Balloon expandable bifurcated stent graft and method of use thereof

Abstract

In an exemplary embodiment, the present disclosure provides 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 preloaded in a portion of the stent or delivery device. In an exemplary embodiment, the present disclosure provides 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 at least one balloon preloaded in a portion of the stent or delivery device.

Description

[0001] Incorporation by reference into any prior application

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 351,286, filed on June 10, 2022, and U.S. Provisional Application No. 63 / 409,632, filed on September 23, 2022, each of which is incorporated by reference in its entirety. Background Art Technical Field

[0003] The present disclosure relates to bifurcated stent grafts and deployment systems thereof, such as balloon-expandable bifurcated stent grafts and deployment systems thereof.

[0004] Description of the Prior Art

[0005] Aortoiliac occlusive disease (AIOD) is a variant of peripheral arterial disease that affects the infrarenal aorta and iliac arteries. Similar to other arterial diseases, aortoiliac occlusive disease impedes blood flow to distal organs through a narrow lumen or through plaque embolism. Current treatments for peripheral arterial disease such as AIOD include surgical bypass, angioplasty, kissing stents, and a technique and device known as aortic bifurcation coverage endovascular reconstruction.

[0006] Overview of Some Exemplary Embodiments

[0007] Disclosed herein are embodiments of a method and apparatus for treating a diseased vasculature of a patient's body, including but not limited to the infrarenal aorta and iliac arteries and other bifurcated and non-bifurcated arteries or vessels of the body. Any embodiments of the systems, methods, and devices disclosed herein are configured or can be configured to treat any bifurcated and non-bifurcated vasculature in the body. In some embodiments, the method and apparatus include expanding an integral bifurcated balloon expandable stent graft that may be covered with graft material across arterial disease affecting the infrarenal aorta and iliac arteries, and placing the integral bifurcated stent device on the bifurcation of the aorta.

[0008] Disclosed herein are embodiments of deployment systems and methods for treating bifurcated and non-bifurcated vessels in vivo, including but not limited to the infrarenal aorta and iliac arteries. Exemplary embodiments include a balloon capable of expanding a main body and an ipsilateral limb of a bifurcated one-piece graft, wherein the balloon can be a stepped balloon that allows the stent graft to be fully expanded in a single balloon expansion step, and wherein a distal portion of the stepped balloon is positioned within the main graft portion of the stent graft and has a larger expanded diameter than a more proximal portion of the balloon positioned within a smaller diameter ipsilateral branch of the stent graft.

[0009] Disclosed herein are embodiments of deployment systems and methods for treating bifurcated and non-bifurcated vessels in vivo, including but not limited to the infrarenal aorta and iliac arteries. In some embodiments, the system may include an expansion element, such as a "bead" (which may include an enlarged portion, a bulb, or a protrusion in certain embodiments), which may be pre-assembled and loaded with the rest of the device or may be subsequently inserted into the device. The bead may pass through the lumen of a curled (also referred to as compressed) object, such as a contralateral limb, and expand the branch to the center of the limb sufficient to allow a balloon catheter to subsequently advance upward and through the stent graft. The bead may be small enough so that it may be removed from the partially expanded contralateral sheath.

[0010] BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figures 1A to 1F are exemplary embodiments of a delivery system and stent device at various stages of deployment.

[0012] Figures 2A to 2E Depicted is expansion of a stent device limb according to an exemplary embodiment.

[0013] Figure 3 , 4 5 and 5 depict expansion of a stent device according to an exemplary embodiment.

[0014] Figure 6 and 7 is an exemplary embodiment of a system having one or more expansion elements and a stent device.

[0015] Figure 8 and 9 is an exemplary embodiment of a system showing expansion of a stent device having an expansion element.

[0016] Fig.10 is an example of occluding a bifurcated vessel.

[0017] Figures 11 to 28 Detailed Description of the Invention An exemplary embodiment of a delivery system having a stent device expansion element and a balloon at various stages of deployment.

[0018] Figures 29A to 29 D depicts expansion of a stent device according to an exemplary embodiment.

[0019] Fig.30 is an exemplary embodiment of a delivery system having a first balloon and a second balloon.

[0020] Figures 31A to 31 B is another exemplary embodiment of a delivery system having a first balloon and a second balloon.

[0021] Figures 32A to 32B is yet another exemplary embodiment of a delivery system having a first balloon and a second balloon.

[0022] Fig.33 is a delivery system according to an exemplary embodiment.

[0023] Detailed Description of Some Embodiments

[0024] Disclosed herein are embodiments of a system 100 for treating diseased vascular systems in vivo, including, but not limited to, aortoiliac occlusive lesions and other pathologies at the aortic bifurcation and other bifurcated and non-bifurcation arteries and vessels. Thus, while certain embodiments are described as treating aortic bifurcations, any embodiments of the systems, methods, and devices disclosed herein are configured or may be configured to treat any bifurcated and non-bifurcation vascular systems in vivo. Some embodiments of the system 100 may have a stent device 120 and a delivery catheter 130. In an exemplary embodiment, the stent device 120 has an integral design to avoid complications that are typically present in the case of modular or multi-part devices.

[0025] Some embodiments of the methods disclosed herein include deploying a covered bifurcated stent device at an aortic bifurcation, wherein the device has a unitary construction and is mechanically expandable (e.g., balloon expandable). Figure 1A , some embodiments of the stent device 120 can have a main body portion 122 that is configured to extend into the aorta; a first downwardly (or distally) extending limb portion 124 that is configured to extend into 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) that is configured to extend into a second iliac artery (e.g., the other of the ipsilateral and contralateral arteries or limbs). Figure 1A The stent device 120 is shown in a deployed and expanded state. Although some of the figures show an aneurysmal aortic bifurcation, the use of the embodiments disclosed herein is not limited to use in treating abdominal aortic aneurysms. Embodiments of the devices disclosed herein can be used to treat a variety of diseases and conditions of the aorta and aortic bifurcation, including but not limited to AIOD and other aneurysmal, embolic, and occlusive aortic conditions. Some embodiments of the stent device 120 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 conditions (such as a closed or partially closed aorta).

[0026] As will be disclosed in more detail below, any embodiment of the stent device 120 disclosed herein can be an uncovered mechanically expandable (e.g., balloon expandable) stent or a covered mechanically expandable (e.g., balloon expandable) stent of a one-piece construction or other one-piece configuration, wherein the main body portion 122, the first downwardly extending leg portion 124, and the second downwardly extending leg portion 126 are connected together before deployment. In some embodiments, the main 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 main body portion 122, the first downwardly extending leg portion 124, and the second downwardly extending leg portion 126 can be formed separately and coupled together. In some embodiments, the main 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 coupled to the main 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 covering 128 .

[0027] The frame 126 can have any desired or suitable shape or configuration and can be made of laser cut tubing, wire, or other known or later developed techniques and materials. In any embodiment, the expandable frame 126 of the stent device 120 can be made of 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 of any suitable graft material, including polyester, polyester / spandex, expandable polytetrafluoroethylene (ePTFE), or any other suitable or acceptable material. Some embodiments of the stent device 120 may include a balloon expandable bifurcated stent structure that forms an inverted "Y" shape similar to an integral stent graft structure. In such embodiments, the main body portion 122 in the expanded configuration may have a larger outer diameter and inner diameter than the leg portions 124, 126 extending downward. In any embodiment disclosed herein, the expansion balloon can be a stepped balloon to allow the stent graft to be fully expanded in a single balloon expansion step. In such a configuration, a distal portion of the stepped balloon may be positioned within the main graft portion of the stent and have a larger expanded diameter than a more proximal portion of the balloon, which may be positioned within a smaller diameter ipsilateral branch of the stent graft.

[0028] refer to Figure 1B, some embodiments of the stent device 120 can be deployed using a catheter 130, which 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 curled around an inner core of the delivery catheter 130 in a compressed configuration. Some embodiments of the catheter 130 can be advanced through a puncture site in a first iliac artery by an introducer, and can be advanced through a bifurcation of the aorta, or through any puncture site or opening into any portion of the patient's vasculature. The contralateral wire 136 can be withdrawn through a second puncture site in a second iliac artery. Reference Figure 1C , the sheath 134 can be withdrawn through the first puncture site, thereby exposing the stent device 120, which can then be moved toward the bifurcation, wherein the first limb portion 124 is withdrawn into the first artery (for example, but not limited to the ipsilateral iliac artery), and the second limb portion 126 is moved or withdrawn into the second iliac artery (for example, but not limited to the contralateral iliac artery). The stent device 120 can still be in a retracted or low-profile state at this stage. In some embodiments, the stent 120 can be withdrawn toward the aortic bifurcation, so that the bifurcated portion of the stent 120 moves into contact with the aortic bifurcation, thereby placing the stent 120 at the aortic bifurcation.

[0029] refer to Figure 1D , the main body portion 122 and the first limb portion 124 can then be expanded, such as with an expansion 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 without an outer sheath. The outer sheath 134 is Figure 1D120 is shown as being retained in the first iliac artery. However, in some embodiments, the outer sheath 134 can be withdrawn before inflating the expansion balloon or actuating other mechanical expansion components to expand the main body portion 122 and the first limb portion 124. In some embodiments, when the stent device 120 is advanced into the aorta, the expansion balloon can be positioned within the main body portion 122 and the first limb portion 124. In some embodiments, after the stent device 120 has been positioned in the desired position in the patient's aorta, the expansion balloon can be advanced into the first limb portion 124 and the main body portion 122. As described above, in some embodiments, the expansion balloon can be a stepped balloon to allow the stent graft to be fully expanded 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 has a larger expansion diameter than the more proximal portion of the balloon, which can be positioned within the smaller diameter ipsilateral branch of the stent graft. In other embodiments, a single expansion balloon can be used to expand the main body portion 122 and the first limb portion 124. For example, in a first step, the body portion 122 may be expanded, and then the balloon may be deflated and moved to then expand the first limb portion 124. In an exemplary embodiment, in a first step, the first limb portion 124 may be first expanded with a balloon, and then the balloon may be advanced into the body portion to expand the body portion 122. Additionally, while the present disclosure describes the use of a balloon to expand portions of the device 120, other expansion devices, such as mechanically expandable devices, may also be used.

[0030] In some patients, the second iliac artery may be stenotic or otherwise partially or completely closed, making it difficult or impractical to advance a dilation balloon or other mechanical dilation device into the second limb portion 126. To address this issue, some embodiments of the system 100 may include one or more low-profile dilation elements 140 that can be moved through the main body portion 122, the first limb portion 124, and / or the second limb portion 126 to partially dilate the main body portion 122, the first limb portion 124, and / or the second limb portion 126 so that a dilation balloon or other mechanical dilation component can be advanced into the main body portion 122, the first limb portion 124, and / or the second limb portion 126. For example, but not limited to, in some embodiments, the low profile expansion element 140 (also referred to herein as a "bead") can have a low profile shape that can move through the main body portion 122, the first limb portion 124, and / or the second limb portion 126, and partially expand the main body portion 122, the first limb portion 124, and / or the second limb portion 126, despite the force applied to the main body portion 122, the first limb portion 124, and / or the second limb portion 126 due to the embolic pathology of the patient's vascular system. In some embodiments, the low profile expansion element 140 can have a solid cross-section. In some embodiments, the low profile expansion element 140 can have an elongated shape, such as a cylindrical shape. In some embodiments, the low profile expansion element 140 can be preassembled and loaded with the rest of the stent device. As discussed, the low profile expansion element 140 can move through the curled or contracted second limb portion 126, and can expand the second limb portion 126 to be sufficient to allow balloon catheterization and then fully expand the second limb portion 126. Some embodiments of the low-profile dilation element 140 may be sized and configured to be withdrawn through a contralateral introducer sheath.

[0031] In any embodiments disclosed herein, the low profile expansion element 140 can be self-expanding or can be actively expanding. Self-expanding beads can be implemented in a variety of ways, such as self-expanding foam, open-cell polyurethane foam, flexible nitinol membranes, or variations thereof. In an exemplary embodiment, the expansion element can be expanded inside a portion (e.g., a limb) of a crimped stent device and then retracted before or during removal of the expansion element.

[0032] refer to Figure 1EIn some embodiments, a low-profile expansion element 140 can be coupled to a hollow wire 142 that can be advanced over the contralateral wire 136 such that the low-profile expansion element 140 can be moved through the second limb portion 126 by withdrawing the hollow wire 140 through the second puncture site. The inner diameter or cross-sectional size of the low-profile expansion element 140 can be greater than the diameter or cross-sectional size of the curled (also referred to as compressed) second limb portion 126 such that the second limb portion 126 expands when the low-profile expansion element 140 is moved through the second limb portion 126. Thereafter, reference is made to Figure 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 accommodate an expansion balloon or other mechanical expansion component therein despite external forces acting on the second limb portion 126. The expansion balloon or other mechanical expansion component can then be advanced over the contralateral wire 136 through the contralateral introducer sheath 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 through the ipsilateral introducer sheath and down into the second limb portion 126 to complete the expansion of the second limb portion 126. In some embodiments, the stent device 120 can be positioned so that the legs of the stent graft are pulled downward to place the graft on the aortic bifurcation before any expansion is performed. In other embodiments, the stent device 120 can be positioned so that the legs of the stent graft are pulled downward to place the graft on the bifurcation of the aorta while the stent 120 is partially or fully expanded or after the stent 120 is partially or fully expanded.

[0033] Although the figures and description describe the use of a low-profile dilation element 140 to dilate the second limb portion 126, in other embodiments, the low-profile dilation element 140 can be used to dilate other portions of the stent device 120, including the body portion 122 and / or the first limb portion 124. In some embodiments, the low-profile dilation element 140 can have an angled or beveled proximal end portion 142 to facilitate movement of the low-profile dilation element 140 through the second limb portion 126 and to cause the second limb portion 126 to dilate more gradually as the low-profile dilation element 140 moves through the second limb portion 126. In some embodiments, the low-profile dilation element 140 can have an extended tapered portion that can be half or more of the length of the low-profile dilation element 140, or one-quarter to three-quarters of the length of the low-profile dilation element 140, or one-quarter to the entire length of the low-profile dilation element 140, or any value or range of values ​​within the foregoing ranges. In some embodiments, the diameter of the low-profile dilation element 140 can be greater than about 0.05 inches; less than about 0.25 inches; between about 0.05 inches and about 0.25 inches; between about 0.10 inches and about 0.25 inches; between about 0.10 inches and about 0.20 inches; or between about 0.10 inches and about 0.125 inches; including all values ​​(e.g., decimal values) within the foregoing ranges. In an exemplary embodiment, the initial (unexpanded) diameter of the dilation element prior to dilation is greater than about 0.05 inches, greater than about 0.10 inches, greater than about 0.175 inches, greater than about 0.20 inches, or greater than about 0.25 inches, including all values ​​(e.g., decimal values) within the foregoing ranges. In an exemplary embodiment, the expanded diameter of the dilation element after dilation is less than about 0.05 inches, less than about 0.10 inches, less than about 0.175 inches, less than about 0.20 inches, or less than about 0.25, including all values ​​(e.g., decimal values) within the foregoing ranges.

[0034] In some embodiments, the low profile expansion element 140 can be configured to expand the limb of the stent to 30% of the final expanded diameter of the corresponding limb, or from 15% or about 15% or less to 40% or about 40% or more of the final expanded diameter of the corresponding limb, or from 20% or about 20% to 30% or about 30% of the final expanded diameter of the corresponding limb, or any value or to and from any value in the foregoing range. In an exemplary embodiment, the inner diameter of the contralateral limb is in the range of about 0.5 to 14 mm, including every decimal and integer value in this range. For example, the inner diameter of the curled contralateral limb can be about 0.5 to 5 mm, preferably between about 1 to 3 mm. After partial expansion using the expansion element, the inner diameter of the contralateral limb can be about 1 to 5 mm, preferably about 3 to 5 mm. In the case of subsequent balloon expansion, the inner diameter of the contralateral limb can be about 5 to 14 mm, depending on the anatomical structure.

[0035] Exemplary embodiments disclosed herein may advantageously provide a simplified surgical procedure. By maintaining an integrated bifurcation design, the drawbacks of kissing stents and certain versions of covered endovascular reconstruction of the aortic bifurcation (CERAB), namely, unequal blood flow distribution between the two limbs, may be avoided. Additionally, some embodiments of the balloon expandable stent disclosed herein may be more advantageous for the treatment of aortoiliac occlusive disease (AIOD), in part because some embodiments of the stent device 120 disclosed herein provide the physician with the ability to achieve not only higher radial strength in a smaller profile, but also an intermediate diameter / radial stiffness point driven by physician control of expansion.

[0036] Some embodiments of the system 100 may 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 transferring the system through the introducer and anatomical structures, and / or a contralateral limb line for facilitating capture and positioning of the second limb portion 126 into the contralateral iliac artery for passage through and through an entering pre-cannulated contralateral limb line. Appendices A and B are part of U.S. Patent No. 8,808,350, which discloses some embodiments of the ENDOLOGIX AFX delivery system, which, as described above, may be incorporated into any embodiment of the system 100. Therefore, the entire disclosure of U.S. Patent No. 8,808,350, including its drawings, forms part of the present disclosure, including the specification and drawings set forth. In any embodiments disclosed herein, any components, features, or other details of systems 100, 200, 300 may have any components, features, or other details of any embodiment disclosed in Appendix A, or may be used in any combination with any components, features, or details of systems 100, 200, 300 or methods of use disclosed herein according to any steps of any method embodiment disclosed in Appendix A, as if such embodiments were explicitly disclosed herein.

[0037] Figure 2A An example embodiment of a low profile expansion element 140 is shown. Figure 2B An example embodiment of a second limb portion 126 of a stent is shown in a crimped state. The second limb portion is also referred to herein as a crimped contralateral limb or a compressed contralateral limb. Figures 2C to 2E An example embodiment of a second limb portion 126 of a stent is shown in a crimped state, with an expansion element 140 shown moving through the second limb portion 126 and expanding the second limb portion 126 as the expansion element 140 moves through the second limb portion 126 . Figures 2C to 2E The circle in each of the figures in FIG. 1 identifies the expansion element 140 in the second limb portion 126. Figure 2E , expansion element 140 has moved through the entire length or nearly the entire length of second limb portion 126 , so that the entire length or nearly the entire length of second limb portion 126 has been partially expanded by expansion element 140 .

[0038] Figure 3 An embodiment of a stent device is shown in a crimped state, wherein a main body portion and a first limb portion of the stent device are being balloon expanded or are being prepared for balloon expansion. Figure 4 The second limb portion of the stent device is shown partially expanding as the expansion element moves through the second limb portion of the stent device. Figure 5 The stent device is shown after the expansion element has been fully pulled through the second limb portion of the stent device. Figure 4 and5 The circle in each of the figures identifies the expansion element 140 in the second limb portion 126.

[0039] Any other embodiment of the system 100 or the support 120 may have Figures 3A to 3C Any component, feature or other detail of any embodiment shown in any combination with any other component, feature and / or other component of such embodiment.

[0040] Figure 6 Another embodiment of a system 200 for treating aortoiliac occlusive lesions and other pathologies at the aortic bifurcation is shown, showing a bifurcated stent device 120 in a crimped or collapsed state. In any embodiment disclosed herein, any component, feature, or other detail of the system 200 may have any component, feature, or other detail of any other system embodiment disclosed herein, or be used according to any step of any other method embodiment disclosed herein, including but not limited to any embodiment of the system 100 or its method of use described herein, and any combination of any component, feature, or detail of the system 200 or its method of use disclosed herein. Similarly, any component, feature, step, or other detail of any other system or method embodiment disclosed herein (including but not limited to the system 100 or its method of use) may have any combination of any component, feature, step, or other detail of any embodiment of the system 200 or its method of use.

[0041] 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 Figure 6 , the first expansion element 210 can be used to expand the main 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 entered through a first puncture side (e.g., but not limited to, through a first femoral puncture site, such as in the ipsilateral iliac artery). The first expansion element 210 can be moved through the main body portion 122 and the first limb portion 124 of the stent device 120 by withdrawing the first wire 212 through the main body portion 122 and the first limb portion 124 (e.g., through the first puncture site), thereby partially, completely, or substantially completely expanding the main body portion 122 and / or the first limb portion 124 of the stent device 120.

[0042] Similarly, the second expansion element 220 can be used to expand the second limb portion 126 of the stent device 120. The second expansion element 220 can be coupled to a second wire 222 that can be passed through a second puncture side (e.g., but not limited to, in a second femoral puncture site—e.g., in the contralateral iliac artery). The second expansion element 220 can be moved through the main body portion 122 and the second limb portion 126 of the stent device 120 by withdrawing the second wire 222 through the main body portion 122 and the second limb portion 124 (e.g., through the second puncture site), thereby partially, completely, or substantially completely expanding the second limb portion 126 of the stent device 120. In some embodiments, although not required, the second expansion element 220 can be moved through the main body portion 122 and the second limb portion 126 of the stent device 120 after at least the main body portion 122 has been partially, completely, or substantially completely expanded. In some embodiments, although not required, the second expansion element 220 can be moved through the body portion 122 and the second limb portion 126 of the stent device 120 after the body portion 122 and the first limb portion 124 of the stent device have been partially, fully, or substantially fully expanded.

[0043] Figure 7 The stent device 120 is shown after the main body 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 line 212. Although not shown, the first line can be retained in the stent device. As shown in the figure, the second limb portion 124 is still in a curled state, wherein the second expansion element 220 is positioned at the distal end of the stent device 120. In this state, the second expansion element 220 can then be moved through the main body 122 and the second limb portion 124 of the stent device 120 by withdrawing the second line 222, so that the second limb portion 126 of the stent device is partially, completely or substantially completely expanded. If the main body 122, the first limb portion 124 and / or the second limb portion 126 are only partially expanded by the expansion elements 210, 220, the main body 122, the first limb portion 124 and / or the second limb portion 126 can be fully expanded 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 be withdrawn through the first puncture site and the second puncture site, respectively.

[0044] Again, as with any other embodiments 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 bullet-like tapered cylindrical shape, a bead shape, or other shapes.

[0045] In some embodiments, when the stent device is crimped onto 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 or coupled to a delivery catheter (not shown) distal to the main body portion 122 of the stent device 120. In some cases, this can 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 and adjacent to the first expansion element 210, spaced apart from the first expansion element 210, or slightly overlapping 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.

[0046] In any embodiments disclosed herein, the delivery device can be configured to selectively support the distal end of the stent device 120 to inhibit the stent device from collapsing or substantially collapsing or substantially moving in an axial direction as the expansion element moves through the stent device. In one embodiment, a locking mechanism (such as a tether) can be provided at the proximal region of the device, thereby connecting it to the delivery system line and thereby preventing any potential collapse of the body as the expansion element advances toward the bifurcation.

[0047] In any embodiments disclosed herein, one or more expansion elements may be configured to be selectively expandable. For example, but not limited to, one or more expansion elements may have a removable sheath that may be configured to hold or maintain the corresponding expansion element in a collapsed or pre-expanded state. The removable sheath may be configured to be torn off the expansion element or otherwise removed from the expansion element. The expansion element may be configured to self-expand once the removable sheath is removed. In some embodiments, the removable sheath may be coupled to a wire (such as a hollow wire) that may be used to withdraw the removable sheath from at least the expansion element and / or the body. In some embodiments, the removable sheath may be made of a perforated plastic shrink wrap. In some embodiments, the removable sheath may be configured to be removed from the expansion element by withdrawing the wire coupled to the removable sheath and / or the wire coupled to the expansion element relative to the expansion element. In some embodiments, the wire coupled to the expansion element may have sufficient rigidity or otherwise be configured not to buckle when the wire coupled to the removable sheath is withdrawn relative to the expansion element.

[0048] Figure 8 Another embodiment of a system 300 for treating aortoiliac occlusive lesions and other pathologies at the aortic bifurcation is shown, showing a bifurcated stent device 120, wherein the second limb portion 126 of the stent device 120 is in a crimped or collapsed state. In any embodiment disclosed herein, any component, feature, or other detail of the system 300 may have any component, feature, or other detail of any other system embodiment disclosed herein, or be used according to any step of any other method embodiment disclosed herein, including but not limited to any embodiment of the system 100, 200 or its method of use described herein, and any combination of any component, feature, or detail of the system 300 or its method of use disclosed herein. Similarly, any component, feature, step, or other detail of any other system or method embodiment disclosed herein (including but not limited to the system 100, 200 or its method of use) may have any combination of any component, feature, step, or other detail of any embodiment of the system 300 or its method of use.

[0049] In some embodiments, the system 300 can have a delivery catheter 302 having a distal tip 304 and any other features disclosed herein or any other delivery catheter embodiment for deploying a bifurcated stent. 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 multiple portions (e.g., two or more, or three or more) of increasing diameter through the stent device 120. In any embodiments disclosed herein, as Figure 8 As shown, the expansion element 320 can be positioned proximal to the distal tip 302 of the delivery catheter. In any embodiments disclosed herein, the expansion element can be positioned adjacent to the proximal end portion of the distal tip. 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 connected to a wire 322. The wire 322 can be solid or can be hollow, sized and configured to pass over the guide wire. The expansion element 320 can be self-expanding and can be supported in a collapsed or reduced size state by a removable sheath 328. The removable sheath 328 can be connected to a wire 330, which can be a hollow wire configured to pass over the wire 322.

[0050] As mentioned, the expansion element 320 can be coupled to a wire 322 that can be passed through a second puncture side and entered (e.g., but not limited to, through a second femoral puncture site—e.g., in the contralateral 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 and into the second limb portion 124 of the stent device 120 and positioned in the distal end portion of the second limb portion 126 of the stent device 120. Thereafter, the removable sheath 328 can be removed from the expansion element 320 so that the expansion element 320 can self-expand to a second state of the expansion element 320 in which the expansion element has an increased size compared to the first state of the expansion element 320 (i.e., when the expansion element is constrained by the removable sheath). Fig. 9The expansion element 320 is shown after the expansion element 320 has been moved into the second limb portion 126 of the stent device 126 and expanded to the second state of the expansion element 320 by removing the removable sheath 328. The removable sheath 328 can be removed from the expansion element 320 and the body by withdrawing the 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 withdrawing the wire 322 coupled to the expansion element 320 through the second puncture site. In any embodiments herein, the second limb portion 126 of the stent device 120 can be partially, completely, or substantially completely expanded by the expansion element 320. Thereafter, an expansion balloon or other expansion device can be advanced through the second puncture site and upward through the second limb portion 126 of the stent 120 to further expand the second limb portion 126.

[0051] In some embodiments, the expandable element can be 100% larger (i.e., doubled in size) or approximately 100% larger in a radial direction perpendicular to the centerline axis of the expandable element when the expandable element is in the second state compared to when the expandable element is in the first state. In some embodiments, the expandable element can be 50% or approximately 50% larger to 200% larger, approximately 200% or more larger in the radial direction when the expandable element is in the second state compared to when the expandable element is in the first state, or can be 75% or approximately 75% larger to 150% or approximately 150% larger in the radial direction when the expandable element is in the second state compared to when the expandable element is in the first state, or any value or range of values ​​within any of the foregoing ranges.

[0052] Other details:

[0053] In any of the embodiments disclosed herein, the stent device 120 can be a non-bifurcated stent, wherein the expansion element can be used to partially, completely, or substantially completely expand all or a portion of the non-bifurcated stent.

[0054] In any embodiments disclosed herein, one or more, two or more, three or more expansion elements can be preloaded in 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 embodiments disclosed herein, when the stent is crimped to the delivery catheter, the expansion element can be at least partially positioned within the second limb portion of the stent (e.g., adjacent to the bifurcation of the stent). In any embodiments disclosed herein, when the stent is crimped to the delivery catheter, the expansion element can be at least partially positioned within the main body portion of the stent.

[0055] In any embodiments disclosed herein, any portion of the stent (including embodiments of the stent 120 disclosed herein) can be self-expanding. For example, but not limited to, in some embodiments, the stent device 120 can be configured such that the main body portion 122, the first limb portion 124 and / or the second limb portion 126 can be self-expanding, while other portions of the main body portion 122, the first limb portion 124 and the second limb portion 126 can be balloon expandable or otherwise mechanically expandable. For example, but not limited to, in some embodiments, the main body portion 122 and the first limb portion 124 of any embodiment disclosed herein can be self-expanding, while the second limb portion 126 is balloon expandable. Alternatively, the main body portion 122 of any embodiment disclosed herein can be self-expandable, while the first limb portion 124 and the second limb portion are balloon expandable. Any self-expandable portion can be fixed within an outer sheath, can be fixed in a collapsed state with a removable sheath, or in other ways.

[0056] In any embodiments disclosed herein, the stent device 120 or any portion thereof, the expansion device (e.g., a balloon), and / or the expansion element 140 or other embodiments of the expansion element disclosed herein can have radiopaque markers, radiopaque coatings, or other features that increase fluoroscopic visibility. In addition, in any embodiments disclosed herein, the expansion element can have a PTFE covering or coating or be made of PTFE.

[0057] In any embodiments disclosed herein, in addition to the first limb portion and the second limb portion disclosed herein, the stent may also have one or more branch limbs, limb extensions, or other aspects or openings for accommodating branch limbs (such as for the renal artery, lumbar artery, or other aspects) passing therethrough.

[0058] In any embodiments disclosed herein, a portion of the stent (such as a distal portion of the main body portion 122 of the stent 120) can be removably coupled or tethered to a portion of a delivery catheter to at least inhibit (e.g., prevent) the stent from migrating and / or collapsing in an axial direction when an expansion element moves through the stent. A removable suture or other selectively removable fastening element can be coupled to, for example, but not limited to, a distal end portion (i.e., the end portion closest to the heart) to at least inhibit (e.g., prevent) the stent from migrating and / or collapsing in an axial direction when an expansion element moves through the stent. In some embodiments, a proximal stent can be used to anchor or secure the distal end portion of the stent 120 to the patient's vasculature.

[0059] Some embodiments of the delivery system for balloon expandable bifurcated stent grafts can utilize an introducer to obtain vascular access. In certain embodiments, the trunk and ipsilateral limb of the stent graft can be installed on the expandable inner core of the delivery catheter (wherein the balloon expandable inner core is installed in the lumen of the trunk and ipsilateral limb of the stent graft). The delivery catheter with the stent graft can be advanced through the introducer. As mentioned, the distal end of the delivery catheter can include a non-damaging tip to transfer the system through the introducer and the anatomical structure. The main handle of the delivery catheter can be configured to dock with the introducer.

[0060] The above-described systems and methods use a single expansion element 140 (referred to as a "bead"). In a modified embodiment, two or more beads may be used. In such an arrangement, one bead may open or partially expand the main body and the ipsilateral limb, and a second bead may be used to open or partially expand the contralateral limb. In such an arrangement, the balloon catheter is then advanced into the main body and the ipsilateral limb to fully open these portions. This arrangement will allow the initial profile of the delivery catheter to be further reduced. In a modified embodiment, two or more beads of different maximum diameters and / or shapes may be used to open the second limb portion 126 (or other portions of the stent). For example, a first bead of a smaller overall diameter may be used to initially expand a portion of the stent, and then a second bead of a larger overall diameter may be used to further expand a portion of the stent.

[0061] In some embodiments, the system 100 may have advantageous specific advantages, such as lower profile, improved accuracy, and increased radial strength.

[0062] In some embodiments, self-expanding beads can be used to eliminate one or more expansion balloons. In any embodiments disclosed herein, the beads can be self-expanding beads that can be implemented in a variety of ways, such as self-expanding foam, open-cell polyurethane foam, flexible nitinol membrane, wire cage structure, metal mesh cage or its variations. Some embodiments can have a tube in the contralateral limb, which can have the advantage of maintaining the lumen of the limb. The bead locking mechanism can be implemented in any of a variety of different ways (such as heat shrink covering) or sutures secured in place with a wire lock.

[0063] Another conceptual variation that may be included in any of the method embodiments disclosed herein is the incorporation of a cross lumen so the contralateral line is cannulated from the ipsilateral side and captured from the contralateral side, which in some embodiments may provide a track for beads to be fed by the physician from the external cannulated ipsilateral side of the patient, into the bifurcation and out the contralateral side of the patient. In some embodiments, the beads may be replaced with a balloon assembly that may be attached to a Luer post exiting the contralateral side of the patient.

[0064] Figures 10 to 27 Certain embodiments of the present disclosure are further illustrated in Fig.10 Initially, bifurcated vessel 1000 has one or more occlusions 1008, 110, and 1011 in the lumens of the aorta 1002 and branch arteries 1004, 1006. The occlusions effectively reduce the lumen size 1014, 1016, and 1018 in the aorta and branch arteries, respectively, compared to non-occluded areas 1012, 1020, and 1022.

[0065] To solve this situation, Fig.11 and 12 The exemplary systems and methods shown include delivering a contralateral guide wire (CW) 1100 through the ipsilateral limb 1004 into the aorta 1002. The CW 1100 is captured with a snare 1104 at the end of a snare wire 1102 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 the delivery system 1108 into the aorta 1002. The delivery system may be positioned completely or only partially within the occluded 1014 region of the aorta 1002.

[0066] Depicts the remaining Figures 13 to 27 , even though it is understood that they exist in the main lumen, the branch lumen, or both lumens. Fig.13 , 14 As shown in FIGS. 15 and 15 , a delivery system 1108 provides a bifurcated device 1300 (stent or stent graft) disposed on a bifurcation such that the ipsilateral limb 1140 is located in a first vessel bifurcation and the contralateral limb 1130 is located in a second bifurcation, wherein the body 1160 is positioned in the main vessel lumen. Advantageously, an expansion element (e.g., a bead) 1200 is preloaded in the ipsilateral limb 1140 of the device in a pre-deployed state and is configured to travel over the CW 1100, thereby producing an expanded 1302 contralateral limb. Of course, the bead 1200 may also expand the ipsilateral limb 1140 before entering the contralateral limb. The contralateral limb expansion may be performed partially or completely relative to the vessel bifurcation lumen. The expansion element may be preloaded on the outside of the ipsilateral limb, on the inside at the proximal end, and at or near the bifurcation of the device.

[0067] Also shown is a delivery system guide wire (GW) 1110 positioned within the device 1300 and extending out of the body 1160 along with the delivery device tip 1112. As noted in the present disclosure, the expansion element may be self-expanding. To this end, Fig.15 The dilation element 1200 is shown positioned in a contralateral limb having an increased diameter relative to its initial preloaded state, thereby producing greater contralateral limb dilation 1302.

[0068] Alternatively, the expansion element 1200 can be pre-loaded at or near the proximal end of the body of the device 1300, such as Fig.16 Here, the CW and GW are locked together by a locking mechanism 1320. The locking mechanism may include a GW lumen and a CW lumen, wherein the CW is locked in the lumen together with a locking wire that releasably holds the CW. The CW may include any raised, tapered, or otherwise altered features to ensure secure locking within the lumen. Fig.17 As shown, the expansion element 1200 travels along the CW 1100 and eventually leaves the contralateral limb 1130 to expand it. Here, the expansion element 1200 can also expand the body 1160 of the device 1300.

[0069] After the contralateral limb 1130 is partially expanded, the balloon 1330 is guided along CW 1100 into the limb 1130 in direction 1332, as shown in FIG. Fig.18 Of course, when using Figures 13 to 15 When the device and method are used, the balloon can be inserted from the ipsilateral limb, such as Fig.21 As depicted. Fig.18 Inflation of the balloon as shown produces a fully expanded contralateral limb 1302, ultimately increasing the diameter of the vessel. Balloon 1330 can generally take on any shape or size suitable for fully expanding the limb as well as the body. Thus, the balloon length can span the entire contralateral limb 1130 or the entire length of the device (both the contralateral limb and the body). In addition, balloon 1330 can include one or more cross-sectional sizes along its length. As a non-limiting example, the balloon can be a stepped balloon. For example, Fig. 20 A balloon is shown spanning the length of the device and having a larger cross-section at the proximal region so that when inflated, both the body and the contralateral limb expand (1304 and 1302).

[0070] Ideally, the expansion element traverses the device with minimal impedance. Therefore, the expansion element can be encapsulated in a low friction lumen (such as PTFE). In addition, CW 1100 and the length of expansion element 1200 can be encapsulated in lumen 1250, such as Fig. 22 This feature is generally applicable to all exemplary embodiments, including Figures 13 to 15 Those embodiments presented in .

[0071] like Fig.23 and 24As shown, more than one expansion element may be used in the exemplary systems and methods. Here, a first expansion element 1200 and a second expansion element 1400 are preloaded in the delivery system at the proximal end of the device 1300. The first expansion element 1200 moves over the CW 1100, while the second expansion element 1400 moves over the GW 1110. Both lines are fixed in a locking mechanism 1320. The relative positioning of the expansion elements 1200, 1400 can be varied. In addition, one or both can be placed inside the device, and the shapes can be independent or complementary to allow for a lower profile. In addition, the translation sequence can be different, and the expansion elements 1200 and 1400 can be moved in directions 1350 and 1360, respectively, at different relative times.

[0072] Once the contralateral limb 1130 is expanded, the expansion balloon 1500 can be placed into the ipsilateral limb 1140 in direction 1402, such as Fig.25 As with the contralateral expansion balloon, the ipsilateral balloon 1500 can be of any shape and length desired to expand the ipsilateral limb, body, or both, such as Fig.26 and 27 Specifically, balloon 1500 may be a stepped balloon, wherein when inflated, body 1410 and ipsilateral limb 1420 of the device are expanded.

[0073] After expansion of the body and limbs of the device 1300, the delivery system may be removed, leaving the bifurcated device in place, thereby improving the effective diameter of the main vessel lumen and branches.

[0074] Fig.28 An embodiment of a stent system 2000 including a stent 2002 (which may be a covered stent) or at least a portion thereof and a stent deployment system 2004 for deploying the stent 2002 or at least a portion thereof is shown. Fig.28 A stent device 2002 is shown positioned at an aortic bifurcation in the vasculature of a patient.

[0075] In any embodiment, system 2000 can be used to treat diseased vascular systems in vivo, including but not limited to aortoiliac occlusive lesions and other pathologies at the aortic bifurcation, iliac bifurcation, and other bifurcated and non-bifurcated arteries and vessels. Therefore, although some embodiments are described as treating aortic bifurcation, any embodiment of the system, method, and device disclosed herein is configured or can be configured to treat any bifurcated and non-bifurcated vascular systems in vivo. Although not required, some embodiments of stent 2002 can have an integral design to avoid complications that are usually present in the case of modular or multi-part devices. Some embodiments of the method disclosed herein include deploying a covered bifurcated stent device at the aortic bifurcation, wherein the stent is mechanically expandable (e.g., balloon expandable), self-expandable, or a hybrid mechanically expandable self-expandable device, wherein some parts of the stent device (e.g., the main body, the first branch part, and / or the second branch part) are mechanically expandable, and other parts of the stent device (e.g., the main body, the first branch part, and / or the second branch part that are not mechanically expandable) are self-expandable.

[0076] Any embodiment of stent 2002 may have any components, features, or other details of any bifurcated stent embodiment disclosed herein, in any combination with any components, features, and / or other details of stent 2002. Any embodiment of stent deployment system 2004 may have any components, features, or other details of any stent deployment system embodiment disclosed herein, in any combination with any components, features, and / or other details of stent deployment system 2004.

[0077] Figures 29A to 29 D shows an embodiment of at least a portion of an embodiment of a stent 2002 deployed in a bifurcation and expansion of a first branch portion 2012 and a second branch portion 2014 of the stent 2002. Figures 28 to 29 D. Some embodiments of the stent device 2002 can have a body portion 2010 configured to extend into the aorta; a first downwardly extending limb portion 2012 configured to extend into a first iliac artery (e.g., an ipsilateral or contralateral artery or limb); and a second downwardly extending limb portion 2014 (also referred to herein as a contralateral limb) configured to extend into a second iliac artery (e.g., the other of the ipsilateral and contralateral arteries or limbs), such as Fig.28 shown.

[0078] Although the figures illustrate an aneurysmal aortic bifurcation, the use of the embodiments disclosed herein is not limited to use in treating abdominal aortic aneurysms. Embodiments of the devices disclosed herein may be used to treat a variety of diseases and conditions of the aorta and aortic bifurcation, including but not limited to aortoiliac occlusive disease (AIOD) and other aneurysmal, embolic, and occlusive aortic conditions. Some embodiments of the stent device 2002 disclosed herein may have the advantage of having a lower profile than some variations of conventional self-expanding stent devices, which may be advantageous when treating certain conditions, such as a closed or partially closed aorta.

[0079] Any embodiments of the stent device 2002 disclosed herein can be an uncovered mechanically expandable (e.g., balloon expandable) stent or a covered mechanically expandable (e.g., balloon expandable) stent of a one-piece construction or other one-piece configuration, wherein the main body portion 2010, the first downwardly extending leg portion 2012, and the second downwardly extending leg portion 2014 are connected together before deployment. In some embodiments, the main 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 main body portion 2010, the first downwardly extending leg portion 2012, and the second downwardly extending leg portion 2014 can be formed separately and coupled together. In some embodiments, the main 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 coupled to the main body portion 2010 and the first downwardly extending leg portion 2012.

[0080] 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 other known or later developed techniques and materials. In any embodiment, the frame 2014 of the stent device 2002 can be made of 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 of any suitable graft material, 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 bifurcated stent structure that forms an inverted "Y" shape similar to an integral stent graft structure. In such embodiments, the main body portion 2010 in the expanded configuration can have a larger outer diameter and inner diameter than the leg portions 2012, 2014 extending downward.

[0081] Some embodiments of system 2000 may be used to treat diseased bifurcated vessels that may have one or more aneurysms, occlusions, or other aspects in the aorta and / or branch arteries. Figures 28 to 29D. In any embodiments disclosed herein, the delivery device 2004 can have an expansion balloon 2020 that can be preloaded in the stent 2002 and can be configured to extend across the bifurcation. For example, but not limited to, in some embodiments, the expansion balloon 2020 can be configured to extend through all or a portion of the first branch portion 2012 of the stent 2002, through 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.

[0082] In some embodiments, the expansion balloon 2020 can be made of a flexible material that is configured to bend around a bifurcation in the stent 2002 when the expansion balloon 2020 is in a deflated state and when the expansion balloon 2020 is in an inflated state. In some embodiments, the expansion balloon 2020 can be configured to be biased to bend around a bifurcation in the stent 2002 at least when the expansion balloon 2020 is in an expanded state (also in a Figures 30 to 32 B). For example, but not limited to, in some embodiments, the expansion balloon 2020 can have a longer length along the side of the expansion balloon 2020 that is positioned farther away from the center of the bending radius of the expansion balloon 2020 and / or farther away from the bifurcation. In some embodiments, the surface of the expansion balloon 2020 that is positioned farther away from the center of the bending radius of the expansion balloon 2020 and / or farther away from the bifurcation can have corrugations to allow the expansion balloon 2020 to maintain the desired bending angle of the bifurcation when the expansion balloon 2020 is expanded. In some embodiments, the surface of the expansion balloon 2020 that is positioned farther away from the center of the bending radius of the expansion balloon 2020 and / or farther away from the bifurcation can be more flexible than other portions of the expansion balloon 2020 to maintain the desired bending angle of the bifurcation when the expansion balloon 2020 is expanded. Some embodiments of the expansion balloon 2020 can have any combination of the foregoing features, and all such combinations are specifically contemplated herein, as if expressly stated herein. In any embodiments disclosed herein, the balloon 2020 can be pre-loaded in the stent 2002 .

[0083] like Fig.28 As shown, in some embodiments, the inner shaft 2038 can extend through the expansion balloon 2020. The contralateral wire 2040 can extend through the first branch portion 2012 and the second branch portion 2014 to help position the second branch portion 2014 in a second branch (e.g., the contralateral branch) of the patient's vasculature. In some embodiments, the wire 2040 can be delivered through the ipsilateral limb into the aorta and captured with a snare at the end of the snare wire inserted through the contralateral limb. The snare wire can then be pulled distally to move the wire 2040 into the contralateral limb.

[0084] Fig.29A An embodiment of a stent 2002 deployed from a sheath 2026 is shown. However, the outer catheter sheath 2026 is not required for the system 2000. Fig.29A Stent 2002 is shown having been positioned in a bifurcation of a patient's vasculature, with the body of stent 2002 positioned in the patient's aorta, a first branch portion 2012 of stent 2002 positioned in the first branch of the patient's vasculature, and a second branch portion 2014 of stent 2002 positioned in the second branch of the patient's vasculature. A balloon or at least a portion of balloon 2020 extends through all or a portion of first branch portion 2012 of stent 2002, past the bifurcation in the patient's vasculature and / or the bifurcation in stent 2002, and through all or a portion of second branch portion 2014 of stent 2002. Fig.29C Stent 2002 is shown before balloon 2020 has been expanded. Fig.29D Stent 2002 is shown after balloon 2020 has been expanded or at least partially expanded such that first branch portion 2012 of stent 2002 and second branch portion 2014 of stent 2002 are expanded with balloon 2020 .

[0085] In some embodiments, the balloon 2020 can be configured to expand only the first branch portion 2012 and the second branch portion 2014 of the stent 2002. In some embodiments, the balloon 2020 can be configured to also extend into the main body portion 2010 of the stent 2002 to expand the first branch portion 2012 and the second branch portion 2014 of the stent 2002 and expand the main body portion 2010 of the stent 2002 simultaneously or approximately simultaneously. Fig.30 , the second balloon 3500 can be positioned in the limb or body portion 3100 of the stent device 3000 and can be configured to expand simultaneously or approximately simultaneously with the first balloon 3400, or to expand after the first balloon 3400 is expanded or before the first balloon 3400 is expanded. Thereafter, the second balloon 3500 can be deflated and withdrawn through the first branch 3200 of the patient's vasculature or through the second branch 3300 of the patient's vasculature. In some embodiments, as Fig.31A and 31 As shown in FIG. 2B , the first balloon 3400 can extend through the first branch portion 3200 of the stent device 3000 and enter the main body portion 3100 of the stent device, and the second balloon 3500 can be positioned in the second branch portion 3300 of the stent device 3000. The first balloon 3400 can be a stepped balloon so that it expands the main body 3100 and the first branch 3200, as shown in FIG. Fig.31B Therefore, in combination with the expanded second balloon 3500, the entire stent device 3000 is expanded.

[0086] 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 can be more flexible than the first balloon 3400 (if any) extending through the main body portion of the stent device 3000. Fig.32A and 32 In the exemplary embodiment shown in B, the second balloon 3500 expands the first branch 3200 and the second branch 3300 while the first balloon 3400 expands the main body 3100 of the stent device 3000 . Fig.33 4140 and 4240, respectively. The first balloon 4120 is connected to and positioned with the outer shaft 4100, while the second balloon 4220 is connected to and positioned with the inner shaft 4200. The inner shaft 4200 can be slidably received within the outer shaft 4100 and have a closed end 4300. The second balloon 4220 can have an inflation port 4160 for expanding the balloon 4220 with an inflation material. Although not shown, the first balloon will also have a port for the inflation material.

[0087] Some embodiments of system 2000 can be configured so that stent 2002 is curled around the inner core of delivery catheter 2022 with compression configuration. Some embodiments of catheter 2022 can be advanced through the puncture site in the first iliac artery by an introducer, and can be advanced through the bifurcation of the aorta, or advanced through any puncture site or opening into any part of the patient's vascular system. The contralateral line 2040 can be extracted through the second puncture site in the second iliac artery. In some embodiments, sheath 2026 can be extracted through the first puncture site, thereby exposing stent device 2002, which can then move toward bifurcation, wherein the first branch portion 2012 is extracted into the first iliac artery (such as but not limited to the ipsilateral iliac artery), and the second limb portion 2014 moves or is extracted into the second iliac artery (such as but not limited to the contralateral iliac artery). When the stent is positioned in the patient's vascular system, the stent device 2002 can still be in a contracted or low profile state. In some embodiments, the stent 2002 can be withdrawn toward the aortic bifurcation so that the bifurcated portion of the stent 2002 moves into contact with the aortic bifurcation, thereby placing the stent 2002 at the aortic bifurcation. The main body portion 2010 and the first branch portion 2012 can then be expanded, such as with an expansion balloon or other mechanically expandable device, or if the stent is a hybrid stent, the main body portion and / or the first branch portion 2012 can be self-expanding.

[0088] Fig.33Another embodiment of a stent deployment system is shown. Fig.33 , the expansion lumen of each expansion balloon of two or more expansion balloons can be coaxially positioned. This can significantly reduce the profile of the device and simplify the delivery procedure. For example, but not limited to, a first balloon (e.g., balloon 1) can be coupled to a first axis (e.g., an outer axis), and a second balloon (e.g., balloon 2) can be coupled to a second axis (e.g., an inner axis). The outer axis can be positioned above the outer surface of the inner axis and around the outer surface of the inner axis so that the outer axis is coaxial or approximately coaxial with the inner axis. In some embodiments, the first balloon can be used to expand a first branch portion of the stent, and the second balloon can be used to expand a second branch portion of the stent or a main body portion of the stent.

[0089] Although certain embodiments of the present invention have been described, these embodiments are presented only by way of example and are not intended to limit the scope of the present disclosure. In fact, the novel methods and systems described herein may be embodied in various other forms. In addition, various omissions, substitutions, and changes may be made to the systems and methods described herein without departing from the spirit of the present disclosure. The attached claims and their equivalents are intended to cover such forms or modifications that fall within the scope and spirit of the present disclosure. Therefore, the scope of the present invention is limited only by reference to the attached claims.

[0090] Features, materials, characteristics or groups described in conjunction with a particular aspect, embodiment or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except where combinations of at least some of these features and / or steps are mutually exclusive. Protection is not limited to the details of any foregoing embodiments. Protection extends to any novel one or any novel combination of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel one or any novel combination of the steps of any method or process so disclosed.

[0091] In addition, certain features described in the context of separate embodiments in this disclosure may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented in multiple embodiments individually or in any suitable sub-combination. In addition, although features may be described above as functioning in certain combinations, in some cases, one or more features may be deleted from the claimed combination, and the combination may be claimed as a sub-combination or a variation of a sub-combination.

[0092] In addition, although the operations may be depicted in the drawings or described in the specification in a particular order, such operations do not need to be performed in the particular order shown or in a continuous order, or all operations do not need to be performed to achieve the desired result. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously or between any described operations. In addition, the operations may be rearranged or reordered in other embodiments. It will be appreciated by those skilled in the art that in some embodiments, the actual steps taken in the process shown and / or disclosed may be different from those shown in the figures. According to an embodiment, some of the above steps may be removed, or other steps may be added. In addition, the features and attributes of the above disclosed specific embodiments may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. In addition, the separation of the various system components in the above embodiments should not be understood as requiring such separation in all embodiments, and it should be understood that the components and systems may generally be integrated together in a single product or packaged into multiple products.

[0093] For purposes of the present disclosure, certain aspects, advantages, and novel features are described herein. Not all such advantages may be achieved according to any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or performed in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as taught or suggested herein.

[0094] Unless expressly stated otherwise or otherwise understood in the context of use, conditional language (such as "can," "could," "might," or "may") is generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic (with or without user input or prompting) for deciding whether such features, elements, and / or steps are included or are to be performed in any particular embodiment.

[0095] Unless expressly stated otherwise, conjunction language (such as the phrase "at least one of X, Y, and Z") should be interpreted according to the context of normal usage to convey that an item, term, etc. may be X, Y, or Z. Thus, such conjunction language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0096] The degree language used herein (such as the terms "approximately", "about", "generally" and "substantially") represents a value, amount or characteristic that is close to still performing the desired function or achieving the desired result. For example, the terms "approximately", "about", "generally" and "substantially" can refer to an amount that is less than 10% of the amount, less than 5%, less than 1%, less than 0.1% and less than 0.01%. As another example, in certain embodiments, the terms "roughly parallel" and "substantially parallel" refer to a value, amount or characteristic that is less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree or 0.1 degrees from exact parallelism. The scope disclosed herein also covers any and all overlaps, sub-ranges and combinations thereof, as well as any specific values ​​within these ranges. Language (such as "at most", "at least", "greater than", "less than", "between", etc.) includes the described numbers. The numbers and values ​​used herein are preceded by terms (such as "about" or "approximately") that include the described numbers. For example, "approximately 7 mm" includes "7 mm", and numbers and ranges preceded by terms (such as "about" or "approximately") should be interpreted as disclosing numbers and ranges with or without such terms preceding the numbers or values, such that the present application supports claiming numbers, values, and ranges disclosed in the specification and / or claims with or without terms (such as "about" or "approximately") preceding such numbers, values, or ranges, for example, "about two times to about five times" also includes disclosure of a range of "two times to five 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, and may be limited by the claims as set forth in this section or elsewhere in this specification or as set forth in the future. The language of the claims should be interpreted broadly based on the language employed in the claims, and is not limited to the examples described in this specification or during the prosecution of the application, which examples should be interpreted as non-exclusive.

[0097] Appendix A - Disclosure of U.S. Patent No. 8,808,350 Background Art

[0099] An introducer catheter or introducer sheath can be used to place a catheter into a blood vessel in a minimally invasive manner. The introducer catheter sheath typically includes a tubing inserted into the blood vessel and a seal or valve at the proximal end of the tubing positioned outside the body. The seal can provide a hemostatic seal to prevent blood loss. A stent or other medical prosthesis is typically passed through the introducer sheath into the blood vessel or body passage. Therefore, the introducer sheath provides a continuous passage for delivering a stent or other medical prosthesis, protects the inner wall of the blood vessel or body passage from damage when the stent or other prosthesis is advanced through the body passage, and provides a hemostatic seal to prevent blood loss.

[0100] In some cases, the catheter requires extensive manipulation within the vessel. For example, placement of a stent or stent graft may require precise positioning of the delivery catheter axially and rotationally at a specific location within the vessel. Additionally, deployment of the stent may require precise manipulation of the delivery system within the introducer. In these cases, the operator must carefully control the positioning of the introducer and delivery system. A delivery system that allows a user or practitioner to precisely control the axial positioning of the stent or prosthesis during deployment is desired. Summary of the invention

[0101] Embodiments disclosed herein relate to a catheter system for inserting and positioning a diagnostic device or a therapeutic device into a blood vessel. The system includes an introducer or an introducer sheath (also referred to herein as an outer sheath) and at least one delivery catheter. The introducer catheter can be introduced into the bloodstream through the percutaneous puncture site. The docking mechanism can engage the proximal end 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.

[0102] The catheter system may include an introducer catheter and a delivery catheter, wherein the introducer catheter includes an outer sheath and a seal having an adjustable hemostatic valve connected to a proximal portion of the outer sheath. The introducer catheter and the delivery catheter may be configured such that the delivery catheter may be removably engaged with the introducer catheter, such that when the delivery catheter is engaged with the introducer catheter, the delivery catheter may be axially secured to the introducer catheter to prevent significant axial movement between the introducer catheter and the delivery catheter, and such that the catheters can be manipulated in an axial direction as a single unit.

[0103] Alternatively, the delivery catheter and the introducer catheter can be configured so 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 so that its inner core can be locked or substantially prevented from rotating relative to the outer sheath of the introducer catheter and / or relative to the introducer catheter. A method for placing a stent or medical prosthesis in a blood vessel is also disclosed, wherein the stent or medical prosthesis passes through the introducer sheath, and the proximal end of the introducer catheter physically engages with the distal end portion of the delivery catheter or removably docks with the distal end portion to prevent significant axial movement between the introducer sheath and the delivery catheter.

[0104] Some endoprostheses (including stents, grafts, stent grafts and anatomical treatment devices, all such endoprostheses are collectively referred to herein as a stent or multiple stents) may need to be accurately placed in both the axial direction and the rotational direction. For example, a stent or stent graft with a fenestration requires these fenestrations to be accurately placed relative to a branch vessel. The catheter system disclosed herein can be configured to allow the delivery catheter and therefore the stent to rotate relative to the introducer sheath. In some embodiments, 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 lubricating substances), or by applying a hydrophilic coating to the outer surface of the inner core of the delivery catheter or the restraining sheath, the friction that may otherwise hinder the rotational freedom of the delivery catheter can be further reduced. The lubricant can be applied to the target surface.

[0105] Thus, when the delivery catheter is rotated within the introducer sheath, the introducer sheath can remain rotationally stationary or fixed. This can protect the delivery catheter and stent from damage, twisting or stress during the rotational manipulation of the delivery catheter and stent, and also prevent the rotation of the delivery catheter or stent from causing any damage or stress to the vessel wall.

[0106] In addition, the delivery catheter can be configured to allow a user or medical practitioner to selectively control or prevent the rotational movement of the delivery catheter and the stent relative to the introducer catheter, or the 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, and the threaded hub is configured to selectively contract or tighten against the outer wall of the delivery catheter inner core. By contracting the hub against the inner core, the inner core can be prevented or inhibited from rotating relative to the introducer catheter. By loosening the hub relative to the inner core, the rotational freedom of the inner core or the delivery catheter relative to the introducer sheath can be restored. BRIEF DESCRIPTION OF THE DRAWINGS

[0107] These and other features, aspects and advantages will now be described in conjunction with certain embodiments with reference to the accompanying drawings. However, the embodiments shown are only examples and are not intended to be limiting. The following is a brief description of the drawings.

[0108] Figure 1A is a schematic representation of a catheter system including a docking arrangement for physically engaging a catheter with an introducer sheath.

[0109] Figure 1B yes Figure 1A A schematic representation of the catheter system shown in , showing the catheter engaged with an introducer sheath.

[0110] Figure 2Ais a schematic representation of another catheter system including a docking arrangement for physically engaging a catheter with an introducer sheath.

[0111] Figure 2B yes Figure 2A A schematic representation of the catheter system shown in , showing the catheter engaged with an introducer sheath.

[0112] Figure 2C yes Figure 2A A schematic representation of the catheter system shown in , showing the mechanism for disengaging the catheter from the introducer sheath.

[0113] Figure 3A is a schematic representation of another catheter system including a docking arrangement for physically engaging a catheter with an introducer sheath, the catheter system being configured to deliver a stent or stent graft into a blood vessel.

[0114] Figure 3B yes Figure 3A A schematic representation of the catheter system shown in , showing the catheter engaged with an introducer sheath.

[0115] Figure 3C yes Figure 3A Schematic representation of the catheter system shown in FIG, showing the axial insertion of the stent into the Figure 3A The tubular sheath of the introducer sheath shown in FIG.

[0116] Figure 3D is a schematic representation of the catheter system shown in 3A, showing the stent in Figure 3A The introducer sheath is shown deployed after the tubular sheath has been retracted from the stent.

[0117] Figure 4 is an oblique view of a catheter system including an introducer and a delivery catheter.

[0118] Figure 5 yes Figure 4 Oblique view of the introducer shown in .

[0119] Fig. 6A yes Figure 5 A first exploded assembly view of the introducer is shown in FIG.

[0120] Figure 6B yes Figure 5 A second exploded assembly view of the introducer is shown in FIG.

[0121] Figure 7 yes Figure 4 An oblique view of the delivery catheter shown in FIG.

[0122] Fig. 8A yes Figure 7A first exploded assembly view of the delivery catheter is shown in FIG.

[0123] Figure 8B yes Figure 7 A second exploded assembly view of the delivery catheter is shown in FIG.

[0124] Fig. 9 yes Figure 4 An oblique view of the catheter system shown in , showing the delivery catheter before the docking mechanism of the delivery catheter has engaged with the docking mechanism of the introducer.

[0125] Fig.10 yes Figure 4 An oblique view of the catheter system shown in , showing the delivery catheter after the docking mechanism of the delivery catheter has engaged with the docking mechanism of the introducer.

[0126] Fig.11 yes Figure 4 End view of the catheter system shown in .

[0127] Fig.12 yes Figure 4 As shown in Fig.11 A cross-sectional view of the catheter system taken at line 12-12.

[0128] Fig.13 yes Figure 4 An enlarged cross-sectional view of the catheter system shown in Fig.12 Close-up of 13-13.

[0129] Fig.14 yes Figure 4 An enlarged cross-sectional view of the catheter system shown in Fig.13 Close-up of 14-14.

[0130] Fig.15 yes Figure 4 As shown in Fig.11 A cross-sectional view of the catheter system taken at line 15-15.

[0131] Fig.16 is an oblique view of a catheter system having a delivery catheter assembly docked to an introducer catheter assembly.

[0132] Fig.17 yes Fig.16 An oblique view of the delivery catheter assembly.

[0133] Fig.18 yes Fig.16 A top view of the delivery catheter assembly.

[0134] Fig.19 yes Fig.16Side view of the delivery catheter assembly.

[0135] Fig. 20 yes Fig.16 An oblique view of a delivery catheter assembly showing the sheath in a fully retracted position relative to the core member.

[0136] Fig.21 yes Fig.16 0014] A side view of a delivery catheter showing a handle member and an inner core in a first, pre-deployment position relative to a housing axis of the delivery catheter.

[0137] Fig. 22 yes Fig.16 0014] A side view of a delivery catheter showing the handle member and inner core in a second partially deployed position relative to a housing axis of the delivery catheter.

[0138] Fig.23 yes Fig.16 0026] A side view of a delivery catheter of FIG. 1 showing the handle member and inner core in a third fully advanced position on the housing shaft of the delivery catheter.

[0139] Fig.24 is an oblique view of the core engagement assembly and inner core showing the inner core in a first disengaged position relative to the inner core engagement assembly, with other components of the delivery catheter removed from this view for clarity.

[0140] Fig.25 is a cross-sectional view of a portion of a delivery catheter through an axial centerline of the delivery catheter showing the inner core in a first disengaged position relative to the inner core engagement assembly.

[0141] Fig.26 Yes Fig.24 An oblique view of the inner core engagement assembly and the inner core in FIG. 1 shows that the inner core is in a second partially engaged position relative to the inner core engagement assembly.

[0142] Fig. 27 Yes Fig.26 A side view of the inner core engagement assembly and the inner core in FIG. 1 , showing the inner core in a second partially engaged position relative to the inner core engagement assembly.

[0143] Fig.27A It passes through Fig.29 27A-27A is a cross-sectional view of a portion of a delivery catheter taken along line 27A-27A, illustrating one or more components of the delivery catheter in a first position.

[0144] Fig.27B It passes through Fig.29 27A-27A is a cross-sectional view of a portion of the delivery catheter taken along line 27A-27A, illustrating one or more components of the delivery catheter in a second position.

[0145] Fig.28 Yes Fig.26 A top view of the inner core engagement assembly and the inner core in FIG. 1 shows the inner core in a second partially engaged position relative to the inner core engagement assembly.

[0146] Fig.29 is a cross-sectional view of a portion of a delivery catheter through an axial centerline of the delivery catheter showing the inner core in a second partially engaged position relative to the inner core engagement assembly.

[0147] Fig.30 Yes Fig.24 An oblique view of the inner core engagement assembly and the inner core in FIG. 1 shows that the inner core is in a third engagement position relative to the inner core engagement assembly.

[0148] Fig.31 Yes Fig.30 A side view of the inner core engagement assembly and the inner core in FIG. 1 , showing the inner core in a third engagement position relative to the inner core engagement assembly.

[0149] Fig.32 Yes Fig.30 A top view of the inner core engagement assembly and the inner core in FIG. 1 shows that the inner core is in a third engagement position relative to the inner core engagement assembly.

[0150] Fig.33 is a cross-sectional view of a portion of the delivery catheter through an axial centerline of the delivery catheter showing the inner core in a third engaged position relative to the inner core engagement assembly.

[0151] Fig.34 is a cross-sectional view of a portion of a delivery catheter through an axial centerline of the delivery catheter showing the inner core in a disengaged position relative to the inner core engagement assembly.

[0152] Fig.35 is a cross-sectional view of a portion of a delivery catheter through an axial centerline of the delivery catheter showing the inner core in an engaged position relative to the inner core engagement assembly.

[0153] Fig.36 is an illustration of a prosthesis partially deployed by a delivery catheter.

[0154] Fig.37 It is possible to Fig.36 Side view of an exemplary stent deployed with the delivery catheter shown in FIG.

[0155] Fig.38 is a schematic side view of a catheter system with an introducer catheter assembly showing a stent loaded into an outer sheath of the introducer catheter.

[0156] Fig.39is a schematic side view of a catheter system having a deployment catheter assembly showing a stent supported therein and a branch vessel line assembly loaded in a delivery catheter.

[0157] Fig.40 is Fig.39 A cross-sectional view of the branch vessel line assembly taken at line 40-40.

[0158] Fig.41 yes Fig.39 An enlarged schematic diagram of portion 41 - 41 of a branch vessel line assembly. DETAILED DESCRIPTION

[0159] The following detailed description is now directed to certain specific embodiments. In this specification, reference is made to the accompanying drawings, wherein like components are represented by like numbers throughout the specification and the drawings. Various embodiments of a catheter system are described below, which can include an introducer sheath and a docking arrangement. The catheter system disclosed herein can be used in diagnostic or therapeutic procedures, such as, but not limited to, an endovascular prosthesis deployment procedure.

[0160] Figure 1A is a schematic representation of a catheter system 10 that includes a docking arrangement configured to physically engage a catheter 20 with an introducer 12 . Figure 1B yes Figure 1A , showing a catheter 20 engaged with an introducer 12. The catheter 20 or any catheter disclosed herein may be a diagnostic or therapeutic catheter, or any other suitable catheter. The introducer 12 may include a tubular sheath 14, a seal 16, and a female docking mechanism 18. The first seal 16 may be a rubber seal, an interference fit or close tolerance fit between adjacent components, an adjustable hemostatic valve, or any other suitable sealing component or feature.

[0161] The catheter 20 has a shaft 24 and a male docking mechanism 22. Figure 1B , the catheter 20 is inserted into the introducer 12, and the female docking mechanism 18 is engaged with the male docking mechanism 22. When the docking mechanisms are engaged, the docking mechanisms prevent the introducer 12 and the catheter 20 from moving axially relative to each other. In addition, the catheter system 10 is configured so that the catheter 20 can be rotated within the introducer 12, even when the catheter 20 is docked with the introducer 12.

[0162] The introducer 12 includes a tubular introducer sheath 14 and a seal 16 connected to the proximal end of the introducer sheath 14 (which seal can also be a rubber seal, an interference fit or a close tolerance fit, an adjustable hemostatic valve, or any other suitable sealing component or feature). The overall design of the sheath 14 and the seal 16 can be similar to the design of commercially available introducers or any other introducers currently known or later developed. The catheter 20 has an outer dimensional profile (cross profile) that can be sized and / or configured to pass through the introducer sheath 14. The proximal end of the catheter 20 and the proximal end of the introducer sheath 14 are configured to be permanently or removably engaged with each other and allow the catheter 20 to rotate within the introducer sheath 14 while substantially limiting the axial movement of the catheter 20 relative to the introducer sheath 14.

[0163] The size of the introducer lumen is determined relative to the size of the outer sheath (containing the stent graft), in one configuration, they have the same size and the introducer acts as a sheath, because the stent graft is pushed through the lumen that reaches the introducer from its initial positioning in the outer sheath. In a second configuration, the introducer lumen is larger than the outer diameter of the outer sheath, and the two are easily rotated relative to each other according to the needs of rotational alignment. In addition, the introducer material can be a softer or more flexible material than the outer sheath, so although the stent graft can be initially loaded into a firm high-strength sheath material, it can be squeezed into a lower strength, more flexible introducer material within the time required for the stent graft to be delivered to its treatment site. The material that may be used to provide this feature includes any type of soft polymer extrusion, including nylon, PEBAX and PE.

[0164] After the catheter and the introducer are engaged, the combined system can be operated by a single operator. The catheter system 10 is configured so that the catheter 20 can be rotated substantially freely within the introducer sheath 14, which can allow accurate rotational positioning of the catheter within the introducer. After the operation is completed, the catheter 20 is disengaged from the introducer 12 so that the catheter 20 can be removed from the patient's body. In addition, the introducer 12 can be repositioned to perform a second intervention, and a second catheter can be inserted and engaged with the introducer 12 to perform additional operations.

[0165] Figure 2A is a schematic representation of a catheter system 40 including a docking arrangement for physically engaging a catheter 50 with an introducer 42 . Figure 2B is a schematic representation of catheter system 40 showing catheter 50 engaged with introducer 42 . Figure 2C yes Figure 2A A schematic representation of the catheter system 40 shown in FIG. 4 illustrates a mechanism for disengaging the catheter 50 from the introducer 42 .

[0166] Specifically, Figure 2C It is schematically illustrated 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 elongated and can include a lever 56.

[0167] Figure 3A is a schematic representation of a catheter system 60 including a docking arrangement for physically engaging a catheter 70 with an introducer 62, the catheter system 60 being configured to deliver a stent or stent graft 80 into a blood vessel.

[0168] Figure 3B yes Figure 3A A schematic representation of a catheter system 60 is shown in FIG. 5 , showing a catheter 70 engaged with an introducer 62 . Figure 3C yes Figure 3A Schematic representation of a catheter system 60 is shown in FIG. 1, illustrating the axial insertion of a stent or stent graft 80 into the Figure 3A The tubular sheath 64 of the introducer 62 is shown in FIG. Figure 3D yes Figure 3A A schematic representation of the catheter system 60 shown in FIG. Figure 3A The stent 80 is shown deployed after the tubular sheath 64 of the introducer 62 has been retracted from the stent 80 .

[0169] The self-expanding stent or stent graft is typically retained in 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 maintain the stent or stent graft in a collapsed low profile configuration during delivery. The stent or stent graft can be deployed in the desired location of the vessel by removing the deployment sheath and allowing the stent or stent graft to expand radially against the vessel wall. In order to pass such a delivery catheter into the desired vessel, the catheter system can be configured so that the inner diameter of the introducer sheath is greater than the outer diameter of the deployment sheath. Clinicians prefer low-profile introducer sheaths to minimize damage to the vessel and allow entry into small vessels.

[0170] A cartridge system has been developed in which a stent or stent graft can be transferred from a delivery sheath into an introducer sheath, and the stent or stent graft can be passed through the introducer sheath to a target location. In such cartridge systems, the introducer sheath effectively acts as a deployment sheath. This transfer eliminates the need for a second sheath and minimizes the profile of the system in the vessel. The docking arrangement provides a secure engagement of the delivery catheter and the introducer sheath before the stent or stent graft is transferred into the introducer sheath. This prevents potential user errors in the transfer and further converts the delivery catheter and introducer sheath into a single-user system.

[0171] like Figures 3A to 3DAs shown, the catheter system 60 is used to transfer and deploy a stent or stent graft 80 into a blood vessel (vessel not shown). As shown, the introducer 62 includes a tubular sheath 64 inserted into the patient's body. The proximal end 62a of the introducer 62 can be sized and / or configured to accommodate the deployment sheath 74 of the catheter 70. The introducer sheath can also have a seal 66 (referred to herein as the first seal) and a female docking mechanism 68, similar to any embodiment of the above-mentioned seal, hemostatic valve and / or docking mechanism. The seal 66 can be an annular rubber seal (as shown), an interference fit or close tolerance fit between adjacent components, an adjustable hemostatic valve or any other suitable sealing component or feature. The stent delivery catheter 70 can include an inner core 78, a bag 82 that can accommodate the collapsed stent 80, a deployment sheath 74 that can hold the collapsed stent 80, and a catheter tip 76.

[0172] like Figure 3B As shown, when the docking mechanisms 68 and 72 are engaged, the catheter 70 can be inserted into the introducer 62. In some embodiments (not shown), the deployment sheath 74 of the delivery catheter 70 can be sized and configured to be received within the larger diameter proximal end 62a of the introducer sheath and extend into 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 larger diameter proximal end 62a of the introducer sheath, rather than being received within the distal tubular sheath 64 of the introducer 62. In some embodiments, as shown Figure 3C and 3D As illustrated, the deployment sheath 74 and tubular sheath 64 may be sized and configured such that when the deployment sheath 74 has been advanced through the proximal end 62a of the introducer sheath, the similar size or shape of the distal tubular sheath 64 may prevent the deployment sheath 74 from being advanced through the distal tubular sheath 64. The inner and / or outer diameters of the deployment sheath 74 and tubular sheath 64 may be substantially the same.

[0173] like Figure 3C As shown, the inner core 78 of the catheter 70 can be pushed distally, 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. Therefore, the tubular sheath 64 can be used 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 passes through a traditional introducer sheath, the sheath of the introducer must have a larger diameter than the deployment sheath of the delivery catheter to accommodate the stent and the deployment sheath. 2) Other advantages mentioned:

[0174] In the described configuration, the device can be rotated after being introduced into the introducer but before being deployed, and in addition, the device can be accurately positioned due to the low friction between the introducer and the outer sheath. When devices with expansion diameters of 25 and 28 mm diameter are to be used, the same (one size) introducer sheath can be used to deliver either or both devices. Only when a larger 34 mm diameter device with a larger compressed cross profile is to be delivered, a larger introducer is required. The fact that the introducer and delivery catheter are mechanically engaged and form a single integral structure that can be held with one hand allows a single user to manipulate the entire system with two hands (one hand holds the core stationary, while the other hand manipulates the sheath retraction mechanism).

[0175] As is known in the art, a delivery catheter with a loaded stent graft is generally less trackable and pushable than an introducer sheath supported by an expander. This is due to the fact that the stent graft changes the local stiffness of the catheter. This can cause the delivery catheter to kink during insertion. By first placing the introducer sheath with the expander, a conduit is established for placement of the stent graft. The likelihood of the delivery system kinking while pacing through the sheath is very small.

[0176] Figure 4 1 is an oblique view of another catheter system 100, which includes an introducer catheter 102 (also referred to as an introducer) and a delivery catheter 104. The delivery catheter 104 can be configured to deliver an endoluminal prosthesis, or for any other suitable use. Therefore, the embodiments of the catheters and introducers disclosed herein can be configured to be used for any suitable purpose, and the embodiments of the introducers disclosed herein can be configured to receive any suitable catheter design.

[0177] Figure 5 yes Figure 4 An oblique view of the introducer 102 of the catheter system 100 is shown in FIG. Fig. 6A and 6B yes Figure 5 1 and 2 are exploded views of the introducer 102 shown in FIG. Figures 4 to 6 , the introducer 102 may have a body 106 , a threadably engageable hub portion 108 , an introducer sheath 110 , and a threaded cap 111 configured to threadably engage with a threaded end portion of the body 106 .

[0178] In some embodiments, the first tube 107 may be supported by the body 106 to provide an orifice or access port into the body 106. The first tube 107 may be used to flush the introducer 102 with saline or other suitable substances at any stage, such as but not limited to, before an endoluminal prosthesis is advanced through the introducer 102, or before other procedures in which the introducer may be used. The first tube 107 may support any suitable medical connector and / or valve on its distal end.

[0179] The introducer sheath 110 can have an elongated portion 110a extending to any predetermined or desired length. As will be discussed in more detail below, similar to the introducer 12 of the catheter system 10 described above, the introducer sheath 110 can be configured so that an endoluminal prosthesis advanced into the introducer sheath 110 can be constrained or limited by the introducer sheath 110. In this arrangement, the inner diameter and / or outer diameter of the introducer sheath 110 can be substantially the same or similar to the inner diameter and / or outer diameter of the outer sheath of the delivery catheter engaged with the introducer 102. The cross-section of the elongated portion 110a can be circular (as shown), or can define any suitable cross-sectional shape, such as, but not limited to, a triangle, a square, a hexagon, an octagon, or a polygon.

[0180] In addition, if Fig. 6A As best shown in FIG. 1 , the introducer sheath 110 can have a flared end portion 110 b that can be configured to abut the front surface 106 a of the body 106 . Fig. 6A , the elongated portion 110a of the introducer sheath 110 can pass through the opening formed in the cap 111 so 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 supporting the introducer sheath 110 can be threadedly engaged with the body 106 so that the introducer sheath 110 can be supported by the body 106.

[0181] In addition, refer to Fig. 6A and 6B , a tubular support or spacer 109 can be inserted over the elongated portion 110a of the introducer sheath 110 and positioned proximate to the flared portion 110b. The tubular spacer 109 can improve the fit and, therefore, the seal between the outer surface of the catheter sheath 110 and the cap 111. The tubular spacer 109 can also provide additional support for the introducer sheath 110.

[0182] Figure 7 yes Figure 4 004 of an embodiment of the catheter system 100 is shown in FIG.

[0183] Fig. 8A and 8B yes Figure 7 1 and 2. There are first and second exploded assembly views of the delivery catheter 104 shown in FIG.

[0184] Fig. 9 yes Figure 4 , which is an oblique view of the catheter system 100 shown in , shows the delivery catheter 104 before the docking mechanism of the delivery catheter 104 has engaged with the docking mechanism of the introducer 102.

[0185] Fig.10 yes Figure 4 , which is an oblique view of the catheter system 100 shown in , illustrates the delivery catheter 104 after the docking mechanism of the delivery catheter 104 has engaged with the docking mechanism of the introducer 102.

[0186] Fig.11 yes Figure 4 An end view of the catheter system is shown in FIG. 1 , with the delivery catheter 104 engaged with the introducer 102 . Fig.12 yes Figure 4 As shown in Fig.11 A cross-sectional view of an embodiment of the catheter system 100 taken at line 12-12. Fig.13 yes Figure 4 As shown in Fig.12 An enlarged cross-sectional view of the catheter system 100 is defined by curve 13-13. Fig.14 yes Figure 4 As shown in Fig.13 An enlarged cross-sectional view of an embodiment of a catheter system defined by curve 14-14. Finally, Fig.15 yes Figure 4 As shown in Fig.11 A cross-sectional view of the catheter system taken at line 15-15.

[0187] like Fig.12 and 15 As most clearly shown in FIG. 1 , the hub portion 108 of the introducer 102 can have a docking mechanism or flange 112, or can be configured to removably receive or engage with the delivery catheter 104. In some embodiments, such as in the illustrated embodiment, the docking mechanism 112 of the introducer 102 can be configured as a female receptacle configured to receive a male docking member of the catheter 104, as will be 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.

[0188] refer to Fig.12 , 1315, some embodiments of the sealing portion of the introducer 102 will be described. As described above, the hub portion 108 can be configured to threadably engage with the body 106. The body 108 can define an inner annular surface 116 that can be angled (so as not to be perpendicular to the axial centerline of the catheter system 100). The surface 116 can be at an angle of about 75 degrees relative to the axial centerline of the catheter system 100, or at an angle of about 65 degrees or less to about 80 degrees or more relative 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.

[0189] Similarly, the hub portion 108 can define an inner annular surface 118 that can be angled so as to be non-perpendicular to the axial centerline of the catheter system 100. The surface 118 of the hub portion 108 can be angled at about 75 degrees relative 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 at an angle of about 65 degrees or less to about 80 degrees or more relative to the axial centerline of the catheter system 100. In some embodiments, such as in the illustrated embodiment, the shape and angular orientation of the surface 118 of the hub portion 108 can be substantially less than 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.

[0190] An annular sealing 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 sealing member 120 can be formed of an elastic material such as silicone, rubber, or any other suitable material. The sealing member 120 can be configured so that when the hub portion 108 is threadedly connected to the body 106, the surface 118 of the hub portion 108 can move axially toward the surface 116 of the body 106, thereby compressing or squeezing the sealing member 120. The relative angles of the surface 116 of the body 106 and the surface 118 of the hub portion 108 can cause the sealing member 120 to be forced against the outer sheath 122 of the delivery catheter 104 or other components of the delivery catheter 104 that are engaged with the introducer 102, thereby creating an adjustable seal between the outer sheath 122 of the delivery catheter 104 and the introducer 102, and the outer sheath can protrude distally from the end portion of the delivery catheter 104. The level of seal may be adjusted by tightening or loosening the hub portion 108 of the introducer 102 relative to the body 106 of the introducer 102. The introducer 102 may be configured to provide a seal for devices having profiles ranging from 1 Fr to 20 Fr.

[0191] Alternatively, in some embodiments, any seal or seal portion described herein may be an interference fit or close tolerance fit between adjacent components, such as the outer sheath 122 of the introducer 102 and one or more inner surfaces of the body 106 or hub portion 108. In some embodiments, any seal or seal portion described herein may be an interference fit or close tolerance fit between the inner core 154 and one or more inner surfaces of the body 140 or hub portion 142 of the catheter 104.

[0192] like Figure 7 , 8A As shown in FIG. 8B , some embodiments of the delivery catheter 104 may include a body 140 and a hub portion 142 threadably engaged with the body 140. Some embodiments of the delivery catheter 104 may also have an outer sheath 122 supported by the body 140. Specifically, the outer sheath 122 may be removably supported by the body 140 using a cap 123 threadably supported by the body 140. In addition, the outer sheath 122 may have an elongated portion 122a extending to any predetermined or desired length.

[0193] As described above, the inner diameter and / or outer diameter of the outer sheath 122 of the delivery catheter 104 can be substantially the same or similar to the inner diameter and / or outer diameter of the introducer sheath 110. The cross-section of the elongated portion 122a can be circular (as illustrated), or can define any suitable cross-sectional shape, such as, but not limited to, a triangle, a square, a hexagon, an octagon, or a polygon.

[0194] The outer sheath 122 may have a flared end portion 122b that may be configured to abut against the front surface 140a of the body 140. Fig. 8A , the elongated portion 122a of the outer sheath 122 can pass through the opening formed in the cap 123, so that the flared portion 122b of the outer sheath 122 can engage and / or overlap with the inner surface of the cap 123. In this configuration, as described above, the cap 123 supporting the outer sheath 122 can be threadedly engaged with the body 140 so that the outer sheath 122 is supported by the body 140.

[0195] In addition, refer to Fig. 8A and 8B , a tubular support or spacer 125 can be inserted over the elongated portion 122a of the outer sheath 122 and positioned proximate to the flared portion 122b of the outer sheath 122. The tubular spacer 125 can improve the fit between the outer surface of the outer sheath 122 and the cap 123 and thus the seal therebetween. The tubular spacer 125 can also provide additional support for the outer sheath 122.

[0196] Similar to the hub portion 108 of the introducer 102, the hub portion 142 of the delivery catheter 104 can be configured to threadably engage with the body 140 of the delivery catheter 104. The body 140 can define an inner annular surface 146 that can be angled so as not to be perpendicular to the axial centerline of the catheter system 100. The surface 146 can be angled at about 75 degrees relative to the axial centerline of the catheter system 100, or at an angle of about 80 degrees or more to about 65 degrees or less relative 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.

[0197] In some embodiments, the second tube 141 may be supported by the body 140 to provide an orifice or access port into the body 140. The second tube 141 may be used to flush the delivery catheter 104 with saline or other suitable substances at any stage, such as but not limited to, prior to advancing an endoluminal prosthesis through the delivery catheter 104 and / or introducer 102, or prior to other procedures in which the delivery catheter may be used. The second tube 141 may support any suitable medical connector and / or valve on its distal end.

[0198] Similarly, the hub portion 142 can define an inner annular surface 148 that can be angled so as to be non-perpendicular to the axial centerline of the catheter system 100. The surface 148 of the hub portion 142 can be angled at about 75 degrees relative 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, or at an angle of about 65 degrees or less to about 80 degrees or more relative to the axial centerline of the catheter system 100. The surface 148 can be substantially perpendicular to the axial centerline of the catheter system 100.

[0199] Similar to the introducer, in some embodiments, a seal or seal portion including an annular sealing 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 sealing member 150 can be formed of an elastic material such as silicone, rubber, or any other suitable material. The sealing member 150 can be configured so that when the hub portion 142 is threaded onto the body 140, the surface 148 of the hub portion 142 can move axially toward the surface 146 of the body 140, thereby compressing or squeezing the sealing member 150. The relative angles of the surface 146 of the body 140 and the surface 148 of the hub portion 142 can cause the sealing member 150 to be forced against the inner core 154 of the delivery catheter 104, thereby creating an adjustable seal between the inner core 154 of the delivery catheter 104 and the outer sheath 122.

[0200] The level of sealing can be adjusted by tightening or loosening the hub portion 142 of the delivery catheter 104 relative to the body 140 of the delivery catheter 104. In addition, the rotational freedom of the inner core 154 of the delivery catheter 104 can be inhibited or prevented by tightening the sealing member 150 as described above. Thus, the force applied by the sealing member 150 on the inner core 154 can be adjusted to allow the inner core 154 and / or other components to rotate relative to the body 140 and hub portion 142 of the delivery catheter 104. Figure 4 As shown, 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 thereon to increase the torque or rotational force that can be applied to the inner core 154. Alternatively, the seal or sealing portion within the catheter 104 can be formed by an interference or close tolerance 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 hub portion 142 of the catheter 104).

[0201] The inner core 154 may have a band or other marking 155 near its distal end. The marking 155 may be sized, positioned, and configured to provide a medical practitioner with a visual indication of the position of the end portion 154a of the inner core 154 and / or the position of the catheter tip 162 as the inner core 154 is being advanced into or withdrawn from the introducer 102.

[0202] In some embodiments, Fig.12 and 13 As most clearly shown in FIG. 1 , an additional sealing member 160 can 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 fin-type seal formed of an elastic material (such as, but not limited to, rubber having one or more slits therein) in a conical shape to allow the distal tip 162 and the outer sheath 122 to pass therethrough. In some embodiments, a support flange 161 can be supported within the body 106 and positioned behind the seal 160 to support the seal 160 and maintain the position of the seal 160 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 of a soft material (such as rubber) and can be configured to be atraumatic to prevent any damage to the patient's vasculature when the catheter 104 is advanced through the patient's vasculature.

[0203] As described above, in some embodiments, such as in the illustrated embodiment, the docking mechanism 112 of the introducer 102 can be configured to receive a portion of the male docking member or catheter 104. Figure 7 , 8A 8B, one or more deflectable tabs 170 can be supported by the body 140 of the catheter 104. The tabs 170 can be deflected by pressing or applying a radially inward force to the pads 172, thereby causing the ends of the tabs 170 to move radially inward toward the axial centerline of the body 104. By deflecting the tabs 170 inward, the body 140 of the catheter 104 can be axially moved into engagement with the hub portion 108 of the introducer 102. When the body 140 of the catheter 104 is axially moved into engagement with the hub portion 108 of the introducer 102, the tabs 170 can automatically deflect inward. Once the body 140 of the catheter 104 is axially moved into engagement with the hub portion 108 of the introducer 102 so as to abut against the hub portion 108 of the introducer, the tabs 170 can be released, thereby removably locking the body 140 of the catheter 104 to the hub portion 108 of the introducer 102.

[0204] In this configuration, the catheter 104 can be axially engaged with or locked to the introducer 102 so that a user can simultaneously axially manipulate the introducer 102 and the catheter 104. Additionally, in some embodiments, in this configuration, as discussed above, the catheter system 100 can be configured such that at least the inner core 154 of the catheter 104 can be rotated relative to the body 140 of the catheter 104 and the introducer 102.

[0205] In some embodiments, Figure 7 , 8A As shown in FIG. 8B , the inner core 154 has a central tube or wire 176 configured to support a stent (such as Figure 7 and 12 14). In addition, one or more beads or tabs 174 can be formed on or supported by the central tube or wire 176. Tabs 174 can be configured to increase 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 can be configured such that an opening passes through the distal tip 162, the central tube 176, and the inner core 154. The opening can be configured such that at least the distal tip 162, the central tube 176, and the inner core 154 can be advanced over a guidewire positioned within the patient's vasculature, such as the guidewire described in U.S. patent application Ser. No. 12 / 101,863, filed on April 11, 2008, entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS, which is hereby incorporated by reference in its entirety as if fully set forth herein.

[0206] Additionally, in some embodiments (not shown), the tabs 174 can be sized, spaced, and otherwise configured to provide axial support for multiple individual stent segments. For example, but not limited to, multiple individual or tethered stent segments can be positioned within a tubular or bifurcated graft, and the stent graft can be positioned relative to the tabs 174 such that the tabs 174 are positioned between the stent segments. This arrangement can reduce the overall diameter of the outer sheath 122, the introducer sheath 110, and other components comprising the catheter system, can enhance the axial support provided by the tabs 174 to the endoluminal prosthesis, and can allow for a more even distribution of support forces between the tabs 174 and the endoluminal prosthesis. The tabs 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, such as links, bends, loops and / or other connectors including embodiments of stents disclosed in U.S. Patent No. 6,077,296, entitled ENDOLUMINAL VASCULAR PROSTHESIS, which is hereby incorporated by reference as if fully set forth herein.

[0207] refer to Figures 13 to 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 in the introducer 102. The outer sheath 122 can be sized and configured such that the distal end portion 122c of the outer sheath 122 can terminate within the introducer 102 before or proximally of the proximal end or flared portion 110b of the introducer sheath 110. Although not required, the introducer 102 can have a constricted portion 113 formed in the body 106 of the introducer. In some embodiments, such as Fig.14 As most clearly shown in FIG. 1 , the catheter system 100 can be configured such that the distal end 122c of the outer sheath 122 terminates prior to or immediately adjacent to the constricted portion 113 of the body 106 of the introducer 102 .

[0208] In some embodiments (not shown), the distal end portion 122c of the outer sheath 122 can be positioned close to or adjacent to the proximal end portion or 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.

[0209] Thus, the outer sheath 122 and introducer sheath 110 of the catheter 104 can be configured to provide a lumen with a generally uniform cross-sectional size through the catheter system through which the endoluminal prosthesis can be advanced. The lumen through the catheter system 100 can be substantially continuous through which the endoluminal prosthesis can be advanced so that the endoluminal prosthesis can be advanced through the catheter system 100 without being obstructed or caught by any component or feature of the catheter system 100 while the endoluminal prosthesis is being advanced. The lumen can be substantially continuous but with a short gap of about 1 mm to about 3 mm in the lumen (such as, but not limited to, the distal end of the outer sheath 122 adjacent to the catheter 104 and / or the proximal end or flared end 110 b adjacent to the introducer sheath 110). For example, in some embodiments, a short gap may 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 as some components comprising the catheter system 100 are threadedly engaged with other components comprising the catheter system 100. Furthermore, in some embodiments, one or more surfaces of other components of the catheter 104 or introducer 102 in addition to the outer sheath 122 and the introducer sheath 110 (such as, but not limited to, the constricted portion 113 of the body 106 of the introducer 102 discussed above) may form part of a lumen through the catheter system 100.

[0210] As described above, the outer sheath 122 can constrain or limit the endoluminal prosthesis supported by the central tube 176. In this configuration, when the catheter tip 162, the central core 154 and the endoluminal prosthesis (such as but not limited to Figure 7 and 12 14) is advanced through the outer sheath 122, the outer sheath 122 can restrict the endoluminal prosthesis and prevent the endoluminal prosthesis from expanding before reaching the target location in the patient's vascular system. In addition, the catheter system 100 can be configured so that when the catheter tip 162, the central core 154 and the endoluminal prosthesis are advanced through the distal end 122c of the outer sheath 122, the contracted portion 113 and subsequently the introducer sheath 110 can radially restrict the endoluminal prosthesis when the endoluminal prosthesis is advanced through the introducer sheath 110.

[0211] The endoluminal prosthesis or stent 157 can be a tubular stent, a bifurcated stent, or any other desired stent, graft, stent-graft, or endoluminal prosthesis (collectively referred to herein as a stent or stents), including but not limited to any stent or graft disclosed in U.S. Patent Application Serial No. 12 / 101,863, which is cited above and incorporated herein by reference as if fully set forth herein. Thus, the catheter system 100 or catheter 104 can be configured to deploy any suitable or desired stent or stents.

[0212] Thus, in this configuration, the endoluminal prosthesis can be transferred from the outer sheath 122 to the introducer sheath 110. In this arrangement, using the introducer sheath 110 as a restrictor can allow the outer diameter of the introducer sheath 110 to be reduced, which can minimize trauma to the patient's vasculature and facilitate deployment of the endoluminal prosthesis.

[0213] Many embodiments of docking mechanisms and catheter systems have been described in conjunction with Figures 1 to 15. It is apparent to one of ordinary skill in the art that there are many potential embodiments of permanent or removable docking mechanisms that may be suitable for medical use and contemplated herein. For example, in some embodiments, a nut-screw combination may be used to connect the introducer sheath and catheter. As another example, a bayonet locking mechanism may also be used, such as a bayonet locking mechanism for a camera lens. In some embodiments, any components or features of some embodiments of the catheter disclosed herein or other catheters available in the art may be combined to form additional embodiments, all of which are contemplated herein.

[0214] Fig.16 The catheter system disclosed in has an introducer catheter assembly (also referred to herein as an introducer catheter) and a delivery catheter assembly (also referred to herein as a delivery catheter).

[0215] The catheter system disclosed herein can be used for diagnostic or therapeutic procedures, such as but not limited to endovascular prosthesis deployment procedures. It is obvious to those skilled in the art that the catheter system embodiments disclosed herein can be used to deliver prostheses to support general body tissues and various blood vessels and aneurysms. Examples of such blood vessels that can be treated with the catheter system embodiments 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, etc. Other organs or body tissues that can be treated with some of the catheter system embodiments disclosed herein include the prostate, bile duct, esophagus, trachea, fallopian tubes, vas deferens, ureters, tear ducts, and salivary ducts.

[0216] The catheter systems disclosed herein can be configured to deploy a variety of endoluminal prostheses, including mechanically expandable stents, self-expanding stents, drug eluting stents, grafts, bifurcated and non-bifurcated stent grafts, fenestrated stent grafts, suprarenal stent extensions, stent segments, anatomical treatment devices, medical prostheses deployable in any suitable area of ​​the body, and any stent or prosthesis disclosed in: U.S. application serial number 12 / 101,863 filed on April 11, 2008, U.S. application serial number 12 / 496,446 filed on July 1, 2009, U.S. application serial number 12 / 769,506 filed on April 28, 2010, and U.S. Patent No. 6,077,296, which are hereby incorporated by reference as if fully set forth herein.

[0217] The stent can have an oversized graft having a middle portion that is not sutured or otherwise attached to the stent frame. In this configuration, the middle portion can be expanded against the inner wall of the vessel or passage to further improve the seal between the graft and the vessel wall. In addition, the stent can have an oversized graft made of a highly collapsible flexible material (e.g., expanded polytetrafluoroethylene) so that when the stent is expanded, the graft can form tight folds in the sealing area to reduce the cross-sectional area of ​​the leakage zone between the stent and the vessel wall.

[0218] For simplicity, all such aforementioned stents or prostheses are collectively referred to herein as one or more stents unless otherwise defined. Thus, while the following illustrations and disclosure may describe stents and may show deployment in specific passages or body regions, it is contemplated that any embodiment disclosed herein may be used to deploy any desired prosthesis in any suitable part of the body with or without modification within the capabilities of those skilled in the art.

[0219] Fig.16 is an oblique view of the catheter system 100 having the delivery catheter assembly 104 docked with the introducer catheter assembly 102 . Figures 17 to 19 1 are an oblique view, a top view, and a side view of the delivery catheter assembly 104 of FIG. Figures 16 to 17, the catheter system 100 has a docking arrangement, wherein the proximal end portion of the introducer catheter assembly 102 can receive and dock with the distal end portion 121a of the body 121 (also referred to herein as the housing member or housing shaft) of the delivery catheter assembly 104. The introducer catheter 102 can have an outer sheath 110 (also referred to herein as the introducer sheath) supported by and extending from the distal end portion of the introducer catheter 102. Similarly, the delivery catheter assembly 104 has a tubular sheath 127 (also referred to herein as the 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.

[0220] Additional details about the features and components of such docking arrangements and other details about catheter systems are disclosed in the following: U.S. Application Serial No. 12 / 101,863, entitled "BIFURCATEDGRAFT DEPLOYMENT SYSTEMS AND METHODS," filed on April 11, 2008, and U.S. Application Serial No. 12 / 496,446, entitled "CATHETER SYSTEM AND METHODS OF USINGSAME," filed on July 1, 2009, both of which are incorporated by reference as if fully set forth herein. Any embodiment of the catheter system, delivery catheter, and introducer catheter disclosed herein may have any components, features, materials, or other details of any embodiment of the catheter disclosed in the aforementioned applications, which in combination become part of the present disclosure.

[0221] One or more stents can be loaded in, supported by, and delivered by the catheter system 100 embodiments disclosed herein. During assembly of the delivery catheter assembly 104 or just prior to surgery, one or more stents can be loaded into the delivery catheter assembly 104 by compressing the stent around the outer surface of the inner core member 115 of the delivery catheter assembly 104.

[0222] The removable limiter and / or the outer sheath of the introducer catheter and / or the delivery catheter can keep the stent in a compressed state. Under the compressed state, the stent can remain in a roughly fixed axial positioning relative to the inner core, so that the axial or rotational movement of the inner core will cause the axial and rotational movement of the stent. As will be discussed, the inner core can have features, such as fins, beads, tabs or other protrusions, to improve the traction or grip between the compression stent and the inner core or the inner core wire. The inner core with the stent compressed around its outer surface will be advanced through the introducer catheter or the contraction element adjacent to the introducer catheter, so that the stent is compressed to the approximate inner diameter of the outer sheath protruding from the introducer catheter.

[0223] The inner core member 115 can have a core wire 117 forming a portion of the inner core member 115. An atraumatic distal tip 119 can be supported at a distal end portion of the core wire 117. The inner core member 115, the core wire 117, and the distal tip 119 can include a continuous lumen therethrough 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. In the stent loaded state, the stent can collapse or compress around at least a portion of the inner core wire 117.

[0224] As mentioned, the catheter system can be configured such that the inner core member 115 can slide axially relative to the outer sheath 110. In this configuration, the stent can be deployed in a target area of ​​the 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 radial constraint to the stent, exposing the stent will allow the self-expanding stent to self-expand against the vessel wall when the outer sheath 110 is retracted.

[0225] As will be described in more detail, some embodiments of the catheter systems 100 disclosed herein are configured such that when a user or surgeon manipulates the delivery catheter assembly 104 slowly and with mechanical advantage in a first manner, the delivery catheter can be used to slowly and controllably deploy a stent or a portion of a stent from the delivery catheter assembly 104. Some embodiments of the catheter systems disclosed herein are further configured such that when a user or surgeon manipulates the delivery catheter assembly 104 quickly by directly pulling on an adjustment member in a second manner, the delivery catheter assembly 104 is used to more quickly deploy a stent or a portion of a stent from the delivery catheter assembly 104.

[0226] The catheter system disclosed herein can be configured to accommodate any combination of the above-described deployment modes. For example, a user or surgeon can first manipulate the delivery catheter in a first mode to slowly deploy a stent from the delivery catheter assembly 104, and then, once the correct positioning of the partially deployed stent is confirmed, the surgeon can manipulate the delivery catheter assembly 104 in a second mode to quickly deploy the remainder of the stent.

[0227] refer 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 the female receiving portion 105 supported at the proximal end portion of the introducer catheter 102. The introducer catheter 102 supports an outer sheath 110 at its distal end, and the outer sheath 110 defines a lumen therethrough 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 a lumen in the outer sheath 110.

[0228] Delivery catheter assembly 104 has a body or housing shaft 121 having a distal end portion 121a and a proximal end portion 121b. Housing shaft 121 has a generally tubular cross-sectional shape and has external threads 126 along a portion of housing shaft 121 (referred to as threaded portion 126).

[0229] The housing shaft 121 supports a slidable handle member 128 that can be 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 will be described, the delivery catheter assembly 104 is configured so 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 causes simultaneous and equal movement of the inner core member 115. The delivery catheter assembly 104 can be configured so that the handle member 128 is prevented from rotating relative to the housing shaft 121 and thus when the handle member 128 is engaged with the inner core member 115, the introducer catheter 102 and the outer sheath 110 prevent any unintentional rotation of the inner core member 115.

[0230] The threaded portion 126 extends along about 60% of the length of the housing shaft 121. The threaded portion 126 may extend along about 40% to about 70% of the length of the housing shaft 121. The threaded portion 126 may be positioned adjacent to the proximal end portion 121b of the housing shaft 121. The length of the threaded portion 126 may be about 20% to about 200% of the length of the stent to be deployed by the catheter. For example, if only the proximal end portion of the stent is to be deployed by rotation of the adjustment member 130, the length of the threaded portion may be about 20% to about 50% of the length of the stent. As used in the present disclosure, the term about may mean plus or minus 15% of the value.

[0231] The handle member 128 may be prevented from rotating in a variety of ways. For example, the handle member 128 may have one or more features such as tabs, protrusions, or the like that may protrude into one or more channels or grooves formed in the housing shaft 121. Fig.16As shown in , the housing shaft 121 can have a single slot 134 extending linearly along a portion of the length of the housing shaft 121, the slot 134 being configured to slidingly receive a tab, protrusion, or other similar feature supported by the handle member 128 therein.

[0232] The handle member 128 strikes the inner core engagement assembly 139 supported by the handle member 128. As described above, the delivery catheter assembly 104 is configured so that when the inner core member 115 is axially engaged with the handle member 128, any axial movement of the handle member 128 will cause the inner core member 115 to simultaneously move axially relative to the introducer catheter 102 and the outer sheath 110. Pressing the inner core engagement assembly 139 can release the inner core member 115 from the handle member 128 so that the inner core member 115 can move axially relative to the handle member 128. In some configurations, the inner core member 115 can rotate relative to the handle member 128 even if the inner core member 115 is axially engaged with the handle member 128.

[0233] As described above, the rotatable adjustment member 130 is supported by the housing shaft 121. The rotatable adjustment member 130 is threadedly engaged with the external 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 in the axial direction toward the distal end portion 121a of the housing shaft 121. Rotating or turning the rotatable adjustment member 130 in the second opposite direction causes the rotatable adjustment member 130 to move in the axial direction away from the distal end portion 121a of the housing shaft 121 of the delivery catheter assembly 104. Due to the threaded engagement between the rotatable adjustment member 130 and the housing shaft 121, the rotatable adjustment member 130 can be prevented from sliding axially relative to the housing shaft 121. Therefore, the handle member 128 can slide axially relative to the housing shaft 121 but prevent rotation, and the rotatable adjustment member 130 can rotate relative to the housing shaft 121 but prevent axial sliding.

[0234] In use, the surgeon can grasp the handle member 128 with one hand (e.g., left hand) and grasp the rotatable adjustment member 130 (which is initially positioned axially adjacent to the proximal side 130a of the housing shaft) with the other hand. The surgeon moves the inner core member 115 to engage with the handle member 128. In order 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 withdrawing the housing shaft 121 of the delivery catheter assembly 104, which is axially fixed to the introducer catheter 102 and the outer sheath 110. When the outer sheath 110 is axially retracted relative to the inner core member 115 fixed to the housing shaft 121, the handle member 128 is held in a fixed position to hold the inner core member 115 fixed, wherein the inner core engagement (and release) assembly 139 engages with the inner core member 115. Retracting the housing shaft 121 portion of the delivery catheter assembly 104 can be accomplished by grasping and rotating the rotatable adjustment member 130 or directly by applying a pulling force to retract the rotatable adjustment member 130 relative to the handle member 128. This step makes it desirable to withdraw the outer sheath 110 relative to the inner core member 115.

[0235] When the rotatable adjustment member 130 axially abuts the proximal end 128a of the handle member 128, a slower incremental withdrawal of the outer sheath 110 relative to the inner core member 115 is achieved. Rotating the rotatable adjustment member 130 in a first direction while holding the handle member 128 in a fixed axial position will slowly and incrementally and controllably retract or withdraw the housing shaft 121 of the delivery catheter assembly 104, and thus withdraw the outer sheath 110. Such controlled withdrawal of the outer sheath 110 is typically performed during the initial deployment phase of exposing and deploying the stent to allow the surgeon to better control and accurately position the stent in the target location.

[0236] In summary, in this configuration, with the handle member 128 initially positioned on the proximal portion of the housing shaft 121, the surgeon can controllably retract the outer sheath 110 to expose the stent by holding 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 to retract the housing shaft 121 and the outer sheath 110 relative to the handle member 128 and the inner core member 115. Once the surgeon is confident that the stent is in the desired position, the surgeon can more quickly retract the outer sheath 110 relative to the inner core member 115 by grasping the housing shaft 121 and retracting it axially relative to the handle member 128.

[0237] like Figures 17 to 19As shown, the delivery catheter assembly 104 can have a selectively engageable locking feature, such as a locking engagement ring 147, positioned on the inner core member 115. As will be described in more detail below, the engagement ring 147 can be configured to removably engage with 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 so that axial movement of the handle member 128 causes the inner core member 115 to move axially at the same time. Even when in a locked or engaged position, the inner core member 115 can also be freely rotated relative to the engagement assembly 139 and the handle member 128. The engagement ring 147 can be adhered to the outer surface of the inner core member 115, formed integrally therewith, or otherwise permanently fixed to the outer surface.

[0238] refer to Figures 17 to 19 , some embodiments of the engagement ring 147 can have a tapered surface 149 and an annular channel 152. The tapered surface 149 can increase the ease with which the engagement ring 147 can be advanced into the engagement assembly 139. Additional details regarding these components will be described below.

[0239] Fig. 20 yes Fig.16 1, showing the inner core member 115 in a fully or nearly fully advanced position relative to the delivery catheter assembly 104. In this position, the inner core member 115, inner core wire 117, and distal tip 119 are all advanced past 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, inner core wire 117, and distal tip 119 are also advanced relative to the end of the outer sheath 110, so that the stent supported by the inner core member 115 will be at least partially exposed, and in some cases completely exposed.

[0240] Figures 21 to 23 yes Fig.16 1, respectively, showing the sheath in a first pre-deployed position, a second partially deployed position, and a third fully retracted position, as well as the positioning of the housing shaft 121, the handle member 128, and the inner core member 115 of the delivery catheter assembly 104. The delivery catheter assembly 104 is configured so that the handle member 128 is positioned along the housing shaft 121 in a first position (e.g., Fig.21 shown) and at least a third position (such as Fig.23121a of the housing shaft 121 of the delivery catheter assembly 104.

[0241] The rotatable adjustment member 130 is separable from the handle member 128 so that the adjustment member 130 and the housing shaft 121 can be moved independently of the handle member 128. The adjustment member 130 includes an internal thread that engages with an external thread on the threaded portion 126 of the housing shaft 121. When the adjustment member 130 maintains contact with the handle member 128 as the adjustment member rotates, rotating the adjustment member 130 in a first direction causes the housing shaft 121 and the sheath to axially retract. The rotation of the adjustment member 130 is used to control the speed of the housing shaft 121 to slowly retract, or the axial force applied to the adjustment member provides a choice of rapid retraction.

[0242] The handle member 128 is selectively engageable with the core member 115 . Fig.24 1 is an oblique view of the core engagement assembly 139 and the core member 115 showing the core member 115 in a first disengaged position relative to the core engagement assembly 139, with other components of the delivery catheter removed from this view for clarity. Fig.25 is a cross-sectional view of a portion of the delivery catheter assembly 104 through 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 Yes Fig.24 139 and the oblique view of the inner core engagement assembly 139 and the inner core member 115 in FIG. 1 , showing the inner core in a second partially engaged position relative to the inner core engagement assembly.

[0243] refer to Figures 24 to 26In some embodiments of the delivery catheter assembly 104, an 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 have a generally frustoconical shape, and the channel 152 can be formed around the engagement ring 147, thereby forming an annular groove. The engagement ring 147 is adhered to the inner core member 115, formed integrally therewith, or otherwise secured thereto or supported therefrom at any desired location along the length of the inner core member 115.

[0244] refer to Figures 24 to 26 , the body member 155 of the engagement assembly 139 supports one or more tabs or arms 159 configured to engage with the engagement ring 147. The one or more arms 159 can have an inwardly facing tab or protrusion 166 supported at a proximal end 159b of the one or more arms 159. The arms 159 are supported by the body member 155 in a cantilever configuration such that a base portion 159a of the one or more arms 159 is fixed to the body member 155 and such that a proximal end portion 159b of the one or more arms 159 is unsupported. The arms 159 are supported by the body member 155.

[0245] The engagement ring 147 is configured to engage the inner core member 115 by causing the inner core member 115 to move in a first (distal) direction (by Fig.24 The arrow A1 in the figure indicates that the engagement ring 147 slides until the engagement ring 147 engages with the engagement assembly 139 and is received by the inner core engagement assembly 139. Fig.26 As shown, when the inner core member 115 and the engagement ring 147 are moved toward the engagement assembly 139, the tapered front surface 149 of the engagement ring 147 causes the tabs or arms 163 to expand as the engagement ring 147 is advanced into the engagement assembly 139. Figures 26 to 28 As the core member 115 is further advanced relative to the handle member 128, when the projections 166 of the arms 159 are axially aligned with the channel 152, the projections 166 of the arms 159 can compress and contract (pop open) toward each other and enter the channel 152 due to the bias of one or more arms 159. Figures 30 to 32 As shown, the core member 115 is axially engaged with the handle member 128 until the user disengages the engagement assembly 139 from the engagement ring 147. Even when axially engaged with the handle member 128, the core member 115 is free to rotate relative to the handle member 128.

[0246] The engagement assembly 139 is further configured to move one or more arms 159 in a radial direction (to spread them apart, such as Fig.27B159) will cause the projection 166 of the arm 159 to be lifted away from the channel 152 of the engagement ring 147. One or more expansion tabs 173 are supported by the body portion 175 or are configured to exert the necessary radial force (expand) on the arm 159 to lift the projection 166 away from the engagement ring 147. The expansion tabs 173 can have a tapered shape so that moving the expansion tabs 173 in a downward direction relative to the one or more arms 159 deflects the arms 159 outward. Pressing the button 180 forces the expansion tabs 173 downward, thereby deflecting the arms 159 outward, causing the engagement ring 147 to be axially released and moved axially away from the engagement assembly 139.

[0247] Fig.34 is a cross-sectional view of a portion of the delivery catheter through 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.

[0248] Fig.35 1 is a cross-sectional view of a portion of the delivery catheter assembly 104 through 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 shown herein, the biasing mechanism or spring member 184 is supported by the handle member 128 and is configured to bias the button 180, and therefore the deployment tab 175, away from the inner core member 115 in a first direction.

[0249] In addition, reference Figures 34 to 35 , the handle member 128 has a stop member 198 that is configured to limit the range of motion of the engagement ring 147 and the core member 115 relative to the handle member 128. For example, the first end 198a of the stop member 198 is configured to abut against the front surface 149 of the engagement ring 147 when the engagement ring 147 is advanced into the handle member 128.

[0250] The stent can be preloaded in the introducer catheter assembly or the introducer sheath so that the stent does not need to be transferred to the catheter assembly or the introducer sheath during the surgical operation. In one device, the delivery catheter system can have some or all of the other features of the delivery catheter disclosed herein, including the introducer sheath, the inner core, and the inner core. In this inclusive device, the inner core can be permanently connected to the handle member 128 so that the delivery catheter does not need to be configured to selectively engage with the inner core, thereby simplifying assembly and potentially simplifying surgical operations. Therefore, in some embodiments of this inclusive delivery catheter assembly, the delivery catheter assembly can have all components, features, details or configurations of the embodiments of the above-mentioned catheter system 100, wherein the lock engagement ring 147 of the inner core engagement assembly 139 and the inner core member 115 can be replaced with the non-selectable connection or other connections between the inner core member 115 and the handle member 128.

[0251] Fig.36 is an illustration of a prosthesis partially deployed by the delivery catheter assembly 104 . Fig.37 is a partial side view illustrating a stent that may be deployed with the delivery catheter assembly 104 . Fig.36 The deployment catheter shown in the drawings can be adapted for deployment of any suitable prosthesis and is not limited to Fig.37 The deployment of the bracket is shown in . Fig. 20 , 36 37, one or more beads or tabs 174 can be formed on or supported by the core wire 117. Tabs 174 can be configured to increase the axial support or connection between the inner core wire 117 and the stent 214 supported by the core wire 117 when the stent is supported on the core wire 117 in a compressed manner. In addition, tabs 174 can be sized, spaced, and otherwise configured to provide axial support to multiple separate stent segments (not shown). For example, multiple separate or tethered stent segments can be positioned within a tubular or bifurcated graft or other aspects, and the stent can be positioned relative to tabs 174 so that tabs 174 are positioned between stent segments 216 or between vertices, knuckles, or connection points 218 of interconnected struts.

[0252] In the configuration shown, beads or tabs 174 supported by core wire 117 can engage struts 216 or connection points 218 of stent 214 to help prevent axial sliding of the stent relative to the inner core wire 117 of the portion of stent 214 that remains compressed within outer sheath 110. This arrangement provides greater control of 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 in Fig.36 As shown in .

[0253] In addition, positioning the tabs 174 between the struts 216 or connection points 218 can reduce the compressed diameter or cross profile of the compression prosthesis, the outer sheath 110, and other components including the catheter system. This arrangement can also allow a more even distribution of support forces between the tabs 174, the inner core wire 117, and the stent 214. The tabs 174 can be sized, spaced, and otherwise configured to be positioned adjacent to the links, bends, rings, and / or other connectors formed in the tubular or bifurcated stent (such as the links, bends, rings, and / or other connectors of the embodiments of the stent disclosed in U.S. Patent No. 6,077,296, entitled ENDOLUMINAL VASCULAR PROSTHESIS), which is hereby incorporated by reference as if fully set forth herein.

[0254] In any catheter system embodiments disclosed herein, the catheter system can be configured as described herein so that when the stent is loaded into an introducer or introducer sheath, the stent can be compressed from a first diameter or size to a second diameter or size. The first diameter or size can be the fully relaxed or expanded diameter of the stent, or the first diameter or size can be a partially compressed diameter. For example, for some embodiments disclosed herein, the stent can be compressed from a first diameter (as defined or controlled by a sheath of a delivery catheter or by an assembly device surrounding the stent) to a second diameter (as defined or controlled by an introducer sheath). The rate of reduction of the stent when it is advanced into the introducer can be reduced from about 50% to about 95%, which means that the second diameter can be about 50% to about 95% of the first diameter.

[0255] Fig.38 302. It is a side view of a catheter system 300 with an introducer catheter assembly 302, showing that a stent is loaded into an outer sheath of the introducer catheter assembly 302. Only a portion of a delivery catheter 304 is shown, and for clarity, some features of the introducer catheter assembly 302 have been omitted. The catheter system 300 and / or the introducer catheter assembly 302 can have any assembly, feature, material or other details of any embodiment of the catheter system or introducer catheter assembly disclosed herein or incorporated by reference, including the U.S. application serial number 12 / 496,446 of the title submitted on July 1, 2009 as "catheter system and its method of use (CATHETER SYSTEM AND METHODS OF USING SAME)". In addition, the embodiment of the introducer catheter assembly 302 can be configured to work with any delivery catheter assembly embodiment disclosed herein or incorporated by reference.

[0256] refer to Fig.38 , the introducer catheter assembly 302 can have a body portion 306 and an outer sheath 310 supported at a distal end 306a of the body portion 306. An inner hole or opening 312 on the interior of the introducer catheter assembly 302 can be coaxial with the opening formed by the outer sheath 310. The introducer catheter assembly 302 can have a tapered or curved wall portion 314 that is configured to compress the stent 320 from a first diameter "a" to a second diameter "b" that is equal to the inner diameter of the (introducer) outer sheath 310 when the stent 320 is advanced through the introducer catheter assembly 302.

[0257] 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 immediately adjacent to the constricted portion of the body portion 306. In this configuration, the stent can be loaded into a delivery catheter having a diameter "a" in a relaxed or mostly relaxed (i.e., expanded) state and compressed to a final compressed diameter "b" by the tapered wall portion 314 of the introducer catheter assembly 302, thereby reducing stress applied to the stent prior to loading the stent in the introducer catheter assembly 302.

[0258] The sheath supported by the delivery catheter (e.g., sheath 316 or sheath 127 discussed above) can overlap or at least be advanced into the proximal portion of the introducer or outer sheath 310, 110, or so that the sheath 316 or sheath 127 discussed above can be advanced through the entire length of the introducer or outer sheath 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 compressed when passing through the distal portion of the delivery catheter sheath into the introducer or introducer sheath.

[0259] The introducer catheter assembly 302 can be configured to receive and deploy any of a variety of prostheses, including non-bifurcated and bifurcated stents and stent grafts, stent segments, fenestrated stents, and other similar stents or stent grafts disclosed herein or otherwise. The introducer catheter assembly 302 or any other introducer catheter assembly embodiment disclosed herein can be configured to receive and removably couple any of a variety of delivery catheters, including an accessory stent catheter, a suprarenal stent or stent extension catheter, or a bifurcated stent delivery catheter.

[0260] The outer sheath 310 or any other outer sheath embodiment disclosed herein has an inner diameter of approximately 0.237 in. and an outer diameter of approximately 0.253 in. When used to deliver a bifurcated stent, the sheath 316 has an inner diameter of approximately 0.251 in. and an outer diameter of approximately 0.263 in. When used to deliver an adjunct stent or a non-bifurcated stent, the sheath 316 has an inner diameter of approximately 0.241 in. and an outer diameter of approximately 0.263 in.

[0261] When used to deliver a bifurcation stent, the inner core of the catheter system ( Fig.38 The inner core of any catheter system has an outer diameter of about 0.213 in. when used to deliver a non-bifurcated stent.

[0262] Fig.394 is a schematic side view of a catheter system 400 having a deployment catheter assembly 404 including 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 is a self-expanding bifurcated stent, as shown herein, or may be any other stent or medical prosthesis disclosed or incorporated herein by reference or otherwise. The delivery catheter 404 may also include a branch vessel line assembly 417 loaded in the delivery catheter 404.

[0263] Fig.40 is Fig.39 A cross-sectional view of the branch vessel line assembly 417 taken at line 40-40 of Fig.41 Is Fig.39 FIG. 4 is an enlarged schematic diagram of a portion of a branch vessel line assembly 417 defined by curve 41-41 of FIG. Branch vessel line assembly 417 includes inner wire 418 positioned at least partially within hollow tube or guide wire 420. Branch vessel line assembly 417, inner wire 418, or hollow tube 420 may have any size, features, materials, or other details of the dual concentric guide wires disclosed in U.S. application Ser. No. 11 / 623,022, filed Jan. 12, 2007, which is incorporated by reference as if fully set forth herein.

[0264] The hollow tube 420 can protrude through the lumen interior of the stent 416 so that the distal end 420a of the hollow tube 420 protrudes beyond the end portion 416a of the stent 416. In addition, the hollow tube 420 has a curved or kinked portion 420b located proximal to the end of the stent 416. The outer sheath 410 maintains the curved portion 420b of the hollow tube 420 in a curved position or orientation (a first state) so as to mechanically connect or lock the inner wire 418 axially to the hollow tube 420 until the curve or bend in the curved portion 420b is relaxed. As will be discussed, the curve or bend in the curved portion 420b can be relaxed by retracting or withdrawing the outer sheath 410 through 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 will be axially fixed to the hollow tube 420, allowing the inner wire 418 to be axially retracted without disengaging from the hollow tube 420. When the outer sheath 410 is retracted past the curved portion 420b of the hollow tube 420, the hollow tube 420 relaxes such that the curved portion 420b is no longer axially locked to the inner wire 418. In this second relaxed state, the inner wire 418 can be axially advanced or retracted into or out of the hollow tube 420.

[0265] In this arrangement, the inner wire 418 can be advanced through a first puncture site in a first branch vessel or channel (such as the ipsilateral iliac artery) and then withdrawn through a second branch vessel or channel (such as the contralateral iliac artery) using any suitable crossing technique. For example, the inner wire can be advanced through the ipsilateral iliac artery in a slit lumen formed in a double lumen expander. The expander can be withdrawn and set aside, allowing the inner wire 418 to pass through the slit in the lumen of the double lumen expander, thereby positioning the proximal end of the inner wire 418 within the abdominal aorta. In this positioning, the inner wire 418 can be snare and retracted through the contralateral iliac artery and through the second puncture site.

[0266] Many embodiments of the catheter system have been described in conjunction with the accompanying drawings. It will be apparent to one of ordinary skill in the art that there are many possible embodiments of the catheter system that may be suitable for medical use and are contemplated herein. For example, any components or features of some embodiments of the catheter disclosed herein or other catheters available in the art may be combined to form additional embodiments, all of which are contemplated herein.

[0267] Although the foregoing description has shown, described, and pointed out the features applied to various embodiments, it will be understood that various omissions, substitutions, and changes may be made to the form and details of the devices or processes shown without departing from the spirit of the present disclosure. In addition, the various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, as will be appreciated, certain embodiments described herein may be embodied in a form that does not provide all of the features and benefits described herein, as some features may be used or practiced separately from other features.

[0268] Claims

[0269] 1. A catheter system, comprising:

[0270] A delivery catheter, the delivery catheter comprising:

[0271] a body having a proximal end portion and a distal end portion;

[0272] a delivery catheter sheath projecting distally from a distal end portion of the body;

[0273] an inner core configured to support a stent thereon, the inner core being axially advanceable through the body of the delivery catheter and the delivery catheter sheath;

[0274] 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 together in an axial direction; and

[0275] an adjustment member supported by the body, the adjustment member being configured such that rotation of the adjustment member causes the adjustment member to move axially along the body;

[0276] The handle member is capable of axially moving along the body of the delivery catheter between the distal end portion of the body and the adjustment member by causing the handle member to slide axially relative to the body or by causing the adjustment member to rotate relative to the body when the adjustment member is rotated to provide an axial contact force with the handle member.

[0277] 2. The catheter system of claim 1, wherein the inner core is non-selectably coupled to the handle member.

[0278] 3. The catheter system of 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 engages with the inner core, the handle member and the inner core move together in an axial direction.

[0279] 4. The catheter system of claim 1, wherein the inner core comprises a core wire supporting a plurality of tabs axially spaced apart along at least a portion of the inner core, the tabs being positioned on the core wire such that the stent overlaps with one or more of the tabs when the stent is in a loaded state.

[0280] 5. The catheter system of claim 4, wherein the inner core comprises a core wire and the plurality of tabs are axially spaced apart along at least a portion of the core wire.

[0281] 6. The catheter system of claim 4, wherein the plurality of tabs are configured to engage an inner skeleton of the stent in a stent-loaded state.

[0282] 7. The catheter system of claim 1, further comprising an introducer catheter comprising a body and a tubular introducer sheath protruding from a distal end portion of the body, the introducer catheter being configured to selectively engageably receive the delivery catheter.

[0283] 8. The catheter system of claim 7, wherein the introducer sheath is configured to axially receive at least the inner core therethrough.

[0284] 9. The catheter system of claim 7, wherein the diameter of the stent can be reduced by 5% to 50% as the stent is advanced into the introducer sheath by passing the stent through a tapered passage within the introducer catheter.

[0285] 10. The catheter system of claim 7, wherein at least a portion of the inner surface of the introducer sheath is covered with a low friction coating comprising at least one of: polytetrafluoroethylene, silicone, hydrophobic silicone, and another lubricating substance.

[0286] 11. A catheter system according to claim 7, wherein the introducer catheter is capable of selectively engaging with the delivery catheter so that when the delivery catheter is engaged with the introducer catheter, axial movement of either the introducer catheter and the delivery catheter will cause the other of the introducer catheter and the delivery catheter to move simultaneously and isoaxially.

[0287] 12. The catheter system of claim 7, wherein the catheter system is configured such that when the introducer catheter and the delivery catheter are engaged, the delivery catheter is rotatable relative to the introducer catheter.

[0288] 13. The catheter system of claim 7, wherein the catheter system is configured such that when the delivery catheter is engaged with the introducer catheter, the delivery catheter sheath and the introducer sheath do not overlap.

[0289] 14. The catheter system of claim 7, wherein the catheter system is configured such that when the delivery catheter is engaged with the introducer catheter, at least a distal portion of the delivery catheter sheath overlaps with at least a proximal portion of the introducer sheath, or a proximal portion of the introducer sheath overlaps with at least a distal portion of the delivery catheter sheath.

[0290] 15. The catheter system of claim 7, wherein the catheter system is configured such that when the delivery catheter is engaged with the introducer catheter, the tapered distal portion of the delivery catheter sheath is advanced into the proximal portion of the introducer sheath.

[0291] 16. The catheter system of claim 7, wherein the inner diameter of the delivery catheter sheath is greater than the inner diameter of the introducer sheath.

[0292] 17. A catheter system according to claim 1, wherein the inner core includes a core wire, which supports a plurality of splices axially spaced apart along at least a portion of the inner core, and the splices are positioned on the core wire so that the stent overlaps with one or more of the splices when the stent is loaded.

[0293] 18. The catheter system of claim 1, wherein the stent comprises a graft that is attached to the stent at at least a distal end portion of the graft rather than in a middle portion of the graft.

[0294] 19. A delivery catheter system comprising:

[0295] a body having a proximal end portion and a distal end portion;

[0296] an outer sheath protruding from the distal end portion of the body;

[0297] an inner core configured to support a stent thereon, the inner core being axially advanceable through the body and the outer sheath of a delivery catheter;

[0298] 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 together in an axial direction; and

[0299] an adjustment member supported by the body of the delivery catheter, the adjustment member configured such that rotation of the adjustment member provides a mechanical advantage for axially moving the adjustment member along the body;

[0300] The handle member is capable of axially moving relative to the body of the delivery catheter between the distal end portion of the body and the adjustment member by causing the handle member to slide axially relative to the body or by causing the adjustment member to rotate relative to the body when the adjustment member contacts the handle member, thereby causing the inner core to move axially relative to the outer sheath.

[0301] 20. The catheter system of claim 19, wherein the inner core is irreversibly coupled to the handle member.

[0302] 21. The catheter system of claim 19, wherein the inner core comprises a core wire supporting a plurality of tabs axially spaced apart 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 when the stent is in a loaded state.

[0303] 22. The catheter system of claim 21, wherein the inner core comprises a core wire and the plurality of tabs are axially spaced apart along at least a portion of the core wire.

[0304] 23. The catheter system of claim 21, wherein the plurality of tabs are configured to engage an endoskeleton of the stent in a stent loaded state.

Claims

1. A device for treating a patient, the device comprising: delivery catheter; A compressed expandable bifurcated stent having a main body portion, a first limb portion, and a second limb portion; as well as An expansion element is preloaded in a portion of the stent or delivery device.

2. The device according to claim 1 further comprises an expansion balloon, which is pre-loaded in at least the main body portion and the first limb portion, so that the main body portion and the first limb portion are curled around the expansion balloon in a pre-deployed state.

3. A device according to claim 1 or 2, wherein the expansion element is configured to partially expand the second limb portion of the stent when the expansion element is pulled through the second limb portion of the stent.

4. A device according to any one of claims 2 to 3, wherein the expansion balloon is a stepped balloon, wherein a distal portion of the stepped balloon is positioned within the main body portion and has a larger expansion diameter than a more proximal portion of the expansion balloon, and the more proximal portion is positioned within the first limb portion.

5. The device of any one of claims 1 to 4, wherein the compressed expandable bifurcated stent comprises a graft covering.

6. The device according to any one of claims 1 to 5, wherein the expansion element is coupled to a hollow wire. The device of claim 6 , wherein the hollow wire is positioned above the conductive wire.

8. The device according to any one of claims 1 to 7, wherein the expansion element comprises a tapered portion.

9. The device of any one of claims 1 to 8, wherein the expansion element is self-expanding.

10. The device of claim 9, wherein the expansion element is expandable from a first state to a second state, wherein when the expansion element is in the second state, the expansion element is larger in a radial direction.

11. The device according to any one of claims 9 to 10, wherein the expansion element is covered by a removable sheath coupled to a wire.

12. The device of any one of claims 1 to 11, further comprising a second expansion element, wherein the second expansion element is configured to expand at least a first limb portion of the stent.

13. The device of any one of claims 1 to 12, wherein the device is configured to treat the infrarenal aorta and iliac arteries of the patient.

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

15. A method for treating a patient, the method comprising: advancing a delivery catheter through a femoral artery puncture site into the patient's aorta to advance an expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion into the patient's aorta; expanding the main body portion and the first limb portion of the stent; as well as An expansion element is moved through the second limb portion of the stent to partially expand the second portion of the stent.

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

17. The method of any one of claims 15 to 16, wherein the method comprises treating the infrarenal aorta and iliac arteries of the patient.

18. The method of any one of claims 15 to 17, wherein the expansion element is positioned within the delivery catheter as the delivery catheter is advanced into the patient's aorta.

19. The method of any one of claims 15 to 18, wherein expanding the main 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 of any one of claims 15 to 19, wherein moving an 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 of claim 20, wherein the hollow wire is pulled over a conductive wire.

22. A method according to any one of claims 15 to 21, 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 iliac arteries, the device comprising: delivery catheter; a compressed balloon expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion; an expansion element preloaded in a portion of the stent; as well as an expansion balloon preloaded in at least the main body portion and the first limb portion such that the main body portion and the first limb portion are curled around the expansion balloon in a pre-deployed state; in: The expansion element is configured to partially expand the second limb portion of the stent when the expansion element is pulled through the second limb portion of the stent.

24. A method for treating the infrarenal aorta and iliac arteries, the method comprising: advancing a delivery catheter through a femoral artery puncture site into the patient's aorta to advance a balloon-expandable bifurcated stent having a body portion, a first limb portion, and a second limb portion into the patient's aorta; Using an expansion balloon to expand the main 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; as well as The second limb portion of the stent is further expanded using a second expansion balloon.

25. A device for treating a patient, the device comprising: delivery catheter; A compressed expandable bifurcated stent having a main body portion, a first limb portion, and a second limb portion; as well as An expansion element is preloaded in at least a portion of the stent or delivery device.

26. The device according to claim 25, further comprising an expansion balloon, which is pre-loaded in at least the main body portion and the first limb portion, so that the main body portion and the first limb portion are curled around the expansion balloon in a pre-deployed state.

27. The device of claims 25-26, wherein the expansion element is configured to at least partially expand the second limb portion of the stent when the expansion element is inflated.

28. A device according to any one of claims 26 to 27, wherein the expansion balloon is a stepped balloon, wherein a distal portion of the stepped balloon is positioned within the main body portion and has a larger expansion diameter than a more proximal portion of the expansion balloon, and the more proximal portion is positioned within the first limb portion.

29. The device of any one of claims 26 to 27, wherein the dilation balloon extends the entire length of the body.

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

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

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

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

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

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

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