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  • 权利要求
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    • 专利摘要:
    intraluminal prosthesis. the present invention relates to an intraluminal prosthesis that includes a stent architecture that has a series of stent elements that are repeated along a circumferential geometric axis (a1, a2). a series of stent elements include v-shaped stent elements (v1, v2, v3, v4, v1, v2, v3) that have at least four different orientations, and v-shaped stent elements (v1, v2, v3, v4, v1, v2, v3) that connect adjacent v-shaped stent elements (v1, v2, v3, v4, v1, v2, v3). a series of stent elements includes r-shaped stent elements (r1, r2, r3, r4, r1, r2, r3, r4, r5, r6) that have at least four different orientations, and stent elements in u (u1, u2) which have at least two different orientations, the u-shaped stent elements (u1, u2) connecting adjacent r-shaped stent elements. (r1, r2, r3, r4, r1, r2, r3, r4, r5, r6) adjacent series of stent elements can be connected by connectors (c1, c2). portions of the stent elements may become narrow in width over a length thereof. the stent architecture may include radiopaque element receiving members. the stent architecture can be formed by machining a metal or polymer tube. the intraluminal prosthesis may include one or more graft layers.
    公开号:BR112014028242B1
    申请号:R112014028242-0
    申请日:2013-03-12
    公开日:2021-04-13
    发明作者:Andrzej J. Chanduszko
    申请人:C.R. Bard, Inc；
    IPC主号:
    专利说明:

    PRIORITY
    [001] This request claims the priority benefit of the following three requests, each of which is incorporated by reference in its entirety into this request: 1) Provisional Application No. US 61 / 646,806, filed on May 14, 2012; 2) Provisional Application No. 61 / 678,485, filed on August 1, 2012; and 3) Provisional Application No. 61 / 708,445, filed on October 1, 2012. BACKGROUND
    [002] Intraluminal prostheses used to keep blood vessels open or dilate them are commonly known as stents. Stents have been developed for use in various lumens in the body, including, for example, the biliary tree, the venous system, peripheral arteries, and coronary arteries. Stent constructions generally include cylindrical frames that define a plurality of openings.
    [003] There are two broad classes of stents: self-expanding stents and balloon-expanding stents. Self-expanding stents are typically characterized by intraluminal expansion when a restrictive force is removed, such as an outer shell of a stent delivery system, and / or in the presence of an elevated temperature (due to its material properties). Self-expanding stents are generally loaded into a stent delivery system by retracting the stent from an expanded configuration in a larger first diameter to a configuration retracted in a smaller second diameter. Balloon-expandable stents are typically characterized by intraluminal expansion by means of an inflation force, such as a balloon catheter. Balloon-expandable stents are usually loaded into a balloon catheter through a crimp process to change the stent to a retracted configuration, and are plastically deformed when the balloon is inflated in the body vessel to the expanded configuration.
    [004] There are two basic architectures for stents, circumferential and helical. Circumferential configurations generally include a series of cylindrical rings, formed by a series of connected supports, joined together by connecting elements or bridges along a longitudinal geometric axis of the stent. Helical configurations include a continuous helical structure along the longitudinal geometric axis of the stent with adjacent windings, formed by a series of connected supports, connected by one or more connecting elements or bridges.
    [005] Stents for use in the arterial and venous systems can be made by machining a pattern of supports and connecting elements of a metal tube, typically by laser machining the pattern on the tube. The pattern of supports and connection elements can be configured depending on the desired attributes. For example, the pattern can be configured to enhance flexibility or foldability. The pattern can also be configured to ensure uniform expansion and avoid shortening of the stent through intraluminal expansion.
    [006] Synthetic vascular grafts are used routinely to restore blood flow in patients suffering from vascular diseases. For example, prosthetic grafts made of expanded polytetrafluoroethylene (ePTFE) are commonly used and have shown favorable clearance rates, meaning that, depending on a given period of time, the graft maintains an open lumen for blood flow through it. Grafts formed from ePTFE include a microstructure characterized by separate nodes connected by fibrils, the distance between the nodes being defined as internodal distance (IND), and are generally extruded both as a tube and as a sheet or film that is modeled on a pipe. Grafts can also be created from woven or knitted fibers in a generally tubular shape. Stents can be completely or partially covered with a graft material, such as ePT-FE, on the luminal surface, abluminal surface or both luminal and abluminal surfaces of the stent.
    [007] Stents can include image intensification features in such a way that they can be seen fluoroscopically after intraluminal positioning. Examples of such features include radiopaque markers attached to the stent or integral to the stent, or attached to one or more graft layers associated with the stent. Image enhancement features generally include a material that is highly visible under fluoroscopy, such as gold, platinum, tantalum and alloys thereof. SUMMARY
    [008] Intraluminal prostheses that include stent architectures are described in this document. In one embodiment, a stent architecture includes a series of stent elements that repeat along a circumferential geometric axis, with the stent elements including V-shaped stent elements that have a first leg portion, a second leg portion, and a peak portion, with the V-shaped stent elements having at least four different orientations, and V-shaped stent elements that connect adjacent V-shaped stent elements so that the second leg portion of each of the V-shaped stent elements is connected to a V-shaped element, the second leg portion of each of the V-shaped stent elements becoming narrow in width towards to the V-shaped stent element. In one embodiment, the first leg portion of each of the V-shaped stent elements is parallel to a longitudinal geometric axis of the stent architecture. In one embodiment, the stent architecture includes a plurality of series of stent elements, adjacent series of stent elements connected by a plurality of connectors. In one embodiment, the plurality of connectors is straight and connects the peak portions of selected V-shaped stent elements from adjacent series of stent elements. In one embodiment, the connectors have a width equal to the width of the first leg portion of the V-shaped stent elements.
    [009] In one embodiment, the peak portion of a first orientation of the V-shaped stent element is longitudinally spaced at a distance from the peak portion of a second orientation of the V-shaped stent element, where the the first orientation and the second orientation are adjacent to each other. In one embodiment, the V-shaped stent elements have four orientations and the peak portion of each of the four orientations of the V-shaped stent element is longitudinally spaced at a distance from the peak portion of its adjacent stent element. V-shaped. In one embodiment, the distance is in the range of about 0.127 mm (0.005 inches) to about 0.889 mm (0.035 inches).
    [0010] In one embodiment, the adjacent series of v-shaped elements and V-shaped stent elements are connected by a plurality of connectors. In one embodiment, the connectors include a radius of curvature and are generally curved. In one embodiment, the curved connectors have a first orientation and a second orientation opposite from the first orientation. In one embodiment, the first orientation of the curved connectors is aligned along a circumferential geometric axis of the connector, and the second orientation of curved connectors is aligned along an circumferential geometric axis of the adjacent connector, the first orientation being aligned. of the curved connectors and the second aligned orientation of the curved connectors alternate along a longitudinal geometric axis of the stent architecture. In one embodiment, the first orientation of the curved connectors and the second orientation of the curved connectors alternate along each circumferential geometric axis. In one embodiment, the curved connectors have a width less than any width of the V-shaped stent elements and the V-shaped stent elements.
    [0011] In one embodiment, the stent architecture includes zigzag rings fixed to a proximal end and a distal end thereof.
    [0012] In one embodiment, a stent architecture includes a plurality of zigzag rings, where each ring includes a series of stent elements that are repeated along a circumferential geometric axis, the stent elements including first, second, third, and fourth stent elements connected by first, second, third, and fourth peak portions, adjacent zigzag rings connected by a plurality of connectors to form stent cells, with stent cells along a circumferential geometric axis has the same shape, the shape of the stent cells along a first circumferential geometric axis different from the shape of the stent cells along a second adjacent circumferential geometric axis. In one embodiment, the stent elements of a first zigzag ring are a mirror image of the stent elements of an adjacent second zigzag ring.
    [0013] In one embodiment, a stent architecture that has a plurality of stent cells that includes a series of stent elements that are repeated along a circumferential geometric axis, the stent elements including stent elements in shape of R that have at least four different orientations, with the R-shaped stent elements having at least one first straight portion, and U-shaped stent elements that have at least two different orientations, with the stent elements U-shaped stents connect adjacent R-shaped stent elements so that the first straight portion of each of the R-shaped stent elements is connected to a U-shaped stent element, with the first straight portion of each of the R-shaped stent elements becomes narrow in width towards the U-shaped stent element. In one embodiment, the R-shaped stent elements include at least first, second, tert floor and fourth curved radius portions. In one embodiment, the plurality of stent cells includes a first stent cell and a second stent cell different from the first stent cell, the first and second stent cells alternating along the circumferential geometric axis.
    [0014] In one embodiment, the R-shaped stent elements include a first R-shaped stent element in a first orientation, a second R-shaped stent element in a second orientation different from the first orientation, a third R-shaped stent element oriented in a third orientation different from the first and second orientations, and a fourth R-shaped stent element in a fourth orientation different from the first, second, and third orientations. In one embodiment, the U-shaped stent elements include a first U-shaped stent element in a first orientation and a second U-shaped stent element oriented in a second orientation other than the first orientation. In one embodiment, the first R-shaped stent element is connected to the second U-shaped stent element and the second R-shaped stent element, where the second R-shaped stent element is connected to the first R-shaped stent element and the first U-shaped stent element, where the first U-shaped stent element is connected to the second R-shaped stent element and the third R-shaped stent element , where the third R-shaped stent element is connected to the first U-shaped stent element and the fourth R-shaped stent element, and where the fourth R-shaped stent element is connected to the third R-shaped stent element and the second U-shaped stent element.
    [0015] In one embodiment, the stent architecture includes a plurality of connectors that connect adjacent series of stent elements. In one embodiment, the adjacent series of stent elements and connectors define stent cells. In one embodiment, a first stent cell pattern and a second stent cell pattern alternate along a circumferential geometric axis. In one embodiment, the first and second stent cell patterns are longitudinally displaced along a longitudinal geometric axis of the stent architecture.
    [0016] In one embodiment, the connectors connect the first R-shaped stent element in a first series of stent elements to the third R-shaped stent element in a second adjacent series of stent elements. In one embodiment, the connectors additionally connect the fourth R-shaped stent element in the first series of stent elements to the second R-shaped stent element in the second adjacent series of stent elements. In one embodiment, the plurality of connectors is attached to one of the first, second, third, and fourth curved radius portions of the R-shaped stent elements. In one mode, the connectors connect the first stent element in U shape in the first series of stent elements to the second U shape stent element in the second adjacent series of stent elements.
    [0017] In one embodiment, the connectors that connect the R-shaped stent elements include a radius of curvature and are generally curved. In one embodiment, the curved connectors have a first orientation and a second orientation opposite from the first orientation. In one embodiment, the first orientation of the curved connector is convex and the second orientation of the curved connector is concave for a given perspective. In one embodiment, the first orientation of the curved connectors is aligned along a circumferential geometric axis of the connector, and the second orientation of curved connectors is aligned along a circumferential geometric axis of the adjacent connector, the first orientation being aligned. of the curved connectors and the second aligned orientation of the curved connectors alternate along a longitudinal geometric axis of the stent architecture. In one embodiment, the first orientation of the curved connectors and the second orientation of the curved connectors alternate along each circumferential geometric axis. In one embodiment, the connectors that connect the R-shaped stent elements are straight. In one embodiment, the connectors at the ends of the stent architecture are curved and the connectors in the middle of the stent architecture are straight.
    [0018] In one embodiment, the straight connectors connect the first U-shaped stent element in the first series of stent elements to the second U-shaped stent element in the second adjacent series of stent elements.
    [0019] In one embodiment, the stent architecture includes receiving members that extend from one or both ends. In one embodiment, the receiving members are shaped to receive a radiopaque element. In one embodiment, the receiving members include a post-portion and an enlarged portion. In one embodiment, the receiving members include a hole or opening sized to receive a radiopaque element therein.
    [0020] In one embodiment, a stent architecture includes a plurality of stent cells, the stent cells including a series of stent elements that repeat along a circumferential geometric axis, the stent elements including R-shaped stent elements that have at least one first straight portion, and U-shaped stent elements that connect adjacent R-shaped stent connection elements so that the first straight portion of each of the stent elements R-shaped stent is connected to a U-shaped element, with the first straight portion of each of the R-shaped stent elements becoming narrow in width towards the U-shaped stent element. In this embodiment, the plurality of stent cells includes a first stent cell and a second stent cell different from the first stent cell, the first and second stent cells alternating along the circular geometric axis. cunferential.
    [0021] In one embodiment, an intraluminal prosthesis includes a stent architecture formed by machining a tube, the stent architecture having a plurality of stent cells with a plurality of connectors that connect the stent cells, with the stent cells include a series of stent elements that repeat along a circumferential geometric axis, the stent elements including R-shaped stent elements that have at least first, second, third and fourth curved radius portions , with R-shaped stent elements having at least four different orientations, and U-shaped stent elements having at least two different orientations, with U-shaped stent elements connecting adjacent select elements R-shaped stent elements In one embodiment, the R-shaped stent elements include a first R-shaped stent element in a first orientation, a second ste element n-shaped Rt in a second orientation different from the first orientation, a third R-shaped stent element oriented in a third orientation different from the first and second orientations, and a fourth R-shaped stent element in a fourth orientation different from the first, second, and third orientations. In one embodiment, the U-shaped stent elements include a first U-shaped stent element in a first orientation and a second U-shaped stent element oriented in a second orientation other than the first orientation. In one embodiment, the first R-shaped stent element is connected to the second U-shaped stent element and the second R-shaped stent element, where the second R-shaped stent element is connected to the first R-shaped stent element and the first U-shaped stent element, where the first U-shaped stent element is connected to the second R-shaped stent element and the third R-shaped stent element , where the third R-shaped stent element is connected to the first U-shaped stent element and the fourth R-shaped stent element, and where the fourth R-shaped stent element is connected to the third R-shaped stent element and the second U-shaped stent element. In one embodiment, each R-shaped stent element includes at least one first straight portion that becomes narrow in width towards the connected U-shaped element. U-shaped stent.
    [0022] Stent architectures according to modalities described in this document may include coverage. In one embodiment, the coverage includes one or more graft layers attached to the stent architecture. In one embodiment, the one or more graft layers include an expanded internal polyfluoroethylene (ePTFE) graft layer and an external ePTFE graft layer. In one embodiment, the inner layer of ePTFE graft and the outer layer of ePTFE graft are positioned over the stent architecture as extruded tubes of non-sintered ePTFE, and are sintered with each other through openings in the stent. BRIEF DESCRIPTION OF THE DRAWINGS
    [0023] FIGURE 1A is a plan view of a stent modality in an expanded configuration.
    [0024] FIGURE 1B is a top view of the stent modality of FIGURE 1A in a cut out configuration.
    [0025] FIGURE 1C is a plan view of the stent modality of FIGURE 1A that indicates various dimensions.
    [0026] FIGURE 2A is a plan view of a stent modality in an expanded configuration.
    [0027] FIGURE 2B is a top view of the stent modality of FIGURE 2A in a cut out configuration.
    [0028] FIGURE 3A is a plan view of a stent modality in an expanded configuration.
    [0029] FIGURE 3B is a top view of the stent modality of FIGURE 1A in a cut out configuration.
    [0030] FIGURE 3C is a front view of the stent modality of FIGURE 3A in a collapsed configuration.
    [0031] FIGURE 4A is a plan view of a stent modality in an expanded configuration.
    [0032] FIGURE 4B is a top view of the stent modality of FIGURE 4A in a cut out configuration.
    [0033] FIGURE 4C is a top view of a stent modality in a cut out configuration.
    [0034] FIGURE 5A is a plan view of a stent modality in an expanded configuration.
    [0035] FIGURE 5B is a top view of the stent modality of FIGURE 5A in a cut out configuration.
    [0036] FIGURE 5C is a top view of a stent modality in a cut out configuration.
    [0037] FIGURE 6A is a plan view of a stent modality in an expanded configuration.
    [0038] FIGURE 6B is a top view of the stent modality of FIGURE 6A in a cut out configuration.
    [0039] FIGURE 6C is a plan view of the stent modality of FIGURE 6A that indicates various dimensions.
    [0040] FIGURE 6D is a front view of the stent modality of FIGURE 6A in a collapsed configuration.
    [0041] FIGURE 7A is a plan view of a stent modality in an expanded configuration.
    [0042] FIGURE 7B is a top view of the stent modality of FIGURE 7A in a cut out configuration.
    [0043] FIGURE 7C is a plan view of the stent embodiment of FIGURE 7A that indicates various dimensions.
    [0044] FIGURE 7D is an isometric view of the stent modality of FIGURE 7A in a cut out configuration.
    [0045] FIGURE 8A is a plan view of a stent modality in an expanded configuration.
    [0046] FIGURE 8B is a top view of the stent modality of FIGURE 8A in a cut out configuration.
    [0047] FIGURE 9A is a plan view of a stent modality in an expanded configuration.
    [0048] FIGURE 9B is a top view of the stent modality of FIGURE 9A in a cut out configuration.
    [0049] FIGURE 9C is a plan view of the stent modality of FIGURE 9A that indicates various dimensions.
    [0050] FIGURE 10A is a plan view of a stent modality in an expanded configuration.
    [0051] FIGURE 10B is a top view of the stent modality of FIGURE 10A in a cut out configuration.
    [0052] FIGURE 11A is a plan view of a stent modality in an expanded configuration.
    [0053] FIGURE 11B is a top view of the stent modality of FIGURE 10A in a cut out configuration. DESCRIPTION
    [0054] The following description and attached FIGURES, which describe and show certain modalities, are made to demonstrate, in a non-limiting way, several possible configurations of an expandable stent frame according to various aspects and features of the present disclosure. The patterns shown and described in this document can be incorporated into any intraluminal prosthesis, such as a self-expanding stent or a balloon-expandable stent, without limitation. In one embodiment, the patterns disclosed in this document can be machined (for example, laser machined) in a metal tube without suture or polymer. Non-limiting examples of potential metal tubes include stainless steel (for example, AISI 316 SS), titanium, cobalt-chromium alloys, and nickel titanium (nitinol). In other embodiments, the patterns disclosed in this document can be formed on a sheet of metal or polymer that is laminated into a tubular shape. The tubes or sheets can be heat treated before machining the pattern on them, and the tubes or sheets can be annealed and / or electro-polished. Other known methods of pre-processing and pre-processing are also contemplated in this document.
    [0055] As used in this document, the term "stent architecture" means the various features of the stent that contribute to its shape, including the pattern on the stent wall. The term "stent cell" means a portion of the pattern in the stent wall that can be repeated along a circumferential and / or longitudinal path.
    [0056] The stents described in this document can be covered by one or more graft layers. The presence of a graft layer on the luminal surface and / or abluminal surface of a stent can influence the design of the stent architecture. For example, the expansion behavior of the stent can be adapted to prevent rupture or tearing of the graft material during installation. It was observed that the greater the uniformity of stent expansion, the less problems with rupture, detixation, etc. graft. Another consideration that may influence the design of the stent architecture includes excessive shortening of the stent during the expansion of a collapsed delivery configuration to an expanded installed configuration, which can induce inaccurate stent installation. Still other considerations include stent flexibility and stent clearance in vivo, and minimal stent profile in the collapsed delivery configuration.
    [0057] In certain modalities described in the present document, the stent architecture is designed to avoid excessive shortening (that is, the stent is shortened as it moves from the collapsed configuration to the expanded configuration), which can lead to imprecise installation stent in a body vessel, and to ensure uniform radial expansion. For example, it has been found that narrowing the support width at strategic locations in a given stent cell promotes uniform expansion of the stent cell.
    [0058] The intraluminal prostheses described in this document may include stents encapsulated by a graft material, as described in patent document No. US 5,749,880 and patent document No. US 6,124,523, each of which is incorporated as a reference in its entirety to this request. In one embodiment, an internal ePTFE graft layer is positioned in a mandrel. In one embodiment, the inner layer of ePTFE graft placed over the mandrel is an extruded tube of non-sintered eP-TFE. The stent is placed on the inner layer of the ePTFE graft in such a way that the luminal (inner) surface of the stent establishes contact with the inner layer of the ePTFE graft, and an outer layer of the ePTFE graft is positioned on the abluminal surface ( of the stent. In one embodiment, the outer layer of ePTFE graft placed on the stent is also an extruded tube of non-sintered ePTFE. In one embodiment, the internal and external ePTFE graft layers are extruded in their encapsulation diameters (that is, none of them are radially manipulated before encapsulation). In one embodiment, the encapsulation diameters are about 4 mm. In one embodiment, the stent is completely encapsulated along its length so that both the proximal and distal ends of the stent are covered with ePTFE graft material. In one embodiment, the stent is encapsulated in a diameter slightly smaller than the cut diameter, but larger than the diameter collected from delivery.
    [0059] One or more layers of PTFE tape can then be wrapped over the outer layer of ePTFE graft, and the assembly is placed on a heating device, such as an oven, to sinter the layers of internal ePTFE graft and external to each other through the openings in the stent architecture. Following the sintering step, the layer (s) of PTFE tape is (are) removed and the stent graft is corrugated (in the case of a balloon-expandable stent) or retracted (in the case of a stent expansion) in its collapsed configuration. In one embodiment, the inner layer of the ePTFE graft and the outer layer of the ePTFE graft have the same microstructure and thickness. In one embodiment, the microstructure includes a uniaxial fibril orientation. In one embodiment, the internal and external ePTFE graft layers have an internodal distance (IND) in the range of about 10 μm to about 40 μm. In one embodiment, each of the internal and external ePTFE graft layers has a thickness in the range of about 0.07 mm to about 0.13 mm. In one embodiment, each of the internal and external ePTFE graft layers has a thickness in the range of about 0.10 mm to 0.15 mm, preferably about 0.14 mm.
    [0060] In one embodiment, the stent graft assembly can be reinforced with an intermediate layer of ePTFE graft, which includes separate rings or strips of ePTFE about 2 mm wide positioned at the proximal end of the stent graft, the center of the stent graft, and the distal end of the stent graft. The ePTFE graft interlayer may be sintered ePTFE material. Examples of members between layers are described in U.S. Patent Document No. 6,451,047, which is incorporated by reference in its entirety by reference to this application. The intermediate ePTFE graft layer may have the same node alignment as the internal and external ePTFE graft layers or may be different from them, for example, perpendicular or at a 45 ° angle.
    [0061] The drawings in the present document shown showing the various stents in an expanded configuration are flat portraits arranged of the stents following the formation of the pattern, for example, by laser machining a polymer tube or metal material. This is a possible expanded configuration shown for ease of reference. It should be appreciated that, depending on the size of the vessel in which the stents described in this document are inserted, the stent can be expanded to a diameter greater than the diameter depicted, which would slightly alter the shape and / or the ratio of elements of stent and / or connectors between each other (for example, aspects of the stent that are parallel to the longitudinal geometric axis of the stent can be oblique in larger expanded diameters). The indicated drawings showing the various stents in a cut-out configuration are seen from the top of the stent following its formation, for example, by laser machining a metal or polymer tube. In one embodiment, the stent architectures and standards described in this document are formed in a tube that has a diameter of about 4.8 mm. In one embodiment, the stent architectures and standards described in this document are formed in a tube that has a diameter of about 6.4 mm. Of course, these are non-limiting examples of pipe diameters, as a wide range of pipe diameters are contemplated in this document. In general, the tube diameter will be selected based on the target vessel diameter to which the stent is intended to be placed (for example, larger tube diameters will be selected for larger target vessels). The stent modality described in this document can have a longitudinal length from an end proximal to a distal end, indicated as l in the FIGURES, in the range of about 15 mm to about 70 mm, although shorter and longer lengths are also considered temples without limitation, depending on the particular stent application.
    [0062] Referring to FIGURES 1A to 1C, a first stent architecture 10 is shown, including a sequentially repeated pattern of stent cells 12 and 14 aligned along a series of circumferential geometric axes perpendicular to a geometric axis longitudinal L. Any number of circumferential geometric axes along which the stent cell pattern is arranged is possible, depending on several dimensional stent features including, for example, total stent length, stent cell length, length connector, etc. Stent cells 12 and 14 are formed by stent elements described in this document according to the similarity of their letter, the stent elements that are repeated along the circumferential geometric axes. According to one embodiment, the R-shaped stent elements are similar or identical to those described in U.S. No. 6,821,292, which is incorporated by reference in its entirety into this application.
    [0063] Starting from the top left side of FIGURE 1A, a series of repeating stent elements is shown along a first side 16 of stent cells 12 and 14, the stent elements including R shapes and shapes U, that is, R-shaped stent elements and U-shaped stent elements. Generally, R-shaped stent elements include a first straight portion s1, followed by a first curved radius portion r1, followed by by a second portion of curved radius r2, followed by a third portion of curved radius r3, followed by a fourth portion of curved radius r4, followed by a second straight portion s2. Generally, U-shaped stent elements include a curved radius portion r5. The stent element R1 is connected to the stent element R2, which is connected to the stent element U1, which is connected to the stent element R3, which is connected to the stent element R4, which is connected to the stent element U2, which is connected to the stent element R1. The stent elements R1, R2, R3, R4 have a similar shape, but are oriented differently from each other with respect to a circumferential geometric axis and / or a longitudinal geometric axis. The stent elements U1 and U2 face in opposite directions with respect to a circumferential geometric axis. The same series of repeating stent elements (arranged identically with respect to the circumferential geometric axis A1 and longitudinal geometric axis L) continues along a second side 18 of the stent cells 12 and 14, but is shifted so that the sequence begins with stent element R3 which is directly adjacent to R1 of the series along the first side 16. Thus, starting from the top of FIGURE 1A along the second side 18, the series of stent elements is R3, R4, U2 , R1, R2, U1, R3, etc.
    [0064] The first side 16 is connected to the second side 18 by means of connectors C1 and C2 in which each includes a curved radius portion r6. The stent element R1 on the first side 16 is connected to the stent element R3 on the second side via connector C1. In the embodiment shown in FIGURES 1A to 1C, connector C1 is attached to stent elements R1 and R3 around the second portion of radius r2 and is oriented to be convex in relation to stent cell 12 and concave in relation to the stent cell 14. The stent element R4 on the first side 16 is connected to the stent element R2 on the second side 18 by connector C2 also around the second portion of radius r2 of each stent element R4 and R2, the connector C2 oriented in the opposite way with respect to connector C1 so that connector C2 is also convex with respect to stent cell 12 and concave with respect to stent cell 14. In other embodiments, the connectors along a given circumferential geometric axis can only be C1 connectors or C2 connectors (for example, see FIGURE 2) so that all connectors are oriented in the same direction.
    [0065] Starting from the left side of FIGURE 1A and moving towards the right side of FIGURE 1A along the longitudinal geometric axis L, the stent cells 12 and 14 along the circumferential geometric axis A1 are connected to the stent 12 and 14 along circumferential geometric axis A3 through connectors C1 and C2. More specifically, adjacent stent cells 14 are connected by C2 on stent elements R4 and R2 and by C1 on stent elements R1 and R3 to thereby form a stent cell 12 between them. Consequently, the same stent cell pattern of circumferential geometric axes A1 and A3 is formed along a geometric axis A2 displaced by a stent cell in relation to it. It is also observed that the same displaced repetition pattern is observed along adjacent longitudinal geometric axes. In the embodiment shown in FIGURES 1A to 1C, the length of the stent cells 12 and 14 (that is, measured by a point on the longitudinal geometric axis L to a different point on the longitudinal geometric axis L) along circumferential geometric axes A1, A2 , A3, etc. it is the same along length 1 of stent 10. However, it is contemplated for other modalities that the length of stent cells 12 and / or 14 along a given circumferential geometric axis is greater or less than those of an axis adjacent circumferential geometric. For example, in one embodiment, the length of stent cells 12 and 14 is longer at the ends of the stent and shorter in the intermediate regions of the stent. Such a configuration provides a more rigid medium and softer ends to facilitate a certain desired expansion pattern. Likewise, although the height of stent cells 12 and 14 (that is, measured from a point on a circumferential geometric axis to a different point on the circumferential geometric axis) along circumferential geometric axes A1, A2, A3, etc. be the same, it is contemplated that the height of stent cells 12 and 14 would vary along a given circumferential geometric axis or would vary in relation to adjacent circumferential geometric axes.
    [0066] FIGURE 1B is a top view of stent 10. In one embodiment, stent 10 is produced from a metal or polymer tube that is laser machined to form the stent architecture. In one embodiment, the tube has a thickness of about 0.1905 mm (0.0075 inches) and a diameter of about 5 mm. In an embodiment in which stent 10 is covered with one or more graft layers, stent 10 can be expanded to a larger diameter to cover with the graft layer (s), it can be covered with the graft layer (s) in the cut diameter, or it can be corrugated to a smaller diameter to cover with the graft layer (s), following post-processing steps such as, for example, electropolishing. The foregoing modalities are equally applicable to each of the stent architectures described in this document.
    [0067] In the embodiment of FIGURES 1A to 1C, the width of the selected stent elements becomes narrow to promote uniform expansion of the stent. As discussed above, such uniform expansion is preferred, for example, for stents covered with graft material to prevent rupture or deformation of the graft material upon installation. In other embodiments, the thickness of selected stent elements is reduced instead of, or in conjunction with narrowing, the width of the stent. In the embodiment shown in FIGURES 1A to 1C, the width of the first straight portion s1 of each stent element R1-R4 of stent 10 tapers or becomes narrow towards the respective stent elements U1 and U2. In other embodiments, the first straight s1 portions of only selected stent elements R1-R4 taper or become narrow. In still other modalities, different portions of the R-shaped elements may have a wider or narrower width than other portions thereof.
    [0068] In FIGURE 1C, widths w1-w5 are shown at different locations in the support cells. The width w1 is in a section of stent element R3, the width w2 is in a section of stent element U2 (which, in the modality shown, has the same width in the corresponding section of stent element U1), the width w3 is in a stent element section R2, width w4 is in a connector section C1, and w5 is in a stent element section R1. In the modality shown, the widths in w1, w3, and w5 are the same, the width in w2 is less than the widths of w1, w3, and w5, and the width in w4 is less than the width in w2. The width of the straight portion s1 of the stent elements R1 through R4 becomes narrow and tapers from the first curved radius portion r1 of the same (for example, the width w5) to the stent elements U1-U2 (for example, the width w2) that connects the stent elements R1-R4. In one embodiment, which can be used in a vessel diameter of about 5 mm to about 10 mm (for example, an iliac artery), the widths of w1, w3 and w5 are in the range of about 0.127 mm (0 .0050 inch) to about 0.254 mm (0.0100 inch), for example, about 0.1905 mm (0.0075 inch); the width in w2 is in the range of about 0.1016 mm (0.0040 inches) to about 0.1778 mm (0.0070 inches), for example, about 0.1397 mm (0.0055 inches); and the width in w4 is in the range of about 0.0635 mm (0.0025 inch) to about 0.1397 mm (0.0055 inch), for example, about 0.0889 mm (0.0035 inch) . For smaller or larger vessels, the dimensions can therefore be smaller or larger.
    [0069] Also shown in FIGURE 1C is the distance D1 and D2 from stent cell 14, where D1 is measured from the radius center of the curved radius portion r3 of the stent element R3 to the radius center of the curved radius portion r5 of the stent element U2, and where D2 is measured from the radius center of the curved radius portion r5 of the stent element U1 to the radius center of the curved radius portion r1 of the stent element R4. In the modality shown, D1 is equal to D2, but in other modalities D1 can be greater or less than D2. In a modality the distances D1 and D2 are in the range of about 0.762 mm (0.030 inches) to about 1.524 mm (0.060 inches), for example, about 1.016 mm (0.040 inches). Stent architectures with similar repeated stent elements and / or connectors, as described in this document (for example, stents 20, 30, 40, 50), would have the same or similar dimensions to those described in connection with stent 10.
    [0070] Depending on the desired level of flexibility and folding capacity, the curved connectors C1 and C2 can be thinner (for example, more flexible) or thicker (for example, less flexible). Depending on the desired expansion characteristics, the cross section of the stent elements can be changed. For example, if the R-shaped stent elements and U-shaped stent elements have the same dimensions, the U-shaped stent elements will naturally be more rigid; therefore, to promote uniform expansion, U-shaped stent elements may be taller or thinner than R-shaped stent elements. However, a higher U-shaped stent element would induce a larger compressed profile, and therefore, in the embodiment shown, the U-shaped stent elements have a thinner width than the R-shaped stent elements.
    [0071] FIGURES 2A to 2B illustrate stent 20 which has the same repeated elements from stent R1 to R4 and U1-U2 to stent 10; however, stent 20 differs from stent 10 in at least the following ways. First, the connectors are oriented in a similar way along each circumferential geometric axis, where, along uneven numbered circumferential geometric axes A1, A3, etc. the connectors are connectors C2, and in which, along circumferential geometric axes of numbering par A2, A4, etc. the connectors are C1 connectors. In other embodiments, the connectors may be the same along one or more adjacent circumferential geometric axes. In one embodiment, the widths of the stent elements R1-R4 and U1-U2, and the connectors C1 and C2 for stent 20 can be the same as described above in connection with stent 10.
    [0072] Second, stent 20 includes receiving members 22 extending from each of the opposite ends of stent 20, with members 22 extending from each U2 end stent element of stent cells 12 The receiving members 22 include a post-portion 24 and an enlarged portion 26 at the end of the remote member 22 of the stent element U2. In one embodiment, the enlarged portion 26 is sized to receive a radiopaque element, for example, a radiopaque element that has a C shape that attaches to the enlarged portion 26. In other embodiments, the enlarged portion may include a dimensioned hole or aperture. to receive a radiopaque element therein, as shown in FIGURES 11A to 11B. In one embodiment, the width of the post portion 24 of the receiving members 22 is about 0.1397 mm (0.0055 inches), and the width of the enlarged member is about 0.0100. In one embodiment, the post-portion 24 has a cylindrical shape and the enlarged portion 26 has a spherical shape or other atraumatic shape to prevent injury to the insertion vessel. As shown in FIGURES 2A to 2B, the receiving members 22 are of a length so that the end of the same aligns circumferentially with the outermost end of the stent elements at each opposite end of the stent 20. Aligning the ex -most external ends of the stent elements and receiving members, in a modality that includes one or more graft layers, the graft layer (s) can be in the form of a tube without changing the ends of the ( s), with the receiving members supporting the tubular ends of the graft layer (s) by retracting and / or expanding the stent. It is noted that the receiving members of FIGURES 2A and 2B can be incorporated into any of the other stent architectures described in this document.
    [0073] FIGURE 2B is a top view of stent 20. In one embodiment, stent 20 is produced from a metal or polymer tube that is laser machined to form the stent architecture.
    [0074] FIGURES 3A to C illustrate stent 30 having the same repeated elements of stent R1-R4 and U1-U2 as stent 10; however, stent 30 differs from stent 10 in relation to the connectors between stent cells 12 and 14. Stent 30 includes straight connectors C3, which connect stent element R1 to stent element R3 and connect stent element R2 to the stent element R4 around the second portion of radius r2. In other embodiments, the C3 connector connects only the stent elements R1 and R3 or R2 and R4 to provide a more flexible architecture, for example, so that there are three C3 connectors along a given circumferential geometric axis instead of the six connectors C3 on stent 30. In one embodiment, the width of the C3 connectors is in the range of about 0.127 mm (0.0050 inches) to about 0.254 mm (0.0100 inches), for example, about 0.1905 mm ( 0.0075 inch). It should be appreciated that the widths and / or components of the C3 connectors could vary along one or more circumferential geometry axes and / or along one or more longitudinal geometry axes, depending on the desired characteristics. For example, the width can be increased for a more rigid stent and decreased for a more flexible stent.
    [0075] FIGURE 3B is a top view of stent 30. In one embodiment, stent 30 is produced from a metal or polymer tube that is laser machined to form the stent architecture.
    [0076] FIGURE 3C illustrates stent 30 in its collected configuration. Due to the inventive arrangement of stent elements R1-R4 and U1- U2, the various shapes and curves of the stent cells fit together in a coordinated manner, thus providing a very small profile and facilitating retraction (or in the case of a stent expandable balloon, crimp) of the stent to a retracted configuration. It is observed that the configuration collected from stents 10 and 20, although not shown in this document, seem very similar to the configuration collected from stent 30 in relation to stent elements R1-R4 and U1-U2.
    [0077] FIGURES 4A 4B illustrate stent 40 with the same repeated elements of stent R1-R4 and U1-U2 as stent 10; however, stent 40 uses connectors C1, C2 and C3. In particular, the stent cells along the two end circumferential geometric axes at both ends of the stent 40 are in the same configuration as the stent 20, and the stent cells along the circumferential geometric axes between them are connected by C3 connectors . FIGURE 4B is a top view of stent 40. In one embodiment, stent 40 is produced from a metal or polymer tube that is laser machined to form the stent architecture. FIGURE 4C is a top view of stent 42, which is the stent architecture of stent 40 with the addition of receiving members extending from each of the opposite ends of stent 40, as described above in connection with FIGURES 2A to 2B.
    [0078] FIGURE 5A illustrates stent 50, which is similar to stent 40, but instead of connectors C3 which are fixed around the second portion of radius r2 of stent elements R1-R4, they are fixed around the third portion of radius r3. In addition, stent 50 includes receiving members 22 extending from each of the opposite ends of stent 50, as described above in connection with FIGURES 2A to 2B. FIGURE 5B is a top view of stent 50. In one embodiment, stent 50 is produced from a metal or polymer tube that is laser machined to form the stent architecture. FIGURE 5C is a top view of stent 52, which is the stent stent architecture 50 without the receiving members extending from opposite ends.
    [0079] FIGURES 6A to 6D illustrates stent 60 with a stent architecture that has different stent elements than stents 10, 20, 30, 40 and 50 shown in FIGURES 1 to 5. That is, instead of elements R-shaped and U-shaped stent, stent 60 includes V-shaped stent elements v1-v4, indicated in the drawings as v1-v4, each of which includes a first leg portion parallel to the axis longitudinal geometric L, a peak portion, and a second leg portion angled in relation to the longitudinal geometric axis, and V-shaped stent elements V1-V2. Starting from the top left side of FIGURE 6A, a series of repetition of stent elements is shown along a first side 66 of stent cells 62 and 64. Stent elements v1, v2, v3, v4 have a similar shape, but they are oriented differently from each other with respect to a circumferential geometric axis and / or a longitudinal geometric axis. The stent elements V1 and V2 turn in opposite directions in relation to a circumferential geometric axis L. The same series of repetition of stent elements (arranged in the same way in relation to the circumferential geometric axis A1 and longitudinal geometric axis L) continues at along a second side 68 of stent cells 62 and 64, but is shifted so that the sequence starts with stent element v3 which is directly adjacent to v1 of the series along the first side 66. Thus, starting from the top of the FIGURE 6A along the second side 68, the series of stent elements is v3, v4, V2, v1, v2, V1, v3, etc. The first side 66 is connected to the second side 68 via connectors C3. The stent element v1 on the first side 66 is connected to the stent element v3 on the second side 68 in each case along the circumferential geometric axis A1 in which the stent elements v1 and v3 are adjacent to each other. Connectors C3 are attached to stent elements v1 and v3 around a peak portion of them to align with their first leg portion which is parallel to the longitudinal geometric axis L. On stent 60, connectors C3 have a width equal to the width of the first leg portion of v1 and v3. The side of the stent elements adjacent to the second side 68 (towards the middle of the stent 60) is connected to the second side 68 in the same way, that is, stent elements v1 and v3 are connected by connectors C3 in places where the peak portion of v1 is adjacent to the peak portion of v3. This pattern continues below the length of the stent 60.
    [0080] It is observed that the stent elements v2 and v4 are not connected to each other by a connector when their peak portions are adjacent to each other. In other embodiments, these peak portions are connected by a connector, for example, one of the connectors C1, C2 or C3. In yet other embodiments, instead of stent 60 which includes only C3 connectors, one or both of the C1 and C2 connectors can be used (see, for example, FIGURES 9A to 9C). In still other modalities, the connectors could connect V1 and V2 instead of the connection of v1 and v3 and / or v2 and v4 or in addition to it. For example, in one embodiment, a straight connector could connect V1 and V2 in places where the peak portions of them become distant from each other (that is, through the stent cell 62). It is also observed that, in the modality shown, the peak portions of the stent elements v1-v4 are longitudinally spaced at a distance D3 from the peak portions of V1 and V2, which, in a modality with a diameter of about 6 mm is in the range of about 0.254 mm (0.010 inch) to about 0.50 mm (0.020 inch), for example, about 0.381 mm (0.015 inch). In other embodiments, the peak portions are aligned circumferentially.
    [0081] FIGURE 6B is a top view of stent 60. In one embodiment, stent 60 is produced from a metal or polymer tube that is laser machined to form the stent architecture. In one embodiment, stent 60 has a diameter of about 6 mm and a thickness of about 0.2159 mm (0.0085 inches) after electropolishing. In an embodiment in which stent 60 is covered with one or more graft layers, stent 60 can be expanded to a larger diameter to cover with the graft layer (s), it can be covered with the graft layer (s) in the cut diameter, or it can be corrugated to a smaller diameter to cover with the graft layer (s), following the post-processing steps such as, for example, electropolishing. The foregoing modalities are equally applicable to each of the stent architectures described in this document.
    [0082] In the embodiment of FIGURES 6A to 6D, the width of selected portions of the stent elements v1-v4 is tapered to a narrow width so that the stent elements V1-V2 promote uniform expansion of the stent. As discussed above, such uniform expansion is preferred, for example, for stents covered with graft material to prevent rupture or deformation of the graft material upon installation. In other embodiments, the thickness of the selected stent elements is reduced rather than the tapered and narrow widths of them or in conjunction with it. In FIGURE 6C, widths w6 to w9 are shown at different locations in the support cells. Width w6 is at the beginning of the second leg portion of stent element v2, width w7 is along the length of the first leg portion of stent elements v1 and v2, width w8 is in a section of stent element V1 , and the w9 width is in a section of connector C3. In the mode shown, the widths of w6, w7, and w9 are the same, and the width of w8 is less than the widths of w6, w7, and w9. It is observed that the first leg portion and peak portions of stent elements v1-v4 have the same width along its length (i.e., w6, w7), but the second leg portion of each of the elements stent v1-v4 tapers from width w6 to width w8 along their length. In one embodiment, which can be used in a vessel diameter of about 5 mm to about 15 mm, the widths of w6, w7 and w9 are in the range of about 0.1778 mm (0.0070 inches) to the fence 0.3048 mm (0.0120 inch), for example, about 0.2413 mm (0.0095 inch), and the width in w8 is in the range of about 0.1016 mm (0.0040 inch) to about 0.2286 mm (0.0090 inch), for example, about 0.1651 mm (0.0065 inch). For smaller or larger vessels, the dimensions can therefore be smaller or larger.
    [0083] FIGURES 7A to 7C illustrate stent 70 with a stent architecture that includes V-shaped stent elements v1-v4, indicated in the drawings as v1-v4, each of which includes a first portion of leg parallel to the longitudinal geometric axis L, a peak portion, and a second leg portion angled in relation to the longitudinal geometric axis, and V-shaped stent elements V1-V2. Starting from the top left side of FIGURE 7A, a series of repetition of stent elements is shown along a first side 76 of stent cells 72 and 74. The stent elements v1, v2, v3, v4 have a similar shape, but they are oriented differently from each other with respect to a circumferential geometric axis and / or a longitudinal geometric axis. The stent elements V1 and V2 rotate in opposite directions in relation to a circumferential geometric axis L. The same series of repetition of stent elements (arranged identically in relation to the circumferential geometric axis A1 and longitudinal geometric axis L) continues along a second side 78 of the stent cells 72 and 74, but is shifted so that the sequence starts with stent element v3 which is directly adjacent to v1 of the series along the first side 76. Thus, starting from the top of FIGURE 7A along the second side 78, the series of stent elements is v3, v4, V2, v1, v2, V1, v3, etc. the first side 76 is connected to the second side 78 by means of connectors C3. The stent element v1 of the first side 76 is connected to the stent element v3 of the second side 78 in each case along the circumferential geometric axis A1 in which the stent elements v1 and v3 are adjacent to each other. Connectors C3 are attached to stent elements v1 and v3 around a peak portion of them to align with their first leg portion which is parallel to the longitudinal geometric axis L. On stent 70, connectors C3 have a width equal to the width of the first leg portion of v1 and v3. The side of stent elements adjacent to the second side 78 (towards the middle of the stent 70) is connected to the second side 78 in the same way, that is, stent elements v1 and v3 are connected by connectors C3 in places where the portion peak of v1 is adjacent to the peak portion of v3. This pattern continues below the length of the stent 70.
    [0084] It is observed that the stent elements v2 and v4 are not connected to each other by a connector when their peak portions are adjacent to each other. In other embodiments, these peak portions are connected by a connector. In yet other embodiments, instead of stent 70 which includes only C3 connectors, other types of connector can be used. In still other ways, the connectors could connect V1 and V2 instead of connecting v1 and v3 and / or v2 and v4 or in addition to them. For example, in one embodiment, a straight connector could connect V1 and V2 in locations where the peak portions of the connector become distant from each other (that is, through the stent cell 72). In one embodiment, the peaks connected by one or more of the C3 connectors can touch, so that the effective length of one or more of the C3 connectors is zero.
    [0085] FIGURE 7B is a top view of stent 70. FIGURE 7D is an isometric view of stent 70. In one embodiment, stent 70 is produced from a metal or polymer tube that is laser machined for form the stent architecture. In one embodiment, stent 70 has a diameter of about 6 mm and a thickness of about 0.2159 mm (0.0085 inch) post-electropolishing. In an embodiment in which stent 70 is covered with one or more graft layers, stent 70 can be expanded to a larger diameter to cover with the graft layer (s), it can be covered with the graft layer (s) in the cut diameter, or it can be corrugated to a smaller diameter to cover with the graft layer (s), following the post-processing steps such as, for example, electropolishing.
    [0086] In the embodiment of FIGURES 7A to C, the width of selected portions of stent elements v1-v4 is tapered to a narrow width so that stent elements V1-V2 promote uniform expansion of the stent. In other embodiments, the thickness of selected stent elements is reduced instead of tapering and narrowing their widths or in conjunction with them. In FIGURE 7C, widths w6 to w9 are shown at different locations in the support cells. Width w6 is at the beginning of the second stent element leg portion v2, width w7 is along the length of the first stent element leg portion v1 and v2, width w8 is at a stent element section V1 , and width w9 is in a connector section C3. In the mode shown, the widths of w6, w7, and w9 are the same, and the width of w8 is less than the widths of w6, w7, and w9. It is observed that the first leg portion and peak portions of stent elements v1-v4 have the same width along its length (i.e., w6, w7), but the second leg portion of each of the elements stent v1-v4 tapers from width w6 to width w8 along its length. In one embodiment, which can be used in a vessel diameter of about 5 mm to about 15 mm, the widths of w6, w7 and w9 are in the range of about 0.1778 mm (0.0070 inches) to the fence 0.3048 mm (0.0120 inch), for example, about 0.2413 mm (0.0095 inch), and the width in w8 is in the range of about 0.1016 mm (0.0040 inch) to about 0.2286 mm (0.0090 inch), for example, about 0.1651 mm (0.0065 inch). For smaller or larger vessels, the dimensions can therefore be smaller or larger.
    [0087] In FIGURE 7C, the peak portions of the stent elements v1-v4 are shown longitudinally spaced at a distance D3 from the peak portions of V1 and V2, which in a modality with a diameter of about 6 mm is in the range from about 0.127 mm (0.005 inch) to about 0.889 mm (0.035 inch), for example, about 0.4572 mm (0.018 inch). In other embodiments, the peak portions are aligned circumferentially. Also in FIGURE 7C, the peak portions of the stent elements v2 and v4 are shown longitudinally spaced, respectively, a distance D4 from the peak portions of the stent elements v3 and v1, which, in one embodiment in a diameter of about 6 mm, is in the range of about 0.127 mm (0.005 inch) to about 0.889 mm (0.035 inch), for example, about 0.3048 mm (0.012 inch). The D4 distance provides increased spacing for the unconnected peaks to allow additional space for expansion to better ensure that the unconnected peaks will not come into contact during delivery and / or installation.
    [0088] FIGURES 8A and 8B show stent 80 with a stent architecture formed by a series of zigzag rings formed from stent elements z1-z4 in the form of straight support members positioned at an angle to the longitudinal geometric axis L and connected together by peak portions p1-p4, where stent element z1 is connected to stent element z2 by peak portion p1, stent element z2 is connected to stent element z3 by peak portion p2, the stent element z3 is connected to the stent element z4 by the peak portion p3, and the stent element z4 is connected to the stent element z1 by the peak portion p4. Adjacent zigzag rings of repeated stent elements z1-z4 and p1-p4 are connected together by connectors C3 to form stent cells 84 and 86. It is observed that the stent cells have the same shape along a given axis circumferential geometric, and the stent cells along a circumferential geometric axis are different from those of an adjacent circumferential geometric axis. Thus, as shown in FIGURE 8A, stent cells 84 formed by connecting zigzag ring 81 to zigzag ring 82 are the same along circumferential geometric axis A1, but differ from stent cells 86 along axis circumferential geometric shape A2 formed by connecting the zigzag ring 82 to the zigzag ring 83. The different shapes of stent cells 84 and 86 are produced by displacing stent elements in the zigzag rings along an axis circumferential geometric and "inverting" the stent elements from one zigzag ring to the next. In this way, the zigzag ring 82 is the mirror image of the zigzag ring 81 and is shifted so that the peak portion p3 of the zigzag ring 81 is connected to the peak portion p1 of the zigzag ring 82, and the ring in zigzag 83 is the mirror image of zigzag ring 82 (that is, the same orientation as zigzag ring 81) and is shifted so that peak portion p2 of zigzag ring 82 is connected to peak portion p4 of the zigzag ring 83. This pattern is repeated below the length of stent 80.
    [0089] Note that a line drawn through connectors C3 along the longitudinal geometric axis L is slightly angled in relation to it as illustrated by path P1 and path P2. In one embodiment, the width of stent elements z1 and z2 tapers in one direction towards the peak portion p1, which has a relatively smaller width, while the width of stent elements z3 and z4 is constant over the length of the stents. same and is the same width as the peak portions p2, p3, and p4. In one embodiment, the width of the stent elements z3, z4 and peak portions p2, p3, and p4 are in the range of about 0.127 mm (0.0050 inches) to about 0.254 mm (0.0100 inches), for example example, about 0.1905 mm (0.0075 inch), and the width of the peak portion p1 is in the range of about 0.1016 mm (0.0040 inch) to about 0.1778 mm (0.0070 inches), for example, about 0.1397 mm (0.0055 inches). In one embodiment, the width of the connectors C3 is the same as the width of the peak portion p1. For smaller or larger vessels, the dimensions can therefore be smaller or larger.
    [0090] FIGURE 8B is a top view of stent 80. In one embodiment, stent 80 is produced from a metal or polymer tube that is laser machined to form the stent architecture.
    [0091] FIGURES 9A to 9C illustrates stent 90 with stent 60 stent architecture, but with connectors C1 and C2 instead of C3 connectors. As with stent 60, stent 90 includes V-shaped stent elements v1-v4, indicated in the drawings as v1-v4, each of which includes a first leg portion parallel to the longitudinal geometric axis L, a portion peak, and a second leg portion angled in relation to the longitudinal geometric axis, and V-shaped stent elements V1-V2. Starting from the top left side of FIGURE 9A, a series of repetition of stent elements is shown along a first side 95 of stent cells 92 and 94. Stent elements v1, v2, v3, v4 have a similar shape, but they are oriented differently from each other with respect to a circumferential geometric axis and / or a longitudinal geometric axis. The stent elements V1 and V2 face in opposite directions with respect to a circumferential geometric axis L. The same series of repetition of stent elements (arranged identically with respect to the circumferential geometric axis A1 and the longitudinal geometric axis L) continues along a second side 97 of the stent cells 92 and 94, but is shifted so that the sequence starts with stent element v3 that is directly adjacent to v1 of the series along the first side 96. Thus, starting from the top of FIGURE 9A along second side 97, the series of stent elements is v3, v4, V2, v1, v2, V1, v3, etc. the first side 95 is connected to the second side 97 by means of connectors C1. The repeating series of stent elements along a third side 99 is the same as that of the first side 95. The third side 99 is connected to the second side 97 by means of connectors C2.
    [0092] It is observed that the connectors are the same along the circumferential geometric axes A1 and A2 (either of the connectors C1 or C2) and the rows of alternative connectors along the length of the stent 90. The stent element v1 the first side 95 is connected to the stent element v3 of the second side 97 in each case along the circumferential geometric axis A1 in which the stent elements v1 and v3 are adjacent to each other. Connectors C1 are attached to stent elements v1 and v3 around a peak portion of them to align with the first leg portion of the same which is parallel to the longitudinal geometric axis L. The third side 99 is connected to the second side 97 in the same way, that is, the stent elements v1 and v3 are connected by connectors C2 in places where the peak portion of v1 is adjacent to the peak portion of v3. This pattern continues below the length of the stent 90. It is also observed that, in the modality shown, the peak portions of the stent elements v1-v4 are longitudinally spaced at a distance D3 from the peak portions of v1 and V2, which, in one embodiment is in the range of about 0.254 mm (0.010 inch) to about 0.50 mm (0.020 inch), for example, about 0.381 mm (0.015 inch-wide). In other embodiments, the peak portions are aligned circumferentially.
    [0093] FIGURE 9B is a top view of stent 90. In one embodiment, stent 90 is produced from a metal or polymer tube that is laser machined to form the stent architecture. In one embodiment, stent 90 has a diameter of about 6 mm and a thickness of about 0.2159 mm (0.0085 inch) post-electropolishing. In an embodiment in which stent 90 is covered with one or more graft layers, stent 90 can be expanded to a larger diameter to cover with the graft layer (s), it can be covered with the graft layer (s) in the cut diameter, or it can be corrugated to a smaller diameter to cover with the graft layer (s), following the post-processing steps such as, for example, electropolishing.
    [0094] In the embodiment of FIGURES 9A to 9C, as in the fashion of FIGURES 6A-D, the width of the selected portions of the stent elements v1-v4 is tapered to a narrow width so that the stent elements V1-V2 promote expansion stent uniform. In other embodiments, the thickness of selected stent elements is reduced instead of tapering and narrowing their widths or in conjunction with them. In FIGURE 9C, widths w6 to w9 are shown at different locations in the support cells. Width w6 is at the beginning of the second leg portion of stent element v2, width w7 is along the length of the first leg portion of stent elements v1 and v2, width w8 is in a section of stent element V1 , and width w9 is in a section of connector C1. In the modality shown, the widths of w6 and w7 are the same, the width of w8 is smaller than the widths of w6 and w7, and the width of w9 is smaller than the widths of w6, w7, and w8. It is observed that the first leg portion and peak portions of stent elements v1 to v4 have the same width along their length (i.e., w6, w7), but the second leg portion of each of the elements stent v1-v4 tapers from width w6 to width w8 along their length. In one embodiment, which can be used in a vessel diameter of about 5 mm to about 15 mm, the widths of w6 and w7 are in the range of about 0.1778 mm (0.0070 inches) to about 0 .3048 mm (0.0120 inch), for example, about 0.2413 mm (0.0095 inch), the width in w8 is in the range of about 0.1016 mm (0.0040 inch) to about 0 .2286 mm (0.0090 inch), for example, about 0.1665 mm (0.0065 inch), and the width in w9 is in the range of about 0.0508 mm (0.0020 inch) to about 0.1524 mm (0.0060 inch), for example, about 0.1016 mm (0.0040 inch). For smaller or larger vessels, dimensions can therefore be smaller or larger.
    [0095] FIGURES 10A and B show stent 100, which is a variation of stent 60, which has essentially the same stent architecture with the addition of zigzag ring rings 102 and 104 at the opposite proximal and distal ends. The zigzag rings are formed from stent elements 106, 107 in the form of straight support members positioned at an angle to the longitudinal geometric axis L and connected together by the peak portions 108 and 109. The zigzag ring 102 is connected to the cells of stent on stent element v3 at three locations along circumferential geometric axis A1, and the zigzag ring 104 is connected to stent cells on stent element v1 at three locations along circumferential geometric axis A2. In other embodiments, the zigzag rings 102 and 104 can be connected to other locations along the stent cells.
    [0096] FIGURE 10B is a top view of stent 100. In one embodiment, stent 100 is produced from a metal or polymer tube that is laser machined to form the stent architecture.
    [0097] FIGURES 11A-B illustrate stent 110 which has the same repeated elements of stent R1 to R4 and U1 to U2 as stent 30; however, stent 110 differs from stent 30 in relation to connectors. While stent 30 includes straight connectors C3, which connect stent element R1 to stent element R3 and connect stent element R2 to stent element R4 around the second portion of radius r2, stent 110 includes straight connectors C4 that connect stent element U1 to stent element U2 when stent elements U1 and U2 on adjacent sides / series, such as sides / series 112 and 114, turn towards each other. In another embodiment, straight connectors C4 connect stent element U1 to stent element U2 when stent elements U1 and U2 on adjacent sides / series, such as sides / series 112 and 114, become distant from each other . In yet another embodiment, the straight connectors C4 connect all of the stent elements U1 to all of the stent elements U2 on adjacent sides / series (that is, both those that face each other and those that face away from each other. other). In one embodiment, the width of the C4 connectors is in the range of about 0.127 mm (0.0050 inches) to about 0.254 mm (0.0100 inches), for example, about 0.1905 mm (0.0075 inches) . In one embodiment, the length of the C4 connectors is in the range of about 1.7 mm to about 2.1 mm, for example, about 1.9 mm. It should be appreciated that the widths and / or lengths of the C4 connectors could vary along one or more circumferential geometric axes and / or along one or more longitudinal geometric axes, depending on the desired characteristics. For example, the width can be increased for a more rigid stent and decreased for a more flexible stent. It should also be appreciated that the width of individual C4 connectors could vary over their length, for example, becoming narrow from one or both sides connecting the stent elements U1 and U2 towards the middle of the connector C4, or alternatively increasing the width of one or both sides that connect stent elements U1 and U2 towards the middle of connector C4.
    [0098] Stent 110 includes receiving members 122 that extend from each of the opposite ends of stent 110, with members 122 extending from each element of stent U2 (for example, as shown, six in total, three on each side). In one embodiment, members 122 extend from less than all of the stent elements U2 on one or both ends of stent 110. In one embodiment, members 122 preferably extend from one or more stent elements U1 on one or both stent ends 110. In one embodiment, members 122 extend from one or more of both stent elements U1 and U2 on one or both stent ends 110. Such alternative arrangements for the number and positioning of stent members reception 122 are also contemplated in relation to the re-ception members 22 of FIGURES 2A to 2B and other stent architectures described in the present document. The receiving members 122 include a post-portion 124 and an enlarged portion 126 at the end of the remote member 122 of the stent element U2. The enlarged portion 126 includes a hole or aperture 128 sized to receive a radiopaque element in the same form of gold, tantalum, platinum, tungsten, and / or other suitable radiopaque materials. In one embodiment, the width of the post portion 124 of the receiving members 122 is about 0.2413 mm (0.0095 inch), and the diameter of the hole or aperture 128 is about 0.0145. The receiving members 122 are of a length such that the end of them generally aligns circumferentially with the outermost end of the stent elements at each opposite end of the stent 110. Aligning the outermost ends of the stent elements and receiving members, in a modality that includes one or more graft layers, the graft layer (s) can be in the form of a tube without changing its ends, with the receiving members supporting the tubular ends of the graft layer (s) by retracting and / or expanding the stent. It is noted that the receiving members of FIGURES 11A and B can be incorporated into any of the other stent architectures described in this document.
    [0099] FIGURE 11B is a top view of stent 110. In one embodiment, stent 110 is produced from a metal or polymer tube that is laser machined to form the stent architecture.
    [00100] Although the invention has been described in terms of particular variations and illustrative FIGURES, those of ordinary skill in the art will recognize that the invention is not limited to the described variations or FIGURES. For example, in any of the described stent architectures, the width, length and / or thickness of the stent elements and / or connectors can be varied to enhance the desired performance. In addition, where the methods and steps described above indicate certain events that occur in a certain order, those of ordinary skill in the art will recognize that the ordering of certain steps can be modified and that such modifications are in accordance with the variations of the invention. In addition, certain steps can be carried out concurrently in a parallel process when possible, as well as carried out sequentially as described above. Therefore, to the extent that there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is envisaged that this patent will also cover those variations.
    权利要求:
    Claims (11)
    [0001]
    1. Intraluminal prosthesis, characterized by the fact that it comprises: a stent architecture comprising: a series of stent elements that are repeated along a circumferential geometric axis (A1, A2), the stent elements include: first to fourth V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3), each having a first leg portion, a second leg portion and a peak portion between the first leg portion and the second leg portion, relative positions of the first to the fourth V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) being different from one another, a first V-shaped stent element (v1 , v2, v3, v4, V1, V2, V3) that connects the second V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) and the third V-shaped stent element ( v1, v2, v3, v4, V1, V2, V3) such that the second leg portion of each of the second and third V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) is connected to the pr first V-shaped stent element (v1, v2, v3, v4, V1, V2, V3), and a second V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) that connects the first V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) and the fourth V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) such that the second leg portion of each of the first and fourth V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) is connected to the second V-shaped stent element (v1, v2, v3, v4, V1, V2, V3), where the first leg portion of the first V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) and the first leg portion of the second V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) are connected to each other and the first leg portion of the third V-shaped stent element (v1, v2, v3 , v4, V1, V2, V3) and the first leg portion of the fourth V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) are connected to each other, and the second leg portion of each of the first to fourth V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) becomes narrow in width towards the first or second stent element in V format (v1, v2, v3, v4, V1, V2, V3).
    [0002]
    2. Intraluminal prosthesis, according to claim 1, characterized by the fact that it still comprises one or more graft layers attached to the stent architecture.
    [0003]
    3. Intraluminal prosthesis, according to claim 2, characterized by the fact that one or more graft layers include an inner layer of ePTFE graft and an outer layer of ePTFE graft.
    [0004]
    4. Intraluminal prosthesis, according to claim 3, characterized by the fact that the inner layer of ePTFE graft and the outer layer of ePTFE graft are positioned on the stent architecture as extruded tubes of non-sintered ePTFE and in which the inner layer of the ePTFE graft and the outer layer of the ePTFE graft are sintered together through openings in the stent architecture.
    [0005]
    5. Intraluminal prosthesis, according to claim 1, characterized by the fact that the first leg portion of each of the V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) is parallel to a longitudinal geometric axis (L) of the prosthesis.
    [0006]
    6. Intraluminal prosthesis, according to claim 1, characterized by the fact that the stent architecture (60, 70, 80, 90, 100) comprises a plurality of series of stent elements, adjacent series of stent elements connected by a plurality of connectors (C1, C2, C3).
    [0007]
    7. Intraluminal prosthesis, according to claim 6, characterized by the fact that the plurality of connectors (C1, C2, C3) are straight and connect peak portions of selected elements of V-shaped stent (v1, v2, v3 , v4, V1, V2, V3) of adjacent series of stent elements.
    [0008]
    8. Intraluminal prosthesis, according to claim 7, characterized by the fact that the connectors (C3) have a width equal to the width of the first leg portion (v1, v3) of the V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3).
    [0009]
    9. Intraluminal prosthesis, according to claim 1, characterized by the fact that the peak portion of the first V-shaped stent element (v1, v2, v3, v4, V1, V2, V3) is spaced longitudinally distance from the peak portion of the second V-shaped stent element.
    [0010]
    10. Intraluminal prosthesis, according to claim 9, characterized by the fact that the peak portion of each of the first to fourth V-shaped stent elements (v1, v2, v3, v4, V1, V2, V3) it is longitudinally spaced at a distance from the peak portion (D3, D4) of its V-shaped stent element (v1, v2, v3, v4, V1, V2, V3).
    [0011]
    11. Intraluminal prosthesis, according to claim 9, characterized by the fact that the distance is in the range of about 0.127 mm (0.005 inches) to about 0.889 mm (0.035 inches).
    类似技术:
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    同族专利:
    公开号 | 公开日
    AU2013263411A1|2014-12-04|
    JP6220386B2|2017-10-25|
    KR20150008401A|2015-01-22|
    US20130304192A1|2013-11-14|
    CA2873440C|2020-06-02|
    CA3081285A1|2013-11-21|
    CN104302250B|2017-03-15|
    NZ701992A|2016-03-31|
    CN106667630B|2019-03-29|
    US9066825B2|2015-06-30|
    NZ716708A|2016-08-26|
    EP2849688A4|2015-11-04|
    KR20200060789A|2020-06-01|
    WO2013172938A1|2013-11-21|
    CN104302250A|2015-01-21|
    AU2013263411B2|2017-05-25|
    JP2015516263A|2015-06-11|
    KR102157676B1|2020-09-21|
    US20200170815A1|2020-06-04|
    CN106667630A|2017-05-17|
    BR112014028242A2|2017-06-27|
    US20150297376A1|2015-10-22|
    EP2849688A1|2015-03-25|
    CA2873440A1|2013-11-21|
    KR102116936B1|2020-06-01|
    US10588765B2|2020-03-17|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-02-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-04-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261646806P| true| 2012-05-14|2012-05-14|
    US61/646,806|2012-05-14|
    US201261678485P| true| 2012-08-01|2012-08-01|
    US61/678,485|2012-08-01|
    US201261708445P| true| 2012-10-01|2012-10-01|
    US61/708,445|2012-10-01|
    PCT/US2013/030598|WO2013172938A1|2012-05-14|2013-03-12|Uniformly expandable stent|
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