Priority bending intravascular device

Abstract

Apparatuses, systems, and methods including intravascular devices are provided. The intravascular device may include a graft, the 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 strap extending substantially longitudinally along the graft to define a reinforcement portion that resists bending of the endovascular device at the reinforcement portion such that the endovascular device preferentially bends substantially away from and substantially opposite the reinforcement portion.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Provisional Patent Application No. 63 / 533,551, filed on August 18, 2023, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to devices, systems, and methods for use in medical devices. More specifically, this disclosure relates to devices, systems, and methods including intravascular devices. Background Technology

[0004] Endovascular devices can be implanted within body cavities, including but not limited to those of the vascular system, biliary tract, lymphatic system, respiratory system, or gastrointestinal system. These devices can be implanted endovascularly or surgically. However, difficulties may arise during such procedures. For example, the device may need to traverse a tortuous path or be implanted into a non-linear geometry. Summary of the Invention

[0005] This document discloses an endovascular device comprising a graft, a stent, and a connecting band extending substantially longitudinally along the graft. Various aspects of this specification relate to endovascular devices that preferentially bend to conform to or otherwise adapt to the geometry of a lumen within the body, such as a lumen defined by a vascular system. This preferential bending can help ensure proper orientation of the endovascular device within such a body cavity. In some embodiments, preferential bending is facilitated by a reinforcing portion defined by the connecting band, such that the endovascular device preferentially bends in a direction generally away from or generally opposite to the reinforcing portion. In various examples, the reinforcing portion generally corresponds to a more bend-resistant portion of the endovascular device, resulting in the endovascular device preferentially bending generally opposite to the reinforcing portion. Additionally or alternatively, the connecting band may connect the stent to the graft, such that portions of the stent are secured (e.g., to facilitate preferential bending or other features). For example, various aspects of this specification relate to endovascular devices that reduce or prevent guide wire entrapment in the stent or guide wire hooking onto the stent during fenestration cannulation. In some embodiments, the connecting strap may be fixedly positioned on the bracket portion near the entrance or exit of the window to help reduce jamming, snagging, or other interference with the operability of the window.

[0006] According to one example (“Example 1”), an endovascular device includes: 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 connecting band extending substantially longitudinally along the graft to define a reinforcing portion that resists bending of the endovascular device at the reinforcing portion, such that the endovascular device bends preferentially substantially away from and substantially opposite to the reinforcing portion.

[0007] According to another example (“Example 2”), further to Example 1, the reinforcing portion is located on the outer curve of the intravascular device defined along the periphery of the intravascular device, and the intravascular device preferentially curves toward the inner curve defined along the periphery of the intravascular device and the outer curve of the intravascular device generally opposite to the outer curve of the intravascular device.

[0008] According to another example (“Example 3”), further to either Example 1 or 2, the scaffold includes a plurality of scaffold rows along the length of the graft, the plurality of scaffold rows including a first scaffold row and a second scaffold row adjacent to the first scaffold row, the connecting band securing a first fixing portion of the first scaffold row to the graft and securing a second fixing portion of the second scaffold row to the graft.

[0009] According to another example (“Example 4”), further to any of Examples 1-3, wherein the graft includes a window and the connecting band is aligned with the window.

[0010] According to another example (“Example 5”), further to any of Examples 1-3, the graft includes a window, and the connecting band is circumferentially offset from the window.

[0011] According to another example (“Example 6”), and further to any of Examples 4-5, the connecting strip is positioned adjacent to the opening.

[0012] According to another example (“Example 7”), further to either Example 1 or 2, the intravascular device further includes a second connecting band that extends substantially longitudinally along the graft to define a second reinforcing portion, such that the intravascular device is preferentially curved generally opposite to the second reinforcing portion, the second connecting band being longitudinally offset from the connecting band along the graft.

[0013] According to another example (“Example 8”), further to either Example 1 or 2, the first scaffold row includes a first series of vertices, the first series of vertices including a plurality of free vertices not fixed to the graft and one or more fixed vertices fixed to the graft by the connecting strap.

[0014] According to another example (“Example 9”), further to Example 8, the graft includes a window, and the one or more fixed vertices are positioned approximately longitudinally adjacent to the window.

[0015] According to another example (“Example 10”), further to Example 1, the intravascular device is configured as a thoracic aortic stent graft.

[0016] According to one example (“Example 11”), an endovascular device includes: a graft including a length, an outer surface, an inner surface, and a thickness extending between the outer surface and the inner surface, the inner surface defining a lumen, the graft including a first opening defining a first opening 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 adjacent to the at least one opening; and a connecting band coupling a portion of the first stent row to the graft, wherein the first stent row defines a series of vertices, and the connecting band coupling at least one of the series of vertices to the graft, such that the at least one vertices of the first stent row are secured.

[0017] According to another example (“Example 12”), further to Example 11, the intravascular device can be converted to a curved configuration that defines an outer curve along which the connecting band is oriented.

[0018] According to another example (“Example 13”), and further to any of Examples 11-12, the connecting band is attached to the outside of the graft and extends substantially longitudinally along the length of the graft.

[0019] According to another example (“Example 14”), and further to any of Examples 11-13, the connecting strip is an adhesive strip.

[0020] According to another example (“Example 15”), and further to any of Examples 11-14, the width of the connecting band is approximately the same as the width of one of the vertices in the series of vertices.

[0021] According to another example (“Example 16”), further to any of Examples 11-14, the width of the connecting band is greater than the width of the single vertex in the series of vertices.

[0022] According to another example (“Example 17”), further to Example 11, the graft defines a second opening that is substantially longitudinally aligned with the first opening.

[0023] According to one example (“Example 18”), a method includes: delivering an endovascular device via a lumen to a patient’s main lumen, and aligning the endovascular device along the curvature of the main lumen such that the endovascular device is transformed into a curved configuration. The endovascular device includes 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 connecting band extending substantially longitudinally along the graft to define a reinforcing portion that resists bending of the endovascular device at the reinforcing portion, such that the endovascular device preferentially bends substantially opposite to the reinforcing portion.

[0024] According to another example (“Example 19”), further to Example 18, the method also includes aligning at least one opening of the intravascular device along the lateral branch lumen of the main lumen.

[0025] According to another example (“Example 20”), further to Example 19, the method also includes delivering the branching member into the lateral branch lumen through the at least one opening of the intravascular device.

[0026] According to another example (“Example 21”), a system includes an endovascular device and a guide wire. The endovascular device includes: a graft including a length, a thickness, an outer surface, and an inner surface, the inner surface defining a lumen, and the thickness extending between the outer surface and the inner surface, the graft including a first opening defining a first opening through the thickness; a stent coupled to the graft and extending over at least a portion of the graft's length, the stent including a first stent row positioned adjacent to the first opening; and a guide wire configured to extend through the lumen of the graft, the guide wire defining an exit point at the first opening, a retaining portion of the first stent row positioned at or near the exit point.

[0027] According to another example (“Example 22”), further to Example 21, the guide wire is used for inserting the window, and the connecting strip prevents the guide wire from being locked.

[0028] According to another example (“Example 23”), further to either Example 21 or 22, the fixing portion of the first bracket row helps to reduce jamming and / or snagging of the guide wire at the exit point.

[0029] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concepts provided in this disclosure. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive. Attached Figure Description

[0030] The accompanying drawings, which are included and form part of this specification, illustrate embodiments and, together with the specification, serve to explain the principles of this disclosure, are provided to provide a further understanding of the present disclosure. For reference, the terms “top” or “upper,” “bottom” or “lower,” and “side” used with respect to view orientation are intended to indicate the orientation of the device about its central longitudinal axis at different rotational angles. For example, where a “top” view corresponds to an angle rotation of 0 degrees, a “bottom” view would be offset by a rotational angle of 180 degrees relative to the “top” view, and a “side” view would be offset by a rotational angle of 90 degrees.

[0031] Figure 1 This is a top view of an intravascular device with a connecting strap according to one embodiment; Figure 2 According to one embodiment Figure 1 The intravascular device is in a side view of a curved configuration; Figure 3 According to one embodiment Figure 1 A top view of an intravascular device including at least one window and at least one connecting strap; Figure 4 According to one embodiment Figure 3 A top view of a further intravascular device; Figure 5 According to one embodiment Figure 3 The intravascular device is in a side view of a curved configuration; Figure 6 According to one embodiment Figure 3 A partial view of an intravascular device having multiple connecting bands; Figure 7 According to one embodiment Figure 3 A partial view of an intravascular device with a spiral connecting band; Figure 8 According to one embodiment Figure 7 A further partial view of the intravascular device, showing both a spiral connecting band and a substantially longitudinally aligned connecting band; Figure 9 According to one embodiment Figure 3 A partial view of an intravascular device with a wide connecting band; Figure 10 According to one embodiment Figure 3 A partial view of an intravascular device with a variable-width connecting band; Figure 11 According to one embodiment Figure 1-10 A side view of any one of the endovascular devices implanted in the patient's main lumen; and Figure 12 According to one embodiment Figure 11 A further side view of the intravascular device, showing multiple branching components. Detailed Implementation

[0032] Definitions and Terms

[0033] This disclosure is not intended to be interpreted in a restrictive manner. For example, the terms used in the application should be interpreted broadly within the context in which those skilled in the art would assign meaning to such terms.

[0034] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the measured value and also includes any measured value reasonably close to the measured value. A measured value reasonably close to the measured value deviates from the measured value by a reasonably small amount, as understood and readily determined by one of ordinary skill in the art. Such deviations can be attributed to, for example, measurement errors, differences in the measurement value and / or manufacturing device calibration, human error in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters taking into account differences in measurement values ​​related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, and / or the like. If it is determined that the value of such a reasonably small difference is not readily determined by one of ordinary skill in the art, the terms "about" and "approximately" can be understood to mean plus or minus 10% of the value.

[0035] Description of various embodiments

[0036] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0037] Figure 1 The apparatus shown is provided as an example of various features of an apparatus, and although the combinations of those features shown are clearly within the scope of this disclosure, the example and its illustrations do not imply that the inventive concept provided herein is limited to fewer features, additional features, or alternative features. Figure 1 One or more of those features shown.

[0038] Figure 1 This is a top view of an endovascular device 10 according to 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 end 14, a central longitudinal axis L, and a lumen 16 extending along the central longitudinal axis L within the endovascular device 10. The endovascular device 10 may include a graft 20 and a stent 30 supporting and coupling the graft 20, the endovascular device 10 being configured as a stent-graft. In some embodiments, the endovascular device 10 may include, but is not limited to, for example, an endovascular prosthesis for thoracic and abdominal branches, a thoracic aortic stent graft, or a conformal endovascular prosthesis.

[0039] As shown, graft 20 includes a length 22, a thickness 24, an outer surface 26, and an inner surface 28. The central longitudinal axis L of the endovascular device 10 generally corresponds to the central longitudinal axis of graft 20 defined along length 22. The inner surface 28 may define a lumen 16 extending along length 22. Stent 30 may be coupled to graft 20. Stent 30 may extend over at least a portion of length 22 of graft 20. Stent 30 may include a plurality of stent rows extending along at least a portion of length 22 of graft 20. The plurality of stent rows may be discrete stent rows (e.g., individual loops) 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, wherein the second stent row 38 is adjacent to the first stent row 32. Each of the plurality of stent rows may include a sinusoidal or wavy pattern, and each of the plurality of stent rows may each define a series of vertices. The first stent row 32 may define a first series of vertices 34 oriented toward the first end 12 of the intravascular device 10 and a second series of vertices 36 oriented toward the second end 14 of the intravascular device 10. Similarly, the second stent row 38 may define a first series of vertices 40 oriented toward the first end 12 of the intravascular device 10 and a second series of vertices 42 oriented toward the second end 14 of the intravascular device 10.

[0040] The endovascular device 10 may also include a connecting band 50. The connecting band 50 may extend substantially longitudinally (e.g., substantially along a central longitudinal axis L) along at least a portion of the graft 20 to define a reinforcing portion 52, such that the endovascular device 10 is preferentially curved generally relative to the reinforcing portion 52. The reinforcing portion 52 may extend along the length of the connecting band 50 and be defined by a portion of the stent 30 covered by the connecting band 50. The endovascular device 10 may be from a flat configuration (e.g., as shown in the image) Figure 1 (as shown) transforms into a curved configuration (e.g., as shown) Figure 2 (As shown). When transitioning to a curved configuration, the intravascular device 10 preferentially curves substantially away from or substantially opposite to the reinforcing portion 52 to define the curved portion 54 (e.g., as shown). Figure 2 (As shown). The reinforcement portion(s) 52 may be located on a first side 11 of the intravascular device 10 (e.g., any one of the top, bottom, or side portions of the intravascular device 10) defined along the periphery of the intravascular device 10. In some embodiments, the reinforcement portion(s) is located at various locations along the top surface 19, as shown by reference line 17 extending up to 180 degrees along the top surface. The intravascular device 10 may preferentially bend toward a second side 13 defined along the periphery of the intravascular device 10, wherein the second side 13 is substantially opposite to the first side 11 (e.g., any one of the top, bottom, or side portions of the intravascular device 10). In some embodiments, the first side 11 of the intravascular device 10 may correspond to the outer curve 56 defined by the bend 54, and the second side 13 of the intravascular device 10 may correspond to the inner curve 58 of the bend 54. However, the opposite configuration is also contemplated. When the stent 30 is in a bend configuration, the center of the stent 30 may be a neutral axis. In some embodiments, the outer curve 56 is bent approximately 180 degrees relative to the longitudinal axis L. Although in Figure 1 The figure is shown as a general rectangle, but the connecting band 50 may include any shape, including but not limited to square, circle, ellipse and / or rectangle.

[0041] The connecting band 50 can be attached to the stent 30. Depending on the application, the connecting band 50 can be attached to any number of stent rows (e.g., first stent row 32 and / or second stent row 38). In some embodiments, the connecting band 50 can be applied only to the first stent row 32. In other embodiments, the connecting band 50 can be applied to both the first stent row 32 and the second stent row 38. In a further embodiment, the connecting band 50 can be applied to more than two stent rows (e.g., on at least a portion of the stent 30), or it can extend over the entire length 22 of the graft 20. The connecting band 50 can secure both the stent 30 and the graft 20, such that the stent 30 and the graft 20 are joined together.

[0042] The portion of the support 30 connected to the connecting strap 50 can define the fixing portion 55 of the support 30, wherein the fixing portion 55 of the support 30 is fixed to the graft 20. For example... Figure 1As shown in the embodiments, the connecting strap 50 can secure a first fixing portion 55a of the first support row 32 to the graft 20 and a second fixing portion 55b of the second support row 38 to the graft 20. The first fixing portion 55a of the first support row 32 may include one or more vertices of the first series of vertices 34 and / or one or more vertices of the second series of vertices 36. The second fixing portion 55b of the second support row 38 may include one or more vertices of the first series of vertices 40 and / or one or more vertices of the second series of vertices 42. The portions of the first support row 32 and the second support row 38 not connected to the graft 20 by the connecting strap 50 may be free vertices 45 not fixed to the graft 20. In some embodiments, the fixing portion 55 of the support 30 may be flattened relative to the free portion of the support 30. In other words, the fixing portion 55 of the support 30 may have a near-zero tilt angle, while the free portion of the support 30 may have a larger non-zero tilt angle. This tilt angle may be the angle at which the support 30 or one or more vertices of the support 30 protrude relative to the surface of the graft 20 (e.g., the outer surface 26).

[0043] The connecting band 50 can be flexible, allowing the intravascular device 10 to be converted to a curved configuration (e.g., as shown in the image). Figure 2 As shown), the connecting band 50 bends along with the intravascular device 10 and remains connected to the intravascular device 10. In some embodiments (e.g., as shown) Figure 6 As shown), the connecting band 50 may include a plurality of connecting bands 50 extending circumferentially around the scaffold 30 and the graft 20. These plurality of connecting bands 50 may be discrete connecting bands 50 (e.g., as shown). Figure 6 As shown), it can be a single wide connecting band 50 (e.g., as shown). Figure 9 (as shown), or may include combinations thereof. In some embodiments, the width of the connecting strap 50 is approximately 0.3 inches. In other embodiments, the width of the connecting strap 50 is between approximately 0.1 inches and 0.5 inches, or between approximately 0.5 inches and approximately 1 inch.

[0044] The connecting band 50 may include a material that is stronger or stiffer in the longitudinal direction relative to the circumferential direction. This material may include microstructures of nodes and fibrils, including but not limited to substantially longitudinally oriented fibrils. This can reduce the likelihood of the connecting band 50 breaking when the intravascular device 10 changes to a curved configuration or when the intravascular device 10 passes through the vascular system.

[0045] The connecting band 50 can be an adhesive tape or a graft attachment tape. The adhesive tape may include, but is not limited to, fluorinated ethylene propylene (FEP). The connecting band 50 can be thermally attached or attached to the intravascular device 10. The connecting band 50 can be removably attached to the intravascular device 10 such that it can be removed from the intravascular device 10 after the intravascular device 10 has been implanted in a patient. In other embodiments, the connecting band 50 can be printed onto the intravascular device 10. When printed, the connecting band 50 can be removable from the intravascular device 10.

[0046] Go to Figure 3 The graft 20 of the endovascular device 10 may also include at least one opening 60. This at least one opening 60 may be an orifice through the graft wall (e.g., through both the outer surface 26 and inner surface 28 of the graft 30) or an orifice through the graft wall associated with an internal tubular or branching member (e.g., also described as a port). The opening 60 may be defined through a thickness 24 of the graft 20 such that the outer surface 26 of the graft 20 is in fluid communication with the inner surface 28 or lumen 16 of the graft 20. The graft 20 may include a plurality of openings, which may include a first opening 60a, a second opening 60b, and / or a third opening 60c, although additional openings are also considered. The first opening 60a, the second opening 60b, and the third opening 60c may be aligned along the length 22 of the graft 20 or along a central longitudinal axis L, as shown below. Figure 3 and Figure 4 As shown. However, in some embodiments, the first window 60a, the second window 60b, and the third window 60c may be longitudinally or circumferentially offset from each other. Although in Figure 3 The window is shown as a generally square shape, but the at least one window 60, the first window 60a, the second window 60b, and / or the third window 60c can include any shape, including but not limited to circular, elliptical, and / or rectangular. The first window 60a, the second window 60b, and / or the third window 60c can include the same shape and size, or they can be different from each other.

[0047] like Figure 3 As shown, the intravascular device may include more than one connecting band 50. Figure 3 This is a top view of the intravascular device 10, including a first connecting band 50a and a second connecting band 50b, wherein the first connecting band 50a and the second connecting band 50b are connected to... Figure 1-2The first connecting band 50 is substantially similar to the second connecting band 50a. The second connecting band 50b may extend substantially longitudinally along at least a portion of the graft 20 to define the second reinforcing portion 52b, such that the intravascular device 10 preferentially bends in a direction substantially away from or substantially opposite to the second reinforcing portion 52b. The second connecting band 50b may be substantially aligned with (e.g., substantially longitudinally aligned) the first connecting band 50a, or may be offset from (e.g., longitudinally or circumferentially offset) the first connecting band 50a. Similarly, the second reinforcing portion 52b may be substantially aligned with (e.g., substantially longitudinally aligned) the first reinforcing portion 52a, or may be offset from (e.g., longitudinally or circumferentially offset) the first reinforcing portion 52a. The second connecting band 50b may be substantially longitudinally aligned with the second fenestration 60b.

[0048] The intravascular device 10 may also include a third connecting band 50c, which can be connected to... Figure 1-2 The connecting band 50, the first connecting band 50a, and / or the second connecting band 50b are substantially similar. The first connecting band 50a may be substantially aligned with the first window 60a (e.g., substantially longitudinally aligned along the length 22 of the graft 20 or along the central longitudinal axis L of the graft 20), the second connecting band 50b may be aligned with the second window 60b, and the third connecting band 50c may be aligned with the third window 60c. In some embodiments, the connecting bands 50a, 50b, and 50c may be coupled to the intravascular device 10 such that the connecting bands 50a, 50b, and 50c are adjacent to at least one of the windows 60a, 60b, and 60c. The connecting bands 50a, 50b, and 50c may be positioned substantially longitudinally adjacent or substantially laterally adjacent to the windows 60a, 60b, and 60c. The third connecting band 50c may extend substantially longitudinally along at least a portion of the graft 20 to define the third reinforcing portion 52c, such that the intravascular device 10 preferentially bends in a direction substantially away from or substantially opposite to the third reinforcing portion 52c. When the intravascular device 10 is converted to a bent configuration (e.g., as...), Figure 5 As shown, the third connecting band can be aligned with the first connecting band 50a, the second connecting band 50b, or both the first connecting band 50a and the second connecting band 50b (e.g., substantially longitudinally aligned) to define the outer curve 56 of the bend 54. The third connecting band 50c can also be offset from the first connecting band 50a, the second connecting band 50b, or both the first connecting band 50a and the second connecting band 50b (e.g., longitudinally offset or circumferentially offset). The third connecting band 50c can be substantially longitudinally aligned with the third opening 60c.

[0049] In some embodiments, such as Figure 3As shown, connecting bands 50a, 50b, and 50c may extend over at least a portion of the length of a single support row. A first connecting band 50a may be connected to a first support row 32 and defines a first fixing portion 62 at at least one vertex of a first series of vertices 34 and at least one vertex of a second series of vertices 36 of the first support row 32. A second connecting band 50b may extend over at least a portion of a second support row 38 and defines a second fixing portion 64 at at least one vertex of a first series of vertices 40 and a second series of vertices 42 of the second support row 38. A third connecting band 50c may extend over at least a portion of a third support row 44 and defines a third fixing portion 66 at at least one vertex of a first series of vertices 46 and a second series of vertices 48 of the third support row 44. Figure 9-10 As shown and further described, any one of the first connecting band 50a, the second connecting band 50b, and the third connecting band 50c may have a greater width, such that more than one vertex in the first series of vertices or the second series of vertices is covered by the connecting band. In some embodiments, the first connecting band 50a, the second connecting band 50b, and the third connecting band 50c have substantially the same length, thickness, and width as each other. In other embodiments, one or more of the first connecting band 50a, the second connecting band 50b, and / or the third connecting band 50c have different lengths, thicknesses, and / or widths as each other.

[0050] In other embodiments, such as Figure 4 As shown, connecting strips 50a, 50b, and 50c may extend over less than the entire single support row. Connecting strips 50a, 50b, and 50c may include patches covering a single vertex. A first connecting strip 50a may be connected to the first support row 32 and define a first fixed portion 68 at at least one vertex of a first series of vertices 34 or at least one vertex of a second series of vertices 36 of the first support row 32. The first connecting strip 50a may be positioned at either the entrance position 61a or the exit position 63a of the first opening 60a (e.g., as shown in the image). Figure 5 (As shown). Similarly, the second connecting band 50b can be connected to the second support row 38 and a second fixed portion 70 defined on at least one vertex of the first series of vertices 40 or at least one vertex of the second series of vertices 42 of the second support row 38. Similar to the first connecting band 50a, the second connecting band 50b can be positioned at either the entrance or exit position of the second opening 60b. Similarly, the third connecting band 50c can be connected to the third support row 44 and a second fixed portion 72 defined on at least one vertex of the first series of vertices 46 or at least one vertex of the second series of vertices 48 of the third support row 44. Similar to the first connecting band 50a, the third connecting band 50c can be positioned at either the entrance or exit position of the third opening 60c.

[0051] Figure 5 This is a side view of an intravascular device 10 in a curved configuration, which has Figure 3-4 The first, second, and third windows 60a, 60b, and 60c are provided. The first, second, and third windows 60a, 60b, and 60c can be aligned along the outer curve 56 of the bend 54. Similarly, the first, second, and third connecting bands 50a, 50b, and 50c can be aligned along the outer curve 56 of the bend 54. In some embodiments, the outer curve 56 bends approximately 180 degrees relative to the longitudinal axis L. The first, second, and third reinforcing portions 65a, 65b, and 65c can form the outer curve 56 when the intravascular device 10 bends preferentially away from all three first reinforcing portions 65a, 65b, and 65c. In other embodiments, the first, second, and third reinforcing portions 65a, 65b, and 65c can be misaligned or offset, resulting in different curvatures when the intravascular device 10 bends preferentially, wherein the different curvatures can be aligned with different geometries within the vascular system.

[0052] When the intravascular device 10 is in a curved configuration, the connecting band (e.g., Figure 1-2 The connecting band 50, the first connecting band 50a, the second connecting band 50b, and / or the third connecting band 50c can hold the plurality of stent rings of the stent 30 in place relative to each other and can reduce compression or shortening of the stent 30 along the outer curve 56 of the bend 54. The connecting band can be applied at or near the point of maximum bend 57 to help the plurality of stent rows of the stent 30 extend relative to each other in the bend configuration, thereby reducing compression or shortening of the endovascular device 10. The connecting band can also reduce the tendency of the plurality of stent rings to stack on each other during bending of the endovascular device 10. The connecting band can increase the rigidity of the stent 30 in the reinforcing portions of the endovascular device 10 (e.g., any one of the first, second, and / or third reinforcing portions 65a, 65b, 65c) or reduce its flexibility. In some embodiments, the position of the connecting band 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 curvature of the patient's target vessel and any openings of the endovascular device 10 are aligned with the branch vessel location of the target vessel. The reinforcement can cause the intravascular device 10 to bend preferentially along the reinforcement, which can increase control over the movement and bending of the intravascular device 10 during surgical or transluminal delivery procedures. Surgical and transluminal delivery procedures will be discussed in more detail later.

[0053] When the intravascular device 10 includes at least one fenestration (e.g., any one or more of a first fenestration 60a, a second fenestration 60b, or a third fenestration 60c), the connecting straps (e.g., any one or more of connecting strap 50, the first connecting strap 50a, the second connecting strap 50b, and the third connecting strap 50c) can also help reduce or prevent obstruction during cannulation (e.g., as...). Figure 11-12 (As shown) a situation where the guide wire 100 becomes stuck. When cannulation is performed through openings in the graft 20 (e.g., any one or more of the first opening 60a, the second opening 60b, or the third opening 60c), the guide wire 100 may become stuck in at least one of the series of vertices of the support 30, or may interfere with or contact the support 30 in an undesirable manner. A coupling tape may be attached to selected vertices of the support 30 (e.g., vertices adjacent to the openings where the guide wire 100 may become stuck) to create a fixed portion that keeps the selected vertices connected to the graft 20. The coupling tape may also flatten the selected, fixed vertices relative to free vertices (e.g., the free portion of the support 30) (e.g., by a reduced angle of inclination at the fixed portion of the support 30), making it less likely that the guide wire 100 will become stuck in the support 30 or contact the support 30 in an undesirable manner. Selected vertices may include vertices positioned substantially longitudinally adjacent to any of the openings, including vertices immediately in front of and / or behind the opening (e.g., at the entrance or exit position of the opening), to reduce the likelihood of the guide wire 100 being jammed or undesirably contacting the support 30 during insertion or exit of the opening. Jamming of the guide wire 100 may also include undesirable interference between the guide wire 100 and one or more elements (e.g., multiple vertices) of the support 30, the graft 30, or other related components.

[0054] Similarly, in some embodiments, the guide wire 100 may include a looped end. When cannulation is performed through an opening in the graft 20 (e.g., any one or more of a first opening 60a, a second opening 60b, or a third opening 60c), the looped end of the guide wire 100 may be hooked by at least one of a series of vertices of the support 30. A connecting band 50 may be attached to selected vertices of the support 30 (e.g., vertices located proximal and / or distal to the opening where the looped end of the guide wire 100 may be hooked) to create a fixation portion that keeps the selected vertices connected to the graft 20. By selectively creating the fixation portion, the selected vertices are avoided, and the likelihood of the looped end of the guide wire 100 being hooked by the support 30 is reduced.

[0055] Connecting bands (e.g., any one or more of connecting band 50, first connecting band 50a, second connecting band 50b, and third connecting band 50c) may be applied primarily in the generally central region 15 or canine region 15 of the stent 30, between the first end 12 and the second end 14. The canine region 15 of the stent 30 may experience more bending relative to the first end 12 and the second end 14 of the stent 30. For at least this reason and others, the canine region 15 may require connecting bands to provide increased stiffness or reinforcement when transitioning to a bending configuration to reduce shortening of the stent 30. The canine region 15 may also require connecting bands to reduce compression and / or stacking of adjacent stent rows of the endovascular device 10 during bending. Furthermore, fenestrations (e.g., any one or more of first fenestration 60a, second fenestration 60b, or third fenestration 60c) may be located in the canine region 15, such that cannulation occurs in the canine region 15.

[0056] In other embodiments, in addition to or replacing connecting strips (e.g., any one or more of connecting strip 50, first connecting strip 50a, second connecting strip 50b, and third connecting strip 50c), the graft 20 may be formed with increased stiffness at selected locations to create a reinforcing portion. This may include, but is not limited to, selectively increasing the thickness of the graft 20 at selected locations with additional material, or using a material with higher stiffness along the graft 20 at selected locations. The reinforcing portion 65 may be located between the support 30 and the graft 20, or may be positioned above the support 30. When in a bent configuration, the reinforcing portion 65 may impart increased stiffness and reduce shortening of the graft 20.

[0057] Figure 6-10 An alternative embodiment of a first connecting band 50a coupled to an intravascular device 10 according to some embodiments is shown. Although Figure 6-10 This is shown with respect to the first fenestration 60a, but it is conceivable that a similar configuration could be implemented with the second fenestration 60b and / or the third fenestration 60c. In other embodiments, when the intravascular device 10 does not include a fenestration (e.g., as...), Figure 1-2 As shown), a similar orientation for the connecting strip 50 can be conceived. Furthermore, regarding... Figure 6-10 Any of the configurations shown can be used with one of the windows (e.g., any one of the first window 60a, the second window 60b, or the third window 60c) while the other window has a different configuration.

[0058] Figure 6This is a cross-sectional view of an intravascular device 10 having a plurality of connecting bands 80 substantially circumferentially aligned with each other. The plurality of connecting bands 80 may be circumferentially aligned with each other and extend along at least a portion of at least one stent row (e.g., a first stent row 32 and / or a second stent row 38), and may be configured to each cover a single apex on the at least one stent row. The plurality of connecting bands 80 may be coupled with… Figure 1-5 The connecting strips 50, 50a, 50b, and 50c shown are substantially similar. Having multiple circumferentially aligned first connecting strips 80 can produce a greater effect than using a single connecting strip with a similar width (e.g., Figure 5 The first reinforcing portion 65a) creates a stronger and / or stiffer reinforcing portion 82. Multiple connecting straps 80 can be aligned with at least one of the inlet position 61a or outlet position 63a of the first opening 60a, which can reduce or prevent the guide wire 100 from getting stuck when entering or leaving the first opening 60a.

[0059] Figure 7 This is a cross-sectional view of an intravascular device 10 having a helical connecting band 84 according to some embodiments. The helical connecting band 84 may be connected to a single stent row (e.g., a first stent row 32), or it may be connected to multiple stent rows (e.g., a first stent row 32 and a second stent row 38) and wrapped around the graft 20. The helical connecting band 84 may be a single helical connecting band 84, or it may include multiple helical connecting bands 84. A single helical connecting band 84 may extend over the entire length 22 of the graft 20, or it may extend over a portion of the length of the graft 20 (e.g., over a single stent row or all stent rows less than stent 30). The helical connecting band 84 may be connected to several vertices of a plurality of vertices of the first stent row 32. The helical connecting band 84 may be coupled with... Figure 1-5 Any of the connecting bands 50, 50a, 50b, and 50c shown are substantially similar. The reinforcing portion 86 of the intravascular device 10 may extend over the portion of the stent 30 covered by the spiral connecting band 84. In some embodiments, such as Figure 8 As shown, the intravascular device 10 may include both a spiral connecting band 84 and a substantially longitudinally aligned first connecting band 50a, wherein the substantially longitudinally aligned first connecting band 50a is connected above or below the spiral connecting band 84. This is in contrast to a single connecting band of similar width (e.g., a separate...). Figure 5Compared to the first reinforcing portion 65a, the combination of the spiral connecting band 84 and the substantially longitudinally aligned first connecting band 50a can create a stronger and / or stiffer reinforcing portion 88 for preferential bending of the intravascular device 10. The individual spiral connecting band 84, or its combination with the substantially longitudinally aligned first connecting band 50a, can be aligned with at least one of the inlet position 61a or outlet position 63a of the first opening 60a, which can reduce or prevent the guide wire 100 from becoming stuck as it enters or exits the first opening 60a.

[0060] Figure 9 This is a cross-sectional view of an intravascular device 10 having a wide connecting band 90 according to some embodiments. The wide connecting band 90 can be connected to... Figure 1-5 The connecting bands 50, 50a, 50b, and 50c shown are substantially similar. The wide connecting band 90 can be wider than the width of a single vertex of the first support row 32 and can cover more than one of the vertices of the first support row 32, including two vertices, three vertices, etc. Figure 9 As shown. With a narrower connecting band (e.g., Figure 5 Compared to the first reinforcing portion 65a), the wide connecting band 90 can create a reinforcing portion 92 of the intravascular device 10, which can provide increased reinforcement and stiffness. The wide connecting band 90 can be aligned with at least one of the inlet position 61a or outlet position 63a of the first opening 60a, which can reduce or prevent the guide wire 100 from getting stuck when entering or leaving the first opening 60a.

[0061] Figure 10 This is a cross-sectional view of an intravascular device 10 having a variable-width connecting band 94 according to some embodiments. In some embodiments, the width of the variable-width connecting band 94 may vary along its longitudinal length. A relatively wide portion 96 of the variable-width connecting band 94 may be positioned adjacent to a first opening 60a, and a relatively narrow portion 98 may connect to the relatively wide portion 96. The variable-width connecting band 94 may taper to the relatively wide portion 96, or its width may be varied without tapering, such as... Figure 10 As shown. In some embodiments, the variable-width connecting band 94 may change its width continuously or discontinuously at the entrance position 61a and / or exit position 63a adjacent to the opening 60a. The relatively wider portions 96 of the variable-width connecting band 94 may be substantially longitudinally aligned with each other along the length 22 of the graft 20 to achieve a stiffening effect or reinforcement of a single substantially longitudinal connecting band (e.g., Figure 9 The wide connecting band 90 and the reinforcing portion 92 are included. The relatively wide portion 96 can also be used without multiple connecting bands (e.g., as shown in the image). Figure 6In the case of multiple connecting bands 80, several vertices of multiple vertices of the first support row 32 are covered.

[0062] Figure 11 A guide wire 100 within the lumen 16 of an intravascular device 10 according to some embodiments is shown. The intravascular device 10 can be used with respect to... Figure 1-10 Similar to any endovascular device shown. Endovascular device 10 can be implanted into the patient's main lumen 102. Endovascular device 10 can be delivered via lumen to the patient's main lumen 102 (e.g., where the main lumen 102 may include, but is not limited to, vessels such as the aortic arch, thoracic aorta, ascending aorta, descending aorta, abdominal aorta, or other vessels that require tortuosity and / or have vascular branches). Connecting band ( Figure 1-10 The connecting bands (any one of 50, 50a, 50b, 50c, 80, 84, 90 and / or 94) can be connected to the intravascular device 10 before implantation. In some embodiments, the position and size of the connecting bands, reinforcing portions and / or fenestrations can be customized for the patient by performing a CT scan or other measurement type before implantation.

[0063] The intravascular device 10 can be aligned along the curvature of the main lumen 102, such that the intravascular device 10 transforms into a curved configuration corresponding to the curvature of the main lumen 102. A reinforcing portion formed by the connecting band (e.g., Figure 1-10 The reinforcing portions 65, 65a, 65b, 65c, 82, 86, 88, and / or 92 can impart stiffness to the intravascular device 10, allowing it to preferentially rotate into a curved configuration position away from the reinforcing portions. The reinforcing portions can also impart stiffness to aid in the steering and orientation of the intravascular device 10 through the vascular system and can further facilitate the transformation of the intravascular device 10 to a curved orientation within the main lumen 102. The reinforcing portions can also help align any openings of the intravascular device 10 with a single lateral branch lumen 104 or multiple lateral branch lumen 104a, 104b, 104c of the main lumen 102 (e.g., lateral branch lumen of the aortic arch). The guide wire 100 can be used for cannulation of the multiple lateral branch lumen 104a, 104b, 104c of the main lumen 102.

[0064] Figure 12 The presentation illustrates the delivery of multiple branch components 106a, 106b, 106c via an intravascular device 10. The guide wire 100 may include multiple guide wires 100 or a single branch guide wire 100, such that the multiple branch components 106a, 106b, 106c can be guided and delivered through the lumen 16 of the intravascular device 10 to corresponding lateral branch lumens 104a, 104b, 104c.

[0065] The graft components described herein can be formed from a variety of biocompatible materials. In some cases, the graft may include, but is not limited to, polymers such as polyethylene (PE) or expanded polyethylene (ePE), or may include fluoropolymers such as polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). In some cases, the graft may be formed from, for example, but not limited to, polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer or combinations thereof. In some cases, bioresorbable or bioabsorbable materials may be used, such as bioresorbable polymers or bioabsorbable polymers. In some cases, the graft may include polyester, polyolefins, carboxymethyl cellulose fabrics, polyurethane or other woven, nonwoven, or (thin) film elastomers.

[0066] In addition, NiTi can be used as a material for frames or scaffolds (and any frames discussed herein), but other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Eligiloy, or any other suitable biocompatible material and combinations thereof, can be used as frame materials. The hyperelasticity and flexibility of NiTi enhance the conformability of the scaffold. Furthermore, NiTi can be shaped to a desired form. That is, NiTi can be shaped such that when the frame is unconstrained, such as when the frame is deployed from the delivery system, the frame tends to self-expand into the desired shape.

[0067] The intravascular device of this application has been generally described above, and specific embodiments have been described. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Therefore, the embodiments are intended to cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

[0068] Various modifications and additions can be made to the discussed example embodiments without departing from the scope of the invention. For example, although the embodiments described above relate to specific features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the features described above.

Claims

1. An intravascular device, comprising: The graft, the graft including length; A scaffold, the scaffold being coupled to the graft and extending over at least a portion of the length of the graft; as well as A connecting band extends substantially longitudinally along the graft to define a reinforcing portion that resists bending of the intravascular device at the reinforcing portion, such that the intravascular device preferentially bends substantially away from and substantially opposite to the reinforcing portion.

2. The intravascular device according to claim 1, characterized in that, The reinforcing portion is located on the outer curve defined along the periphery of the intravascular device, and the intravascular device preferentially curves toward the inner curve defined along the periphery of the intravascular device and the outer curve of the intravascular device, which are generally opposite to each other.

3. The intravascular device according to any one of claims 1 to 2, characterized in that, The scaffold includes a plurality of scaffold rows along the length of the graft, the plurality of scaffold rows including a first scaffold row and a second scaffold row adjacent to the first scaffold row, the connecting strap securing a first fixing portion of the first scaffold row to the graft and securing a second fixing portion of the second scaffold row to the graft.

4. The intravascular device according to any one of claims 1 to 3, characterized in that, The graft includes a window, and the connecting band is aligned with the window.

5. The intravascular device according to claim 1 or 3, characterized in that, The graft includes a window, and the connecting band is offset circumferentially from the window.

6. The intravascular device according to claim 4 or 5, characterized in that, The connecting strip is positioned adjacent to the window.

7. The intravascular device according to any one of claims 1 to 2, characterized in that, It also includes a second connecting band that extends substantially longitudinally along the graft to define a second reinforcing portion, such that the intravascular device is preferentially curved generally opposite to the second reinforcing portion, the second connecting band being longitudinally offset from the connecting band along the graft.

8. The intravascular device according to any one of claims 1 to 2, characterized in that, The first scaffold row includes a first series of vertices, which includes a plurality of free vertices not fixed to the graft and one or more fixed vertices fixed to the graft via the connecting strap.

9. The intravascular device according to claim 8, characterized in that, The graft includes a window, and the one or more fixed vertices are positioned approximately longitudinally adjacent to the window.

10. The intravascular device according to claim 1, characterized in that, It was configured as a thoracic aortic stent graft.

11. An intravascular device comprising: A graft, the graft including a length, an outer surface, an inner surface, and a thickness extending between the outer surface and the inner surface, the inner surface defining a lumen, the graft including a first opening defined through the thickness; A support, the support being coupled to the graft and extending over at least a portion of the length of the graft, the support including a first row of supports adjacent to the at least one fenestration; as well as A connecting band connects a portion of the first support row to the graft, wherein the first support row defines a series of vertices, and the connecting band connects at least one of the series of vertices to the graft, such that at least one vertex of the first support row is secured.

12. The intravascular device according to claim 11, characterized in that, The intravascular device can be converted to a curved configuration, the curved configuration defining an outer curve, and the connecting band is oriented along the outer curve.

13. The intravascular device according to any one of claims 11 to 12, characterized in that, The connecting band is attached to the outside of the graft and extends substantially longitudinally along the length of the graft.

14. The intravascular device according to any one of claims 11 to 13, characterized in that, The connecting strip is an adhesive strip.

15. The intravascular device according to any one of claims 11 to 14, characterized in that, The width of the connecting band is approximately the same as the width of one of the vertices in the series of vertices.

16. The intravascular device according to any one of claims 11 to 14, characterized in that, The width of the connecting band is greater than the width of any one of the vertices in the series of vertices.

17. The intravascular device according to claim 11, characterized in that, The graft defines a second window that is substantially longitudinally aligned with the first window.

18. A method, the method comprising: An intravascular device is delivered via a lumen into the patient's main lumen, the intravascular device comprising... The graft, the graft including length, A scaffold, the scaffold being coupled to the graft and extending over at least a portion of the length of the graft, and A connecting band extending substantially longitudinally along the graft to define a reinforcing portion that resists bending of the intravascular device at the reinforcing portion, such that the intravascular device preferentially bends substantially opposite to the reinforcing portion; and Align the intravascular device along the curvature of the main lumen, thereby transforming the intravascular device into a curved configuration.

19. The method according to claim 18, characterized in that, It also includes aligning at least one opening of the intravascular device along the lateral branch lumen of the main lumen.

20. The method according to claim 19, characterized in that, It also includes delivering the branching member into the lateral branch lumen through the at least one opening of the intravascular device.

21. A system comprising: Intravascular device, the intravascular device comprising, A graft, the graft including length, thickness, an outer surface and an inner surface, the inner surface defining a lumen, and the thickness extending between the outer surface and the inner surface, the graft including a first opening defining a passage through the thickness. A support, the support being coupled to the graft and extending over at least a portion of the length of the graft, the support including a first row of supports adjacent to the first fenestration positioning. A connecting strap connects at least a portion of the first support row to the graft to define a fixed portion of the first support row; as well as A guide wire configured to extend through the lumen of the graft, the guide wire defining an exit point at the first opening, and the fixing portion of the first support row positioned at or near the exit point.

22. The system according to claim 21, characterized in that, The guide wire is used to insert a tube into the window, and the connecting band prevents the guide wire from being jammed.

23. The system according to claim 21 or 22, characterized in that, The fixing portion of the first bracket row helps to reduce jamming and / or snagging of the guide wire at the outlet point.

Images