Spiral scaffold with enhanced curlability

Abstract

This invention relates to an intravascular device having undulating patterned struts and loops, wherein at least one strut has a curved profile for reducing the compression diameter. The strut configuration includes one or more curved segments facing opposite convex and concave orientations, thereby creating spaces or hollows for relatively aligned portions of the device to rest against when the device is compressed. The undulating pattern can be staggered such that adjacent loops in the helical direction are axially offset relative to a vertical axis perpendicular to the longitudinal direction, wherein the loops can be positioned aligned with adjacent struts in the helical direction. The device can include struts of varying lengths, which can contribute to an increased expansion diameter. The curved strut design with a curved profile can be used with any intravascular stent design.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. nonprovisional patent application No. 16 / 794,359, filed February 19, 2020, the entire contents of which are incorporated herein by cross-reference. Technical Field

[0003] This invention generally relates to endovascular devices, such as stents, implanted in blood vessels (e.g., blood vessels) to open vessels that are narrowed or blocked due to, for example, coronary artery disease (CAD), restore blood flow, and / or maintain patency. More specifically, this invention relates to endovascular devices, including stents, having a reduced compression or coiling profile and / or an increased expansion profile. Background Technology

[0004] Various types of stents are known in the art. Typically, stents are mesh-like metallic structures, tubular in shape, and expandable from small unexpanded diameters to large expanded diameters. For implantation techniques, stents are usually mounted on the distal portion of a catheter, held in place with a coiled, unexpanded diameter. The unexpanded stent is delivered through a catheter guided by a guidewire that slidably extends through the catheter to the intended implantation site, such as a blood vessel or coronary artery, via the vascular or gastrointestinal system. Once the stent is in place at the intended implantation site, it expands radially, typically by force, such as by expanding a balloon on the medial side of the stent, or by allowing the stent to self-expand, such as by removing a cannula from around a self-expanding stent. In both cases, the expanded stent overcomes the tendency for the vessel to narrow again, thus maintaining patency.

[0005] A stent can be manufactured by laser-cutting a stent pattern into a metal tube or a flat metal sheet. In the latter case, the sheet is then rolled up and secured, for example by welding, mechanical locking, or other means, to form the tubular structure of the stent.

[0006] One type of support is called a spiral or coiled support. Such support designs are described, for example, in U.S. Patents 6,503,270 and 6,355,059, both of which are incorporated herein by reference in their entirety. This support design is constructed as a spiral support, wherein the support roll is formed from strips of coiled cells, wherein the cells form a meandering pattern comprising a series of bends formed by alternating arrangements of struts connected to loops. Other similar spiral coiled support structures are known in the art, for example, in U.S. Patents 8,382,821, 9,456,910, 9,155,639, 9,039,755, and 9,603,731, which are incorporated herein by reference in their entirety. These support designs are constructed as spiral supports, wherein the support roll is formed from flat or tubular metal, wherein the cells are formed from spirally coiled support rolls with an undulating pattern.

[0007] In existing stent technology, a trade-off is typically struck between longitudinal (or axial) flexibility and radial strength, and the ability to tightly compress or coil the stent onto the catheter. This allows the stent to be more easily delivered through narrow, tortuous vascular systems (e.g., small side branches), and therefore it does not shift relative to the catheter or dislodge prematurely before controlled implantation into the vessel. Existing stent designs also typically balance providing sufficient radial strength during stent expansion to adequately support the vessel lumen with providing sufficient longitudinal flexibility to easily conform to the natural curvature of the vessel.

[0008] The curling or compression diameter of existing stents is limited by interference between adjacent struts, adjacent loops, and / or combinations thereof. Furthermore, in self-expanding stents, interference between adjacent struts and / or loops can cause high stress / strain concentration in a portion of the strut, which may prevent the stent from fully expanding upon deployment. For example, if a self-expanding stent is compressed beyond its elastic limit in an attempt to provide a smaller outer diameter, the stent will not recover to its desired expanded diameter due to permanent deformation.

[0009] Therefore, there has been a long-standing need in the art for stents to simultaneously possess sufficient radial strength, high longitudinal flexibility, and compliance with the natural curvature and motion of blood vessels. Stents also require a reduced compression profile for enhanced delivery through small-diameter or tortuous vessels (e.g., in lateral branches of coronary anatomy) and an increased expansion profile for deployment in large-diameter vessels (e.g., in the main branches of coronary anatomy), while maintaining low stress / strain concentration on portions of the stent. Thus, to allow stents to be used in any clinical situation compared to conventional stents, stents need to have an increased expansion diameter and a reduced compression diameter, while achieving optimal stress / strain distribution along the stent. Furthermore, to achieve a reduced compression profile and lower stress / strain concentration, and to minimize harmful interactions between adjacent struts, interference between adjacent struts and / or loops within the compression profile needs to be limited. Minimizing harmful interactions between adjacent struts includes, for example: (a) reducing damage to the stent coating caused by contact between adjacent struts, (b) reducing the likelihood of damage to the bladder of the bladder catheter caused by compression of the bladder material between adjacent struts, (c) reducing stresses applied to the struts due to interactions between adjacent struts, and / or (d) reducing the force required for curling due to reduced interactions between struts. Summary of the Invention

[0010] This invention relates to a stent having an increased expansion diameter and / or a decreased compression diameter, such that the stent has a reduced outer diameter in its compressed state compared to conventional stents. The stent of this invention includes a curved strut design within a stent coil profile, which reduces the compression outer diameter compared to any given conventional stent. Any reduction in the compression diameter has significant clinical implications and the potential to achieve enhanced coilability.

[0011] The support according to the invention comprises a continuous member having struts with an undulating pattern, which are connected to a helically wound loop. In one embodiment, at least in a compression configuration of the support, at least one strut of the support includes one or more bends, arcs, or undulations in the strut design. For example, a bend strut design may include first and second bends, arcuate or cornered sections facing opposite convex or concave orientations. These opposing bends or corners are joined together at one or more locations along the strut. As the support is compressed, the loop, which is oppositely aligned to the bend section (e.g., the first or second bend section), moves a desired distance toward the opposing bend section to form a bolstering arrangement and achieve a smaller desired compression diameter than conventional supports. For example, the loop and the opposing bend section may be moved or compressed to substantially contact each other, where “substantially contact” is defined as the loop contacting or nearly contacting the bend section of the opposing strut. The bolstering arrangement in the compression configuration of the support advantageously achieves a lower curl profile than conventional supports because the bends in the struts create a space in which the opposing loop can bolster in the curl orientation. The curved support of this invention can be used with any support design that has undulations.

[0012] One or more supports may include one or more curved sections, wherein the curved sections are distributed along the support length as needed when the feed diameter is being coiled. In one embodiment, the curved pattern may include a first curved section and a second curved section extending from each end of the curved support towards a middle section of the curved support with opposite curvatures, such that the length of the curved support includes both concave and convex curvatures. In one embodiment, all supports of the continuous component may be curved supports. In another embodiment, the continuous component may have a hybrid support design, such that some supports are curved supports while some supports are straight supports. In yet another embodiment, the continuous component does not include curved supports. In this embodiment, the first and second end loops connected to the continuous component may include curved supports.

[0013] Adjacent loops in the helical direction can be axially offset relative to an axis perpendicular to the longitudinal direction to form an alternating pattern of adjacent loops, such that the loops are positioned aligned with the ends of adjacent supports in the helical direction. In one embodiment, the alternating pattern of adjacent loops is positioned such that when the support is compressed to the coiled conveyor diameter, loops adjacent to the first and second curved sections in the helical direction are positioned aligned with and abut against the first and second curved sections, respectively, forming an abutting arrangement. The abutting arrangement allows the loops adjacent to the first and second curved sections in the helical direction to contact or nearly contact the first and second curved sections, respectively, when the support is compressed to the coiled conveyor diameter.

[0014] One pillar may have a different length than the others. In one embodiment, a pair of pillars includes varying lengths, thereby facilitating an alternating pattern of adjacent loops, wherein the pillar pair includes long and short pillars such that adjacent pillars in the helical direction have varying lengths.

[0015] The support column can have a variable width; for example, the width near the middle section of the column may be smaller than the width near the ends, or vice versa. In this embodiment, the width of the loop may be greater than the width of any part of the column.

[0016] The stent includes a continuous component having a tubular shape and extending from a first end to a second end along the longitudinal direction of the stent. The continuous component may include multiple coils having a coil delivery diameter and an expansion implantation diameter. Depending on the specific application, the coils may include any number of coil segments. For example, a coil may include a single coil segment, or it may include two, three, four, or more coil segments that may be interconnected as needed to form cells within the coil. It should be understood that the features of the invention described herein, including those contributing to an increase in expansion diameter and / or a decrease in compression diameter, are applicable to stent designs with any number of coil segments in the coils. In one exemplary embodiment, each of the plurality of coils includes two interconnected coil segments, these two interconnected coil segments including a first coil segment and a second coil segment, the first and second coil segments being interconnected with each other to form a cell therebetween and oriented in the helical direction of the stent. The first and second coil segments may have an undulating pattern including struts and loops, wherein the loops are portions in the undulating pattern having approximately 180-degree turns. Each end of the loop is coupled to one end of a strut to form a pair of struts.

[0017] The support may also include a link connecting two interconnected segments of each coil in the longitudinal direction. The two interconnected segments of each coil can be interconnected by a direct connection. In one embodiment, the link may be a straight connector and may extend in the gap between the two interconnected segments. The link and / or the direct connection may be located at the point where the gap between the interconnected segments is the shortest distance, connecting to the first and second segments of the coil at a loop on the first and second segments. The loop connecting the first and second segments of the coil may be referred to as an attachment loop.

[0018] In another embodiment, the support may further include a first end ring positioned at a first end of the connecting member and a second end ring positioned at a second end of the continuous member, wherein the first and second end rings may extend from adjacent turn rings. The first and second end rings may form approximately right-angled columns at the longitudinal ends of the support. Each end ring may include one or more circumferential end turn segments interconnected in the longitudinal direction and may include loops in an undulating pattern coupled to paired struts. Similar to the turn rings of the continuous member, the circumferential end turn segments may be interconnected by links and / or direct connections. In one embodiment, the transition between the continuous member turn ring and the first and second end rings may include at least one transition cell formed by the continuous member and one of the first and second end rings.

[0019] Furthermore, similar to continuous components, in one embodiment, the struts of the first and second end rings may have variable lengths, creating axially offset loops in the circumferential direction. Alternatively or supplementarily, the struts of the first and second end rings may have variable widths along their length, similar to the widths described for struts in continuous components. Alternatively or supplementarily, the widths of the loops of the first and second end rings may differ from (e.g., be greater than or less than) the width of any portion of the strut.

[0020] The first and second end rings may similarly include at least one curved support, wherein, when the support is compressed to the coiled conveyor diameter, at least one loop is positioned aligned with and abuts against one of the first and second curved sections of the curved support adjacent to the loop in the circumferential direction. In one embodiment, all supports of the first and second end rings may have curved supports. In another embodiment, the first and second end rings may have a hybrid support design, such that some supports are curved supports and some supports are straight supports. In yet another embodiment, the first and second end rings do not include curved supports, but instead have straight supports.

[0021] The inventions disclosed herein may relate to coronary artery stents. However, the devices according to embodiments disclosed herein can be used as stents for non-coronary applications, such as peripheral vascular stents, cerebral stents, or other non-coronary applications. For coronary applications, the length of the stent can vary from 8 to 50 mm, with an unfolded diameter of 1.5 to 6 mm. Furthermore, for coronary applications, the cell design of the stent can have fewer interconnections (e.g., links or direct connections) and therefore larger cells, so that the provided stent has sufficiently large cells to increase lateral branch access, which is advantageous for application in tortuous coronary vessels with multiple lateral branches. The stent cells can have the same or similar size along substantially the entire length of the stent or at least along the body of the stent (excluding the ends) to provide similar lateral branch access throughout. The spacing or number of interconnections may depend on the target stent diameter or the desired cell size. Attached Figure Description

[0022] Figure 1 The diagram shown is a plan view of a support structure in the cut configuration according to an embodiment of the present invention.

[0023] Figure 2 yes Figure 1 Enlarged view of the enclosed cells of a continuous structure within a scaffold.

[0024] Figure 3 This is an enlarged view of a pair of struts connected to the support loop in the cut configuration according to another embodiment of the present invention.

[0025] Figure 4 What is shown is based on Figure 3 The support structure of the embodiment is viewed from a first-person perspective and is in the three-dimensional model of the cut configuration.

[0026] Figure 5 What is shown is based on Figure 4 The support structure is viewed from a second perspective and is in the three-dimensional model of the cut configuration.

[0027] Figure 6 What is shown is based on Figure 4 The support structure is viewed from a first-person perspective and is in the three-dimensional model of the cut configuration.

[0028] Figure 7 What is shown is based on Figure 5 The support structure is viewed from a second perspective and is in the three-dimensional model of the cut configuration.

[0029] Figure 8 What is shown is based on Figure 4 The support structure is viewed from a third-person perspective and is in the three-dimensional model of the cut configuration.

[0030] Figure 9 What is shown is based on Figure 8 The support structure is viewed from a third-person perspective and is in the three-dimensional model of the cut configuration.

[0031] Figure 10 What is shown is Figure 4 The support is in a coiled conveying configuration.

[0032] Figure 11 What is shown is Figure 5 The support is in a coiled conveying configuration.

[0033] Figure 12 What is shown is Figure 6 The support is in a coiled conveying configuration.

[0034] Figure 13 What is shown is Figure 7 The support is in a coiled conveying configuration.

[0035] Figure 14 What is shown is Figure 8 The support is in a coiled conveying configuration.

[0036] Figure 15 What is shown is Figure 9 The support is in a coiled conveying configuration.

[0037] Figure 16 What is shown is Figure 4 The support is in an expanded configuration.

[0038] Figure 17 What is shown is Figure 5 The support is in an expanded configuration.

[0039] Figure 18 What is shown is Figure 6 The support is in an expanded configuration.

[0040] Figure 19 What is shown is Figure 7 The support is in an expanded configuration.

[0041] Figure 20 What is shown is Figure 8 The support is in an expanded configuration.

[0042] Figure 21 What is shown is Figure 9 The support is in an expanded configuration.

[0043] Figure 22 The support shown in a tubular view according to any embodiment of the invention is in a curled configuration and has a polymer coating.

[0044] Figure 23 Based on the tubular view Figure 22 The support in the embodiment is in a radially expanded configuration and has a polymer coating. Detailed Implementation

[0045] This invention relates to support structures, and in particular, to an improvement over existing support structures by providing a meandering or undulating pattern of struts connected to loops in an advantageously designed manner. This meandering or undulating pattern provides a reduced curl profile and / or an increased expansion profile, as well as an optimal stress / strain distribution along the support structure. The support structure can be longitudinally flexible and radially rigid, wherein “longitudinal flexibility” is defined as the ability of the support structure to bend about a support axis extending in the longitudinal direction of the support structure. A “loop” is defined as a portion of the meandering pattern having a turn of approximately 180 degrees (i.e., a U-turn), while a “strut” is a portion of the meandering pattern having a turn of less than 180 degrees. Each end of the loop is connected to an end of a strut, such that each loop is connected to a pair of struts, forming an undulation in the meandering or undulating pattern.

[0046] The features of the present invention, individually or in combination, advantageously provide a support having an increased expansion outer diameter and / or a reduced compression outer diameter in an expanded configuration compared to conventional supports.

[0047] In particular, in one embodiment, the meandering or undulating pattern of the stent is oriented in a helical direction to advantageously limit or avoid interference between adjacent loops in the stent's coiled configuration. Due to the helical orientation, adjacent loops are advantageously offset axially relative to an axis perpendicular to the longitudinal direction of the stent, forming an interlaced pattern. The helically arranged interlaced pattern can be uniformly interlaced, such that adjacent loops in the helical direction do not have scalloped edges or contours. Instead of aligning adjacent loops in the helical direction, the interlaced pattern advantageously allows loops to be positioned aligned with adjacent struts in the helical direction of the stent, thereby avoiding some interference between adjacent loops in the coiled configuration. Loops can be positioned aligned with the ends of adjacent struts. Due to the large turning radius of the loops, the coiled diameter of the loops is still limited, and in the stent's coiled configuration, the loops constitute the largest part of the stent.

[0048] An undulating pattern of loops can be connected to two supports of varying lengths, such that the undulating pattern of the support comprises alternating long and short supports. This arrangement of varying support lengths also advantageously limits or avoids interference between adjacent loops in the support's curled configuration. The alternating pattern of long and short supports contributes to a reduced support curl profile by advantageously creating an interlaced or staggered pattern of adjacent loops relative to the transverse axis (i.e., the axis perpendicular to the longitudinal direction of the support). The interlaced pattern of adjacent loops advantageously avoids interference between adjacent loops in the curled configuration.

[0049] In addition to reducing the curl profile, altering the arrangement of strut lengths further provides the advantage of achieving an increased expansion profile. Longer strut lengths can expand to a larger diameter upon unfolding compared to shorter struts. By providing a stent with alternating arrangements of long and short struts, wherein each loop is connected to both a long and a short strut, the stent of the present invention can advantageously expand to an increased expansion profile (due to the long struts) and compress to a reduced curl profile (at least in part because the short struts contribute to creating an interlaced pattern). Furthermore, the alternating arrangement of long and short struts also advantageously contributes to or enhances the flexibility of the stent and its coverage of the vessel wall.

[0050] The arrangement of variable support lengths can depend on the specific application of the support and can vary in a random or repetitive periodic pattern. For example, a pair of supports, some pairs of supports, or all pairs of supports may include two supports of varying lengths (e.g., one long support and one short support). Where one or some pairs of supports include supports of varying lengths, the remaining pairs of supports may include two supports of the same length. Furthermore, for example, the length of the supports may vary between different pairs of supports, such that, for example, the long support in one pair of supports may have a different length than the long support in another pair of supports, and / or the short support in one pair of supports may have a different length than the short support in another pair of supports. The length of the supports in the end ring may vary in a pattern that is the same as or different from the length of the supports in the continuous components. In one embodiment, the supports in the end ring may not have variable lengths (i.e., they may have the same length), while at least one support in the continuous component may have varying lengths. Alternatively, at least one support in the end ring may have variable lengths, while the supports in the continuous component may have the same length.

[0051] The struts of the support of the present invention may have one or more curved sections, for example, first and second curved sections with opposite curvatures, extending from each end of the strut towards the intersection of the struts (e.g., in the middle section of the strut). In one embodiment, the strut is curved, curved, or arched, such that the strut is not straight or linear from one end of the strut to the other, particularly in a coiled configuration. In a pair of struts connected to a loop, the arc of the curved section of the strut closest to the loop may bend inward (e.g., concave) toward the opposing strut of that strut pair, while the arc of the curved section of the strut furthest from the loop may bend outward (e.g., convex) away from the opposing strut of that strut pair, such that the strut has one concave curved section and one convex curved section. The curved design of the strut may be referred to as a “curved structure”, wherein the end of the strut connected to the loop bends inward toward the center of the loop and then outward away from the center of the loop. The bending pattern of this strut exists and is maintained in both the unexpanded and expanded configurations of the support, and during configuration changes, such that the bending sections are substantially not straightened. When the support is compressed, the bending pattern in the strut creates spaces or hollow sections in which adjacent loops can be fitted in a resting or insert arrangement, which advantageously allows for a tighter compaction or compression of the support in the curled configuration. When the support is compressed into a curled profile, the bending strut pattern allows loops to fit into the bending sections (e.g., concave portions) of the strut adjacent to or opposite to the loops in the helical direction, thereby advantageously providing a reduced curled profile. Compared to the compression diameter of conventional supports where the struts are substantially straight or substantially extended during or when compressed, the support of the present invention, having at least one bending strut in a curled configuration, advantageously has a smaller compression diameter because straight or substantially straight struts cannot achieve the advantageous insert arrangement of the present invention.

[0052] The number and / or arrangement of curved struts can depend on the specific application of the stent, wherein the number of curved struts is inversely proportional to the stent's coil delivery diameter. For example, a stent for coronary arteries may have more curved struts than a stent for peripheral vessels because the anatomy of coronary vessels is narrower than that of peripheral vessels, thus requiring a smaller coil profile than that used for peripheral vessels. According to the invention, the stent, in its compression and / or expansion configuration, may also have straight or linear struts, curved struts for long and / or short struts, struts of different lengths, and any combination of struts of the same or similar lengths, some of which may be straight / linear struts while others are curved. Furthermore, the stent may have such different strut lengths in a random or repetitive uniform pattern.

[0053] In a compressed configuration of the stent, at least some struts are curved, in a uniform or random pattern, while other struts may not be curved (i.e., straight). For example, alternating struts are curved, where, for example, only the long struts are curved. In another embodiment, struts near the ends of the stent may be straight, while the remaining struts may be curved, or vice versa. In embodiments where opposing struts in a pair (i.e., two successive struts) both have one or more curves, the curves of the opposing struts may be opposite (e.g., mirrored), but this is not necessary in other embodiments. In another embodiment, substantially all struts of the stent include one or more curved sections, where at least in the compressed configuration of the stent, no (or substantially none) struts are straight. “Substantially all struts” can be defined as approximately 75% or more of the struts in the stent.

[0054] The curved strut design, combined with the staggered pattern of adjacent loops in the helical direction, allows the loops to be positioned aligned with the ends of adjacent struts in the helical direction. This ensures that when the support is compressed into a curled profile, the loops are advantageously aligned with and rest against the inwardly curved (e.g., concave) sections of the adjacent struts (in the helical direction) towards the adjacent loops. Because the loops (which constitute the largest portion of the support pattern due to their turning radius) advantageously rest against the (e.g., concave) curved sections of the adjacent struts, the curled profile of the support can be further reduced, avoiding interference between adjacent loops and minimizing interference between loops and adjacent struts. Thus, while the staggered pattern of adjacent loops reduces the curled profile by minimizing interference caused by adjacent loops, the curved strut design further reduces the curled profile by additionally minimizing interference between loops and adjacent struts. Because the curved sections of the struts at least partially surround the adjacent loops, for example, surrounding one end of the loop to approximately the middle section of the loop, interference between loops and adjacent struts is reduced. The curved strut design allows the curved sections of the strut (opposite to the adjacent loops in the helical direction) to have a shape complementary to the adjacent loops, thus creating a complementary or key-locking fit between the loops and the opposing curved sections of the adjacent struts. Therefore, the coiled profile of the invention is further reduced because the curved sections advantageously conform to and allow for the abutment of adjacent loops. Consequently, the curved sections of the struts advantageously maintain a curved strut pattern (not straight or extended) within the coiled configuration of the support.

[0055] The optimal stress / strain distribution along the support can be further advantageously achieved by redistributing the stress / strain applied to the support to prevent permanent deformation and allow it to fully expand or compress. The stress / strain applied to the support can be advantageously redistributed by altering the relative strength or flexibility of different sections of the support, for example, by redistributing the stress / strain away from the loops. For example, the amount of material used to form different sections of the support can be varied to change the relative strength or flexibility of these sections. This variation in the strength or flexibility of the support sections can be achieved by increasing the thickness or width of the loop sections to increase their strength relative to the strut sections, thereby redistributing the stress / strain away from the loop sections. Alternatively or as a supplement, the strut width can also gradually decrease from both ends towards the middle section of the strut to further redistribute the stress / strain away from the loop sections and towards the middle section of the strut sections of the support.

[0056] In one embodiment, the scaffold may include a polymer material. The polymer material may be electrospun onto the scaffold. At least two of a plurality of turns of the polymer material may be interconnected. The polymer material may be a biodegradable polymer or other polymers. In one embodiment, the polymer material may also include an embedded drug.

[0057] Figure 1 The illustration shows a support 100 in a cut configuration according to an embodiment of the invention, shown in a longitudinally opened and flattened view for illustrative purposes only. In use, the support 100 has a tubular shape and can be made by rolling an extruded tube or a flat sheet into a tubular shape. The desired support design or pattern can be laser-cut onto the extruded tube, or laser-cut or chemically etched onto the flat sheet, which is then rolled up. Figure 1 The stent 100 is shown in a cut configuration, which is the middle outline of the stent 100, at which point the stent 100 has been formed (i.e. manufactured) but has not yet been rolled to the delivery diameter and has not yet been expanded to the implantation unfolding diameter.

[0058] The support 100 is a tubular structure having a continuous member 105 extending from a first end 105a to a second end 105b along the longitudinal direction L of the support 100. The continuous member 105 is arranged with a helical orientation along the helical direction H of the support 100. In one embodiment, such as Figure 1As shown, the continuous tubular structure includes a first end ring 110A and a second end ring 110B, positioned to extend from a first end 105a and a second end 105b, respectively. The first end ring 110A and the second end ring 110B extend around the circumference of the support 100 in the circumferential direction C, such that the first end ring 110A and the second end ring 110B are oriented approximately at a right angle or 90° to the longitudinal direction L at the longitudinal ends 100a and 110b of the support 100 to form right-angled prisms. Approximately right-angled with respect to the first end ring 110A and the second end ring 110B is defined as any angular orientation closer to 90° than the helical orientation of the continuous member 105. In another embodiment (not shown), the support 100 is a continuous member 105 without the first end ring 110A and the second end ring 110B, such that the longitudinal ends 100a-b of the support 100 are the first and second ends 105a-b, and do not form right-angled prisms relative to the longitudinal direction of the support.

[0059] The continuous component 105 includes a plurality of turns 115. The turns 115 are continuously oriented in a helical direction H between a first end 105a and a second end 105b, such that the turns 115 are oriented at an angle to the longitudinal direction L of the support 100. Each turn 115 may include one or more turns. Figure 1 In the exemplary embodiment shown, each turn 115 includes a first turn segment 115A and a second turn segment 115B, which are interconnected to form two interconnected turn segments 115A-B. The first turn segment 115A and the second turn segment 115B are interconnected to form a cell 117 between them, and are oriented along the helical direction H of the support 100 such that the cell segments 117 form a helix of cells between the first end 105a and the second end 105b. The area surrounded by the cell segment 117 is an open space or gap between the interconnected turn segments 115A-B.

[0060] The first turn segment 115A and the second turn segment 115B each have a meandering or undulating pattern and extend generally parallel to each other in the helical direction H. The undulations of the first turn segment 115A and the second turn segment 115B include struts 120, which are connected to each other by a pattern of loops 125 referred to as peaks 125a and valleys 125b.

[0061] Loop 125 is a section in the undulating pattern with a turn of approximately 180 degrees (i.e., a U-turn), while strut 120 does not. One or more struts 120 may have one or more bends less than 180 degrees (e.g., one or more curved sections). Some struts 120 may not have bends (i.e., they may be straight or linear members). Each end of loop 125 is connected to one end of strut 120, thereby forming a pair of struts 122 connected to loop 125. The pair of struts 122 are two struts connected within turn 115 to a common loop and adjacent to each other in the helical direction H.

[0062] The number and / or position of the supports 120 with the curved support design can vary depending on the specific application. The support 100 has more curved supports 120, resulting in a greater reduction in the curl profile, because the curved supports of the present invention allow for greater spacing between adjacent loops 125 and supports 120 (e.g., in...). Figure 2-3 The first and second curved sections 135a-b shown are more tightly compacted in the helical direction H, allowing interference (or contact) to be avoided between adjacent loops 125. For example, a stent 100 for implantation in a coronary artery may have more struts 120 with curved strut designs compared to a stent 100 for implantation in a peripheral artery, where the coronary anatomy typically contains vessels that are narrower and more tortuous than the peripheral anatomy. In embodiments with a mixed curved / straight strut design, non-curved (i.e., straight) struts 120 may be located at or near the longitudinal ends 100a-b of the stent 100, for example in the first end loop 110A and the second end loop 110B, and / or in the turns 115 of the continuous member 105 at the first end 105a and the second end 105b. Alternatively or as a supplement, non-curved (i.e., straight) struts 120 may be randomly or uniformly distributed throughout the stent 100.

[0063] Loops 125 form a meandering pattern such that peaks 125a and valleys 125b are arranged in an alternating pattern in the helical direction H of each of the first and second turn segments 115A-B. Peak 125a is a loop 125 that bends toward the opposing interconnecting turn segments 115A-B in the turn 115, and is therefore the outer loop 125a of cell 117. Valley 125b is a loop 125 that bends away from the opposing interconnecting turn segments 115A-B in the turn 115, and is therefore the inner loop 125b of cell 117. Valley 125b is closer along the longitudinal direction L to the center of cell 117 surrounded by interconnecting turn segments 115A-B than peak 125a. The center of cell 117 is a point along a point axis P that extends between two interconnecting points that interconnect the first and second turn segments 115A-B to define cell 117. The number, type, and / or location of interconnections in each turn 115 of the support can be at regular or uniform intervals (e.g., Figure 1 The three pairs of adjacent valleys 125b in the spiral direction shown in the diagram may be at random intervals and may depend on the specific application (e.g., coronary or peripheral vascular applications). Some or all of the interconnections may extend substantially longitudinally along the longitudinal direction L of the stent 100, but may also extend or be oriented in other directions (e.g., circumferential and / or spiral directions).

[0064] like Figure 1 As shown, the two interconnecting segments 115A-B in the turn 115 can be substantially out of phase with each other, such that along the longitudinal direction L, the peaks 125a of the first and second segments 115A-B are substantially aligned or facing each other, while the valleys 125b of the first and second segments 115A-B are substantially aligned or facing each other. In this out-of-phase embodiment, the distance (i.e., open space or gap) spanning a cell 117 length (along the longitudinal direction L) between the aligned valleys 125b of the first and second segments 115A-B in the turn 115 is less than the distance spanning a cell 117 length between the aligned peaks 125a of the first and second segments 115A-B in the turn 115. In another embodiment (not shown), the two interconnecting segments 115A-B in the turn 115 can be substantially in phase with each other, such that along the longitudinal direction L, the peaks 125a of the first segment 115A can be substantially aligned or facing the valleys 125b of the second segment 115B. In another embodiment, the support 100 may have interconnected turns 115A-B of mixed phase in the turns 115, such that some or at least one interconnected turns 115A-B in the turns 115 may be substantially out of phase with each other, while the remaining interconnected turns 115A-B in the remaining turns 115 may be substantially in phase with each other.

[0065] like Figure 1As shown, the first segment 115A in the coil 115 and the second segment 115B in the adjacent coil 115 can be substantially in phase with each other, such that along the longitudinal direction L, the peak 125a of the first segment 115A can be substantially aligned with or face the valley 125b of the second segment 115B in the adjacent coil 115. In another embodiment (not shown), the first segment 115A in the coil 115 and the second segment 115B in the adjacent coil 115 can be substantially out of phase with each other, such that along the longitudinal direction L, the peak 125a of the first segment 115A is substantially aligned with or faces the peak 125a of the second segment 115B in the adjacent coil 115, while the valley 125b of the first segment 115A is substantially aligned with or faces the valley 125b of the second segment 115B in the adjacent coil 115. In yet another embodiment, the support 100 may have adjacent turns 115 of mixed phase, such that some or at least one first turn segment 115A in the turns 115 and a second turn segment 115B in the adjacent turns 115 may be substantially in phase with each other, while adjacent first and second turns 115A-B in the remaining adjacent turns 115 may be substantially out of phase with each other.

[0066] The loop 125 is axially offset relative to the vertical axis of the longitudinal direction L. Figure 1 In the illustrated embodiment, the apex (outer tip) of loop 125 is aligned with the end of an adjacent or opposing strut 120 that connects to the adjacent loop 125 at its end. An alternating pattern A of adjacent loops in the helical direction H is shown. Figure 2 In this configuration, the apex 125c of loop 125 is aligned with the end 120c of the adjacent support 120 in the helical direction H. Other staggered patterns may be incorporated into the support 100 of the invention, wherein the plurality of turns 115 of the support 100 may have a consistent staggered pattern, or may have varying staggered patterns, for example, in different turns 115 and / or within the same turn 115.

[0067] exist Figure 1 In this configuration, the strut pair 122 includes two struts 120 of different lengths connected to a common loop 125. For example, the strut pair 122 includes a long strut 120a and a short strut 120b, wherein the long strut 120a is longer than the short strut 120b. Figure 1 In the process, the lengths of the long support 120a and the short support 120b are determined such that adjacent loops 125 in the helical direction H are axially offset relative to the vertical axis of the length direction L of the support 100 to form an alternating pattern A of adjacent loops, wherein the loop 125 (e.g., at its apex 125c) is positioned to align with the end 120c of the adjacent support 120.

[0068] The support 100 includes at least one strut 120 or a pair of struts 122, the length of which differs from the remaining struts 120 or strut pair 122 of the support 100. Alternatively, in another embodiment (not shown), the support of the invention may include struts all having the same length. Figure 1 In the illustrated embodiment, long struts 120a and short struts 120b are arranged alternately around the helical direction H. The strut lengths can similarly vary in the first end ring 110A and the second end ring 110B. Figure 1 In the illustrated embodiment, at least one support 120 of the first end ring 110A and the second end ring 110B has a different length than the remaining supports 120 of the first end ring 110A and the second end ring 110B, and at least one support 120 of the continuous member 105 has a different length than the remaining supports 120 of the continuous member 105.

[0069] Figure 1 The support 100 includes at least one strut 120 having a curved strut design that contributes to a reduction in the compression profile of the support 100. The curved strut design or pattern includes at least one strut having one or more bends along its length. In cases where the strut length includes multiple bends, at least one strut 120 includes at least two bends facing opposite directions, such that the strut pairs 122 connected by loops 125 form a curved pattern, structure, or shape 130, such as... Figure 1 As shown in the diagram. In the coiled configuration of the support 100, the curved support design of at least one support 120 with at least two opposite bends allows adjacent loops 125 in the helical direction H (e.g., Figure 2The bottom and top loops 125d-e) rest against two opposing bends, respectively, to provide a reduced compression diameter. Alternatively or as a supplement, at least one strut 120 of the support 100 may be formed into a curved shape 130 along the length of the strut 120, such that in the curled configuration of the support 100, at least one adjacent loop 125 in the helical direction H (e.g., top or bottom loop 125) rests against the opposing bend of the strut 120, thereby providing a reduced compression diameter. In one embodiment (not shown), at least one strut 120 includes a curved strut design, wherein the strut 120 has a curve in a first segment along the length of the strut 120, while the remaining length of the strut 120 is linear or straight (i.e., without a curve), such that adjacent loops 125 in the helical direction H (e.g., top or bottom loop 125) may rest against the curved first segment of the strut 120 in the curled configuration of the support 100. The one or more bends in at least one strut 120 of the support 100 (in any and all embodiments) are held in the curled profile of the support 100 such that when the support is compressed or during compression, the one or more bends do not straighten substantially, thereby providing a leaning arrangement and a reduced curled profile of the support 100.

[0070] Figure 2 What is shown is Figure 1An enlarged view of the enclosed cell 117 of the continuous structure 105 in the support 100, where the curved design is more clearly visible. The curved support design of at least one support 120 includes a first curved segment 135a and a second curved segment 135b extending in opposite directions from each end 120c of the support 120 toward a central section of the support 120, wherein each end 120c is a portion of the support 120 adjacent to the loop 125. One of the curved segments 135a-b is preferably convex, while the other curved segment 135a-b is concave. For example, in a pair of supports 122 where at least one support 120 has a curved support design, the first curved segment 135a of the support 120 extends from the end of the loop 125 connected to the pair of supports 122 and bends inward (e.g., concave) toward the opposing support 120 in the pair of supports 122 to form a curved structure 130. A second curved section 135b of the support column 120 extends from the middle section of the support column 120 along a generally longitudinal direction L to the end of the adjacent loop 125, wherein the second curved section 135b bends outward (e.g., protrudes) away from the opposing support column 120 in the support column pair 122 to form a curved structure 130. The curved support column design (e.g., the first and second curved sections 135a-b) creates a space, hollow, or region / volume for the adjacent loops 125 (e.g., 125d-e) in the helical direction H to be fitted into the created space (i.e., rest against the curved sections 135a-b) when the support 100 is compressed or in a coiled conveying configuration. For example, the resting arrangement is such that when the support is compressed, the first curved section 135a and the adjacent loop 125d below the first curved section 135a (in the helical direction H) move toward each other, such that the lower adjacent loop 125d rests against the first curved section 135a in the coiled conveying configuration. Similarly, when the support is compressed, the adjacent loops 125e above the second curved section 135b (in the helical direction H) move toward each other, such that in the coiled conveying configuration, the upper adjacent loops 125e abut against the second curved section 135b. In the configuration obtained by cutting the support 100, as... Figure 2 As shown, the first and second curved sections 135a-b are aligned with, but not against, the adjacent bottom and top loops 125d-e (along the vertical axis of the longitudinal direction L), respectively. Similarly, in the expansion, implantation, or deployment configuration of the stent 100, the first and second curved sections 135a-b may be aligned with, but not against, the adjacent bottom and top loops 125d-e (along the vertical axis of the longitudinal direction L), respectively.

[0071] The regions aligned and configured to rest against the first and second curved segments 135a-b of the corresponding bottom and top adjacent loops 125d-e in the curled profile of the support 100, are in... Figure 2 This is indicated by crosshairs. For example... Figure 2 As shown, the first curved section 135a is aligned at the end of the support 120 with the apex 125c of the lower adjacent loop 125d in the helical direction H, while the first curved section 135a is aligned near the middle section of the support 120 with the end of the lower adjacent loop 125d, such that the first curved section 135a is aligned with the adjacent (e.g., bottom) loop 125d. Therefore, the adjacent loops 125 in the helical direction H are axially offset relative to the vertical axis of the longitudinal direction L, i.e., staggered. The staggered arrangement pattern A of the adjacent loops in the helical direction H is staggered, so that when the support 100 is compressed into a curled profile, overlap between adjacent loops 125 is avoided or limited, thereby enabling a reduced compression diameter. Furthermore, the staggered arrangement pattern A of adjacent loops positions adjacent loops 125 so that they are aligned with corresponding opposing curved sections 135a-b of adjacent supports 120 (along the vertical axis of the longitudinal direction L), wherein, when the support 100 is compressed into a curled profile, the loops 125 rest against the corresponding opposing curved sections 135a-b, thereby further reducing the compression diameter. In one embodiment, the resting arrangement allows at least one loop 125 to have a substantially complementary fit with the opposing curved sections 135a-b in the helical direction H. The resting arrangement allows at least one loop 125 to rest against (or nearly rest in contact with) the opposing curved sections 135a-b when the support is in a curled configuration.

[0072] The first and second bending sections 135a-b are substantially not straightened during compression or when the support 100 is in a compressed configuration, such that the first and second bending sections 135a-b maintain their respective bending patterns and achieve a reduced curl profile of the support 100. In any and all embodiments of the invention, when the support 100 is compressed or when the support 100 is in a compressed configuration, the first and / or second bending sections 135a-b of at least one strut 120 must be bent (e.g., remain bent or become more bent) such that at least one adjacent loop 125 in the helical direction H is configured to rest against the opposing or corresponding first and / or second bending sections 135a-b, thereby reducing the compression diameter of the support 100. In one embodiment, the first and second bending sections 135a-b are bent (i.e., not straightened) during the curling, cutting, and expansion diameter of the support 100. In another embodiment, to provide an increased expansion diameter, the first and / or second curved sections 135a-b can be substantially straightened in the expansion profile of the support 100, such that the first and / or second curved sections 135a-b become straighter compared to a more curved curled or cut profile, or can become completely straight. Because the support 120 is flexible, it can be substantially straight in the expansion profile and / or become more curved in the curled profile.

[0073] The curvature of the first and second curved sections 135a-b can be determined based on the specific application. Greater curvature in the first and second curved sections 135a-b results in a greater reduction in the coiled profile, and may therefore be preferred in coronary applications compared to peripheral vascular applications. The curvature can be defined as the curvature angle of each of the first and second curved sections 135a-b. The curvature angle is generated by the curvature of the strut 120 at the first and second curved sections 135a-b and provides gaps, spaces, or hollows so that adjacent loops can rest against each other in the coiled configuration of the stent 100. The curvature angle provides a maximum height 137 ( ) of gap, space, or hollow created by one or more curvatures in the strut 120. Figure 3 The curvature angle is less than 90 degrees but greater than 0 degrees, and can be greater than 35 degrees. The curvature magnitudes of the first and second curved sections 135a-b of the support 120 can be the same or different, and the curvature magnitudes in different supports 120 can be the same or different. In one embodiment, the curvature height 137 ( Figure 3 (That is, the maximum height 137 of the gap or space created by the bending of the first and / or second bending sections 135a-b) can be greater than 0 micrometers but less than about 150 micrometers, and can preferably be at least 30 micrometers. Alternatively or as a supplement, the height 137 of the bend can be substantially the same as or equal to the width of the loop 125 (e.g., the width of the lower portion of the loop 125, which is configured to rest against the space created by the bending of the bending sections 135a-b). Alternatively, the height 137 of the bend can be the width 139 of the loop 125. Figure 3 Approximately half of ).

[0074] Similarly, the number and / or location of the supports 120 with the curved support design can vary depending on the specific application. The support 100 includes at least one support 100 having a curved support design comprising at least one of first and second curved sections 135a-b. Figure 1 and Figure 2 In the illustrated embodiment, for example, a hybrid curved / straight strut design is shown in an alternating pattern, such that each strut pair 122 includes a long strut 120a with first and second curved segments 135a-b having opposite orientations and a short straight strut 120b. Figure 1 and Figure 2In the illustrated embodiment, the continuous component 105 includes alternating patterns of curved long struts 120a and straight short struts 120b, while the struts 120 of the end rings 110A-B are straight and not curved. However, in other embodiments and as required by the specific application, the end rings 110A-B may include at least one strut 120 with a curved strut design. Furthermore, in other embodiments with alternating patterns, the short struts 120b may include a curved strut design, while the long struts 120a may be straight, or both struts 120 in the strut pair 122 (e.g., long strut 120a and short strut 120b) may include a curved strut design.

[0075] exist Figure 1 and Figure 2 In the illustrated embodiment, the first and second turn segments 115A-B are interconnected by at least one link 119 to form a cell 117. The link 119 is a connector or strut extending in the longitudinal direction L of the stent 100, and / or may extend diagonally (not shown) to form two interconnected turn segments 115A-B and surround the cell 117. The link 119 extends in the gap between the first and second turn segments 115A-B, thereby closing or forming the cell 117. The link 119 may be a flexible connector, allowing the stent 100 to conform to the curvature of the vascular anatomy. Figure 1 In the illustrated embodiment, link 119 is a straight or linear connector without bends. Alternatively, in another embodiment (not shown), link 119 may have one or more loops or bends, or some links 119 in the bracket 100 may be linear connectors while others may have loops or bends. As an alternative to link 119, first and second turn segments 115A-B may be directly connected to each other to form a cell 117 without link 119. In another embodiment, bracket 100 may include a combination of links 119 and direct connections for interconnecting the first and second turn segments 115A-B in the turn ring 115. Other interconnections and direct connections are possible and fall within the scope of the invention; this can be achieved, for example, by welding, adhesives, metal connectors, polymer materials, or any form of physical bonding or other fastening, interlocking, or connection. The loop 125 with interconnections provided above may be referred to as an "attached loop" 126, while the loop 125 without interconnections provided above may be referred to as a "free loop" 127, as... Figure 2 As shown.

[0076] The number, type, and / or location (e.g., spacing or placement) of interconnections (e.g., links 119 and / or direct connections) can depend on the specific application (e.g., coronary or peripheral vascular applications), where the interconnections determine the size and shape of cell 117. For example, in Figures 1-2 In the exemplary embodiment shown, the first and second turns 115A-B in the turns 115 are connected by a link 119 at every sixth loop 125 (or every third valley 125b). Accordingly, in Figures 1-2 In the exemplary embodiment shown, each cell 117 is surrounded by two links 119 (between attached loops 126), twelve struts 120, and ten free loops 127. Furthermore, for example, as... Figure 2 As shown, the attached loop 126 is a valley 125b, such that the link 119 is positioned to connect the apex of the valley 125b of the first turn segment 115A and the apex of the valley 125b of the second turn segment 115B, with these two apexes aligned along the longitudinal direction L. Thus, in this embodiment, the link 119 is arranged to connect the first and second turn segments 115A-B at the location where the gap or distance between them is minimal, resulting in a shorter link 119 (compared to a link that can span the maximum distance between two interconnecting turn segments 115A-B). In alternative embodiments, the number, spacing, and / or location of the interconnections (i.e., links 119 or direct connections) may differ. Figure 1 and Figure 2 The situation shown.

[0077] In some embodiments, each of the links 119 may have the same width as each other and / or the same width relative to the first and second turns 115A-B or a portion thereof. Alternatively, the links 119 may have different widths, for example, a width smaller than the first and second turns 115A-B (or any portion thereof), or different widths relative to each other, which is suitable for the particular application. Links 119 with narrower widths provide greater flexibility to the stent than links 119 with wider widths, while links 119 with wider widths provide greater structural integrity and stiffness to the stent. The links 119 may have a uniform thickness or a variable thickness along their length. Furthermore, in some embodiments, the plurality of links 119 have the same length or a length that varies at uniform or random intervals. In one embodiment, for a coronary stent, the length of the link 119 may vary from 0.05 mm to 0.15 mm, and the width may vary from 0.03 mm to 0.07 mm. In another embodiment, for peripheral vascular stents, the length of the connector 119 can vary from 0.5 mm to 1.0 mm, and the width can vary from 0.05 mm to 0.1 mm. The length and width of the connector 119 can depend on the stent application (e.g., coronary artery or peripheral vessel), the deployment type (e.g., balloon expandable or self-expanding), and / or the target stent diameter.

[0078] Similarly, the length and width of strut 120 may depend on the stent application (e.g., coronary or peripheral), deployment type (e.g., balloon expandable or self-expanding), and / or the target stent diameter. All or some struts 120 may have the same width and / or length as each other, or different widths and / or lengths. In one embodiment, for a coronary stent, the length of strut 120 may vary from 0.5 mm to 1.5 mm, and the width from 0.04 mm to 0.1 mm. In another embodiment, for a peripheral vascular stent, the length of strut 120 may vary from 1.3 mm to 2.5 mm, and the width from 0.08 mm to 0.14 mm. Furthermore, all or some struts 120 may have a single width from one end to the other, or all or some struts 120 may have more than one width along the length of strut 120 from one end to the other. Strut 120 (at any point along its length) may have the same or different width compared to loop 125.

[0079] Figure 3 The diagram shows an enlarged view of a strut pair 122 connected to a loop 125 of a support 100 in a cut configuration according to another embodiment of the invention. In some embodiments of the invention, each strut 120 in the strut pair 122 may have the same length, wherein each strut 120 has a curved strut design. Figure 3 In one embodiment shown, each of the long strut 120a and short strut 120b of the strut pair 122 has a curved strut design including first and second curved sections 135a-b, and is connected to each other by a loop 125. The curved strut design 135a-b of the long strut 120a is essentially a mirror image (or the opposite of) the curved strut design 135a-b of the short strut 120b in the strut pair 122. Figure 3 In the embodiment of the pillar pair 122 with the curved pillar design shown, the pillar pair 122 with the curved pillar design and the pillar pair 122 with the straight pillar design can be arranged alternately or otherwise uniformly, or they can be arranged in a random pattern. However, without departing from the scope or spirit of the invention, the curved pillar design may be present only in one pillar 120 of the pillar pair 122, and / or each of the pillar pair 122 may have the same length. Figure 3 The stent of the illustrated embodiment may include all or some of the features combined in any way, as described above and / or for Figure 1 and Figure 2 The embodiments shown are described below. Figure 3The illustration shows an embodiment in which the supports 120a-b have different widths from one end to the other, and the loop 125 has a width greater than any portion of the supports 120a-b, in order to optimally redistribute the stress / strain concentration applied to the support 100 away from the loop 125 and towards the supports 120. Figure 3 As shown, the width 139 of loop 125 is approximately 98 micrometers, while the width of struts 120a-b varies between approximately 79 and 83 micrometers. The width of struts 120a-b can gradually decrease or taper from both ends toward the middle section of the strut to redistribute stress / strain away from loop 125 and toward the middle section of struts 120a-b.

[0080] Return to reference Figure 1 The first and second ends 105a-b of the continuous component 105 include a first end ring 110A and a second end ring 110B at the longitudinal ends 100a-b of the support 100. The first end ring 110A may include at least one first circumferential end ring segment 140A and at least one second circumferential end ring segment 140B, which are interconnected in the longitudinal direction L, thereby forming two interconnected circumferential end ring segments 140A-B at the longitudinal end 100a of the support 100. Similarly, the second end ring 110B includes at least one first circumferential end ring segment 145A and at least one second circumferential end ring segment 145B, which are interconnected in the longitudinal direction L, thereby forming two interconnected circumferential end ring segments 145A-B at the other longitudinal end 100b of the support 100. The two interconnecting circumferential end segments 140A-B and 145A-B are substantially similar to the first and second segments 115A-B of the turn 115, except that each of the two interconnecting circumferential end segments 140A-B and 145A-B is oriented circumferentially around the support 100 in the circumferential direction C, rather than in the helical direction H. The two interconnecting circumferential end segments 140A-B and 145A-B in the circumferential direction C form a first end ring 110A and a second end ring 110B, the orientation of which is approximately a right-angled prism with respect to the longitudinal direction L of the support 100 (forming a right angle or a 90° angle relative to the longitudinal direction L of the support 100). The longitudinal ends 100a-b of the support 100 (at the end rings 110A-B) may have a straight cross-sectional profile. When the longitudinal ends 100a-b of the support 100 are not straight (e.g., due to the uneven interlacing or staggered pattern of adjacent loops in the circumferential direction C), the longitudinal ends 100a-b have an uneven pattern (e.g., scalloped edges), which may be random or periodic patterns.

[0081] Regarding common features, end rings 110A-B include one or more of the following exemplary features in the same manner as discussed for continuous component 105: undulating patterns containing loops connected to strut pairs (including in-phase or out-of-phase orientations), variable (or invariable) strut lengths, staggered or offset patterns of adjacent loops, curved strut designs (including, but not limited to, alignment and abutment arrangements between loops and strut curved sections), stress / strain redistribution (e.g., variable strut widths, and / or loops with different widths relative to the strut widths), cell-based designs (including the number and / or placement spacing of links and / or direct connections), and / or any other combination of features, embodiments, or configurations as described for continuous component 105.

[0082] The first end ring 110A and the second end ring 110B extend from their adjacent turn 115. The transition from the turn 115 of the continuous member 105 to the first and / or second end rings 110A-B can result in one or more cells referred to as transition cells. The transition cells may differ from other cells of the support 100 (e.g., cell 117) in that the transition cells may be formed or surrounded by at least a portion of an undulating pattern (i.e., struts and / or loops) containing the first and / or second turn segments 115A-B and by at least a portion of an undulating pattern (i.e., struts and / or loops) containing the first and / or second circumferential end turn segments 140A-B, 145A-B. Thus, the transition cells are surrounded by both the continuous member 105 and the first and / or second end rings 110A-B, rather than by only the continuous member 105 or only by the first or second end rings 110A-B.

[0083] Furthermore, the area surrounded by the transition cells may differ in size and / or shape from the area surrounded by cells 117 of the continuous component 105 and / or by cells formed between the two interconnected circumferential end turns 140A-B, 145A-B. The one or more transition cells between the first end turn 110A and the adjacent turn 115, and the one or more transition cells between the second end turn 110B and the adjacent turn 115, may be the same or different, for example, in terms of number, size, shape, orientation, location, and / or interconnection type (e.g., linkage or direct connection). Furthermore, in embodiments with multiple transition cells between the first end turn 110A and the adjacent turn 115, these transition cells may be the same or different. Similarly, the multiple transition cells between the second end turn 110B and the adjacent turn 115 may be the same or different.

[0084] Figure 1Exemplary first, second, and third transition cells 150, 155a, and 155b are shown; however, other transition cells with different sizes and / or configurations are also within the scope of the invention, as long as the transition cell is formed between the continuous member 105 and the first or second end rings 110A-B. Figure 1 The exemplary first, second, and third transition cells 150, 155a, and 155b shown may include any one or a combination thereof, or other transition cells (not shown). Depending on the specific application requirements, the struts constituting the boundaries of the transition cells 150, 155a, and 155b may have the same or variable lengths to enclose the desired area size and / or to impart the desired flexibility or structural stiffness to the struts 100 at the transition between the continuous component 105 and the first or second end loops 110A-B. Some, all, or no struts in the transition cells 150, 155a, and 155b may include a curved strut design, staggered or offset patterns of adjacent loops, and / or a redistribution of stress / strain concentration away from the loops (e.g., by struts having variable widths and / or loops having a larger width relative to the struts).

[0085] A first transition cell 150 is formed between the first end ring 110A and the adjacent rings 115 of the continuous member 105. The first transition cell 150 is surrounded by a portion of an undulating pattern containing a first ring segment 115A, a second ring segment 115B, and a first circumferential end ring segment 140A. The first transition cell 150 is surrounded by an interconnection 160 (e.g., a direct connection) between the first circumferential end ring segment 140A (e.g., at its support) and the first ring segment 115A (e.g., at the apex of its valley 125b). The first transition cell 150 is also surrounded by an interconnection 162 (e.g., a link 119) between the first ring segment 115A (e.g., at the apex of its valley 125b) and the second ring segment 115B (e.g., at the apex of its valley 125b). Furthermore, the first transition cell 150 is surrounded by an interconnection 164 (e.g., a direct connection) between the second ring segment 115B (e.g., at its support 120) and the first circumferential end ring segment 140A (e.g., at the apex of its peak). Figure 1 In the illustrative embodiment shown, the boundary of the first transition cell 150 is formed by six pillars 120 connected by five free loops 125 in the first turn segment 115A, one pillar 120 in the second turn segment 115B, and six pillars connected by five loops in the first circumferential end turn segment 140A.

[0086] The second transition cell 155a is substantially similar to the first transition cell 150, but is formed between the second end ring 110B and the adjacent turn 115 of the continuous component 105. The second transition cell 155a is surrounded by a portion of an undulating pattern containing the first turn segment 115A, the second turn segment 115B, and the first circumferential end turn segment 145A. The second transition cell 155a is surrounded by an interconnection 170 (e.g., a direct connection) between the first circumferential end turn segment 145A (e.g., at its support) and the second turn segment 115B (e.g., at the apex of its valley 125b). The second transition cell 155a is also surrounded by an interconnection 172 (e.g., a link 119) between the first turn segment 115A (e.g., at the apex of its valley 125b) and the second turn segment 115B (e.g., at the apex of its valley 125b). Furthermore, the second transition cell 155a is surrounded by an interconnection 174 (e.g., a direct connection) between the first turn segment 115A (e.g., at its support 120) and the first circumferential end turn segment 145A (e.g., at the apex of its peak). The boundary of the second transition cell 155a is formed by six supports 120 in the second turn segment 115B connected by five free loops 125 of the second turn segment 115B, one support 120 of the first turn segment 115A, and six supports in the first circumferential end turn segment 145A connected by five loops of the first circumferential end turn segment 145A.

[0087] The third transition cell 155b is formed between the second end ring 110B and the adjacent turn 115 of the continuous member 105. The third transition cell 155b is surrounded by a portion of an undulating pattern containing the second turn segment 115B, the first circumferential end turn segment 145A, and the second circumferential end turn segment 145B. The third transition cell 155b is surrounded by an interconnection 176 (e.g., a link) between the first circumferential end turn segment 145A (e.g., at the apex of its valley) and the second circumferential end turn segment 145B (e.g., at the apex of its valley). The third transition cell 155b is also surrounded by an interconnection 178 (e.g., a link) between the second turn segment 115B (e.g., at the apex of its valley 125b) and the second circumferential end turn segment 145B (e.g., at the apex of its valley). Furthermore, the third transition cell 155b is surrounded by an interconnection 170 (e.g., a direct connection) between the first circumferential end turn segment 145A (e.g., its support) and the second turn segment 115B (e.g., at the apex of its valley 125b). The boundary of the third transition cell 155b is formed by six pillars in the second circumferential end turn segment 145B connected by five free loops in the second circumferential end turn segment 145B, four pillars 120 in the second turn segment 115B connected by three loops 125, and three pillars in the first circumferential end turn segment 145A connected by two loops in the first circumferential end turn segment 145A. In another embodiment (not shown), a transition cell similar to the third transition cell 155b can be similarly formed between the first end ring 110A and the adjacent turn ring 115, wherein the transition cell can be surrounded by the first turn segment 115A, the first circumferential end turn segment 140A, and the second circumferential end turn segment 140B.

[0088] The stents disclosed herein can be used in coronary arteries or non-coronary applications such as peripheral vascular stents, cerebral stents, or other non-coronary applications. For coronary applications, the stent length can vary from 6 to 60 mm, with an expanded outer diameter of 1.5 to 5.5 mm and a compressed delivery outer diameter of 0.7 to 1.2 mm. For non-coronary applications (e.g., peripheral applications), the stent length can vary from 20 to 250 mm, with an expanded diameter of 3 to 8 mm and a compressed delivery diameter of 0.7 to 2.0 mm. Furthermore, for coronary applications, the stent can have a cell design with fewer interconnections (e.g., links or direct connections) and therefore larger cells, so that the provided stent has sufficiently large cells to increase lateral branch access, which is advantageous for use in tortuous coronary vessels with multiple lateral branches. The stent cells can have the same or similar dimensions along substantially the entire length of the stent or at least along the body of the stent (excluding the ends) to provide similar lateral branch access and support throughout. Figure 1In the illustrative embodiment shown, each turn 115 of the stent 100 has three interconnects and nine peaks or crowns 125a. However, for a specific application and the required stent size, any other number of interconnects or peaks can be selected. For example, in another embodiment, each turn may have two interconnects and six peaks or crowns, thereby forming a stent with a smaller diameter.

[0089] Figures 4 to 21 What is shown is based on Figure 3 A three-dimensional view of the bracket 100 in the embodiment shown. Figures 4 to 9 The cut configuration of the support 100 is shown from different perspectives. Figures 10 to 15 The coiled transport configuration of the support 100 is shown from different perspectives. Figures 16 to 21 The expanded configuration of the support 100 is shown from different perspectives.

[0090] Compared to conventional stents, the features of the present invention described herein, individually or in combination, advantageously achieve an increased expansion diameter and / or a reduced compression diameter. For example, in embodiments of the invention having a combination of long and short struts, an increased expansion diameter can be achieved through the long struts. A reduced compression diameter can be achieved, for example, through a curved strut design that facilitates a reclining arrangement in a stent's coiled configuration. Alternatively or supplementary features that may further contribute to a reduced compression diameter include, for example, staggered or interlocking patterns of loops, which may be derived from, for example, helically oriented turns and / or variable-length struts. Furthermore, compared to conventional stents, the stents of the present invention advantageously maximize the distance between adjacent struts, thereby minimizing their interaction, which could be detrimental to the stent, stent coating, and / or endcap.

[0091] Figures 4 to 21 The embodiments shown are essentially similar to Figure 1 and Figure 2 In the illustrated embodiment, all struts 120, except for the continuous component 105 and the first end ring 110A and the second end ring 110B, have a curved strut design including first and second curved sections 135a-b. It should be noted that in any embodiment of the invention, the support 100 may include a curved strut design on all, some, or one strut, depending on, for example, the specific application and / or the desired expansion or compression support diameter.

[0092] In addition, similar to Figure 1 , Figures 4 to 21 The embodiment shown includes a coil 115 containing two interconnecting coil segments 115A-B, and two interconnecting circumferential end coil segments 140A-B and 145A-B at the longitudinal ends 100a-b of the support 100. Figures 4 to 21The illustrated embodiment also shows an interlaced or staggered pattern of adjacent loops 125 in the helical direction H, similar to that for... Figure 1 The description is as follows, as are the struts 120a-b with variable lengths. Also similar to... Figure 1 , Figures 4 to 21 The cell design containing cell 117 and link 119 is shown; however, as mentioned above, some or all of link 119 can be replaced by direct connection or other connection methods. Figures 4 to 21 The support 100 may also include the optimal redistribution of stress / strain concentrations discussed above, wherein, for example, all, some, or one loop 125 may have a width wider than the strut 120, and / or all, some, or one strut 120 may have a variable width along the strut length. Additionally, Figures 4 to 21 The implementation, as discussed above, may include one or more transition cells. For example, the third transition cell 155b is displayed... Figure 4 , Figure 6 , Figure 8-10 , Figure 12 , Figure 14-16 , Figure 18 and Figure 20-21 middle. Figures 4 to 21 The support 100 and any other embodiment described herein may have one, some or all of the features described herein.

[0093] Figures 4 to 9 The image shows a support 100 in its cut configuration. The cut configuration of the support 100 is the profile obtained when the support 100 is laser-cut from a tube, or when the metal sheet is laser-cut or chemically etched and then wound and fixed into a tubular form. Although the support 100 is in... Figures 4 to 9 The outer diameter in the exemplary cut configuration is smaller than that in Figures 16 to 21 The outer diameter in the expanded configuration is larger than that in the... Figures 10 to 15 The outer diameter in the coiled conveying configuration, however, should be understood that the support of the present invention can be cut to any desired outer diameter for the resulting configuration.

[0094] like Figures 4 to 9 As shown, at least one strut 120 of the support 100 includes a curved strut design containing first and second curved sections 135a-b. Furthermore, as... Figures 4 to 9As shown, the loops 125 in the helical direction H are arranged in a non-overlapping (e.g., staggered) relationship. That is, the loops 125 are aligned with the struts 120 in the helical direction H. In particular, the curved sections 135a-b of the struts 120 are aligned with the adjacent loops 125 in the helical direction H. In the resulting configuration, the loops 125 are aligned but spaced a certain distance from the curved sections 135a-b, such that the loops 125 do not rest against the opposing curved sections 135a-b.

[0095] Figures 10 to 15 The image shows a stent 100 in a coiled delivery configuration (or a partially coiled configuration). The outer diameter of the stent 100 in the coiled (or partially coiled) configuration is smaller than its outer diameter in the expanded configuration. In the coiled configuration, the struts 120 move closer to each other as the stent 100 is compressed onto an expandable member such as a bladder or catheter. Alternatively or as a supplement, the radius of curvature of the loop 125 may be reduced as the stent 100 is compressed into the coiled configuration.

[0096] like Figures 10 to 15 As shown, at least one strut 120 of the support 100 includes a curved strut design containing first and second curved sections 135a-b. Because the loop 125 is aligned with the curved sections 135a-b of the strut 120, the curling process causes the loop 125 to move toward the opposing curved sections 135a-b of complementary shapes in the adjacent strut 120 in the helical direction H, thereby achieving a reclining arrangement. The support 100 can curl more tightly than conventional supports because of the reclining arrangement achieved in the curled profile, wherein the curved sections 135a-b do not straighten substantially during or when compressed. In particular, the support 100 can curl more tightly than conventional supports because the curved sections 135a-b create space in which adjacent loops 125 can recline. The created space results in a curved shape 130, wherein the internal distance between the strut pairs 122 decreases at the inward curvature of the strut 120. Figures 10 to 15 As shown, loop 125 is tightly coiled or compressed to contact or nearly contact the first or second curved section 135a-b. Loop 125 is offset from adjacent loops (to form offset loops in the helical direction H), such that loop 125 is positioned proximal to the upper loop and distal to the lower loop, or vice versa, thus avoiding interference between adjacent loops 125.

[0097] In one embodiment, the first and / or second curved sections 135a-b maintain the same curvature as in the cut configuration (or expanded configuration) such that the curvature of the first and / or second curved sections 135a-b does not change when the struts 120 move closer to each other during compression or compression (on the guide tube). In another embodiment, the first and / or second curved sections 135a-b become more curved during or when curling, increasing the curvature of the first and / or second curved sections 135a-b, thereby further reducing the compression diameter 100 of the stent. In yet another embodiment, the first and / or second curved sections 135a-b become less curved during or when curling, but maintain at least a certain degree of curvature and are substantially not straightened in order to achieve a resting arrangement of the struts and loops.

[0098] Figures 16 to 21 The image shows a support 100 in an expanded (or partially expanded) configuration. The outer diameter of the support 100 in the expanded (or partially expanded) configuration is larger than the outer diameter in the coiled conveying configuration. Figures 16 to 21 In the illustrated embodiment, the stent 100 is expanded or deployed to an outer diameter of 3.0 mm, but other diameters may also be suitable for specific applications. In the deployed configuration, as the stent 100 expands via a guide conduit (e.g., an expandable member of a balloon or conduit) or self-expands, the struts 120 move away from each other, thereby increasing the radius of curvature of the loop 125.

[0099] like Figures 16 to 21 As shown, at least one strut 120 of the support 100 includes a curved strut design containing first and second curved sections 135a-b. Furthermore, as... Figures 16 to 21 As shown, the loops 125 in the helical direction H maintain a non-overlapping (e.g., staggered) relationship, wherein the loops 125 are aligned with (but separated by a distance from) the curved sections 135a-b of the support 120.

[0100] In one embodiment, the first and / or second curved sections 135a-b maintain the same curvature as the cut or curled configuration, such that the curvature of the first and / or second curved sections 135a-b does not change as the supports 120 move away from each other during or during expansion. In another embodiment, the first and / or curved sections 135a-b become more curved during or during expansion, such that the curvature of the first and / or second curved sections 135a-b increases. In yet another embodiment, the first and / or second curved sections 135a-b become less curved during or during expansion, but maintain at least a certain degree of curvature and are substantially not straightened. In yet another embodiment, the first and / or second curved sections 135a-b straighten or substantially straighten during or during expansion, thereby further increasing the expansion diameter of the support 100.

[0101] Figures 22 to 23 The illustration depicts a stent 100 according to any embodiment discussed herein, having an optional polymer coating 200. The polymer coating 200 may be made of or comprise a biodegradable or biocompatible polymer, and / or may comprise a drug, such as a drug in formulation form. Furthermore, the polymer coating 200 may be in the form of a fibrous web. The polymer coating 200 may be applied by, for example, electrospinning, physical vapor deposition (PVD), chemical vapor deposition (CVD), thermal evaporation, sputtering, spraying, or other methods known in the art. The polymer coating 200 may be applied to all or part of the stent 100 in a continuous or discontinuous manner, and may or may not be embedded in the stent 100. In one embodiment, the polymer coating 200 may be applied in or extend into the gaps between adjacent turns 115 and / or into the gaps formed by cell 117. The elastic range of the polymer coating 200 (e.g., a fibrous web) is preferably sufficient during and after implantation to allow for expansion and maximum bending of the stent 100 without reaching its elastic limit. Furthermore, the polymer coating 200 can be substantially porous, thereby allowing blood and nutrient fluid flow, or the polymer coating 200 can be applied to the stent 100 in a manner that allows the stent 100 to be substantially porous (i.e., not fluid-tight). The porosity value of the polymer coating 200 is significantly greater than that of graft materials used in substantially fluid-tight grafts or stent-transplant devices. Alternatively, the polymer coating 200 material can be completely non-porous, but can be made (e.g., punctured) to include openings, for example, for blood and nutrient flow and / or lateral branching pathways.

[0102] In one embodiment, the polymer coating 200 may be formed as a continuous sheet of polymer material covering the support 100. The continuous sheet may be a porous sheet surrounding the outer surface of the support or embedding the support therein. The polymer coating 200 may be porous by forming holes and / or perforations in the continuous sheet. The holes and / or perforations may or may not be irregular in shape and may be uniformly or non-uniformly distributed throughout the support 100. The holes and / or perforations may be formed on portions of the continuous sheet that do not surround or embed the metal components of the support 100 (e.g., struts 120 and loops 125). The size of the holes may range from 2.0 to 500 micrometers, and the size of the perforations may be larger than the holes. In another embodiment, the polymer coating 200 may be a fiber web with a porous structure that allows fluid flow. The fiber web itself may be porous or may be arranged at variable distances (e.g., gaps) to provide a non-fluid-sealed support 100. The polymer may interconnect with adjacent unconnected helical turns in the support. In any of the above embodiments, the polymer may interconnect with one or more turns of the stent. In some embodiments, the polymer interconnects with each turn of the stent. The polymer coating 200 may be readily punctured, for example, by a catheter or guidewire tip, to obtain lateral branch access. The polymer coating 200 may be applied between the metal portions of the stent 100 and / or may be coated onto the metal portions of the stent 100, for example, onto the stent strut. Coating methods are known to those skilled in the art, for example, as described in U.S. Patent No. 7,959,664 entitled “Flat Process of Drug Coating for Stents,” the entire contents of which are incorporated herein by reference.

[0103] The scaffold of the present invention can be formed from metals, polymers, other flexible materials, and / or other biocompatible materials. The scaffold can be made of stainless steel, cobalt-chromium alloy (“CoCr”), platinum-chromium alloy, nickel-titanium (“NiTi”), or other known materials or alloys. The scaffold pattern or design described herein can be etched or laser-cut into a flat metal strip or plate. Alternatively, the scaffold can be made from a tube, wherein the scaffold pattern or design has been etched or laser-cut into the tube. In either case, the scaffold will have a pattern similar to that described herein and will resemble a metal wire. It is also conceivable that the scaffold can be formed by helically winding a flat strip or wire having the scaffold pattern or design described herein. In one embodiment, the invention contemplates encapsulating or embedding the scaffold in a biocompatible polymer such that the polymer structurally supports the scaffold but does not restrict longitudinal and / or torsional movement, thereby forming a scaffold with high radial strength and high longitudinal (i.e., length direction) flexibility.

[0104] The stent of the present invention can be balloon-expandable or self-expandable. When delivering a stent using a balloon-expandable stent system, the stent is coiled onto the balloon at the distal end of the catheter assembly and then delivered to the implantation site, such as the coronary artery, using techniques known in the field of interventional cardiology. The balloon is then inflated, applying radial force within the stent, and the stent expands to its working diameter. Alternatively, the stent can be self-expandable, in which case the stent is held in a restricted diameter using mechanical means (e.g., a sleeve) before and during delivery to the implantation site. Once the stent is positioned at the implantation site, the sleeve is removed, and the stent then expands to its working diameter.

[0105] The support structure can be arranged to provide a unit-format support design, wherein cells are formed between first and second turn segments, between helical turn segments and circumferential end turn segments, and / or between first and second circumferential end turn segments. An example design is described in, but is not limited to, U.S. Patent No. 6,723,119, which is incorporated herein by reference in its entirety. Another example design is the support pattern described in U.S. Patent No. 7,141,062 (“62”). The support in '62 includes triangular cells, meaning that a cell is formed by three segments, each segment having a loop portion, and three associated points where they combine to form each cell. One or more rows of such cells can be assembled in a strip, which may be helically coiled from the support structure. Similarly, cells in the support structure described in U.S. Patent No. 5,733,303 (“303”) to Israel et al. can be used as a support structure, simply a helically coiled support structure. Patent '303 describes a support having cells formed by four segments, each segment having a loop portion and four associated points where they combine to form the respective cells, also referred to as square cells. Such square cells can be formed from the first and second turns and connecting rods of the support of the present invention. Each of these designs is explicitly incorporated herein by reference. Other similar suitable cell support designs known in the art are readily applicable to the spiral support of the present invention, such as rhomboid cells or non-rhomboid cells.

[0106] An undercoat layer can optionally be applied to the scaffold of the present invention. The undercoat layer is applied to the metal structure of the scaffold and prior to the application of an optional polymer coating or material. The undercoat layer can promote bonding between the optional polymer material and the scaffold. The undercoat layer can be applied or adhered to the scaffold by a variety of methods (e.g., roller coating, dip coating, spray coating, etc.). The undercoat layer can be a polymer, such as a biostable or biodegradable polymer. Biostable polymers used for the undercoat layer can be polyurethane or acrylate polymers. Biodegradable polymers used for the undercoat layer can be combined with biodegradable polymers used for encapsulating or embedding the scaffold (e.g., [missing information]). Figure 22 and Figure 23The polymer coating (200) may be the same as or different from the substrate. The polymer used for the undercoat is selected to adhere to the metal structure of the scaffold under specific conditions, while the polymer used to encapsulate or embed the scaffold can adhere to the undercoat under different conditions. The polymer used for the undercoat can be dissolved in most solvents, and its flexibility should be sufficient to withstand significant deformation during and after scaffold deployment.

[0107] Polymers for optionally wrapping or embedding stents (e.g.) Figure 22 and Figure 23 The polymer can be placed within or embedded in several portions of the stent, and can partially or completely support the stent structure. The polymer is made of a biocompatible material. The biocompatible material can be a durable polymer, such as polyester, polyanhydride, polyethylene, polyorthogonal, polyphosphazene, polyurethane, polycarbonate polyurethane, silicone, polyolefin, polyamide, polycaprolactam, polyimide, polyvinyl alcohol, acrylic polymers and copolymers, polyether, cellulose, and any combination thereof or with other polymers in the form of blends or copolymers. Particularly useful are silicone-based modified polycarbonate polyurethane and / or expanded polytetrafluoroethylene (ePTFE). Alternatively, the biocompatible material can be a biodegradable polymer. The polymer can be a porous network formed from polymer fibers. The polymer may also include an antiproliferative drug that inhibits smooth muscle cell growth and helps prevent restenosis (vascular restenosis) at the stent implantation site. Depending on the specific surgical requirements and the technical characteristics of the polymer, the combination of drug and polymer offers the advantage of controlled drug elution over a predetermined time period (e.g., 30 days, 60 days, or 90 days). Drug elution can be controlled, for example, by selecting the polymer or a mixture of polymer and drug, the polymer pore size, fiber diameter or fiber structure, or any structural feature that affects the diffusion coefficient. The biodegradable polymer can be selected to be completely biodegraded within the vessel wall within a predetermined time period and after drug elution. The biodegradable polymer can be selected from the group consisting of: polyglycolic acid, polylactide, polycaprolactone, polydioxanone, poly(lactide-co-glycolic acid), polyhydroxybutyrate, polyhydroxyvalerate, trimethylene carbonate, polyphosphate, polyphosphate-polyurethane, polyamino acids, polycyanoacrylate, fibrin, fibrinogen, cellulose, starch, collagen, hyaluronic acid, and fusions, mixtures, and copolymers of these substances.

[0108] The stent according to the invention may selectively contain one or more drugs that inhibit or reduce smooth muscle cell migration and proliferation, and reduce restenosis. Examples of such drugs include, for example, rapamycin, paclitaxel, sirolimus, everolimus, zotamoxetine, lidafolimus, piolimox, and the like. The drugs may be provided on a metallic stent (e.g., struts and / or loops) and / or on polymeric materials or coatings (e.g.,... Figure 22 and Figure 23 The polymer coating 200 is applied. For example, the drug may be provided as part or all of the coating covering the stent 100 and / or the polymer coating 200. The metal stent may be surface-treated to have a profile (e.g., indentation, pit, or perforation) for receiving the drug therein or on it. Alternatively or supplemented, the polymer material may have a profile (e.g., indentation, pit, or perforation) for receiving the drug therein or on it.

[0109] In one embodiment, the drug can be selectively “printed” onto a target area of ​​the stent and / or polymer. In one embodiment, the drug may be confined only to and / or provided to areas subject to lower mechanical stress after implantation. In one embodiment, the drug or drug / polymer formulation is deposited or printed using inkjet technology. The inkjet device includes an inkjet head with a small orifice. When voltage is applied to the inkjet device, the device contracts for milliseconds and ejects a small droplet of the desired product (e.g., a drug or drug / polymer formulation). The droplet diameter is adjustable and variable, and moving the inkjet head or target object (e.g., a stent) enables selective and precise product deposition / printing.

[0110] The desired outcome is to design stent structures that, after neointimal growth and the stent struts "embedded" in the tissue, do not interfere with the vasomotor function of the implanted vessel. This reduction or elimination of interference is achieved by lowering the stent's mechanical resistance to bending / torsion (i.e., through stent design and / or polymer coating). The exemplary stent configurations described herein provide metallic stents that radially support the vessel but impose minimal mechanical constraints along the longitudinal and torsional directions. Specifically, the stents of this invention impose minimal mechanical constraints on the lateral bending, torsion, elongation, and vasodilation / vasoconstriction of the vessel.

[0111] It should also be noted that although the structural components of the support of the present invention are not separate structures, but are integrally formed with each other (by means of, for example, laser cutting or chemical etching) to form the continuous tubular shape of the support of the present invention, structural components such as interconnecting turns, supports, loops, links and / or end rings, and other features are mentioned separately for ease of identification and discussion. Furthermore, it should be noted that references to the same reference numerals in different figures denote the same features.

[0112] It should be understood that the above description and figures represent only illustrative examples of embodiments. For example, it can be understood that the curved strut design described herein facilitates a reclining arrangement for reducing the stent compression diameter. This curved strut design can be incorporated as needed into any suitable endovascular device (e.g., stent, graft, or stent-graft device), including, for example, stents having any number of loops within the loop. For the reader's convenience, the above description focuses on representative examples of possible embodiments, i.e., examples that teach the principles of the invention. Other embodiments may arise from different combinations of various portions of different embodiments. This specification does not attempt to exhaustively list all possible variations.

Claims

1. An intravascular device, comprising: A continuous component having a tubular shape and extending from a first end to a second end along the longitudinal direction of the intravascular device, wherein the continuous component comprises: Multiple coils, having a coiled delivery diameter and an expanded implantation diameter, and oriented along the helical direction of the intravascular device. The plurality of turns have an undulating pattern including struts and loops, wherein the loops are U-shaped bends in the undulating pattern, and each end of the loop is connected to the end of a strut forming a strut pair. In this arrangement, adjacent loops along the helical direction are axially offset relative to a vertical axis perpendicular to the longitudinal direction, forming an alternating pattern of adjacent loops. This ensures that the loops are positioned aligned with the ends of adjacent supports along the helical direction. At least one of the supports is a curved support, comprising a curved pattern along a length of the curved support at the point of coiling conveying diameter, wherein the curved pattern comprises first and second curved sections with opposite curvatures extending from each end of the curved support toward a middle section of the curved support, and The staggered arrangement of adjacent loops is positioned such that, when in the coiled conveying diameter, the loops adjacent to the first and second curved sections in the helical direction are positioned to align with and rest against the first and second curved sections respectively, forming a resting arrangement.

2. The intravascular device according to claim 1, wherein, The length of the curved support includes both concave and convex curvature.

3. The intravascular device according to claim 2, wherein, The first bending section extends from the end of the loop connected to the strut pair, the first bending section of the bent strut bends inward toward the opposing strut in the strut pair, and the second bending section bends outward away from the opposing strut in the strut pair, wherein the bent strut maintains a bending pattern when in the coiled delivery diameter and the expanded implantation diameter, such that the first and second bending sections do not straighten during strut compression.

4. The intravascular device according to claim 1, wherein, The pillars of a pillar pair include pillars of varying lengths, thereby facilitating the formation of an interlaced pattern of adjacent loops. The pillar pair includes long pillars and short pillars, such that adjacent pillars in the helical direction have varying lengths, and wherein the pillar length of the long pillar is greater than the pillar length of the short pillar.

5. The intravascular device according to claim 4, wherein, At least one of the long and short pillars has a curved pattern along the length of the pillar.

6. The intravascular device according to claim 5, wherein, The long column in the column pair includes first and second curved sections, wherein the short column in the column pair is substantially straight and does not include the first and second curved sections, wherein the first curved section of the long column bends inward toward the short column to form a curved pattern.

7. The intravascular device according to claim 5, wherein, Both the long and short pillars in the pillar pair include first and second curved sections, wherein the first curved section in the long pillar and the first curved section in the short pillar bend inward toward each other to form a curved pattern.

8. The intravascular device according to claim 1, wherein, The bolstering arrangement is such that when the intravascular device is compressed to the coiled delivery diameter, the loops adjacent to the first and second curved sections in the helical direction respectively contact the first and second curved sections.

9. The intravascular device according to claim 1, wherein, At least one support has a varying width, wherein the width near the middle section of the support is less than the width near the end of the support, and wherein the width of the loop is greater than the width of any part of the support.

10. The intravascular device according to claim 1, wherein, Each of the plurality of turns includes two interconnected turns, the two interconnected turns including a first turn and a second turn, the first turn and the second turn being interconnected with each other to form a cell between them.

11. The intravascular device according to claim 10, wherein, In a turn, the first turn segment interconnected with the second turn segment is out of phase with the second turn segment, and adjacent first and second turn segments that are not interconnected in adjacent turns are in phase.

12. The intravascular device according to claim 10, wherein, The continuous component also includes a link that interconnects two interconnected segments of each turn in the longitudinal direction, wherein the link is a straight connector without bending and extends in the gap between the two interconnected segments.

13. The intravascular device according to claim 12, wherein, To form a loop, the connecting rod connects the first and second loop segments at adjacent loops in the longitudinal direction to form an attachment loop.

14. The intravascular device according to claim 13, wherein, The attachment loop is the loop where the gap is smallest, so that the connecting rod connects the first and second turns of the coil at the attachment loop on the first and second turns at the point where the gap is smallest.

15. The intravascular device according to claim 14, wherein, The connecting rod is located at every sixth loop to form an attachment loop and interconnect the first and second turns.

16. The intravascular device of claim 2, further comprising a first end loop located at a first end of a continuous member and a second end loop located at a second end, the first and second end loops extending from adjacent turns thereto, wherein, The first and second end rings are oriented in the circumferential direction and form approximately right-angled prisms at the longitudinal end of the intravascular device relative to the longitudinal direction.

17. The intravascular device according to claim 16, wherein, Each end ring includes one or more circumferential end ring segments interconnected in the longitudinal direction, and includes an undulating pattern consisting of loops connected to a pair of struts, the one or more circumferential end ring segments including struts having variable lengths that create axially offset loops in the circumferential direction.

18. The intravascular device according to claim 16, wherein, Each end loop includes at least one loop with an interlaced pattern and at least one curved strut with a curved pattern, such that when the intravascular device is compressed to a coiled delivery diameter, the at least one loop is positioned aligned with and abuts against one of the first and second curved sections of the at least one curved strut adjacent in the circumferential direction.

19. The intravascular device of claim 1, further comprising a polymer material electrospun onto the intravascular device, wherein, The polymer material includes a drug.

20. The intravascular device according to claim 1, wherein, Each of the plurality of turns is a single turn segment.

21. The intravascular device according to claim 17, wherein, The staggered pattern of adjacent loops in the turn forms a uniform stagger, and wherein the axially staggered loops in the first and second end turns form a non-uniform stagger, such that the loops in the first and second end turns form scalloped edges.

22. The intravascular device of claim 17, further comprising at least one transition cell surrounded by an undulating pattern of a continuous component and an undulating pattern of one of the first and second end rings.

23. The intravascular device according to claim 1, wherein, All the supports of the continuous component are curved supports with a curved pattern.

24. The intravascular device according to claim 1, wherein, At least one support of the continuous component is a curved support with a curved pattern, and wherein the remaining supports are straight supports without a curved pattern.

25. The intravascular device according to claim 17, wherein, All the supports of the first and second end rings are straight supports.

26. The intravascular device according to claim 18, wherein, All the supports of the first and second end rings are curved supports with a curved pattern.

27. The intravascular device according to claim 18, wherein, At least one support of the first and second end rings is a curved support with a curved pattern, and wherein the remaining supports are straight supports without a curved pattern.

28. The intravascular device according to claim 1, wherein, The bending pattern along the length of the bending pillar includes a bending section and a straight section.

29. The intravascular device according to claim 1, wherein, Endovascular devices are one of the following: peripheral vascular stents, coronary stents, and stent grafts.

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