142. For example, as illustrated in FIGS. 16 and 17, the plurality of eyelets 140 are provided at each of the superior apexes 244 of the top stent 142.Accordingly, the snare loop 138 and / or the snare lumen 136 does not overlap with the main graft body 144 when the main graft body 144 is in a constrained circumferentially collapsed configuration (FIG. 16) and thereby causing the stent-graft device 200 to have a lower / reduced profile. In some examples, the snare loop 138 and / or snare lumen 136 overlap with the ungrafted portion of the top stent 142.

[0281] FIGS. 19 and 20 illustrate another example stent-graft device 200 where the snare loop 138 and snare lumen 136 is positioned around a mid portion of the top stent 142. For example, as provided in FIG. 19, the plurality of eyelets 140 are provided along an arm portion 240 of the top stent 142, where the arm portion 240 extends between a superior apex 244 and an opposing inferior apex 242 of the top stent 142. In some implementations, as illustrated in FIG. 19, the plurality of plurality of eyelets 140 can be provided along a midline of the top stent 142, that is, at a point along the top stent 142 half way between the superior apexes 244 and the opposing inferior apex 242. Because the snare loop 138 is coupled to the top stent 142 at a location distal the superior apexes 244, the snare tube 136 includes a snare tube extension 214 coupled to the distal end of the snare tube 136. The snare tube extension 214 adjusts the distal opening of the snare tube 136 to a location proximate the plurality of eyelets 140.

[0282] FIG. 19 illustrates the top stent 142 and the main graft body 144 in an unconstrained configuration and FIG. 20 illustrates the top stent 142 and main graft body 144 in a constrained configuration. In the constrained configuration, the top stent 142 and at least a portion of the main graft body 144 are constrained circumferentially having a reduced diameter / profile. By providing the snare loop 138 around a mid portion of the top stent 142 the constrained provide of the top stent 142 and main graft body 144 allows for a longer length of the top stent 142 to be constrained, when compared to an example stent-graft device 200 providing the snare loop 138 at the superior apexes 244 of the top stent 142.

[0283] FIGS. 21 and 22 illustrate another example stent-graft device 200 including two snare loops 138 axially spaced along the top stent 142. FIG. 21 shows the example stent-graft device 200 including a first snare loop 234 provided at the proximal end of the top stent 142 and a second snare loop 238 positioned between the first snare loop 234 and the first end 172 (superior end) of the main graft body 144. As a result, and as shown in FIG. 22, by including a plurality of axially spaced snare loops 138, when in the constrained configuration, the top stent 142 and the main graft body 144 flare distal of the (lower) second snare loop 238, further constraining the superior / cranial edge of the top stent 142 and the main graft body 144, reducing incidence of the top stent 142 catching and damaging the vessel wall (V) when the main graft body 144 positioned / repositioned within the target blood vessel.

[0284] For example, the stent-graft device 200 of FIGS. 21 and 22 can include a first snare loop 234 and a second snare loop 238. The first snare loop 234 passes through a first snare tube 232 extending through / within the outer sheath 134. The first snare loop 234 being releasably engaged with a first plurality of eyelets 140a circumferentially spaced around the top stent 142. The second snare loop 238 passes through a second snare tube 236 extending through / within the outer sheath 134. The second snare loop 238 being releasably engaged with a second plurality of eyelets 140b circumferentially spaced around the top stent 142 at a location between the first snare loop 234 and the first end 172 of the main graft body 144. As such, the second snare loop 238 is positioned distal the first snare loop 234. Each of the first snare loop 234 and the second snare loop 238 are operative for selectively adjusting the top stent 142 from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration (FIG. 21).

[0285] As provided in FIG. 21, the first snare loop 234 is positioned through a first plurality of eyelets 140a provided at a first end of the top stent 142 (e.g., the superior / cranial end of the top stent 142), and the second snare loop 238 is positioned through a second plurality of eyelets 140b provided along the top stent 142 between first snare loop 234 and the first end 172 of the top stent 142. In some examples,the first plurality of eyelets 140a are provided at and / or proximal of the plurality of superior apexes 244 of the top stent 142. The second plurality of eyelets 140b are provided along the top stent 142 at a location distal each of the plurality of superior apexes 244. For example, as illustrated in FIG. 21, the second plurality of eyelets 140b are provided along a midline of the top stent 142. In some examples, the location of the second plurality of eyelets 140b can be adjusted to control the flare of the caudal portion of top stent 142 and / or main graft body 144.

[0286] In some examples, the top stent 142 includes a hook / barb 256 adjacent at least one of the first plurality of eyelets 140a. The hook / barb 256 is positioned distal at least one of the first plurality of eyelets 140a. For example, as shown in FIG. 21, the barb 256 is positioned between the first plurality of eyelets 140a and the second plurality of eyelets 140b. In some examples, the barb 256 includes a plurality of barbs 256 at varied axial positions along the top stent 142. In some examples, providing the first plurality of eyelets 140a axially spaced from the second plurality of eyelets 140b allows for a longer length of the top stent 142 to be constrained, making it easier to reposition the main graft body 144. In the constrained configuration, flaring of the top stent 142 / main graft body 144 occurs closer to the barb 256 than compared to other snare loop locations, prevents or reduces the likelihood that the superior apexes 244 and / or hooks 246 will overlap when the top stent 142 is in the constrained configuration and allows the flaring barb 256 to be hidden from the vessel wall (V), preventing the barb 256 from catching or otherwise damaging the vessel wall (V) during positioning / repositioning the main graft body 144.

[0287] FIG. 23 illustrates another example stent-graft device 200 where the main graft body 144 is coupled to the top stent 142 adjacent a superior end of the top stent 142. In some examples, the main graft body 144 is coupled to the top stent 142 such that the first end 172 (superior end) of the main graft body 144 is located proximate the superior apex 244 of the top stent 142. In some examples, the main graft body 144 is coupled to the top stent 142 such that the first end 172 (superior end) of the main graft body 144 is coupled to the top stent 142 at a location between the superior apex 244 and the inferior apex 242. Coupling the main graft body 144 at a location closer to the superior end 244 of the top stent 142 improves constraining of the superior / cranial edge of the graft material of the main graft body 144 when repositioning the stent-graft device 200. This also allows for smoother movement in the of the stent-graft device 200 / main graft body 144 within the target blood vessel thereby lowering the risk of trauma to the vessel.

[0288] In some implementations the stent-graft device 200 includes two snare loops 138 activated by a trigger wire 230 causing the snare loops 138 to separate and / or release from restraining the top stent 142, thereby allowing the main graft body 144 to deploy and expand with the target blood vessel. Forexample, as illustrated in FIGS. 24-27, the stent-graft device 200 includes a first snare loop 210 and a second snare loop 212. The first snare loop 210 passes through the snare tube 136 and a first positioning receptacle / first eyelet 222 provided on the top stent 142. Similarly, the second snare loop 212 passes through the snare tube 136 and a second positioning receptacle / second eyelet 224 provided on the top stent 142. In some examples, the first eyelet 222 and second eyelet 224 are provided on the top stent 142, and the first snare loop 210 and second snare loop 212 are coupled to the corresponding first eyelet 222 and second eyelet 224 via suture loops.

[0289] The first snare loop 210 and the second snare loop 212 are operative for selectively adjusting the top stent 142 between the unconstrained circumferentially expanded configuration illustrated in FIG. 17, and the constrained circumferentially collapsed configuration illustrated in FIG. 16. FIGS. 25-27 provide partial cross sectional views of the stent-graft device 200 of FIGS. 16-17 in various unconstrained and constrained configurations. For example, in some implementations, the first snare loop 210 and / or the second snare loop 212 are movable between a first position illustrated in FIG. 25, where the top stent 142 is in the unconstrained circumferentially expanded configuration, and a second position illustrated in FIG. 26, where the top stent 142 is in the constrained circumferentially collapsed configuration.

[0290] FIG. 25 illustrates a partial cross sectional view of the stent-graft device 200 of FIGS. 16-17 along section line B-B (FIG. 17). In FIG. 25, the first snare loop 210 and second snare loop 212 are shown in the unconstrained configuration. As shown in FIG. 25, the first snare loop 210 extends around a first side of the inner member 164 and the second snare loop 212 extends around the opposing second side of the inner member 164. The first eyelet 222 (including a plurality of first eyelets 222) is provided on the first side of the top stent 142 and the second eyelet 224 (including a plurality of second eyelets 224) is provided on the opposing second side of the top stent 142.

[0291] FIG. 26 illustrates a partial cross sectional view of the 200 of FIGS. 16-17 along section line C-C (FIG. 16). In FIG. 26, the first snare loop 210 and the second snare loop 212 are shown in the constrained configuration. For example, in some implementations, withdrawing the first snare loop 210 and / or second snare loop 212 within the snare tube 136 causes the first snare loop 210 and / or second snare loop 212 to shorten and / or tighten along and / or around the top stent 142, thereby moving the top stent 142 from the unconstrained circumferentially expanded configuration, shown FIG. 25, to the constrained circumferentially collapsed configuration, shown in FIG. 26. In the constrained circumferentially collapsed configuration, the top stent 142 and at least a portion of the main graft body144 are constrained and maintains a reduced diameter / profile, thereby reducing risk of damage to the vessel as the sent-graft device 200 is positioned or repositioned in the target blood vessel.

[0292] FIG. 27 illustrates a partial cross sectional view of the 200 of FIGS. 16-17 with the first snare loop 210 and second snare loop 212 are released from the unconstrained main graft body 144. When the main graft body 144 is positioned within the blood vessel at the desired treatment site, the first snare loop 210 and the second snare loop 212 can be released from the top stent 142. For example, in some implementations, the first snare loop 210 and the second snare loop 212 are coupled to a trigger wire 230 for releasing the first snare loop 210 and the second snare loop 212 from the top stent 142. In some examples, the first snare loop 210 and second snare loop 212 can be releasably and / or movably coupled to the trigger wire 230. It is contemplated that similar mechanisms are used to release the trigger wire 230 as used to activate / release the first snare loop 210 and / or second snare loop 212. As illustrated in FIGS. 16-19, the trigger wire 230 extends through the outer sheath 134, through the main graft body 144, to the nose cone 158. The proximal end of the trigger wire 230 extends through the outer sheath 134 to be manipulated by the user.

[0293] As illustrated in FIG. 25, in some examples, a length of the first snare loop 210 and the second snare loop 212 extend around the trigger wire 230. In some examples, the first snare loop 210 and the second snare loop 212 include a length of a suture material coupling them to the trigger wire 230. In some examples, tightening the trigger wire 230 causes the first snare loop 210 and the second snare loop 212 to release from the trigger wire 230 and the main graft body 144 / top stent 142. For example, movement of the trigger wire 230 in a direction toward the proximal end of the outer sheath 134 causes the first snare loop 210 and the second snare loop 212 to release from the main graft body 144 / top stent 142.

[0294] In some implementations, activating the trigger wire 230 activates the contralateral tether 152 releasing the first limb stent 34 / ipsi lateral limb 148 and the ipsilateral tether 154 releasing the second limb stent 36 / contralateral limb 150. For example, in some implementations, activating the trigger wire 230 causes the top stent 142, the first limb stent 34 of the ipsilateral limb 148, and the second limb stent 36 of the contralateral limb 150 to release at the same time. In some implementations, the trigger wire 230 is activated in phases, releasing the top stent 142, the first limb stent 34 / ipsilateral limb 148, and the second limb stent 36 / contralateral limb 150 at different times.

[0295] In some implementations, the trigger mechanism, including the trigger wire 230 and tethers, includes similar structure and function to the snare loop 138 (illustrated in FIGS. 16 and 17), and in someimplementations, the structure and function to the first snare loop 210 and second snare loop 212 (illustrated in FIGS. 19-27).

[0296] For example, in some implementations, as illustrated in FIG. 19, the trigger mechanism includes a contralateral tether 152 for releasing the contralateral limb 150 and an ipsilateral tether 154 for releasing the ipsilateral limb 148. The contralateral tether 152 and the ipsilateral tether 154 can be coupled to the trigger wire 230 using structure similar to that used to couple the first snare loop 210 and second snare loop 212 to the trigger wire 230. In this implementation, activating the trigger wire 230 releases the contralateral limb 150 and the ipsilateral limb 148 before the top stent 142. As provided in FIG. 19, a wire holder 156 is provided at the distal end of the inner member 164 adjacent the nose cone 158 preventing the trigger wire 230 from moving (proximally) axially.

[0297] In some implementations, the stent-graft device 200 includes two trigger wires 230, where the first of the trigger wires 230 releases the top stent 142 and the second of the trigger wires 230 releases the contralateral limb 150 and the ipsilateral limb 148. When two trigger wires 230, the order of the stent / limb release can be varied according to user preference. For example, the first of the trigger wires 230 can be used to release the top stent 142 and the second of the trigger wires 230 can be used to release the contralateral limb 150 and ipsilateral limb 148. Where in some implementations, the first trigger wire 230 is activated first. In other implementations the second trigger wire 230 is activated first. In further implementations, the first and second trigger wires 230 are activated at the same time.

[0298] In one aspect, the main graft body, first limb gate, and second branch graft comprise ePTFE (polytetrafluoroethylene). In another aspect, the ePTFE is an ultrathin composite made of, for example, up to 10 ply layers or more with layers as thin as about 0.00015". Sintering can be performed under high temperature with compression to adhere all ePTFE layers. In this aspect, the ePTFE has multi directional strength with orientation of the layers that prevent creep in all directions. In this aspect, creep or movement of ePTFE should be avoided or minimized as it will allow for continuous expansion of the graft. In some implementations, inner and outer layers of the ePTFE are sintered together separately and then sandwiched around the stent structure of the stent-graft device 200. An intermediate FEP layer is included as a binder, and is fused at a lower temperature than the sintering temperature. In another aspect, the ePTFE can be configured to be impermeable to blood serum by the addition of, for example, an FEP (fluorinated ethylene propylene) layer(s), in order to provide a substantially blood tight seal. In a further aspect, the total thickness of the ePTFE as sintered is about 0.0015".

[0299] In some instances, 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 ScaffoldMaterials Through Physicomechanical, Thermal, and Enzymatic Degradation Techniques. Annals of Surgery, March 2012; U.S. Pat. Application Pub. No. US20180326120.

[0300] A method of repairing an abdominal aortic aneurysm in a patient using the stent-graft device 200 of FIGS. 16-27 is described herein. During a repair procedure, a puncture can be made in an insertion site blood vessel located above a diaphragm of the patient, thereby creating a passage in the insertion site blood vessel. For example, access into the blood vessel is made using the Seidinger technique. In some implementations, a puncture can be made in an insertion site blood vessel located below a diaphragm of the patient, thereby creating a passage in the insertion site blood vessel. In some implementations, the stent-graft device 200 is inserted into the insertion site blood vessel by a single arterial puncture or incision. In some implementations, the insertion site blood vessel has a diameter less than or equal to the diameter of a femoral artery of the patient. For example, the insertion site blood vessel can include brachial, radial, ulnar, axillary, carotid, and / or subclavian arteries. In an example including the axillary artery, the insertion site blood vessel can include a second or proximal third portion of the axillary artery. In some examples, the insertion site blood vessel is a subclavian artery.

[0301] An outer / introducer sheath and guidewire are advanced into the common iliac artery with the aneurysm. The outer / introducer sheath is removed with the guidewire remaining in the desired position.

[0302] The stent-graft device 200 is advanced within the insertion site blood vessel to the target blood vessel. In some implementations, the target blood vessel includes an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, and / or a suprarenal aorta. In some implementations, the target blood vessel further includes the iliac arteries and / or visceral vessels. In some implementations, the stent-graft device 200 is advanced within the insertion site blood vessel and / or target blood vessel with the direction of blood flow in the aorta. That is, the stent-graft device 200 is not advanced against the direction of blood flow.

[0303] In some implementations, positioning the main graft body 144 in the target blood vessel includes advancing the outer sheath 134 in the target blood vessel to a location in proximity to the aneurysm.

[0304] The outer sheath 134 is then withdrawn from the main graft body 144 initially exposing the inferior end of the main graft body 144 (e.g., initially exposing the ipsilateral limb 148 and the contralateral limb 150). In some implementations, withdrawing the outer sheath 134 from the main graft body 144 further includes maintaining an axial position of the main graft body 144 within the bloodvessel by engaging at least one of the top stent 142 and / or or the main graft body 144 with the pusher 280 received within the outer sheath 134. The pusher 280 engages the first end 172 of the main graft body 144 maintaining the position of the main graft body 144 within the target blood vessel as the delivery sheath 134 is withdrawn from the main graft body 144. As described herein, during insertion and withdraw of the outer sheath 134, the top stent 142 of the main graft body 144 is maintained in a constrained configuration by a snare loop 138 and / or suture loop.

[0305] With the outer sheath 134 withdrawn and the main graft body 144 positioned in the target blood vessel of the patient, the top stent 142 of the main graft body 144 is deployed. In some implementations, deploying the top stent 142 / main graft body 144 includes loosening and / or releasing the tension provided on the top stent 142 by the snare loop 138 such that the top stent 142 and the first end 172 of the main graft body 144 moves from the constrained configuration to the unconstrained configuration.

[0306] In some implementations, it is necessary to reposition the main graft body 144 within the target blood vessel. In these instances, the top stent 142 and main graft body 144 are moved from the unconstrained configuration back to the constrained configuration. In some examples, this includes tightening the snare loop 138 to return the top stent 142 and / or the main graft body 144 to / towards the constrained configuration. The main graft body 144 is then repositioned withing the target blood vessel at the new delivery location, and the top stent 142 and main graft body 144 are re-deployed within the target blood vessel of the patient at the new location.

[0307] In some implementations, as illustrated in FIGS. 28-38, the stent-graft device 200 includes a corset 300 for constraining the main graft body 144. The corset 300 can be used to constrain the main graft body 144 making it easier to initially position and / or reposition within the target blood vessel. FIG. 28 is a side view of an example stent-graft device including a dual snare loop, dual apex stabilizer, and a corset 300. As illustrated in FIG. 28, the corset 300 maintains the main truck portion of the main graft body 144 in a partially constrained / circumferentially collapsed configuration. Similarly, as illustrated in FIG. 28, the corset 300 also helps to maintain the top stent 142 in a partially constrained / circumferentially collapsed configuration. As a result, when the corset 300 is engaged, the stent-graft device 200 has a reduced / constrained diameter, thereby making it easier to position and / or reposition within the target blood vessel. In some implementations, the corset 300 maintains the main graft body 144 (e.g., embedded stents within the main graft body 144) and / or top stent 142 to at least 50% of their full / expanded diameter. In some implementations, the corset 300 maintains the main graft body 144 (e.g., embedded stents within the main graft body 144) and / or top stent 142 at approximately 70% oftheir full / expanded diameter. As described herein, this reduced diameter helps to position and reposition the main graft body 144 with limited vessel contact, thereby reducing friction and prevent damage to the aortic vessel wall.

[0308] In some implementations, restraining the main graft body 144 can help to prevent axial movement (e.g., distal movement) of the graft edge caused by blood flow captured in the partially expanded main graft body 144. For example, in some implementation including a dual snare loop (illustrated in FIGS. 24-27), when the delivery sheath 80 is removed from the main graft body 144 the proximal and distal end of the main graft body 144 are maintained in a constrained / collapsed configuration. That is, the proximal apexes / barbs of the top stent 142 and the first end 172 of the main graft body 144 are maintained toward the inner member 164 (guidewire lumen) by the dual snare loop (first snare loop 210 / second snare loop 212), and the second end 174 of the main graft body 144 is tethered to the shelf 126 / wire holder 156 by the tether 152. In contrast, the unrestrained portion (e.g., middle portion) of the main graft body 144 can expand freely. The unstrained / expanded portion of the main graft body 144 could capture blood flow through the artery, making the main graft body 144 difficult to move and complicating retraction of the main graft body 144 and / or second end 174 of the main graft body 144.

[0309] Using the corset 300 to control expansion of the main graft body 144 allows the user to control placement of the stent-graft device 200 while also reducing concern of unwanted axial movement of the main graft body 144 / top stent 142. For example, in some implementations, the user is able to partially release the snare loop 138 (or first snare loop 210 / second snare loop 212) to confirm barb placement and location of the top stent 142 in the target blood vessel, use of the corset 300 helps to prevent billowing / ballooning of the main graft body 144 by caused by blood flow through the device, thereby helping to prevent any distal movement of the main graft body 144, which in turn helps to center the top stent 142 / main graft body 144 within the target blood vessel.

[0310] The corset 300 may include a trigger wire 330 that when activated allows the constrained portion of the main graft body 144 / top stent 142 to move from the constrained configuration to the unconstrained configuration, similar to how activating the trigger wire 230 allows the snare loop 138 (first snare loop 210, second snare loop 212) to loosen and / or release the top stent 142. In some implementations, the corset 300 trigger wire 330 can be released separately from the trigger wire 230 (top stent 142). As such that expansion of the main graft body 144 relative to the top stent 142 can be controlled. While in some implementations, the trigger wire 330 is released simultaneously with trigger wire 230 (top stent 142). As such, the top stent 142 and main graft body 144 can move together towardthe unconstrained / expanded configuration. In some implementations the trigger wire 330 is coupled to or otherwise continuous with the trigger wire 230 of the top stent 142. In other implementations, the trigger wire 330 is separate from the trigger wire 230 of the top stent 142. As such, full and / or partial expansion of the main graft body 144 and top stent 142 can be separately controlled.

[0311] As described herein, in some implementations, the corset 300 and trigger wire 330 are external to the main graft body 144. In other implementations, the corset 300 and the trigger wire 330 are primarily internal to the main graft body 144. In further implementations, the corset 300 is at least partially embedded within the main graft body 144 and the trigger wire 330 is provided internal and / or external to the main graft body 144.

[0312] In some implementations, the corset 300 is anchored to the main graft body 144 and / or top stent 142 to help prevent axial and / or rotational migration of the corset 300 along and / or around the main graft body 144 / top stent 142. For example, the corset 300 can be coupled to the main graft body 144 and / or top stent 142 by a mechanical fastener, chemical fastener (for example, an adhesive), thermal process, or other suitable coupling process known in the art. For example, in some implementations, the corset 300 is coupled to the main graft body 144 and / or top stent 142 by a mechanical fastener such as a suture. In some implementations, the corset 300 is coupled to the main graft body 144 / top stent 142 at a single anchor point around the circumference of the corset 300. In some implementations, the corset 300 is coupled to the main graft body 144 / top stent 142 at from two to five anchor points. In other implementations, the corset 300 is coupled to the main graft body 144 / top stent 142 around a portion and / or the entire circumference of the corset 300.

[0313] In some implementations, as illustrated in FIG. 28, the corset 300 is provided by a stent-like structure coupled to the main graft body 144. As illustrated in FIG. 28, the stent-like structure of the 300 can extend around the outer surface of the main graft body 144 and / or be completely or partially embedded within / between the layers of the 144.

[0314] FIG. 29 is an enlarged view of the corset eyelet 302 for coupling the corset 300 to the trigger wire 330. As illustrated in FIGS. 28 and 29, corset eyelets 302 are provided at the apexes of the stent-like structure of the corset 300. A tether wire can be coupled to the corset eyelets 302 and extend around the main graft body 144 / corset 300, similar to the first snare loop 210 and / or second snare loop 212 coupled to the top stent 142. The trigger wire 330 can be coupled to a primary corset eyelet 302 directly or by a tether 304 (e.g., suture loop). When the trigger wire 330 is activated, the tether wire is loosened and / or released allowing corset 300 to expand, which in turn frees the underlying portion of the main graft body 144 / top stent 142 to expand.

[0315] In some implementations, the top stent 142 includes a tether wire 304 coupled to various eyelets 140 provided around the top stent 142. As described herein, the tether wire 304 can be coupled directly to the eyelets 140, or coupled to the eyelets 140 by an other connection including a suture loop.

[0316] In some implementations, the tether wire 304 is also coupled to the eyelets of the top stent 142 for controlling expansion of the top stent 142. FIGS. 30-32 shows cross-sectional views of FIG. 28 taken along section line A-A in various tether wire 304 configurations. As provided in FIGS. 30-32, the tether wire 304 can be coupled to select eyelets 140 such that when the tether wire 304 is loosened the top stent 142 is allowed to partially open in a pre-determined configuration. For example, in some implementations, when the tether wire 304 is loosened / released, it only allows the snare loop 138 (first snare loop 210, second snare loop 212) to partially open in a pre-determined configuration. Similarly, when the tether wire 304 is engaged, the top stent 142 is maintained in a constrained and / or partially constrained configuration

[0317] In some implementations, the tether wire 304 is configured to control expansion of the top step 142 into a "figure eight" shape. For example, as illustrated FIG. 30, the tether wire 304 this coupled to a first eyelet 140a and a second eyelet 140b, where the first eyelet 140a is spaced circumferentially around the top stent 142 from the second eyelet 140b. FIG. 31 illustrates a second example of the tether wire 304 coupled to a first eyelet 140a and a second eyelet 140b spaced circumferentially around the top stent 142. In the example provided in FIG. 31, the positions of the first eyelet 140a and second eyelet 140b align closer with the snare loop positions that are attached to the delivery system. In some implementations, this configuration allows for freer expansion and collapsing of the snare loop due to its alignment, and can reduce friction / pinch-points between the snare loop and the top stent 142.

[0318] With the tether 304 constrained (e.g., maintaining tension on the tether wire 304), the first and second eyelet 140a, 140b, and corresponding apexes of the top stent 142, are constrained towards the inner member 164 while the remaining eyelets / apexes are allowed freer movement / expansion. The location of the constrained apexes forms a "figure eight" of the top stent 142 apexes. The "figure eight" shape allows the outer barbs provided on the unconstrained apexes of the top stent 142 to be placed against the vessel wall and thus axially securing the top stent 142 and helping to ensure final barb location without any distal movement of the main graft body 144.

[0319] With the top stent 142 and main graft body 144 in the desired position, the snare loop 138 (first snare loop 210, second snare loop 212) can then be fully opened. In the process of fully opening the snare loop 138, there is no distal movement since the outer barbs provided on the unconstrained apexes of the top stent 142 of the "figure eight" shape are holding the top stent 142 in place. The triggerwire 230 and trigger wire 330 are then fully released and the top stent 142 and main graft body 144 delivered within the target blood vessel. By controlling the expansion of the main graft body 144 and the top stent 142, the user is able to more accurately position and reposition the stent-graft device 200, reducing treatment time, while also minimizing risk of trauma to the blood vessels and damage to the stent-graft device 200.

[0320] FIG. 32 illustrates an example tether 304 configuration where the tether wire 304 is coupled to a single eyelet 140a. In this example, the tether wire 304 is held taught during the entire procedure, and released when the top stent 142 is fully released, and corresponding barbs engaged with the vessel wall.

[0321] FIG. 33 is a side view on a stent-graft device 200 including a plurality of corsets 300 for selectively maintaining the top stent and the main graft body 144 in a constrained / circumferentially collapsed configuration. The first corset 300a and the second corset 300b are positioned along the main graft body 144 between stent gaps as illustrated in FIG. 34, providing an enlarged partial side view of the device of FIG. 33.

[0322] Similar to the corset 300 described in reference to FIG. 28, the first corset 300a and the second corset 300b maintain the main graft body 144 and / or top stent 142 at least 50% of their full / expanded diameter. In some implementations, the first corset 300a and the second corset 300b maintain the main graft body 144 and / or top stent 142 at approximately 70% of their full / expanded diameter.

[0323] In some implementations, the first corset 300a and second corset 300b are held at their axial location with the use of ringlets-shaped retaining members 306. As shown in FIG. 35, providing a cross- sectional view of the main graft body 144 of FIG. 37 taken along section line A-A, in some examples, the retaining members 306 are formed as short tubular-shaped member (e.g., metallic tubing) with an internal lumen aligned with the circumferential direction of the first corset 300a and second corset 300b. In some implementations, the retaining members 306 are embedded between the inner and outer layers of main graft body 144 (e.g., between the ePTFE graft material). As illustrated in FIG. 36, in some implementations, the first corset 300a and second corset 300b will pass through openings provided in the inner and / or outer layer of the main graft body 144 and through the retaining member 306. For example, in some implementations, the corset 300 penetrates / passes through openings outer layer of the 144 and through the retaining member 306 embedded within the layers of the main graft body 144 material, helping to maintain luminal / radial integrity of the main graft body 144. In some implementations, any openings or perforations of the corset 300 are filled with an aqueous FEP solution.

[0324] FIG. 37 is a partial side view on a stent-graft device 200 including a stent-like corset 300 for selectively maintaining the top stent 142 and the main graft body 144 in a constrained / circumferentiallycollapsed configuration. As illustrated in FIG. 37, the stent structure forming the corset 300 are maintained in a constrained / collapsed configuration by coupling of the corset 300 with the trigger wire 330. In some implementations, the corset 300 is coupled to the trigger wire 330 by passing a tether wire from the stent apex, around the trigger wire 330 and back to the stent apex. For example, the tether wire 304a can pass from a first eyelet 140a provided on the corset 300, around the trigger wire 330 and back to the first eyelet 140a. The tether wire 304a can be tied off or otherwise secured to the first eyelet 140a. Each of the remaining stent apexes can be similarly coupled to the trigger wire 330 by a portion of tether wire extending around the trigger wire 330 and secured to the stent apex. When the trigger wire 330 is released, the portion of tether wire 304 (e.g., tether wire 304a) is released and from the trigger wire 330 and the corset 300 is free to expand radially. In some implementations, the released portion of the tether wire 304 it is pulled back to be inside the delivery system shaft. In some implementations, the released portion of the tether wire 304 is removed from the delivery system by the operator.

[0325] In another implementation, portion of the tether wire 304 is coupled between the trigger wire 330 and adjacent apexes of the stent-like corset 300. For example, in some implementations, the portion of the tether wire 304 extends from a proximal apex (at a first eyelet 140a), around the trigger wire 330, to a distal apex (at a second eyelet 140b), where the proximal and distal apexes are adjacent and / or spaced apart around the circumference of the corset 300. For example, in some implementations, the portion of the tether wire 304 passes from the first eyelet 140a, around the trigger wire 330, to the second eyelet 140b (adjacent circumferentially from the first eyelet 140a). In this example, the first eyelet 140a and the second eyelet 140b are spaced axially along the corset 300. Each of the remaining stent apexes can be similarly coupled to the trigger wire 330 by a portion of tether wire 304 extending from a first stent apex, around the trigger wire, and to a second axially and / or circumferentially spaced stent apex. When the trigger wire 330 is released, the portion of tether wire (e.g., tether wire 304a) is released and from the trigger wire 330 and the corset 300 is free to expand radially.

[0326] As described herein, in some implementations the tether wire 304 is coupled to the trigger wire 330 such that activating the trigger wire 330 causes the tether wire 304 to loosen / release, thereby allowing the stent-like corset 300 to expand. In some implementations, the corset 300 is released by withdrawing the trigger wire 330 from the corset 300.

[0327] A further device and method for repairing an aortoiliac and iliac aneurysm in a patient using a stent-graft device 200 similar to those described herein. As described herein with respect to other example stent-graft devices, the ipsilateral limb 148 is positioned and deployed in the first branch of theiliac artery, and the contralateral limb 150 is positioned and deployed in the second branch of the iliac artery. It is contemplated that the stent-graft devices described herein can be used to provide an iliac branch endoprosthesis for repairing both an iliac aneurysm and an abdominal aortic aneurysm. In some implementations, multiple stent-graft devices 200 are used in combination to provide an iliac branch endoprosthesis.

[0328] The exemplary iliac branch endoprosthesis stent-graft device is illustrated in FIG. 39. The iliac branch endoprosthesis device includes a first stent-graft device 200a positioned in the at the iliac aneurysm and a second stent-graft device 200b positioned at the abdominal aortic aneurysm. Both the first stent-graft device 200a and the second stent-graft device 200b include function and structure similar to those stent-graft devices described herein. As provided in FIG. 39, the second stent-graft device 200b is positioned in the aortic aneurysm and includes a main graft body 144 and bifurcated inferior end including an ipsilateral limb 148 and contralateral limb 150 as described herein.

[0329] The first stent-graft device 200a is positioned in the iliac aneurysm, and similarly includes a main graft body 144 and bifurcated inferior end including an external iliac limb 182 and an internal iliac limb 184. The main graft body 144, external iliac limb 182 and internal iliac limb 184 of the first stent-graft device 200a is similar to structure and function to the main graft body 144, ipsilateral limb 148, and the contralateral limb 150 of the second stent-graft device 200b.

[0330] As illustrated in FIG. 39, the external iliac limb 182 is sized and configured to be received within the external iliac artery 15, and the internal iliac limb 184 is sized and configured to be received within the internal iliac artery 17.

[0331] In some implementations, the internal iliac limb 184 is shorter (axially) than the external iliac limb 182. In some implementations, the internal iliac limb 184 is formed from the bifurcated portion of the second main graft body. In some implementations, the internal iliac limb 184 is separately formed from the main graft body 144 and coupled to the main graft body 144 during delivery / implantation. For example, the internal iliac limb 184 is a separately formed limb stent structure including a graft material coupled to an underlying expandable stent.

[0332] In some implementations, the iliac branch endoprosthesis further includes a first iliac stent device 190 extending between the second stent-graft device 200b and the first stent-graft device 200a, and a second iliac stent device 192 extending between the second stent-graft device 200b and the contralateral iliac artery 19. For example, in some implementations, the first iliac stent device 190 and the second iliac stent device 192 each includes a stent structure with a graft body / material coupled thereto. As illustrated in FIG. 39, the first iliac stent device 192 extends between a distal end of theipsilateral limb 148 of the second stent-graft device 200b and the superior end of the main graft body 144 of the first stent-graft device 200a. Likewise, the second iliac stent device 192 extends from a distal end of the contralateral limb 150 of the second stent-graft device 200b and the contralateral iliac artery 19. as provided in FIG. 39, the second iliac stent device 192 device is sized and configured to be received within a non-aneurysmal common iliac artery.

[0333] A method of repairing an aortoiliac and iliac aneurysm is described herein. During a repair procedure, a puncture is made in an insertion site blood vessel located above a diaphragm of the patient, thereby creating a passage in the insertion site blood vessel. For example, access into the blood vessel is made using the Seidinger technique. In some implementations, a first stent-graft device is inserted into the insertion site blood vessel by a single arterial puncture or incision. In some implementations, the insertion site blood vessel has a diameter less than or equal to the diameter of a femoral artery of the patient. For example, the insertion site blood vessel can include brachial, radial, ulnar, axillary, carotid, and / or subclavian arteries. In an example including the axillary artery, the insertion site blood vessel can include a second or proximal third portion of the axillary artery. In some examples, the insertion site blood vessel is a subclavian artery.

[0334] As shown in FIGS. 40A, Panel 1, a puncture or incision is made in a blood vessel located above a patient's diaphragm using a "top down" approach. An introducer sheath is advanced into the blood vessel to a location just proximal to the most distal renal artery. In some implementations, the introducer sheath is an 11 Fr sheath. The guidewire 78 and a guide catheter are advanced through the introducer sheath, down the suprarenal abdominal aorta 12 past renal arteries 14, across the aneurysmal infrarenal aorta 16, into the ipsilateral iliac artery 18, and into the external iliac artery 15, while the internal iliac artery 17 and the contralateral iliac artery 19 remains uninstrumented.

[0335] As shown in FIG. 40A, Panel 2, the guide catheter is removed, and the guidewire 78 remains in the desired position in the external iliac artery 15.

[0336] As shown in FIG. 40A, Panel 3, the outer sheath 134 and a first stent-graft device 200a, including the main graft body 144 and external iliac limb 182, is advanced over the guidewire 78 to the desired position in the external iliac artery 15 distal to the iliac aneurysm. The main graft body 144 can be positioned within the outer sheath 134 such that the internal iliac limb 184 is located proximal the common iliac bifurcation and aligned as needed to have the internal iliac limb 184 face the internal iliac side. In some implementations, the graft is rotated within the outer sheath 134 such that the internal iliac limb 184 is appropriately positioned.

[0337] FIG. 40B illustrates deployment of the outer sheath 134 and the delivery / release of the external iliac limb 182 in the aneurysmal ipsilateral iliac artery 18.

[0338] In Panel 1 of FIG. 40B, the external iliac limb 182 is shown partially deployed and oriented both axially and rotationally as desired in the target anatomy.

[0339] As illustrated in Panel 2 of FIG. 40B, the outer sheath 134 is withdrawn from the first stent-graft device 200a initially exposing the external iliac limb 182. As the outer sheath 134 is retracted, the external iliac limb 182 is released and expands. As described herein, in some implementations the external iliac limb 182 self-expands upon withdraw of the outer sheath 134, and in some implementations, the external iliac limb 182 expands upon activation of the corresponding trigger wire / tethers. In some implementations, the external iliac limb 182 is balloon expanded.

[0340] In some implementations, withdrawing the outer sheath 134 from the first stent-graft device 200a further includes maintaining an axial position of the main graft body 144 within the blood vessel by engaging at least one of the top stent 142 and / or or the main graft body 144 with the pusher 280 received within the outer sheath 134. The pusher 280 engages the first end 172 of the main graft body 144 maintaining the position of the main graft body 144 within the target blood vessel as the delivery sheath 134 is withdrawn from the main graft body 144.

[0341] Panels 3 and 4 of FIG. 40B illustrate withdraw of the outer sheath 134 from the first stent-graft device 200a. With the outer sheath 134 withdrawn, and the main graft body 144 positioned in the target blood vessel of the patient, the top stent 142 of the main graft body 144 is deployed. In some implementations, deploying the top stent 142 / main graft body 144 includes loosening and / or releasing the tension provided on the top stent 142 by the snare loop 138 such that the top stent 142 and the first end 172 of the main graft body 144 moves from the constrained configuration to the unconstrained configuration.

[0342] As illustrated in Panels 4 and 5 of FIG. 40B, the outer sheath 134 and the inner member 164 are removed.

[0343] FIG. 40C shows the deployment sequence for the internal iliac limb 184 in a similar manner to the deployment of the external iliac limb 182 and / or main graft body 144. Panel 1 of FIG. 40C shows the guidewire 78 repositioned from the external iliac artery 15 to the internal iliac artery 17.

[0344] As shown in FIG. 40C, Panel 2, the outer sheath 134 including the internal iliac limb 184 is advanced over the guidewire 78 to the desired position in the internal iliac artery 17 distal to the iliac aneurysm.

[0345] As illustrated in Panels 3 and 4 of FIG. 40C, as the outer sheath 134 is withdrawn from the internal iliac limb 184, the internal iliac limb 184 is released and expands. As described herein, in some implementations the internal iliac limb 184 self-expands upon withdraw of the outer sheath 134, and in some implementations, the internal iliac limb 184 expands upon activation of the corresponding trigger wire / tethers. In some implementations, the internal iliac limb 184 is balloon expanded. For example, in some implementations, the internal iliac limb 184 is balloon expanded in the area of overlap between the internal iliac limb 184 and the main graft body 144.

[0346] As illustrated in Panel 5 of FIG. 40C, the outer sheath 134 and the inner member 164 are removed from the internal iliac limb 184.

[0347] FIG. 40D shows the deployment sequence for a second stent-graft device 200b in the aneurysmal infrarenal aorta 16, in a similar manner to the deployment of the first stent-graft device 200a in the aneurysmal ipsilateral iliac artery 18.

[0348] In Panel 1 of FIG. 40D, the guidewire 78 is moved from the internal iliac artery 17 into the external iliac artery 15 and down to the distal aspect and the outer sheath 134 and second stent-graft device 200b are advanced distal the renal arteries 14.

[0349] As illustrated in Panel 2 of FIG. 40D, the outer sheath 134 is then withdrawn from the main graft body 144 initially exposing the ipsilateral limb 148 and the contralateral limb 150. As described herein, the axial position of the main graft body 144 can be maintained within the blood vessel by engaging the top stent 142 and / or or the main graft body 144 with the pusher 280 received within the outer sheath 134. Similar to the first stent-graft device 200a, the second stent-graft device 200b may include radiopaque markers for aid in orienting and viewing the device under fluoroscopy.

[0350] Panels 3-5 of FIG. 40D illustrate withdraw of the outer sheath 134 from the second stent-graft device 200b. With the outer sheath 134 withdrawn, and the main graft body 144 positioned in the target blood vessel of the patient, the top stent 142 of the main graft body 144 is deployed. In some implementations, deploying the top stent 142 / main graft body 144 includes loosening and / or releasing the tension provided on the top stent 142 by the snare loop 138 such that the top stent 142 and the first end 172 of the main graft body 144 moves from the constrained configuration to the unconstrained configuration.

[0351] As described herein, in some implementations main graft body 144, ipsilateral limb 148 and / or contralateral limb 150 self-expand upon withdraw of the outer sheath 134. In some implementations, the main graft body 144, ipsilateral limb 148 and / or contralateral limb 150 expand upon activation of the corresponding trigger wire / tethers as described herein. In some implementations, the main graftbody 144, ipsilateral limb 148 and / or contralateral limb 150 are balloon expanded. The outer sheath 134 and the inner member 164 are removed from the second stent-graft device 200b.

[0352] FIG. 40E shows the deployment sequence for a first iliac stent device 190 extending between and coupling the first stent-graft device 200a and the second stent-graft device 200b, in a similar manner to the deployment of either the first stent-graft device 200a or second stent-graft device 200b, including their various components.

[0353] Panel 1 of FIG. 40E illustrates the outer sheath 134 including the first iliac stent device 190 is advanced over the guidewire 78 to the desired position in the ipsilateral iliac artery 18, and within the main graft body 144 of the first stent-graft device 200a.

[0354] As illustrated in Panels 2-4 of FIG. 40E, the outer sheath 134 is withdrawn from first iliac stent device 190, and the first iliac stent device 190 is released and expands. As described herein, in some implementations the first iliac stent device 190 self-expands upon withdraw of the outer sheath 134, and in some implementations, the first iliac stent device 190 expands upon activation of the corresponding trigger wire / tethers. In some implementations, the first iliac stent device 190 is balloon expanded. The first iliac stent device 190 is positioned with respect to the main graft body 144 of the first stent-graft device 200a and the ipsilateral limb 148 of the second stent-graft device 200b, but that there is sufficient overlap between the components allowing for a secure connection when the first iliac stent device 190 is expanded. In some implementations, the first iliac stent device 190 is coupled to the first stent-graft device 200a and second stent-graft device 200b by an interference fit. In some implementations, the first iliac stent device 190 is coupled to the first stent-graft device 200a and second stent-graft device 200b by a mechanical and / or a chemical fastener as described herein. The plurality of sutures 124 and the inner member 164 are removed from the first iliac stent device 190.

[0355] FIG. 40F shows the deployment sequence for a second iliac stent device 192 extending between and coupling the second stent-graft device 200b and the contralateral iliac artery 19 in a similar manner to the deployment of either the first stent-graft device 200a, second stent-graft device 200b, and first iliac stent device 190, including their various components.

[0356] Panel 1 of FIG. 40F illustrates the guidewire 78 repositioned from the ipsilateral iliac artery 18 to the contralateral iliac artery 19.

[0357] As shown in FIG. 40F, Panel 2, the outer sheath 134 including the second iliac stent device 192 is advanced over the guidewire 78 to the desired position in the contralateral iliac artery 19 distal to the aortic aneurysm.

[0358] As illustrated in Panels 3 and 4 of FIG. 40F, as the outer sheath 134 is withdrawn from the second iliac stent device 192, the second iliac stent device 192 is released and expands. As described herein, in some implementations the second iliac stent device 192 self-expands upon withdraw of the outer sheath 134, and in some implementations, the second iliac stent device 192 expands upon activation of the corresponding trigger wire / tethers. In some implementations, the second iliac stent device 192 is balloon expanded. For example, in some implementations, the second iliac stent device 192 is balloon expanded in the area of overlap between the contralateral limb 150 of the second stentgraft device 200b, and the area overlap between the second iliac stent device 192 and the contralateral iliac artery 19. The outer sheath 134 and the inner member 164 are removed from the contralateral iliac artery 19, aneurysmal infrarenal aorta 16, and the suprarenal abdominal aorta 12.

[0359] In some implementations, the order or configuration of components of the stent-graft device and associated procedures can vary. For example, in some implementations, the second iliac stent device 192 can be deployed or otherwise inserted prior to the deployment or insertion of first iliac stent device 190.

[0360] In some implementations, an angiogram and / or other imaging step us completed to confirm placement and blood flow through the stent-graft device. Necessary adjustments in position and expansion of the various stent-graft components can be completed as needed. The introducer catheter is removed and the access site closed.

[0361] In some implementations, a method of repairing an aortoiliac and / or iliac aneurysm is described according to the disclosure herein. In some implementations, the method can include single or unilateral femoral (below the diaphragm) arterial access, as shown in FIGS. 41A-41B. During a repair procedure, a puncture can, for example, be made in an insertion site blood vessel located below a diaphragm of the patient, thereby creating a passage in the insertion site blood vessel. For example, a puncture can be made in a femoral artery of a patient. In some implementations, a first stent-graft device is inserted into the insertion site blood vessel by a single arterial puncture or incision. In some implementations, the arterial puncture or incision can be in a femoral artery to provide access to a contralateral iliac artery and / or the ipsilateral iliac artery. In other implementations, the insertion site blood vessel can include brachial, radial, ulnar, axillary, carotid and / or subclavian arteries.

[0362] FIGS. 41A-41B illustrate a method of repairing an aneurysm accessed through a single femoral arterial access (below the diaphragm) contralateral to the iliac aneurysm. That is, the stent-graft device is delivered through an artery contralateral to the iliac aneurysm. As shown in FIG. 41A, Panel 1, a puncture or incision can be made in a blood vessel located below the patient's diaphragm. An introducersheath can be advanced into the blood vessel to a location just proximal to the most distal renal artery. As shown in FIG. 41A, an introducer sheath can be advanced up the iliac artery 19 contralateral to the iliac aneurysm, and then down the iliac artery 18 to provide access to the external iliac artery 15 and the internal iliac artery 17. In some implementations, the introducer sheath is an 11 Fr sheath. The guidewire 78 and a guide catheter are advanced through the introducer sheath, up the iliac artery 19 and across and down into iliac artery 18, and into the external iliac artery 15 and internal iliac artery 17. As such, FIGS. 41A-41B illustrate an "ipsi-contra" approach, with initial insertion on the iliac artery 19 (ipsilateral) side and subsequent introduction into the iliac artery 18 (contralateral) side, which can provide access to the same surgical sites as outlined above in various "top-down" approaches. According to the disclosure herein, in some implementations the devices and methods described herein can similarly be used in a opposite approach, with initial insertion in the iliac artery 18 side and subsequent introduction or advancement into the iliac artery 19 side. As a result, it can be appreciated that the devices and methods disclosed herein can be used in different procedures and from differing surgical approaches.

[0363] As shown in FIG. 41A, Panel 1, an incision or puncture can be made in the femoral artery contralateral to the iliac aneurysm and at a location inferior the iliac artery 19. A guidewire 78 and guide catheter can be advanced through the incision, up the iliac artery 19 and across and down the iliac artery 18 into the external iliac artery 15. As shown in FIG. 41A, Panel 1, the guide catheter can be removed and the guidewire 78 remains in the desired position extending into the external iliac artery 15.

[0364] As shown in FIG. 41A, Panel 2, the outer sheath 134 and a first stent-graft device 200a, including the main graft body 144 and external iliac limb 182, is advanced over the guidewire 78 to the desired position in the external iliac artery 15. The main graft body 144 can be positioned within the outer sheath 134 such that the internal iliac limb 184 is located proximal the common iliac bifurcation and aligned as needed to have the internal iliac limb 184 face the internal iliac side. In some implementations, the graft is rotated within the outer sheath 134 such that the internal iliac limb 184 is appropriately positioned.

[0365] FIG. 41A, Panel 3, illustrates deployment of the outer sheath 134 and the delivery / release of the external iliac limb 182 in the aneurysmal iliac artery 18. In Panel 3, the external iliac limb 182 is shown partially deployed and oriented both axially and rotationally as desired in the target anatomy.

[0366] As illustrated in Panels 3-4 of FIG. 41A, the outer sheath 134 is withdrawn from the first stentgraft device 200a initially exposing the external iliac limb 182. As the outer sheath 134 is retracted, theexternal iliac limb 182 is released and expands. As described herein, in some implementations the external iliac limb 182 self-expands upon withdraw of the outer sheath 134, and in some implementations, the external iliac limb 182 expands upon activation of the corresponding trigger wire / tethers. In some implementations, the external iliac limb 182 is balloon expanded.

[0367] In some implementations, withdrawing the outer sheath 134 from the first stent-graft device 200a further includes maintaining an axial position of the main graft body 144 within the blood vessel by engaging at least one of the top stent 142 and / or or the main graft body 144 with the pusher 280 received within the outer sheath 134. The pusher 280 engages the first end 172 of the main graft body 144 maintaining the position of the main graft body 144 within the target blood vessel as the delivery sheath 134 is withdrawn from the main graft body 144.

[0368] Panels 3 and 4 of FIG. 41A illustrate withdrawal of the outer sheath 134 from the first stent-graft device 200a. With the outer sheath 134 withdrawn, and the main graft body 144 positioned in the target blood vessel of the patient, the top stent 142 of the main graft body 144 is deployed. In some implementations, deploying the top stent 142 / main graft body 144 includes loosening and / or releasing the tension provided on the top stent 142 by the snare loop 138 such that the top stent 142 and the first end 172 of the main graft body 144 moves from the constrained configuration to the unconstrained configuration.

[0369] As illustrated in Panels 4 and 5 of FIG. 41A, the outer sheath 134, the inner member 164, and the guidewire 78 can be withdrawn from the external iliac artery 15. As illustrated in Panel 5, the guidewire 78 can then be repositioned from the external iliac artery 15 into the internal iliac artery 17.

[0370] The use of a single guidewire 78 and the repositioning of the guidewire 78 to be utilized in the deployment of both the internal iliac limb 184 and the external iliac limb 182 of the first stent-graft device 200a can, for example, reduce the access time and risks of error.

[0371] FIG. 41B shows the deployment sequence for the internal iliac limb 184 in a similar manner to the deployment of the external iliac limb 182 and / or main graft body 144.

[0372] As shown in FIG. 41B, Panel 2, the outer sheath 134 including the internal iliac limb 184 is advanced over the guidewire 78 to the desired position in the internal iliac artery 17 distal to the iliac aneurysm.

[0373] As illustrated in Panels 2 and 3 of FIG. 41B, as the outer sheath 134 is withdrawn from the internal iliac limb 184, the internal iliac limb 184 is released and expands. As described herein, in some implementations the internal iliac limb 184 self-expands upon withdraw of the outer sheath 134, and in some implementations, the internal iliac limb 184 expands upon activation of the corresponding triggerwire / tethers. In some implementations, the internal iliac limb 184 is balloon expanded. For example, in some implementations, the internal iliac limb 184 is balloon expanded in the area of overlap between the internal iliac limb 184 and the main graft body 144.

[0374] The outer sheath 134 and the inner member 164 can then removed from the internal iliac limb 184. First iliac stent device 190

[0375] According to the disclosure herein, a second stent-graft device 200b can then be deployed in the aneurysmal infrarenal aorta 16, in a similar manner to the deployment of the first stent-graft device 200a in the aneurysmal iliac artery 18, in a "bottom-up" approach from the iliac artery 19 or the internal iliac artery 17. Similarly, a stent-graft device or second iliac stent device 192 can also be deployed in the internal iliac artery 17.

[0376] Exemplary Aspects

[0377] In view of the described processes and compositions, hereinbelow are described certain more particularly described aspects of the disclosures. These particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the "particular" aspects are somehow limited in some way other than the inherent meanings of the language and formulas literally used therein.

[0378] Example 1. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a stent-graft including: a main graft body having a first end (for example, superior end, cephalad end) and a second end (for example, inferior end, bifurcated end); and a stent connected to (for example, disposed at least partly with and / or constrained on) the main graft body; wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel. In some implementations described herein, the single arterial puncture or incision is located above the diaphragm of the patient. In some implementations described herein, the single arterial puncture or incision is located below the diaphragm of the patient.

[0379] Example 2. The stent-graft system of any example herein, particularly examples 1-2, further comprising: a constraining member (for example, the constraining member may include a snare loop, and / or other device provided over and / or constraining the main graft body and / or the stent) for selectively adjusting the stent between an unconstrained circumferentially expanded configuration (for example, FIG. 16) to a constrained circumferentially collapsed configuration (for example, FIG. 16); and a catheter (for example, inner member, delivery sheath, an outer sheath, a loading sheath, an outer layer) to position the stent-graft at a location in the target blood vessel in proximity to the aneurysm, whereinthe stent-graft is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter.

[0380] Example 3. The stent-graft system of any example herein, particularly example 2, wherein the second end of the main graft body is bifurcated and comprises a first limb (for example, first iliac leg component / ipsilateral limb gate) and a second limb (for example, second iliac leg component / contralateral limb gate).

[0381] Example 4. The stent-graft system of any example herein, particularly example 3, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein a first limb stent is disposed in the first limb and a second limb stent is disposed in the second limb.

[0382] Example 5. The stent-graft system of any example herein, particularly example 3-4, wherein an inner service of each of the first limb and the second limb of the main graft body include an anchor for coupling the each of the first limb and second limb to their respective first limb stent and second limb stent.

[0383] Example 6. The stent-graft system of any example herein, particularly examples 2-5, wherein the catheter comprises a delivery sheath (for example, outer sheath) including a central lumen sized and configured to receive the main graft body therein (for example, where the delivery sheath is movable through the patient's blood vessel for positioning the main graft body and the stent at a location in the target blood vessel in proximity to the aneurysm).

[0384] Example 7. The stent-graft system of any example herein, particularly example 6, wherein the main graft body and the stent are received within and oriented relative to the delivery sheath such that removal (and / or retraction) of the delivery sheath from the main graft body (for example, and / or the target blood vessel) initially exposes the first limb and the second limb (for example, the first limb and the second limb are located between a distal opening of the delivery sheath and the main graft body / first end of the main graft body).

[0385] Example 8. The stent-graft system of any example herein, particularly examples 6-7, wherein, when the main graft body is retained within the delivery sheath, the first end of the main graft body is oriented toward and / or adjacent a proximal end of the delivery sheath (for example, the proximal end of the delivery sheath including the portion of the delivery sheath positioned outside the patient) and the second end of the main graft body is oriented toward and / or adjacent a distal end of the delivery sheath (for example, the distal end of the delivery sheath including the portion of the delivery sheath positioned inside the blood vessel and including a distal opening through which the main graft body and stent passes to the treatment site).

[0386] Example 9. The stent-graft system of any example herein, particularly examples 6-8, wherein the delivery sheath is arranged to constrain the main graft body and the stent while retained therein. In some examples, the constraining member includes the delivery sheath.

[0387] Example 10. The stent-graft system of any example herein, particularly examples 6-9, further including a pusher received within the delivery sheath for engaging at least one of the stent or the main graft body at the location in the target blood vessel in proximity to the aneurysm when the delivery sheath moved proximally to expose the main graft body.

[0388] Example 11. The stent-graft system of any example herein, particularly example 10, wherein the pusher is sized and configured to move axially (and / or rotationally) within the delivery sheath.

[0389] Example 12. The stent-graft system of any example herein, particularly examples 10-11, wherein the pusher is sized and configured to maintain a position while the delivery sheath is moved axially (and / or rotationally) along the pusher.

[0390] Example 13. The stent-graft system of any example herein, particularly examples 10-12, wherein the pusher has a central lumen sized and configured to receive the main graft body and the stent.

[0391] Example 14. The stent-graft system of any example herein, particularly examples 10-13, wherein a distal end of the pusher is located adjacent the first end of the main graft body and / or a first end of the stent, wherein, when the main graft body and the stent are received within the delivery sheath, the distal end of the pusher is proximal of the first end of the stent and / or the first end of the main graft body, such that removal (and / or retraction) of the delivery sheath from the main graft body initially exposes bifurcated the second end of the main graft body.

[0392] Example 15. The stent-graft system of any example herein, particularly examples 10-14, wherein the pusher is composed of a stiffer material than the delivery sheath. In some examples, the pusher includes a lubricious coating for reducing friction between the pusher and the delivery sheath, as the pusher moves axially (and / or rotationally) therein.

[0393] Example 16. The stent-graft system of any example herein, particularly examples 6-15, further including: a contrast lumen provided within the delivery sheath for providing a flow of a contrast fluid to a site proximate the aneurysm.

[0394] Example 17. The stent-graft system of any example herein, particularly example 16, wherein, when the main graft body is retained within the delivery sheath, a distal end of the contrast lumen is provided between a proximal end of the delivery sheath and a proximal end of the main graft body.

[0395] Example 18. The stent-graft system of any example herein, particularly examples 2-17, wherein the first end of the main graft body is located at an upper end of the main graft body (for example,superior end) such that when positioned in the patient's blood vessel the upper end of the main graft body is located in a superior position (for example, cephalad position, oriented toward the patient's head), wherein the second end of the main graft body is located at a lower end of the main graft body (for example, inferior end) such that when positioned within the patient's blood vessel the lower end of the main graft body is located at an inferior position (for example, caudal position, oriented toward patient's feet).

[0396] Example 19. The stent-graft system of any example herein, particularly examples 2-18, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape (for example, cylindrical shape); a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb.

[0397] Example 20. The stent-graft system of any example herein, particularly examples 2-19, wherein the main graft body comprises a densified material (for example, the densified material can include ePTFE). In some examples, the main graft body is coupled to the stent via spot welding.

[0398] Example 21. The stent-graft system of any example herein, particularly examples 2-20, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop (for example, adapted to release the main graft body in the target blood vessel) passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0399] Example 22. The stent-graft system of any example herein, particularly example 21, wherein tightening of the snare loop maintains the first end of the main graft body (for example, superior / cephalad end) in the constrained configuration and loosening of the snare loop induces release of the first end of the main graft body into the unconstrained configuration.

[0400] Example 23. The stent-graft system of any example herein, particularly example 22, wherein the snare loop can re-constrain the first end of the main graft body after an expansion of the first end of the main graft body and control repositioning of the main graft body in the target blood vessel.

[0401] Example 24. The stent-graft system of any example herein, particularly examples 21-23, wherein the snare loop does not overlap with the main graft body when the main graft body is in a constrained circumferentially collapsed configuration (for example, thereby providing a lower profile system).

[0402] Example 25. The stent-graft system of any example herein, particularly examples 21-24, wherein the snare loop is positioned through a plurality of positioning receptacles (for example, eyelets) provided on the top stent.

[0403] Example 26. The stent-graft system of any example herein, particularly example 25, wherein each of the plurality of positioning receptacles (for example, eyelets) further comprises an eyelet (e.g., where the snare loop is coupled to the eyelet via a suture loop).

[0404] Example 27. The stent-graft system of any example herein, particularly examples 25-26, wherein the plurality of positioning receptacles (eyelets) are provided at a first end of the top stent (e.g., superior / cephalad / cranial end of the top stent). In some examples, the plurality of positioning receptacles (for example, eyelets) are provided at each of the superior apexes of the top stent.

[0405] Example 28. The stent-graft system of any example herein, particularly examples 25-27, wherein the plurality of positioning receptacles (for example, eyelets) are provided along an arm portion of the top stent, the arm portion extending between a superior apex and an opposing inferior apex of the top stent. For example, as illustrated in FIG. 19, the plurality of positioning receptacles (eyelets) can be provided along a midline of the top stent.

[0406] Example 29. The stent-graft system of any example herein, particularly examples 21-28, wherein the snare loop includes: a first snare loop passing through the snare tube and a first positioning receptacle (for example, first eyelet) provided on the top stent (for example, in some examples the first positioning receptacle (for example, eyelet) is an eyelet provided on the top stent and the first snare loop is coupled to the eyelet via a suture loop); and a second snare loop passing through the snare tube and a second positioning receptacle (for example, eyelet) provided on the top stent, the second positioning receptacle (for example, eyelet) provided on an opposing segment of a perimeter of the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from the unconstrained circumferentially expanded configuration to the constrained circumferentially collapsed configuration.

[0407] Example 30. The stent-graft system of any example herein, particularly example 29, wherein the first snare loop and / or the second snare loop are movable between first position where the top stent is in the unconstrained circumferentially expanded configuration and a second position where the top stent is in the constrained circumferentially collapsed configuration.

[0408] Example 31. The stent-graft system of any example herein, particularly examples 29-30, wherein the first positioning receptacle (for example, eyelet) is positioned along an arm portion of the top stent, the arm portion extending between a superior apex and an opposing inferior apex of the top stent.

[0409] Example 32. The stent-graft system of examples 29-31, wherein the first snare loop and the second snare loop are coupled to a trigger wire for releasing the first snare loop and the second snare loop from the top stent.

[0410] Example 33. The stent-graft system of any example herein, particularly example 32, wherein the main graft body includes a tubular first end portion adjacent the first end of the main graft body and a bifurcated second end portion opposite the tubular first end portion and adjacent the second end of the main graft body, the bifurcated second end portion including a first limb and a second limb, wherein activating the trigger wire causes the first snare loop and the second snare loop to release from the top stent, wherein activating the trigger wire activates the tether for releasing the first and second limb.

[0411] Example 34. The stent-graft system of any example herein, particularly examples 32-33, wherein the trigger wire extends between the nose cone and a proximal end of the catheter for manipulation by the user.

[0412] Example 35. The stent-graft system of any example herein, particularly examples 29-34, wherein the snare tube includes a snare tube extension coupled to the distal end of the snare tube.

[0413] Example 36. The stent-graft system of examples 2-35, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the main graft body is coupled to the top stent adjacent a superior end of the top stent.

[0414] Example 37. The stent-graft system of any example herein, particularly example 36, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0415] Example 38. The stent-graft system of any example herein, particularly example 37, wherein the snare loop passes through a first positioning receptacle (for example, eyelet) proved on the top stent.

[0416] Example 39. The stent-graft system of any example herein, particularly examples 37-38, where the snare loop includes: a first snare loop passing through the snare tube and a first positioning receptacle (for example, eyelet) provided on the top stent (for example, in some examples the first positioning receptacle is an eyelet provided on the top stent and the first snare loop is coupled to the eyelet via a suture loop); and a second snare loop passing through the snare tube and a second positioning receptacle (eyelet) provided on the top stent, the second positioning receptacle (eyelet) provided on an opposing segment of a perimeter of the top stent, wherein the first snare loop and thesecond snare loop are operative for selectively adjusting the top stent from the unconstrained circumferentially expanded configuration to the constrained circumferentially collapsed configuration.

[0417] Example 40. The stent-graft system of any example herein, particularly examples 36-39, wherein the main graft body and the top stent are not in an end-to-end configuration.

[0418] Example 41. The stent-graft system of any example herein, particularly examples 2-40, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a first snare tube passing through the delivery sheath; a first snare loop passing through the first snare tube, the first snare loop being releasably engaged with a first plurality of circumferentially spaced positions on the top stent; a second snare tube passing through the delivery sheath; and a second snare loop passing through the second snare tube, the second snare loop being releasably engaged with a second plurality of circumferentially spaced positions on the top stent; wherein the second circumferentially spaced positions on the top stent is positioned distal to the first plurality of circumferentially spaced positions on the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0419] Example 42. The stent-graft system of any example herein, particularly example 41, wherein the first snare loop is positioned through a first plurality of positioning receptacles (eyelets) provided at a first end of the top stent (for example, the superior / cranial end of the top stent), wherein the second snare loop is positioned through a second plurality of positioning receptacles (eyelets) provided along the top stent between the first end of the top stent and the second end of the top stent (e.g., the inferior end of the top stent).

[0420] Example 43. The stent-graft system of any example herein, particularly examples 41-42, wherein the first plurality of positioning receptacles (eyelets) are provided at / proximal of a plurality of superior apexes of the top stent, wherein the second plurality of positioning receptacles (eyelets) are provided along the top stent at a location distal each of the plurality of superior apexes.

[0421] Example 44. The stent-graft system of any example herein, particularly examples 41-43, further including a hook / barb provided adjacent at least one of the first plurality of positioning receptacles (eyelets).

[0422] Example 45. The stent-graft system of any example herein, particularly examples 42-44, wherein the hook / barb are positioned distal at least one of the first plurality of positioning receptacles (eyelets).

[0423] Example 46. The stent-graft system of any example herein, particularly examples 43-45, wherein the hook / barb includes a plurality of hooks / barbs staggered around the stent.

[0424] Example 47. The stent-graft system of any example herein, particularly examples 2-46, wherein the stent comprises a top stent adjacent the first end of the main graft body and a first tether releasably connected to the top stent for positioning the top stent and the first end of the main graft body in the target blood vessel.

[0425] Example 48. The stent-graft system of any example herein, particularly example 47, wherein the top stent further comprises a second tether releasably connected to the top stent for positioning the top stent and the first end of the main graft body in the target blood vessel.

[0426] Example 49. The stent-graft system of any example herein, particularly example 48, wherein the first tether and the second tether are configured to substantially fix the distal end of main graft body to a first nose cone to permit traction and avoid crumpling of main graft body during deployment.

[0427] Example 50. The stent-graft system of any example herein, particularly examples 2-49, wherein the stent comprises a top stent adjacent the first end of the main graft body.

[0428] Example 51. The stent-graft system of any example herein, particularly example 50, wherein the stent-graft system further comprises: a connecting ring which connects the top stent to the main graft body.

[0429] Example 52. The stent-graft system of any example herein, particularly example 51, wherein the connecting ring connects the main graft body at a position substantially adjacent the first end of the main graft body, and connecting members connecting the connecting ring to the top stent.

[0430] Example 53. The stent-graft system of any example herein, particularly examples 2-52, wherein the stent is encapsulated in a densified material (for example, wherein the densified material is ePTFE).

[0431] Example 54. The stent-graft system of any example herein, particularly examples 2-53, further comprising a centering device to facilitate the centering and positioning of the main graft body.

[0432] Example 55. The stent-graft system of any example herein, particularly example 54, wherein the centering device is located in proximity to the first end of the main graft body and configured to be removably or temporarily deployed and expanded in the target blood vessel for centering the main graft body and / or the stent the target blood vessel.

[0433] Example 56: The stent-graft system of any example herein, particularly examples 1-55, further including a corset extending at least partially around the stent-graft for selectively maintaining the stent-graft in an at least partially circumferentially constrained configuration.

[0434] Example 57: The stent-graft system of any example herein, particularly example 56, wherein the corset selectively maintains the at least a portion of the main graft body and at least a portion of the stent in a partially circumferentially constrained configuration, and wherein when the corset is released,the portion of the main graft body and the portion of the stent are released and free to circumferentially expand.

[0435] Example 58: The stent-graft system of any example herein, particularly examples 56-57, wherein the corset includes a trigger wire that when activated releases the corset, thereby releasing the portion of the main graft body and the portion of the stent freeing them to circumferentially expand.

[0436] Example 59: The stent-graft system of any example herein, particularly example 58, wherein the corset includes a tether wire coupled to a portion of the corset and maintaining the corset in a constrained configuration, wherein the trigger wire is coupled to a tether wire such that when the trigger wire is activated the tether wire is released and the stent-graft is free to circumferentially expand, and wherein the tether wire is coupled to the corset by an eyelet provided on the corset (for example, in some implementations, the corset includes a plurality of eyelets and the tether wire extends through each of the plurality of eyelets).

[0437] Example 60. The stent-graft system of any example herein, particularly examples 1-58, wherein the target blood vessel is selected from the group consisting of an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta. In some implementations, the target blood vessel is a branch vessels selected from the group consisting of the superior mesenteric artery, celiac artery, renal arteries, and inferior mesenteric artery.

[0438] Example 61. The stent-graft system of any example herein, particularly examples 1-60, wherein the insertion site blood vessel has a diameter less than or equal to the diameter of a femoral artery of the patient.

[0439] Example 62. The stent-graft system of any example herein, particularly examples 1-61, wherein the insertion site blood vessel is selected from the group consisting of brachial, radial, ulnar, axillary, carotid, and subclavian arteries.

[0440] Example 63. The stent-graft system of any example herein, particularly example 62, wherein the insertion site blood vessel is an axillary artery.

[0441] Example 64. The stent-graft system of any example herein, particularly example 63, wherein the insertion site blood vessel is a second or proximal third portion of the axillary artery.

[0442] Example 65. The stent-graft system of any example herein, particularly examples 1-64, wherein the insertion site blood vessel is a subclavian artery.

[0443] Example 66. A method of repairing an abdominal aortic aneurysm in a patient, comprising: puncturing an insertion site blood vessel located above a diaphragm of the patient and creating a passage in the insertion site blood vessel; inserting a stent-graft system in a passage of the insertion siteblood vessel, the stent-graft system comprising a top stent and a main graft body in a constrained circumferentially collapsed configuration; positioning the main graft body of the stent-graft system in a target blood vessel of the patient; and deploying the top stent and the main graft body of the stent-graft system in the target blood vessel of the patient.

[0444] Example 67. The method of any example herein, particularly example 66, wherein the stentgraft system further includes a delivery sheath including a central lumen sized and configured to receive the main graft body and the stent, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape (for example, cylindrical shape); and a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb; wherein positioning the main graft body in the target blood vessel includes: advancing the delivery sheath in the target blood vessel to a location in proximity to the aneurysm, and withdrawing the delivery sheath from the main graft body initially exposing the first limb and the second limb provided on the second end portion .

[0445] Example 68. The method of any example herein, particularly example 67, wherein positioning the main graft body in the target blood vessel further includes: positioning and deploying the first limb in a first branch of an iliac artery, and positioning and deploying the second limb in a second branch of an iliac artery.

[0446] Example 69: The method of any example herein, particularly examples 66-68, wherein the main graft body is deployed within the aorta, wherein the iliac artery is contralateral to the insertion site blood vessel such that the first limb and the second limb of the main graft body are positioned and deployed in the first and second branch of the iliac artery contralateral to the insertion site blood vessel.

[0447] Example 70. The method of any example herein, particularly example 67-69, wherein withdrawing the delivery sheath from the main graft body further includes maintaining an axial position of the main graft body within the blood vessel by engaging at least one of the stent or the main graft body with a pusher received within the delivery sheath.

[0448] Example 71. The method of any example herein, particularly example 70, wherein the pusher engages the first end of the main graft body maintaining the position of the main graft body within the target blood vessel as the delivery sheath is withdrawn from the main graft body.

[0449] Example 72. The method of any example herein, particularly examples 66-71, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spacedpositions on the top stent and being operative for selectively adjusting the top stent between the constrained circumferentially collapsed configuration to an unconstrained circumferentially expanded configuration; wherein deploying the main graft body includes loosening of the snare loop to release the first end of the main graft body into the unconstrained configuration.

[0450] Example 73. The method of any example herein, particularly example 72, further including repositioning the main graft body of the stent-graft system in a target blood vessel of the patient including: tightening the snare loop to return the main graft body to the constrained configuration; positioning the main graft body of the stent-graft system in a new location in the target blood vessel of the patient; and deploying the main graft body of the stent-graft system in the target blood vessel of the patient at the new location.

[0451] Example 74: The method of any example herein, particularly examples 63-73, further including: maintaining at least a portion of the main graft body and / or a portion of the top stent in a partially circumferentially constrained configuration by providing a corset at least partially around the main graft body; and after positioning the portion main graft body in the target blood vessel, activating a trigger wire to release the corset such that the main graft body and / or portion of the top stent are free to circumferentially expand.

[0452] Example 75. The method of any example herein, particularly examples 66-74, wherein the target blood vessel includes the aorta, at least one of the iliac arteries, and / or visceral vessels. In some examples, the target blood vessel includes the aorta and the iliac artery contralateral to the insertion site blood vessel.

[0453] Example 76. The method of any example herein, particularly examples 66-75, wherein puncturing an insertion site blood vessel includes a single arterial puncture or incision.

[0454] Example 77. The method of any example herein, particularly examples 66-76, wherein inserting a stent-graft system in a passage of the insertion site blood vessel includes inserting the stent-graft system into the patient's aorta, and advancing the stent-graft system with the direction of blood flow in the aorta. In some examples, the stent-graft system is not advanced against the direction of blood flow.

[0455] Example 78. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising; a main graft body having a first end and a second end; a stent connected to (e.g., disposed at least partly with and / or constrained on) the main graft body; a delivery sheath to position the main graft body and the stent at a location in the target blood vessel in proximity to the aneurysm, the delivery sheath being oriented relative to the main graft body and the at least one stent so that removal (and / or retraction) of the delivery sheath) from the target blood vessel initially exposes the second end(for example, inferior end) of the main graft body and subsequently exposes the first end (for example, superior end) of the main graft body, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0456] Example 79. The stent-graft system of any example herein, particularly example 78, wherein the main graft body has a tubular (for example, cylindrical) shape.

[0457] Example 80. The stent-graft system of any example herein, particularly examples 78-79, wherein the main graft body is a fenestrated aortic graft and / or thoracic aortic graft.

[0458] Example 81. A graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a main graft body having a first end (for example, superior end, cephalad end) and a second end (for example, inferior end, bifurcated end); a coupling member (for example, a hook, barb, surface texture, suture, or any other coupling feature known in the art) for coupling the main graft body to a target blood vessel (e.g., coupling the main graft body to the interior wall surface of the target blood vessel); a constraining member (for example, the constraining member may include a snare loop, and / or other device provided over and / or constraining the main graft body) for selectively adjusting the stent between an unconstrained circumferentially expanded configuration (for example, FIG. 16) to a constrained circumferentially collapsed configuration (for example, FIG. 16); and a catheter (for example, inner member, delivery sheath, an outer sheath, a loading sheath, an outer layer) to position the main graft body at a location in the target blood vessel in proximity to the aneurysm, wherein the main graft body is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0459] Example 82. The graft system of any example herein, particularly example 81, wherein the second end of the main graft body is bifurcated and comprises a first limb (for example, first iliac leg component / ipsilateral limb gate) and a second limb (for example, second iliac leg component / contralateral limb gate).

[0460] Example 83. The graft system of any example herein, particularly example 82, wherein the first limb and the second limb each include a limb coupling member (for example, a hook, barb, surface texture, suture, or any other coupling feature known in the art) for coupling the first and second limbs to a target blood vessel (for example, coupling the first and second limbs to the interior wall surface of the target blood vessel).

[0461] Example 84. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising: (1) a first stent-graft device including: a main graft body having a superior end (e.g., cephalad end) and an inferior end, and a stent connected to (for example, disposed at least partly with and / or constrained on) the main graft body adjacent the superior end; a first limb (for example, ipsilateral limb) coupled to and extending distally from the inferior end of the main graft body; a second limb (for example, contralateral limb) coupled to and extending distally from the inferior end of the main graft body; (2) a second stent-graft device including: a second main graft body having a superior end (for example, cephalad end) and an inferior end, and a stent connected to (for example, disposed at least partly with and / or constrained on) the second main graft body adjacent the superior end; a third limb (for example, external iliac leg limb) coupled to and extending from an inferior end of the first limb, the third limb sized and configured to be received within the external iliac artery; a fourth limb (e.g., internal iliac leg limb) coupled to and extending from the inferior end of the first limb, the fourth limb sized and configured to be received within the internal iliac artery; (3) a first iliac stent device including: a graft body having a superior end (for example, cephalad end) and an inferior end; and a stent connected to (for example, disposed at least partly with and / or constrained on) the graft body; and (4) a second iliac stent device including: a graft body having a superior end and an inferior end; and a stent connected to the graft body of the second iliac stent, wherein first iliac stent device extends between a distal end of the first limb (for example, ipsilateral limb) of the first stent-graft device and the superior end of the second main graft body of the second stent-graft device, wherein the second iliac stent device extends from a distal end of the second limb (for example, contralateral limb) of the first stentgraft device, the second iliac stent device sized and configured to be received within a non-aneurysmal common iliac artery.

[0462] Example 85. The stent graft system of any example herein, particularly example 84, further including a constraining member (for example, the constraining member may include a snare loop, and / or other device provided over and / or constraining the main graft body and / or the stent) for selectively adjusting the first stent-graft device, the second stent-graft device, the first iliac stent device and / or the second iliac stent device between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; and a catheter (for example, inner member, delivery sheath, an outer sheath, a loading sheath, an outer layer) to position at least one of the first stent-graft device, the second stent-graft device, the first iliac stent device, or the second iliac stent device at a location in the target blood vessel in proximity to the aneurysm, wherein at least one of the first stent-graft device, the second stent-graft device, the first iliac stent device, or the secondiliac stent device is provided at a distal end portion of the catheter and is oriented such that an inferior end of the corresponding first stent-graft device, the second stent-graft device, the first iliac stent device, or the second iliac stent device is adjacent a distal end of the catheter, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

[0463] Example 86. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a stent-graft including: a main graft body having a first end and a second end; and a stent connected to the main graft body; wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel.

[0464] Example 87. The stent-graft system of any example herein, particularly example 86, further comprising: a constraining member for selectively adjusting the stent between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; and a catheter to position the stent-graft at a location in the target blood vessel in proximity to the aneurysm, wherein the stent-graft is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter.

[0465] Example 88. The stent-graft system of any example herein, particularly examples 86-87, wherein the second end of the main graft body is bifurcated and comprises a first limb and a second limb.

[0466] Example 89. The stent-graft system of any example herein, particularly example 88, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein a first limb stent is disposed in the first limb and a second limb stent is disposed in the second limb.

[0467] Example 90. The stent-graft system of any example herein, particularly examples 88-89, wherein an inner surface of each of the first limb and the second limb of the main graft body include an anchor for coupling the each of the first limb and second limb to their respective first limb stent and second limb stent.

[0468] Example 91. The stent-graft system of any example herein, particularly examples 87-90, wherein the catheter comprises a delivery sheath including a central lumen sized and configured to receive the main graft body therein.

[0469] Example 92. The stent-graft system of any example herein, particularly example 91, wherein the main graft body and the stent are received within and oriented relative to the delivery sheath such that removal of the delivery sheath from the main graft body initially exposes the first limb and the second limb.

[0470] Example 93. The stent-graft system of any example herein, particularly examples 91-92, wherein, when the main graft body is retained within the delivery sheath, the first end of the main graft body is oriented toward and / or adjacent a proximal end of the delivery sheath and the second end of the main graft body is oriented toward and / or adjacent a distal end of the delivery sheath.

[0471] Example 94. The stent-graft system of any example herein, particularly examples 91-93, wherein the delivery sheath is arranged to constrain the main graft body and the stent while retained therein.

[0472] Example 95. The stent-graft system of any example herein, particularly examples 85-94, further including a pusher received within the delivery sheath for engaging at least one of the stent or the main graft body at the location in the target blood vessel in proximity to the aneurysm when the delivery sheath moved proximally to expose the main graft body.

[0473] Example 96. The stent-graft system of any example herein, particularly example 95, wherein the pusher is sized and configured to move axially within the delivery sheath.

[0474] Example 97. The stent-graft system of any example herein, particularly examples 95-96, wherein the pusher is sized and configured to maintain a position while the delivery sheath is moved axially along the pusher.

[0475] Example 98. The stent-graft system of any example herein, particularly examples 95-97, wherein the pusher has a central lumen sized and configured to receive the main graft body and the stent.

[0476] Example 99. The stent-graft system of any example herein, particularly examples 95-98, wherein a distal end of the pusher is located adjacent the first end of the main graft body and / or a first end of the stent, wherein, when the main graft body and the stent are received within the delivery sheath, the distal end of the pusher is proximal of the first end of the stent and / or the first end of the main graft body, such that removal of the delivery sheath from the main graft body initially exposes bifurcated the second end of the main graft body.

[0477] Example 100. The stent-graft system of any example herein, particularly examples 95-99, wherein the pusher is composed of a stiffer material than the delivery sheath.

[0478] Example 101. The stent-graft system of any example herein, particularly examples 91-100, further including: a contrast lumen provided within the delivery sheath for providing a flow of a contrast fluid to a site proximate the aneurysm.

[0479] Example 102. The stent-graft system of any example herein, particularly example 101, wherein, when the main graft body is retained within the delivery sheath, a distal end of the contrast lumen is provided between a proximal end of the delivery sheath and a proximal end of the main graft body.

[0480] Example 103. The stent-graft system of any example herein, particularly examples 87-102, wherein the first end of the main graft body is located at an upper end of the main graft body such that when positioned in the patient's blood vessel the upper end of the main graft body is located in a superior (for example, cephalad) position, wherein the second end of the main graft body is located at a lower end of the main graft body such that when positioned within the patient's blood vessel the lower end of the main graft body is located at an inferior (for example, caudal) position.

[0481] Example 104. The stent-graft system of any example herein, particularly examples 86-103, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape; a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb.

[0482] Example 105. The stent-graft system of any example herein, particularly examples 87-104, wherein the main graft body comprises a densified material.

[0483] Example 106. The stent-graft system of any example herein, particularly examples 86-105, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stentgraft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0484] Example 107. The stent-graft system of any example herein, particularly example 106, wherein tightening of the snare loop maintains the first end of the main graft body in the constrained configuration and loosening of the snare loop induces release of the first end of the main graft body into the unconstrained configuration.

[0485] Example 108. The stent-graft system of any example herein, particularly example 107, wherein the snare loop can re-constrain the first end of the main graft body after an expansion of the first end of the main graft body and control repositioning of the main graft body in the target blood vessel.

[0486] Example 109. The stent-graft system of any example herein, particularly examples 106-108, wherein the snare loop does not overlap with the main graft body when the main graft body is in a constrained circumferentially collapsed configuration.

[0487] Example 110. The stent-graft system of examples any example herein, particularly 106-109, wherein the snare loop is positioned through a plurality of positioning receptacles provided on the top stent.

[0488] Example 111. The stent-graft system of any example herein, particularly example 110, wherein each of the plurality of positioning receptacles further comprises an eyelet.

[0489] Example 112. The stent-graft system of any example herein, particularly examples 110-111, wherein the plurality of positioning receptacles are provided at a first end of the top stent.

[0490] Example 113. The stent-graft system of any example herein, particularly examples 110-112, wherein the plurality of positioning receptacles are provided along an arm portion of the top stent, the arm portion extending between a superior apex and an opposing inferior apex of the top stent.

[0491] Example 114. The stent-graft system of any example herein, particularly examples 106-113, wherein the snare loop includes: a first snare loop passing through the snare tube and a first positioning receptacle provided on the top stent; and a second snare loop passing through the snare tube and a second positioning receptacle provided on the top stent, the second positioning receptacle provided on an opposing segment of a perimeter of the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from the unconstrained circumferentially expanded configuration to the constrained circumferentially collapsed configuration.

[0492] Example 115. The stent-graft system of any example herein, particularly example 114, wherein the first snare loop and / or the second snare loop are movable between first position where the top stent is in the unconstrained circumferentially expanded configuration and a second position where the top stent is in the constrained circumferentially collapsed configuration.

[0493] Example 116. The stent-graft system of any example herein, particularly examples 114-115, wherein the first positioning receptacle is positioned along an arm portion of the top stent, the arm portion extending between a superior apex and an opposing inferior apex of the top stent.

[0494] Example 117. The stent-graft system of any example herein, particularly examples 114-116, wherein the first snare loop and the second snare loop are coupled to a trigger wire for releasing the first snare loop and the second snare loop from the top stent.

[0495] Example 118. The stent-graft system of any example herein, particularly example 117, wherein the main graft body includes a tubular first end portion adjacent the first end of the main graft body and a bifurcated second end portion opposite the tubular first end portion and adjacent the second end of the main graft body, the bifurcated second end portion including a first limb and a second limb, wherein activating the trigger wire causes the first snare loop and the second snare loop to release from the top stent; wherein activating the trigger activates the tether for releasing the first and second limb.

[0496] Example 119. The stent-graft system of any example herein, particularly examples 117-118, wherein the trigger wire extends between the nose cone and a proximal end of the catheter for manipulation by the user.

[0497] Example 120. The stent-graft system of any example herein, particularly examples 114-119, wherein the snare tube includes a snare tube extension coupled to the distal end of the snare tube.

[0498] Example 121. The stent-graft system of any example herein, particularly examples 86-120, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the main graft body is coupled to the top stent adjacent a superior end of the top stent.

[0499] Example 122. The stent-graft system of any example herein, particularly example 121, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0500] Example 123. The stent-graft system of any example herein, particularly example 122, wherein the snare loop passes through a first positioning receptacle proved on the top stent.

[0501] Example 124. The stent-graft system of any example herein, particularly examples 122-123, where the snare loop includes: a first snare loop passing through the snare tube and a first positioning receptacle provided on the top stent; and a second snare loop passing through the snare tube and a second positioning receptacle provided on the top stent, the second positioning receptacle provided on an opposing segment of a perimeter of the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from the unconstrained circumferentially expanded configuration to the constrained circumferentially collapsed configuration.

[0502] Example 125. The stent-graft system of any example herein, particularly examples 86-124, wherein the main graft body and the top stent are not in an end-to-end configuration.

[0503] Example 126. The stent-graft system of any example herein, particularly examples 86-125, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stentgraft system further comprises: a first snare tube passing through the delivery sheath; a first snare loop passing through the first snare tube, the first snare loop being releasably engaged with a first plurality of circumferentially spaced positions on the top stent; a second snare tube passing through the delivery sheath; and a second snare loop passing through the second snare tube, the second snare loop being releasably engaged with a second plurality of circumferentially spaced positions on the top stent;wherein the second circumferentially spaced positions on the top stent is positioned distal to the first plurality of circumferentially spaced positions on the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

[0504] Example 127. The stent-graft system of any example herein, particularly example 126, wherein the first snare loop is positioned through a first plurality of positioning receptacles provided at a first end of the top stent, wherein the second snare loop is positioned through a second plurality of positioning receptacles provided along the top stent between the first end of the top stent and the second end of the top stent.

[0505] Example 128. The stent-graft system of any example herein, particularly examples 126-127, wherein the first plurality of positioning receptacles are provided at / proximal of a plurality of superior apexes of the top stent, wherein the second plurality of positioning receptacles are provided along the top stent at a location distal each of the plurality of superior apexes.

[0506] Example 129. The stent-graft system of any example herein, particularly examples 126-128, further including a hook / barb provided adjacent at least one of the first plurality of positioning receptacles.

[0507] Example 130. The stent-graft system of any example herein, particularly examples 126-129, wherein the hook / barb are positioned distal at least one of the first plurality of positioning receptacles.

[0508] Example 131. The stent-graft system of any example herein, particularly examples 128-130, wherein the hook / barb includes a plurality of hooks / barbs staggered around the stent.

[0509] Example 132. The stent-graft system of any example herein, particularly examples 86-131, wherein the stent comprises a top stent adjacent the first end of the main graft body and a first tether releasably connected to the top stent for positioning the top stent and the first end of the main graft body in the target blood vessel.

[0510] Example 133. The stent-graft system of any example herein, particularly example 132, wherein the top stent further comprises a second tether releasably connected to the top stent for positioning the top stent and the first end of the main graft body in the target blood vessel.

[0511] Example 134. The stent-graft system of any example herein, particularly example 133, wherein the first tether and the second tether are configured to substantially fix the distal end of main graft body to a first nose cone to permit traction and avoid crumpling of main graft body during deployment.

[0512] Example 135. The stent-graft system of any example herein, particularly examples 86-134, wherein the stent comprises a top stent adjacent the first end of the main graft body.

[0513] Example 136. The stent-graft system of any example herein, particularly example 135, wherein the stent-graft system further comprises: a connecting ring which connects the top stent to the main graft body.

[0514] Example 137. The stent-graft system of any example herein, particularly example 136, wherein the connecting ring connects the main graft body at a position substantially adjacent the first end of the main graft body, and connecting members connecting the connecting ring to the top stent.

[0515] Example 138. The stent-graft system of any example herein, particularly examples 86-137, wherein the stent is encapsulated in a densified material.

[0516] Example 139. The stent-graft system of any example herein, particularly examples 86-138, further comprising a centering device to facilitate the centering and positioning of the main graft body.

[0517] Example 140. The stent-graft system of any example herein, particularly example 139, wherein the centering device is located in proximity to the first end of the main graft body and configured to be removably or temporarily deployed and expanded in the target blood vessel for centering the main graft body and / or the stent the target blood vessel.

[0518] Example 141. The stent-graft system of any example herein, particularly examples 86-140, further including: a corset extending at least partially around the stent-graft for selectively maintaining the stent-graft in an at least partially circumferentially constrained configuration.

[0519] Example 142. The stent-graft system of any example herein, particularly example 141, wherein the corset selectively maintains the at least a portion of the main graft body and at least a portion of the stent in a partially circumferentially constrained configuration, and wherein when the corset is released, the portion of the main graft body and the portion of the stent are released and free to circumferentially expand.

[0520] Example 143. The stent-graft system of any example herein, particularly examples 141-142, wherein the corset includes a trigger wire that when activated releases the corset, thereby releasing the portion of the main graft body and the portion of the stent freeing them to circumferentially expand.

[0521] Example 144. The stent-graft system of any example herein, particularly example 143, wherein the corset includes a tether wire coupled to a portion of the corset and maintaining the corset in a constrained configuration, wherein the trigger wire is coupled to a tether wire such that when the trigger wire is activated the tether wire is released and the stent-graft is free to circumferentially expand, and wherein the tether wire is coupled to the corset by an eyelet provided on the corset (for example, in some implementations, the corset includes a plurality of eyelets and the tether wire extends through each of the plurality of eyelets).

[0522] Example 145. The stent-graft system of any example herein, particularly examples 86-144, wherein the target blood vessel is selected from the group consisting of an infrarenal aorta, a juxtarenal aorta, a pararenal aorta, a thoracic aorta, or a suprarenal aorta.

[0523] Example 146. The stent-graft system of any example herein, particularly examples 86-145, wherein the insertion site blood vessel has a diameter less than or equal to the diameter of a femoral artery of the patient.

[0524] Example 147. The stent-graft system of any example herein, particularly examples 86-146 wherein the insertion site blood vessel is selected from the group consisting of brachial, radial, ulnar, axillary, femoral, iliac, carotid, and subclavian arteries.

[0525] Example 148. The stent-graft system of any example herein, particularly example 147, wherein the insertion site blood vessel is a femoral artery.

[0526] Example 149. The stent-graft system of any example herein, particularly examples 86-148, wherein the insertion site blood vessel is an iliac artery contralateral to the iliac artery aneurysm.

[0527] Example 150. The stent-graft system of any example herein, particularly examples 86-149, wherein the insertion site blood vessel is a iliac artery ipsilateral to the iliac artery aneurysm.

[0528] Example 151. The stent-graft system of any example herein, particularly examples 86-150, further comprising a trigger wire at least partially coupled to the stent-graft, wherein activating the trigger wire deploys the first limb and the second limb.

[0529] Example 152. A method of repairing an abdominal aortic aneurysm in a patient, comprising: puncturing an insertion site blood vessel located below a diaphragm of the patient and creating a passage in the insertion site blood vessel; inserting a stent-graft system in a passage of the insertion site blood vessel, the stent-graft system comprising a top stent and a main graft body in a constrained circumferentially collapsed configuration; positioning the main graft body of the stent-graft system in a target blood vessel of the patient; and deploying the top stent and the main graft body of the stent-graft system in the target blood vessel of the patient.

[0530] Example 153. The method of any example herein, particularly example 152, wherein the stentgraft system further includes a delivery sheath including a central lumen sized and configured to receive the main graft body and the stent, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape; and a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb; wherein positioning the main graft body in the target blood vessel includes: advancing the delivery sheath in the target blood vessel to a location in proximity to theaneurysm, and withdrawing the delivery sheath from the main graft body initially exposing the first limb and the second limb provided on the second end portion.

[0531] Example 154. The method of any example herein, particularly examples 152-153, wherein positioning the main graft body in the target blood vessel further includes: positioning and deploying the first limb in a first branch of an iliac artery, and positioning and deploying the second limb in a second branch of an iliac artery.

[0532] Example 155. The method of any example herein, particularly examples 152-154, wherein the main graft body is deployed within the aorta, wherein the iliac artery is contralateral to the insertion site blood vessel such that the first limb and second limb of the main graft body are positioned and deployed in the first and second branch of the iliac artery contralateral to the insertion site blood vessel.

[0533] Example 156. The method of any example herein, particularly examples 152-155, wherein withdrawing the delivery sheath from the main graft body further includes maintaining an axial position of the main graft body within the blood vessel by engaging at least one of the stent or the main graft body with a pusher received within the delivery sheath.

[0534] Example 157. The method of any example herein, particularly example 156, wherein the pusher engages the first end of the main graft body maintaining the position of the main graft body within the target blood vessel as the delivery sheath is withdrawn from the main graft body.

[0535] Example 158. The method of any example herein, particularly examples 152-157, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent between the constrained circumferentially collapsed configuration to an unconstrained circumferentially expanded configuration; wherein deploying the main graft body includes loosening of the snare loop to release the first end of the main graft body into the unconstrained configuration.

[0536] Example 159. The method of any example herein, particularly example 158, further including repositioning the main graft body of the stent-graft system in a target blood vessel of the patient including: tightening the snare loop to return the main graft body to the constrained configuration; positioning the main graft body of the stent-graft system in a new location in the target blood vessel of the patient; and deploying the main graft body of the stent-graft system in the target blood vessel of the patient at the new location.

[0537] Example 160. The method of any example herein, particularly examples 152-159, further including: maintaining at least a portion of the main graft body and / or a portion of the top stent in a partially circumferentially constrained configuration by providing a corset at least partially around the main graft body; and after positioning the portion main graft body in the target blood vessel, activating a trigger wire to release the corset such that the main graft body and / or portion of the top stent are free to circumferentially expand.

[0538] Example 161. The method of any example herein, particularly examples 152-160, wherein the target blood vessel includes the aorta, at least one of the iliac arteries, and / or visceral vessels (for example, wherein the target blood vessel includes the aorta and the iliac artery contralateral to the insertion site blood vessel).

[0539] Example 162. The method of any example herein, particularly examples 152-161, wherein puncturing an insertion site blood vessel includes a single arterial puncture or incision.

[0540] Example 163. The method of any example herein, particularly examples 152-162, wherein inserting a stent-graft system in a passage of the insertion site blood vessel includes inserting the stentgraft system into the patient's aorta, and advancing the stent-graft system with the direction of blood flow in the aorta.

[0541] Example 164: The method of any example herein, particularly examples 152-163, wherein the top stent comprises an infrarenal stent and a plurality of barbs, wherein the infrarenal stent is primarily covered by the main graft body such that the plurality of barbs remain exposed.

[0542] Example 165. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising; a main graft body having a first end and a second end; a stent connected to the main graft body; a delivery sheath to position the main graft body and the stent at a location in the target blood vessel in proximity to the aneurysm, the delivery sheath being oriented relative to the main graft body and the at least one stent so that removal of the delivery sheath) from the target blood vessel initially exposes the second end of the main graft body and subsequently exposes the first end of the main graft body, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient.

[0543] Example 166. The stent-graft system of any example herein, particularly example 165, wherein the main graft body has a tubular shape.

[0544] Example 167. The stent-graft system of any example herein, particularly examples 165-166, wherein the main graft body is a fenestrated aortic graft and / or thoracic aortic graft.

[0545] Example 168. A graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a main graft body having a first end and a second end; a coupling member for coupling the main graft body to a target blood vessel; a constraining member for selectively adjusting the stent between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; and a catheter to position the main graft body at a location in the target blood vessel in proximity to the aneurysm, wherein the main graft body is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located below a diaphragm of the patient.

[0546] Example 169. The graft system of any example herein, particularly example 168, wherein the second end of the main graft body is bifurcated and comprises a first limb and a second limb.

[0547] Example 170. The graft system of any example herein, particularly examples 168-169, wherein the first limb and the second limb each include a limb coupling member for coupling the first and second limbs to a target blood vessel.

[0548] Example 171: A method of deploying a stent-graft device in an iliac artery, the method comprising: puncturing an insertion site blood vessel at a location below the diaphragm of the patient and creating a passage in the insertion site blood vessel, where the insertion site blood vessel contralateral to a target iliac artery; inserting a stent-graft system in a passage of the insertion side blood vessel, the stent-graft system including a top stent and a graft body in a constrained circumferentially collapsed configuration; and positioning the stent-graft system in the target iliac artery of the patient; and deploying a top stent of the and the graft body of the stent-graft system in the target blood vessel of the patient

[0549] Example 172: A method according to any example herein, particularly example 171, wherein the insertion site blood vessel is at least one of the ipsilateral femoral artery or the ipsilateral iliac artery.

[0550] Example 173: A method according to any example herein, particularly examples 171-172, wherein puncturing the insertion site blood vessel is punctured at a single arterial puncture or incision.

[0551] Example 174: A method according to any example herein, particularly example 171-173, wherein the stent-graft system further includes a delivery sheath including a central lumen sized and configured to receive the main graft body and the stent, wherein the stent-graft device includes a main graft body having a first end and bifurcated second end, the bifurcated second end including a first limb and a second limb, wherein positioning the graft body in the target iliac artery includes: advancing the delivery sheath in the target blood vessel to a location in proximity to the aneurysm, and withdrawingthe delivery sheath from the main graft body initially exposing the first limb and the second limb provided on the bifurcated second end portion.

[0552] Example 175: A method according to any example herein, particularly examples 171-174, wherein the positioning the stent-graft system in the target iliac artery of the patient further includes: positioning and deploying the first limb in a first branch of the target iliac artery, and positioning and deploying the second limb in a second branch of the target iliac artery.

[0553] Example 176: A method according to any example herein, particularly examples 171-175, wherein positioning the stent-graft system in the target iliac artery of the patient includes: first deploying the main graft body of the stent-graft system in the target iliac artery, then positioning and deploying at least one of the first limb and the second limb in the corresponding first and second branch of the target iliac artery.

[0554] Example 177: A method according to any example herein, particularly examples 171-175, wherein positioning the stent-graft system in the target iliac artery of the patient includes: first deploying at least one of the first limb and the second limb in the corresponding first and second branch of the target iliac artery, then deploying the main graft body of the stent-graft system in the target iliac artery.

[0555] While the aspects described herein have been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described aspects are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claims. Accordingly, it is intended that the present disclosure not be limited to the described aspects, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

Claims1. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising: a stent-graft including: a main graft body having a first end and a second end; and a stent connected to the main graft body; wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel, wherein the puncture or incision is located above or below a diaphragm of the patient.

2. The stent-graft system of claim 1, further comprising: a constraining member for selectively adjusting the stent between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; and a catheter to position the stent-graft at a location in the target blood vessel in proximity to the aneurysm, wherein the stent-graft is provided at a distal end portion of the catheter and is oriented such that the second end of the main graft body is adjacent a distal end of the catheter.

3. The stent-graft system of any one of claims 1-2, wherein the second end of the main graft body is bifurcated and comprises a first limb and a second limb.

4. The stent-graft system of claim 3, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein a first limb stent is disposed in the first limb and a second limb stent is disposed in the second limb.

5. The stent-graft system of any one of claims 2-4, wherein the catheter comprises a delivery sheath including a central lumen sized and configured to receive the main graft body therein.

6. The stent-graft system of claim 5, wherein the main graft body and the stent are received within and oriented relative to the delivery sheath such that removal of the delivery sheath from the main graft body initially exposes the first limb and the second limb.

7. The stent-graft system of claim 5, wherein, when the main graft body is retained within the delivery sheath, the first end of the main graft body is oriented toward and / or adjacent a proximal end of the delivery sheath and the second end of the main graft body is oriented toward and / or adjacent a distal end of the delivery sheath.

8. The stent-graft system of claim 5, further including a pusher received within the delivery sheath for engaging at least one of the stent or the main graft body at the location in the target blood vessel in proximity to the aneurysm when the delivery sheath moved proximally to expose the main graft body.

9. The stent-graft system of claim 8, wherein a distal end of the pusher is located adjacent the first end of the main graft body and / or a first end of the stent, wherein, when the main graft body and the stent are received within the delivery sheath, the distal end of the pusher is proximal of the first end of the stent and / or the first end of the main graft body, such that removal of the delivery sheath from the main graft body initially exposes bifurcated the second end of the main graft body.

10. The stent-graft system of any one of claims 2-9, wherein the first end of the main graft body is located at an upper end of the main graft body such that when positioned in the patient's blood vessel the upper end of the main graft body is located in a superior (cephalad) position, wherein the second end of the main graft body is located at a lower end of the main graft body such that when positioned within the patient's blood vessel the lower end of the main graft body is located at an inferior (caudal) position.

11. The stent-graft system of any one of claims 2-10, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape; a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb.

12. The stent-graft system of any one of claims 2-11, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

13. The stent-graft system of claim 12, wherein tightening of the snare loop maintains the first end of the main graft body in the constrained configuration and loosening of the snare loop induces release of the first end of the main graft body into the unconstrained configuration.

14. The stent-graft system of claim 12, wherein the snare loop includes: a first snare loop passing through the snare tube and a first positioning receptacle provided on the top stent; and a second snare loop passing through the snare tube and a second positioning receptacle provided on the top stent, the second positioning receptacle provided on an opposing segment of a perimeter of the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from the unconstrained circumferentially expanded configuration to the constrained circumferentially collapsed configuration.

15. The stent-graft system of claim 14, wherein the first snare loop and / or the second snare loop are movable between first position where the top stent is in the unconstrained circumferentially expanded configuration and a second position where the top stent is in the constrained circumferentially collapsed configuration.

16. The stent-graft system of any one of claims 14-15, wherein the main graft body includes a tubular first end portion adjacent the first end of the main graft body and a bifurcated second end portion opposite the tubular first end portion and adjacent the second end of the main graft body, the bifurcated second end portion including a first limb and a second limb, wherein the first snare loop and the second snare loop are coupled to a trigger wire for releasing the first snare loop and the second snare loop from the top stent, wherein activating the trigger wire causes the first snare loop and the second snare loop to release from the top stent, wherein activating the trigger wire activates the tether for releasing the first and second limb.

17. The stent-graft system of any one of claims 2-16, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a first snare tube passing through the delivery sheath; a first snare loop passing through the first snare tube, the first snare loop being releasably engaged with a first plurality of circumferentially spaced positions on the top stent; a second snare tube passing through the delivery sheath; anda second snare loop passing through the second snare tube, the second snare loop being releasably engaged with a second plurality of circumferentially spaced positions on the top stent; wherein the second circumferentially spaced positions on the top stent is positioned distal to the first plurality of circumferentially spaced positions on the top stent, wherein the first snare loop and the second snare loop are operative for selectively adjusting the top stent from an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration.

18. The stent-graft system of claim 17, wherein the first snare loop is positioned through a first plurality of positioning receptacles provided at a first end of the top stent, wherein the second snare loop is positioned through a second plurality of positioning receptacles provided along the top stent between the first end of the top stent and the second end of the top stent, wherein the first plurality of positioning receptacles are provided at / proximal of a plurality of superior apexes of the top stent, wherein the second plurality of positioning receptacles are provided along the top stent at a location distal each of the plurality of superior apexes.

19. The stent-graft system of any one of claims 1-18, further including: a corset extending at least partially around the stent-graft for selectively maintaining the stent-graft in an at least partially circumferentially constrained configuration, wherein the corset selectively maintains the at least a portion of the main graft body and at least a portion of the stent in a partially circumferentially constrained configuration, wherein when the corset is released, the portion of the main graft body and the portion of the stent are released and free to circumferentially expand.

20. The stent-graft device of claim 19, wherein the corset includes a trigger wire that when activated releases the corset, thereby releasing the portion of the main graft body and the portion of the stent freeing them to circumferentially expand.

21. The stent-graft device of any one of claims 19-20, wherein the corset includes a tether wire coupled to a portion of the corset and maintaining the corset in a constrained configuration, wherein the trigger wire is coupled to a tether wire such that when the trigger wire is activated the tether wire is released and the stent-graft is free to circumferentially expand,wherein the tether wire is coupled to the corset by an eyelet provided on the corset.

22. A stent-graft system for repair of an aneurysm in a target blood vessel of a patient comprising:(1) a first stent-graft device including: a main graft body having a superior end and an inferior end, and a stent connected to the main graft body adjacent the superior end; a first limb coupled to and extending distally from the inferior end of the main graft body; a second limb coupled to and extending distally from the inferior end of the main graft body;(2) a second stent-graft device including: a second main graft body having a superior end and an inferior end, and a stent connected to the second main graft body adjacent the superior end; a third limb coupled to and extending from an inferior end of the first limb, the third limb sized and configured to be received within the external iliac artery; a fourth limb coupled to and extending from the inferior end of the first limb, the fourth limb sized and configured to be received within the internal iliac artery;(3) a first iliac stent device including: a graft body having a superior end and an inferior end; and a stent connected to the graft body; and(4) a second iliac stent device including: a graft body having a superior end and an inferior end; and a stent connected to the graft body of the second iliac stent, wherein first iliac stent device extends between a distal end of the first limb of the first stent -graft device and the superior end of the second main graft body of the second stent-graft device, wherein the second iliac stent device extends from a distal end of the second limb of the first stent-graft device, the second iliac stent device sized and configured to be received within a non-aneurysmal common iliac artery.

23. The stent graft system of claim 22, further including a constraining member for selectively adjusting the first stent-graft device, the second stent-graft device, the first iliac stent device and / or the second iliac stent device between an unconstrained circumferentially expanded configuration to a constrained circumferentially collapsed configuration; anda catheter to position at least one of the first stent-graft device, the second stent-graft device, the first iliac stent device, or the second iliac stent device at a location in the target blood vessel in proximity to the aneurysm, wherein at least one of the first stent-graft device, the second stent-graft device, the first iliac stent device, or the second iliac stent device is provided at a distal end portion of the catheter and is oriented such that an inferior end of the corresponding first stent-graft device, the second stent-graft device, the first iliac stent device, or the second iliac stent device is adjacent a distal end of the catheter, wherein the main graft body is configured to be inserted through a single arterial puncture or incision in an insertion site blood vessel located above a diaphragm of the patient.

24. A method of repairing an abdominal aortic aneurysm in a patient, comprising: puncturing an insertion site blood vessel located below a diaphragm of the patient and creating a passage in the insertion site blood vessel; inserting a stent-graft system in a passage of the insertion site blood vessel, the stentgraft system comprising a top stent and a main graft body in a constrained circumferentially collapsed configuration; positioning the main graft body of the stent-graft system in a target blood vessel of the patient; and deploying the top stent and the main graft body of the stent-graft system in the target blood vessel of the patient.

25. The method of claim 24, wherein the stent-graft system further includes a delivery sheath including a central lumen sized and configured to receive the main graft body and the stent, wherein the main graft body includes: a first end portion adjacent the first end of the main graft body, the first end portion having a tubular shape; and a second end portion adjacent the second end of the main graft body, where the second end portion is bifurcated and includes a first limb and a second limb; wherein positioning the main graft body in the target blood vessel includes: advancing the delivery sheath in the target blood vessel to a location in proximity to the aneurysm, and withdrawing the delivery sheath from the main graft body initially exposing the first limb and the second limb provided on the second end portion.

26. The method of any one of claims 24-25, wherein positioning the main graft body in the target blood vessel further includes: positioning and deploying the first limb in a first branch of an iliac artery, and positioning and deploying the second limb in a second branch of an iliac artery.

27. The method of any one of claims 24-26, wherein the main graft body is deployed within the aorta, wherein the iliac artery is contralateral to the insertion site blood vessel such that the first limb and second limb of the main graft body are positioned and deployed in the first and second branch of the iliac artery contralateral to the insertion site blood vessel.

28. The method of any one of claims 24-27, wherein the stent comprises a top stent adjacent the first end of the main graft body, wherein the stent-graft system further comprises: a snare tube passing through the delivery sheath; and a snare loop passing through the snare tube, the snare loop being releasably engaged with a plurality of circumferentially spaced positions on the top stent and being operative for selectively adjusting the top stent between the constrained circumferentially collapsed configuration to an unconstrained circumferentially expanded configuration; wherein deploying the main graft body includes loosening of the snare loop to release the first end of the main graft body into the unconstrained configuration.

29. The method of claim 28, further including re-positioning the main graft body of the stent-graft system in a target blood vessel of the patient including: tightening the snare loop to return the main graft body to the constrained configuration; positioning the main graft body of the stent-graft system in a new location in the target blood vessel of the patient; and deploying the main graft body of the stent-graft system in the target blood vessel of the patient at the new location.

30. The method of any one of claims 24-29, wherein the target blood vessel includes the aorta, at least one of the iliac arteries, and / or visceral vessels, wherein puncturing an insertion site blood vessel includes a single arterial puncture or incision,wherein inserting a stent-graft system in a passage of the insertion site blood vessel includes inserting the stent-graft system into the patient's aorta, and advancing the stent-graft system with the direction of blood flow in the aorta.

31. A method of deploying a stent-graft device in an iliac artery, the method comprising: puncturing an insertion site blood vessel at a location below the diaphragm of the patient and creating a passage in the insertion site blood vessel, where the insertion site blood vessel contralateral to a target iliac artery; inserting a stent-graft system in a passage of the insertion side blood vessel, the stentgraft system including a top stent and a graft body in a constrained circumferentially collapsed configuration; positioning the stent-graft system in the target iliac artery of the patient; and deploying a top stent of the and the graft body of the stent-graft system in the target blood vessel of the patient.

32. The method of claim 31, wherein the insertion site blood vessel is at least one of the ipsilateral femoral artery or the ipsilateral iliac artery.

33. The method of any one of claims 31-32, wherein the stent-graft system further includes a delivery sheath including a central lumen sized and configured to receive the main graft body and the stent, wherein the stent-graft device includes a main graft body having a first end and bifurcated second end, the bifurcated second end including a first limb and a second limb, wherein positioning the graft body in the target iliac artery includes: advancing the delivery sheath in the target blood vessel to a location in proximity to the aneurysm, and withdrawing the delivery sheath from the main graft body initially exposing the first limb and the second limb provided on the bifurcated second end portion.

34. The method of any one of claims 31-33, wherein the positioning the stent-graft system in the target iliac artery of the patient further includes: positioning and deploying the first limb in a first branch of the target iliac artery, and positioning and deploying the second limb in a second branch of the target iliac artery.

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