Longitudinally flexible expandable stent
Abstract
A stent (10) comprising · a plurality of corrugated bands (16) and a plurality of connecting columns (44), each corrugated band comprising a plurality of straight and alternating straight straps (22), · adjacent corrugated bands (16 ) connected through a connecting column (44) by means of a plurality of connecting rods (20), · each connecting brace (20) connected at one end to a turn of a corrugated band (16) and connected at the other one turn end of another undulating band (16), · comprising the turns of a wavy band connected turns (58) that are connected to a connecting strap and unconnected turns (55) that are not connected to a connecting rod (20), · comprising at least one of the wavy bands (16) a repeating pattern of three strips (22) of the band and then extending five strips (22) of the band between connected turns (58) as the wavy band (16) is run, · comprising the connection columns (44) first connecting columns (44a) and second connecting columns (44b), the connecting rods (20a) of the first connecting columns (44a) being parallel to each other, the connecting rods (20b) of the second columns (44b) not being parallel ) of connection to the connecting rods (20) of the first columns (44a) of disconnection, characterized in that · the wavy bands (16) comprise first wavy bands (85) and second wavy bands (89), aligned with each other the turns of the first wavy bands (85) in a longitudinal direction of the stent, the turns of the first wavy bands (85) of the turns of the second wavy bands (89) displaced in a longitudinal direction of the stent.
Term
0.7 yearsto projected expiry
Projected expiry 12 June 2027, counted from filing; an application has no term until it is granted.
- Priority
- Filed
- Published
- Today
- Projected expiry
10 claims: 10 independent, 0 dependent
- 1REIVINDICACIONES 1. Un stent (10) que comprende • una pluralidad de bandas onduladas (16) y una pluralidad de columnas (44) de conexión, comprendiendo cada banda ondulada una pluralidad de tirantes rectos (22) de banda y vueltas 5 alternantes, • bandas onduladas adyacentes (16) conectadas a través de una columna (44) de conexión por medio de una pluralidad de tirantes (20) de conexión, • cada tirante (20) de conexión conectado en un extremo a una vuelta de una banda ondulada (16) y conectado en el otro extremo a una vuelta de otra banda ondulada (16), 10 • comprendiendo las vueltas de una banda ondulada vueltas conectadas (58) que se conectan a un tirante de conexión y vueltas no conectados (55) que no se conectan a un tirante (20) de conexión, • comprendiendo al menos una de las bandas onduladas (16) un patrón de repetición de tres tirantes (22) de banda y luego extendiéndose cinco tirantes (22) de banda entre vueltas conectadas (58) según se recorre la banda ondulada (16), 15 • comprendiendo las columnas (44) de conexión primeras columnas (44a) de conexión y segundas columnas (44b) de conexión, siendo paralelos entre sí los tirantes (20a) de conexión de las primeras columnas (44a) de conexión, siendo no paralelos los tirantes (20b) de conexión de las segundas columnas (44b) de conexión a los tirantes (20) de conexión de las primeras columnas (44a) de conexión, 20 caracterizado porque • las bandas onduladas (16) comprenden primeras bandas onduladas (85) y segundas bandas onduladas (89), alineadas entre sí las vueltas de las primeras bandas onduladas (85) en una dirección longitudinal del stent, desplazadas las vueltas de las primeras bandas onduladas (85) de las vueltas de las segundas bandas onduladas (89) en una dirección longitudinal del stent. 25 2. El stent de la reivindicación 1, en el que una pluralidad de las bandas onduladas (16) comprende un patrón de repetición de tres tirantes (22) de banda y luego cinco tirantes de banda que se extienden entre vueltas conectadas.
- 3El stent de la reivindicación 2, que comprende al menos una banda ondulada (16) que tiene ocho tirantes de banda que se extienden entre vueltas conectadas (58). 30 4. El stent de la reivindicación 3, en el que las primeras bandas onduladas (16) y las segundas bandas onduladas (16) se alternan a lo largo de la longitud del stent (10).
- 5El stent de la reivindicación 4, en el que una vuelta conectada (58) de una primera banda ondulada está alineada con una vuelta no conectada (55) de una primera banda ondulada adyacente (16) en una dirección longitudinal del stent. 35 6. El stent de la reivindicación 5, en el que las primeras columnas (44) de conexión y las segundas columnas (44) de conexión se alternan a lo largo de la longitud del stent.
- 7El stent de la reivindicación 1, en el que una anchura máxima de un tirante (22) de banda es menor que una anchura máxima de una vuelta.
- 8El stent de la reivindicación 1, en el que las vueltas de una banda ondulada comprenden picos proximales y 40 valles distales alternantes, estando alineados los picos proximales de una banda ondulada (16) en torno a una circunferencia común del stent (10).
- 9El stent de la reivindicación 8, en el que una banda ondulada dada comprende tres tirantes (22) de banda que se extienden entre un primer pico proximal conectado (64) que se conecta con un tirante (20) de conexión y un primer valle distal conectado (130) que se conecta con un tirante (20) de conexión, y comprende, además, 45 cinco tirantes (22) de banda que se extienden entre el primer valle distal conectado (130) y un segundo pico proximal conectado (64).
- 10El stent de la reivindicación 9, comprendiendo, además, la banda ondulada dada (16) tres tirantes (22) de banda que se extienden entre el segundo pico proximal conectado (64) y un segundo valle distal conectado (132), y cinco tirantes (22) de banda que se extienden entre el segundo valle distal conectado (132) y el primer 50 pico proximal conectado (64).
- 11El stent de la reivindicación 1, comprendiendo una banda ondulada dada dos vueltas no conectadas (55) entre una primera vuelta conectada (58) y una segunda vuelta conectada (58) y cuatro vueltas no conectadas (55) entre la segunda vuelta conectada (58) y una tercera vuelta conectada (58) según se recorre la banda ondulada (16).
- 12El stent de la reivindicación 11, en el que la banda ondulada dada (16) comprende, además, dos vueltas no conectadas (55) entre la tercera vuelta conectada (58) y una cuarta vuelta conectada (58) y cuatro vueltas no conectadas (55) entre la cuarta vuelta conectada (58) y la primera vuelta conectada (58) según se recorre la banda ondulada (16).
- 13El stent de la reivindicación 12, en el que los tirantes (20) de conexión que se conectan a la primera vuelta conectada (58) y a la tercera vuelta conectada (58) son paralelos entre sí y no paralelos a tirantes (20) de conexión que se conectan a la segunda vuelta conectada (58) y a la cuarta vuelta conectada (58).
Independent claims10
93 paragraphs, as filed
p00001Flexible expandable stent longitudinally
p00002Background of the invention
p00003Field of the Invention
p00004In some embodiments, the present invention is about implantable medical devices and their manufacture.
p00005Description of the related technique
p00006A stent is a medical device introduced into a body light and is well known in the art. Normally, a stent is implanted endoluminally into a blood vessel at the site of a stenosis or aneurysm, that is, by so-called "minimally invasive techniques" in which the stent is administered in a radially reduced configuration, optionally restricted in a configuration radially compressed by a sheath and / or a catheter, by means of a stent delivery system or "introducer" to the site where it is required. The introducer can enter the body from an access location outside the body, such as through the patient's skin, or through a "cutting" technique in which the inlet blood vessel is exposed by minor surgical means.
p00007Stents, grafts, stent grafts, vena cava filters, expandable structures, and similar implantable medical devices, collectively referred to herein as stents, are radially expandable stents that are normally intravascular implants capable of being implanted from transluminal shape and enlarged radially after being introduced percutaneously. Stents can be implanted in a variety of vessels or body lights such as in the vascular system, in the urinary tract, in the bile ducts, in the fallopian tubes, in coronary vessels, in secondary vessels, etc. Stents can be used to strengthen the body vessels and to prevent restenosis after an angioplasty in the vascular system. They can be self-expanding, expanded by an internal radial force, such as when mounted on a balloon, or a combination of self-expanding and expandable by balloon (hybrid expandable).
p00008The stents may be created by procedures that include cutting or stripping a design of a tubular supply, of a flat sheet that is cut or stripped and subsequently wound or of one or more threads.
p00009or interwoven braids.
p00010WO 01/01889 A describes a self-expanding tubular stent comprising a plurality of stent segments. Each stent segment is formed of an elongated tape having cut portions thereof to form a wave-like undulating pattern, whose opposite edges are fixed to each other, so that they form a generally cylindrical configuration. A disclosed method performs the formation of such an expandable tubular stent by providing in advance an elongated flat ribbon of biocompatible stent material and by selectively removing portions of such material to form an undulating pattern similar to a wave along the length of the tape. Then, the tape is wound in a generally cylindrical configuration and the opposite ends of the tape are fixed together to form a generally cylindrical and expandable section of spiral stent.
p00011Brief Summary of the Invention
p00012In some embodiments, the invention provides an expandable tubular stent as disclosed in the appended claims, which comprises a plurality of cylindrically shaped open cylindrical segments aligned on a common longitudinal axis to define a generally tubular stent body, each segment being defined by a member formed in a flexible undulating pattern of substantially parallel interconnected braces with pairs thereof having alternating interconnecting end portions to define the periphery of the expandable stent segment, and in which the connected end portions of braces paired in each segment, before the stent expands, they are placed substantially in front of connected end portions of paired braces in adjacent segments. The segments are interconnected by a plurality of interconnecting elements extending from some of the end portions connected in a segment to some of the end portions connected in adjacent segments, such that there are three or more sections between connection points from a side of each segment to its other side. In addition, the connecting elements extend angularly from the connecting end portion of a segment to the connecting end portion of an adjacent segment, not to an opposite connecting end portion in an adjacent segment, so that after expansion of the stent adjacent segments are displaced from each other around the periphery of the stent body to accommodate stent flexion within paired braces without interference between adjacent segments, instead of by means of flexible connectors articulated between segments. As a result, the connectors between the segments are not intended to flex or bend under normal use.
p00013In at least one embodiment, a stent comprises a plurality of corrugated bands and a plurality of connecting braces. Adjacent wavy bands are connected by at least one connecting rod. Each band
p00015corrugated comprises a plurality of straight straps of band and alternating turns. Each connecting rod is connected at one end to one turn of a wavy band and is connected at the other end to a turn of another wavy band. The turns of a corrugated band comprise connected turns that are connected to a connecting rod and unconnected turns that are not connected to a connection strap. At least one of the wavy bands comprises a repeating pattern of three band straps and then five band straps extending between connected turns as the wavy band is run.
p00016In at least one embodiment, a stent comprises a plurality of wavy bands and a plurality of connecting columns. Each wavy band comprises straight strips of band that extend between turns. The turns include proximal peaks and distal valleys. Each connection column comprises a plurality of connection struts, connecting each connection tie between a proximal peak of a wavy band and a distal valley of another wavy band. At least one undulating band comprises three band braces that extend between a first connected proximal peak that is connected to a connecting rod and a first connected distal valley that is connected to a connection strap. The corrugated band further comprises five band braces that extend between the first connected distal valley and a second connected proximal peak.
p00017In at least one embodiment, a stent comprises a plurality of wavy bands and a plurality of connecting columns. Each undulating band comprises a plurality of straight web straps and alternating turns. Adjacent wavy bands are connected through a connection column by means of a plurality of connection braces. Each connecting rod is connected at one end to one turn of a wavy band and is connected at the other end to a turn of another wavy band. The turns of a corrugated band comprise connected turns that are connected to a connecting rod and unconnected turns that are not connected to a connection strap. At least one of the wavy bands comprises two unconnected turns between a connected first turn and a connected second turn and four unconnected turns between the connected second turn and a connected third turn as the wavy band is run.
p00018In at least one embodiment, a stent comprises a plurality of corrugated bands that include a first corrugated band, a second corrugated band and a third corrugated band, and a plurality of connection braces that include a first connection brace, a second brace connection and a third connection tie. Each wavy band comprises alternating proximal peaks and valleys connected by straight band braces. Proximal peaks include connected proximal peaks that are connected to a connection tie and to unconnected proximal peaks that do not connect with a connection strap. The distal valleys include connected distal valleys that connect with a connection tie and unconnected distal valleys that do not connect with a connection tie. Each connecting rod is connected between a connected distal valley of a wavy band and a connected proximal peak of another wavy band. The first connecting rod is connected between a first connected distal valley of the first corrugated band and a portion of the second corrugated band. The second connecting rod is connected between the second wavy band and the third wavy band. The third connecting rod is connected to a second connected distal valley of the third corrugated band. The proximal peaks of the first wavy band are circumferentially displaced from the proximal peaks of the second wavy band. The proximal peaks of the first wavy band are aligned circumferentially with the proximal peaks of the third wavy band. The first connected distal valley is circumferentially aligned with a first unconnected distal valley of the third undulating band. The first distal valley not connected is circumferentially adjacent to the second distal valley connected.
p00019These and other embodiments that characterize the invention are pointed out with particularity in the claims appended hereto and which form part thereof. However, for a further understanding of the invention, its advantages and objectives obtained through its use, reference should be made to the drawings that form an additional part thereof and the attached descriptive material, in which embodiments and embodiments are illustrated and described. Additional of the invention.
p00020Brief description of the various views of the drawing (s)
p00021A detailed description of the invention will be described hereinafter, with specific reference to the drawings.
p00022Figure 1 shows a plan view of an example of an expanded stent configuration.
p00023Figure 2 shows the pattern of Figure 1 in an unexpanded tubular stent.
p00024Figure 3 shows an expanded stent of the stent shown in Figure 1.
p00025Figure 4 shows a flat view of an alternate stent without expanding.
p00026Figure 5 shows a flat pattern for an embodiment of a stent according to the invention.
p00027Figure 6 shows a three-dimensional isometric view of an embodiment of a stent.
p00028Figure 7 shows a flat pattern representation of the stent pattern of Figure 5 in an expansion state that is larger than that shown in Figure 5. 3
p00029Figure 8 shows a flat pattern representation of the stent pattern of Figure 5 in an expansion state that is greater than that shown in Figure 7.
p00030Figure 9 shows a flat pattern representation of the stent pattern of Figure 5 in an expansion state that is larger than that shown in Figure 8.
p00031Figure 10 shows a flat pattern representation of the stent pattern of Figure 5 in an expansion state that is greater than that shown in Figure 9. The expansion state shown can be considered to be an overexpansion state.
p00032Detailed description of the invention
p00033Although the present invention can be implemented in many different ways, specific embodiments of the invention are described in detail herein. The present description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
p00034For the purposes of this disclosure, similar reference numbers in the figures will refer to similar characteristics unless otherwise indicated.
p00035With reference to the Figures, Figures 1 and 2 show a fragmentary plan view of an unexpanded configuration of the stent and the tubular stent itself (not expanded), respectively. That is, the stent is shown for the sake of clarity in Figure 1 in plan and can be made of a flat pattern 10 (Figure 1) which is given a tubular shape when the pattern is wound, so that the edges are joined 12 and 14 (Figure 1). Then, the edges can be joined by welding or the like to provide a configuration such as that shown in Figure 2.
p00036In these Figures it can be seen that the configuration is composed of a plurality of adjacent segments generally indicated at 16, each of which is formed with a flexible undulating pattern of substantially parallel braces 18. The pairs of braces are interconnected in end portions alternating 19a and 19b. As can be seen in Figure 1, the interconnecting end portions 19b of a segment are positioned opposite the interconnecting end portions 19a of adjacent segments. As shown, the end portions are generally elliptical but can be rounded or square or pointed or similar. Any extreme portion configuration is acceptable with the proviso that it provides an undulating pattern, as shown. When the flat shape 10 is formed in an unexpanded tube as shown in Figure 2, the segments are cylindrical but the end portions 19 of adjacent segments remain in a mutually opposite position.
p00037Interconnection elements 20 extend from an end portion 19 of a segment 16 to another end portion 19 of another adjacent segment 16 but not to an end portion 19 placed in front of an adjacent segment 16. At least three braces are included between the points in each side of a segment 16 in which an interconnection element 20 makes contact with an end portion 19. This results in the interconnection elements 20 extending in an angular direction between segments around the periphery of the tubular stent. Preferably, the interconnection elements 20 have the same length but may vary from one segment to another. In addition, the diagonal direction can be reversed from one segment to another extending up in one case and down in another, although all the connecting elements between any pair of segments are substantially parallel. Figure 1, for example, shows that they extend down, from right to left. Upwards they would extend ascendingly from left to right in this configuration.
p00038As a result of this angular extension of the interconnecting elements 20 between adjacent segments and loops, after expansion of the stent as can be seen in Figure 3, the nearest adjacent extreme portions 19 between the segments 16 are offset from each other and are no longer facing each other, so as to minimize the possibility of adhesion or overlap between segments, that is, to pinch.
p00039The number of interconnection elements 20 may vary depending on the circumstances in any particular case. Three per segment are satisfactory for the configuration shown and normally at least three will be used.
p00040The alternative design shown in Figure 4 includes longer braces 18a in the two end segments 16a than in the intermediate segments 16. This allows the end segments (16a) to have less compressive strength than the intermediate segments (16). which provides a more progressive transition from the native vessel to the stent support structure. Otherwise, the configuration is the same as shown in Figure 1.
p00041In some embodiments, segments 16 can also be described as wavy bands. The interconnection elements 20 can also be described as connection braces. The end portions 19 can also be described as turns. The extreme portions 19a can also be described as proximal peaks. The extreme portions 19b can also be described as distal valleys.
p00042Figure 5 shows a flat pattern for an embodiment of a stent 10 having a proximal end 13, a distal end 15 and a plurality of wavy bands 16. Each wavy band 16 comprises a plurality of band braces 22 and a plurality of turns 28. The band braces 22 and the laps 28 alternate as the corrugated band 16 runs. Therefore, each band shoulder 22 has a first end 21 connected to a turn 28 and a second end 23 connected to another turn 28. Each turn 28 is connected between two band struts 22 that are adjacent to each other in a circumferential direction. of the stent.
p00043As shown in Figure 5, a strap 22 is straight along its length. In other examples that are not part of the invention, a band tie 22 may include a curvature in one or more directions. A corrugated band 16 may further comprise band braces 22 that are formed differently from each other. Other examples of possible configurations of the band braces 22 are disclosed in US Patent Application Publication No. 2002/0095208 and in US Patent Application No. 1 1/262692.
p00044The turns 28 of an undulating band 16 comprise proximal peaks 24 and alternating distal valleys 26. Each proximal peak 24 is generally convex with respect to the proximal end 13 and concave with respect to the distal end 15 of the stent 10. Each distal valley 26 is generally convex with respect to the distal end 15 and concave with respect to the proximal end 13 of the stent 10. Each turn 28 further comprises an inner side 41 and an outer side 43. The proximal peaks 24 are oriented with the outer side 43 closer to the proximal end 13 of the stent 10 than the inner side 41. The distal valleys 26 are oriented with the outer side 43 closer to the distal end 15 of the stent 10 than the inner side 41.
p00045A stent 10 can have any suitable number of wavy bands 16. In various embodiments, a wavy band 16 can have any suitable number of band braces 22 and any suitable number of turns 28.
p00046A wavy band 16 may cover any suitable distance along the length of the stent 10. In some embodiments, a stent 10 may comprise wavy bands 16 that span different distances. A method for increasing a lengthwise section of a corrugated band 16 is to increase the length of the band braces 22.
p00047In some embodiments, the proximal peaks 24 of a given wavy band 16 are aligned around a common circumference of the stent 10, and the distal valleys 26 are similarly aligned around another common circumference of the stent 10. Each circumference may be oriented orthogonally with respect to a longitudinal axis 11 of stent 10. When the turns 28 are aligned around a circumference, one end of the outer side 43 of each turn 28 can make contact with a common reference circumference. In some other embodiments, various peaks 24 may be displaced from other peaks 24 in a given undulating band 16, and various valleys 26 may be displaced from other valleys 26 in band 16.
p00048Each band brace 22 comprises a width, which can be measured in a normal direction to the length of the brace 22. In some embodiments, all braces 22 in a given wavy band 16 have the same width. In some embodiments, the widths of various braces 22 in a wavy band 16 may be different from each other. In some embodiments, the width of a brace 22 may change along the length of the brace 22. In some embodiments, the width of the straps 22 of a wavy band 16 may be different from the width of the straps 22 of another wavy band 16.
p00049Each turn 28 has a width, which can be measured in a normal direction next to the turn 28 (for example, normal to a tangential line). In some embodiments, the width of a turn 28 may be greater than the width of one or more stent straps 22 of the stent 10. In some embodiments, the width of a turn 28 may be less than the width of one or more stent straps 22 10. In some embodiments, the width of a turn 28 varies from one end of turn 28 to the other. For example, a turn 28 can be connected to a tie 22 at one end that has the same width as the tie 22. The width of turn 28 increases, and in some embodiments it reaches a maximum at an intermediate point of turn 28. Then , the width of the turn 28 is reduced to the width of another shoulder 22, which may be connected to the second end of the turn 28.
p00050The wavy bands 16 that are adjacent to each other along the length of the stent 10 are connected by at least one connecting rod 20. In some embodiments, a connecting rod 20 extends between the turns 28 of adjacent wavy bands 20. For example, a first end 25 of a connecting rod 20 can be connected to a distal valley 26 of a corrugated strip 16, and a second end 27 of the connecting rod 20 can be connected to a proximal peak 24 of an adjacent wavy band 16.
p00051The connecting rods 16 can be connected to any portion of a corrugated strip 16.
p00052In some embodiments, a connecting tie 20 is connected to a turn 28 as shown in Figure 5. In some examples that are not part of the invention, a connecting tie 20 can be connected to a band tie 22.
p00053In some embodiments, a connecting rod 20 is linear or straight along its length. In some embodiments, a connecting rod 20 may include a curvature along its length, and may also include multiple portions of curvature, for example a convex portion and a concave portion that may be connected to an inflection point.
p00054Each connecting tie 20 comprises a width, which can be measured in a direction normal to the length of the tie rod 20. In some embodiments, each connecting tie 20 has the same width. In some other embodiments, a connecting rod 20 may have a width that is different from that of another connecting rod 20. In some embodiments, the width of a tie rod 20 may change along the length of the tie rod.
p0005520.
p00056In US Patent Nos. 6261319 and 6478816, and in the published US Patent Application No. 20040243216, some additional examples of configurations that can be used for connecting rods 16 are disclosed.
p00057The connecting braces 20 comprise a first type of connecting rod 36 and a second type of connecting rod 38. A first connecting rod 36 extends in a first direction. The first connecting rod 36 is oriented at a first angle with respect to an axis 11 in the longitudinal direction of the stent. A second connecting rod 38 extends in a second direction that is different from the first direction, or is not parallel thereto. The second connecting rod 38 may be oriented at a second angle with respect to an axis 11 in the longitudinal direction of the stent. In some embodiments, the first angle and the second angle may have the same magnitude but different orientations. For example, a first connecting rod 36 can form an angle of 70 ° with an axis 11 in the longitudinal direction of the stent, while a second connecting rod 38 can form a negative angle of 70 ° with the axis 11 in the longitudinal direction of the stent In some embodiments, a first angle may comprise a mirror image of a second angle on the other side of a line parallel to axis 11 longitudinally of the stent. In some embodiments, the first type of tie rod 36 may have a different shape than the second type of tie rod 38.
p00058In some embodiments, an area of the stent 10 located between two adjacent wavy bands 16 can be considered a connecting column 44. Each connection column 44 comprises a plurality of connection braces 20. All connection braces 20 in a connection column 44 can be similar to each other. For example, each connecting rod 20 in a first connecting column 44a may comprise a first type of connecting rod 36. Each connecting tie 20 in a second connecting column 44b may comprise a second type of connecting tie 38.
p00059In some embodiments, the first connecting columns 44a and the second connecting columns 44b may alternate along the length of the stent 10. Therefore, each inner wavy band 16 may be positioned between a first connecting column 44a and a second column 44b connection. Accordingly, the connecting braces 20 that are connected to one side of a corrugated strip 16 may comprise first connecting braces 36, and the connecting braces 20 that are connected to the other side of the corrugated band 16 may comprise second braces 38 of connection.
p00060The turns 28 may comprise connected turns 58 or unconnected turns 55 depending on whether the turn 28 is connected to a connecting rod 50 or not. Similarly, the proximal peaks 26 may comprise connected proximal peaks 64 or unconnected proximal peaks 74, and the distal valleys 26 may comprise connected distal valleys 66 or unconnected distal valleys 76.
p00061A wavy band 16 may have more unconnected turns 55 than connected turns 58. In some embodiments, a wavy band 16 has three unconnected turns 55 for each connected turn 58. The 3: 1 ratio of unconnected turns 55 with respect to Connected turns 58 can also be applied to proximal peaks 24 and distal valleys 26.
p00062In some embodiments, as a wavy band 16 is run, there is a repeat pattern of x number of unconnected turns 55 between a connected turn 58 and the next connected turn 58, and then and number of turns not connected until the next connected turn 58, being y greater than x. For example, with reference to Figure 5, as a wavy band 16a runs from a connected first turn 58a to a connected second turn 58b, there are two unconnected turns 55. Therefore, x can be equal to two. As the undulating band 16a is run from the connected second round 58b to a connected third round 58c, there are four unconnected turns 55. Therefore, it can be equal to four. Then, the pattern will be repeated, with x = 2 unconnected turns 55 between the connected third round 58c and a connected fourth round 58d, etc. In some embodiments, y is a multiple of x, for example y = 2x.
p00063In some embodiments, starting from a connected turn 58, a corrugated band 16 may comprise three strips 22 of the band between the connected turn 58 and the next connected turn 58 in a first direction. The undulating band 16 may further comprise five strips 22 of the band between the connected turn 58 and the next connected turn 58 in a second direction. For example, with reference to Figure 5, a wavy band 16a includes three band braces 22 between a connected turn 58b and the next connected turn 58a
p00064in a first circumferential direction 71. The undulating band 16a also includes five strips 22 of the band between the connected turn 58b and the next connected turn 58c in a second circumferential direction 73.
p00065In some embodiments, as a wavy band 16 is run, there may be a repeat pattern of three band straps 22 between a connected lap 58 and the next connected lap 58, and then five band straps 22 until the next connected loop 58. For example, with reference to Figure 5, as a wavy band 16a is run from a connected first turn 58a to a connected second turn 58b, there are three band braces 22. As the undulating band 16a is run from the connected second round 58b to a connected third round 58c, there are five band braces 22. Then, the pattern will be repeated, with three strips 22 of the band between the connected third round 58c and a connected fourth round 58d, etc.
p00066In some embodiments, an extreme wavy band 16e which is located at the proximal end 13 or at the distal end 15 of the stent 10 comprises seven unconnected turns 55 between two connected turns 58. The end wavy band 16e may further comprise eight braces 22 of band between two connected turns 58.
p00067In some embodiments, the connecting braces 20 of adjacent connecting columns 44 are offset from each other in a circumferential direction of the stent. For example, a connecting rod 20a is displaced in a circumferential direction of the stent with respect to another connecting rod 20b located in an adjacent connecting column 44. Therefore, in some embodiments, a reference line 8 oriented parallel to the longitudinal axis 11 of the stent that intersects a connecting rod 20a will not intersect the other connecting rod 20b.
p00068The band braces 22 of an undulating band 16 may comprise first band braces 22a and second alternating band braces 22b. In some embodiments, all first band straps 22a are parallel to each other, as shown in the flat pattern of Figure 5. All second band straps 22b are parallel to each other and are not parallel to the first band straps 22a .
p00069The wavy bands 16 comprise a first type of wavy band 85 and a second type of wavy band
p0007089. All the first types of wavy band 85 are aligned with each other, so that similar portions of each band 85 are aligned along the length of the stent 10. All second types of wavy band 89 are aligned with each other, so that Similar portions of each band 89 are aligned along the length of stent 10. Each first type of wavy band 85 is offset with respect to each second type of wavy band 89, so that similar portions of the different types of bands 85, 89 are not aligned along the length of the stent.
p00071In some embodiments, the first type of wavy band 85 and the second type of wavy band 89 may alternate along the length of the stent 10. Therefore, the wavy bands 16 that are located adjacent to each other along the length of the Stent length 10 may be offset from each other in a circumferential direction of the stent. Each two wavy bands 16 may be aligned with each other in a circumferential direction of the stent. For example, a stent 10 may comprise a first wavy band 16a, a second wavy band 16b and a third wavy band 16c along its length. The first and third corrugated bands 16a, 16c comprise a first type of corrugated band 85, and the second corrugated band 16b comprises a second type of corrugated band 89. The first corrugated band 16a is offset with respect to the second corrugated band 16b in a circumferential stent direction. Therefore, a reference line 8 extending parallel to the longitudinal axis 11 of the stent will not intersect similar portions of the first wavy band 16a and the second wavy band 16b. As shown, the reference line 8 bisects a proximal peak 24 of the first wavy band 16a but does not bisect a proximal peak 24 of the second wavy band 16b. Similarly, the second wavy band 16b is offset with respect to the third wavy band 16c. The first wavy band 16a and the third wavy band 16c are aligned with each other in a circumferential direction of the stent. Therefore, the reference line 8 bisects a proximal peak 24 of both the first wavy band 16a and the third wavy band 16c.
p00072A wavy band 16 of a given type 85, 89 may have connected turns 58 that are aligned with unconnected turns 55 of another wavy band 16 of the same type 85, 89 along the length of the stent 10. For example, the first Wavy band 16a of Figure 5 includes a connected turn 58c that is longitudinally aligned with an unconnected turn 55a of the third wavy band 16c.
p00073A wavy band 16 of a given type 85, 89 may have connected turns 58 that are offset with respect to the connected turns 58 of the next adjacent wavy band 16 of the same type 85, 89 by a proximal peak or a distal valley. For example, the first wavy band 16a of Figure 5 includes a connected proximal peak 58c that is offset 6 with respect to a connected proximal peak 58e of the third wavy band 16c by a proximal peak 24. Similarly, the first undulating band 16a includes a connected distal valley 58d that is displaced with respect to a connected distal valley 58f of the third undulated band 16c by a distal valley 26. Therefore, in some embodiments, the connecting braces 20 of similar adjacent types of connecting columns 44a, 44b are offset from each other in the circumferential direction of the stent by an amount equal to the separation 6, 7 between adjacent proximal peaks or between adjacent distal valleys 26.
p00074With reference to Figures 1 and 5, in some embodiments, a stent comprises at least a first wavy band 101, a second wavy band 102, a third wavy band 103 and a fourth wavy band
p00075104. Each undulated band 101-104 comprises connected proximal peaks 64, unconnected proximal peaks 74, connected distal valleys 66 and unconnected distal valleys 76. Each undulated band 101-104 includes at least two unconnected proximal peaks 74 for each connected proximal peak, and at least two distal valleys not connected 76 for each connected distal valley 66.
p00076A first connecting rod 121 is connected between a first connected distal valley 130, located in the first corrugated band 101, and a connected proximal peak 64 of the second corrugated band 102. A second connecting rod 122 is connected between the second corrugated band. 102 and the third band on dulada 103. A third connecting rod 123 is connected between a second connected distal valley 132, located in the third corrugated band 103, and a connected proximal peak 64 of the fourth corrugated band 104.
p00077The first connected distal valley 130 is circumferentially aligned with a first unconnected distal valley 116 of the third undulated band 103. The first unconnected distal valley 116 is directly adjacent in a circumferential direction to the second connected distal valley 132.
p00078Each connected distal valley 66 of the first undulating band 101 is circumferentially aligned with an unconnected distal valley 76 of the third undulating band 103. In addition, each unconnected distal valley 76 of the third corrugated band 103 that is circumferentially aligned with a connected distal valley 66 of the first corrugated band 101 is offset relative to a connected distal valley 66 of the third corrugated band 103 in a circumferential direction by a distal valley (for example, separation 7 as shown in Figure 5).
p00079The third connecting rod 123 is oriented at a non-zero angle with respect to the longitudinal axis 11 of the stent and, therefore, comprises a component lc of circumferential length oriented in a circumferential direction of the stent. The circumferential length component lc extends from the second connected distal valley 132 in a circumferential direction to the first unconnected distal valley 116. Therefore, in some embodiments, the connecting braces 20 that are connected to connected distal valleys 66 of the third corrugated band 103 extend at an angle to the longitudinal axis 11 of the stent, the angle being oriented in the direction of a adjacent unconnected distal valley 76 (for example, distal valley 116) that is circumferentially aligned with a connected distal valley 66 (for example, distal valley 130) of the first undulating band 101.
p00080The second corrugated band 102 comprises three band braces 22 between the first connecting brace 121 and the second connecting brace 122. Therefore, there are three band braces 22 located between the connected distal valley 66 that is connected to the first connecting rod 121 and the connected proximal peak 64 that is connected to the second connection strap 122.
p00081Each connected distal valley 66 of the second undulating band 102 is circumferentially aligned with an unconnected distal valley 76 of the fourth undulating band 104. In addition, each unconnected distal valley 76 of the fourth undulating band 104 that is circumferentially aligned with a connected distal valley 66 of the second undulating band 102 is offset relative to a connected distal valley 66 of the fourth undulating band 104 in a circumferential direction by a distal valley (for example, separation 7 as shown in Figure 5).
p00082Figure 6 shows a substantially cylindrical three-dimensional stent 10 according to the flat pattern shown in Figure 5. The stent 10 is shown in a nominal state of expansion and its diameter could be further reduced, for example by being crimped on an administration catheter, or it could be expanded further.
p00083Figure 7 shows an example of a stent 10 in a state of expansion that is greater than that of Figure 5.
p00084Figure 8 shows an example of a stent 10 in a state of expansion that is greater than that of Figure 7.
p00085Figure 9 shows an example of a stent 10 in a state of expansion that is greater than that of Figure 8.
p00086Figure 10 shows an example of a stent 10 in a state of expansion that is greater than that of Figure 9. The amount of expansion shown can be described as a state of overexpansion. In general, a stent 10 that is actually used in a body vessel will undergo an expansion smaller than the amount shown in Figure 10. However, the pattern of the stent 10 shown is capable of providing a vessel support even in a substantially overextended state.
p00087As disclosed in the appended claims, the stent may be made of any suitable biocompatible material, including one or more polymers, one or more metals or combinations of polymer / s and metal / s. Examples of suitable materials include biodegradable materials that are also biocompatible. By biocompatible it is meant that a material will undergo a decay or decomposition into harmless compounds as part of a normal biological process. Suitable biodegradable materials include polylactic acid, polyglycolic acid (PGA), collagen or other connective proteins or natural materials, polycaprolactone, hyaluronic acid, adhesive proteins, copolymers of these materials as well as materials.
p00088compounds and combinations thereof and combinations of other biodegradable polymers. Other polymers that can be used include polyester and polycarbonate copolymers. Examples of suitable metals include, without limitation, stainless steel, titanium, tantalum, platinum, tungsten, gold and alloys of any of the aforementioned metals. Examples of suitable alloys include platinum-iridium alloys, cobalt-chromium alloys including Elgiloy and Phynox, MP35N alloy and nickel titanium alloys, for example, Nitinol.
p00089As disclosed in the appended claims, the stent may be made of shape memory materials such as superelastic nitinol or spring steel, or it may be made of materials that are plastically deformable. In the case of materials with shape memory, the stent can be provided with a memorized shape and then be deformed to a reduced diameter shape. The stent can be restored to its memorized form after being heated to a transition temperature and by removing any restrictions from it.
p00090As disclosed in the appended claims, the stent can be created by methods that include cutting or stripping a design from a tubular supply, from a flat sheet that is cut or stripped and subsequently rolled or from one or more strands or interwoven braids. Any other suitable technique that is known in the art or that is subsequently developed to manufacture the inventive stents disclosed herein can also be used.
p00091In some embodiments the stent, the administration system or another portion of the assembly may include one or more areas, bands, coatings, members, etc. which are detectable by imaging modalities such as X-rays, MRI, ultrasound, etc. In some embodiments at least a portion of the stent and / or the adjacent assembly is at least partially radiopaque.
p00092In some embodiments the at least a portion of the stent is configured to include one or more mechanisms for the administration of a therapeutic agent. Often, the agent will be in the form of a coating or other layer (or layers) of material placed on a surface region of the stent, which is adapted to be released at the site of stent implantation or in areas adjacent thereto.
p00093A therapeutic agent can be a drug or other pharmaceutical product such as non-genetic agents, genetic agents, cellular material, etc. Some examples of suitable non-genetic therapeutic agents include, without limitation: antithrombogenic agents such as heparin, heparin derivatives, vascular cell growth promoters, growth factor inhibitors, Paclitaxel, etc. Some other examples of therapeutic agents include everolimus and sirolimus, their analogues and conjugates. When an agent includes a genetic therapeutic agent, such genetic agent may include, without limitation: DNA, RNA and their derivatives and / or respective components; hedgehog proteins, etc. When a therapeutic agent includes cellular material, the cellular material may include, without limitation: cells of human origin and / or non-human origin, as well as their respective components and / or derivatives thereof. When the therapeutic agent includes a polymeric agent, the polymeric agent may be a polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS), polyethylene oxide, silicone rubber and / or any other suitable substrate.
p00094The previous disclosure is intended to be illustrative and not exhaustive. The present description will suggest many variations and alternatives for a person with a normal level of mastery of the technique. The various elements shown in the individual figures and described above can be combined or modified for a combination as desired. It is intended that all of these alternatives and variations be included within the scope of the claims in which the expression "comprising" means "including, but not limited to the same."
193 members in 15 offices
Priority claims3
| Document | Office | Kind | Date |
|---|---|---|---|
| 519552 | United States of America | – | |
| 51955206 | United States of America | A | |
| 2007013714 | United States of America | W |
Members193
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| WO9626689A1 | World Intellectual Property Organization (WIPO) | A1 | |
| EP0758216A1 | European Patent Office (EPO) | A1 | |
| JPH11505441A | Japan | A | |
| CA2316286A1 | Canada | A1 | |
| CA2531876A1 | Canada | A1 | |
| WO0030563A1 | World Intellectual Property Organization (WIPO) | A1 | |
| WO0030563B1 | World Intellectual Property Organization (WIPO) | B1 | |
| EP1049421A1 | European Patent Office (EPO) | A1 | |
| EP1163889A2 | European Patent Office (EPO) | A2 | |
| US2001056298A1 | United States of America | A1 | |
| US2002007212A1 | United States of America | A1 | |
| US6348065B1 | United States of America | B1 | |
| US2002055770A1 | United States of America | A1 | |
| EP0758216B1 | European Patent Office (EPO) | B1 | |
| AT220308T | Austria | T | |
| ATE220308T1 | Austria | T1 | |
| US2002095208A1 | United States of America | A1 | |
| CA2397373A1 | Canada | A1 | |
| CA2643556A1 | Canada | A1 | |
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| US2002177893A1 | United States of America | A1 | |
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| US2003083736A1 | United States of America | A1 | |
| EP1163889A3 | European Patent Office (EPO) | A3 | |
| EP1318765A2 | European Patent Office (EPO) | A2 | |
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| US2004181276A1 | United States of America | A1 | |
| EP1463461A1 | European Patent Office (EPO) | A1 | |
| CN1545400A | China | A | |
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| EP1719479A2 | European Patent Office (EPO) | A2 | |
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| EP1477136B1 | European Patent Office (EPO) | B1 | |
| EP1852089A2 | European Patent Office (EPO) | A2 | |
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| ATE376401T1 | Austria | T1 | |
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| EP1318765B1 | European Patent Office (EPO) | B1 | |
| DE69937415T2 | Germany | T2 | |
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| DE60132603D1 | Germany | D1 | |
| US2008065195A1 | United States of America | A1 | |
| CA2661339A1 | Canada | A1 | |
| WO2008033174A2 | World Intellectual Property Organization (WIPO) | A2 |
Numbers
- Publication
- 2390982
- Application
- 7809466
Titles2
- Spanish
- Stent expansible flexible longitudinalmente
- English
- Flexible expandable stent longitudinally
Classification
- CPC, 6
- A61F2/91
- A61F2/915
- A61F2002/91525
- A61F2002/91533
- A61F2002/91558
- A61F2230/0054
- IPC, 1
- A61F2 90