Endovascular device with preferential bending

Abstract

Apparatuses, systems, and methods that include an endovascular device are provided. The endovascular device may include a graft including a length and a stent coupled to the graft and extending over at least a portion of the length of the graft. The endovascular device may further include a coupling strip extending substantially longitudinally along the graft to define a reinforced portion, the reinforced portion resisting bending of the endovascular device at the reinforced portion such that the endovascular device preferentially bends generally away from and generally opposite to the reinforced portion.

Description

ENDOVASCULAR DEVICE WITH PREFERENTIAL BENDINGCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of Provisional Application No. 63 / 533,551 , filed August 18, 2023, which is incorporated herein by reference in its entirety for all purposes.FIELD

[0002] The present disclosure relates generally to apparatuses, systems, and methods for medical devices. More specifically, the disclosure relates to apparatuses, systems, and methods that include endovascular devices.BACKGROUND

[0003] Endovascular devices may be implanted into body lumens, including but not limited to, those of the vasculature, biliary, lymph, respiratory, or gastrointestinal systems. Such endovascular devices may be implanted transluminally or surgically. However, during such procedures, difficulties can arise. For example, the endovascular device may need to travel through torturous paths or may need to be implanted in nonlinear geometries.SUMMARY

[0004] An endovascular device comprising a graft, a stent, and a coupling strip extending substantially longitudinally along the graft is disclosed herein. Various aspects of this specification relate to endovascular devices that preferentially bend to conform to or otherwise accommodate geometries of lumens in the body such as those defined by the vasculature. Such preferential bending may help ensure proper orientation of the endovascular device in such body lumens. In some embodiments, preferential bending is facilitated by the coupling strip defining a reinforced portion such that the endovascular device preferentially bends in a direction generally away from, or generally opposite to, the reinforced portion. In various examples, the reinforced portion generally corresponds to a portion of the endovascular device that is more resistant to bending, thus causing the endovascular device to preferentially bend generally opposite the reinforced portion. Additionally, or alternatively, the coupling strip may couple the stent to the graft such that portions of the stent are immobilized (e.g., to facilitatepreferential bending or other features). For example, various aspects of this specification relate to endovascular devices that reduce or obstruct jailing of guidewires in the stent or catching of guidewires on the stent during cannulation through a fenestration. In some embodiments, the coupling strip may immobilize portions of the stent that are positioned proximate to an entrance or exit of the fenestration to help reduce instances of jailing, catching, or other interference with operability of the fenestration.

[0005] According to one example (“Example 1”), an endovascular device comprises a graft including a length, a stent coupled to the graft and extending over at least a portion of the length of the graft, and a coupling strip extending substantially longitudinally along the graft to define a reinforced portion, the reinforced portion resisting bending of the endovascular device at the reinforced portion such that the endovascular device preferentially bends generally away from and generally opposite to the reinforced portion.

[0006] According to another example (“Example 2”), further to Example 1 , the reinforced portion is located on an outer curve of the endovascular device defined along a circumference of the endovascular device and the endovascular device preferentially bends toward an inner curve of the endovascular device defined along the circumference of the endovascular device generally opposite to the outer curve of the endovascular device.

[0007] According to another example (“Example 3”), further to any of Examples 1 or 2, the stent includes a plurality of stent rows along the length of the graft, the plurality of stent rows including a first stent row and a second stent row adjacent to the first stent row, the coupling strip securing a first immobilized portion of the first stent row to the graft and securing a second immobilized portion of the second stent row to the graft.

[0008] According to another example (“Example 4”), further to any of Examples 1 -3, wherein the graft includes a fenestration and the coupling strip is aligned with the fenestration.

[0009] According to another example (“Example 5”), further to any of Examples 1 -3, the graft includes a fenestration and the coupling strip is circumferentially offset from the fenestration.

[0010] According to another example (“Example 6”), further to any of Examples 4-5, the coupling strip is positioned proximate the fenestration.

[0011] According to another example (“Example 7”), further to any of Examples 1or 2, the endovascular device further comprises a second coupling strip extending substantially longitudinally along the graft to define a second reinforced portion such that the endovascular device preferentially bends generally opposite the second reinforced portion, the second coupling strip being longitudinally offset along the graft from the coupling strip.

[0012] According to another example (“Example 8”), further to any of Examples 1 or 2, the first stent row includes a first series of apices including a plurality of free apices unsecured to the graft and one or more immobilized apices secured to the graft by the coupling strip.

[0013] According to another example (“Example 9”), further to Example 8, the graft includes a fenestration and the one or more immobilized apices are located generally longitudinally-adjacent the fenestration.

[0014] According to another example (“Example 10”), further to Example 1 , the endovascular device is configured as a thoracic stent graft.

[0015] According to one example (“Example 11”), an endovascular device comprises a graft including a length, an exterior surface, an interior surface, the interior surface defining a lumen, and a thickness extending between the exterior surface and the interior surface, the graft including a first fenestration defined through the thickness, a stent coupled to the graft and extending over at least a portion of the length of the graft, the stent including a first stent row, proximate to the at least one fenestration, and a coupling strip coupling a portion the first stent row to the graft wherein the first stent row defines a series of apices and the coupling strip couples at least one apex in the series of apices to the graft such that the at least one apex of the first stent row is immobilized.

[0016] According to another example (“Example 12”), further to Example 11 , the endovascular device is transitionable to a bent configuration, the bent configuration defining an outer curve, the coupling strip being oriented along the outer curve.

[0017] According to another example (“Example 13”), further to any of Examples 11-12, the coupling strip is coupled to the exterior of the graft and extends substantially longitudinally along the length of the graft.

[0018] According to another example (“Example 14”), further to any of Examples 11 -13, the coupling strip is an adhesive strip.

[0019] According to another example (“Example 15”), further to any of Examples 11-14, a width of the coupling strip is approximately the same width as a width of oneapex in the series of apices.

[0020] According to another example (“Example 16”), further to any of Examples 11-14, a width of the coupling strip is larger than a width of the one apex in the series of apices.

[0021] According to another example (“Example 17”), further to Example 11 , the graft defines a second fenestration substantially longitudinally aligned with the first fenestration.

[0022] According to one example (“Example 18”), a method comprises transluminally delivering the endovascular device to a main lumen of a patient and aligning the endovascular device along a curvature of the main lumen such that the endovascular device is transitioned to a bent configuration. The endovascular device including a graft including a length, a stent coupled to the graft and extending over at least a portion of the length of the graft, and a coupling strip extending substantially longitudinally along the graft to define a reinforced portion, the reinforced portion resisting bending of the endovascular device at the reinforced portion such that the endovascular device preferentially bends generally opposite the reinforced portion.

[0023] According to another example (“Example 19”), further to Example 18, the method further comprises aligning at least one fenestration of the endovascular device along a side branch lumen of the main lumen.

[0024] According to another example (“Example 20”), further to Example 19, the method further comprises delivering a branch member to the side branch lumen through the at least one fenestration of the endovascular device.

[0025] According to another example (“Example 21”), a system comprises an endovascular device and a guidewire. The endovascular device including a graft including a length, a thickness, an exterior surface, and an interior surface, the interior surface defining a lumen, and a thickness extending between the exterior surface and the interior surface, the graft including a first fenestration defined through the thickness, a stent coupled to the graft and extending over at least a portion of the length of the graft, the stent including a first stent row positioned proximate to the first fenestration, and the guidewire configured to extend through the lumen of the graft, the guidewire defining an exit point at the first fenestration, the immobilized portion of the first stent row positioned at or proximate to the exit point.

[0026] According to another example (“Example 22”), further to Example 21 , the guidewire is used to cannulate the fenestration and the coupling strip obstructs jailing ofthe guidewire.

[0027] According to another example (“Example 23”), further to either Example 21 or 22, the immobilized portion of the first stent row helps to reduce jailing and / or catching of the guidewire at the exit point.

[0028] The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple 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 in nature rather than restrictive in nature.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the disclosure. For reference, the terms “top” or “upper”, “bottom” or “lower”, and “side” as used with regard to the orientation of the views are meant to denote orientations of the device at different rotational angles around the central longitudinal axis of the device. For example, where the “top” view corresponds to an angular rotation of 0 degrees, the “bottom” view would be offset from the “top” view at a rotational angle of 180 degrees, and the “side” view by a rotational angle of 90 degrees.

[0030] FIG. 1 is a top view of an endovascular device with a coupling strip, in accordance with an embodiment;

[0031] FIG. 2 is a side view of the endovascular device of FIG. 1 in a bent configuration, in accordance with an embodiment;

[0032] FIG. 3 is a top view of the endovascular device further to FIG. 1 including at least one fenestration and at least one coupling strip, in accordance with an embodiment;

[0033] FIG. 4 is a top view of the endovascular device further to FIG. 3, in accordance with an embodiment;

[0034] FIG. 5 is a side view of the endovascular device of FIG. 3 in a bent configuration, in accordance with an embodiment;

[0035] FIG. 6 is a partial view of the endovascular device of FIG. 3 with a plurality of coupling strips, in accordance with an embodiment;

[0036] FIG. 7 is a partial view of the endovascular device of FIG. 3 with a helical coupling strip, in accordance with an embodiment;

[0037] FIG. 8 is a partial view of the endovascular device further to FIG. 7 with both the helical coupling strip and a substantially longitudinally-aligned coupling strip, in accordance with an embodiment;

[0038] FIG. 9 is a partial view of the endovascular device of FIG. 3 with a wide coupling strip, in accordance with an embodiment;

[0039] FIG. 10 is a partial view of the endovascular device of FIG. 3 with a variable-width coupling strip, in accordance with an embodiment;

[0040] FIG. 11 is a side view of the endovascular device of any of FIGS. 1-10 implanted in a main lumen of a patient, in accordance with an embodiment; and

[0041] FIG. 12 is a side view of the endovascular device further to FIG. 11 with a plurality of branch members, in accordance with an embodiment.DETAILED DESCRIPTIONDefinitions and Terminology

[0042] This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

[0043] With respect to terminology of inexactitude, the terms “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences 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 in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and / or manipulation of objects by a person or machine, and / or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.Description of Various Embodiments

[0044] Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

[0045] The device shown in FIG. 1 is provided as an example of various features of the device and, although the combination of those illustrated features is clearly within the scope of invention, that example and its illustration is not meant to suggest the inventive concepts provided herein are limited from fewer features, additional features, or alternative features to one or more of those features shown in FIG. 1.

[0046] FIG. 1 is a top view of an endovascular device 10, in accordance with some embodiments. The endovascular device may define a first end 12, a second end 14, a length between the first end 12 and the second lend 14, a central longitudinal axis L, and a lumen 16 extending the length within the endovascular device 10 along the central longitudinal axis L. The endovascular device 10 may include a graft 20 and a stent 30 supporting the graft 20 and coupled thereto, the endovascular device 10 being configured as a stent-graft. In some embodiments, the endovascular device 10 may include, but is not limited to, a thoracoabdominal branch endoprosthesis, a thoracic stent graft, or a conformable endoprosthesis, for example.

[0047] As shown, the graft 20 includes a length 22, a thickness 24, an exterior surface 26, and an interior surface 28. The central longitudinal axis L of the endovascular device 10 generally corresponds to the central longitudinal axis of the graft 20 defined along the length 22. The interior surface 28 may define the lumen 16, where the lumen 16 extends along the length 22. The stent 30 may be coupled to the graft 20. The stent 30 may extend over at least a portion of the length 22 of the graft 20. The stent 30 may include a plurality of stent rows that extend along at least a portion of the length 22 of the graft 20. The plurality of stent rows may be discrete stent rows (e.g., individual rings) or may be made of a single wire in a continuous helix. The plurality of stent rows may include a first stent row 32 and a second stent row 38, where the second stent row 38 is adjacent to the first stent row 32. Each row in the plurality ofstent rows may include a sinusoidal or undulating pattern and each stent row in the plurality of stent rows may each define a series of apices. The first stent row 32 may define a first series of apices 34 that are oriented toward the first end 12 of the endovascular device 10 and a second series of apices 36 that are oriented toward the second end 14 of the endovascular device 10. Similarly, the second stent row 38 may define a first series of apices 40 that are oriented toward the first end 12 of the endovascular device 10 and a second series of apices 42 that are oriented toward the second end 14 of the endovascular device 10.

[0048] The endovascular device 10 may further include a coupling strip 50. The coupling strip 50 may extend substantially longitudinally along at least a portion of the graft 20 (e.g., extend generally along the central longitudinal axis L) to define a reinforced portion 52 such that the endovascular device 10 preferentially bends substantially opposite to the reinforced portion 52. The reinforced portion 52 may extend over the length of the coupling strip 50 and be defined by the portion of the stent 30 covered by the coupling strip 50. The endovascular device 10 may be transitionable from a straight configuration (e.g., as shown in FIG. 1) to a bent configuration (e.g., as shown in FIG. 2). When transitioning to the bent configuration, the endovascular device 10 preferentially bends generally away from or generally opposite to the reinforced portion 52 to define a bend 54 (e.g., as shown in FIG. 2). The reinforced portion(s) 52 may be located on a first side 11 of the endovascular device 10 defined along a circumference of the endovascular device 10 (e.g., any of a top portion, a bottom portion, or a side portion of the endovascular device 10). The reinforced portion(s) in some embodiments are located in various locations along top surface 19 as indicated by reference line 17 extending up to 180 degrees along the top surface. The endovascular device 10 may preferentially bend towards a second side 13 of the endovascular device 10 defined along the circumference of the endovascular device 10, where the second side 13 is generally opposite to the first side 11 (e.g., any of the top portion, the bottom portion, or the side portion of the endovascular device 10). In some embodiments, the first side 11 of the endovascular device 10 may correspond to an outer curve 56 defined by the bend 54 and the second side 13 of the endovascular device 20 may correspond to an inner curve 58 of the bend 54. However, the opposite configuration is also contemplated. The center of stent 30 may be a neutral axis when the stent 30 is in the bent configuration. In some embodiments, the outer curve 56 is bent about 180 degrees relative to the longitudinal axis L. Although shown asapproximately rectangular in FIG. 1 , the coupling strip 50 may comprise any shape including, but not limited to, a square, a circle, an oval, and / or a rectangle.

[0049] The coupling strip 50 may be coupled to the stent 30. The coupling strip 50 may be coupled to any number of rows in the stent rows (e.g., the first stent row 32 and / or the second stent row 38) depending on the application. In some embodiments, just the first stent row 32 in the plurality of stent rows may have the coupling strip 50 applied thereto. In other embodiments, the coupling strip 50 may be applied to both the first stent row 32 and the second stent row 38. In further embodiments, the coupling strip 50 may be applied to more than two stent rows (e.g., over at least a portion of the stent 30) or may extend over the entire length 22 of the graft 20. The coupling strip 50 may be secured to both the stent 30 and the graft 20 such that the stent 30 and the graft 20 are coupled together.

[0050] Portions of the stent 30 where the coupling strip 50 is coupled to may define an immobilized portion 55 of the stent 30 where the immobilized portion 55 of the stent 30 is secured to the graft 20. As shown in the embodiment of FIG. 1 , the coupling strip 50 may secure a first immobilized portion 55a of the first stent row 32 to the graft 20 and secure a second immobilized portion 55b of the second stent row 38 to the graft 20. The first immobilized portion 55a of the first stent row 32 may include one or more apices of the first series of apices 34 and / or one or more of the apices in the second series of apices 36. The second immobilized portion 55b of the second stent row 38 may include one or more of the first series of apices 40 and / or one or more of the second series of apices 42. The portions of the first stent row 32 and the second stent row 38 that are not coupled to the graft 20 by the coupling strip 50 may be free apices 45 that are unsecured to the graft 20. In some embodiments, the immobilized portion 55 of the stent 30 may be flattened relative to the free portions of the stent 30. In other words, the immobilized portion 55 of the stent 30 may have a cant angle near zero where the free portions of the stent 30 have a larger, nonzero cant angle. The cant angle may be the angle at which the stent 30, or one or more apieces of the stent 30, project relative to a surface (e.g., the exterior surface 26) of the graft 20.

[0051] The coupling strip 50 may be flexible such that the coupling strip 50 bends along with the endovascular device 10 and remains coupled to the endovascular device 10 when the endovascular device 10 is transitioned to the bent configuration (e.g., as shown in FIG. 2). In some embodiments (e.g., as shown in FIG. 6), the coupling 50 may comprise a plurality of coupling strips 50 that extend circumferentiallyabout the stent 30 and graft 20. The plurality of coupling strips 50 may be discrete coupling strips 50 (e.g., as shown in FIG. 6), may be a single, wide coupling strip 50 (e.g., as shown in FIG. 9), or may include a combination thereof. In some embodiments, a width of the coupling strip 50 is approximately 0.3 inches. In other embodiments, the width of the coupling strip 50 is between approximately 0.1 inches and 0.5 inches, or between approximately 0.5 inches to approximately 1 inch.

[0052] The coupling strip 50 may comprise a material that is stronger or stiffer in a longitudinal direction relative to a circumferential direction. The material may comprise a microstructure of nodes and fibrils, that includes, but is not limited to, substantially longitudinally oriented fibrils. This may reduce the possibility of the coupling strip 50 fracturing when the endovascular device 10 transitions to the bent configuration or when the endovascular device 10 travels through the vasculature.

[0053] The coupling strip 50 may be an adhesive strip, or a graft attach tape. The adhesive strip may include, but in not limited to, a fluorinated ethylene propylene (FEP). The coupling strip 50 may be coupled or attached to the endovascular device 10 via thermal attachment. The coupling strip 50 may be removably coupled to the endovascular device 10 such that the coupling 50 can be removed from the endovascular device 10 after the endovascular device 10 is implanted in a patient. In other embodiments, the coupling strip 50 may be printed onto the endovascular device 10. When printed, the coupling strip 50 may be removable from the endovascular device 10.

[0054] Turning to FIG. 3, the graft 20 of the endovascular device 10 may further include at least one fenestration 60. The at least one fenestration 60 may be an aperture through a graft wall (e.g., through both the exterior surface 26 and the interior surface 28 of the graft 30) or an aperture through the graft wall that is associated with an interior tubular member or branch member (e.g., also described as a portal). The fenestration 60 may be defined through the thickness 24 of the graft 20 such that the exterior surface 26 of the graft 20 and the interior surface 28 or lumen 16 of the graft 20 are in fluid communication. The graft 20 may include a plurality of fenestrations which may include a first fenestration 60a, a second fenestration 60b, and / or a third fenestration 60c, although additional fenestrations are contemplated. The first fenestration 60a, the second fenestration 60b, and the third fenestration 60c may be aligned along the length 22 of the graft 20 or along the central longitudinal axis L, as shown in FIGS 3 and 4. However, in some embodiments, the first fenestration 60a, thesecond fenestration 60b, and the third fenestration 60c may be longitudinally offset or circumferentially offset from each other. Although shown as approximately square in FIG. 3, the at least one fenestration 60, the first fenestration 60a, the second fenestration 60b, and / or the third fenestration 60c may comprise any shape including, but not limited to, circles, ovals, and / or rectangles. The first fenestration 60a, the second fenestration 60b, and / or the third fenestration 60c may comprise the same shape and size, or may vary from each other.

[0055] As shown in FIG. 3, the endovascular device may include more than one coupling strip 50. FIG. 3 is a top view of the endovascular device 10 including a first coupling strip 50a and a second coupling strip 50b, where the first coupling strip 50a and the second coupling strip 50b are substantially similar to coupling strip 50 of FIGS. 1-2. The second coupling strip 50b may extend substantially longitudinally along at least a portion of the graft 20 to define a second reinforced portion 52b such that the endovascular device 10 preferentially bends in a direction generally away from, or generally opposite to, the second reinforced portion 52b. The second coupling strip 50b may be substantially aligned (e.g., generally longitudinally aligned) with the first coupling strip 50a or may be offset (e.g., longitudinally offset or circumferentially offset) from the first coupling strip 50a. Similarly, the second reinforced portion 52b may be substantially aligned (e.g., substantially longitudinally aligned) with the first reinforced portion 52a or may be offset (e.g., longitudinally offset or circumferentially offset) from the first reinforced portion 52a. The second coupling strip 50b may be substantially longitudinally aligned with the second fenestration 60b.

[0056] The endovascular device 10 may further include a third coupling strip 50c, which may be substantially similar to any of the coupling strip 50 of FIG. 1-2, the first coupling strip 50a, and / or the second coupling strip 50b. The first coupling strip 50a may be substantially aligned (e.g., generally longitudinally aligned along the length 22 of the graft 20 or along the central longitudinal axis L of the graft 20) with the first fenestration 60a, the second coupling strip 50b may be aligned with the second fenestration 60b, and the third coupling strip 50c may be aligned with the third fenestration 60c. In some embodiments, the coupling strips 50a, 50b, 50c may be coupled to the endovascular device 10 such that the coupling strips 50a, 50b, and 50c are proximate to at least one of the fenestrations 60a, 60b, and 60c. The coupling strip 50a, 50b, 50c may be positioned either substantially longitudinally-adjacent or substantially laterally-adjacent to the fenestration 60a, 60b, 60c. The third coupling strip50c may extend substantially longitudinally along at least a portion of the graft 20 to define a third reinforced portion 52c such that the endovascular device 10 preferentially bends in a direction generally away from, or generally opposite to, the third reinforced portion 52c. The third coupling strip may be aligned (e.g., substantially longitudinally aligned) with either the first coupling strip 50a, the second coupling strip 50b, or both the first and second coupling strips 50a, 50b to define the outer curve 56 of the bend 54 when endovascular device 10 is transitioned to the bent configuration (e.g., as shown in FIG. 5). The third coupling strip 50c may also be offset (e.g., longitudinally offset or circumferentially offset) from either the first coupling strip 50a, the second coupling strip 50b, or both the first and second coupling strips 50a, 50b. The third coupling strip 50c may be substantially longitudinally aligned with the third fenestration 60c.

[0057] In some embodiments, as shown in FIG. 3, the coupling strips 50a, 50b, and 50c may extend over at least a portion of a length of a single stent row. The first coupling strip 50a may couple to the first stent row 32 and define a first immobilized portion 62 on at least one apex of the first series of apices 34 and at least one apex of the second series of apices 36 of the first stent row 32. The second coupling strip 50b may extend over at least a portion of the second stent row 38 and define a second immobilized portion 64 on at least one apex of the first series of apices 40 and the second series of apices 42 of the second stent row 38. The third coupling strip 50c may extend over at least a portion of the third stent row 44 and define a third immobilized portion 66 on at least one apex of the first series of apices 46 and the second series of apices 48 of the third stent row 44. As shown and further described in FIGS. 9-10, any of the first coupling strip 50a, the second coupling strip 50b, and the third coupling strip 50c may have a larger width such that more than one apex of either the first series of apices or second series of apices are covered by the coupling strip. In some embodiments, the first coupling strip 50a, the second coupling strip 50b, and the third coupling strip 50c are substantially the same length, thickness, and width as each other. In other embodiments, one or more of the first coupling strip 50a, the second coupling strip 50b, and / or the third coupling strip 50c has a different length, thickness, and / or width than each other.

[0058] In other embodiments, as shown in FIG. 4, the coupling strips 50a, 50b, and 50c may extend over less than all of a single stent row. The coupling strips 50a, 50b, and 50c may comprise patches that cover a single apex. The first coupling strip 50a may couple to the first stent row 32 and define a first immobilized portion 68 on atleast one apex of the first series of apices 34 or at least one apex of the second series of apices 36 of the first stent row 32. The first coupling strip 50a may be positioned at either an entrance position 61 a or an exit position 63a of the first fenestration 60a (e.g., as shown in FIG. 5). Similarly, the second coupling strip 50b may couple to the second stent row 38 and define a second immobilized portion 70 on at least one apex of the first series of apices 40 or at least one apex of the second series of apices 42 of the second stent row 38. The second coupling strip 50b may be positioned at either an entrance position or an exit position of the second fenestration 60b, similar to the first coupling strip 50a. Similarly, the third coupling strip 50c may couple to the third stent row 44 and define a second immobilized portion 72 on at least one apex of the first series of peaks 46 or at least one apex of the second series of peaks 48 of the third stent row 44. The third coupling strip 50c may be positioned at either an entrance position or an exit position of the third fenestration 60c, similar to the first coupling strip 50a.

[0059] FIG. 5 is a side view of the endovascular device 10 in the bent configuration with the first fenestration 60a, the second fenestration 60b, and the third fenestration 60c of FIGS. 3-4. The first, second, and third fenestrations 60a, 60b, 60c may be aligned along the outer curve 56 of bend 54. Similarly, the first, second, and third coupling strips 50a, 50b, 50c may be aligned along the outer curve 56 of bend 54. In some embodiments, the outer curve 56 is bent about 180 degrees relative to the longitudinal axis L. The first reinforced portion 65a, the second reinforced portion 65b, and the third reinforced portion 65c may form the outer curve 56 as the endovascular device 10 preferentially bends away from all three of the first reinforced portion 65a, the second reinforced portion 65b, and the third reinforced portion 65c. In other embodiments, the first reinforced portion 65a, the second reinforced portion 65b, and the third reinforced portion 65c may be un-aligned, or offset, such that different curvatures are created when the endovascular device 10 is preferentially bent, where the different curvatures may align with different geometries within the vasculature.

[0060] The coupling strip (e.g., any of the coupling strip 50 of FIGS. 1-2, the first coupling strip 50a, the second coupling strip 50b, and / or the third coupling strip 60c) may keep the plurality of stent rings of the stent 30 in place relative to each other and may reduce compression or foreshortening of the stent 30 along the outer curve 56 of the bend 54 when the endovascular device 10 is in the bent configuration. The coupling strip may be applied at or proximate to a maximum bending point 57 to help the plurality of stent rows of the stent 30 be extended from each other in the bent configuration toreduce compression or foreshortening of the endovascular device 10. The coupling strip may also reduce the tendency of the plurality of stent rings to stack upon each other during bending of the endovascular device 10. The coupling strip may increase stiffening, or decrease flexibility, of the stent 30 in the reinforced portions (e.g., any of first, second, and / or third reinforced portions 65a, 65b, 65c) of the endovascular device 10. In some embodiments, the location of the coupling strip may be influenced by the desired curvature or geometry of the endovascular device 10 such that the curvature of the endovascular device 10 matches the target vessel curvature of the patient and any fenestration of the endovascular device 10 align with the target vessel’s branch vessel locations. The reinforced portions may lead to preferential bending of the endovascular device 10 along the reinforced portions which may lead to increased control over movement and bending of the endovascular device 10 during surgical or transluminal delivery procedures. The surgical procedures and transluminal delivery procedures will be discussed subsequently in more detail.

[0061] When the endovascular device 10 includes at least one fenestration (e.g., any one or more of the first fenestration 60a, the second fenestration 60b, or the third fenestration 60c), the coupling strips (e.g. , any one or more of the coupling strip 50, the first coupling strip 50a, the second coupling strip 50b, and the third coupling strip 50c) may also help reduce instances or obstruct instances of jailing of a guidewire 100 during cannulation (e.g., as shown in FIG. 11-12). When cannulating through the fenestration of the graft 20 (e.g., any one or more of the first fenestration 60a, the second fenestration 60b, or the third fenestration 60c), the guidewire 100 may become stuck in at least one apex in the series of apices of the stent 30 or otherwise interfere with or contact the stent 30 in an unwanted manner. The coupling strip may be coupled to selected apieces of the stent 30 (e.g., apieces proximate to the fenestration where the guidewire 100 may be jailed) to create the immobilized portions which keep the selected apieces coupled to the graft 20. The coupling strip may also keep the selected, immobilized apices flattened (e.g., with a reduced cant angle in the immobilized portion of the stent 30) relative to the free apieces (e.g., the free portion of the stent 30) such that the guidewire 100 is less likely to become stuck in or otherwise contact the stent 30 in an unwanted manner. The selected apices may include apieces positioned substantially longitudinally adjacent to any one of the fenestrations, including the apieces immediately forward and / or rearward of the fenestration (e.g., at the entrance or exit positions of the fenestration) to reduce the possibility of the guidewire100 being jailed or otherwise contacting the stent 30 in an unwanted manner upon entrance or exit from the fenestration during cannulation. Jailing of the guidewire 100 may further include unwanted interference between the guidewire 100 and one or more elements of the stent 30 (e.g., the plurality of apices), the graft 30, or other associated components.

[0062] Similarly, in some embodiments, the guidewire 100 may include a looped end. When cannulating through the fenestration of the graft 20 (e.g., any one or more of the first fenestration 60a, the second fenestration 60b, or the third fenestration 60c), the looped end of guidewire 100 may become caught by at least one apex in the series of apices of the stent 30. The coupling strip 50 may be coupled to selected apieces of the stent 30 (e.g., apieces positioned proximal and / or distal to the fenestration where the looped end of guidewire 100 may be caught) to create the immobilized portions which keep the selected apieces coupled to the graft 20. By selectively creating the immobilized portions, selected apieces are kept out of the way and the possibility of the looped end of the guidewire 100 being caught on the stent 30 is reduced.

[0063] The coupling strip (e.g., any one or more of the coupling strip 50, the first coupling strip 50a, the second coupling strip 50b, and the third coupling strip 50c) may be applied primarily in a generally central area 15, or dog bone area 15, of the stent 30, between the first end 12 and the second end 14. The dog bone area 15 of the stent 30 may experience more bending relative to the first end 12 and second end 14 of the stent 30. For at least this reason, among others, the dog bone area 15 may require coupling strips to provide increase stiffness or reinforced portions when transitioning to the bent configuration to reduce foreshortening of the stent 30. The dog bone area 15 may also require the coupling strip to reduce compression and / or stacking of adjacent stent rows of the endovascular device 10 during bending. Further, the fenestrations (e.g., any one or more of the first fenestration 60a, the second fenestration 60b, or the third fenestration 60c) may be located in the dog bone area 15 such that cannulation occurs in the dog bone area 15.

[0064] In other embodiments, in addition to the coupling strip (e.g., any one or more of the coupling strip 50, the first coupling strip 50a, the second coupling strip 50b, and the third coupling strip 50c), or alternatively from the coupling strip, the graft 20 may be made with increased stiffness in selected locations to create a reinforced portion that may include, but is not limited to, selectively increasing the thickness of the graft 20 with additional material in selected locations or by using a material with higher stiffness inselective locations along the graft 20. The reinforced portion 65 may be located between the stent 30 and the graft 20 or may be positioned over the stent 30. The reinforced portion 65 may impart increased stiffness and reduce foreshortening of the graft 20 when in the bent configuration.

[0065] FIGS. 6-10 illustrate alternative embodiments of the first coupling strip 50a coupled to the endovascular device 10, in accordance with some embodiments. Although FIGS. 6-10 are shown with respect to the first fenestration 60a, it is contemplated that similar configurations can be implemented with the second fenestration 60b and / or the third fenestration 60c. In other embodiments, when the endovascular device 10 does not include fenestrations (e.g., as shown in FIGS. 1-2), similar orientations of the coupling strip 50 are contemplated. Further, any of the configurations shown in with respect to FIGS. 6-10 may be used with one of the fenestrations (e.g., any of the first fenestration 60a, the second fenestration 60b, or the third fenestration 60c) while another of the fenestrations has a different configuration.

[0066] FIG. 6 is a section view of the endovascular device 10 with multiple coupling strips 80, which are substantially circumferentially-aligned with each other. The multiple coupling strips 80 may be circumferential aligned with each other and extend along at least a portion of at least one stent row (e.g., the first stent row 32 and / or the second stent row 38) and may be configured to each cover a single apex on the at least one stent row. The multiple coupling strips 80 may be substantially similar to any of the coupling strips 50, 50a, 50b, 50c as shown in FIGS. 1-5. Having multiple coupling first strips 80 circumferentially-aligned may create a stronger and / or stiffer reinforced portion 82 than the reinforced portion created with a single coupling strip of similar width (e.g., the first reinforced portion 65a in FIG. 5). The multiple coupling strips 80 may be aligned with at least one of the entrance position 61a or the exit position 63a of the first fenestration 60a, which may reduce or obstruct the occurrence of guidewire jailing when a guidewire 100 enters or exits the first fenestration 60a.

[0067] FIG. 7 is a section view of the endovascular device 10 with a helical coupling strip 84, in accordance with some embodiments. The helical coupling strip 84 may be coupled to a single stent row (e.g., the first stent row 32), or may be coupled to multiple stent rows (e.g., the first stent row 32 and the second stent row 38) and wound around the circumference of the graft 20. The helical coupling strip 84 may be a single helical coupling strip 84 or may include a plurality of helical coupling strips 84. A single helical coupling 84 may extend over the entire length 22 of the graft 20 or may extendover a partial length of the graft 20 (e.g., over a single stent row or less than all of the stent rows of the stent 30). The helical coupling strip 84 may be coupled to multiple apexes in the plurality of apices of the first stent row 32. The helical coupling strip 84 may be substantially similar to any of the coupling strips 50, 50a, 50b, 50c as shown in FIGS. 1-5. A reinforced portion 86 of the endovascular device 10 may extend over the portions of the stent 30 covered by the helical coupling strip 84. In some embodiments, as shown in FIG. 8, the endovascular device 10 may include both a helical coupling strip 84 and a substantially longitudinally-aligned first coupling strip 50a, where the substantially longitudinally-aligned first coupling strip 50a is coupled over or under the helical coupling strip 84. The combination of the helical coupling strip 84 and the substantially longitudinally-aligned first coupling strip 50a may both create a stronger and / or stiffer reinforced portion 88 for preferential bending of the endovascular device 10 as compared to a single coupling strip of similar width (e.g., the first reinforced portion 65a in FIG. 5 alone). The helical coupling strip 84 alone or in combination with the substantially longitudinally-aligned first coupling strip 50a may be aligned with at least one of the entrance position 61 a or the exit position 63a of the first fenestration 60a, which may reduce or obstruct the occurrence of guidewire jailing when the guidewire 100 enters or exits the first fenestration 60a.

[0068] FIG. 9 is a section view of the endovascular device 10 with a wide coupling strip 90, in accordance with some embodiments. The wide coupling strip 90 may be substantially similar to any of the coupling strips 50, 50a, 50b, 50c as shown in FIGS. 1-5. The wide coupling strip 90 may be wider than the width of one apex of the first stent row 32 and may cover more than one apex in the plurality of apieces of the first stent row 32 including two apieces, three apieces, and so on, as shown in FIG. 9. The wide coupling strip 90 may create a reinforced portion 92 of the endovascular device 10 which may impart increased reinforcement and stiffness in the reinforced portion 92 as compared to a narrower coupling strip (e.g., the first reinforced portion 65a in FIG. 5). The wide coupling strip 90 may be aligned with at least one of the entrance position 61 a or the exit position 63a of the first fenestration 60a, which may reduce or obstruct the occurrence of guidewire jailing when the guidewire 100 enters or exits the first fenestration 60a.

[0069] FIG. 10 is a section view of the endovascular device 10 with a variablewidth coupling strip 94, in accordance with some embodiments. In some embodiments, the variable-width coupling strip 94 may vary in width along a longitudinal length of thevariable-width coupling strip 94. Relatively wider portions 96 of the variable-width coupling strip 94 may be positioned proximate to the first fenestration 60a and relatively narrow portions 98 may connect the relatively wider portions 96. The variable width coupling strip 64 may taper to the relatively wider portions 96 or may change widths without tapering, as shown in FIG. 10. In some embodiments, the variable-width coupling strip 94 may continuously or discontinuously change widths proximate to the entrance position 61 a and / or exit position 63a of the fenestration 60a. The relatively wider portions 96 of the variable-width coupling strip 94 may be substantially longitudinally aligned with each other along the length 22 of the graft 20 to get the stiffening effect or reinforced portion of a single, substantially longitudinal coupling strip (e.g., the wide coupling strip 90 and reinforced portion 92 of FIG. 9). The relatively wider portions 96 may also cover multiple apieces in the plurality of apieces of apieces of the first stent row 32 without the use of multiple coupling strips (e.g., such that the multiple coupling strips 80 of FIG. 6).

[0070] FIG. 11 illustrates a guidewire 100 within the lumen 16 of the endovascular device 10, in accordance with some embodiments. The endovascular device 10 may be similar to any of the endovascular devices shown with respect to FIGS. 1-10. The endovascular device 10 may be implanted into a main lumen 102 of a patient. The endovascular device 10 may be transluminally delivered to the main lumen 102 of the patient (e.g., where the main lumen 102 may include, but is not limited to, a vessel such as the aortic arch, thoracoabdominal aorta, ascending thoracic, descending thoracic, abdominal aorta, or other vessels that require bending and / or have vessel branches). The coupling strip (any of coupling strips 50, 50a, 50b, 50c, 80, 84, 90, and / or 94 of FIGS. 1-10) may be coupled to the endovascular device 10 prior to implantation. In some embodiments, the position, and dimensions of the coupling strip, reinforced portion, and / or fenestrations may be customized to the patient by performing be driven by CT scan or other measurement types prior to implantation.

[0071] The endovascular device 10 may be aligned along a curvature of the main lumen 102 such that the endovascular device 10 is transitioned to a bent configuration that corresponds to the curvature of the main lumen 102. The reinforced portions (e.g., any of the reinforced portions 65, 65a, 65b, 65c, 82, 86, 88, and / or 92 of FIGS. 1-10) formed by the coupling strip may impart stiffness to the endovascular device 10 such that the endovascular device 10 preferentially rotates into the bent configuration position away from the reinforced portion. The reinforced portions mayalso impart stiffness to help steer and orient the endovascular device 10 through the vasculature and can also facilitate transitioning the endovascular device 10 into the bent orientation within the main lumen 102. The reinforced portions may also help steer any fenestrations of the endovascular device 10 into alignment with a single side branch lumen 104 or a plurality of side branch lumens 104a, 104b, 104c of the main lumen 102 (e.g., the side branch lumens of an aortic arch). The guidewire 100 may be used to cannulate the plurality of side branch lumens 104a, 104b, 104c of the main lumen 102.

[0072] FIG. 12 illustrates delivery of a plurality of branch members 106a, 106b, 106c through the endovascular device 10. The guidewire 100 may include a plurality of guidewires 100 or a single branched guidewire 100 such that the plurality of branch members 106a, 106b, 106c may be guided and delivered through the lumen 16 of the endovascular device 10 to the respective side branch lumens 104a, 104b, 104c.

[0073] The graft component described herein may be formed from a variety of biocompatible materials. In certain instances, the graft may include, but is not limited to, a polymer such as polyethylene (PE) or expanded polyethylene (ePE) or may include a fluoropolymer, such as a polytetrafluoroethylene (PTFE) or an expanded polytetrafluoroethylene (ePTFE). In some instances, the graft may be formed of, such as, but not limited to, a polyester, a silicone, a urethane, a polyethylene terephthalate, or another biocompatible polymer, or combinations thereof. In some instances, bioresorbable or bioabsorbable materials may be used, for example a bioresorbable or bioabsorbable polymer. In some instances, the graft can include Dacron, polyolefins, carboxy methylcellulose fabrics, polyurethanes, or other woven, non-woven, or film elastomers.

[0074] In addition, nitinol (NiTi) may be used as the material of the frame, or stent (and any of the frames, or discussed herein), but other materials such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other appropriate biocompatible material, and combinations thereof, can be used as the material of the frame. The super-elastic properties and softness of NiTi may enhance the conformability of the stent. In addition, NiTi can be shape-set into a desired shape. That is, NiTi can be shape-set so that the frame tends to self-expand into a desired shape when the frame is unconstrained, such as when the frame is deployed out from a delivery system.

[0075] The endovascular device of this application has been described above both generically and with regard to specific embodiments. It will be apparent to thoseskilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

[0076] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the above-described features.

Claims

WHAT IS CLAIMED IS:

1. An endovascular device comprising: a graft including a length; a stent coupled to the graft and extending over at least a portion of the length of the graft; and a coupling strip extending substantially longitudinally along the graft to define a reinforced portion, the reinforced portion resisting bending of the endovascular device at the reinforced portion such that the endovascular device preferentially bends generally away from and generally opposite to the reinforced portion.

2. The endovascular device of claim 1 , wherein the reinforced portion is located on an outer curve of the endovascular device defined along a circumference of the endovascular device and the endovascular device preferentially bends toward an inner curve of the endovascular device defined along the circumference of the endovascular device generally opposite to the outer curve of the endovascular device.

3. The endovascular device of any one of claims 1 to 2, wherein the stent includes a plurality of stent rows along the length of the graft, the plurality of stent rows including a first stent row and a second stent row adjacent to the first stent row, the coupling strip securing a first immobilized portion of the first stent row to the graft and securing a second immobilized portion of the second stent row to the graft.

4. The endovascular device of any one of claims 1 to 3, wherein the graft includes a fenestration and the coupling strip is aligned with the fenestration.

5. The endovascular device of any one of claims 1 or 3, wherein the graft includes a fenestration and the coupling strip is circumferentially offset from the fenestration.

6. The endovascular device of claims 4 or 5, wherein the coupling strip is positioned proximate the fenestration.

7. The endovascular device of any one of claims 1 to 2, further comprising a second coupling strip extending substantially longitudinally along the graft to define a second reinforced portion such that the endovascular device preferentially bends generally opposite the second reinforced portion, the second coupling strip being longitudinally offset along the graft from the coupling strip.

8. The endovascular device of any one of claims 1 to 2, wherein the first stent row includes a first series of apices including a plurality of free apices unsecured to the graft and one or more immobilized apices secured to the graft by the coupling strip.

9. The endovascular device of claim 8, wherein the graft includes a fenestration and the one or more immobilized apices are located generally longitudinally-adjacent the fenestration.

10. The endovascular device of claim 1 , configured as a thoracic stent graft.

11. An endovascular device comprising: a graft including a length, an exterior surface, an interior surface, the interior surface defining a lumen, and a thickness extending between the exterior surface and the interior surface, the graft including a first fenestration defined through the thickness; a stent coupled to the graft and extending over at least a portion of the length of the graft, the stent including a first stent row, proximate to the at least one fenestration; and a coupling strip coupling a portion the first stent row to the graft wherein the first stent row defines a series of apices and the coupling strip couples at least one apex in the series of apices to the graft such that the at least one apex of the first stent row is immobilized.

12. The endovascular device of claim 11 , wherein the endovascular device is transitionable to a bent configuration, the bent configuration defining an outer curve, the coupling strip being oriented along the outer curve.

13. The endovascular device of any one of claims 11 to 12, wherein the coupling strip is coupled to the exterior of the graft and extends substantially longitudinally along the length of the graft.

14. The endovascular device of any one of claims 11 to 13, wherein the coupling strip is an adhesive strip.

15. The endovascular device of any one of claims 11 to 14, wherein a width of the coupling strip is approximately the same width as a width of one apex in the series of apices.

16. The endovascular device of any one of claims 11 to 14, wherein a width of the coupling strip is larger than a width of the one apex in the series of apices.

17. The endovascular device of claim 11 , wherein the graft defines a second fenestration substantially longitudinally aligned with the first fenestration.

18. A method comprising: transluminally delivering the endovascular device to a main lumen of a patient, the endovascular device including, a graft including a length, a stent coupled to the graft and extending over at least a portion of the length of the graft, and a coupling strip extending substantially longitudinally along the graft to define a reinforced portion, the reinforced portion resisting bending of the endovascular device at the reinforced portion such that the endovascular device preferentially bends generally opposite the reinforced portion; and aligning the endovascular device along a curvature of the main lumen such that the endovascular device is transitioned to a bent configuration.

19. The method of claim 18, further comprising aligning at least one fenestration of the endovascular device along a side branch lumen of the main lumen.

20. The method of claim 19, further comprising delivering a branch member to the side branch lumen through the at least one fenestration of the endovascular device.

21. A system comprising: an endovascular device including, a graft including a length, a thickness, an exterior surface, and an interior surface, the interior surface defining a lumen, and a thickness extending between the exterior surface and the interior surface, the graft including a first fenestration defined through the thickness, a stent coupled to the graft and extending over at least a portion of the length of the graft, the stent including a first stent row positioned proximate to the first fenestration, a coupling strip coupling at least a portion of the first stent row to the graft to define an immobilized portion of the first stent row; and a guidewire configured to extend through the lumen of the graft, the guidewire defining an exit point at the first fenestration, the immobilized portion of the first stent row positioned at or proximate to the exit point.

22. The system of claim 21 , wherein the guidewire is used to cannulate the fenestration and the coupling strip obstructs jailing of the guidewire.

23. The system of any one of claims 21 or 22, wherein the immobilized portion of the first stent row helps to reduce jailing and / or catching of the guidewire at the exit point.

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