Devices and methods for treating obstructions

Abstract

A device having a support structure and a covering material, the device operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising a body including a primary portion, a first branch, and a second branch, the primary portion defining a primary lumen, the primary portion defined between a first open end and a branch portion, the first branch defining a first branch lumen, the first branch extending from the primary portion to the first branch open end at the branch portion, the second branch defining a second branch lumen, the second branch extending from the primary portion to the second branch open end at the branch portion, the body having sufficient radial wall strength to resist radially inward forces and collapse of the primary, first branch, and second branch lumens.

Description

[Technical field]

[0001] This application claims the benefit of Provisional Patent Application No. 63 / 093269, filed October 18, 2020, which is incorporated by reference in its entirety for all purposes.

[0002] The present disclosure relates generally to devices, systems and methods for treating occlusions in a branched vascular system, and more particularly to devices, systems and methods for implantation into a branched blood vessel or artery that is patent and provides blood flow past the occluded vessel. [Background technology]

[0003] Patients may develop blockages in various parts of their vascular system. Blockages can reduce blood flow and result in various complications including pain, loss of function of a body part, and contribution to other symptoms. Treatment of various parts of the vascular system may require the placement of one or more medical devices. Placement of a medical device that effectively restores blood flow through a blocked vessel in a bifurcated vessel or artery presents unique challenges. Figure 1 of the present disclosure illustrates a typical branched artery that is at least partially blocked. Summary of the Invention

[0004] According to one embodiment ("Example 1"), a device is provided having a support structure and a coating material. The device is operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising a first elongated segment having two opposing ends and defining a first primary lumen extending therebetween, the first elongated segment being operable to be at least partially positioned in the first bifurcated portion of the partially occluded lumen, and a second elongated segment having two opposing ends and defining a second primary lumen extending therebetween, the second elongated segment being operable to be at least partially positioned in the second bifurcated portion of the partially occluded lumen, a combined cross-section of the first elongated segment and the second elongated segment comprising a combined cross-section equal to or greater than an intraluminal cross-section of the non-bifurcated portion of the at least partially occluded lumen, and the first and second elongated segments having sufficient radial wall strength to resist inward radial forces exerted by the at least partially occluded vessel to resist collapse of the first and second primary lumens.

[0005] In a further embodiment ("Example 2") in addition to Example 1, the first and second elongate sections are self-expandable.

[0006] In a further embodiment ("Example 3") in addition to Example 1, the first and second elongated sections are balloon expandable.

[0007] According to one embodiment ("Example 4"), a device is provided having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a primary elongated segment having two opposing ends and defining a primary lumen extending therebetween (a cross-section of the primary elongated segment is equal to or greater than an intraluminal cross-section of the non-bifurcated portion of the at least partially occluded lumen), a first elongated segment having two opposing ends and defining a first secondary lumen extending therebetween (the first elongated segment is operable to be at least partially positioned in the first bifurcated portion of the at least partially occluded lumen), and a second elongated segment having two opposing ends and defining a second primary lumen extending therebetween (the second elongated segment is operable to be at least partially positioned in the second bifurcated portion of the at least partially occluded lumen).

[0008] In a further embodiment ("Example 5") in addition to Example 4, the primary, first and second elongate sections are self-expandable.

[0009] In a further embodiment ("Example 6") in addition to Example 5, the primary, first and second elongated sections are balloon expandable.

[0010] According to one embodiment ("Example 7"), a device is provided having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising a body including a primary portion, a first branch, and a second branch, the primary portion defining a primary lumen, the primary portion having a primary portion length defined between a first open end and a branch, the first branch defining a first branch lumen, the first branch extending from the primary portion to the first branch open end at the branch, the first branch having a first branch length, the second branch defining a second branch lumen, the second branch extending from the primary portion to the second branch open end at the branch, the second branch having a second branch length, the body having sufficient radial wall strength to resist inward radial forces exerted by the at least partially occluded vessel to resist collapse of the primary, first, and second branch lumens.

[0011] In a further embodiment ("Example 8") in addition to Example 7, the body is self-expandable.

[0012] In addition to Example 7, in a further embodiment ("Example 9"), the body is balloon expandable.

[0013] In a further embodiment ("Example 10") in addition to Example 7, the body length is about 2.5 to 5.5 centimeters.

[0014] In a further embodiment ("Example 11") in addition to Example 10, the first and second branch lengths are about 2 to 7 centimeters.

[0015] In a further embodiment ("Example 12") in addition to Example 7, the body comprises a diameter between 8 and 24 centimeters.

[0016] In a further embodiment ("Example 13") in addition to Example 7, the first branch and the second branch include a diameter between 7 and 10 diameters.

[0017] In a further embodiment ("Example 14") in addition to Example 7, the device further comprises a first elongated segment having two opposing ends and defining a lumen extending therebetween (the first elongated segment is operable to be positioned at least partially in the first branch lumen), and a second elongated segment having two opposing ends and defining a lumen extending therebetween (the second elongated segment is operable to be positioned at least partially in the second branch lumen).

[0018] In a further embodiment ("Example 15") in addition to Example 7, the length ratio between the first and second branches and the body is about 1:1.

[0019] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any of the inventive concepts presented in this disclosure. While several examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative and not restrictive. [Brief description of the drawings]

[0020] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the disclosure.

[0021] [Figure 1] FIG. 1 is an illustration of an abdominal aorta with a partial occlusion near the bifurcation or branching of the abdominal arteries, according to one embodiment of the present disclosure.

[0022] [Figure 2A] FIG. 2A is an illustration of a bifurcated stent device deployed in a bifurcated artery, according to one embodiment of the present disclosure.

[0023] [Figure 2B]FIG. 2B is a diagram of components of a bifurcated stent device for deployment in a bifurcated artery, according to an embodiment of the present disclosure.

[0024] [Figure 3A] FIG. 3A is a cross-sectional view of a bifurcated stent device deployed in an artery according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a cross-sectional view of a bifurcated stent device deployed in an artery according to an embodiment of the present disclosure. [Figure 3C] FIG. 3C is a cross-sectional view of a bifurcated stent device deployed in an artery according to an embodiment of the present disclosure. [Figure 3D] FIG. 3D is a cross-sectional view of a bifurcated stent device deployed in an artery according to an embodiment of the present disclosure.

[0025] [Figure 4A] FIG. 4A is a diagram of a bifurcated stent device having a primary portion for deployment in a non-bifurcated portion of an artery, and first and second portions at least partially deployed in a bifurcated portion of an artery, according to one embodiment of the present disclosure.

[0026] [Figure 4B] FIG. 4B is a diagram of components of a bifurcated stent device having a primary section and first and second sections for deployment in a bifurcated artery according to an embodiment of the present disclosure.

[0027] [Figure 5A] FIG. 5A is an illustration of a bifurcated stent graft with integral branches deployed in a bifurcated artery, according to one embodiment of the present disclosure.

[0028] [Figure 5B] FIG. 5B is an illustration of a bifurcated stent graft with an integral branch and optionally first and second portions that may be deployed together with the bifurcated stent graft, according to one embodiment of the present disclosure.

[0029] [Figure 6A] FIG. 6A is an illustration of a bifurcated stent graft with integral branches deployed in a bifurcated artery, the bifurcated stent graft having a truncated primary section and a truncated integral branch, according to one embodiment of the present disclosure.

[0030] [Figure 6B] FIG. 6B is an illustration of a bifurcated stent graft with an integral branch and optionally first and second portions that may be deployed together with the bifurcated stent graft, according to one embodiment of the present disclosure. [Figure 6C] FIG. 6C is an illustration of a bifurcated stent graft with an integral branch and optionally first and second portions that may be deployed together with the bifurcated stent graft, according to one embodiment of the present disclosure.

[0031] definition The present disclosure is not intended to be interpreted in a limiting manner, for example, the terms used in this application should be interpreted broadly in the context of the meaning in the art to which the terms belong.

[0032] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be realized by a variety of methods and devices configured to perform the intended functions. In other words, other methods and devices may be incorporated herein to perform the intended functions. The accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0033] Certain relative terms are used to indicate the relative locations of components and features. For example, "top," "bottom," "upper," "lower," "left," "right," "horizontal," "vertical," "upward," and "downward" are used in a relative rather than absolute sense (e.g., components or features are located relative to one another) unless the context dictates otherwise. Similarly, throughout this disclosure, when processes or methods are shown or described, the methods can be performed in any order or simultaneously, unless it is clear from the context that the method is dependent on a particular act being performed first.

[0034] With respect to the term uncertainty, "about" and "approximately" may be used in certain instances to refer to values ​​that include the stated value and also include any value reasonably close to the stated value. A value reasonably close to a stated value deviates from the stated value by a reasonably small amount that can be understood and readily ascertained by one of ordinary skill in the relevant art. Reasonable deviations may result from measurement errors, variations in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, minor adjustments made to optimize performance and / or structural parameters to account for differences in values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulation of objects by humans or machines, and the like.

[0035] As used herein, "couple" means to join, connect, attach, adhere, fasten or adhere directly or indirectly, permanently or temporarily.

[0036] As used herein, "medical device" can include, for example, stents, grafts and stent-grafts (single, multi-component, bifurcated, branched, etc.), catheters, valves, and drug delivery devices that are acutely or chronically implanted in the vascular system or other body lumen or lumens in the treatment area.

[0037] As used herein, "leakage" means flow into or through an area of ​​treatment that is undesirable or unfavorable, that is outside the lumen or body defined by the medical device, e.g., into or through areas such as "channels" located between a portion of the device and adjacent body tissue, between two devices, or at the intersection of one or more portions of a device and adjacent body tissue.

[0038] As used herein, "ellipse" generally means any shape where there is no point where two lines, curves, or surfaces converge to form an angle. "Ellipse" encompasses traditional Euclidean geometric shapes such as circles and ellipses, as well as other aangular shapes (shapes that have no angles), even if they do not have a common name in Euclidean geometry.

[0039] As used herein, "non-elliptical" means any shape that contains at least one point where two lines, curves, or surfaces converge to form an angle. "Non-elliptical" encompasses traditional Euclidean geometric shapes such as triangles, squares, and rectangles, as well as other angular shapes (shapes with at least one angle) such as half moons, even though they do not have a common name in Euclidean geometry.

[0040] As used herein, "circumference" refers to the boundary line formed by an object, including, for example, the end of a stent or the wall of a stent at a cross section anywhere along the length of the stent. "Circumference" can include the boundary line formed by an object having any shape, including elliptical and non-elliptical as defined herein, a shape generally representing a line that encircles an area. "Circumference" can include the boundary line formed on an object or its cross section, regardless of whether the actual surface or cross section of the object represented by the boundary is continuous or interrupted. For example, an open stent or an object that includes a series of separate line segments, whether or not they physically overlap or touch each other, can describe a "circumference" as used herein.

[0041] As used herein, "substantially matchable" refers to the ability of an object to be dimensionally matched with another object. As used herein, "substantially matchable" can refer to an object being designed and given a preset structure and shape that fits the shape of another object, an object having preset shapes that are at least partially complementary to one another while other portions of the object have shapes that can flexibly and adaptively change to match another object, and an object having the ability and / or compatibility to generally conform in shape to another object without the need for a designed or preset complementarity to another device or object.

[0042] In various embodiments, the devices disclosed herein can include a covering material. The covering material can be any biocompatible or biodegradable material, as described in detail later herein. The covering material according to various embodiments forms a generally continuous surface(s) of the device component to define the lumen and exterior surface of the device component. The covering material need not be completely continuous, but may be interrupted by fenestrations, such as openings at the ends of elongated or branch sections, open stent regions and / or side branch openings. The covering material can be applied to the device in any of a variety of ways, including, for example, wrapping, molding, or forming the covering material around a mandrel.

[0043] According to various embodiments, the devices can include features such as radiopaque markers or similar features that aid in visualization of the device within the body during deployment and positioning.

[0044] In various embodiments, the device can include a coating, the coating of a device component that may come into contact with other objects, including other devices or device components or the interior surfaces of the vascular system.

[0045] In various embodiments, the devices disclosed herein can include a support structure (e.g., a stent of any suitable configuration). The support structure can be any suitable material including, for example, stainless steel, nitinol, and the like. The support structure can include a plurality of stent rings. The stent rings can be operatively connected to one another with wires. The wires used to connect the stent rings can be attached to the apexes of a first stent ring and the valleys of a second stent ring. The stent rings can be arranged such that the apexes-valleys are in phase (e.g., the apexes of the first stent ring share a common midline with the apexes of the second stent ring) or out of phase (e.g., the apexes of the first stent ring share a common midline with the valleys of the second stent ring).

[0046] A device according to various embodiments can include first and second elongated segments, each having two opposing ends and each defining a lumen extending between the two ends. The lumen defined by the elongated segments is referred to as the primary lumen. Each elongated segment can be comprised of two or more separate subsections joined to form a single elongated segment, as described herein, where a single elongated segment comprised of two or more separate subsections defines a single lumen and has two opposing ends. Additionally, when "elongated segment" is used in this disclosure, it can also include "subsection." According to various embodiments, a device can include two or more elongated segments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Those skilled in the art will readily appreciate that the various aspects of the present disclosure can be realized by a variety of methods and devices configured to perform the intended functions. It should also be appreciated that the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate the various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting. Furthermore, although the description below includes a discussion of specific vascular systems such as the aorta or iliac arteries, it is within the scope of the present disclosure that the disclosed device is realized in any applicable vessel of a patient, and more particularly in any bifurcated artery of a blood vessel.

[0048] This disclosure describes a number of non-limiting embodiments, each of which may be used alone or in combination with one another. The device according to various embodiments may be any suitable medical device or devices that may be placed in the vascular system or other body lumen and configured to isolate a treatment site from fluid pressure. In various embodiments, the device may include one or more elongated sections that approximate a cross-sectional shape of the vascular system when implanted at the treatment site.

[0049] For example, Figure 1 illustrates a vascular system in which devices according to various embodiments may be implanted. The vascular system includes an abdominal aorta 101 with major branching arteries including the renal arteries 110, the superior mesenteric artery (SMA) 111, the celiac artery 112, the common iliac artery 113, the external iliac artery 114, and the internal iliac artery 115. In the illustrated embodiment, the abdominal aorta has an occlusion 202 that at least partially occludes the abdominal aorta 101.

[0050] 2A, a bifurcated stent device 200 is positioned within a patient's vessel. The bifurcated stent device 200 comprises two or more elongated segments, such as a first elongated segment 220 and a second elongated segment 230. Each of the elongated segments 220, 230 can include a frame 206 and a covering 208. The frame 206 supports the covering 208. The first elongated segment 220 can be comprised of sub-segments 220a and 220b, and the second elongated segment can be comprised of sub-segments 230a and 230b. The first elongated segment 220 can have proximally facing first and second ends 221 and 222, and similarly, the second elongated segment 230 can have proximally facing first and second ends 231 and 232. The elongated segments can be deployed in any suitable configuration to a treatment site in a vascular system 101, such as the abdominal aorta (FIG. 1) or other body lumen, having at least a partial occlusion 102. For example, the elongated segments can be placed in a configuration to direct the flow of blood or other bodily fluids between a proximal aortic lumen 105 and a distal lumen, such as the common iliac arteries 113 and / or one or more side branch vessels, such as the renal arteries 110 and the internal iliac arteries 115. In the illustrated embodiment, subsections 220a and 230a of the first and second elongated sections 220 and 230 of the device are implanted in a proximal portion of the treatment area to receive blood from the proximal aortic lumen 105 and return it to the renal arteries 110 via the first branch section 223 and the third branch section 233, while subsections 220b and 230b of the device direct blood distally at the second ends 222 and 232 of the first and second elongated sections 220 and 230 to the external iliac artery 114 and via the second branch section 224 and the fourth branch section 234 to the internal iliac artery 115. In various other embodiments, the second ends of the elongated sections can be positioned in other portions of the treatment area, such as the common iliac artery 113, or in an area of ​​normal aorta distal to the occlusion 102. According to various embodiments, the first ends 221 and 231 and second ends 222 and 232 of the first elongated segment 220 and second elongated segment 230 can be positioned in any suitable portion of the treatment area.

[0051] In various embodiments, one or more of the elongated sections can be joined to another medical device. For example, a device comprising two elongated sections similar to subsections 220a and 230a as shown in FIG. 2 can be joined to a proximal end of a bifurcated stent graft at the second end of the elongated section. The bifurcated stent graft functions to deliver blood to a distal portion of the treatment area. A device comprising two elongated sections can be joined to the bifurcated stent graft in a substantially liquid-tight manner during deployment of the elongated sections. Thus, a device according to various embodiments comprising two or more elongated sections and a branch section as described below can be deployed in a proximal portion of the treatment area, such as the proximal aorta with renal artery bifurcation, and joined to a second medical device, such as a bifurcated stent graft suitable for placement in a distal portion of the treatment area, such as the distal portion of the occlusion and the common iliac artery. Combinations of devices according to various embodiments deployed in any portion of the treatment area and joined to other medical devices are within the scope of the present disclosure.

[0052] According to various embodiments, the first elongated segment 220 and the second elongated segment 230 have a combined cross-section that is substantially matchable to an intraluminal cross-section of a body lumen. For example, in any portion of the vessel 101 where the first elongated segment 220 and the second elongated segment 230 occupy the same cross-sectional shape (e.g., the first end 221 of the first elongated segment 220 and the first end 231 of the second elongated segment 230 at the infrarenal aortic neck 203 or the proximal aortic lumen 105 as shown), the first elongated segment 220 and the second elongated segment 230 are substantially matchable to the intraluminal cross-section of the vessel. The substantially matchable cross-sectional shapes of the first elongated segment 220 and the second elongated segment 230 have a combined cross-section that approximates the intraluminal cross-sectional shape of the vessel 101. The ability of the first and second elongated segments to substantially conform in cross-section to the intraluminal cross-section of a vessel can contribute to promoting more desirable blood flow characteristics in the treatment area, such as unobstructed flow, evenly distributed flow, steady flow, or flow consistent with flow through a healthy body lumen.

[0053] In these embodiments, the first elongated segment 220 can have any suitable shape. Similarly, the second elongated segment 230 can have any suitable shape that is generally complementary to the first elongated segment 220. This complementary arrangement occurs where the combined cross-sectional shape of the first and second elongated segments 220, 230 when placed in the vessel 101 substantially approximates the intraluminal cross-sectional shape of the vessel 101 to minimize leakage and improve fluid flow characteristics at the treatment site. For example, the first end 221 of the first elongated segment 220 can have a substantially elliptical cross-sectional shape when placed in the treatment area corresponding to the proximal lumen 105. The first end 231 of the second elongated segment 230 can have a suitably complementary substantially elliptical cross-sectional shape at the end placed in the treatment area corresponding to the proximal lumen 105 when the first and second elongated segments 220, 230 are placed together. In this embodiment, the first end 221 of the first elongated segment 220 and the first end 231 of the second elongated segment 230 each lie at substantially the same level or cross-sectional plane of the vessel, although in other embodiments they may lie in other planes or in a longitudinally displaced relationship. Furthermore, each of the ends has a complementary shape such that the combined shape of the ends forms a generally elliptical cross-section that approximates the generally elliptical cross-section of the vessel 101. The first elongated segment 220 and the second elongated segment 230 substantially conform to the intraluminal cross-section of the proximal lumen 105 to allow blood and other bodily fluids to flow through the lumen of the elongated segments that approximates the vessel 101.

[0054] In various embodiments, the first and second elongate segments can have any size and shape suitable to provide a combined cross-section that is substantially matchable to an intraluminal cross-section of a body lumen. The first and second elongate segments can have a size and shape that are complementary to one another and that, when deployed together within a body lumen, together provide a combined cross-section, such as an ellipse, that generally approximates the size and shape of the body lumen and substantially matches the intraluminal cross-section of the body lumen.

[0055] FIG. 2B illustrates a bifurcated stent device 200 in which the first elongated segment 220 and the second elongated segment 230 each do not include a sub-segment.

[0056] For example, with reference to Figure 3A, the first elongated segment 220 and the second elongated segment 230 can have generally elliptical cross-sections that are complementary to one another such that the combined cross-section of the elongated segments substantially matches the intraluminal cross-section of the vessel 101. In other various embodiments, with reference to Figure 3B, the first elongated segment 220 can have a generally elliptical cross-sectional shape as shown in Figure 3B, and the second elongated segment 230 can have a shape, such as a crescent shape with an internal arc that is complementary to the elliptical shape of the first elongated segment 220, that is complementary to a cross-section or portion of a cross-section of the first elongated segment 220. According to various embodiments, the combined cross-sectional shape of the first elongated segment 220 and the second elongated segment 230 is generally elliptical and approximates the intraluminal cross-section of the vasculature 201 regardless of the individual cross-sectional shapes of the component elongated segments.

[0057] In various embodiments, the device may include three or more elongated segments. With respect to the embodiment described above and shown in Figures 3C and 3D, the three or more elongated segments may have complementary shapes such that the combined cross section of the elongated segments may substantially match the endoluminal cross section of the body lumen, such as an elliptical shape. For example, the first elongated segment 220, the second elongated segment 230, and the third elongated segment 260 may each have a generally pie shape, as shown in Figure 3C. In this configuration, a flat portion of each pie-shaped shape is configured to abut another flat portion of the pie-shaped shape. A curved portion of each pie-shaped shape is configured to approximate a portion of the vessel 201. Other combinations of three or more elongated segments with various complementary cross-sectional shapes are within the scope of the present disclosure, such as the third elongated segment 260 having an elliptical cross section combined with the crescent-shaped first elongated segment 220 and second elongated segment 230 as shown in Figure 3D. Any number of elongated sections having any combination of cross-sectional shapes that when placed together form a combined cross-section that is generally elliptical and / or substantially matches the endoluminal cross-section of a body lumen are within the scope of this disclosure.

[0058] In various embodiments, the elongate segments of the device can have cross-sectional shapes that are shaped or formed prior to deployment of the elongate segments such that the elongate segments assume a preset cross-sectional shape upon deployment. For example, the elongate segments can be shaped or formed to have mutually complementary cross-sectional shapes. The elongate segments can be constrained to another cross-sectional shape prior to deployment for insertion and deployment, and upon deployment, the elongate segments can assume their preset complementary cross-sectional shapes that substantially match the endoluminal cross-section of the body lumen.

[0059] In various other embodiments, the cross-sectional shape of the individual elongate segments can be determined during deployment, such as by the cross-sectional shape of a balloon expansion device used for deployment. For example, the elongate segments can be plastically deformable such that they can assume and maintain the cross-sectional shape of the balloon expansion device used to expand and deploy the elongate segments to the implanted state. A balloon expansion device can be used that allows the elongate segments to expand to an appropriate size and / or cross-sectional shape, such as a circular, elliptical, crescent, pie-shaped, or other cross-sectional shape, such that one or more elongate segments are complementary to one another and substantially match the endoluminal cross-section of the body lumen in which they are deployed.

[0060] In some embodiments, the elongated segment is self-expanding. The elongated segment comprises sufficient radial strength to expand to a preset diameter. Specifically, the elongated segment is expandable to a preset diameter sufficient to provide a cross-section to the vessel to allow sufficient fluid (e.g., blood) flow therethrough. Additionally, the radial strength of the elongated segment is sufficient to limit collapse of the elongated segment within the vessel, e.g., a vessel having an occlusion.

[0061] According to yet another embodiment, the elongate segment may be flexible to accommodate a wide range of cross-sectional shapes and to match the intraluminal cross-section of the body lumen in which it is deployed in its particular cross-sectional shape. In such an embodiment, the intraluminal cross-section of the body lumen in which the elongate segment is deployed may be determined by another elongate segment and / or other medical devices that are temporarily or implanted during deployment of the flexible elongate segment in the body lumen. In other words, the flexible elongate segment may not have a generally pre-set deployed cross-sectional shape, and the cross-sectional shape of the flexible elongate segment is determined by the cross-sectional shape of the body lumen in which it is deployed and the other elongate segments or medical devices that are deployed in the body lumen, regardless of the cross-sectional shape of the body lumen or other elongate segments or medical devices in the body lumen.

[0062] According to various embodiments, one of the elongate segments can have the property of being flexibly adaptable to the cross-sectional shape of the lumen in which it is deployed. In various other embodiments, multiple elongate segments can be so flexibly adaptable. For example, when two flexibly adaptable elongate segments are deployed together in a body lumen, the two elongate segments together will substantially match each other and the intraluminal cross-section of the body lumen in which they are deployed. In such embodiments, a preset complementary cross-sectional shape of the elongate segments is not required. Such embodiments can provide advantages such as the ability to position the elongate segments independently longitudinally and / or rotationally. For example, not having a preset complementarity between one elongate segment and a second elongate segment eliminates the need to align two complementary elongate segments longitudinally and rotationally to provide a predetermined complementary cross-sectional shape.

[0063] Any of the various embodiments described herein allow an elongate segment to substantially align with an intraluminal cross-section of a body lumen only if there are two or more elongate segments in the intraluminal cross-section of the body lumen. In other words, devices according to various embodiments may or may not substantially align with an intraluminal cross-section of a body lumen in a cross-section in which only a single elongate segment is disposed. For example, devices according to various embodiments may include two elongate segments that are the same length but longitudinally displaced from one another within a body lumen such that only one elongate segment is disposed in various cross-sections within the body lumen. In this example, in an intraluminal cross-section of a body lumen occupied by a single elongate segment, the elongate segment may not substantially align with the intraluminal cross-section of the body lumen but may only partially occupy the intraluminal cross-section.

[0064] According to various embodiments, the elongated segment can include an open stent region. The elongated segment can include an open stent region in any portion of the elongated segment. An open stent region of an elongated segment is a portion of the elongated segment that includes support elements but is free of covering material or has an otherwise fluid permeable configuration. The open stent region of an elongated segment can be located in any portion of the elongated segment and can include any portion of the elongated segment. For example, the open stent region can be located at an end of the elongated segment or anywhere along the length of the elongated segment. The open stent portion can include the entire circumference of a portion of the length of the elongated segment or can include a portion of the circumference and length of the elongated segment to form an open stent window in an area of ​​the elongated segment.

[0065] Each of the first, second and / or third elongated segments 220, 230, 260 can be about 5 to about 15 millimeters in diameter. Specifically, the first, second and / or third elongated segments 220, 230, 260 can be 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 millimeters in diameter. The overall length of the bifurcated stent device 200 can be about 15 millimeters to about 80 millimeters. The sheath size of the bifurcated stent device 200 can be about 7 Fr to about 8 Fr.

[0066] 4A, the bifurcated stent device 200 includes a primary stent graft 240. The primary stent graft 240 is operable to be positioned in a non-bifurcated portion of a treatment site in the vascular system 201. The primary stent graft 240 has a size suitable for positioning at the treatment site. The primary stent graft 240 is operable to receive at least a portion of the first elongated segment 220 and the second elongated segment 230. For example, the proximal facing first end 221 of the first elongated segment 220 and the proximal facing first end 231 of the second elongated segment 230 can be positioned within the primary stent graft 240. The first elongated segment 220 and the second elongated segment 230 can be substantially sealed with the primary segment 240 such that fluid can flow into the primary segment 240 and into each of the first elongated segment 220 and the second elongated segment 230. In other embodiments, the first elongated section 220 and the second elongated section 230 are expanded to their respective preset diameters, but may not necessarily form a complete fluid seal with the primary section 240 about their inner circumference. Figure 4B is another embodiment in which the frame includes a diamond design. Implementation of other suitable frame designs is within the scope of this disclosure. The frame may be self-expanding or balloon expandable.

[0067] The primary stent graft 240 may have a diameter of about 18 to about 30 millimeters. The length of the primary stent graft 240 may be about 2 to about 3 millimeters. The sheath size of the bifurcated stent device 200 may be about 14 Fr to about 17 Fr.

[0068] 5A, a preferred bifurcated stent graft 300 with integral branches is configured in a bifurcated vessel lumen. The bifurcated stent graft 300 has a primary body 302 which is a unitary tubular graft 303 having a length 304 from a first end 306 to a branch 308 where a graft bifurcation 310 begins. The bifurcated stent graft 300 has an integral ipsilateral branch 312 having a length 314 from the graft bifurcation 310 to a second end 316. The bifurcated stent graft 300 has an integral contralateral branch 320 having a length 322 from the graft bifurcation 310 to a second end 324 of the contralateral graft branch. In some embodiments, the bifurcated stent graft 300 can have an open or short length of the contralateral branch to receive the contralateral branch and is substantially free of a contralateral branch. The distal end 306 of the primary body 302 is secured to the non-bifurcated portion of the vessel and an integral ipsilateral branch is formed within one of the branches of the bifurcated vessel. The bifurcated stent graft 300 has a lumen extending from the distal end of the primary body 302 into two separate lumens after the graft bifurcation 310.

[0069] Similar to that discussed with respect to the bifurcated stent device 200, in some embodiments, the primary body 302 and the branches 312, 320 of the bifurcated stent graft 300 are self-expanding. The primary body 302 and the branches 312, 320 have sufficient radial strength to expand to a preset diameter. In particular, the elongated segments are operable to expand to a preset diameter sufficient to provide a vessel with a vessel cross-section for sufficient blood flow therethrough. Furthermore, the radial strength of the elongated segments is sufficient to limit collapse of the elongated segments within the vessel (e.g., a vessel having an occlusion).

[0070] In other embodiments, the primary body 302 and the branches 312, 320 of the bifurcated stent graft 300 are balloon expandable. The cross-sectional shape of the individual elongate segments can be determined during deployment, such as by the cross-sectional shape of a balloon expansion device used for deployment. For example, the elongate segments can be plastically deformable such that they can assume and maintain the cross-sectional shape of a balloon expansion device used to expand and deploy the elongate segments to the implanted state. A balloon expansion device can be used that can expand the elongate segments to any suitable size and / or cross-sectional shape, such as a circular, elliptical, crescent, pie-shaped or other cross-sectional shape, such that one or more elongate segments are complementary to one another and substantially match the endoluminal cross-section of the body lumen in which they are deployed.

[0071] The primary body 302 can be about 20 to about 23 millimeters in diameter. The length of the primary body 302 can be about 2 to about 6 millimeters. Specifically, the primary body 302 can be 3, 4, or 5.5 millimeters in length. The sheath size of the bifurcated stent device 200 can be about 14 Fr to about 17 Fr. The branches 312, 320 can be about 10 to about 20 millimeters in diameter, specifically about 13 millimeters in diameter.

[0072] 5B is another embodiment in which the frame includes a diamond design. Other suitable designs are within the scope of this disclosure. Additionally, the bifurcated stent graft 300 can include two or more elongated segments, such as a first elongated segment 340 and a second elongated segment 350. In some embodiments, the primary body 302 and the branches 312, 320 can be self-expanding and the first elongated segment 340 and the second elongated segment 350 can be balloon expandable. In other embodiments, the primary body 302 and the branches 312, 320 can be balloon expandable and the first elongated segment 340 and the second elongated segment 350 can be self-expanding. This allows a physician to select appropriate components of the bifurcated stent graft 300 to effectively restore flow through the vascular system, with the components being selected based on the unique condition of the occluded vessel.

[0073] 6A, the bifurcated stent graft 300 comprises a primary body 302 having a length 304 from a distal end 306 to a branch 308 of less than 4 centimeters. In some embodiments, the length 304 of the primary body 302 is about 1 to about 4 centimeters. In other embodiments, the length 304 of the primary body 302 is about 2 to about 3 centimeters. Specifically, the length 304 of the primary body 302 is about 2.0, 2.5, 3.0, 3.5, or 4.0 millimeters. The length 304 of the primary body 302 can be limited to the above dimensions to limit the possibility of the primary body 302 covering a branch or access point with the bifurcated stent graft 300. The diameter of the primary body 302 is about 8 to 24 millimeters.

[0074] The branches 312, 320 extending from the primary body 302 can be at least 2 centimeters. In some embodiments, the length 314, 322 of the primary body 302 is between 2 and 4 centimeters. In other embodiments, the length 304 of the primary body is between 2 and 3 centimeters. The length 304 of the primary body 302 can be limited to the dimensions mentioned above to limit the possibility of the primary body 302 covering a branch or access point in the bifurcated stent graft 300. The diameter of the branches 312, 320 is between about 7 and about 10 millimeters. In some embodiments, the length ratio between the primary body 302 and the branches can be between about 1:0.75 and about 1.25:1. In some embodiments, the length ratio between the primary body 302 and the branches can be about 1:1.

[0075] Further with respect to the branches 312, 320, each branch 312, 320 can extend from the primary body 302 at a preset position and angle. For example, the first branch 312 and the second branch 320 each define a first longitudinal axis 313 and a second longitudinal axis 321. The first and second branches 312, 320 extend from the primary body 302 such that an angle greater than zero is formed between the first longitudinal axis 313 and the second longitudinal axis 321. The angle formed between the first longitudinal axis 313 and the second longitudinal axis 321 can be between about 0.5 and about 30.0 degrees. In some embodiments, the first longitudinal axis 313 and the second longitudinal axis 321 are parallel to one another. In this embodiment, the bases of the first and second branches 312, 320 are laterally spaced apart from one another to maintain separate lumens.

[0076] 6B and 6C, the bifurcated stent graft 300 may further include two or more elongated segments, such as a first elongated segment 340 and a second elongated segment 350. The first elongated segment 340 may have a first end 341 facing proximally and a second end 342 facing distally, and similarly the second elongated segment 350 may have a first end 351 facing proximally and a second end 352 facing distally. The elongated segments 340, 350 may be deployed such that the first ends 341, 351 are positioned at the branches 312, 320. The elongated segments 340, 350 extend from the branches 312, 320 such that the second ends 342, 352 extend away from the primary body 302. In some embodiments, the elongated segments 340, 350 are positioned at least partially or completely within a branched portion of the vascular system. By including the elongated sections 340, 350 separately from the primary body 302 and branches 312, 320 of the bifurcated stent graft 300, a physician can achieve any length, type, configuration or diameter of the elongated sections 340, 350 for the specific indication in which the bifurcated stent graft 300 is implanted.

[0077] Many graft materials are known, particularly those that can be used as vascular graft materials. In one embodiment, the materials can be used in combination and assembled together to form a graft. The graft materials used in stent grafts can be made from extrusions, coatings, or wrap films, or combinations thereof. Polymers, biodegradable, and natural materials can be used for specific applications.

[0078] Examples of composite polymers include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyformaldehyde, polymethylmethacrylate, polytetrafluoroethylene, polytrifluorochloroethylene, polyvinyl chloride, polyurethane, elastomeric organosilicon polymers, polyethylene, polypropylene, polyurethane, polyglycolic acid, polyester, polyamide, mixtures, blends and copolymers thereof suitable as graft materials. In one embodiment, the graft is made from polyesters such as polyethylene terephthalates, including DACRON® and MYLAR®, and polyaramids such as KEVLAR®, polyfluorocarbons such as polytetrafluoroethylene with and without copolymerized hexafluoropropylene (TEFLON® or GORE-TEX®), and porous or non-porous polyurethanes. In another embodiment, the graft comprises expanded fluorocarbon polymers, particularly PTFE. Among the preferred types of fluoropolymers are polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), copolymers of tetrafluoroethylene (TFE) and perfluoro(propyl vinyl ether) (PFA), homopolymers of polychlorotrifluoroethylene and its copolymers with TFE, copolymers of ethylene chlorotrifluoroethylene (ECTFE), ethylene tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). A particularly preferred material commonly used in prosthetic devices is expanded PTFE (ePTFE). In another embodiment, the graft comprises a combination of the above-mentioned materials. In another embodiment, the graft is substantially impermeable to bodily fluids. A substantially impermeable graft can be made from a substantially impermeable material to bodily fluids or can be composed of a permeable material that has been treated or manufactured to be substantially impermeable to bodily fluids (e.g., by layering various types of materials described above or known in the art). In one embodiment, the primary body and branch members, as described above, are made from any combination of the above-mentioned materials.In another embodiment, the primary body and branch members include expanded PTFE, as described above. In some examples, the bioresorbable or bioabsorbable material can be, for example, a bioresorbable or bioabsorbable polymer. In some examples, the graft can include Dacron, polyolefin, carboxymethylcellulose fibers, polyurethane, or other woven, nonwoven, or film elastomers.

[0079] As mentioned above, the stent can be generally cylindrical when constrained and / or unconstrained and can include a helical arrangement of corrugations having a plurality of helical turns. The corrugations are preferably aligned to be in phase with one another. Specifically, the corrugations have peaks in opposite first and second directions. When the corrugations are in phase, the peaks of adjacent helical turns are aligned such that the peaks can be displaced to the respective peaks of the corresponding corrugations of the adjacent helical turns. In one embodiment, the corrugations have a sinusoidal waveform. In another embodiment, the corrugations are U-shaped. In another embodiment, the corrugations are V-shaped. In another embodiment, the corrugations are ovoid. These shapes are fully described in U.S. Patent No. 6,042,605, filed July 18, 1997, by Gerald Martin, which is incorporated herein by reference in its entirety for all purposes. U.S. Patent No. 10,299,948, filed November 24, 2015, by Jane Bohn, which is likewise incorporated herein by reference in its entirety for all purposes.

[0080] In another embodiment, as mentioned above, the stent may be provided in the form of a series of rings arranged generally coaxially along the graft body.

[0081] In various embodiments, the stent can be fabricated from a variety of biocompatible materials, including commonly known materials (or combinations of materials) used in the fabrication of implantable medical devices. Exemplary materials include 316L stainless steel, cobalt chromium nickel molybdenum iron alloy (cobalt chrome), other cobalt alloys such as L605, tantalum, nitinol, polymers, MP35N steel, polymeric materials, Phynox, Elgiloy, or other suitable biocompatible materials and combinations thereof. In one embodiment, any of the stent grafts described herein are balloon expandable stent grafts. In another embodiment, any of the stent grafts described herein are self-expanding stent grafts. In another embodiment, the stent is a wire-wound stent. In another embodiment, the wire-wound stent includes corrugations. The superelastic properties and flexibility of nitinol can enhance the compliance of the stent. Additionally, Nitinol can be shape-set into a desired configuration, ie, Nitinol can be shape-set to self-expand into a desired shape when the frame is unconstrained, such as when the frame is deployed out of a delivery system.

[0082] Any of a variety of bioactive substances may be implemented with any of the above. For example, one or more of the devices (including portions thereof) may include a bioactive substance. The bioactive substance may be coated onto one or more of the above features to controllably release the substance when the device is implanted. Such bioactive substances may include, but are not limited to, thrombogenic substances such as, but not limited to, heparin. Bioactive agents also include antiproliferative / antimitotic agents including natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epipodophyllotoxins (e.g., etoposide and teniposide), antibiotics (e.g., dactinomycin (actinomycin D), daunorubicin, doxorubicin, and idarubicin), anthracyclines, mitoxantrone, bleomycin, plicamycin (mithramycin), and mitomycin, enzymes (e.g., L-aspartic acid, which systematically metabolizes L-asparagine and deprives cells of the ability to synthesize their own asparagine), antiplatelet agents such as G(GP)IIb / IIIa inhibitors and vitronectin receptor antagonists, nitrogen mustards (e.g., mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (e.g., hexamethylcyclopropanediol ... Antiproliferative / antimitotic alkylating agents such as samethylmelamine and thiotepa, alkylsulfonates busulfan, nitrosoureas (e.g., carmustine (BCNU) and analogs, streptozocin), trazendacarbazine (DTIC), folic acid analogs (e.g., methotrexate), pyrimidine analogs (e.g., fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (e.g., mercaptopurine, thiourea, Antiproliferative / antimitotic antimetabolites such as guanine, pentostatin, and 2-chlorodeoxyadenosine {cladribine}, platinum coordination complexes (e.g., cisplatin and carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide, hormones (e.g., estrogens), anticoagulants (e.g., heparin, synthetic heparin salts, and other thrombin inhibitors), antiplatelet agents (e.g., aspirin, clopidogrel,prasugrel and ticagrelor), vasodilators (e.g., heparin, aspirin), fibrinolytic substances (e.g., plasminogen activator, streptokinase and urokinase), aspirin, dipyridamore, ticlopidine, clopidogrel, abciximab, antimigratory substances, antisecretory substances (e.g., bleberdin), corticosteroids (e.g., cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methyl anti-inflammatory substances such as prednisolone, triamcinolone, betamethasone and dexamethasone, nonsteroidal substances (e.g. salicylic acid derivatives such as aspirin), p-aminophenol derivatives (e.g. acetaminophen), indole and indene acetic acids (e.g. indomethacin, sulindac and etodolac), heteroaryl acetic acids (e.g. tolmetin, diclofenac and ketorolac), arylpropionic acids (e.g. ibuprofen and benzodiazepines), conductors), anthranilic acids (e.g., mefenamic acid and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenybutazone, and oxyfentatrazone), nabumetone, gold compounds (e.g., auranofin, gold thioglucose, and gold sodium thiomalate), immunosuppressants (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil), angiogenic substances (e.g., vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), angiotensin receptor blockers, nitric oxide donors, antisense oligonucleotides and their conjugates, cell cycle inhibitors, mTOR inhibitors, growth factor receptor signaling kinase inhibitors, retinoids, cyclic / CDK inhibitors, HMG coenzyme reductase inhibitors (statins), and protease inhibitors.

[0083] The devices and methods described herein can provide advantages such as modularity, allowing a variety of individual device components to be selected and placed together at the treatment site during a procedure, increasing the physician's ability to adaptively treat a wider range of anatomical variations. Devices according to the present disclosure allow for sizes and configurations of elongate and / or branch section components that can match the unique shape of the vasculature at the treatment site.

[0084] The devices and methods disclosed herein provide physicians with a wider range of treatment options than selecting from a limited range of predefined options. For example, a device according to various embodiments may include two elongate sections that are selected by the physician to provide a combined cross-section suitable to approximate the cross-section of the vessel at the patient's treatment site, and the device may further include branch sections that can be added to the elongate section to better suit the patient's unique needs and anatomy, with branch section sizes determined by the physician based on where the branch sections are connected to the elongate sections and the patient's anatomy, and branch sections added to the device in a modular manner.

[0085] The modularity of the devices and systems according to the present disclosure can provide the above-mentioned advantages while reducing the number of separate devices that a manufacturer must manufacture or a treatment facility must purchase and stock. The devices and systems disclosed herein can provide the advantages of reducing the undeployed size or diameter of a medical device and the trauma associated with the insertion and deployment of a treatment device that comprises a single component inserted into a treatment area.

[0086] For the avoidance of doubt, although the devices and methods disclosed herein have been described in the context of treating a vessel, it should be appreciated that the device may be implantable in any suitable body lumen.

[0087] Thus, the adaptable bifurcated stent devices and methods described in this disclosure provide a mechanism for substantially approximating various anatomical configurations of vessels or other body lumens, including branched vessel lumens, in the treatment area to minimize leakage around the medical device in the treatment area and isolate the treatment area from hydraulic pressure.

[0088] It will be apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit or scope of the present disclosure. Therefore, the present disclosure is intended to cover the modifications and variations of the present disclosure provided they come within the scope of the claims and their equivalents.

[0089] Similarly, numerous features and advantages, including various alternatives, together with details of the structure and function of the device and / or method are set forth in the above description. This disclosure is intended to be illustrative only and is not intended to be exhaustive. It will be apparent to those skilled in the art that various modifications may be made, particularly with respect to the structure, materials, elements, components, shapes, sizes, and arrangements of parts, including combinations within the principles of the invention, to the extent that such modifications do not depart from the spirit and scope of the claims. (Aspect) (Aspect 1) A device having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a first elongated segment having two opposing ends and defining a first primary lumen extending therebetween, the first elongated segment being operable to be positioned at least partially in the first bifurcated portion of the partially occluded lumen; a second elongated segment having opposing ends and defining a second primary lumen extending therebetween, the second elongated segment being operable to be positioned at least partially in the second bifurcated portion of the partially occluded lumen; Equipped with a combined cross-section of the first elongated segment and the second elongated segment comprises a combined cross-section equal to or greater than an intraluminal cross-section of the non-bifurcated portion of the at least partially occluded lumen, and the first and second elongated segments have sufficient radial wall strength to resist a radially inward force exerted by the at least partially occluded blood vessel to resist collapse of the first and second primary lumens. device. (Aspect 2) The device of embodiment 1, wherein the first and second elongated sections are self-expandable. (Aspect 3) 2. The device of embodiment 1, wherein the first and second elongated sections are balloon expandable. (Aspect 4) A device having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a primary elongated segment having two opposing ends and defining a primary lumen extending therebetween, the primary elongated segment having a cross-section that is equal to or greater than a lumen cross-section of the non-bifurcated portion of the at least partially occluded lumen; a first elongated segment having two opposing ends and defining a first secondary lumen extending therebetween, the first elongated segment being operable to be positioned at least partially in the first bifurcated portion of the partially occluded lumen; a second elongated segment having opposing ends and defining a second primary lumen extending therebetween, the second elongated segment being operable to be positioned at least partially in the second bifurcated portion of the partially occluded lumen; A device comprising: (Aspect 5) The device of embodiment 4, wherein the primary, first and second elongate sections are self-expandable. (Aspect 6) The device of embodiment 5, wherein the primary, first and second elongated sections are balloon expandable. (Aspect 7) A device having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a body including a primary portion, a first branch, and a second branch, the primary portion defining a primary lumen, the primary portion defined between a first open end and a branch, the primary portion having a primary portion length, the first branch defining a first branch lumen, the first branch extending from the primary portion to a first branch open end at the branch, the first branch having a first branch length, the second branch defining a second branch lumen, the second branch extending from the primary portion to a second branch open end at the branch, the second branch having a second branch length, the body having sufficient radial wall strength to resist radially inward forces exerted by the at least partially occluded blood vessel to resist collapse of the primary, first, and second branch lumens; A device comprising: (Aspect 8) The device of embodiment 7, wherein the body is self-expandable. (Aspect 9) The device of embodiment 7, wherein the body is balloon expandable. (Aspect 10) The device of embodiment 7, wherein the body has a length of about 2.5 to 5.5 centimeters. (Aspect 11) 11. The device of embodiment 10, wherein the first and second branches are about 2 to 7 centimeters in length. (Aspect 12) The device of embodiment 7, wherein the body comprises a diameter of 8 to 24 centimeters. (Aspect 13) 8. The device of embodiment 7, wherein the first branch and the second branch comprise a diameter of 7 to 10 diameters. (Aspect 14) Furthermore, a first elongated section having two opposing ends and defining a lumen extending therebetween, the first elongated section being operable to be positioned at least partially in the first branch lumen; a second elongated segment having opposing ends and defining a lumen extending therebetween, the second elongated segment being operable to be positioned at least partially in the second branch lumen; Equipped with 8. A device as described in embodiment 7. (Aspect 15) 8. The device of embodiment 7, wherein a length ratio between the first and second branches and the body is about 1:1.

Claims

1. A device having a support structure and a covering material, the device being operable to be delivered to an at least partially occluded lumen including a non-bifurcated portion, a first bifurcated portion, and a second bifurcated portion, the device comprising: a body including a primary portion, a first branch, and a second branch, the primary portion defining a primary lumen, the primary portion defined between a first open end and a branch, the primary portion having a primary portion length, the first branch defining a first branch lumen, the first branch extending from the primary portion to a first branch open end at the branch, the first branch having a first branch length, the second branch defining a second branch lumen, the second branch extending from the primary portion to a second branch open end at the branch, the second branch having a second branch length, the body having sufficient radial wall strength to resist radially inward forces exerted by an at least partially occluded blood vessel to resist collapse of the primary, first, and second branch lumens; Equipped with Furthermore, a first elongated section having two opposing ends and defining a lumen extending therebetween, the first elongated section being operable to be positioned at least partially in the first branch lumen; a second elongated segment having opposing ends and defining a lumen extending therebetween, the second elongated segment being operable to be positioned at least partially in the second branch lumen; A device comprising:

2. The device of claim 1 , wherein the body is self-expandable.

3. The device of claim 1 , wherein the body is balloon expandable.

4. The device of claim 1 , wherein the primary portion has a length of between 2.5 and 5.5 centimeters.

5. The device of claim 4, wherein the first and second branches are between 2 and 7 centimeters in length.

6. The device of claim 1 , wherein the primary portion comprises a diameter of between 8 and 24 centimeters.

7. The device of claim 1 , wherein the first branch and the second branch comprise a diameter of between 7 and 10 diameters.

8. The device of claim 1 , wherein a length ratio between the first and second branches and the primary portion is approximately 1:1.

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