Balloon-expandable branched stent graft and method of using the same

Abstract

In an exemplary embodiment, a device for treating a patient comprises a delivery catheter, a compressed expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion, and an expansion element pre-loaded on a portion of the stent or the delivery device. In an exemplary embodiment, a device for treating a patient comprises a delivery catheter, a compressed expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion, and at least one balloon pre-loaded on a portion of the stent or the delivery device.

Description

Technical Field

[0001] Incorporation by reference to any prior application This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 351,286, filed on Jun. 10, 2022, and U.S. Provisional Patent Application No. 63 / 409,632, filed on Sep. 23, 2022, the contents of each of which are hereby incorporated by reference in their entirety.

Background Art

[0002] The present disclosure relates to branched stent grafts and deployment systems therefor, such as balloon-expandable branched stent grafts and deployment systems therefor.

[0003] Description of Related Art Aortoiliac occlusive disease (AIOD) is a variant of peripheral artery disease that affects the infrarenal aorta and the iliac arteries. Like other arterial diseases, aortoiliac occlusive disease blocks blood flow to distal organs through a narrowed lumen or by embolization of plaque. Current treatments for peripheral artery diseases such as AIOD include surgical bypass, angioplasty, kissing stents, and techniques and devices referred to as covered endovascular reconstruction of the aortic bifurcation.

Summary of the Invention

[0004] Embodiments of methods and devices for treating diseased vasculature of a patient's body are disclosed herein, including, but not limited to, the infrarenal aorta and iliac arteries, as well as other branched and unbranched arteries or blood vessels of the body. Any embodiments of the systems, methods, and devices disclosed herein are configured or configurable to be used for treating any branched and unbranched vasculature within the body. In some embodiments, the methods and devices include expanding a unibody branched balloon-expandable stent graft that may be coated with graft material across arterial disease affecting the infrarenal aorta and iliac arteries, and seating a unibody branched stent device over the bifurcation of the aorta.

[0005] Disclosed herein are embodiments of deployment systems and methods for treating branched and unbranched blood vessels within the body, including, but not limited to, the infrarenal aorta and iliac arteries. Exemplary embodiments include a balloon capable of expanding the body and ipsilateral limb of a branched unibody graft, the balloon being a stepped balloon that allows for complete expansion of the stent graft in a single balloon expansion step, the distal portion of the stepped balloon being positioned within the main graft portion of the stent graft and having an expanded diameter greater than that of the more proximal portion of the balloon, which is positioned within the smaller diameter ipsilateral limb of the stent graft.

[0006] Disclosed herein are embodiments of deployment systems and methods for treating branched and unbranched blood vessels in the body, including but not limited to the infrarenal aorta and the iliac arteries. In some embodiments, the system can include an expansion element, such as "beads" (which can include, in certain embodiments, an expanded section, valve, or protrusion), which can be pre-assembled and loaded with the rest of the device, or inserted into the device later. The beads can track through a crimped (also referred to as compressed) lumen, such as a contralateral limb, and expand the limb enough to allow a balloon catheter to subsequently advance through the center of the stent graft limb. The beads can be made small enough so that the beads can be removed from a partially expanded contralateral sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0007]

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[0008] Disclosed herein are embodiments of a system 100 for treating diseased vasculature in the body, including, but not limited to, aortoiliac occlusive lesions and other pathologies at the aortic bifurcation, as well as other branched and unbranched arteries and blood vessels. Thus, while specific embodiments are described as treating the aortic bifurcation, any embodiment of the systems, methods, and devices disclosed herein are configured, or configurable, to be used for the treatment of any branched and unbranched vasculature in the body. Some embodiments of the system 100 can have a stent device 120 and a delivery catheter 130. In an exemplary embodiment, the stent device 120 has a unibody design to avoid the complexity typically present in modular or multi-part devices.

[0009] Some embodiments of the methods disclosed herein include deploying a covered branched stent device at the aortic bifurcation, the device having a unibody structure and being mechanically expandable (e.g., balloon expandable). Referring to FIG. 1A, some embodiments of the stent device 120 can have a body portion 122 configured to extend within the aorta, a first downwardly (or distally) extending limb portion 124 configured to extend within a first iliac artery (e.g., the ipsilateral or contralateral artery or limb), and a second downwardly extending limb portion 126 (also referred to herein as the contralateral limb) configured to extend within a second iliac artery (e.g., the other of the ipsilateral and contralateral arteries or limbs). FIG. 1A shows the stent device 120 in the deployed and expanded states. Although some of the figures show an aneurytic aortic bifurcation, the use of the embodiments disclosed herein is not limited to use for the treatment of abdominal aortic aneurysms. Embodiments of the devices disclosed herein can be used to treat a wide range of diseases and conditions of the aorta and aortic bifurcation, including, but not limited to, AIOD and other aneurysmal, embolic, and occlusive aortic pathologies. Some embodiments of the stent device 120 disclosed herein can have the advantage of having a lower profile than some variants of conventional self-expanding stent devices, which can be advantageous when treating certain pathologies such as a closed or partially closed aorta.

[0010] As will be disclosed in more detail below, any embodiment of the stent device 120 disclosed herein can be an uncovered mechanical expansion type (e.g., balloon expansion type) stent of a unibody structure or other one-piece configuration, or a covered mechanical expansion type (e.g., balloon expansion type) stent. Before deployment, the body portion 122, the first downwardly extending leg portion 124, and the second downwardly extending leg portion 126 are joined together. In some embodiments, the body portion 122, the first downwardly (or distally) extending leg portion 124, and the second downwardly (or distally) extending leg portion 126 can be integrally formed. In some embodiments, the body portion 122, the first downwardly extending leg portion 124, and the second downwardly extending leg portion 126 can be formed separately and joined together. In some embodiments, the body portion 122 and the first downwardly extending leg portion 124 can be integrally formed, and the second downwardly extending leg portion 126 can be formed separately and joined to the body portion 122 and the first downwardly extending leg portion 124. In some embodiments, the stent device 120 can have an expandable frame 126 and a graft or cover 128.

[0011] Frame 126 can have any desired or suitable shape or configuration and can be made of laser-cut tubing, wire, or by other known or later-developed techniques and materials. In any embodiment, the expandable frame 126 of the stent device 120 can be made from any suitable material, including stainless steel, cobalt chrome, or any other suitable metal alloy or other material. In any embodiment, the graft can be made from any suitable material for the graft, including polyester, polyester / spandex, expanded polytetrafluoroethylene (ePTFE), or any other suitable or acceptable material. Some embodiments of the stent device 120 can include a balloon-expandable bifurcated stent structure that forms an inverted “Y” shape similar to a unibody distent graft structure. In such embodiments, the body portion 122 in the expanded configuration can have an outer diameter and an inner diameter that are larger than the downwardly extending leg portions 124, 126. In any embodiment disclosed herein, the expandable balloon can be a stepped balloon to allow for complete expansion of the stent graft in a single balloon expansion step. In such a configuration, the distal portion of the stepped balloon can be positioned within the main graft portion of the stent and can have an expansion diameter that is larger than the more proximal portion of the balloon, which can be positioned within the smaller diameter side branches of the stent graft.

[0012] Referring to FIG. 1B, some embodiments of the stent device 120 can be deployed using a catheter 130 that can have a distal tip 132 (which can be atraumatic), an outer sheath 134, and a contralateral wire 136. However, in some embodiments, the outer catheter sheath 134 is not necessary for the system 100. Some embodiments of the system 100 can be configured such that the stent 120 is wound in a compressed configuration around the inner core of the delivery catheter 130. Some embodiments of the catheter 130 can be advanced through a puncture site in the first common iliac artery through an introducer, through the bifurcation of the aorta, or through any puncture site or opening into any part of the patient's vasculature. The contralateral wire 136 can be withdrawn through a second puncture site in the second of the common iliac arteries. Referring to FIG. 1C, the sheath 134 can be withdrawn through the first puncture site to expose the stent device 120, and then the stent device 120 can be moved toward the bifurcation such that the first limb portion 124 is withdrawn into the first artery (e.g., but not limited to, the ipsilateral common iliac artery), and the second limb portion 126 can be moved or withdrawn into the second common iliac artery (e.g., but not limited to, the contralateral common iliac artery). The stent device 120 can still be in a contracted or low-profile state at this stage. In some embodiments, the stent 120 can be withdrawn toward the aortic bifurcation such that the bifurcation portion of the stent 120 contacts the aortic bifurcation to seat the stent 120 at the aortic bifurcation.

[0013] Referring to FIG. 1D, the body portion 122 and the first limb portion 124 can then be expanded, such as with an expandable balloon or other mechanically expandable device. The second limb portion 126 can remain in a collapsed or low-profile state. In some embodiments, the catheter can have an outer sheath. In other embodiments, the catheter can be configured to not have an outer sheath. The outer sheath 134 is shown in FIG. 1D as remaining in the first iliac artery. However, in some embodiments, the outer sheath 134 can be withdrawn before the expandable balloon expands or other mechanical expansion means actuate to expand the body portion 122 and the first limb portion 124. In some embodiments, an expandable balloon can be positioned within the body portion 122 and the first limb portion 124 while advancing the stent device 120 within the aorta. In some embodiments, after the stent device 120 is positioned at a desired location in the patient's aorta, an expandable balloon can be advanced within the first limb portion 124 and the body portion 122. As described above, in certain embodiments, the expandable balloon can be a stepped balloon to allow for complete expansion of the stent graft in a single balloon expansion step. In such a configuration, the distal portion of the stepped balloon can be positioned within the main graft portion of the stent and can have a larger expansion diameter than the more proximal portion of the balloon, which can be positioned within a smaller diameter side branch of the stent graft. In other embodiments, a single expandable balloon can be used to expand the body portion 122 and the first limb portion 124. For example, in a first step, the body portion 122 can be expanded, then the balloon can be collapsed and moved, and then the first limb portion 124 can be expanded. In an exemplary embodiment, in a first step, the first limb portion 124 can first be expanded with a balloon, and then the balloon can be advanced within the body portion to expand the body portion 122. Additionally, although the present disclosure describes the use of a balloon to expand portions of the device 120, other expansion devices, such as mechanically expandable devices, can be used.

[0014] In some patients, the second iliac artery is stenotic or otherwise partially or completely occluded, making it difficult or impractical to advance an expandable balloon or other mechanical expansion device into the second limb portion 126. To address this problem, some embodiments of the system 100 include one or more low-profile expansion elements 140 that can move through the body portion 122, the first limb portion 124, and / or the second limb portion 126 to enable advancement of an expandable balloon or other mechanical expansion means within the body portion 122, the first limb portion 124, and / or the second limb portion 126, and can partially expand the body portion 122, the first limb portion 124, and / or the second limb portion 126. For example, without limitation, in some embodiments, the low-profile expansion element 140 (also referred to herein as a "bead") has a low-profile shape that can move through the body portion 122, the first limb portion 124, and / or the second limb portion 126 and can partially expand the body portion 122, the first limb portion 124, and / or the second limb portion 126 despite the forces imparted on the body portion 122, the first limb portion 124, and / or the second limb portion 126 from the occlusive pathology of the patient's vasculature. In some embodiments, the low-profile expansion element 140 can have a dense cross-section. In some embodiments, the low-profile expansion element 140 can have an elongate shape such as a cylindrical shape. In some embodiments, the low-profile expansion element 140 can be pre-assembled and loaded with the remainder of the stent device. As contemplated, the low-profile expansion element 140 can move through the crimped or collapsed second limb portion 126 and expand the second limb portion 126 enough to allow the balloon to pass through the cannula and then fully expand the second limb portion 126. Some embodiments of the low-profile expansion element 140 can be sized and configured to be withdrawn through a contralateral introducer sheath.

[0015] In any of the embodiments disclosed herein, the low-profile expansion element 140 can be self-expanding or actively expanding. Self-expanding beads can be achieved in several modalities such as self-expanding forms, open-cell polyurethane foams, flexible nitinol membranes, or variations thereof. In an exemplary embodiment, the expansion element expands inside a portion (e.g., limb) of a crimped stent device and can then contract before or during removal of the expansion element.

[0016] Referring to FIG. 1E, in some embodiments, a low-profile expansion element 140 can be coupled to a hollow wire 142 that can advance over a contralateral wire 136 such that by pulling the hollow wire 140 through a second puncture site, the low-profile expansion element 140 can be moved through a second limb portion 126. The low-profile expansion element 140 can have a diameter or cross-sectional size that is larger than the inner diameter or cross-sectional size of the second limb portion 126 in a curled (also referred to as compressed) state such that as the low-profile expansion element 140 moves through the second limb portion 126, the second limb portion 126 is expanded. Then, referring to FIG. 1F, the low-profile expansion element 140 can be completely withdrawn from the body and the second limb portion 126 can be in a partially expanded state that is large enough to receive an expansion balloon or other mechanical expansion means therein, despite an external force acting on the second limb portion 126. Next, an expansion balloon or other mechanical expansion means can be advanced through the contralateral introducer sheath over the contralateral wire 136 and into the second limb portion 126 to complete the expansion of the second limb portion 126. In some embodiments, the expansion balloon can be pulled into the second limb portion 126 through the ipsilateral introducer sheath to complete the expansion of the second limb portion 126. In some embodiments, the stent device 120 can be positioned such that prior to any expansion, the legs of the stent graft are pulled down to seat the graft over the bifurcation of the aorta. In other embodiments, the stent device 120 can be positioned such that while the stent 120 is partially or fully expanded, or after the stent 120 is partially or fully expanded, the legs of the stent graft are pulled down to seat the graft over the bifurcation of the aorta.

[0017] The figures and description describe using the low-profile expansion element 140 to expand the second leg portion 126, but in other embodiments, the low-profile expansion element 140 can be used to expand other portions of the stent device 120, including the body portion 122 and / or the first leg portion 124. In some embodiments, the low-profile expansion element 140 can have an angled or beveled proximal end portion 142 to facilitate movement of the low-profile expansion element 140 through the second leg portion 126 and to cause the second leg portion 126 to expand more gradually as the low-profile expansion element 140 moves through the second leg portion 126. In some embodiments, the low-profile expansion element 140 can have a tapered extension portion that can be more than half the length of the low-profile expansion element 140, or between one-quarter and three-quarters of the length of the low-profile expansion element 140, or between one-quarter of the length and the full length of the low-profile expansion element 140, or any value or range of values within the foregoing ranges. In some embodiments, the low-profile expansion element 140 can have a diameter of greater than approximately 0.05 inches, less than approximately 0.25 inches, between approximately 0.05 inches and approximately 0.25 inches, between approximately 0.10 inches and approximately 0.25 inches, between approximately 0.10 inches and approximately 0.20 inches, or between approximately 0.10 inches and approximately 0.125 inches, including all values (e.g., decimal values) within the foregoing ranges. In an exemplary embodiment, the expansion element can have an initial (non-expanded) diameter of greater than approximately 0.05 inches, greater than approximately 0.10 inches, greater than approximately 0.175 inches, greater than approximately 0.20 inches, or greater than approximately 0.25 inches, including all values (e.g., decimal values) within the foregoing ranges. In an exemplary embodiment, the expansion element can have an expanded diameter of less than approximately 0.05 inches, less than approximately 0.10 inches, less than approximately 0.175 inches, less than approximately 0.20 inches, or less than approximately 0.25 inches, including all values (e.g., decimal values) within the foregoing ranges.

[0018] In some embodiments, the low-profile extension element 140 is configured to expand the stent limbs to 30% of the final expanded diameter of each limb, or to 15% or approximately 15% or less to 40% or approximately 40% or more of the final expanded diameter of each limb, or to 20% or approximately 20% to 30% or approximately 30% of the final expanded diameter of each limb, or to any value within the foregoing ranges or between any values. In an exemplary embodiment, the contralateral limb has an inner diameter in the range of about 0.5 to 14 mm, including any fractional and integer values within this range. For example, the crimped contralateral limb may have an inner diameter of about 0.5 to 5 mm, preferably about 1 to 3 mm. Following partial expansion using the expansion element, the contralateral limb may have an inner diameter of about 1 to 5 mm, preferably about 3 to 5 mm. In a subsequent balloon expansion, the contralateral limb may have an inner diameter of about 5 to 14 mm, depending on the anatomical structure.

[0019] The exemplary embodiments disclosed herein can advantageously provide a streamlined surgical procedure. By maintaining a unibody bifurcation design, the disadvantages of kissing stents and some versions of covered endovascular reconstruction of the aortic bifurcation (CERAB), namely, unequal blood flow division between the two limbs, can be avoided. In addition, some embodiments of the balloon-expandable stents disclosed herein are, in part, beneficial for treating aortoiliac occlusive disease (AIOD) in order to provide physicians with the ability to achieve a smaller profile and higher radial strength, as well as to provide physicians with an intermediate diameter / radial stiffness point driven by physician-controlled expansion.

[0020] Some embodiments of system 100 can incorporate one or more components of the ENDOLOGIX AFX delivery system, such as a separate introducer for obtaining vascular access, a main handle and sheath for docking with the introducer, an inner core and atraumatic tip for advancing the system through the introducer and anatomical structures, and / or a pre-cannulated contralateral limb wire for snaring the second limb portion 126 and positioning it within the contralateral common iliac artery to facilitate access to every corner. Appendices A and B are part of U.S. Patent No. 8,808,350, which discloses some embodiments of the ENDOLOGIX AFX delivery system that can be incorporated into any embodiment of system 100 as described above. Accordingly, the entire disclosure of U.S. Patent No. 8,808,350, including the drawings, forms part of this disclosure, including the described specification and drawings. In any embodiment disclosed herein, any component, feature, or other detail of systems 100, 200, or 300 can have any of the components, features, or other details of any of the embodiments disclosed in Appendix A, or can be used in combination with any of the components, features, or details of systems 100, 200, or 300 or methods of use disclosed herein as if such embodiments were expressly disclosed herein, and can be used in accordance with any of the steps of any of the method embodiments disclosed in Appendix A.

[0021] FIG. 2A shows an exemplary embodiment of the low-profile extension element 140. FIG. 2B shows an exemplary embodiment of the second limb portion 126 of the stent in the crimped state. The second limb portion is also referred to herein as the crimped opposite limb or the compressed opposite limb. FIGS. 2C-2E show an exemplary embodiment of the second limb portion 126 of the stent in the crimped state, showing the movement of the extension element 140 through the second limb portion 126 and the expansion of the second limb portion 126 as the extension element 140 moves through the second limb portion 126. The circles in each of FIGS. 2C-2E identify the extension element 140 in the second limb portion 126. In FIG. 2E, the extension element 140 has moved over the entire length or substantially the entire length of the second limb portion 126 such that the entire length or substantially the entire length of the second limb portion 126 is partially expanded by the extension element 140.

[0022] FIG. 3 shows an embodiment of the stent device in the crimped state, where the body portion and the first limb portion of the stent device are balloon-expanded or are prepared for balloon expansion. FIG. 4 shows that the second limb portion of the stent device is partially expanded as the extension element moves through the second limb portion of the stent device. FIG. 5 shows the stent device after the extension element has been fully pulled through the second limb portion of the stent device. The circles in each of FIGS. 4 and 5 identify the extension element 140 in the second limb portion 126.

[0023] Any other embodiment of the system 100 or the stent 120 can have any combination of any of the other components, features, and / or other details of such an embodiment with any of the components, features, or other details of any of the embodiments shown in FIGS. 3A-3C.

[0024] FIG. 6 shows another embodiment of a system 200 for treating aortic-iliac occlusive lesions and other pathologies in the aortic bifurcation, showing a branched stent device 120 in a crimped or collapsed state. In any of the embodiments disclosed herein, any component, feature, or other detail of the system 200 can be in any combination with a component, feature, or detail of the system 200 or its method of use disclosed herein, including, but not limited to, any of the embodiments of the system 100 or its method of use disclosed herein, and can have any of the components, features, or other details of any of the embodiments of any other system disclosed herein, or can be used in accordance with any of the steps of any of the embodiments of any other method disclosed herein. Similarly, any component, feature, step, or other detail of any of the embodiments of any other system or method disclosed herein, including, but not limited to, the system 100 or its method of use, can have any of the components, features, steps, or other details of any of the embodiments of the system 200 or its method of use in any combination.

[0025] In some embodiments, the stent device 120 can be partially or fully expanded (or substantially fully expanded) by pulling or moving one or more, two or more, or three or more expansion elements through the stent device 120. In one example, referring to FIG. 6, a first expansion element 210 can be used to expand the body portion 122 and / or the first limb portion 124 of the stent device 120. The first expansion element 210 can be coupled to a first wire 212 that can be accessed through a first puncture side (e.g., through, but not limited to, a first femoral puncture site, such as in the ipsilateral iliac artery). By pulling the first wire 212 through the body portion 122 and the first limb portion 124 (e.g., through the first puncture site), the first expansion element 210 can be moved through the body portion 122 and the first limb portion 124 of the stent device 120, thereby expanding the body portion 122 and / or the first limb portion 124 of the stent device 120 partially, fully, or substantially fully.

[0026] Similarly, a second expansion element 220 can be used to expand the second leg portion 126 of the stent device 120. The second expansion element 220 can be coupled to a second wire 222 that can be accessed through a second access side (e.g., but not limited to, at a second femoral puncture site, e.g., at the contralateral iliac artery). By pulling the second wire 222 through the body portion 122 and the second leg portion 124 (e.g., through the second puncture site), the second expansion element 220 can be moved through the body portion 122 and the second leg portion 126 of the stent device 120, thereby expanding the second leg portion 126 of the stent device 120 partially, fully, or substantially fully. In some embodiments, although not necessary, after at least the body portion 122 is partially, fully, or substantially fully expanded, the second expansion element 220 can be moved through the body portion 122 and the second leg portion 126 of the stent device 120. In some embodiments, although not necessary, after the body portion 122 and the first leg portion 124 of the stent device are partially, fully, or substantially fully expanded, the second expansion element 220 can be moved through the body portion 122 and the second leg portion 126 of the stent device 120.

[0027] FIG. 7 shows the stent device 120 after the body portion 122 and the first limb portion 122 of the stent device 120 have been partially expanded by the first expansion element 210. The expansion element 210 is removed along the first wire 212. Although not shown, the first wire may remain within the stent device. Also as shown, the second limb portion 124 is still in a crimped state and the second expansion element 220 is positioned distally of the stent device 120. In this state, the second wire 222 can then be withdrawn and the second expansion element 220 can be moved through the body portion 122 and the second limb portion 124 of the stent device 120 by partially, fully, or substantially fully expanding the second limb portion 126 of the stent device. If the body portion 122, the first limb portion 124, and / or the second limb portion 126 are only partially expanded by the expansion elements 210, 220, the first limb portion 124, and / or the second limb portion 126 can be fully or substantially fully expanded using an expansion balloon or any other suitable expansion device at any step in the process. The first expansion element 210 and the second expansion element 220 can each be drawn through the first puncture site and the second puncture site, respectively.

[0028] As will be repeated, similar to any other embodiment disclosed herein, the first expansion element 210 and / or the second expansion element 220 can have any suitable or desired shape, size, or other details. For example, but not limited to, the first expansion element 210 and / or the second expansion element 220 can have a tubular or cylindrical shape, a tapered cylindrical shape such as a bullet, a bead shape, or otherwise.

[0029] In some embodiments, when the stent device is crimped on the delivery catheter, the first expansion element 210 and / or the second expansion element 220 (and / or any other expansion element) can be positioned within a delivery catheter (not shown) distal to the body portion 122 of the stent device 120 or coupled to the delivery catheter (not shown). This can, in some instances, reduce the overall profile size of the delivery device (e.g., when the stent device is in a crimped state on the delivery device). In some embodiments, the second expansion element 220 can be positioned distal to, adjacent to, spaced apart from, or slightly overlapping with the first expansion element 210. When the second expansion element 220 is positioned distal to or adjacent to the first expansion element 210 without overlapping the first expansion element 210, the overall profile of the delivery device in the region of the expansion elements 210, 220 can be reduced.

[0030] In any of the embodiments disclosed herein, the delivery device can be configured to selectively support the distal end of the stent device 120 to prevent the stent device from collapsing or substantially collapsing or moving substantially axially when moving the expansion element(s) through the stent device. In one embodiment, a locking mechanism such as a tether can be provided in the proximal region of the device and connected to the delivery system wire to prevent potential collapse of the body as the expansion element(s) move towards the bifurcation.

[0031] In any of the embodiments disclosed herein, one or more of the expansion elements may be configured to be selectively expandable. For example, without limitation, one or more of the expansion elements can have a removable sheath configured to hold or maintain each expansion element in a collapsed state or a pre-expanded state. The removable sheath can be configured to be peeled off from the expansion element or otherwise removed. The expansion element can be configured to self-expand when the removable sheath is removed. In some embodiments, the removable sheath can be coupled to a wire, such as a hollow wire, that can be used to at least pull out the removable sheath from the expansion element and / or the body. In some embodiments, the removable sheath can be made from a perforated plastic shrink wrap. In some embodiments, the removable sheath can be configured to be removed from the expansion element by pulling out a wire coupled to the removable sheath and / or a wire coupled to the expansion element with respect to the expansion element. In some embodiments, the wire coupled to the expansion element can be configured to have sufficient rigidity or not buckle when the wire coupled to the removable sheath is pulled out with respect to the expansion element.

[0032] FIG. 8 shows another embodiment of a system 300 for treating an aortic-iliac occlusive lesion and other pathologies at the aortic bifurcation, showing a branched stent device 120 in which a second limb portion 126 of the stent device 120 is in a crimped or collapsed state. In any of the embodiments disclosed herein, any component, feature, or other detail of the system 300 can be in any combination with a component, feature, or detail of the system 300 or its method of use disclosed herein, but is not limited to, and can have any of the components, features, or other details of any other embodiment of the system disclosed herein, including embodiments of the systems 100, 200, or their methods of use disclosed herein, and can be used according to any of the steps of any other method embodiment disclosed herein. Similarly, without limitation, any component, feature, step, or other detail of any of the embodiments of other systems or methods disclosed herein, including the systems 100, 200, or their methods of use, can have any of the components, features, steps, or other details of any embodiment of the system 300 or its method of use in any combination.

[0033] In some embodiments, the system 300 can include a delivery catheter 302 having a distal tip 304 and any of the other features of any of the other embodiments of delivery catheters disclosed herein or used for deployment of branched stents. In some embodiments, the stent device 120 can be partially or fully expanded (or substantially fully expanded) by pulling or moving one or more, two or more, or three or more expansion elements through the stent device 120. In some embodiments, the stent device 120 can be partially or fully expanded (or substantially fully expanded) by pulling or moving an expansion element having a plurality of portions (e.g., two or more, or three or more) with increasing diameter longitudinally through the stent device 120. In any of the embodiments disclosed herein, as shown in FIG. 8, the expansion element 320 can be positioned proximal to the distal tip 302 of the delivery catheter. The expansion element can be positioned adjacent to the proximal end portion of the distal tip in any of the embodiments disclosed herein. The expansion element 320 can be used to expand the second limb portion 126 of the stent device 120. The expansion element 320 can be coupled to a wire 322. The wire 322 can be solid or hollow and sized and configured to pass over a guide wire. The expansion element 320 can be self-expanding and can be supported in a crushed or reduced size state by a removable sheath 328. The removable sheath 328 can be coupled to a wire 330 that can be a hollow wire configured to pass over the wire 322.

[0034] As described above, the expansion element 320 can be coupled to a wire 322 that can be accessed through a second puncture side (e.g., but not limited to, at a second femoral puncture site, e.g., at the contralateral common iliac artery). By withdrawing the wire 322 through the body portion 122 and the second limb portion 126 (e.g., through the second puncture site), the expansion element 320 can be moved through the body portion 122 into the second limb portion 124 of the stent device 120 and positioned at the distal end portion of the second limb portion 126 of the stent device 120. Thereafter, a removable sheath 328 can be removed from the expansion element 320 such that the expansion element 320 can self-expand into a second state of the expansion element 320, in which the expansion element 320 has an increased size compared to a first state of the expansion element (i.e., when the expansion element is constrained by the removable sheath). FIG. 9 shows the expansion element 320 after moving the expansion element 320 into the second limb portion 126 of the stent device 126 and expanding the expansion element 320 into the second state by removing the removable sheath 328. The removable sheath 328 can be removed from the expansion element 320 and the body by pulling out a wire 330 coupled to the removable sheath 328. Thereafter, the expansion element 320 can be moved through the second limb 126 of the stent device 120 by pulling out the wire 322 coupled to the expansion element 320 through the second puncture site. In any embodiment herein, the second limb portion 126 of the stent device 120 can be partially, fully, or substantially fully expanded by the expansion element 320. Thereafter, an expansion balloon or other expansion device can be advanced upward through the second limb portion 126 of the stent 120 through the second puncture site to further expand the second limb portion 126.

[0035] In some embodiments, the expansion element can be made 100% larger (i.e., doubled in size), or approximately 100% larger, in a radial direction perpendicular to the central axis of the expansion element when the expansion element is in the second state compared to when it is in the first state. In some embodiments, the expansion element can be made 50% larger, or approximately 50% to 200% larger, or approximately 200% larger, in the radial direction when the expansion element is in the second state compared to when it is in the first state. Or, compared to when the expansion element is in the first state, when the expansion element is in the second state, it can be made 75% or approximately 75% to 150% or approximately 150% larger in the radial direction, or any value or range of values within the above ranges.

[0036] Other details: In any of the embodiments disclosed herein, the stent device 120 can be a non-branching stent, and the expansion element can be used to partially, fully, or substantially fully expand all or a portion of the non-branching stent.

[0037] In any of the embodiments disclosed herein, one or more, two or more, three or more expansion elements can be pre-loaded into the stent, or adjacent to the stent, within the delivery system, or otherwise coupled to the delivery system. For example, but not limited to, in any of the embodiments disclosed herein, the expansion element can be positioned at least partially within the second limb portion of the stent (e.g., adjacent to the bifurcation of the stent) when the stent is crimped onto the delivery catheter. In any of the embodiments disclosed herein, the expansion element can be positioned at least partially within the body portion of the stent when the stent is crimped onto the delivery catheter.

[0038] In any of the embodiments disclosed herein, any portion of the stent (including the embodiments of stent 120 disclosed herein) can be self-expanding. For example, without limitation, in some embodiments, the body portion 122, the first limb portion 124, and / or the second limb portion 126 can be self-expanding, while the remaining portion(s) of the body portion 122, the first limb portion 124, and the second limb portion 126 can be configured as balloon-expandable or otherwise mechanically expandable. For example, without limitation, in some embodiments, the body portion 122 and the first limb portion 124 of any of the embodiments disclosed herein can be self-expanding, while the second limb portion 126 is balloon-expandable. Alternatively, the body portion 122 of any of the embodiments disclosed herein can be self-expanding, while the first limb portion 124 and the second limb portion are balloon-expandable. Any of the self-expanding portions can be fixed within an outer sheath and can be fixed in a collapsed state or otherwise using a removable sheath.

[0039] In any of the embodiments disclosed herein, the stent device 120 or any portion of the stent device 120, the expansion device (e.g., a balloon), and / or the expansion element 140 or other embodiments of the expansion elements disclosed herein can have radiopaque markers, radiopaque coatings, or other features that improve visibility under fluoroscopy. Further, in any of the embodiments disclosed herein, the expansion element can have a PTFE cover or coating or can be made of PTFE.

[0040] In any of the embodiments disclosed herein, the stent can have one or more branched limbs, limb extensions, or otherwise, in addition to the first limb portion and the second limb portion disclosed herein, or can have an opening for receiving a branched limb therethrough, such as for a renal artery, lumbar artery, etc.

[0041] In any of the embodiments disclosed herein, a portion of the stent (such as the distal portion of the body portion 122 of the stent 120) can be removably coupled or retained to a portion of the delivery catheter to prevent (e.g., prevent) at least axial migration and / or crushing of the stent while the expansion element is moving through the stent. A removable suture or other selectively removable fastening element can be coupled, for example, but not limited to, the distal end portion (i.e., the end portion closest to the heart) to prevent (e.g., prevent) at least axial migration and / or crushing of the stent while the expansion element is moving through the stent. In some embodiments, a proximal stent can be used to tether or secure the distal end portion of the stent 120 to the patient's vasculature.

[0042] Some embodiments of a delivery system for a balloon-expandable branched stent graft can utilize an introducer for accessing the vasculature. In some embodiments, the main stem and the ipsilateral limb of the stent graft can be attached to an expandable inner core of the delivery catheter (the balloon-expandable inner core is attached within the lumens of the main stem and the ipsilateral limb of the stent graft). The delivery catheter having the stent graft can be advanced through the introducer. As described, the distal end of the delivery catheter can include an atraumatic tip for advancing the system through the introducer and anatomical structures. A main handle of the delivery catheter can be configured for docking with the introducer.

[0043] The above-described system and method use a single expansion element 140 (referred to as a "bead"). In a modified embodiment, two or more beads can be used. In such a configuration, one bead can open or partially expand the body and the ipsilateral limb, and a second bead can be used to open or partially expand the contralateral limb. In such a configuration, the balloon catheter can then be advanced into the body and the ipsilateral limb to fully open these portions. With this configuration, a further reduction in the initial profile of the delivery catheter would be possible. In a modified embodiment, two or more beads of different maximum diameters and / or shapes can be used to open the second limb portion 126 (or other portion of the stent). For example, by using a first smaller overall diameter bead, a portion of the stent can be initially expanded, and then by using a second larger overall diameter bead, a portion of the stent can be further expanded.

[0044] In some embodiments, the system 100 can have certain advantageous features such as a lower profile, improved accuracy, and increased radial strength.

[0045] In some embodiments, self-expanding beads can be used to eliminate one or more expansion balloons. In any of the embodiments disclosed herein, the beads can be self-expanding beads that can be achieved in several ways such as a self-expanding form, an open cell polyurethane foam, a flexible nitinol membrane, a wire cage structure, a metal mesh cage, or a variant thereof. Some embodiments can have a tube on the contralateral limb, which can have the advantage of maintaining the lumen of the limb. The bead locking mechanism can be achieved in any of several different ways such as heat shrink coverage or a suture held in place with a wire lock.

[0046] Another conceptual variation that may be included in embodiments of any of the methods disclosed herein is to incorporate a crossover lumen, such that the contralateral wire is cannulated from the same side and constricted from the opposite side, whereby in some embodiments, a track for the delivery of beads can be provided by the physician re-cannulating into the bifurcation from outside the same side of the patient and out from the opposite side of the patient. In some embodiments, the beads can be replaced with a balloon assembly that can be attached to a luer post exiting the opposite side of the patient.

[0047] Certain embodiments of the present disclosure are further illustrated in FIGS. 10-27. Beginning with FIG. 10, the bifurcated vessel 1000 has one or more occlusions 1008, 110, and 1011 in the lumens of the aorta 1002 and the branch arteries 1004, 1006. The occlusions result in effectively reduced lumen sizes 1014, 1016, and 1018 in the aorta and the branch arteries as compared to the non-occluded regions 1012, 1020, and 1022, respectively.

[0048] To address this condition, the exemplary system and method shown in FIGS. 11 and 12 include a contralateral guidewire (CW) 1100 that is delivered into the aorta 1002 through the ipsilateral limb 1004. The CW 1100 is captured by a snare 1104 located at the end of a snare wire 1102 that is inserted through the contralateral limb 1006. The snare wire 1102 is then pulled distally to move the CW 1100 into the contralateral limb 1006 and to move the delivery system 1108 into the aorta 1002. The delivery system can be positioned entirely or only partially within the occluded region 1014 of the aorta 1002.

[0049] The remaining FIGS. 13 - 27 are depicted without occlusion, but it is understood that occlusion may be present in the main lumen, the branch lumen, or both lumens. Next, as shown in FIGS. 13, 14, and 15, the delivery system 1108 provides a branched device 1300 (stent or stent graft) seated on the branch such that the ipsilateral limb 1140 is at the first vascular branch and the contralateral limb 1130 is at the second branch, and the body 1160 is positioned within the main vascular lumen. Advantageously, the expansion element (e.g., beads) 1200 is pre - loaded onto the ipsilateral limb 1140 of the device in the pre - deployment state and configured to move over the CW 1100 to effect an expanded 1302 contralateral limb. Of course, the beads 1200 may also expand the ipsilateral limb 1140 in a similar manner before entering the contralateral limb. The contralateral limb expansion may be partial or complete with respect to the vascular branch lumen. The expansion element may be pre - loaded on the outside of the ipsilateral limb, on the inside at the proximal end, at or near the device branch.

[0050] Also, as shown, the delivery system guide wire (GW) 1110 is positioned within the device 1300 and extends out from the body 1160 together with the delivery device tip 1112. As described in the present disclosure, the expansion element may be self - expanding. For that purpose, FIG. 15 illustrates the expansion element 1200 positioned on the contralateral limb, where the expansion element 1200 has an increased diameter relative to the initial pre - loaded state of the expansion element 1200, resulting in a larger contralateral limb expansion 1302.

[0051] Alternatively, the expansion element 1200 may be pre-loaded at or near the proximal end of the body of the device 1300, as shown in FIG. 16. Here, the CW and GW are locked together via a locking mechanism 1320. The locking mechanism can include the GW lumen and the CW lumen, and the CW is locked in the lumen with a lock wire that releasably holds the CW. The CW may include raised, tapered, or otherwise modified features to ensure a secure lock within the lumen. As shown in FIG. 17, the expansion element 1200 moves the CW 1100 longitudinally and ultimately out of the contralateral limb 1130 to expand the contralateral limb 1130. Again, the expansion element 1200 may similarly expand the body 1160 of the device 1300.

[0052] Following partial expansion of the contralateral limb 1130, as depicted in FIG. 18, the balloon 1330 is directed into the limb 1130 along the CW 1100 in the direction 1332. Of course, the balloon may be inserted from the ipsilateral limb, as depicted in FIG. 21, when the devices and methodologies of FIGS. 13 - 15 are employed. Inflating the balloon as shown in FIG. 18 results in complete expansion of the contralateral limb 1302 and an increase in the final vascular diameter. The balloon 1330 can be of essentially any shape or size suitable for fully expanding the limb and body. Thus, the length of the balloon can span the entire contralateral limb 1130 or the total length of the device (both the contralateral limb and the body). Further, the balloon 1330 can include one or more cross-sectional sizes along the length of the balloon 1330. As a non-limiting example, the balloon can be a stepped balloon. For instance, FIG. 20 illustrates a balloon spanning the length of the device and having a larger cross-section in the proximal region such that when inflated, both the body and the contralateral limb are expanded (1304 and 1302).

[0053] It is desirable for the expansion element to cross the device with minimal impedance. Thus, the expansion element can be encapsulated in a low-friction lumen such as PTFE. Further, the lengths of CW1100 and the expansion element 1200 can be encapsulated in the lumen 1250 as depicted in FIG. 22. This feature is generally applicable to all exemplary embodiments including those presented in FIGS. 13 - 15.

[0054] In exemplary systems and methods such as those shown in FIGS. 23 and 24, multiple expansion elements can be used. Here, a first expansion element 1200 and a second expansion element 1400 are pre-loaded in a delivery system at the proximal end of the device 1300. The first expansion element 1200 tracks on CW1100 and the second expansion element 1400 tracks on GW1110. Both wires are secured at the locking mechanism 1320. The relative positioning of the expansion elements 1200, 1400 can vary. Further, one or both can be disposed inside the device and the shapes can be independent or complementary to allow for a lower profile. Further, the order of translation can be different and the expansion elements 1200 and 1400 can move at different relative times in directions 1350 and 1360 respectively.

[0055] When the contralateral limb 1130 is expanded, an expansion balloon 1500 can be inserted into the ipsilateral limb 1140 in direction 1402 as shown in FIG. 25. Similar to the contralateral expansion balloon, the ipsilateral balloon 1500 can take on any shape and length desired to expand the ipsilateral limb, the body, or both as shown in FIGS. 26 and 27. In particular, the balloon 1500 can be a stepped balloon that expands the body 1410 and the ipsilateral limb 1420 of the device when inflated.

[0056] Following the expansion of the body and limbs of the device 1300, the delivery system is removed leaving the branching device in place, thereby improving the effective diameter of the main blood vessel lumen and branches.

[0057] FIG. 28 shows an embodiment of a stent system 2000 that includes a stent 2002 (which may be a covered stent) or at least a portion of the stent 2002, and a stent deployment system 2004 used to deploy the stent 2002 or at least a portion of the stent 2002. FIG. 28 shows a stent device 2002 positioned at the aortic bifurcation of a patient's vasculature.

[0058] In any embodiment, the system 2000 can be used to treat diseased vasculature in the body, including, but not limited to, aortic-iliac occlusive lesions and other pathologies in aortic bifurcations, iliac bifurcations, and other branched and unbranched arteries and blood vessels. Thus, while specific embodiments are described as treating aortic bifurcations, any embodiment of the systems, methods, and devices disclosed herein can be configured or can be configured to be used for the treatment of any branched and unbranched vasculature in the body. Optionally, but not necessarily, some embodiments of the stent 2002 can have a unibody design to avoid the complexity typically present in modular or multi-part devices. Some embodiments of the methods disclosed herein include deploying a covered branched stent device at an aortic bifurcation, where the stent is mechanically expandable (e.g., balloon-expandable), self-expandable, or a hybrid mechanically expandable self-expandable device, and some portions of the stent device (e.g., the body portion, the first branch portion, and / or the second branch portion) are mechanically expandable, and other portions of the stent device (e.g., the body portion, the first branch portion, and / or the second branch portion that are not mechanically expandable) are self-expandable.

[0059] Any embodiment of the stent 2002 can have any of the components, features, or other details of any of the embodiments of the branched stents disclosed herein, in any combination with any of the components, features, and / or other details of the stent 2002. Any embodiment of the stent deployment system 2004 can have any of the components, features, or other details of any of the embodiments of the stent deployment systems disclosed herein, in any combination with any of the components, features, and / or other details of the stent deployment system 2004.

[0060] Figures 29A - 29D show one embodiment of the deployment of at least a portion of an embodiment of the stent 2002 at the bifurcation, and the expansion of the first branched portion 2012 and the second branched portion 2014 of the stent 2002. Referring to FIGS. 28 - 29D, some embodiments of the stent device 2002 can have a body portion 2010 configured to extend within the aorta, as shown in FIG. 28, a first downwardly extending limb portion 2012 configured to extend within a first iliac artery (e.g., the ipsilateral or contralateral artery or limb), and a second downwardly extending limb portion 2014 (also referred to herein as the contralateral limb) configured to extend within a second iliac artery (e.g., the other of the ipsilateral and contralateral arteries or limbs).

[0061] The figures show an aneurysmal aortic bifurcation, but the use of the embodiments disclosed herein is not limited to use for the treatment of abdominal aortic aneurysms. Embodiments of the devices disclosed herein can be used to treat a wide range of diseases and conditions of the aorta and aortic bifurcations, including but not limited to aortic iliac occlusive disease (AIOD) as well as other aneurysmal, embolic, and occlusive aortic pathologies. Some embodiments of the stent device 2002 disclosed herein can have the advantage of having a lower profile than some variations of conventional self - expanding stent devices, which can be advantageous when treating certain pathologies such as a closed or partially closed aorta.

[0062] Any embodiment of the stent device 2002 disclosed herein can be an uncovered mechanical expansion type (e.g., balloon expansion type) stent of a unibody structure or other one-piece configuration, or a covered mechanical expansion type (e.g., balloon expansion type) stent. Before deployment, the body portion 2010, the first downwardly extending leg portion 2012, and the second downwardly extending leg portion 2014 are joined together. In some embodiments, the body portion 2010, the first downwardly extending leg portion 2012, and the second downwardly extending leg portion 2014 can be integrally formed. In some embodiments, the body portion 2010, the first downwardly extending leg portion 2012, and the second downwardly extending leg portion 2014 can be formed separately and joined together. In some embodiments, the body portion 2010 and the first downwardly extending leg portion 2012 can be integrally formed, and the second downwardly extending leg portion 2014 can be formed separately and joined to the body portion 2010 and the first downwardly extending leg portion 2012.

[0063] The frame 2014 of the stent 2002 can have any desired or suitable shape or configuration and can be made of laser-cut tubing, wire, or can be made by other known or later-developed techniques and materials. In any embodiment, the frame 2014 of the stent device 2002 can be made from any suitable material, including stainless steel, cobalt chromium, or any other suitable metal alloy or other material. In any embodiment, the graft can be made from any suitable material for the graft, including polyester, polyester / spandex, expanded polytetrafluoroethylene (ePTFE), or any other suitable or acceptable material. Some embodiments of the stent device 2002 can include a balloon-expandable branched stent structure that forms an inverted “Y” shape similar to a unibody stent graft structure. In such an embodiment, the body portion 2010 of the expanded configuration can have an outer diameter and an inner diameter that are larger than the downwardly extending leg portions 2012, 2014.

[0064] Using some embodiments of the system 2000, diseased branched blood vessels that can have one or more aneurysms, occlusions, etc. in the aorta and / or branched arteries can be treated. Referring to FIGS. 28 - 29D, in any embodiment disclosed herein, the delivery device 2004 can have an expandable balloon 2020 that can be pre-loaded onto the stent 2002 and configured to expand across the bifurcation. For example, without limitation, in some embodiments, the expandable balloon 2020 can be configured to extend through all or a portion of the first branched portion 2012 of the stent 2002, past the bifurcation in the patient's vasculature and / or in the stent 2002, and through all or a portion of the second branched portion 2014 of the stent 2002.

[0065] In some embodiments, the expandable balloon 2020 can be made of a flexible material configured to bend around the branch in the stent 2002 when the expandable balloon 2020 is in the deflated state and when the expandable balloon 2020 is in the inflated state. In some embodiments, the expandable balloon 2020 can be configured to be biased to bend around the branch of the stent 2002 (also illustrated in FIGS. 30-32B), at least when the expandable balloon 2020 is in the expanded state. For example, without limitation, in some embodiments, the expandable balloon 2020 can have a longer length along the side surface of the expandable balloon 2020 positioned further away from the center of the bending radius of the expandable balloon 2020 and / or further away from the branch. In some embodiments, the surface of the expandable balloon 2020 positioned further away from the center of the bending radius of the expandable balloon 2020 and / or further away from the branch can have corrugations to enable the expandable balloon 2020 to maintain a desired angle of bending for the branch when the expandable balloon 2020 is expanded. In some embodiments, the surface of the expandable balloon 2020 positioned further away from the center of the bending radius of the expandable balloon 2020 and / or further away from the branch can be more flexible than other portions so that the expandable balloon 2020 maintains a desired angle of bending for the branch when the expandable balloon 2020 is expanded. Some embodiments of the expandable balloon 2020 can have any combination of the above features, and all such combinations are specifically contemplated herein as if expressly recited herein. In any of the embodiments disclosed herein, the balloon 2020 can be pre-loaded onto the stent 2002.

[0066] As shown in FIG. 28, in some embodiments, the inner shaft 2038 can extend through the expandable balloon 2020. A contralateral guide wire 2040 can extend through the first branch portion 2012 and the second branch portion 2014 to assist in positioning the second branch portion 2014 in a second branch (e.g., a contralateral branch) of the patient's vasculature. In some embodiments, the guide wire 2040 can be delivered into the aorta through the ipsilateral limb and captured by a snare located at the end of a snare wire inserted through the contralateral limb. The snare wire can then be pulled distally to move the guide wire 2040 to the contralateral limb.

[0067] FIG. 29A shows one embodiment of deploying the stent 2002 from the sheath 2026. However, the outer catheter sheath 2026 is not essential to the system 2000. For a stent 2002 as shown in FIG. 29A, the body of the stent 2002 is positioned in the patient's aorta, the first branch portion 2012 of the stent 2002 is positioned in a first branch of the patient's vasculature, and the second branch portion 2014 of the stent 2002 is positioned in a second branch of the patient's vasculature, and is already positioned at the bifurcation of the patient's vasculature. The balloon or at least a portion of the balloon 2020 extends through all or a portion of the first branch portion 2012 of the stent 2002, past the bifurcation in the patient's vasculature and / or the bifurcation in the stent 2002, and through all or a portion of the second branch portion 2014 of the stent 2002. FIG. 29C shows the stent 2002 before the balloon 2020 is expanded. FIG. 29D shows the stent 2002 after the balloon 2020 has been expanded or at least partially expanded such that the first branch portion 2012 of the balloon 2020 and the second branch portion 2014 of the stent 2002 are expanded by the balloon 2020.

[0068] In some embodiments, balloon 2020 can be configured to expand only the first branch portion 2012 and the second branch portion 2014 of stent 2002. In some embodiments, balloon 2020 can be configured to extend into the body portion 2010 of stent 2002 to expand the first branch portion 2012 and the second branch portion 2014 of stent 2002 and, simultaneously or substantially simultaneously, expand the body portion 2010 of stent 2002. In some embodiments, referring to FIG. 30, a second balloon 3500 can be positioned on a limb or body portion 3100 of stent device 3000 and configured to expand simultaneously or substantially simultaneously with a first balloon 3400, or after the first balloon 3400 is expanded, or before the first balloon 3400 is expanded. Thereafter, the second balloon 3500 can be collapsed and withdrawn through a first branch 3200 of the patient's vasculature or via a second branch 3300 of the patient's vasculature. In some embodiments, as shown in FIGS. 31A and 31B, a first balloon 3400 can extend through a first branch portion 3200 of stent device 3000 into the body portion 3100 of the stent device, and a second balloon 3500 can be positioned on a second branch portion 3300 of stent device 3000. The first balloon 3400 can be a stepped balloon, as shown in FIG. 31B, such that the first balloon 3400 expands the body 3100 and the first branch 3200. Thus, in combination with the expanded second balloon 3500, the entire stent device 3000 is expanded.

[0069] In some embodiments, the second balloon 3500 extending through the first branch portion 3200 and the second branch portion 3300 of the stent device 3000, if present, may be more flexible than the first balloon 3400 extending through the body portion of the stent device 3000. In the exemplary embodiments shown in FIGS. 32A and 32B, the second balloon 3500 expands the first branch 3200 and the second branch 3300, while the first balloon 3400 expands the body 3100 of the stent device 3000. FIG. 33 is an exemplary embodiment of a delivery system 4000 for inflating the first balloon 4120 and the second balloon 4220 via the first inflation port 4140 and the second inflation port 4240, respectively. The first balloon 4120 is connected to and positioned with the outer shaft 4100, and the second balloon 4220 is connected to and positioned with the inner shaft 4200. The inner shaft 4200 is slidably received within the outer shaft 4100 and can have a closed end 4300. The second balloon 4220 can have an inflation port 4160 for expanding the balloon 4220 with inflation material. Although not shown, the first balloon will also have a port for the inflation material.

[0070] In some embodiments of the system 2000, the stent 2002 can be configured to coil in a compressed configuration around the inner core of the delivery catheter 2022. Some embodiments of the catheter 2022 can be advanced through a puncture site in the first common iliac artery through an introducer, through a bifurcation of the aorta, or through any puncture site, or can open to any part of the patient's vasculature. The contralateral wire 2040 can be withdrawn through a second puncture site in the second of the common iliac arteries. In some embodiments, the sheath 2026 can be withdrawn through the first puncture site to expose the stent device 2002, and then the stent device 2002 can be moved toward the bifurcation to withdraw the first branch portion 2012 into the first common iliac artery (e.g., but not limited to, the ipsilateral common iliac artery), and the second limb portion 2014 can be moved or withdrawn into the second common iliac artery (e.g., but not limited to, the contralateral common iliac artery). The stent device 2002 can still be in a contracted or low-profile state while the stent is positioned in the patient's vasculature. In some embodiments, the stent 2002 can be withdrawn toward the aortic bifurcation such that the bifurcation portion of the stent 2002 contacts the aortic bifurcation to seat the stent 2002 in the aortic bifurcation. Then, the body portion 2010 and the first branch portion 2012 can be expanded with an expansion balloon or other mechanically expandable device, or if the stent is a hybrid stent, the body portion and / or the first branch portion 2012 can be self-expanded.

[0071] FIG. 33 shows another embodiment of the stent deployment system. Referring to FIG. 33, the inflation lumens for each of two or more expansion balloons can be coaxially positioned. This can substantially reduce the profile of the device and simplify the delivery procedure. For example, without limitation, a first balloon (e.g., balloon 1) can be coupled to a first shaft (e.g., an outer shaft), and a second balloon (e.g., balloon 2) can be coupled to a second shaft (e.g., an inner shaft). The outer shaft can be positioned over and around the outer surface of the inner shaft such that the outer shaft is coaxial or substantially coaxial with the inner shaft. In some embodiments, a first balloon can be used to expand a first branched portion of the stent, and a second balloon can be used to expand a second branched portion of the stent or the body portion of the stent.

[0072] Certain embodiments of the invention have been described, but these embodiments are presented by way of example only and are not intended to limit the scope of the disclosure. In fact, the novel methods and systems described herein may be embodied in a variety of other forms. Further, various omissions, substitutions, and changes in the systems and methods described herein may be made without departing from the spirit of the disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure. Accordingly, the scope of the invention is defined only by reference to the appended claims.

[0073] Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example are understood to be applicable, unless mutually incompatible, to any other aspect, embodiment, or example described in this section or elsewhere in this specification. All features disclosed in this specification (including any appended claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. This protection is not limited to the details of any of the foregoing embodiments. This protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any appended claims, abstract, and drawings), or any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0074] Furthermore, specific features described in the context of separate implementations of this disclosure can also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation can also be implemented separately in multiple implementations, or in any suitable partial combination. Additionally, although features may be described as acting in a particular combination, in some cases, one or more features from the claimed combination can be deleted from the combination, and the combination can be claimed as a sub-combination or a variant of a sub-combination.

[0075] Furthermore, the operations may be depicted in the drawings or described in the specification in a particular order, but such operations need not be performed in the particular order shown or sequentially to achieve the desired result, nor is it necessary that all operations be performed. Other operations not depicted or described may be incorporated into the exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the operations described. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will understand that in some embodiments, the actual steps taken in the processes illustrated and / or disclosed may differ from those shown in the figures. Depending on the embodiment, certain ones of the steps described above may be deleted, and others may be added. Additionally, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of the various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described are generally integrated together in a single product or packaged in multiple products.

[0076] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages can be achieved by any particular embodiment. Thus, for example, those skilled in the art will recognize that the invention may be embodied or practiced in a manner that achieves one advantage or a group of advantages taught herein without necessarily achieving other advantages that may be taught or suggested herein.

[0077] Conditional phrases such as "can", "could", "might", or "may", unless otherwise specified or understood differently within the context in which they are used, generally are intended to convey that while a particular embodiment includes a particular feature, element, or step, other embodiments do not. Thus, such conditional phrases generally are not intended to imply that a feature, element, and / or step is necessary for one or more embodiments in any way, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or steps are included in or are to be performed in any particular embodiment, whether or not there is user input or guidance.

[0078] Unless otherwise specified, conjunctive phrases such as the phrase "at least one of X, Y, and Z" generally are understood in the context in which they are used as being used to convey that an item, term, etc. can be any one of X, Y, or Z. Thus, such conjunctive phrases generally are not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0079] Terms of degree such as "about", "approximately", "generally", and "substantially" as used herein still represent a value, quantity, or characteristic that performs the desired function or achieves the desired result and is close to the recited value, quantity, or characteristic. For example, the terms "about", "approximately", "generally", and "substantially" can refer to a quantity within a range of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited quantity. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to a value, quantity, or characteristic that deviates from exact parallelism by 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree or less. The ranges disclosed herein also include any and all overlaps, subranges, and combinations thereof, as well as any specific value within those ranges. Phrases such as "at most", "at least", "greater than", "less than", "between" include the recited numbers. Numbers and values preceded by terms such as "about" or "approximately" as used herein include the recited numbers. For example, "about 7 mm" includes "7 mm", and numbers and ranges preceded by terms such as "about" or "approximately" should be interpreted as disclosing the numbers, values, and ranges disclosed in this specification and / or the claims, whether or not such terms are present before the numbers or values, so as to support claiming such numbers, values, and ranges, including the disclosure of a range such as "about 2 times to about 5 times" as being within the range of "2 times to 5 times". The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere in this specification, but can be defined by the claims, as presented in this section or elsewhere in this specification, or as presented in the future. The phrases of the claims should be construed broadly based on the phrases employed in the claims and not limited to the examples described in this specification or the examples during the prosecution of this application, and such examples should be construed as non-exclusive.

[0080] Appendix A - Disclosure from U.S. Patent No. 8,808,350 Background Art An introducer catheter or introducer sheath can be used for minimally invasive placement of a catheter into a blood vessel. An introducer catheter sheath typically comprises a tube inserted into a blood vessel and a seal or valve at the proximal end of the tube positioned outside the body. The seal can provide a hemostatic seal against blood loss. A stent or other medical prosthesis is typically passed through the introducer sheath into a blood vessel or body passageway. Thus, the introducer sheath provides continuous access for delivery of a stent or other medical prosthesis and protects the inner wall of the blood vessel or body passageway from damage and provides a hemostatic seal against blood loss when advancing the stent or other prosthesis through the body passageway.

[0081] There are situations where a catheter requires substantial manipulation within a blood vessel. For example, placement of a stent or stent graft may require that the delivery catheter be accurately positioned axially and rotationally at a specific location within the blood vessel. In addition, deployment of a stent may require precise operation of the delivery system within the introducer. In these situations, the operator must carefully control the position of both the introducer and the delivery system. There is a need for a delivery system that enables a user or healthcare provider to accurately control the axial position of a stent or prosthesis during deployment.

[0082] Summary of the Invention The embodiments disclosed herein relate to a catheter system for inserting and positioning a diagnostic or therapeutic device within a blood vessel. The system includes an introducer or introducer sheath (also referred to herein as the outer sheath) and at least one delivery catheter. The introducer catheter can be introduced into the bloodstream through a percutaneous puncture site. A docking mechanism can engage the proximal end portion of the introducer catheter assembly with the distal end portion of the delivery catheter and can prevent axial movement between the introducer catheter assembly and the delivery catheter assembly.

[0083] The catheter system can include an introducer catheter and a delivery catheter, and the introducer catheter can include an outer sheath and a seal having an adjustable hemostatic valve connected to the proximal portion of the outer sheath. The introducer catheter and the delivery catheter can be configured such that the delivery catheter can engage removably with the introducer catheter so as to prevent substantial axial movement between the introducer catheter and the delivery catheter when the delivery catheter is engaged with the introducer catheter and to enable the catheter to be axially manipulated as a single unit.

[0084] Alternatively, the delivery catheter and the introducer catheter can be configured such that when the delivery catheter is engaged with the introducer catheter, the inner core of the delivery catheter can rotate relative to the introducer catheter and the introducer sheath (also referred to herein as the outer sheath). Alternatively, the delivery catheter can be configured such that the inner core of the delivery catheter can be locked or substantially prevented from rotational movement relative to the outer sheath of the introducer catheter and / or relative to the introducer catheter. Also disclosed is a method of placing a stent or medical prosthesis intravascularly, wherein the stent or medical prosthesis is passed through an introducer sheath and the proximal end of the introducer catheter physically engages or removably docks with the distal end portion of the delivery catheter to prevent substantial axial movement between the introducer sheath and the delivery catheter.

[0085] Some intravascular prostheses, including stents, grafts, stent grafts, and dissociation treatment devices (all such intravascular prostheses are collectively referred to herein as stents (plural)), may require accurate placement in both the axial and rotational directions. For example, stents or stent grafts having fenestrations require accurate placement of those fenestrations relative to the branch vessels. The catheter systems disclosed herein can be configured to allow rotation of the delivery catheter relative to the introducer sheath, and thus relative to the stent. In some embodiments, friction that can impede the freedom of rotation of the delivery catheter can be further reduced by lining the inner surface of the introducer sheath and / or the tubular sheath of the deployment catheter with a low friction coating such as polytetrafluoroethylene, silicone, hydrophobic silicone, or other lubricious material, or by applying a hydrophilic coating to the outer surface of the inner core, or by constraining the sheath of the delivery catheter. The lubricant can be wiped onto the target surface.

[0086] Thus, while the delivery catheter is rotating within the introducer sheath, the introducer sheath can remain rotationally stationary or fixed. This protects the delivery catheter and the stent from being damaged, torqued, or stressed during the rotational operation of the delivery catheter and the stent, and also prevents damage or stress to the blood vessel wall due to rotation of the delivery catheter or the stent.

[0087] In addition, the delivery catheter can be configured to allow a user or healthcare provider to selectively control or prevent rotational movement of the delivery catheter and the stent relative to the introducer catheter, or rotational movement of the inner core of the delivery catheter and the stent relative to the outer sheath of the delivery catheter. For example, the delivery catheter can include a threaded hub supported at the proximal end portion of the delivery catheter that is configured to selectively contract or tighten against the outer wall of the inner core of the delivery catheter. By contracting the hub against the inner core, the inner core can be prevented or blocked from rotating relative to the introducer catheter. By loosening the hub relative to the inner core, the freedom of rotation of the inner core or the delivery catheter relative to the introducer sheath can be restored.

[0088] Here, these and other features, aspects, and advantages will be described in connection with specific embodiments with reference to the accompanying drawings. However, the illustrated embodiments are merely examples and are not intended to be limiting. The following is a brief description of the drawings.

[0089] [Brief Description of the Drawings] [FIG. 1A] is a schematic diagram of a catheter system having a docking configuration for physically engaging a catheter with an introducer sheath. [FIG. 1B] is a schematic diagram of the catheter system shown in FIG. 1A, showing the catheter engaged with the introducer sheath. [Fig. 2A]Schematic diagram of another catheter system with a docking configuration for physically engaging a catheter with an introducer sheath. [Fig. 2B]Schematic diagram of the catheter system shown in Fig. 2A, showing the catheter engaged with the introducer sheath. [Fig. 2C]Schematic diagram of the catheter system shown in Fig. 2A, showing a mechanism for disengaging the catheter from the introducer sheath. [Fig. 3A]Schematic diagram of another catheter system with a docking configuration for physically engaging a catheter with an introducer sheath, the catheter system being configured to deliver a stent or a stent graft to a blood vessel. [Fig. 3B]Schematic diagram of the catheter system shown in Fig. 3A, showing the catheter engaged with the introducer sheath. [Fig. 3C]Schematic diagram of the catheter system shown in Fig. 3A, illustrating the axial insertion of a stent into the tubular sheath of the introducer sheath shown in Fig. 3A. [Fig. 3D]Schematic diagram of the catheter system shown in Fig. 3A, illustrating that the stent is deployed after the tubular sheath of the introducer sheath shown in Fig. 3A has been retracted from the stent. [Fig. 4]Perspective view of a catheter system comprising an introducer and a delivery catheter. [Fig. 5]Perspective view of the introducer shown in Fig. 4. [Fig. 6A]First exploded view of the introducer shown in Fig. 5. [Fig. 6B]Second exploded view of the introducer shown in Fig. 5. [Fig. 7]Perspective view of the delivery catheter shown in Fig. 4. [Fig. 8A]First exploded view of the delivery catheter shown in Fig. 7. [Fig. 8B]Second exploded view of the delivery catheter shown in Fig. 7. [FIG. 9] A perspective view of the catheter system shown in FIG. 4, showing the delivery catheter before the docking mechanism of the delivery catheter engages with the docking mechanism of the introducer. [FIG. 10] A perspective view of the catheter system shown in FIG. 4, showing the delivery catheter after the docking mechanism of the delivery catheter engages with the docking mechanism of the introducer. [FIG. 11] An end view of the catheter system shown in FIG. 4. [FIG. 12] A cross-sectional view of the catheter system shown in FIG. 4 taken along line 12-12 of FIG. 11. [FIG. 13] An enlarged cross-sectional view of the catheter system shown in FIG. 4, showing a close-up of 13-13 of FIG. 12. [FIG. 14] An enlarged cross-sectional view of the catheter system shown in FIG. 4, showing a close-up of 14-14 of FIG. 13. [FIG. 15] A cross-sectional view of the catheter system shown in FIG. 4 taken along line 15-15 of FIG. 11. [FIG. 16] A perspective view of a catheter system having a delivery catheter assembly docked to an introducer catheter assembly. [FIG. 17] A perspective view of the delivery catheter assembly of FIG. 16. [FIG. 18] A top view of the delivery catheter assembly of FIG. 16. [FIG. 19] A side view of the delivery catheter assembly of FIG. 16. [FIG. 20] A perspective view of the delivery catheter assembly of FIG. 16, illustrating that the sheath is in a fully retracted position relative to the inner core member. [FIG. 21] A side view of the delivery catheter of FIG. 16, showing that the handle member and the inner core are in a first position before deployment relative to the housing shaft of the delivery catheter. [FIG. 22] A side view of the delivery catheter of FIG. 16, showing that the handle member and the inner core are in a second partial deployment position relative to the housing shaft of the delivery catheter. [Figure 23] A side view of the delivery catheter of FIG. 16, showing the handle member and the inner core in a third fully advanced position on the housing shaft of the delivery catheter. [Figure 24] A perspective view of the inner core engagement assembly and the inner core, showing the inner core in a first disengaged position relative to the inner core engagement assembly. Other components of the delivery catheter are excluded from this figure for clarity. [Figure 25] A cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing the inner core in a first disengaged position relative to the inner core engagement assembly. [Figure 26] A perspective view of the inner core engagement assembly and the inner core as in FIG. 24, showing the inner core in a second partial engagement position relative to the inner core engagement assembly. [Figure 27] A side view of the inner core engagement assembly and the inner core as in FIG. 26, showing the inner core in a second partial engagement position relative to the inner core engagement assembly. [Figure 27A] A cross-sectional view of a portion of the delivery catheter taken along line 27A-27A of FIG. 29, showing one or more components of the delivery catheter in a first position. [Figure 27B] A cross-sectional view of a portion of the delivery catheter taken along line 27A-27A of FIG. 29, showing one or more components of the delivery catheter in a second position. [Figure 28] A top view of the inner core engagement assembly and the inner core as in FIG. 26, showing the inner core in a second partial engagement position relative to the inner core engagement assembly. [Figure 29] A cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing the inner core in a second partial engagement position relative to the inner core engagement assembly. [Figure 30] A perspective view of the inner core engagement assembly and the inner core as in FIG. 24, showing the inner core in a third engagement position relative to the inner core engagement assembly. [Figure 31] A side view of the inner core engagement assembly and the inner core as in Figure 30, showing that the inner core is in the third engagement position relative to the inner core engagement assembly. [Figure 32] A top view of the inner core engagement assembly and the inner core as in Figure 30, showing that the inner core is in the third engagement position relative to the inner core engagement assembly. [Figure 33] A cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing that the inner core is in the third engagement position relative to the inner core engagement assembly. [Figure 34] A cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing that the inner core is in the disengaged position relative to the inner core engagement assembly. [Figure 35] A cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing that the inner core is in the engaged position relative to the inner core engagement assembly. [Figure 36] An illustrative view of a prosthesis partially deployed by a delivery catheter. [Figure 37] A side view of an exemplary stent that can be deployed using the delivery catheter illustrated in Figure 36. [Figure 38] A schematic side view of a catheter system having an introducer catheter assembly, showing that a stent is loaded within the outer sheath of the introducer catheter. [Figure 39] A schematic side view of a catheter system having a deployment catheter assembly showing support of a stent therein, and a branched vascular wire assembly loaded in a delivery catheter. [Figure 40] A cross-sectional view of the branched vascular wire assembly taken along line 40-40 of Figure 39. [Figure 41] An enlarged schematic view of portion 41-41 of the branched vascular wire assembly of Figure 39.

[0090] Mode for Carrying Out the Invention Here, the embodiments for carrying out the following invention are directed to certain specific embodiments. In this specification, the drawings are referred to, and like parts are designated by like numerals throughout the specification and drawings. Described below are various embodiments of a catheter system that can comprise an introducer sheath and a docking configuration. The catheter systems disclosed herein can be used in diagnostic or therapeutic procedures such as, but not limited to, endovascular prosthesis deployment procedures.

[0091] FIG. 1A is a schematic view of a catheter system 10 comprising a docking configuration for physically engaging a catheter 20 with an introducer 12. FIG. 1B is a schematic view of the catheter system 10 shown in FIG. 1A, showing the catheter 20 engaged with the introducer 12. The catheter 20 or any catheter disclosed herein can be a diagnostic or therapeutic catheter, or any other suitable catheter. The introducer 12 can comprise a tubular sheath 14, a seal 16, and a female docking mechanism 18. The first seal 16 can be a rubber seal, an interference or precision fit between adjacent components, an adjustable hemostatic valve, or any other suitable seal component or feature.

[0092] The catheter of the catheter 20 has a shaft 24 and a male docking mechanism 22. As illustrated in FIG. 1B, the catheter 20 is inserted into the introducer 12, and the female docking mechanism 18 engages the male docking mechanism 22. The docking mechanism prevents the introducer 12 and the catheter 20 from moving axially relative to each other when the docking mechanism is engaged. Additionally, the catheter system 10 is configured such that the catheter 20 can rotate within the introducer 12 even when the catheter 20 is docked with the introducer 12.

[0093] The introducer 12 includes a tubular introducer sheath 14 and a seal 16 connected to the proximal end of the introducer sheath 14 (which may also be a rubber seal, interference fit or precision fit, adjustable hemostatic valve, or any other suitable seal component or feature). The overall design of the sheath 14 and the seal 16 can be similar to that of a commercially available introducer or any other introducer design currently known or later developed. The catheter 20 has an outer profile (cross-sectional profile) sized and / or configured to pass through the introducer sheath 14. The proximal ends of the catheter 20 and the introducer sheath 14 are configured to engage with each other either permanently or removably and to allow rotation of the catheter 20 within the introducer sheath 14 while substantially restricting axial movement of the catheter 20 relative to the introducer sheath 14.

[0094] With respect to sizing the introducer lumen relative to the size of the outer sheath (including the stent graft), in one configuration, they are the same size and the introducer acts as a sheath when the stent graft is pushed from its initial position within the outer sheath to the lumen of the introducer. In a second configuration, the introducer lumen is larger than the outer diameter of the outer sheath and the two rotate easily relative to each other only as much as is required for rotational alignment. Further, the introducer material can be more flexible than the outer sheath or a flexible material, so that the stent graft can first be loaded into a strong high-strength sheath material, but can be pushed through to a lower-strength, more highly flexible introducer material for the short time necessary to deliver it to the treatment site. Examples of materials that can be used to provide this feature include any type of soft polymer extrusion including nylon, PEBAX, and PE.

[0095] After engagement of the catheter and the introducer, the combined system is operable by a single operator. The catheter system 10 is configured such that the catheter 20 can rotate substantially freely within the introducer sheath 14, which can enable accurate rotational positioning of the catheter within the introducer. After completion of the procedure, the catheter 20 is disengaged from the introducer 12 so that the catheter 20 can be removed from the patient's body. Additionally, the introducer 12 can be repositioned for a second intervention, and a second catheter can be inserted into and engaged with the introducer 12 for additional procedures.

[0096] FIG. 2A is a schematic view of a catheter system 40 having a docking configuration for physically engaging a catheter 50 with an introducer 42. FIG. 2B is a schematic view of the catheter system 40 showing the catheter 50 engaged with the introducer 42. FIG. 2C is a schematic view of the catheter system 40 shown in FIG. 2A, showing a mechanism for disengaging the catheter 50 from the introducer sheath 42.

[0097] In particular, FIG. 2C schematically illustrates that the catheter 50 can be disengaged from the male docking mechanism 52 and the introducer 42 by compressing a lever or tab 56. Thus, as illustrated, the male docking mechanism 52 can be elongate and can comprise a lever 56.

[0098] FIG. 3A is a schematic view of a catheter system 60 having a docking configuration for physically engaging a catheter 70 with an introducer 62, the catheter system 60 being configured to deliver a stent or stent graft 80 to a blood vessel.

[0099] FIG. 3B is a schematic view of the catheter system 60 shown in FIG. 3A, showing the catheter 70 engaged with the introducer 62. FIG. 3C is a schematic view of the catheter system 60 shown in FIG. 3A, illustrating the axial insertion of a stent or stent graft 80 into the tubular sheath 64 of the introducer 62 shown in FIG. 3A. FIG. 3D is a schematic view of the catheter system 60 shown in FIG. 3A, illustrating the stent 80 being deployed after the tubular sheath 64 of the introducer 62 shown in FIG. 3A has been retracted from the stent 80.

[0100] Self-expanding stents or stent grafts are typically retained within a deployment sheath within a delivery catheter. The deployment sheath can protect the stent or stent graft and the vessel wall from damage during insertion and can hold the stent or stent graft in a low-profile configuration that prevents crushing during delivery. By removing the deployment sheath and allowing the stent or stent graft to expand radially against the vessel wall, the stent or stent graft can be deployed at the desired location within the vessel. To pass such a delivery catheter into the desired vessel, the catheter system can be configured such that the inner diameter of the introducer sheath is larger than the outer diameter of the deployment sheath. Clinicians prefer the low profile of the introducer sheath to minimize damage to the vessel and to allow access to small vessels.

[0101] A cartridge system has been developed that can transfer a stent or stent graft from a delivery sheath into an introducer sheath and pass the stent or stent graft through the introducer sheath to a target location. In such a cartridge system, the introducer sheath effectively acts as a deployment sheath. The transfer eliminates the need for a second sheath and minimizes the profile of the system in the blood vessel. The docking configuration provides a secure engagement between the delivery catheter and the introducer sheath before transferring the stent or stent graft into the introducer sheath. This prevents potential user errors during transfer and further converts the delivery catheter and introducer sheath into a single-user system.

[0102] As illustrated in FIGS. 3A-3D, a catheter system 60 is used to transfer and deploy a stent or stent graft 80 into a blood vessel (not shown). As illustrated herein, the introducer 62 includes a tubular sheath 64 that is inserted into a patient's body. The proximal end 62a of the introducer 62 can be sized and / or configured to receive the deployment sheath 74 of the catheter 70. The introducer sheath can also have a seal 66 (referred to herein as a first seal) and a female docking mechanism 68, similar to any of the embodiments of the seals, hemostatic valves, and / or docking mechanisms described above. The seal 66 can be an annular rubber seal (as illustrated), an interference or precision fit between adjacent components, an adjustable hemostatic valve, or any other suitable seal component or feature. The stent delivery catheter 70 can include an inner core 78, a pocket 82 that can accommodate the collapsed stent 80, a deployment sheath 74 that can hold the collapsed stent 80, and a catheter tip 76.

[0103] As illustrated in FIG. 3B, the catheter 70 can be inserted into the introducer 62 when the docking mechanisms 68 and 72 are engaged. In some embodiments (not illustrated), the deployment sheath 74 of the delivery catheter 70 can be sized and configured to be received within the proximally located end portion 62a of the introducer sheath having a larger diameter and to extend within the distal tubular sheath 64 of the introducer 62. Alternatively, the deployment sheath 74 of the delivery catheter 70 can be sized and configured to be received within the proximally located end portion 62a of the introducer sheath having a larger diameter rather than within the distal tubular sheath 64 of the introducer 62. In some embodiments, as illustrated in FIGS. 3C and 3D, the deployment sheath 74 and the tubular sheath 64 can be sized and configured such that when the deployment sheath 74 advances through the proximally located end portion 62a of the introducer sheath, the similar size or shape of the distal tubular sheath 64 can prevent the deployment sheath 74 from advancing through the distal tubular sheath 64. The inner diameter and / or outer diameter of the deployment sheath 74 and the tubular sheath 64 can be substantially the same.

[0104] As illustrated in FIG. 3C, the inner core 78 of the catheter 70 can be pushed, thereby transferring the stent 80 from the deployment sheath 74 into the tubular sheath 64 of the introducer 62. The stent 80 can be advanced until the catheter tip 76 reaches the distal end of the tubular sheath 64. In this configuration, the catheter / introducer system effectively becomes a single unit deployment catheter. Thus, the tubular sheath 64 can function as a deployment sheath. The stent 80 can be advanced to the target location in the blood vessel in a collapsed configuration within the protective introducer 62 without increasing the profile of the delivery system. If the delivery catheter is passed through a conventional introducer sheath, the sheath of the introducer would have to be of a larger diameter than the deployment sheath of the delivery catheter to accommodate the stent and the deployment sheath. 2) Other advantages mentioned: In the described configuration, the device can be rotated after it has been introduced into the introducer but before it is deployed, and further, the device can be accurately positioned as a result of the low friction between the introducer and the outer sheath. If devices with expanded diameters of 25 and 28 mm are to be used, the same (one size) introducer sheath can be used for the delivery of either and both devices. Only when a larger 34 mm diameter device with a larger compressed cross-sectional profile is to be delivered is it necessary to use a larger introducer. By creating a single unitary structure in which the introducer and the delivery catheter mechanically engage and can be held with one hand, a single user can operate the entire system with both hands, i.e., hold the core stationary with one hand and operate the sheath retraction mechanism with the other hand.

[0105] As is known in the art, a delivery catheter having a loaded stent graft typically has lower trackability and pushability than an introducer sheath supported by a dilator. This is due to the stent graft changing the local stiffness of the catheter. This can lead to torsion of the delivery catheter during insertion. By first placing an introducer sheath with a dilator, a conduit for placing the stent graft is established. Torsion of the delivery system passing to and fro through the sheath is highly unlikely.

[0106] Figure 4 is a perspective view of another catheter system 100 comprising an introducer catheter 102 (also referred to as an introducer) and a delivery catheter 104. The delivery catheter 104 can be configured for the delivery of an intravascular prosthesis or for any other suitable use. Thus, the catheter and introducer embodiments disclosed herein can be configured for any suitable purpose, and the introducer embodiments disclosed herein can be configured to accommodate any suitable catheter design.

[0107] FIG. 5 is a perspective view of the introducer 102 of the catheter system 100 shown in FIG. 4. FIGS. 6A and 6B are a first exploded assembly view and a second exploded assembly view of the introducer 102 shown in FIG. 5. Referring to FIGS. 4-6, the introducer 102 can have a body 106, a hub portion 108 that can be threadably engaged, an introducer sheath 110, and a threaded cap 111 configured to threadably engage with the threaded end portion of the body 106.

[0108] In some embodiments, a first tube 107 can be supported by the body 106 to provide an orifice or access port into the body 106. The first tube 107 can be used to flush the introducer 102 with saline or other suitable substance at any stage, such as before advancement of an intraluminal prosthesis through the introducer 102 or before other procedures in which the introducer can be used. The first tube 107 can support any suitable medical connector and / or valve on the distal end portion of the first tube 107.

[0109] The introducer sheath 110 can have an elongate portion 110a that extends to any predetermined or desired length. Similar to the introducer 12 of the catheter system 10 described above and discussed in more detail below, the introducer sheath 110 can be configured to constrain or regulate an intraluminal prosthesis advanced within the introducer sheath 110 by the introducer sheath 110. In this configuration, the inner diameter and / or outer diameter of the introducer sheath 110 can be substantially the same as or similar to the inner diameter and / or outer diameter of the sheath outside the delivery catheter that engages the introducer 102. The elongate portion 110a can define any suitable cross-sectional shape, such as (as illustrated) circular in cross-section or, without limitation, triangular, square, hexagonal, octagonal, or polygonal.

[0110] Furthermore, as most clearly shown in FIG. 6A, the introducer sheath 110 can have a flared end portion 110b configured to abut against the front surface 106a of the body 106. Referring to FIG. 6A, the elongate portion 110a of the introducer sheath 110 can pass through an opening formed in the cap 111 such that the flared portion 110b of the introducer sheath 110 can engage and / or overlap with the inner surface of the cap 111. In this configuration, the cap 111 that supports the introducer sheath 110 can engage threadably with the body 106 such that the introducer sheath 110 is supported by the body 106.

[0111] In addition, referring to FIGS. 6A and 6B, a tubular support or tubular spacer 109 can be inserted over the elongate portion 110a of the introducer sheath 110 and positioned substantially adjacent to the flared portion 110b. The tubular spacer 109 can improve the fit and thus the seal between the outer surface of the introducer sheath 110 and the cap 111. The tubular spacer 109 can also provide additional support to the introducer sheath 110.

[0112] FIG. 7 is a perspective view of the delivery catheter 104 of an embodiment of the catheter system 100 shown in FIG. 4.

[0113] FIGS. 8A and 8B are a first exploded view and a second exploded view of the delivery catheter 104 shown in FIG. 7.

[0114] FIG. 9 is a perspective view of the catheter system 100 shown in FIG. 4, showing the delivery catheter 104 before the docking mechanism of the delivery catheter 104 is engaged with the docking mechanism of the introducer 102.

[0115] FIG. 10 is a perspective view of the catheter system 100 shown in FIG. 4, showing the delivery catheter 104 after the docking mechanism of the delivery catheter 104 is engaged with the docking mechanism of the introducer 102.

[0116] FIG. 11 is an end view of the catheter system shown in FIG. 4, with the delivery catheter 104 engaged with the introducer 102. FIG. 12 is a cross-sectional view of an embodiment of the catheter system 100 shown in FIG. 4 taken along line 12-12 of FIG. 11. FIG. 13 is an enlarged cross-sectional view of the catheter system 100 shown in FIG. 4 defined by curve 13-13 of FIG. 12. FIG. 14 is an enlarged cross-sectional view of an embodiment of the catheter system shown in FIG. 4 defined by curve 14-14 of FIG. 13. Finally, FIG. 15 is a cross-sectional view of the catheter system shown in FIG. 4 taken along line 15-15 of FIG. 11.

[0117] As most clearly shown in FIGS. 12 and 15, the hub portion 108 of the introducer 102 can have a docking mechanism or flange 112, or be configured to removably receive or engage the delivery catheter 104. In some embodiments, as in the illustrated embodiment, the docking mechanism 112 of the introducer 102 can be configured as a female receiver configured to receive a male docking member of the catheter 104, as described below. The hub portion 108 can include one or more tabs 114 configured to improve the user's grip on the hub portion 108 and the ability to rotate the hub portion 108 relative to the body 106.

[0118] Referring to FIGS. 12, 13, and 15, some embodiments of the seal portion of the introducer 102 will be described. As described above, the hub portion 108 can be configured to be threadably engageable with the body 106. The body 108 can define an inner annular surface 116 that can be angled (such that it is not perpendicular to the axial centerline of the catheter system 100). The surface 116 can be angled at approximately 75 degrees with respect to the axial centerline of the catheter system 100, or can be angled between approximately 65 degrees or less and approximately 80 degrees or more with respect to the axial centerline of the catheter system 100. The surface 116 can be substantially perpendicular to the axial centerline of the catheter system 100.

[0119] Similarly, the hub portion 108 can define an inner annular surface 118 that can be angled such that it is not perpendicular to the axial centerline of the catheter system 100. The surface 118 of the hub portion 108 can be angled at approximately 75 degrees with respect to the axial centerline of the catheter system 100 in a direction opposite to the direction of the angle defined by the surface 116 of the body 106, or can be angled between approximately 65 degrees or less and approximately 80 degrees or more with respect to the axial centerline of the catheter system 100. In some embodiments, as in the illustrated embodiment, the shape and angular orientation of the surface 118 of the hub portion 108 can be a substantially mirror image of the shape and angular orientation of the surface 116 of the body 106. The surface 118 can be substantially perpendicular to the axial centerline of the catheter system 100.

[0120] The annular seal member 120 can be supported by the introducer 102 and positioned between the surface 116 of the body 106 and the surface 118 of the hub portion 108. The seal member 120 can be formed from an elastic material such as silicone, rubber, or any other suitable material. The seal member 120 can be configured to axially move the surface 118 of the hub portion 108 toward the surface 116 of the body 106 when the hub portion 108 is screwed onto the body 106, thereby compressing or squeezing the seal member 120. The relative angle between the surface 116 of the body 106 and the surface 118 of the hub portion 108 presses the seal member 120 against the outer sheath 122 of the delivery catheter 104, or other components of the delivery catheter 104 engaged with the introducer 102, thereby creating an adjustable seal between the outer sheath 122 of the delivery catheter 104 that can project distally from the end portion of the delivery catheter 104 and the introducer 102. The level of the seal can be adjusted by fastening or relaxing the hub portion 108 of the introducer 102 relative to the body 106 of the introducer 102. The introducer 102 can be configured to provide a seal for a device having a profile in the range of 1Fr to 20Fr.

[0121] Alternatively, in some embodiments, any of the seals or seal portions described herein can be a press fit or precision fit between an adjacent component such as the outer sheath 122 and one or more inner surfaces of the body 106 or the hub portion 108 of the introducer 102. In some embodiments, any of the seals or seal portions described herein can be a press fit or precision fit between the inner core 154 and one or more inner surfaces of the body 140 or the hub portion 142 of the catheter 104.

[0122] As shown in FIGS. 7, 8A, and 8B, some embodiments of the delivery catheter 104 can include a body 140 and a hub portion 142 that can engage the body 140 in a threaded manner. Some embodiments of the delivery catheter 104 can also have an outer sheath 122 supported by the body 140. In particular, the outer sheath 122 can be removably supported by the body 140 using a cap 123 that is threadably supported by the body 140. Further, the outer sheath 122 can have an elongate portion 122a that extends to any predetermined or desired length.

[0123] As described above, the inner diameter and / or outer diameter of the outer sheath 122 of the delivery catheter 104 can be approximately the same as or similar to the inner diameter and / or outer diameter of the introducer sheath 110. The elongate portion 122a can have a circular cross-section (as illustrated), or can define any suitable cross-sectional shape, such as, but not limited to, triangular, square, hexagonal, octagonal, or polygonal.

[0124] The outer sheath 122 can have a flared end portion 122b that can be configured to abut the front surface 140a of the body 140. Referring to FIG. 8A, the elongate portion 122a of the outer sheath 122 can pass through an opening formed in the cap 123 such that the flared portion 122b of the outer sheath 122 can engage and / or overlap the inner surface of the cap 123. In this configuration, the cap 123 that supports the outer sheath 122 can engage the body 140 in a threaded manner as described above such that the outer sheath 122 is supported by the body 140.

[0125] In addition, referring to FIGS. 8A and 8B, the tubular support or tubular spacer 125 can be inserted over the elongate portion 122a of the outer sheath 122 and positioned substantially adjacent to the flared portion 122b of the outer sheath 122. The tubular spacer 125 can fit and thus improve the seal between the outer surface of the outer sheath 122 and the cap 123. The tubular spacer 125 can also provide additional support to the outer sheath 122.

[0126] Similar to the hub portion 108 of the introducer 102, the hub portion 142 of the delivery catheter 104 can be configured to engage threadably with the body 140 of the delivery catheter 104. The body 140 can define an inner annular surface 146 that can be angled such that it is not perpendicular to the axial centerline of the catheter system 100. The surface 146 can be angled at approximately 75 degrees with respect to the axial centerline of the catheter system 100, or can be angled at approximately 80 degrees or more to approximately 65 degrees or less with respect to the axial centerline of the catheter system 100. The surface 146 can be substantially perpendicular to the axial centerline of the catheter system 100.

[0127] In some embodiments, a second tube 141 can be supported by the body 140 to provide an orifice or access port into the body 140. The second tube 141 can be used to flush the delivery catheter 104 with saline or other suitable substance at any stage, such as prior to advancement of an endoprosthesis through the delivery catheter 104 and / or introducer 102, or prior to other procedures in which the delivery catheter can be used. The second tube 141 can support any suitable medical connector and / or valve on the distal end of the second tube 141.

[0128] Similarly, the hub portion 142 can define an inner annular surface 148 that can be angled such that it is not perpendicular to the axial centerline of the catheter system 100. The surface 148 of the hub portion 142 can be angled at approximately 75 degrees with respect to the axial centerline of the catheter system 100, or at an angle between approximately 65 degrees or less and approximately 80 degrees or more with respect to the axial centerline of the catheter system 100, in a direction opposite to the direction of the angle defined by the surface 146 of the body 140. The surface 148 can be substantially perpendicular to the axial centerline of the catheter system 100.

[0129] Similar to that of the introducer, in some embodiments, a seal or seal portion including the annular seal member 150 can be supported by the delivery catheter 104 and positioned between the surface 146 of the body 140 and the surface 148 of the hub portion 142. The seal member 150 can be formed from an elastic material such as silicone, rubber, or any other suitable material. The seal member 150 can be configured such that when the hub portion 142 is screwed onto the body 140, it axially moves the surface 148 of the hub portion 142 toward the surface 146 of the body 140, thereby compressing or squeezing the seal member 150. The relative angle between the surface 146 of the body 140 and the surface 148 of the hub portion 142 can press the seal member 150 against the inner core 154 of the delivery catheter 104, thereby creating an adjustable seal between the inner core 154 and the outer sheath 122 of the delivery catheter 104.

[0130] The level of the seal can be adjusted by fastening or relaxing the hub portion 142 of the delivery catheter 104 relative to the body 140 of the delivery catheter 104. Additionally, the freedom of rotation of the inner core 154 of the delivery catheter 104 can be blocked or prevented by fastening the seal member 150 as described above. Thus, the force exerted by the seal member 150 on the inner core 154 can be adjusted such that the inner core 154 and / or other components are allowed to rotate relative to the body 140 and hub portion 142 of the delivery catheter 104. As illustrated in FIG. 4, an end portion or cap 158 can be supported at the proximal end of the inner core 154 to facilitate the user's ability to axially slide and / or rotate the inner core 154 relative to the body 140 and hub portion 142 of the delivery catheter 104. The cap 158 can have wings or tabs formed on the cap 158 to increase the torque or rotational force that can be exerted on the inner core 154. Alternatively, the seal or seal portion within the catheter 104 can be formed from an interference fit or precision fit between adjacent components such as, but not limited to, the inner core 154 and one or more inner surfaces of the body 140 or the hub portion 142 of the catheter 104.

[0131] The inner core 154 can have a band marking or other marking 155 near the distal end of the inner core 154. The marking 155 can be sized, positioned, and configured to provide a visual indication to the medical practitioner regarding the location of the end portion 154a of the inner core 154 and / or the location of the catheter tip 162 when the inner core 154 is advancing into or being withdrawn from the introducer 102.

[0132] In some embodiments, as most clearly illustrated in FIGS. 12 and 13, an additional seal member 160 may be supported by the body 106 of the introducer 102 to provide an additional seal between the outer sheath 122 of the delivery catheter 104 and the introducer 102. The seal 160 can be a flap-type seal formed from a piece of conical elastic material, such as rubber, having one or more slits therein to allow the distal tip 162 and the outer sheath 122 to pass therethrough. In some embodiments, the flange 161 that is supported may be supported within the body 106 and positioned behind the seal 160 to support the seal 160 and maintain its position so that the seal 160 does not invert when the delivery catheter 104 is removed from the introducer 102. The distal tip 162 can be formed from a flexible material, such as rubber, and can be configured to be non-invasive to prevent damage to the patient's vasculature when advancing the catheter 104 through the patient's vasculature.

[0133] As described above, in some embodiments, as in the illustrated embodiments, the docking mechanism 112 of the introducer 102 can be configured to receive a male docking member or a portion of the catheter 104. In particular, referring to FIGS. 7, 8A, and 8B, one or more deflectable tabs 170 can be supported by the body 140 of the catheter 104. The tab 170 can be deflected by pressing on the pad 172 or applying a radially inward force to the pad 172, causing the end of the tab 170 to move radially inward toward the axial centerline of the body 104. By deflecting the tab 170 inward, the body 140 of the catheter 104 can be axially moved to engage with the hub portion 108 of the introducer 102. When the body 140 of the catheter 104 is axially moved to engage with the hub portion 108 of the introducer 102, the tab 170 can be automatically deflected inward. When the body 140 of the catheter 104 is axially moved to engage with the hub portion 108 of the introducer 102 such that the body 140 abuts the hub portion 108 of the introducer, the tab 170 is released, thereby removably locking the body 140 of the catheter 104 to the hub portion 108 of the introducer 102.

[0134] In this configuration, the catheter 104 can be axially engaged with or locked to the introducer 102 such that a user can axially manipulate the introducer 102 and the catheter 104 simultaneously. Additionally, in some embodiments, in this configuration, as discussed above, the catheter system 100 can be configured to rotate at least the inner core 154 of the catheter 104 relative to the body 140 of the catheter 104 and the introducer 102.

[0135] In some embodiments, as shown in FIGS. 7, 8A, and 8B, the inner core 154 has a central tube or wire 176 configured to support a stent, such as stent 157 illustrated in FIGS. 7 and 12-14. Additionally, one or more beads or tabs 174 may be formed on or supported by the central tube or wire 176. The tab 174 may be configured to enhance axial support or connection between the inner core 154 and the endoluminal prosthesis supported by the central tube 176 when the prosthesis is supported in a collapsed configuration by the central tube 176. The catheter 104 may be configured such that the opening passes through the distal tip 162, the central tube 176, and the inner core 154. The opening may be configured to advance at least the distal tip 162, the central tube 176, and the inner core 154 over a guide wire positioned within the patient's vasculature, as described in U.S. Patent Application No. 12 / 101,863, filed Apr. 11, 2008 (entitled: BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS), which is hereby incorporated by reference in its entirety as if fully set forth herein.

[0136] Additionally, in some embodiments (not illustrated), the tab 174 can be sized, spaced, or otherwise configured to provide axial support to a plurality of individual stent segments. For example, without limitation, a plurality of independent or tethered stent segments can be positioned within a tubular or bifurcated graft, and the stent graft can be positioned relative to the tab 174 such that the tab 174 is positioned between the stent segments. This configuration can reduce the overall diameter of the outer sheath 122, introducer sheath 110, and other components of the catheter system, can enhance the axial support provided to the endoluminal prosthesis by the tab 174, and can allow for a more uniform distribution of the support force between the tab 174 and the endoluminal prosthesis. The tab 174 can be sized, spaced, and otherwise configured to be positioned adjacent to links, bends, loops, and / or other connectors formed in a tubular or bifurcated stent, including stent embodiments disclosed in U.S. Patent No. 6,077,296 entitled ENDOLUMINAL VASCULAR PROSTHESIS, which patent is hereby incorporated by reference as if fully set forth herein.

[0137] Referring to FIGS. 13 - 15, when the deployment catheter 104 is engaged with the introducer 102, the outer sheath 122 of the deployment catheter 104 can be advanced into the axial opening within the introducer 102. The outer sheath 122 can be sized and / or configured such that the distal end portion 122c of the outer sheath 122 can terminate within the introducer 102 in front of or proximal to the proximal end or flared portion 110b of the introducer sheath 110. Although not essential, the introducer 102 can have a constricted portion 113 formed in the body 106 of the introducer. In some embodiments, as most clearly shown in FIG. 14, the catheter system 100 can be configured such that the distal end 122c of the outer sheath 122 terminates in front of or substantially adjacent to the constricted portion 113 of the body 106 of the introducer 102.

[0138] In some embodiments (not illustrated), the distal end portion 122c of the outer sheath 122 can be positioned near or substantially adjacent to the proximal end portion or the flared portion 110b of the introducer sheath 110, regardless of whether the catheter 104 has a constricted portion 113. The inner diameter of the constricted portion 113 can be substantially the same as the inner diameter of the outer sheath 122 and / or the inner diameter of the introducer sheath 110.

[0139] Accordingly, the outer sheath 122 of the catheter 104 and the introducer sheath 110 can be configured to provide a lumen having a generally uniform cross-sectional size through the catheter system through which an intraluminal prosthesis can be advanced. The lumen through the catheter system 100 through which an intraluminal prosthesis can be advanced can be substantially continuous such that the prosthesis can be advanced through the catheter system 100 without being obstructed or snagged by any component or feature of the catheter system 100 when advancing the catheter system 100. The lumen can be substantially continuous and can have a short gap of approximately 1 mm to approximately 3 mm in the lumen, such as adjacent to the distal end of the outer sheath 122 of the catheter 104 and / or adjacent to the proximal end or flared end 110b of the introducer sheath 110. For example, in some embodiments, a short gap can be formed adjacent to the distal end of the outer sheath 122 of the catheter 104 and / or adjacent to the proximal end or flared end 110b of the introducer sheath 110 when some components including the catheter system 100 engage with other components including the catheter system 100 in a screwable manner. Further, in some embodiments, one or more surfaces of other components including the catheter 104 or the introducer 102, in addition to the outer sheath 122 and the introducer sheath 110, such as the constricted portion 113 of the body 106 of the introducer 102 as discussed above, can form a portion of the lumen through the catheter system 100.

[0140] As described above, the outer sheath 122 can restrain or regulate the endovascular prosthesis supported by the central tube 176. In this configuration, when advancing the catheter tip 162, the central core 154, and the endovascular prosthesis (such as, but not limited to, the stent 157 illustrated in FIGS. 7 and 12 - 14) through the outer sheath 122, the outer sheath 122 can regulate the endovascular prosthesis and prevent the endovascular prosthesis from expanding before reaching the target position within the patient's vasculature. Additionally, when advancing the catheter tip 162, the central core 154, and the endovascular prosthesis beyond the distal end 122c of the outer sheath 122, the catheter system 100, the constricted portion 113, and then the introducer sheath 110 can be configured such that the introducer sheath 110 can radially regulate the endovascular prosthesis when advancing the endovascular prosthesis through the introducer sheath 110.

[0141] The endovascular prosthesis or stent 157 can be a tubular stent, a branched stent, or any other desirable stent, graft, stent - graft, or endovascular prosthesis (collectively referred to herein as a stent or stents), including, but not limited to, any of the stents or grafts disclosed in U.S. Patent Application No. 12 / 101,863, which is incorporated herein by reference as if fully set forth herein and as referenced above. Thus, the catheter system 100 or the catheter 104 can be configured to deploy any suitable or desired one or more stents.

[0142] Thus, in this configuration, the endovascular prosthesis can be transferred from the outer sheath 122 to the introducer sheath 110. Using the introducer sheath 110 as a constraining body in this configuration can make it possible to reduce the outer diameter of the introducer sheath 110, thereby minimizing trauma to the patient's vasculature and assisting in the deployment of the endovascular prosthesis.

[0143] Many embodiments of the docking mechanism and catheter system are described in connection with FIGS. 1-15. It will be apparent to those skilled in the art that there are many potential embodiments of the permanent or removable docking mechanism that may be suitable for medical use and are contemplated herein. For example, in some embodiments, a nut-screw combination can be used to connect the introducer sheath and the catheter. As another example, a bayonet-style locking mechanism such as that used for camera lenses can also be used. In some embodiments, additional embodiments can be formed by combining any of the components or features of the catheters disclosed herein, or some embodiments of other catheters available in the field, all of which are contemplated herein.

[0144] The catheter system disclosed in FIG. 16 has an introducer catheter assembly, also referred to herein as an introducer catheter, and a delivery catheter assembly, also referred to herein as an introducer catheter.

[0145] The catheter systems disclosed herein can be used, but are not limited to, diagnostic or therapeutic procedures such as endovascular prosthetic deployment procedures. It will be apparent to those skilled in the art that the embodiments of the catheter systems disclosed herein can generally be used to deliver artificial organs for supporting body tissues as well as various blood vessels and aneurysms. Examples of such blood vessels that can be treated using the embodiments of the catheter systems disclosed herein include the aorta, aortic aneurysms such as abdominal aortic aneurysms, saphenous vein grafts, vena cava, renal arteries, iliac arteries, femoral arteries, popliteal arteries, carotid arteries, cranial arteries, pulmonary arteries, and the like. Other organs or body tissues that can be treated using some embodiments of the catheter systems disclosed herein include the prostate, biliary tract, esophagus, trachea, fallopian tubes, vas deferens, ureters, lacrimal ducts, and salivary ducts.

[0146] The catheter systems disclosed herein can be configured for deployment of a wide range of endoluminal prostheses, including mechanical expandable stents, self-expandable stents, drug eluting stents, grafts, branched and unbranched stent grafts, fenestrated stent grafts, suprarenal stent extensions, stent segments, anatomical treatment devices, medical prostheses deployable in any suitable region of the body, and any of the stents or prostheses disclosed in U.S. Application No. 12 / 101,863, filed Apr. 11, 2008, U.S. Application No. 12 / 496,446, filed Jul. 1, 2009, U.S. Application No. 12 / 769,506, filed Apr. 28, 2010, and U.S. Patent No. 6,077,296.

[0147] The stent can have an oversized graft having a central portion that is not sutured or otherwise attached to the stent frame. In this configuration, the intermediate portion can be capable of expanding against the inner wall of the blood vessel or passageway to further improve the seal between the graft and the blood vessel wall. Additionally, the stent can have an oversized graft of a highly crushable flexible material (e.g., expanded polytetrafluoroethylene). As a result, when the stent is expanded, the graft can form tight folds in the seal zone to reduce the cross-sectional area of the leak zone between the stent and the blood vessel wall.

[0148] For the sake of brevity, all such stents or prostheses as described above are collectively referred to herein as stents (plural) unless otherwise defined. Thus, the illustrative drawings and the disclosure that follows can describe stents and can show deployment in a particular passageway or region of the body, but any of the embodiments disclosed herein are contemplated to be used, with or without modification, within the capabilities of one of ordinary skill in the art for deployment of any desired prosthesis in any suitable part of the body.

[0149] FIG. 16 is a perspective view of a catheter system 100 having a delivery catheter assembly 104 docked to an introducer catheter assembly 102. FIGS. 17-19 are, respectively, a perspective view, a top view, and a side view of the delivery catheter assembly 104 of FIG. 1. Referring to FIGS. 16-17, the catheter system 100 has a docking configuration in which a proximal end portion of the introducer catheter assembly 102 receives and can dock with a distal end portion 121a (also referred to herein as a housing member or housing shaft) of the body 121 of the delivery catheter assembly 104. The introducer catheter 102 can have an outer sheath 110 (also referred to herein as an introducer sheath) supported by and extending from a distal end portion of the introducer catheter 102. Similarly, the delivery catheter assembly 104 has a tubular sheath 127 (also referred to herein as a delivery catheter sheath) extending from the distal end portion 121a of the housing shaft 121. The sheath 127 can be made of polyetheretherketone (PEEK), or any other suitable material.

[0150] Additional details regarding the features and components of such a docking configuration, as well as other details regarding the catheter system, are disclosed in U.S. Application No. 12 / 101,863, filed Apr. 11, 2008, entitled "BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS," and U.S. Application No. 12 / 496,446, filed Jul. 1, 2009, entitled "CATHETER SYSTEM AND METHODS OF USING SAME," both of which are hereby incorporated by reference as if fully set forth herein. Any of the embodiments of the catheter system, delivery catheter, and introducer catheter disclosed herein can have any of the components, features, materials, or other details of any of the catheter embodiments disclosed in the above applications, and combinations thereof are part of this disclosure.

[0151] One or more stents can be loaded into, supported by, and delivered by embodiments of the catheter system 100 disclosed herein. One or more stents or stents can be loaded into the delivery catheter assembly 104 during the assembly of the delivery catheter assembly 104 or immediately prior to a surgical procedure by compressing the stent around the outer surface of the inner core member 115 of the delivery catheter assembly 104.

[0152] The removable restraint and / or outer sheath of the introducer catheter and / or delivery catheter can hold the stent in a compressed state. In the compressed state, the stent can be held in an axially fixed position relative to the inner core such that axial movement or rotational movement of the inner core results in axial movement and rotational movement of the stent. As contemplated, the inner core can have features such as fins, beads, tabs, or other protrusions to improve the traction or grip between the compressed stent and the inner core or inner core wire. Advance an inner core having a stent compressed around its outer surface through a constriction element in or adjacent to the introducer catheter to compress the stent to approximately the inner diameter of the outer sheath protruding from the introducer catheter.

[0153] The inner core member 115 can have a core wire 117 that forms a portion of the inner core member 115. The atraumatic distal tip 119 can be supported at the distal end portion of the core wire 117. The inner core member 115, the core wire 117, and the distal tip 119 can comprise a continuous lumen configured to receive a guide wire therein so that the inner core member 115, the core wire 117, and the distal tip 119 can be advanced over the guide wire. The stent can be collapsible or compressible around at least a portion of the inner core wire 117 under stent loading conditions.

[0154] As described above, the catheter system can be configured such that the inner core member 115 is axially slidable relative to the outer sheath 110. In this configuration, the stent can be deployed in a target region of a patient's vasculature by retracting the outer sheath 110 relative to the inner core member 115, thereby exposing the stent. In some embodiments where the outer sheath 110 provides a radially restraining body to the stent, exposing the stent allows the self-expanding stent to self-expand against the vessel wall as the outer sheath 110 is retracted.

[0155] As will be described in more detail, some embodiments of the catheter system 100 disclosed herein are configured such that when a user or surgeon operates the delivery catheter assembly 104 slowly with mechanical advantages in a first manner, the stent or a portion of the stent can be slowly and controllably deployed from the delivery catheter assembly 104 using the delivery catheter. Some embodiments of the catheter system disclosed herein are further configured such that when a user or surgeon operates the delivery catheter assembly 104 quickly by directly pulling on the adjustment member in a second manner, the stent or a portion of the stent can be deployed more rapidly from the delivery catheter assembly 104 using the delivery catheter assembly 104.

[0156] The catheter systems disclosed herein can be configured to accommodate any combination of the deployment manners described above. For example, a user or surgeon can first operate the delivery catheter in the first manner to slowly deploy the stent from the delivery catheter assembly 104, and then, once the correct positioning of the partially deployed stent is confirmed, the surgeon can then operate the delivery catheter assembly 104 in the second manner to rapidly deploy the remaining portion of the stent.

[0157] Referring to FIG. 16, the distal end portion 121a of the housing shaft 121 of the delivery catheter assembly 104 is removably and axially supported by a female receiving portion 105 that is supported at the proximal end portion of the introducer catheter 102. The introducer catheter 102 supports an outer sheath 110 at the distal end of the introducer catheter 102, and the outer sheath 110 defines a lumen throughout the outer sheath 110 that is configured to slidably receive an inner core member 115 therein. The inner core member 115 can be slidably advanced through an opening or lumen in the delivery catheter assembly 104, through an opening or lumen in the introducer catheter 102, and through the lumen in the outer sheath 110.

[0158] The delivery catheter assembly 104 has a body or housing shaft 121 having a distal end portion 121a and a proximal end portion 121b. The housing shaft 121 generally encloses a tubular cross-sectional shape and has an external thread 126 along a portion of the housing shaft 121 (referred to as the threaded portion 126).

[0159] The housing shaft 121 supports a slidable handle member 128 that is configured to slide axially along the housing shaft 121 between the distal end portion 121a of the housing shaft 121 and a rotatable adjustment member 130 supported by the housing shaft 121. As described, the delivery catheter assembly 104 is configured such that the handle member 128 can be selectively engaged with the inner core member 115. When in the engaged configuration, movement of the handle member 128 results in simultaneous and equal movement of the inner core member 115. The delivery catheter assembly 104 can be configured to prevent rotation of the handle member 128 relative to the housing shaft 121 and, as a result, relative to the introducer catheter 102 and the outer sheath 110, to prevent inadvertent rotation of the inner core member 115 when the handle member 128 is engaged with the inner core member 115.

[0160] The threaded portion 126 extends along approximately 60% of the length of the housing shaft 121. The threaded portion 126 can extend along approximately 40% to approximately 70% of the length of the housing shaft 121. The threaded portion 126 can be positioned adjacent to the proximal end portion 121b of the housing shaft 121. The length of the threaded portion 126 can be approximately 20% to approximately 200% of the length of the stent deployed by the catheter. For example, when only the proximal end portion of the stent is deployed by rotation of the adjustment member 130, the length of the threaded portion can be approximately 20% to approximately 50% of the length of the stent. Throughout the present disclosure, the term can mean plus or minus 15% of the stated value.

[0161] Preventing rotational movement of the handle member 128 can be achieved in any number of ways. For example, the handle member 128 can have one or more tabs, protrusions, or similar features that project into one or more channels or slots formed in the housing shaft 121. As illustrated in FIG. 16, the housing shaft 121 can have a single slot 134 that extends linearly along a portion of the length of the housing shaft 121, and the slot 134 is configured to receive a tab, projection, or other similar feature supported by the handle member 128 by sliding it into the slot 134.

[0162] The handle member 128 surrounds an inner core engagement assembly 139 supported by the handle member 128. As described, the delivery catheter assembly 104 is configured such that any axial movement of the handle member 128 results in simultaneous axial movement of the inner core member 115 relative to the introducer catheter 102 and the outer sheath 110 when the inner core member 115 is axially engaged with the handle member 128. Pressing on the inner core engagement assembly 139 can release the inner core member 115 from the handle member 128, and as a result, the inner core member 115 can be axially moved relative to the handle member 128. In some configurations, the inner core member 115 can be rotated relative to the handle member 128 even when the inner core member 115 is axially engaged with the handle member 128.

[0163] As described, the rotatable adjustment member 130 is supported by the housing shaft 121. The rotatable adjustment member 130 is threadedly engaged with an outer thread on the threaded portion 126 of the handle member 128. In this configuration, rotating or turning the rotatable adjustment member 130 in one direction causes the rotatable adjustment member 130 to advance along the thread and move axially towards the distal end portion 121a of the housing shaft 121. Rotating or turning the rotatable adjustment member 130 in the opposite second direction causes the rotatable adjustment member 130 to move axially away from the distal end portion 121a of the housing shaft 121 of the delivery catheter assembly 104. As a result of the threaded engagement between the rotatable adjustment member 130 and the housing shaft 121, axial sliding of the rotatable adjustment member 130 relative to the housing shaft 121 can be prevented. Thus, the handle member 128 can slide axially but can be prevented from rotating relative to the housing shaft 121, and the rotatable adjustment member 130 can rotate but can be prevented from sliding axially relative to the housing shaft 121.

[0164] During use, the surgeon can hold the handle member 128 with one hand (e.g., the left hand) and the rotatable adjustment member 130 (initially axially positioned adjacent to the proximal portion 130a of the housing shaft) with the other hand. The surgeon moves the inner core member 115 and engages it with the handle member 128. To retract the outer sheath 110 of the introducer catheter 102 relative to the inner core member 115, the surgeon holds the handle member 128 in a fixed position while axially pulling out the housing shaft 121 of the delivery catheter assembly 104 that is axially fixed to the introducer catheter 102 and the outer sheath 110. When the handle member 128 is held in a fixed position using the inner core engagement (and release) assembly 139 engaged with the inner core member 115, the inner core member 115 is fixedly held when the outer sheath 110 is relatively axially retracted relative to the inner core member 115 fixed to the housing shaft 121. Retracting the housing shaft 121 portion of the delivery catheter assembly 104 can be done by gripping and rotating the rotatable adjustment member 130 or by directly applying a pulling force by retracting the rotatable adjustment member 130 relative to the handle member 128. This step causes the outer sheath 110 to be pulled out relative to the inner core member 115 as desired.

[0165] A slower, gradual withdrawal of the outer sheath 110 relative to the inner core member 115 is achieved since the rotatable adjustment member 130 axially abuts the proximal end 128a of the handle member 128. When the rotatable adjustment member 130 is rotated in a first direction while holding the handle member 128 in a fixed axial position, the housing shaft 121 of the delivery catheter assembly 104, and as a result, the outer sheath 110, slowly, gradually, and controllably retracts or is pulled out. This controlled withdrawal of the outer sheath 110 is typically performed during the initial deployment phase of exposing and deploying the stent, allowing for better control and accuracy when the surgeon positions the stent at the target location.

[0166] In short, in this configuration, the handle member 128 is first positioned on the proximal portion of the housing shaft 121, and the surgeon holds the handle member 128 in a fixed position relative to the patient with one hand while using the other hand to rotate the rotatable adjustment member 130 in a first direction, thereby retracting the housing shaft 121 and the outer sheath 110 relative to the handle member 128 and the inner core member 115, so that the outer sheath 110 can be controllably retracted to expose the stent. When the surgeon is confident that the stent is in the desired position, the surgeon can then grasp the housing shaft 121 and axially retract it relative to the handle member 128, thereby retracting the outer sheath 110 more rapidly relative to the inner core member 115.

[0167] As illustrated in FIGS. 17-19, the delivery catheter assembly 104 can have a selectively engagable locking mechanism positioned on the inner core member 115, such as a lock engagement ring 147. As described in more detail below, the engagement ring 147 can be configured to removably engage the inner core engagement assembly 139. As discussed above, when the inner core member 115 is engaged with the engagement assembly 139, the inner core member 115 is axially locked to the engagement assembly 139 such that axial movement of the handle member 128 results in simultaneous axial movement of the inner core member 115. The inner core member 115 can rotate freely relative to the engagement assembly 139 and the handle member 128 even when in the locked or engaged position. The engagement ring 147 can be adhered to the outer surface of the inner core member 115, integrally formed therewith, or otherwise permanently fixed to the outer surface of the inner core member 115.

[0168] Referring to FIGS. 17-19, some embodiments of the engagement ring 147 can have a tapered surface 149 and an annular channel 152. The tapered surface 149 can improve the ease with which the engagement ring 147 can be advanced into the engagement assembly 139. Additional details regarding these components are described below.

[0169] Figure 20 is a perspective view of the delivery catheter assembly 104 of FIG. 16, illustrating the inner core member 115 in a position fully or substantially fully advanced relative to the delivery catheter assembly 104. In this position, the inner core member 115, the inner core wire 117, and the distal tip 119 are all beyond the end of the sheath 127 of the delivery catheter assembly 104. When the delivery catheter assembly 104 is engaged with the introducer catheter 102, the inner core member 115, the inner core wire 117, and the distal tip 119 can also be advanced relative to the end of the outer sheath 110 such that the stent supported by the inner core member 115 is at least partially and in some cases fully exposed.

[0170] Figures 21 to 23 are side views of the delivery catheter of FIG. 16, showing that the sheath is in a first pre-deployment position, a second partial deployment position, and a third fully retracted position, which are the positions of the housing shaft 121, the handle member 128, and the inner core member 115 of the delivery catheter assembly 104, respectively. The delivery catheter assembly 104 is configured such that the handle member 128 slides along the housing shaft 121 between a first position as illustrated in FIG. 21 and at least a third position as illustrated in FIG. 23. Thus, in this configuration, while the handle member 128 is held stationary, the user or surgeon can retract the housing shaft 121 by sliding the housing shaft 121 relative to the handle member 128. Thus, when the handle member 128 is engaged with the inner core member 115, the surgeon can advance the inner core member 115 very quickly relative to the distal end portion 121a of the housing shaft 121 of the delivery catheter assembly 104 by sliding the handle member 128 towards the distal end portion 121a of the housing shaft 121. Similarly, if the surgeon desires to hold the inner core member 115 and the prosthesis in a fixed position within the patient's vasculature, the surgeon or user can hold the handle member 128 in a fixed position and retract the outer sheath 110 of the introducer catheter 102 relative to the inner core member 115 and the prosthesis, thereby axially sliding or retracting the delivery catheter assembly 104 away from the patient's body to expose the prosthesis.

[0171] The rotatable adjustment member 130 is separable from the handle member 128 such that the adjustment member 130 and the housing shaft 121 can move independently of the handle member 128. The adjustment member 130 includes an internal thread that engages an external thread on the threaded portion 126 of the housing shaft 121. By rotating the adjustment member 130 in a first direction, the adjustment member 130 causes the housing shaft 121 and the sheath to retract axially as the adjustment member 130 rotates while maintaining contact with the handle member 128. The rotation of the adjustment member 130 is used to control the slow retraction speed of the housing shaft 121 or to provide an option of rapid retraction where the axial force applied to the adjustment member is concerned.

[0172] The handle member 128 is selectively engageable with the inner core member 115. FIG. 24 is a perspective view of the inner core engagement assembly 139 and the inner core member 115, showing the inner core member 115 in a first disengaged position relative to the inner core engagement assembly 139, with other components of the delivery catheter excluded from this figure for clarity. FIG. 25 is a cross-sectional view of a portion of the delivery catheter assembly 104 along the axial centerline of the delivery catheter assembly 104, showing the inner core member 115 in a first disengaged position relative to the inner core engagement assembly 139. FIG. 26 is a perspective view of the inner core engagement assembly 139 and the inner core member 115 as in FIG. 24, showing the inner core in a second partial engagement position relative to the inner core engagement assembly.

[0173] Referring to FIGS. 24 - 26, in some embodiments of the delivery catheter assembly 104, the engagement ring 147 is supported by the inner core member 115. The engagement ring 147 has a tapered front surface 149 and a channel or recess 152 formed around the outer surface of the engagement ring 147. The front surface 149 can generally have a frustoconical shape, and the channel 152 can be formed all around the engagement ring 147 that forms a ring groove. The engagement ring 147 is adhered to the inner core member 115, integrally formed with the inner core member 115, otherwise fastened to the inner core member 115, or supported by the inner core member 115 at any desired position along the length of the inner core member 115.

[0174] Referring to FIGS. 24 - 26, the body member 155 of the engagement assembly 139 supports one or more tabs or arms 159 configured to engage the engagement ring 147. The one or more arms 159 can have inward tabs or protrusions 166 supported at the proximal ends 159b of the one or more arms 159. The arms 159 are supported by the body member 155 in a cantilever configuration such that the base portions 159a of the one or more arms 159 are fixed to the body member 155 and the proximal end portions 159b of the one or more arms 159 are not supported. The arms 159 are supported by the body member 155.

[0175] The engagement ring 147 is configured to be received by the inner core engagement assembly 139 by sliding the inner core member 115 in a first (distal) direction (represented by arrow A1 in FIG. 24) until the engagement ring 147 engages the engagement assembly 139. As illustrated in FIG. 26, when moving the inner core member 115 and the engagement ring 147 towards the engagement assembly 139, the tapered front surface 149 of the engagement ring 147 widens the spacing of the tabs or arms 163 as the engagement ring 147 advances into the engagement assembly 139, as illustrated in FIGS. 26-28. With further advancement of the inner core member 115 relative to the handle member 128, when the protruding portion 166 of the arm 159 is axially aligned with the channel 152, the protruding portions 166 of the one or more arms 159 can compress and contract (spring) towards each other within the channel 152 due to the biasing of the one or more arms 159. As illustrated in FIGS. 30-32, the inner core member 115 is axially engaged with the handle member 128 until the user disengages the engagement assembly 139 from the engagement ring 147. The inner core member 115 can rotate freely relative to the handle member 128 even when axially engaged with the handle member 128.

[0176] The engagement assembly 139 is further configured to lift and move the protruding portion 166 of the arm 159 away from the channel 152 of the engagement ring 147 by moving one or more arms 159 radially (as shown in FIG. 27B, spreading them). One or more spread tabs 173 are configured to apply the necessary radial (spreading) force to the body portion 175 or to the arm 159 to lift and move the protruding portion 166 away from the engagement ring 147. The spread tab 173 can have a tapered shape such that the arm 159 deflects outwardly by moving the spread tab 173 in a downward direction relative to one or more arms 159. When the button 180 is depressed, a downward force is applied to the spread tab 173, whereby the arm 159 deflects outwardly, and as a result, the engagement ring 147 is axially released and moves axially away from the engagement assembly 139.

[0177] FIG. 34 is a cross-sectional view of a portion of the delivery catheter along the axial centerline of the delivery catheter, showing the inner core member 115 in a disengaged position relative to the inner core engagement assembly 139.

[0178] FIG. 35 is a cross-sectional view of a portion of the delivery catheter assembly 104 along the axial centerline of the delivery catheter assembly 104, showing the inner core member 115 in an engaged position relative to the inner core engagement assembly 139. As illustrated therein, a biasing mechanism or spring member 184 is supported by the handle member 128 and is configured to bias the button 180, and as a result, the spread tab 175, in a first direction away from the inner core member 115.

[0179] Further, referring to FIGS. 34-35, the handle member 128 has a stop member 198 configured to limit the range of movement of the engagement ring 147 and the inner core member 115 relative to the handle member 128. For example, the first end portion 198a of the stop member 198 is configured to abut against the front surface 149 of the engagement ring 147 when advancing the engagement ring 147 into the handle member 128.

[0180] The stent can be pre-loaded into the introducer catheter assembly or introducer sheath so that it is not necessary to transfer the stent into the catheter assembly or introducer sheath during surgery. The delivery catheter system can have, in one device, some or all of the introducer sheath, inner core, and other features of the delivery catheter disclosed herein. Among such encompassing devices, the inner core can be permanently joined to the handle member 128 so that it is not necessary to configure the delivery catheter to be selectively engageable with the inner core, thereby simplifying assembly and potentially simplifying the surgical procedure. Thus, in some embodiments of this encompassing delivery catheter assembly, the delivery catheter assembly can have all of the components, features, details, or configurations of the embodiments of the catheter system 100 described above, and the inner core engagement assembly 139 and lock engagement ring 147 of the inner core member 115 can be replaced with a non-selectable coupling or other connection between the inner core member 115 and the handle member 128.

[0181] FIG. 36 is an illustrative view of a prosthesis partially deployed by delivery catheter assembly 104. FIG. 37 is a partial side view illustrating a stent that can be deployed with delivery catheter assembly 104. The deployment catheter illustrated in FIG. 36 can be adapted for deployment of any suitable prosthesis and is not limited to deployment of the stent illustrated in FIG. 37. Referring to FIGS. 20, 36, and 37, one or more beads or tabs 174 can be formed on or supported by core wire 117. Tabs 174 can be configured to enhance axial support or connection between inner core wire 117 and stent 214 supported by core wire 117 when the stent is compressed and supported on core wire 117. Additionally, tabs 174 can be sized, spaced, or otherwise configured to provide axial support to a plurality of individual stent segments (not illustrated). For example, a plurality of independent or tethered stent segments can be positioned within a tubular graft or branched graft or otherwise, and the stent can be positioned relative to tabs 174 such that tabs 174 are positioned between stent segments 216 or at vertices, knuckles, or connection points 218 that interconnect struts.

[0182] In the configuration shown, beads or tabs 174 supported by core wire 117 can engage struts 216 or connection points 218 of stent 214 and serve to prevent the stent from slipping axially relative to inner core wire 117 for portions of stent 214 that remain compressed within outer sheath 110. This configuration provides better control over stent 214 during the final stages of deployment of stent 214, for example, when only the end portions of stent 214 remain compressed within outer sheath 110 as illustrated in FIG. 36.

[0183] In addition, by positioning the tab 174 between the strut 216 or the connection point 218, the compressed diameter or cross-sectional profile of the compressed prosthesis, the outer sheath 110, and other components of the catheter system can be reduced. This configuration can also enable a more uniform distribution of the support force among the tab 174, the inner core wire 117, and the stent 214. The tab 174 is sized, spaced, and otherwise configured to be positioned adjacent to links, bends, loops, and / or other connectors formed in a tubular stent or a branched stent, including embodiments of stents disclosed in U.S. Patent No. 6,077,296 entitled ENDOLUMINAL VASCULAR PROSTHESIS, which patent is incorporated herein by reference as if fully set forth herein.

[0184] In any of the catheter system embodiments disclosed herein, the catheter system can be configured as described herein such that the stent can be compressed from a first diameter or size to a second diameter or size when the stent is loaded into the introducer or the introducer sheath. The first diameter or size can be the fully relaxed diameter or the expanded diameter of the stent, or the first diameter or size can be a partially compressed diameter. For example, in some of the embodiments disclosed herein, the stent can be compressed from a first diameter defined or controlled by the sheath of the delivery catheter or by an assembly device surrounding the stent to a second diameter defined or controlled by the introducer sheath. The reduction rate of the stent when advanced within the introducer can be from approximately 50% to approximately 95%, which means that the second diameter can be from approximately 50% to approximately 95% of the first diameter.

[0185] FIG. 38 is a side view of a catheter system 300 having an introducer catheter assembly 302, showing a stent loaded onto the outer sheath of the introducer catheter assembly 302. Only a portion of the delivery catheter 304 is illustrated, and certain features of the introducer catheter assembly 302 are omitted for clarity. The catheter system 300 and / or the introducer catheter assembly 302 can have any of the components, features, materials, or other details of any of the embodiments of the catheter systems or introducer catheter assemblies disclosed herein or incorporated by reference, including U.S. Application No. 12 / 496,446, filed Jul. 1, 2009, entitled "CATHETER SYSTEM AND METHODS OF USING SAME". Further, embodiments of the introducer catheter assembly 302 can be configured to cooperate with any of the embodiments of the delivery catheter assemblies disclosed herein or incorporated by reference.

[0186] Referring to FIG. 38, the introducer catheter assembly 302 can have a body portion 306 and an outer sheath 310 supported at the distal end 306a of the body portion 306. An inner aperture or opening 312 within the introducer catheter assembly 302 can be coaxial with an opening formed through the outer sheath 310. The introducer catheter assembly 302 can have a tapered or curved wall portion 314 configured to compress the stent 320 from a first diameter "a" to a second diameter "b" equal to the inner diameter of the (introducer) outer sheath 310 when advancing the stent 320 through the introducer catheter assembly 302.

[0187] The introducer catheter assembly 302 and the delivery catheter can be configured such that the distal end 316a of the sheath 316 terminates before or substantially adjacent to the constricted portion of the body portion 306. In this configuration, the stent is loaded into the delivery catheter in a relaxed state having a diameter "a" or in a nearly relaxed (i.e., expanded) state, and is compressed by the tapered wall portion 314 of the introducer catheter assembly 302 to a final compressed diameter "b", thereby reducing the stress applied to the stent before loading the stent into the introducer catheter assembly 302.

[0188] A sheath supported by the delivery catheter, such as sheath 316 or sheath 127 discussed above, can overlap or be advanceable at least in the proximal portion of the introducer or outer sheaths 310, 110, or as a result, sheath 316 or sheath 127 discussed above can be advanceable over the entire length of the introducer or outer sheaths 310, 110. The distal portion of the sheath supported by the delivery catheter can be tapered. In this configuration, the stent can be further compressed or constricted as it passes the distal portion of the delivery catheter sheath into the introducer or the introducer sheath.

[0189] The introducer catheter assembly 302 can be configured to receive and deploy any of a variety of prostheses, including unbranched and branched stents and stent grafts, stent segments, fenestrated stents, and other similar stents or stent grafts. Embodiments of the introducer catheter assembly 302 or any other introducer catheter assembly disclosed herein can be configured to receive and removably couple to any of a variety of delivery catheters, including an accessory support catheter, a suprarenal stent or stent extension catheter, or a branched stent delivery catheter.

[0190] Embodiments of the outer sheath 310 or any other outer sheath disclosed herein have an inner diameter of approximately 0.237 inches and an outer diameter of approximately 0.253 inches. When used for delivery of a branched stent, the sheath 316 has an inner diameter of approximately 0.251 inches and an outer diameter of approximately 0.263 inches. When used for delivery of an accessory stent or a non-branched stent, the sheath 316 has an inner diameter of approximately 0.241 inches and an outer diameter of approximately 0.263 inches.

[0191] When used for delivery of a branched stent, the inner core of the catheter system (not illustrated in FIG. 38) has an outer diameter of approximately 0.212 inches. When used for delivery of a non-branched stent, the inner core of any catheter system has an outer diameter of approximately 0.213 inches.

[0192] FIG. 39 is a schematic side view of a catheter system 400 having a deployment catheter assembly 404 that includes an inner core 408, an outer sheath 410, a plurality of tabs 412 supported by a core wire 414 axially attached to the inner core 408, and a distal tip 415 axially attached to the core wire 414. A stent 416 is supported by the delivery catheter 404 and surrounded by the outer sheath 410. The stent 416 can be a self-expanding branched stent as illustrated herein, or any other stent or medical prosthesis disclosed or incorporated herein by reference or otherwise. The delivery catheter 404 can further include a branched vascular wire assembly 417 loaded into the delivery catheter 404.

[0193] FIG. 40 is a cross-sectional view of a branched vascular wire assembly 417 taken along line 40-40 of FIG. 39, and FIG. 41 is an enlarged schematic view of a portion of the branched vascular wire assembly 417 defined by curve 41-41 of FIG. 39. The branched vascular wire assembly 417 includes an inner wire 418 positioned at least partially within a hollow tube or guide wire 420. The branched vascular wire assembly 417, inner wire 418, or hollow tube 420 can have any of the size, characteristics, materials, or other details of the dual concentric guide wire disclosed in U.S. Application No. 11 / 623,022, filed Jan. 12, 2007, which is incorporated by reference as if fully set forth herein.

[0194] The hollow tube 420 can project through the inner lumen of the stent 416 such that the distal end 420a of the hollow tube 420 projects beyond the end portion 416a of the stent 416. Additionally, the hollow tube 420 has a curved portion 420b or a twisted portion 420b proximal to the end of the stent 416. The outer sheath 410 holds the curved portion 420b of the hollow tube 420 in a curved position or a curved orientation (a first state) such that the outer sheath 410 mechanically links or locks the inner wire 418 axially to the hollow tube 420 until the curvature or bend in the curved portion 420b is relaxed. As contemplated, the curvature or bend in the curved portion 420b can be relaxed by retracting or pulling out the outer sheath 410 beyond the curved portion 420b of the hollow tube 420, thereby allowing the hollow tube 420 and the inner wire 418 to relax and straighten. Thus, when the hollow tube 420 is in the first state, the inner wire 418 is axially fixed to the hollow tube 420 such that the inner wire 418 does not disengage from the hollow tube 420 and the inner wire 418 axially retracts. When the outer sheath 410 retracts beyond the curved portion 420b of the hollow tube 420, the hollow tube 420 relaxes such that the curved portion 420b is not axially locked to the inner wire 418. In this second relaxed state, the inner wire 418 can be axially advanced or retracted inside and outside of the hollow tube 420.

[0195] In this configuration, the inner wire 418 can be advanced through a first puncture site of a first branch vessel or passage (such as the ipsilateral iliac artery), and then, using any suitable crossing technique, can be drawn out through a second branch vessel or passage (such as the contralateral iliac artery). For example, the inner wire can be advanced through the ipsilateral iliac artery in the slotted lumen formed in the double-lumen dilator. The dilator can be withdrawn and placed aside, and the inner wire 418 can pass through the slit in the lumen of the double-lumen dilator, thereby leaving the proximal end of the inner wire 418 positioned within the abdominal aorta. In this position, the inner wire 418 can be constricted, passed through the contralateral iliac artery, and through the second puncture site, and then withdrawn.

[0196] Many embodiments of the catheter system are described in connection with the accompanying drawings. It will be apparent to those skilled in the art that there are many potential embodiments of the catheter system that may be suitable for medical use and are contemplated herein. For example, additional embodiments can be formed by combining any of the components or features of the catheters disclosed herein, or of other catheters available on the market, and all of these are contemplated herein.

[0197] The above description shows, describes, and points out features as applicable to various embodiments, but it will be understood that various omissions, substitutions, and changes in the form and detail of the illustrated devices or processes may be made without departing from the spirit of the present disclosure. Additionally, the various features and processes described above may be used independently of each other or combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. Further, as will be recognized, the specific embodiments described herein may be embodied in forms that do not provide all of the features and advantages described herein, since some features may be used or implemented separately from other features.

[0198] Claims 1. A catheter system, comprising A delivery catheter comprising: a body having a proximal end and a distal end; a delivery catheter sheath projecting distally from the distal end portion of the body; an inner core configured to support a stent thereon and axially movable through the body of the delivery catheter and the delivery catheter sheath; a handle member supported by the body of the delivery catheter, the delivery catheter being configured such that when the handle member is connected to the inner core, the handle member and the inner core move axially together; an adjustment member supported by the body, the rotation of the adjustment member being configured to axially move the adjustment member along the body; and a delivery catheter comprising the adjustment member; A catheter system, wherein the handle member is axially movable along the body of the delivery catheter between the distal end portion of the body and the adjustment member, either by axially sliding the handle member relative to the body or by rotating the adjustment member relative to the body when the adjustment member provides an axial contact force with the handle member. 2. The catheter system according to claim 1, wherein the inner core is non-selectively coupled to the handle member. 3. The catheter system according to claim 1, wherein the inner core is selectively engageable by the handle member, and the catheter system is configured such that when the handle member is engaged with the inner core, the handle member and the inner core move axially together. 4. The catheter system according to claim 1, wherein the inner core comprises a core wire supporting a plurality of tabs axially spaced along at least a portion of the inner core, the tabs being positioned on the core wire such that the stent overlaps one or more of the tabs in a stent loaded state. 5. The catheter system according to claim 4, wherein the inner core comprises a core wire and a plurality of tabs are axially spaced along at least a portion of the core wire. 6. The catheter system according to claim 4, wherein a plurality of tabs are configured to engage with the inner skeleton of the stent in a stent loaded state. 7. An introducer catheter comprising a body and a tubular introducer sheath protruding from a distal end portion of the body, the catheter system according to claim 1, further comprising an introducer catheter configured to selectively receive the delivery catheter. 8. The catheter system according to claim 7, wherein the introducer sheath is configured to axially receive at least an inner core through the introducer sheath. 9. The catheter system according to claim 7, wherein when the stent is advanced into the introducer sheath by passing the stent through a tapered passage in the introducer catheter, the stent diameter can be reduced by 5% to 50%. 10. The catheter system according to claim 7, wherein at least a portion of the inner surface of the introducer sheath is coated with a low friction coating containing at least one of polytetrafluoroethylene, silicone, hydrophobic silicone, and another lubricant. 11. The introducer catheter is selectively engaged with the delivery catheter such that when the delivery catheter is engaged with the introducer catheter, axial movement of either the introducer catheter or the delivery catheter causes simultaneous and equal axial movement of the other of the introducer catheter and the delivery catheter. 12. The catheter system according to claim 7, configured such that the delivery catheter can rotate relative to the introducer catheter when the delivery catheter and the introducer catheter are engaged. 13. The catheter system according to claim 7, configured such that the delivery catheter sheath and the introducer sheath do not overlap when the delivery catheter is engaged with the introducer catheter. 14. The catheter system according to claim 7, wherein when the delivery catheter is engaged with the introducer catheter, at least a distal portion of the delivery catheter sheath overlaps at least a proximal portion of the introducer sheath, or the proximal portion of the introducer sheath overlaps at least a distal portion of the delivery catheter sheath. 15. The catheter system according to claim 7, wherein when the delivery catheter is engaged with the introducer catheter, a tapered distal portion of the delivery catheter sheath is configured to advance into the proximal portion of the introducer sheath. 16. The catheter system according to claim 7, wherein an inner diameter of the delivery catheter sheath is larger than an inner diameter of the introducer sheath. 17. The catheter system according to claim 1, wherein the inner core comprises a core wire that supports a plurality of axially spaced tabs along at least a portion of the inner core, and the tabs are positioned on the core wire such that the stent overlaps one or more of the tabs in a stent loaded state. 18. The catheter system according to claim 1, wherein the stent is a graft, and the graft is attached to the stent at at least a distal end portion of the graft rather than at a central section of the graft. 19. A delivery catheter system, a body having a proximal end and a distal end; an outer sheath protruding from a distal end portion of the body; an inner core configured to support a stent thereon and axially advanceable through the body and the outer sheath of the delivery catheter; a handle member supported by the body of the delivery catheter, the handle member being axially coupled to the inner core such that the handle member and the inner core move axially together; an adjustment member supported by the body of the delivery catheter, the rotation of the adjustment member being configured to provide a mechanical advantage for axially moving the adjustment member along the body. A delivery catheter system in which the handle member can be axially moved relative to the body of the delivery catheter between the distal end portion of the body and the adjustment member by either sliding the handle member axially relative to the body or rotating the adjustment member relative to the body when the adjustment member is in contact with the handle member, thereby enabling the inner core to be axially moved relative to the outer sheath. 20. The catheter system according to claim 19, wherein the inner core is irreversibly coupled to the handle member. 21. The catheter system according to claim 19, wherein the inner core comprises a core wire supporting a plurality of tabs axially spaced along at least a portion of the inner core, the tabs being positioned on the core wire such that the stent overlaps one or more of the tabs in the stent loaded state. 22. The catheter system according to claim 21, wherein the inner core comprises a core wire and a plurality of tabs are axially spaced along at least a portion of the core wire. 23. The catheter system according to claim 21, wherein the plurality of tabs are configured to engage the inner skeleton of the stent in the stent loaded state.

Claims

**Claim 1** A device for treating a patient, comprising: a delivery catheter; a compressed expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion; and an expansion element pre-loaded on a part of the stent or the delivery device. **Claim 2** The device according to claim 1, further comprising an expansion balloon, wherein in a state before deployment, at least the body portion and the first limb portion are pre-loaded on at least the body portion and the first limb portion such that the body portion and the first limb portion are curled around the expansion balloon. **Claim 3** The device according to claim 1 or 2, wherein the expansion element is configured to partially expand the second limb portion of the stent as the expansion element is pulled through the second limb portion of the stent. **Claim 4** The device according to claim 2 or 3, wherein the expansion balloon is a stepped balloon, a distal portion of the stepped balloon is positioned within the body portion, and has an expanded diameter larger than a more proximal portion of the expansion balloon positioned within the first limb portion. **Claim 5** The device according to any one of claims 1 to 4, wherein the compressed expandable bifurcated stent includes a graft cover. **Claim 6** The device according to any one of claims 1 to 5, wherein the expansion element is coupled to a hollow wire. **Claim 7** The device according to claim 6, wherein the hollow wire is positioned on a guide wire. **Claim 8** The device according to any one of claims 1 to 7, wherein the expansion element includes a tapered portion. **Claim 9** The device according to any one of claims 1 to 8, wherein the expansion element is self-expandable. **Claim 10** The device according to claim 9, wherein the expansion element is expandable from a first state to a second state, and when the expansion element is in the second state, the expansion element is larger in the radial direction. **Claim 11** The device according to claim 9 or 10, wherein the expansion element is covered by a removable sheath coupled to a wire. **Claim 12** The device according to any one of claims 1 to 11, further comprising a second expansion element configured to expand at least the first limb portion of the stent. **Claim 13** The device according to any one of claims 1 to 12, wherein the device is configured to treat the infrarenal aorta and the iliac artery of the patient.

14. The device according to any one of claims 1 to 13, wherein the compressed expandable branched stent is balloon-expandable.

15. A method for treating a patient, comprising: Advancing a delivery catheter into the aorta of the patient through a femoral artery puncture site to advance an expandable branched stent having a body portion, a first limb portion, and a second limb portion into the aorta of the patient; Expanding the body portion and the first limb portion of the stent; Moving an expansion element through the second limb portion of the stent to partially expand the second portion of the stent.

16. The method according to claim 15, further comprising further expanding the second limb portion of the stent using an expansion balloon.

17. The method according to claim 15 or 16, wherein the method comprises treating the infrarenal aorta and the iliac artery of the patient.

18. The method according to any one of claims 15 to 17, wherein the expansion element is positioned within the delivery catheter when advancing the delivery catheter into the aorta of the patient.

19. The method according to any one of claims 15 to 18, wherein expanding the body portion and the first limb portion of the stent comprises using an expansion balloon with a stepped balloon having a larger diameter portion and a smaller diameter portion.

20. The method according to any one of claims 15 to 19, wherein moving the expansion element through the second limb portion of the stent to partially expand the second portion of the stent comprises pulling a hollow wire coupled to the expansion element.

21. The method according to claim 20, wherein the hollow wire is pulled on a guide wire.

22. The method according to any one of claims 15 to 21, further comprising moving a first expansion element through at least the first limb portion of the stent to at least partially expand the first limb portion of the stent before moving the expansion element through the second limb portion of the stent to partially expand the second portion of the stent.

23. A device for treating the infrarenal aorta and the iliac artery, comprising: a delivery catheter; a compressed balloon-expandable branched stent having a body portion, a first limb portion, and a second limb portion; an expansion element pre-loaded on a part of the stent; an expansion balloon pre-loaded on at least the body portion and the first limb portion such that, in a state before deployment, the body portion and the first limb portion are curled around the expansion balloon; and the device, wherein the expansion element is configured to partially expand the second limb portion of the stent as the expansion element is pulled through the second limb portion of the stent. **Claim 24** A method for treating the infrarenal aorta and the iliac artery, comprising: advancing a delivery catheter into the aorta of a patient through a femoral artery puncture site to advance a balloon-expandable branched stent having a body portion, a first limb portion, and a second limb portion into the aorta of the patient; expanding the body portion and the first limb portion of the stent using an expansion balloon; moving an expansion element through the second limb portion of the stent to partially expand the second portion of the stent; and further expanding the second limb portion of the stent using a second expansion balloon. **Claim 25** A device for treating a patient, comprising: a delivery catheter; a compressed expandable branched stent having a body portion, a first limb portion, and a second limb portion; and an expansion element pre-loaded on at least a part of the stent or the delivery device. **Claim 26** The device according to claim 25, further comprising an expansion balloon pre-loaded on at least the body portion and the first limb portion such that, in a state before deployment, the body portion and the first limb portion are curled around the expansion balloon. **Claim 27** The device according to claim 25 or 26, wherein the expansion element is configured to at least partially expand the second limb portion of the stent as the expansion element expands. **Claim 28** The device according to claim 26 or 27, wherein the expandable balloon is a stepped balloon, a distal portion of the stepped balloon is positioned within the body portion, and has an expanded diameter larger than a more proximal portion of the expandable balloon positioned within the first limb portion.

29. The device according to claim 26 or 27, wherein the expandable balloon extends along the entire length of the body.

30. The device according to any one of claims 25 to 29, wherein the expandable balloon extends from an end of the body portion to an end of the limb portion.

31. The device according to any one of claims 25 to 30, wherein the expandable balloon extends from a proximal end of the body portion to a distal end of the first limb portion.

32. The device according to any one of claims 25 to 30, wherein the expansion element extends along the entire length of the second limb.

33. The device according to any one of claims 25 to 30, wherein the expansion element extends from an end of the first limb to an end of the second limb.

34. The device according to any one of claims 25 to 30, wherein the expansion element extends from a distal end of the first limb to a distal end of the second limb.

35. The device according to any one of claims 25 to 34, wherein the expansion element comprises an inner shaft and an outer shaft.

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