In-pipe devices with preferential curvature

Abstract

Apparatus, systems, and methods including an intubatory device are provided. The intubatory device may include a graft having a certain length and a stent coupled to the graft and extending over at least a portion of the length of the graft. The intubatory device may further include a connecting strip extending substantially longitudinally along the graft and defining a reinforcing portion, the reinforcing portion resisting bending of the intubatory device at the reinforcing portion such that the intubatory device generally curves away from the reinforcing portion and generally on the opposite side.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 63 / 533,551, filed on August 18, 2023, which is hereby incorporated by reference in its entirety for all purposes.

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

Background Art

[0003] Background Intraluminal devices can be implanted within a body cavity, including, but not limited to, the vascular system, biliary system, lymphatic system, respiratory system, or gastrointestinal system. Such intraluminal devices can be implanted percutaneously or surgically. However, difficulties can arise during such procedures. For example, an intraluminal device may need to pass through a tortuous path or be implanted in a non - linear shape.

Summary of the Invention

[0004] Summary Disclosed herein are endovascular devices comprising grafts, stents, and connecting strips substantially extending longitudinally along the grafts. Various embodiments herein relate to endovascular devices that preferentially curve to match, or otherwise adapt to, the shape of a body lumen, such as one defined by the vascular system. Such preferential curvature can help ensure proper orientation of the endovascular device within such a body lumen. In some embodiments, the preferential curvature is facilitated by connecting strips defining a reinforcement, and the endovascular device preferentially curves generally away from or generally opposite to the reinforcement. In various examples, the reinforcement generally corresponds to a portion of the endovascular device that is highly resistant to curvature, thereby causing the endovascular device to preferentially curve generally away from the reinforcement. Additionally or alternatively, the connecting strips can connect a stent to a graft to secure a portion of the stent (e.g., to facilitate preferential curvature or other features). For example, various embodiments of this specification relate to intratubular devices that reduce or prevent the trapping of a guidewire within a stent or the capture of a guidewire into a stent when inserting a cannula through a window. In some embodiments, a connecting strip can help reduce trapping, capture, or other interference with the operability of the window by securing a portion of the stent located near the entrance or exit of the window.

[0005] According to one example ("Example 1"), the tubular device includes a graft having a certain length, a stent coupled to the graft and extending over at least a portion of the length of the graft, and a connecting strip extending substantially longitudinally along the graft and defining a reinforcing portion, the reinforcing portion resists bending of the tubular device at the reinforcing portion such that the tubular device preferentially curves generally away from the reinforcing portion and generally on the opposite side.

[0006] In another example ("Example 2"), in addition to Example 1, the reinforcing portion is positioned on the outer bay of the internal pipe device defined along the periphery of the internal pipe device, and the internal pipe device preferentially curves toward the inner bay of the internal pipe device defined along the periphery of the internal pipe device on the generally opposite side of the outer bay of the internal pipe device.

[0007] In another example ("Example 3"), in addition to either Example 1 or Example 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 connecting strips fixing a first fixing portion of the first stent row to the graft and a second fixing portion of the second stent row to the graft.

[0008] In another example ("Example 4"), in addition to any of Examples 1 to 3, the graft includes a window opening, and the connecting strip is aligned with the window opening.

[0009] In another example ("Example 5"), in addition to any of Examples 1 to 3, the graft includes a window opening, and the connecting strip is offset circumferentially from the window opening.

[0010] In another example ("Example 6"), in addition to any of Examples 4-5, the connecting strip is located near the window opening.

[0011] In another example ("Example 7"), in addition to either Example 1 or 2, the intubatory device further includes a second connecting strip that extends substantially longitudinally along the graft and defines a second reinforcing portion, thereby the intubatory device preferentially curving on generally opposite sides of the second reinforcing portion, and the second connecting strip is longitudinally offset from the connecting strip along the graft.

[0012] In another example ("Example 8"), in addition to either Example 1 or 2, the first stent row includes a first set of vertices, which include a number of free vertices not fixed to the graft and one or more fixed vertices fixed to the graft by the connecting strip.

[0013] In another example ("Example 9"), in addition to Example 8, the graft includes window openings, and the one or more fixed vertices are generally adjacent to the window openings in the longitudinal direction.

[0014] In another example ("Example 10"), in addition to Example 1, the intratubular device is configured as a thoracic stent graft.

[0015] According to one example ("Example 11"), the intratubular device includes a graft having a certain length, an outer surface, an inner surface defining a lumen, and a thickness extending between the outer surface and the inner surface, and including a first window opening defined through the thickness; a stent coupled to the graft and extending over at least a portion of the length of the graft, including a first row of stents adjacent to the at least one window opening; and a connecting strip connecting a portion of the first row of stents to the graft, wherein the first row of stents defines a series of vertices, the connecting strip connects at least one of the series of vertices to the graft, and at least one vertex of the first row of stents is fixed.

[0016] According to another example ("Example 12"), in addition to Example 11, the in-pipe device can be transitioned to a curved configuration, the curved configuration defining an outward curve, and the connecting strip oriented along the outward curve.

[0017] In another example ("Example 13"), in addition to any of Examples 11-12, the connecting strip is attached to the outside of the graft and extends substantially longitudinally along the length of the graft.

[0018] According to another example ("Example 14"), in addition to any of Examples 11-13, the connecting strip is an adhesive strip.

[0019] In another example ("Example 15"), in addition to any of Examples 11-14, the width of the connecting strip is approximately the same as the width of one vertex in the series of vertices.

[0020] In another example ("Example 16"), in addition to any of Examples 11-14, the width of the connecting strip is greater than the width of one of the vertices in the set of vertices.

[0021] In another example ("Example 17"), in addition to Example 11, the graft defines a second window opening substantially aligned longitudinally with the first window opening.

[0022] According to one example ("Example 18"), the method includes transluminal delivery of an endovascular device into the main lumen of a patient and aligning the endovascular device along the curvature of the main lumen so that the endovascular device transitions into a curved configuration. The endovascular device includes a graft having a certain length, a stent coupled to the graft and extending over at least a portion of the length of the graft, and a connecting strip extending substantially longitudinally along the graft and defining a reinforcing portion, the reinforcing portion resisting the curvature of the endovascular device at the reinforcing portion such that the endovascular device preferentially curves generally away from the reinforcing portion and generally on the opposite side.

[0023] In another example ("Example 19"), in addition to Example 18, the method further includes aligning at least one window opening of the intratubular device along the side branch lumen of the main lumen.

[0024] In another example ("Example 20"), in addition to Example 19, the method further includes delivering the branching member to the side branch lumen through at least one window opening of the intubular device.

[0025] According to another example ("Example 21"), the system includes an intraluminal device and a guide wire. The intraluminal device is a graft having a length, a thickness, an outer surface, and an inner surface defining a lumen, and a thickness extending between the outer surface and the inner surface, the graft including a first fenestration defined through the thickness, and 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 disposed proximate to the first fenestration. The guide wire is configured to extend through the lumen of the graft, the guide wire defines an exit point at the first fenestration, and a fixed portion of the first stent row is disposed at or proximate to the exit point.

[0026] According to another example ("Example 22"), in addition to Example 21, the guide wire is used to insert a cannula into the fenestration, and the connection strip prevents confinement of the guide wire.

[0027] According to another example ("Example 23"), in addition to Example 21 or 22, the fixed portion of the first stent row serves to reduce confinement and / or capture of the guide wire at the exit point.

[0028] The above examples are illustrative only and should not be construed as limiting or narrowing the scope of the inventive concepts separately provided by this disclosure. Although multiple examples are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary examples. Accordingly, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated into this specification, constitute part thereof, illustrate embodiments, and serve to illustrate the principles of this disclosure together with the description. For reference, the terms “top,” “upper,” “bottom,” “lower,” and “side” used in relation to the orientation of observation are intended to indicate the orientation of the device at different rotation angles about the central longitudinal axis of the device. For example, if the “top” observation corresponds to a rotation angle of 0 degrees, the “bottom” observation is offset by a rotation angle of 180 degrees from the “top” observation, and the “side” observation is offset by a rotation angle of 90 degrees.

[0030] [Figure 1] Figure 1 is a top view of an in-tube device with a connecting strip according to one embodiment.

[0031] [Figure 2] Figure 2 is a side view of the curved in-pipe device of Figure 1 according to one embodiment.

[0032] [Figure 3] Figure 3 is a top view of an in-tube device according to one embodiment, which, in addition to the components of Figure 1, includes at least one window opening and at least one connecting strip.

[0033] [Figure 4] Figure 4 is a top view of an in-pipe device according to one embodiment, in addition to the one shown in Figure 3.

[0034] [Figure 5] Figure 5 is a side view of the curved in-pipe device of Figure 3 according to one embodiment.

[0035] [Figure 6] Figure 6 is a partial view of the in-pipe device of Figure 3, which includes multiple connecting strips, according to one embodiment.

[0036] [Figure 7] Figure 7 is a partial view of the in-tube device of Figure 3, equipped with a helical connecting strip, according to one embodiment.

[0037] [Figure 8] Figure 8 is a partial view of an in-tube device, added to Figure 7, which, according to one embodiment, includes both a helical connecting strip and a substantially longitudinally aligned connecting strip.

[0038] [Figure 9] Figure 9 is a partial view of the in-pipe device of Figure 3, with a wide connecting strip, according to one embodiment.

[0039] [Figure 10] Figure 10 is a partial view of the in-pipe device of Figure 3, which includes a variable-width connecting strip, according to one embodiment.

[0040] [Figure 11] Figure 11 is a side view of one of the intraluminal devices shown in Figures 1-10, implanted in the main lumen of a patient, according to one embodiment.

[0041] [Figure 12] Figure 12 is a side view of an in-pipe device, added to Figure 11, which has multiple branching members according to one embodiment. [Modes for carrying out the invention]

[0042] Detailed explanation Definitions and Terms This disclosure is not intended to be confined to any particular purpose. For example, terms used in this application should be interpreted broadly in the context of the meanings that a person skilled in the art would assign to such terms.

[0043] With regard to imprecise terminology, the terms “about” and “approximately” can be used interchangeably to refer to measurements that include the stated measurement and measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by a reasonably small amount from the stated measurement, as can be understood and readily verified by a person skilled in the art of the relevant technology. Such deviations may result, for example, from measurement errors, differences in the calibration of measuring instruments and / or manufacturing equipment, human error in reading and / or setting of measurements, fine-tuning made to optimize performance and / or structural parameters to account for differences in measurements related to other components, specific implementation scenarios, improper adjustment and / or handling of the object by a person or machine, and / or similar. Where it is determined that a person skilled in the art of the relevant technology cannot readily grasp the value of such a reasonably small difference, the terms “about” and “approximately” can be understood to mean ±10% of the stated value.

[0044] Description of various embodiments Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus 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; in this respect, the drawings should not be construed as limiting.

[0045] The device shown in Figure 1 is provided as an example of various features of the device, and while the illustrated combination of features is clearly within the scope of the present invention, the example and its illustration are not intended to imply that the inventive concept provided herein is limited to fewer features, additional features, or alternative features to one or more of the features shown in Figure 1.

[0046] Figure 1 is a top view of an endotubular device 10 according to several embodiments. The endotubular device can define a first end 12, a second end 14, the 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 endotubular device 10. The endotubular device 10 may include a graft 20 and a stent 30 that supports and is connected to the graft 20, and the endotubular device 10 is configured as a stent graft. In some embodiments, the endotubular device 10 may include, but is not limited to, a thoracoabdominal lateral branch endoprosthesis, a thoracic stent graft, or a compatible endoprosthesis.

[0047] As shown in the figure, the 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 intratubular device 10 generally corresponds to the central longitudinal axis of the graft 20 defined along the length 22. The inner surface 28 can define a lumen 16 extending along the length 22. The stent 30 can be connected to the graft 20. The stent 30 can extend over at least a portion of the length 22 of the graft 20. The stent 30 may include multiple rows of stents extending along at least a portion of the length 22 of the graft 20. The multiple rows of stents may be individual rows of stents (e.g., individual rings) or may be made from a single continuous helical wire. The multiple rows of stents may include a first row of stents 32 and a second row of stents 38, where the second row of stents 38 is adjacent to the first row of stents 32. Each row of the multiple stent rows may include a sinusoidal or wavy pattern, and each row of the multiple stent rows may define a set of vertices. The first stent row 32 may define a first set of vertices 34 directed toward the first end 12 of the tubular device 10 and a second set of vertices 36 directed toward the second end 14 of the tubular device 10. Similarly, the second stent row 38 may define a first set of vertices 40 directed toward the first end 12 of the tubular device 10 and a second set of vertices 42 directed toward the second end 14 of the tubular device 10.

[0048] The internal device 10 may further include a connecting strip 50. The connecting strip 50 extends substantially longitudinally along at least a portion of the graft 20 (for example, generally along the central longitudinal axis L), and can define a reinforcing portion 52 such that the internal device 10 preferentially curves substantially away from the reinforcing portion 52. The reinforcing portion 52 extends along the length of the connecting strip 50 and may be defined by the portion of the stent 30 covered by the connecting strip 50. The internal device 10 may be transitionable from a straight configuration (for example, as shown in Figure 1) to a curved configuration (for example, as shown in Figure 2). When transitioning to a curved configuration, the internal device 10 preferentially curves generally away from the reinforcing portion 52, or generally to the opposite side, to define a curved portion 54 (for example, as shown in Figure 2). The reinforcing portion 52 may be located on a first side 11 of the internal pipe device 10 (e.g., the top, bottom, or side of the internal pipe device 10) defined along the periphery of the internal pipe device 10. In some embodiments, the reinforcing portion is located at various positions along the top surface 19, as indicated by a reference line 17 extending up to 180 degrees along the top surface. The internal pipe device 10 may be preferentially curved toward a second side 13 defined along the periphery of the internal pipe device 10, where the second side 13 is generally opposite to the first side 11 (e.g., the top, bottom, or side of the internal pipe device 10). In some embodiments, the first side 11 of the internal pipe device 10 may correspond to an outward curve 56 defined by the curved portion 54, and the second side 13 of the internal pipe device 20 may correspond to an inward curve 58 of the curved portion 54. However, the reverse configuration is also possible. When the stent 30 is in a curved configuration, the center of the stent 30 can be the neutral axis. In some embodiments, the outward curve 56 is curved about 180 degrees with respect to the longitudinal axis L. Although shown as substantially rectangular in Figure 1, the connecting strip 50 can include any shape, including, but not limited to, square, circular, elliptical, and / or rectangular.

[0049] The connecting strip 50 can be connected to the stent 30. Depending on the application, the connecting strip 50 can be connected to any number of rows of stents (e.g., a first row of stents 32 and / or a second row of stents 38). In some embodiments, the connecting strip 50 may be attached only to the first row of stents 32. In other embodiments, the connecting strip 50 may be applied to both the first row of stents 32 and the second row of stents 38. In further embodiments, the connecting strip 50 may be attached to more than two rows of stents (e.g., over at least a portion of the stent 30) or may extend over the entire length 22 of the graft 20. The connecting strip 50 may be fixed to both the stent 30 and the graft 20 so that the stent 30 and the graft 20 are connected to each other.

[0050] The portion of the stent 30 to which the connecting strip 50 is connected can define a fixed portion 55 of the stent 30, which is fixed to the graft 20. As shown in the embodiment of Figure 1, the connecting strip 50 can fix a first fixed portion 55a of a first stent row 32 to the graft 20 and a second fixed portion 55b of a second stent row 38 to the graft 20. The first fixed portion 55a of the first stent row 32 may include one or more vertices of a first set of vertices 34 and / or one or more vertices of a second set of vertices 36. The second fixed portion 55b of the second stent row 38 may include one or more vertices of a first set of vertices 40 and / or one or more vertices of a second set of vertices 42. The portions of the first stent row 32 and the second stent row 38 that are not connected to the graft 20 by the connecting strip 50 may be free vertices 45 that are not fixed to the graft 20. In some embodiments, the fixed portion 55 of the stent 30 may be flattened relative to the free portion of the stent 30. In other words, if the free portion of the stent 30 has a larger non-zero inclination angle, the fixed portion 55 of the stent 30 may have a nearly zero inclination angle. The inclination angle can be the angle at which the stent 30, or one or more vertices of the stent 30, protrudes relative to the surface of the graft 20 (e.g., the outer surface 26).

[0051] The connecting strip 50 can be flexible so that it bends together with the internal device 10 and remains connected to the internal device 10 when the internal device 10 transitions to a bent configuration (for example, as shown in Figure 2). In some embodiments (for example, as shown in Figure 6), the connecting portion 50 may include a plurality of connecting strips 50 extending circumferentially around the stent 30 and the graft 20. The plurality of connecting strips 50 may be individual connecting strips 50 (for example, as shown in Figure 6), a single wide connecting strip 50 (for example, as shown in Figure 9), or a combination thereof. In some embodiments, the width of the connecting strip 50 is approximately 0.3 inches. In other embodiments, the width of the connecting strip 50 is approximately 0.1 inches to 0.5 inches, or approximately 0.5 inches to approximately 1 inch.

[0052] The connecting strip 50 may include a material that has greater strength or rigidity in the longitudinal direction than in the circumferential direction. The material may include a microstructure of nodes and fibrils, which may include, but are not limited to, fibrils substantially oriented in the longitudinal direction. This reduces the possibility of the connecting strip 50 breaking when the intratubular device 10 transitions to a curved configuration or when the intratubular device 10 moves within the vascular system.

[0053] The connecting strip 50 may be an adhesive strip or a graft attachment tape. The adhesive strip may, but is not limited to, contain fluorinated ethylene propylene (FEP). The connecting strip 50 may be connected to or attached to the tubular device 10 by heat bonding. The connecting strip 50 may be removably bonded to the tubular device 10 so that the connecting strip 50 can be removed from the tubular device 10 after the tubular device 10 has been implanted in a patient. In other embodiments, the connecting strip 50 may be printed on the tubular device 10. Once printed, the connecting strip 50 may be removable from the tubular device 10.

[0054] Referring to Figure 3, the graft 20 of the internal device 10 may further include at least one window 60. The at least one window 60 may be an aperture penetrating the graft wall (e.g., an aperture penetrating both the outer surface 26 and the inner surface 28 of the graft 30), or an aperture penetrating the graft wall and associated with an internal tubular member or branching member (e.g., also called a portal). The window 60 may be defined penetrating the thickness 24 of the graft 20 so that the outer surface 26 of the graft 20 and the inner surface 28 of the graft 20 or the lumen 16 are in fluid communication. The graft 20 may include a plurality of window 60, such as a first window 60a, a second window 60b and / or a third window 60c, but additional window 60s are also possible. The first window opening 60a, the second window opening 60b, and the third window opening 60c may be aligned along the length 22 of the graft 20 or along the central longitudinal axis L, as shown in Figures 3 and 4. However, in some embodiments, the first window opening 60a, the second window opening 60b, and the third window opening 60c may be offset from each other longitudinally or circumferentially. Although shown as substantially square in Figure 3, at least one window opening 60, i.e., the first window opening 60a, the second window opening 60b, and / or the third window opening 60c, may have any shape, including, but not limited to, a circle, an ellipse, and / or a rectangle. The first window opening 60a, the second window opening 60b, and / or the third window opening 60c may have the same shape and size, or they may be different from each other.

[0055] As shown in Figure 3, the intubation device may include a plurality of connecting strips 50. Figure 3 is a top view of the intubation device 10 including a first connecting strip 50a and a second connecting strip 50b, the first and second connecting strips 50a and 50b being substantially similar to the connecting strips 50 in Figures 1 and 2. The second connecting strip 50b extends substantially longitudinally along at least a portion of the graft 20 to define a second reinforcement 52b, thereby allowing the intubation device 10 to generally move away from the second reinforcement 52b or to generally curve preferentially to the opposite side. The second connecting strip 50b may be substantially aligned with the first connecting strip 50a (e.g., generally longitudinally aligned) or offset from the first connecting strip 50a (e.g., longitudinally offset or circumferentially offset). Similarly, the second reinforcing portion 52b may be substantially aligned with the first reinforcing portion 52a (for example, generally aligned longitudinally) or offset from the first reinforcing portion 52a (for example, offset longitudinally or offset circumferentially). The second connecting strip 50b may be substantially aligned longitudinally with the second window opening 60b.

[0056] The intubation device 10 may further include a third connecting strip 50c which may be substantially similar to any of the connecting strips 50, first connecting strip 50a and / or second connecting strip 50b shown in Figures 1-2. The first connecting strip 50a may be substantially aligned with the first window hole 60a (for example, longitudinally aligned along the length 22 of the graft 20 or along the central longitudinal axis L of the graft 20), the second connecting strip 50b may be aligned with the second window hole 60b, and the third connecting strip 50c may be aligned with the third window hole 60c. In some embodiments, the connecting strips 50a, 50b, and 50c may be connected to the intubation device 10 such that the connecting strips 50a, 50b, and 50c are close to at least one window hole 60a, 60b, and 60c. The connecting strips 50a, 50b, and 50c may be positioned substantially adjacent to the window openings 60a, 60b, and 60c in the longitudinal direction, or substantially adjacent to them in the transverse direction. The third connecting strip 50c extends substantially longitudinally along at least a portion of the graft 20 to define a third reinforcement 52c, thereby allowing the in-pipe device 10 to generally move away from the third reinforcement 52c, or to generally preferentially curve to the opposite side. The third connecting strip is aligned with the first connecting strip 50a, the second connecting strip 50b, or both the first and second connecting strips 50a and 50b (for example, substantially longitudinally) to define the outward curve 56 of the curved portion 54 when the in-pipe device 10 transitions to a curved configuration (for example, as shown in Figure 5). Furthermore, the third connecting strip 50c may be offset from the first connecting strip 50a, the second connecting strip 50b, or both the first and second connecting strips 50a and 50b (for example, offset longitudinally or circumferentially). The third connecting strip 50c can be substantially aligned longitudinally with the third window opening 60c.

[0057] In some embodiments, as shown in Figure 3, the connecting strips 50a, 50b, and 50c may extend over at least a portion of the length of a single stent row. The first connecting strip 50a may connect to the first stent row 32 and define a first fixed portion 62 at at least one vertex of the first set of vertices 34 and at least one vertex of the second set of vertices 36 of the first stent row 32. The second connecting strip 50b may extend over at least a portion of the second stent row 38 and define a second fixed portion 64 at at least one vertex of the first set of vertices 40 and at least one vertex of the second set of vertices 42 of the second stent row 38. The third connecting strip 50c may extend over at least a portion of the third stent row 44 and define a third fixed portion 66 at at least one vertex of the first set of vertices 46 and at least one vertex of the second set of vertices 48 of the third stent row 44. As shown in Figures 9-10, any of the first connecting strip 50a, the second connecting strip 50b, and the third connecting strip 50c may have a wider width so that two or more vertices of either the first series of vertices or the second series of vertices are covered by the connecting strip. In some embodiments, the first connecting strip 50a, the second connecting strip 50b, and the third connecting strip 50c are substantially the same length, thickness, and width. In other embodiments, one or more of the first connecting strip 50a, the second connecting strip 50b, and / or the third connecting strip 50c have different lengths, thicknesses, and / or widths.

[0058] In other embodiments, as shown in Figure 4, the connecting strips 50a, 50b, and 50c may extend over a shorter area than the entirety of a single stent row. The connecting strips 50a, 50b, and 50c may include patches covering a single vertex. The first connecting strip 50a may be connected to the first stent row 32 and define a first fixation portion 68 at at least one vertex of the first set of vertices 34 of the first stent row 32, or at least one vertex of the second set of vertices 36. The first connecting strip 50a may be positioned at either the entrance position 61a or the exit position 63a of the first window opening 60a (for example, as shown in Figure 5). Similarly, the second connecting strip 50b may be connected to the second stent row 38 and define a second fixation portion 70 at at least one vertex of the first set of vertices 40 of the second stent row 38, or at least one vertex of the second set of vertices 42. The second connecting strip 50b may be positioned at either the entrance or exit position of the second window opening 60b, similar to the first connecting strip 50a. Similarly, the third connecting strip 50c may be connected to the third stent row 44, and a second fixing portion 72 may be defined at 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 stent row 44. The third connecting strip 50c may be positioned at either the entrance or exit position of the third window opening 60c, similar to the first connecting strip 50a.

[0059] Figure 5 is a side view of the in-tube device 10 in a curved configuration, which includes the first window opening 60a, the second window opening 60b, and the third window opening 60c shown in Figures 3 and 4. The first, second, and third window openings 60a, 60b, and 60c can be aligned along the outward curve 56 of the curved section 54. Similarly, the first, second, and third connecting strips 50a, 50b, and 50c can be aligned along the outward curve 56 of the curved section 54. In some embodiments, the outward curve 56 is curved at approximately 180 degrees with respect to the longitudinal axis L. The first reinforcing section 65a, the second reinforcing section 65b, and the third reinforcing section 65c can form the outward curve 56 when the in-tube device 10 is preferentially bent away from all three of the first reinforcing section 65a, the second reinforcing section 65b, and the third reinforcing section 65c. In other embodiments, the first reinforcing portion 65a, the second reinforcing portion 65b, and the third reinforcing portion 65c may be misaligned or offset so that different curvatures are generated when the intubation device 10 is preferentially bent, in which case the different curvatures may be aligned with different geometries within the vascular system.

[0060] The connecting strips (for example, any of the connecting strips 50, the first connecting strip 50a, the second connecting strip 50b, and / or the third connecting strip 60c shown in Figures 1-2) can maintain the multiple stent rings of the stent 30 in a predetermined position relative to each other, thereby reducing compression or shortening of the stent 30 along the outward curve 56 of the curved portion 54 when the intubation device 10 is in a curved configuration. By applying the connecting strips to or near the point of maximum curvature 57, the multiple stent rows of the stent 30 are stretched relative to each other in the curved configuration, reducing compression or shortening of the intubation device 10. The connecting strips can also reduce the tendency for the multiple stent rings to overlap each other when the intubation device 10 is curved. The connecting strips can increase the rigidity or decrease the flexibility of the stent 30 in the reinforced portion of the intubation device 10 (for example, any of the first, second, and / or third reinforced portions 65a, 65b, and 65c). In some embodiments, the position of the connecting strip is influenced by the desired curvature or shape of the intravascular device 10, where the curvature of the intravascular device 10 matches the curvature of the patient's target vessel, and the window of the intravascular device 10 can be aligned with the position of the branch vessels of the target vessel. The reinforcement leads to preferential bending of the intravascular device 10 along the reinforcement, which may lead to improved control over the movement and bending of the intravascular device 10 during surgical or transcatheter delivery procedures. Surgical and transcatheter delivery procedures are described in more detail below.

[0061] When the intratubular device 10 includes at least one window opening (e.g., one or more of the first window opening 60a, the second window opening 60b, or the third window opening 60c), the connecting strips (e.g., one or more of the connecting strip 50, the first connecting strip 50a, the second connecting strip 50b, and the third connecting strip 50c) can also help reduce or prevent instances of the guidewire 100 being trapped during cannula insertion (e.g., as shown in Figures 11-12). When inserting a cannula into a window opening in the graft 20 (e.g., one or more of the first window opening 60a, the second window opening 60b, or the third window opening 60c), the guidewire 100 may catch on at least one of the vertices of the stent 30, or otherwise interfere with or come into contact with the stent 30 in an undesirable manner. The connecting strip can be coupled to a selected vertex of the stent 30 (e.g., the vertex closest to a window where the guidewire 100 might be trapped), creating a fixed portion that leaves the selected vertex attached to the graft 20. The connecting strip can also hold the selected fixed vertex flat relative to a free vertex (e.g., the free portion of the stent 30) (e.g., by reducing the inclination angle of the fixed portion of the stent 30) so that the guidewire 100 is less likely to get caught on the stent 30 or otherwise make undesirable contact. The selected vertex may include a vertex positioned substantially longitudinally adjacent to one of the window holes, and may include a vertex located immediately anterior and / or posterior to a window hole (e.g., the entrance or exit position of the window hole), thereby reducing the likelihood that the guidewire 100 will be trapped or otherwise make undesirable contact with the stent 30 as it enters or exits the window hole during cannula insertion. Confinement of the guidewire 100 may also include undesirable interference between the guidewire 100 and one or more elements of the stent 30 (e.g., multiple vertices), the graft 30, or other related components.

[0062] Similarly, in some embodiments, the guidewire 100 may include a looped end. When a cannula is inserted into a window in the graft 20 (e.g., one or more of the first window 60a, the second window 60b, or the third window 60c), the looped end of the guidewire 100 may be captured by at least one of the set of vertices of the stent 30. The connecting strip 50 can be connected to a selected vertex of the stent 30 (e.g., a vertex located proximal and / or distal to the window into which the looped end of the guidewire 100 may be captured), forming a fixed portion that keeps the selected vertex connected to the graft 20. By selectively forming the fixed portion, the selected vertex is kept out of the way, and the likelihood of the looped end of the guidewire 100 being captured by the stent 30 is reduced.

[0063] Connecting strips (for example, one or more of connecting strip 50, first connecting strip 50a, second connecting strip 50b, and third connecting strip 50c) may be applied primarily to the generally central region 15 or dogbone region 15 of the stent 30 between the first end 12 and the second end 14. The dogbone region 15 of the stent 30 can be subjected to greater bending than the first end 12 and the second end 14 of the stent 30. For this reason at least, the dogbone region 15 may require connecting strips to provide increased rigidity or reinforcement when transitioning to a curved configuration in order to reduce shortening of the stent 30. The dogbone region 15 may also require connecting strips to reduce compression and / or stacking of adjacent stent rows of the intube device 10 during bending. Furthermore, window openings (for example, one or more of the first window opening 60a, the second window opening 60b, or the third window opening 60c) can be positioned in the dogbone region 15 so that cannula insertion can be performed in the dogbone region 15.

[0064] In other embodiments, in addition to, or from, the connecting strips (e.g., connecting strip 50, one or more of the first connecting strip 50a, the second connecting strip 50b, and the third connecting strip 50c), the graft 20 may be fabricated with increased rigidity at selected locations to form a reinforcement, which may include, but is not limited to, selectively increasing the thickness of the graft 20 using additional material at selected locations, or using a material with higher rigidity at selected locations along the graft 20. The reinforcement 65 may be positioned between the stent 30 and the graft 20, or on the stent 30. The reinforcement 65 may increase the rigidity of the graft 20 and reduce shortening when it is in a curved configuration.

[0065] Figures 6 to 10 show alternative embodiments of the first connecting strip 50a connected to the intubular device 10 according to several embodiments. Although Figures 6 to 10 are shown with respect to the first window hole 60a, similar configurations can be implemented for the second window hole 60b and / or the third window hole 60c. In other embodiments, similar orientations of the connecting strip 50 can be considered when the intubular device 10 does not include a window hole (for example, as shown in Figures 1 to 2). Furthermore, any of the configurations shown with respect to Figures 6 to 10 can be used for one of the window holes (for example, the first window hole 60a, the second window hole 60b, or the third window hole 60c), but the other window holes have different configurations.

[0066] Figure 6 is a cross-sectional view of an intubatory device 10 having a plurality of connecting strips 80 substantially aligned to each other in the circumferential direction. The plurality of connecting strips 80 may be aligned to each other in the circumferential direction 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), with each being configured to cover a single vertex of at least one stent row. The plurality of connecting strips 80 may be substantially similar to any of the connecting strips 50, 50a, 50b, and 50c shown in Figures 1-5. By circumferentially aligning the plurality of first connecting strips 80, a reinforcement 82 can be formed that is stronger and / or more rigid than a reinforcement formed by a single connecting strip of similar width (e.g., the first reinforcement 65a in Figure 5). Multiple connecting strips 80 can be aligned with at least one of the entrance position 61a or exit position 63a of the first window hole 60a, thereby reducing or preventing the occurrence of guide wire trapping when the guide wire 100 enters or exits the first window hole 60a.

[0067] Figure 7 is a cross-sectional view of an intubatory device 10 equipped with a helical connecting strip 84 according to several embodiments. The helical connecting strip 84 can be wrapped around the graft 20, either connected to a single row of stents (e.g., a first row of stents 32) or to multiple rows of stents (e.g., a first row of stents 32 and a second row of stents 38). The helical connecting strip 84 may be a single helical connecting strip 84 or may include multiple helical connecting strips 84. A single helical connecting strip 84 may extend over the entire length 22 of the graft 20 or over a portion of the length of the graft 20 (e.g., over a single row of stents or over a length shorter than all the stents of the stents 30). The helical connecting strip 84 may be connected to multiple vertices of the multiple vertices of the first row of stents 32. The helical connecting strip 84 can be substantially similar to any of the connecting strips 50, 50a, 50b, and 50c as shown in Figures 1 to 5. The reinforcing portion 86 of the intubatory device 10 can extend over the portion of the stent 30 covered by the helical connecting strip 84. In some embodiments, as shown in Figure 8, the intubatory device 10 can include both the helical connecting strip 84 and a substantially longitudinally aligned first connecting strip 50a, where the substantially longitudinally aligned first connecting strip 50a is connected above or below the helical connecting strip 84. The combination of the helical connecting strip 84 and the substantially longitudinally aligned first connecting strip 50a can form a stronger and / or stiffer reinforcing portion 88 for preferentially bending the intubatory device 10 compared to a single connecting strip of similar width (e.g., only the first reinforcing portion 65a in Figure 5). The helical connecting strip 84 can be aligned with at least one of the entrance position 61a or exit position 63a of the first window hole 60a, either alone or in combination with a first connecting strip 50a substantially aligned in the longitudinal direction, thereby reducing or preventing the occurrence of guide wire trapping when the guide wire 100 enters or exits the first window hole 60a.

[0068] Figure 9 is a cross-sectional view of an intubatory device 10 with a wide connecting strip 90 according to several embodiments. The wide connecting strip 90 can be substantially similar to any of the connecting strips 50, 50a, 50b, and 50c as shown in Figures 1 to 5. The wide connecting strip 90 can be wider than the width of one vertex of the first stent row 32 and can cover more than one of several vertices of the first stent row 32, including two vertices and three vertices. The wide connecting strip 90 forms a reinforcement 92 of the intubatory device 10 and can increase the reinforcement and rigidity of the reinforcement 92 compared to a narrower connecting strip (e.g., the first reinforcement 65a in Figure 5). The wide connecting strip 90 can be aligned with at least one of the inlet position 61a or the outlet position 63a of the first window hole 60a, thereby reducing or preventing the occurrence of guidewire trapping when the guidewire 100 enters or exits the first window hole 60a.

[0069] Figure 10 is a cross-sectional view of an in-tube device 10 equipped with a variable-width connecting strip 94 according to several embodiments. In some embodiments, the width of the variable-width connecting strip 94 can vary along its longitudinal length. A relatively wide portion 96 of the variable-width connecting strip 94 is positioned close to the first window opening 60a, and a relatively narrow portion 98 can connect to the relatively wide portion 96. The variable-width connecting strip 64 can be tapered toward the relatively wide portion 96, as shown in Figure 10, or its width can vary without tapering. In some embodiments, the width of the variable-width connecting strip 94 can vary continuously or discontinuously close to the inlet position 61a and / or outlet position 63a of the window opening 60a. The relatively wide portions 96 of the variable-width connecting strip 94 are substantially aligned longitudinally with each other along the length 22 of the graft 20, thereby obtaining the rigidifying effect or reinforcement of a single substantially longitudinal connecting strip (e.g., the wide connecting strip 90 and reinforcement portion 92 in Figure 9). Furthermore, the relatively wide portions 96 can also cover multiple vertices of the multiple vertices of the first stent row 32 without using multiple connecting strips (e.g., as with the multiple connecting strips 80 in Figure 6).

[0070] Figure 11 shows a guidewire 100 within the lumen 16 of an endovascular device 10 according to several embodiments. The endovascular device 10 can be similar to any of the endovascular devices shown in Figures 1-10. The endovascular device 10 can be implanted in the patient's main lumen 102. The endovascular device 10 can be delivered transluminally to the patient's main lumen 102 (e.g., the main lumen 102 may be, but is not limited to, the aortic arch, thoracoabdominal aorta, ascending thoracic aorta, descending thoracic aorta, abdominal aorta, or other vessels requiring curvature and / or having vascular branching). A connecting strip (any of the connecting strips 50, 50a, 50b, 50c, 80, 84, 90 and / or 94 in Figures 1-10) may be connected to the endovascular device 10 before implantation. In some embodiments, the position and dimensions of the connecting strip, reinforcement and / or window holes can be customized to the patient by being driven by a CT scan or other type of measurement before implantation.

[0071] The endovascular device 10 is aligned along the curvature of the main lumen 102, thereby allowing the endovascular device 10 to transition to a curved configuration corresponding to the curvature of the main lumen 102. Reinforcements formed by connecting strips (e.g., any of the reinforcements 65, 65a, 65b, 65c, 82, 86, 88 and / or 92 in Figures 1-10) can provide rigidity to the endovascular device 10 so that it preferentially rotates away from the reinforcements to the curved configuration position. The reinforcements also provide rigidity that helps maneuver and orient the endovascular device 10 within the vascular system and facilitates transitioning the endovascular device 10 to a curved position within the main lumen 102. The reinforcements can also help align the window opening of the endovascular device 10 with a single or multiple side branch lumens 104a, 104b, 104c of the main lumen 102 (e.g., side branch lumens of the aortic arch). The guidewire 100 can be used to insert a cannula into several side branch lumens 104a, 104b, and 104c of the main lumen 102.

[0072] Figure 12 shows the delivery of multiple branch members 106a, 106b, and 106c via the intubation device 10. The guidewire 100 includes multiple guidewires 100 or a single branch guidewire 100, which can guide and deliver the multiple branch members 106a, 106b, and 106c through the lumen 16 of the intubation device 10 to their respective side branch lumens 104a, 104b, and 104c.

[0073] The graft components described herein may be formed from a variety of biocompatible materials. In certain examples, the graft may include, but is not limited to, polymers such as polyethylene (PE) or expanded polyethylene (ePE), and may also include fluoropolymers such as polytetrafluoroethylene (PTFE) or stretched polytetrafluoroethylene (ePTFE). In some cases, the graft may be formed from, but is not limited to, polyester, silicone, urethane, polyethylene terephthalate, or other biocompatible polymers or combinations thereof. In some examples, bioreabsorbable or bioabsorbable materials, such as bioreabsorbable or bioabsorbable polymers, may be used. In some examples, the graft may include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film-like elastomers.

[0074] Furthermore, while nitinol (NiTi) may be used as the material for the frame or stent (and any frame discussed herein), other materials may be used as the frame material, but are not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymer materials, Pyhnox, Elgiloy, or other suitable biocompatible materials, and combinations thereof. The superelastic properties and flexibility of NiTi can improve the fit of the stent. In addition, NiTi can be shaped to a desired form; that is, NiTi can be shaped so that the frame tends to self-expand to a desired shape when the frame is unconstrained, such as when the frame is deployed from a delivery system.

[0075] General and specific embodiments of the in-tube devices of this application have been described above. 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. Accordingly, the embodiments are intended to encompass modifications and variations of the present invention, insofar as they fall within the scope of the appended claims and their equivalents.

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

Claims

1. A graft having a certain length, A stent, which is connected to the graft and extends over at least a portion of the length of the graft, A connecting strip extending substantially longitudinally along the graft and defining the reinforcing portion, A pipe-mounted device including, The reinforcing portion resists bending of the in-pipe device at the reinforcing portion such that the in-pipe device generally curves away from the reinforcing portion and generally preferentially on the opposite side.

2. The reinforcing portion is positioned on the outer bay of the internal pipe device defined along the periphery of the internal pipe device, and the internal pipe device preferentially curves toward the inner bay of the internal pipe device defined along the periphery of the internal pipe device on the generally opposite side of the outer bay of the internal pipe device, according to claim 1.

3. The intratubular device according to claim 1 or 2, wherein the stent includes a plurality of stent rows along the length of the graft, the plurality of stent rows include a first stent row and a second stent row adjacent to the first stent row, and the connecting strip fixes a first fixing portion of the first stent row to the graft and a second fixing portion of the second stent row to the graft.

4. The in-tube device according to any one of claims 1 to 3, wherein the graft includes a window opening, and the connecting strip is aligned with the window opening.

5. The intube device according to any one of claims 1 to 3, wherein the graft includes a window opening, and the connecting strip is offset circumferentially from the window opening.

6. The in-pipe device according to claim 4 or 5, wherein the connecting strip is located near the window opening.

7. The intubation device according to any one of claims 1 to 2, further comprising a second connecting strip that extends substantially longitudinally along the graft and defines a second reinforcing portion, thereby the intubation device preferentially curving on generally opposite sides of the second reinforcing portion, and the second connecting strip being longitudinally offset from the connecting strip along the graft.

8. The intratube device according to any one of claims 1 to 2, wherein the first row of stents includes a first set of vertices, which include a plurality of free vertices not fixed to the graft and one or more fixed vertices fixed to the graft by the connecting strip.

9. The intube device according to claim 8, wherein the graft includes a window opening, and the one or more fixed vertices are arranged generally adjacent to the window opening in the longitudinal direction.

10. The intratubal device according to claim 1, configured as a thoracic stent graft.

11. A graft having a certain length, an outer surface, an inner surface defining a lumen, and a thickness extending between the outer surface and the inner surface, including a first window opening defined through the thickness, A stent coupled to the graft and extending over at least a portion of the length of the graft, comprising a first row of stents adjacent to at least one window opening, and A connecting strip connecting a portion of the first row of stents to the graft, wherein the first row of stents defines a series of vertices, and the connecting strip connects at least one of the series of vertices to the graft, thereby fixing at least one vertex of the first row of stents, In-pipe devices, including those mentioned above.

12. The in-pipe device according to claim 11, wherein the in-pipe device is transitionable to a curved configuration, the curved configuration defines an outward curve, and the connecting strip is oriented along the outward curve.

13. The intube device according to claim 11 or 12, wherein the connecting strip is coupled to the outside of the graft and extends substantially longitudinally along the length of the graft.

14. The in-tube device according to any one of claims 11 to 13, wherein the connecting strip is an adhesive strip.

15. The in-tube device according to any one of claims 11 to 14, wherein the width of the connecting strip is approximately the same as the width of one of the vertices in the series.

16. The in-tube device according to any one of claims 11 to 14, wherein the width of the connecting strip is greater than the width of one of the vertices in the series.

17. The intube device according to claim 11, wherein the graft defines a second window opening substantially aligned longitudinally with the first window opening.

18. Delivering an intravascular device transluminally into the patient's main lumen, where the intravascular device is A graft having a certain length, A stent, which is connected to the graft and extends over at least a portion of the length of the graft, Includes a connecting strip that extends substantially longitudinally along the graft and defines the reinforcing portion, The reinforcing portion resists bending of the internal device at the reinforcing portion such that the internal device preferentially bends toward the opposite side of the reinforcing portion, and To position the internal device along the curvature of the main lumen so that the internal device transitions to a curved configuration, Methods that include...

19. The method according to claim 18, further comprising aligning at least one window opening of the intratubular device along the side branch lumen of the main lumen.

20. The method according to claim 19, further comprising delivering a branching member to the side branch lumen through at least one window opening of the internal device.

21. A graft having a certain length, a certain thickness, an outer surface, and an inner surface defining a lumen, and a thickness extending between the outer surface and the inner surface, comprising a first window opening defined through the thickness, A stent coupled to the graft and extending over at least a portion of the length of the graft, including a first row of stents positioned adjacent to the first window opening, and A connecting strip that connects at least a portion of the first stent row to the graft and defines the fixed portion of the first stent row, In-pipe devices, including, A guidewire configured to extend through the lumen of the graft, the guidewire defining an exit point in the first window hole, A system comprising, wherein the fixed portion of the first stent row is located at or near the exit point.

22. The system according to claim 21, wherein the guide wire is used to insert a cannula into the window opening, and the connecting strip prevents the guide wire from becoming trapped.

23. The system according to claim 21 or 22, wherein the fixed portion of the first stent row helps to reduce the trapping and / or capture of the guide wire at the exit point.

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