US20150057743A1 - Intravascular stent - Google Patents

Abstract

An expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. In one aspect, the stent includes a butterfly pattern to which connecting links are attached. In another aspect, the stent embodies a non-directional structure. One embodiment is a stent in which one or both ends are more flexible than the center portion. Also, the stent may have a non-uniform drug coating. Another embodiment relates to a stent having ends that are more radiopaque than the center portion.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This application is based upon U.S. Provisional Application No. 60/823,239.
BACKGROUND OF THE INVENTION
• The invention relates to vascular repair devices and, in particular, to an approach for designing intravascular stents in which the flexibility profile, the drug coating and/or the radiopacity are modified to meet specific design goals.
• Stents are generally tubular-shaped devices which function to hold open a segment of a blood vessel. They also are suitable for use to support and hold back a dissected arterial lining that can occlude the fluid passageway. That is, whether self-expanding or expandable using force, stents are delivered within vasculature in a radially compressed configuration and then implanted at an interventional site while assuming a radially expanded configuration. At present, there are numerous commercial stents being marketed throughout the world. For example, some known prior art stents have multiple cylindrical rings connected by one or more links. While some of these stents are flexible and have the appropriate radial rigidity needed to hold open a blood vessel, there typically is a tradeoff between flexibility and radial strength and the ability to be tightly compressed or crimped onto a catheter so that it does not move relatively to the catheter or dislodge prematurely prior to controlled implantation at an interventional site.
• Various conventional stents can include a plurality of rings connected by links. In certain stents, the rings include a plurality of peaks and valleys connected by bar arms. When these rings are positioned in phase relatively to one another, W-crests and Y-crests are formed at the points of connection between the links and rings. Once a stent embodying this structure is implanted at an interventional site, a significant amount of strain is placed upon the peaks and valleys. In fact, the link can become angulated or twisted upon stent expansion resulting in an overall twisted stent configuration. Such a twisted stent configuration can suffer from inadequate vessel wall apposition and thus, may not perform optimally in holding a vessel open. Further, the degree of twisting often cannot be predicted due to manufacturing and material variability which consequently limits the reliability of stent function.
• Other factors also contribute to the unpredictability of stent performance. That is, conventional stents embody a pattern of links and rings which can be characterized as directional in configuration. A typical stent can include a pattern of adjacently arranged rings which extend the length of a stent and includes a first end which differs from that of a second end of the stent. Due to this directional structure, such a stent must be placed upon a catheter in a particular direction so that when it is deployed and implanted within vasculature, the stent will be arranged as contemplated to achieve expected performance. Unfortunately, conventional stents embodying directional structure can be placed on a catheter incorrectly due to operator error, and it is difficult to either identify this error or to correct it during a surgical procedure.
• Conventional stents can also be typically designed to have a relatively uniform flexibility across the length of the stent. However, this uniform flexibility is often not optimal for moving the stent through curved portions of the body. Accordingly, what has been needed and heretofore unavailable is a stent that is particularly more flexible at one or both ends than the center portion of the stent for better movement through the body.
• Additionally, conventional stents tend to have a uniform drug coating. This can be problematic when, for example, the physician overlaps stents. Accordingly, what has been needed and heretofore unavailable is a stent that has greater drug coating on the center portion of the stent as compared to one or both ends of the stent. It can be particularly desirable to combine this non-uniform drug coating with a stent having superior flexibility at one or both ends, as described above.
• Further, conventional stents tend to be uniformly radiopaque. However, this uniformity can present problems when, for example, a physician overlaps stents and needs to better monitor the overlapped regions of the stent. Consequently, what has been needed and heretofore unavailable is a stent that has enhanced radiopaque properties at one or both ends of the stent, as compared to the center portion of the stent.
• Accordingly, what is needed is a stent including structure which provides desired flexibility without compromising radial strength and reduces unwanted stresses and twisting. Also, there is a need for a stent which addresses problems associated with directional stents. Moreover, there is a need for a stent which addresses problems associated with stent performance within the body. The present invention satisfies these and other needs.
SUMMARY OF THE INVENTION
• The present invention is directed to an intravascular stent including structure enhancing flexibility without compromising radial strength and minimizing twisting and inherent stresses. The present invention is also directed towards a stent incorporating a non-directional pattern of rings and links.
• In one aspect, the invention includes a flexible intravascular stent for use in a body lumen, comprising a plurality of cylindrical rings aligned along a common longitudinal axis and interconnected to form the stent, each cylindrical ring having a first delivery diameter and a second larger implanted diameter. Each cylindrical ring includes an open W or butterfly pattern to which one end of a link between adjacent rings is connected. Further, each ring includes a plurality of first peaks, second peaks, and third peaks, adjacent third peaks defining the butterfly pattern. Each of the peaks has a height and an apex, the first peaks being taller than the second peaks, and the second peaks being taller than the third peaks. Described in another way, each cylindrical ring has a plurality of first valleys, second valleys, and third valleys, adjacent third valleys forming the butterfly pattern. Moreover, each of the valleys has a depth and an apex, the first valleys being deeper than the second valleys, and the second valleys being deeper than the third valleys.
• At least one link attaches each cylindrical ring to an adjacent cylindrical ring. The links can include an undulation having a curved portion extending transverse to the stent longitudinal axis toward the second peak. Additionally, the curved portion of the undulating link can be longitudinally aligned with the second peak. Also, each undulating link can include an arm that is straight and parallel to the longitudinal axis of the stent and which is circumferentially offset from the second peak.
• The invention further contemplates peaks and valleys having a different radii and/or heights than other or adjacent peaks and valleys. In still another aspect of the invention, at least a portion of the links or cylindrical rings can have a variable thickness configuration and/or a variable width.
• Still another aspect of the invention is directed towards a non-directional stent. Such a stent is not required to be mounted onto a stent delivery system in a particular proximal-distal orientation. The configuration of peaks and valleys at a proximal end of the stent is generally a minor image of the configuration of peaks and valleys at the distal end. Both the proximal end and the distal end cylindrical rings may include various combinations of tall peaks, intermediate peaks, short peaks, deep valleys, intermediate valleys, and shallow valleys. Further, the non-directional stent can include the open W or butterfly pattern. In one embodiment, at least two of the open W or butterfly pattern configurations face in opposite directions from each other along the length of the stent. In addition, it is contemplated that not all of the curved portions of the undulating links face in the same direction in the non-directional stent. Because the proximal and distal ends of the stent are generally minor image configurations or a rotated minor image of the opposite end of the stent, and the configuration of peaks and valleys of the rings is reversed at one or more points along the length of the stent, the non-directional stent may be mounted onto a stent delivery system in either direction.
• The present invention is also directed to an intravascular stent with customized flexibility, drug coating and/or radiopacity properties. In one embodiment, the present invention is directed towards a stent with proximal and/or distal ends that are more flexible than the center portion of the stent. This design may also have a drug coating, in which the drug coating is greater at the center of the stent than at the ends. One or more ends of the stent may be more radiopaque than the center portion of the stent.
• Considering one aspect, the invention includes a stent in which one or both ends are more flexible than the center portion, and a drug coating that is greater on the center portion than at the ends. Consequently, a flexible intravascular stent for use in a body lumen has a plurality of cylindrical rings aligned along a common longitudinal axis. At least one link connects adjacent cylindrical rings. The stent has a first end portion, a center portion, and a second end portion, with at least one of the end portions being more flexible than the center portion. The stent has a drug coating, the drug coating having greater coverage on the center portion than on at least one of the end portions.
• This embodiment may have one or more of the following aspects. Both ends may be more flexible than the center portion. At least one connecting link in one or both of the end portions may be very flexible with, for example, a shape that increases flexibility, such as a shape with multiple turns. At least one or more cylindrical rings in at least one end portion comprises peaks of uniform extent. One or more cylindrical rings in at least one end portion may have members with a “U” or “Y” profile. At least one link in the center portion may have a “U” profile. At least one cylindrical ring in the center portion may have at least one member with a butterfly pattern.
• According to another aspect of the invention, a stent may have one end that is more flexible than the rest of the stent. This will typically be the distal end of the stent which, when flexing through a curve in the body, is the leading edge of the stent and after which the rest of the stent will follow. Such a stent has a plurality of cylindrical rings aligned along a common longitudinal axis. At least one link connects adjacent cylindrical rings. The stent has a first end portion, a center portion, and a second end portion. At least one of the end portions is more flexible than the center portion.
• According to another aspect of the invention, a stent has at least one end that is more radiopaque than the center portion. Such a stent has a plurality of cylindrical rings aligned along a common longitudinal axis. At least one link connects adjacent cylindrical rings. The stent has a first end portion, a center portion, and a second end portion. At least one of the end portions is more radiopaque than the center portion.
• This type of stent may have a design with greater surface area density at one or both of the end portions than at the center portion. Consequently, for a metal stent, an end portion that has the greater surface area density will be more radiopaque than the center portion.
• The present invention therefore provides the stent designer with options for customizing a stent design so as to meet design requirements for a given environment within the body and/or for particular patient requirements.
• Various features recited above may be employed individually, or in combination with other features. Further features and advantages of the present invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying exemplary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:
• FIG. 1 is a plan view of a portion of a flattened stent of one embodiment of the invention which illustrates a pattern of rings and links.
• FIG. 2A is a plan view of a portion of the stent ofFIG. 1 forming a radially compressed cylindrical configuration.
• FIG. 2B is a perspective view of a portion of the stent ofFIG. 2A.
• FIG. 3A is a plan view of a portion of the stent ofFIG. 1 in a flattened configuration and illustrating the rings and links in an expanded configuration.
• FIG. 3B is a perspective view of a portion of the stent ofFIG. 1 in a cylindrical configuration and illustrating the rings and links in an expanded configuration.
• FIG. 4 is an enlarged plan view of a portion of the stent ofFIG. 1.
• FIG. 5 is an enlarged plan view of a portion of an embodiment of a stent including straight links in an expanded configuration.
• FIG. 6 is an enlarged cutaway perspective view of a portion of an embodiment of a stent having struts with varying radial thickness.
• FIG. 7 is an enlarged plan view of a portion of the stent ofFIG. 1.
• FIG. 8 is a plan view of a portion of a flattened stent of another embodiment of the present invention;
• FIG. 9 is a plan view of one embodiment of a non-directional stent in a flattened configuration;
• FIG. 10 illustrates properties of a stent having end regions having greater flexibility than the center, and a center region that has more drug coating than the ends.
• FIG. 11 is a plan view of a portion of a flattened stent having the properties ofFIG. 10 and that illustrates a pattern of rings and links.
• FIG. 12 is a perspective view of the stent ofFIG. 11 as it appears deployed in a straight portion of the body.
• FIG. 13 is a perspective view of the stent ofFIG. 11 as it appears deployed in a curved section of the body.
• FIG. 14 illustrates properties of a stent having a single end that is more flexible than the rest of the stent.
• FIG. 15 illustrates properties of a stent having ends that are more radiopaque than the center portion of the stent.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring to the drawings, which are provided for purposes of illustration and by way of example but not limitation, the present invention is illustrated inFIGS. 1-9B.
• Turning now toFIG. 1, anexemplary stent30 of the present invention is shown in a flattened condition so that the pattern can be clearly viewed, even though the stent is in a cylindrical form in use, such as shown inFIGS. 2A-B. The stent is typically formed from a tubular member, however it can be formed from a flat sheet such as shown inFIG. 1 and rolled into a cylindrical configuration.
• As shown inFIGS. 1-3B,stent30 is made up of a plurality ofcylindrical rings40 which extend circumferentially around the stent. It is to be recognized that there may be fewer or more cylindrical rings than is shown in the illustrated drawings. The rings are aligned along a common longitudinal axis and interconnected bylinks54 to form the stent. Thelinks54 can be generally straight members (SeeFIG. 5) or can include one or more curves or turns as shown in the figures. Moreover, links with undulation can be configured at all locations or any selected locations along the stent. The stent has a delivery diameter42 (FIG. 2A), and expands to an implanted diameter44 (FIGS. 3A and 3B). The stent has aproximal end46 and adistal end48. Typically, since the stent is contemplated to be laser cut from a tube, there are no discreet parts.
• Referring specifically toFIG. 2B, each cylindrical ring includes a cylindricalouter wall surface52 which defines the outermost surface of the stent and a cylindricalinner wall surface53 which defines the innermost surface of the stent. Thelinks54 connect onecylindrical ring40 to an adjacentcylindrical ring40. To preventlinks54 from compromising the longitudinal flexibility of the stent, acurved portion56 is incorporated intolink54. Thiscurved portion56 is connected to one or more substantiallystraight portions58 wherein thestraight portions58 are substantially perpendicular to the longitudinal axis of the stent. Thus, as the stent is being delivered through a tortuous vessel, such as a coronary artery, thecurved portions56 andstraight portions58 of the undulating links will permit the stent to flex in the longitudinal direction which substantially enhances delivery of the stent to the target site. The number of bends and straight portions in a link can be increased or decreased from that shown to achieve different flexibility constructions. In one embodiment (not shown), it is contemplated that the links can comprise a plurality of curved portions andstraight portions58. With the straight portions being substantially perpendicular to the stent longitudinal axis, thelink54 acts much like a hinge at thecurved portion56 to provide flexibility in both crimped and expanded states. The number oflinks54 can be adjusted to vary the longitudinal flexibility in the crimped and expanded states of a stent.
• Thestent30 further can be described as having rings including a plurality of alternative peaks and valleys. The peaks and valleys can have similar or different sizes. In one embodiment, the rings can include one or more open W or butterfly patterns of struts to which links between adjacent rings are connected. Accordingly, the rings can include a plurality ofshort peaks60,tall peaks61,intermediate peaks62,shallow valleys90,deep valleys91, andintermediate valleys92. The peaks and valleys are formed from various length struts andapices112. In one embodiment, the struts includeshort struts66, long struts67, andintermediate struts68. The lengths of these struts can be varied to achieve a desired expansion diameter. As shown, each open W or butterfly pattern is defined by oneshort peak60, twoshort struts66, onelong strut67 and oneintermediate strut68. The struts can be either curved or straight depending upon a particular application. Also, as shown, each peak has a height, the tall peaks being taller than the intermediate peaks, and the intermediate peaks being taller than the short peaks. Additionally, each valley has a depth, the deep valleys being deeper than the intermediate valleys, and the intermediate valleys being deeper than the shallow valleys. In other embodiments, a greater range in the types of heights of peaks and/or a greater range in the types of depths of valleys may be included, as explained in further detail below with references toFIG. 5.
• Additionally, in one aspect, thestent30 can further include one or more Y patterns of struts. With reference toFIG. 2A, the Y pattern is defined by oneintermediate valley92, onelong strut67, and oneintermediate strut68.
• It is also contemplated that a stent of the present invention can further include at least one additional peak (not shown) having a different height than the short peak, the tall peak, and the intermediate peak. Also, the stent can further include at least one additional valley (not shown) having a different depth than the shallow valley, the intermediate valley, and the deep valley. For example, one embodiment may have four different height peaks and four different depth valleys. Moreover, the number of peaks and valleys can vary in number for each ring depending upon the application. Thus, for example, if the stent is to be implanted in a coronary artery, a lesser number of peaks and valleys are required than if the stent is implanted in a peripheral artery, which has a larger diameter than a coronary artery. Moreover, the number of peaks and valleys can be adjusted to vary the expansion diameter. Furthermore, the order or juxta-positioning of various sized peaks and valleys can be varied within a ring or from one ring to another, and the various peaks and valleys of adjacent rings can be aligned or offset from each other. It is to be understood that the definition of an open W pattern should not be limited but generally should imply the presence of a plurality of apexes including both one or more peaks and valleys of different heights and depths.
• In one particular embodiment, as illustrated inFIG. 3A, thepeaks60,61 and62 of eachring40 are oriented towards theproximal end46, and thevalleys90,91 and92 of eachring40 are oriented towards thedistal end48. These rings can be positioned in phase relatively to one another, meaning that the peaks of one ring are separated from the peaks of the adjacent ring by one ring width plus the spacing between the rings. Likewise, the valleys of one ring are separated from the valleys of the adjacent ring by one ring width plus the spacing between the rings.
• As stated, it may be desirable under certain circumstances to position the peaks so that they are out of phase (not shown), that is, the apexes of the peaks of one ring are circumferentially offset from the apexes of the peaks of an adjacent ring. Positioning the peaks, valleys, and links in this manner, provides a stent having desirable expansion capabilities, high radial strength, a high degree of flexibility, and sufficient wall coverage to support a vessel.
• As can be seen, for example, inFIGS. 1-2B,curved portion56,straight portions58 have been designed such that when crimped,intermediate peak62 would nest in the space just distal to thecurved portion56 andstraight portions58. This nesting allows thestent30 to be tightly crimped onto a delivery system to achieve a low crimped OD.
• Referring toFIGS. 2A-2B, the crimping or compressing process, circumferentially moves the undulatinglink54 along with itscurved portion56 closer to theintermediate peak62. Although the various stent struts, curved portions, links, and peaks and valleys may contact each other when the stent is crimped or compressed, it may be desirable to avoid the overlapping ofstruts66,67,68,apexes112, and links54.
• Referring now toFIG. 4, in one embodiment, anarm76 of thelink54 is attached to the apex112 of ashort peak60. The length of the arm may vary in different embodiments. Theother end78 of thelink54 is attached to the apex112 of anintermediate valley92. Notably, in this embodiment, combined height “H” of theshort peak60 and thearm76 is longer than the length of theintermediate peak62 when the stent is in both the compressed and expanded configurations. This allows the stent to be tightly compressed onto a catheter or other stent delivery device, and such structure can be employed to avoid overlapping between the undulatinglink54 and theintermediate peak62. In addition, the circumferential positioning of theintermediate peak62 andtall peaks61 can be varied to avoid theintermediate peak62 andtall peak61 from touchingarm78 oflink54.
• Due to the intricate patterns as disclosed inFIGS. 1-4, the rate of expansion of the various portions of the stent can vary. Accordingly, one aspect of the invention provides for different radii of curvature atvarious apexes112 so that the stent will expand evenly and uniformly. Referring more specifically now toFIG. 4,first radius71 which corresponds withtall peak61 may have a smaller radius of curvature than doessecond radius72 which corresponds withintermediate peak62. Generally, the longer the struts associated with a peak, the more easily that portion of the stent will expand, so that a smaller radius is associated with peaks having twolong struts67 Likewise, for peaks, such asshort peak60, which has struts66 that are shorter than thestruts67 oftall peak61, the apex112 may have agreater radius73 of curvature which will expand more easily in order to compensate for the stiffer bending moments created by the shorter struts66. In yet other embodiments, the radii of curvature of the various peaks and various valleys may be adjusted so that the different types of peaks and valleys expand at different tensions rather than expanding uniformly. In addition, the circumferential positioning of theintermediate peak62 andtall peaks61 can be varied to achieve uniform expansion.
• Theradii75 of theshallow valleys90 may also be varied to provide uniform stent expansion. Since a shallow valley formed by anintermediate strut68 and ashort strut66 can have a tendency to expand more slowly as the stent is expanded compared to a shallow valley formed by along strut67 and ashort strut66, a greater radius of a curvature may be incorporated into the shallow valley having theintermediate strut68. Thus,third radius75 of a firstshallow valley90A may be greater than thefourth radius75 of a second adjacentshallow valley90B. By varying the radii of curvature in the shallow valleys, the stent may expand more evenly and compensate for the varying rates of expansion of adjacent portions in a cylindrical ring.
• Typical stents known in the art undergo a lot of strain as they go from a compressed configuration to an expanded configuration. The strain produced by the expansion of a stent may cause the links to be angulated, resulting in a twisted stent. With reference toFIG. 5, the openW butterfly pattern94 is shown including twoshallow valleys90 connected with each other by ashort peak60. Thebutterfly pattern94 is designed to reduce the strain exerted on thepeaks60,61,62,valleys90,91,92, struts66,67,68, and links54 during expansion of thestent30. Moreover, thebutterfly pattern94 design facilitates achieving better crimping profiles since the short crest and long crest are positioned further away from the linear link, so during crimping the long crest and short crest have a longer distance to travel before hitting the linear link. It is especially beneficial when the stent is coated with a drug because it prevents or at least minimizes a possibility of coating damage. Moreover, the butterfly W crest increases the stent flexibility since bothvalleys90 are two separate components which can move to accommodate any bending when the crimped stent tracks through tortuousity.
• As previously stated, it is also a design feature that more orfewer links54 including curved portions be positioned between adjacent cylindrical rings40. As shown inFIG. 5,straight links84 in addition to undulatinglinks54 may be included to connect adjacent cylindrical rings. The straight links can be employed to provide stability and assist in stent length change, as an adjunct to the undulating links.
• Further, the straight links may be employed in various alternative approaches to provide more rigidity or flexibility in localized areas, such as greater flexibility at one or both ends and/or more rigidity in the center.
• In another aspect of the invention, as shown inFIG. 6, thestent30 is formed so that the various elements of the cylindrical rings40, including the long struts67, short struts66,intermediate struts68,various peaks60,61,62,various valleys90,91,92, and the undulatinglinks54, all can be formed so that each has a variable thickness along the stent length. For example, the undulatinglink54 may be thicker at thearm76 portion than at theextension78 portion of the link. Such structure can reduce deployment pressure while maintaining radial strength. Further, short struts66, long struts67, andintermediate struts68 may vary in thickness (radial thickness) along their length in order to create variable flexibility in the rings.
• Turning now toFIG. 7, in one contemplated embodiment, at least onecylindrical ring40 includes a repeating pattern of peaks and valleys. That is, for example, each pattern segment88 includes in sequence ashort peak60, ashallow valley90B, atall peak61A, adeep valley91, atall peak61B, anintermediate valley92, anintermediate peak62, and ashallow valley90A. The pattern segment may repeat itself as many times as necessary to provide a cylindrical ring of a desired expansion diameter. Also, adjacent cylindrical rings can be connected by one undulatinglink54 per pattern segment. For example, an undulating link may connect theshort peak60 of one cylindrical ring to theintermediate valley92 of an adjacent cylindrical ring. Further, there may be more than one undulatinglink54 or straight link84 (FIG. 5) per pattern segment. In other contemplated embodiments, thelinks54,84 may connect any of the various types ofpeaks60,61,62 andvalleys90,91,92 to any other or same type of peak or valley. Adjacent cylindrical rings can have the same repeating pattern or may have different repeating patterns from each other.
• Referring back now toFIG. 1, in one embodiment, the stent of the present invention includes a repeating pattern segment including four peaks and four valleys, and theshort peak60 of afirst ring40A is linked to and longitudinally aligned with theintermediate valley92 of an adjacentsecond ring40B. Theshort peak60 of thesecond ring40B is linked to and longitudinally aligned with theintermediate valley92 of an adjacentthird ring40C. In other words, the pattern of thesecond ring40B is rotated from the pattern of thefirst ring40A, and the pattern of thethird ring40C is further rotated from the pattern of thesecond ring40B. This rotational pattern results in the short peaks being longitudinally aligned every third cylindrical ring. Such a three ring longitudinal design may then be repeated as desired to add additional length to a stent. In at least one embodiment, the mostproximal end46A or most distal end46B of thestent30 may have arow40E of undulations having all the same length struts66, or67, or68.
• In another embodiment of astent30 of the present invention including open W or butterfly pattern of struts (SeeFIG. 8), substructures of thestent30 has been rearranged to provide a pattern which addresses potential flaring of ends46,48 of the stent. To accomplish this, long struts67 definingdeep valleys91 are connected to thelinks54 and thestruts67,68 defining theintermediate valley92 are positioned circumferentially adjacent thereto. In this way, stresses being released from the W or butterfly structure are transferred to a pair oflong struts67 rather than onelong strut67 and oneintermediate strut68.
• Further aspects pertaining to stents of the foregoing type are described in U.S. patent application Ser. No. 11/507,852, entitled “Intravascular Stent,” which names Diem Ta as the sole inventory and which is incorporated by reference herein in its entirety.
• Referring now toFIG. 9, yet another aspect of thestent30 is embodied in a non-directional stent. Notably, the non-directional stent may be mounted on a delivery device with either the proximal or distal end of the stent oriented towards the distal end of the delivery device with equal effectiveness. Thus, the non-directional stent may be mounted onto a stent delivery system (not shown), for example a balloon catheter, without it being positioned in a preferred proximal-distal orientation.FIG. 9 shows representative features of a portion of the non-directional stent in an as-manufactured (flat) configuration.
• In one embodiment of the non-directional stent, all ofapexes112 of thepeaks61,62 on the mostproximal end46cylindrical ring40 of thestent30 point distally and, all ofapexes112 of thepeaks61,62 on the mostdistal end48cylindrical ring40 point proximally. Similarly, all of thevalleys91,92 of the mostdistal end48ring40 face proximally, and all of the valleys of the mostproximal end46ring40 face distally. Stated another way, all of the peaks on theproximal end46ring40 point towards all of the peaks on thedistal end48ring40. Additionally, all of the valleys on theproximal end46ring40 point towards all of the valleys on thedistal end48ring40.
• In a further aspect, along the entire length of the stent, there may be approximately equal numbers ofpeaks61,62 havingapexes112 that point towards theproximal end46 of thestent30 and peaks having apexes that point towards thedistal end48 of the stent. There may also be along the entire length of the stent approximately equal numbers ofvalleys91,92 havingapexes112 that point towards theproximal end46 of thestent30 and valleys having apexes that point towards thedistal end48 of the stent.
• In still another aspect (not shown), it is contemplated that at least some of the intervening rings40 that are located between theproximal end46 and thedistal end48 may includepeaks61,62 havingapexes112 that point proximally, and some of the other rings may include peaks having apexes that point distally. Similarly, at least some of the intervening rings40 that are located between theproximal end46 and thedistal end48 may includevalleys91,92 havingapexes112 that point proximally, and some of the other rings may include valleys having apexes that point distally. The stent can additionally incorporate the W or butterfly pattern described above.
• Moreover, in each of therings40 of thestent30 there may be approximately equal number ofpeaks61,62 havingapexes112 that point towards theproximal end46 of the stent and peaks having apexes that point towards thedistal end48 of the stent. There may also be in each of the rings of the stent approximately equal number ofvalleys91,92 having apexes that point towards the proximal end of the stent and valleys having apexes that point towards the distal end of the stent.
• Furthermore, not all of theapexes112 of thepeaks61,62 on onering40 need to be aligned in the same direction. For example, some ofapexes112 of thepeaks61,62 on thering40 may point distally48, and some of the apexes of the peaks on thering40 may point proximally46. Also, some ofapexes112 of thevalleys91,92 on thering40 may point distally48, and some of the apexes of the valleys on thering40 may point proximally46. Additionally, the rings may be rotationally offset from each other or configured to be in-phase.
• In at least one additional embodiment, not all of thecurved portions56 of the undulatinglinks54 face in the same orientation in the non-directional stent. For example, as shown inFIG. 9, curved portion56A of undulating link54A faces in an opposite circumferential direction from curved portion56B of undulating link54B.
• Additionally, in the non-directional stent, theintermediate struts68 can be configured to remain adjacent to thecurved portions56 of the undulatinglinks54. Furthermore, thearm76 of the undulatinglink54 is typically connected to ashort peak60 in the various embodiments of the non-directional stent.
• Turning now to another aspect of the invention, a “customized” stent may include customized sections that best meet design requirements for desired stent properties. For example, different pattern designs have benefits specific to the particular pattern design. As a non-limiting illustration, the density of drug coating may be varied to meet particular design requirements. A higher coverage pattern may be useful for even drug distribution.
• As another illustration of a “customized” stent design, altering the flexibility of the stent in certain regions can improve deliverability. Stents have traditionally been designed with one pattern throughout the length. In accordance with the present invention, however, the flexibility of the pattern can be altered to meet competing design requirements, such as deliverability and drug distribution.
• Different patterns can be combined into one stent, or can be used at different portions of the stent, in order to best meet the customer requirements. Alternatively, the thickness and width of the stent strut can be varied (i.e. variable thickness/width) in order to achieve the desired custom design without changing the entire pattern. As a further alternative, different materials can be fused together in order to achieve the custom requirements.
• Considering one embodiment of a “customized” stent design,FIG. 10 depicts in block form a stent that is more flexible at the end portions than in the center, and that has greater drug coverage in the middle that at the ends. The greater flexibility at the ends improves deliverability when the stent is expanded, and the design minimizes edge injury.
• The greater number of links in the center portion minimizes “train-wrecking” and “clam-shell opening” effects of prior art stents when the stent is deployed around a curve. Such curved configurations are often found in the body.
• Alternative approaches to making the stent more flexible include making the struts thinner and/or narrower at the ends, as desired. Similarly, the dimensions of the link can be increased, such as by increasing the height and/or width of a “U” shaped link. Also, the number of links connecting the rings may be reduced in order to increase flexibility at desired areas of the stent. Increasing the number of turns in the links also improves flexibility.
• With respect to varying the drug coating, one approach is to design the areas of the stent that are to have greater drug coating with more surface area than other areas of the stent. The surface area in a given area may be increased by, for example, making the struts wider or thicker, or by otherwise increasing the surface area of the stent design, such as by increasing the number of links and/or struts in a given region of the stent. The higher drug coverage in the center portion offers a more even drug distribution by minimizing the high and low dose areas.
• Another approach with respect to varying the drug coating on the stent is to employ a method of coating the stent that will vary the amount of drug that is coated at a particular location on the stent. For example, if the stent is coated using a spray method, the spray apparatus may be programmed, as with a numerical control system, to vary the density of coating as a function of location on the stent. This may be done by, for example, varying the spray speed along the length of the stent as the stent is being spray coated. Other known methods in the art for applying a coating in a varied fashion may be employed.
• FIGS. 11-13 depict one non-limiting exemplary design of this type. This design has more flexible ends and greater drug distribution in the middle.FIG. 11 illustrates a stent having flexible distal and proximal ends,146 and148, respectively. Thedistal end146 includes three rings,140A-C. In ring140A, for example, there are “U”-shaped members201 that alternate with “M”-shaped members200. This pattern is repeated inrings140B and140C. The rings of thedistal end146 are interconnected withlinks203, which have more turns in the curved section.
• Theproximal end148 also hasrings140E-H. Ring140H, at the far distal end, includes a series of relatively “U”-shaped members, as shown. However, it is noted that the valleys160 and162 have a somewhat different shape. The valley160 has a sharper point, whereas the valley162 is more squared. These relatively sharp valleys160 alternate with the relatively squared valleys162, as shown inFIG. 11.Ring140G is more like the ring140A, in that it includes “M”-shaped and “U”-shaped members, which is also true of thering140F. Therings140F through140H are interconnected with links having more turns in the curved section.
• The design of thedistal end146 and the design of theproximal end148 makes the two ends somewhat more flexible than the center portion. The center portion includes rings such as140D and140E. The rings have an alternating pattern of links with an open W or butterfly pattern, and links with either straight (not shown) or undulating profile. The rings such as140D and140E are interconnected with undulating links.
• The net result of the design inFIG. 11 is that theend portions146 and148 are more flexible than the center portion. This can be advantageous in the body when, for example, the stent is deployed in a sharp curve within the body.
• FIG. 12 illustrates the stent ofFIG. 11 as it appears in a deployed state but without bending. The flexible distal and proximal ends are illustrated, as is the center portion, which is less flexible than the distal and proximal ends.
• FIG. 13 illustrates the stent ofFIG. 12 as it appears when bent. The center portion, while flexible, is less flexible than either of the ends. As previously noted, the greater flexibility at the ends improves deliverability when the stent is expanded. The design also minimizes edge injury within the vessel.
• Another aspect of the stent ofFIGS. 11-13 is the distribution of the drug coating on the stent. The drug coating (not shown) can be concentrated more in the center portion of the stent than on the distal or proximal ends. In the design ofFIG. 11, for example, the pattern of the struts and links is such that there is greater surface area in the center portion than on the distal or proximal ends. Consequently, the distribution of the drug coating in the center portion is naturally greater in this design than the distribution of the drug coating on the end portions.
• Turning now to a further alternative design,FIG. 14 depicts in block fashion a design in which a stent has a distal end that is more flexible than one or more other areas of the stent. In one embodiment, the distal end is more flexible than the rest of the stent. This is useful for deliverability, since once the distal end gets through a bend the rest of the stent will be more likely to follow through the bend.
• To achieve the result ofFIG. 15, the stent design ofFIG. 11 may be modified such that the pattern of the center portion120 is carried out to one of the distal or proximal ends. The remaining end may have the more flexible pattern as shown inFIG. 11. Thus, one end will thereby be more flexible. In this case it will be the distal end that is more flexible, although it must be noted that either pattern of end100 or102 may be employed to achieve this greater flexibility.
• FIG. 15 depicts in block-diagram fashion a stent with more radiopaque ends. This can simply be achieved by, for example, designing the end rings to have a greater density of metal than other portions of the stent. The greater density of metal may be achieved by increasing the width and/or thickness of struts, links and/or other portions of the stent. Any other method known in the art for increasing radiopaque properties may be employed to achieve a stent with one or both ends being more radiopaque than other areas of the stent.
• The stents ofFIGS. 10-15 may be used in the same manner as any current stent or drug eluting stent. For example, for arterial stents, the custom stent can be crimped onto a delivery system and delivered through the arteries to a target lesion in the heart. The stent can be deployed by inflating the balloon to the appropriate pressures.
• It is noted that this approach can be implemented with stents for various parts of the body, such as with coronary, peripheral, carotid, neuro, and other types of stents. The material can be of stainless steel, CoCr, NiTi, a polymeric stent material, any other material suitable for making stents and known in the art, or any future material developed for stents.
• Thestent30 of the present invention can be made in many ways. One method of making the stent is to cut a thin-walled tubular member, such as a stainless steel tubing to remove portions of the tubing in the desired pattern for the stent, leaving relatively untouched the portions of the metallic tubing which are to form the stent. The stent also can be made from other metal alloys such as tantalum, nickel-titanium, cobalt-chromium, titanium, shape memory and superelastic alloys, and the nobel metals such as gold or platinum. In accordance with the invention, it is preferred to cut the tubing in the desired pattern by means of a machine-controlled laser as is well known in the art.
• Other methods of forming the stent of the present invention can be used, such as using different types of lasers, chemical etching, electric discharge machining, laser cutting a flat sheet and rolling it into a cylinder, and the like, all of which are well known in the art at this time.
• The stent of the present invention also can be made from metal alloys other than stainless steel, such as shape memory alloys. Shape memory alloys are well known and include, but are not limited to, nickel-titanium and nickel-titanium-vanadium. Any of the shape memory alloys can be formed into a tube and laser cut in order to form the pattern of the stent of the present invention. As is well known, the shape memory alloys of the stent of the present invention can include the type having superelastic or thermoelastic martensitic transformation or display stress-induced martensite. These types of alloys are well known in the art and need not be further described here.
• The present invention stent is also ideally suited for drug delivery (i.e., delivery of a therapeutic agent) since it has a uniform surface area which ensures uniform distribution of drugs. Typically, a polymer containing the drug is coated onto the stent of the type disclosed in U.S. Pat. Nos. 6,824,559 and 6,783,793 which are incorporated herein by reference.
• It is contemplated that thestent30 of the present invention can be mounted on a stent delivery device or system, for example, a balloon catheter (not shown) similar to those known in the prior art. The stent delivery device includes a distal end for mounting of a stent thereon, and a proximal end configured to remain external to a patient's blood vessel. An example of a stent delivery system is disclosed in U.S. Pat. No. 6,629,994 entitled “INTRAVASCULAR STENT” filed Jun. 11, 2001, the entirety of which is incorporated herein by reference. The present invention, however, is not intended to be limited to delivery using the disclosed stent delivery systems but may be used with other stent delivery systems known in the art. The stent may be tightly compressed or crimped onto the balloon portion of the catheter and remains tightly crimped on the balloon during delivery through the patient's vascular system. When the balloon is inflated, the stent expands radially outwardly into contact with the body lumen, for example, a coronary artery. When the balloon portion of the catheter is deflated, the catheter system is withdrawn from the patient, and the stent remains implanted in the artery.
• Similarly, if the stent of the present invention is made from a self-expanding metal alloy, such as nickel-titanium or the like, the stent may be compressed onto a catheter, and a sheath (not shown) is placed over the stent to hold it in place until the stent is ready to be implanted in the patient. Such sheaths are well known in the art. Once the stent has been positioned at the intended location, the sheath is retracted and the stent self-expands into contact with the wall of the artery. Catheters for delivering self-expanding stents are well known in the art.
• It is to be recognized that the invention may be embodied in other forms without departure from the spirit and essential characteristics thereof. The embodiments described therefore are to be considered in all respects as illustrative and not restrictive. Although the present invention has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of the invention. Accordingly, the scope of the invention is intended to be defined only by reference to the appended claims.

Claims (14)

1-21. (canceled)

22. A flexible non-directional intravascular stent for use in a body lumen, comprising:

a plurality of cylindrical rings aligned along a common longitudinal axis, the stent having a proximal end and a distal end,

each cylindrical ring having a plurality of peaks and a plurality of valleys;

at least one cylindrical ring having an open W-structure facing in a first direction and at least one cylindrical ring having an open W-structure facing in a second direction different from the first direction;

at least one link attaching each cylindrical ring to an adjacent cylindrical ring, the link having a curved portion;

wherein the proximal and distal ends of the stent are mirror images.

23. The stent ofclaim 22, wherein along a length of the stent the apexes of some of the peaks are oriented towards the proximal end of the stent and the apexes of some of the peaks are oriented towards the distal end.

24. The stent ofclaim 22, wherein a most distal cylindrical ring includes apexes of at least some of the peaks pointing towards the proximal end of the stent and a most proximal cylindrical ring includes apexes of at least some of the peaks pointing towards the distal end of the stent.

25. The stent ofclaim 22, wherein a most distal cylindrical ring includes apexes of at least some of the peaks pointing towards the distal end of the stent and a most proximal cylindrical ring includes apexes of at least some of the peaks pointing towards the proximal end of the stent.

26. The stent ofclaim 22, wherein the most distal ring includes at least some of the valleys oriented towards the proximal end of the stent and the most proximal ring includes at least some of the valleys oriented towards the distal end of the stent.

27. The stent ofclaim 22, wherein a plurality of struts define the rings and the link, at least a portion of one strut having a variable thickness.

28. The stent ofclaim 22, wherein a plurality of struts define the rings and the link, at least a portion of one strut having a variable width.

29. A non-directional stent for use in a body lumen, comprising:

a plurality of cylindrical rings aligned along a common longitudinal axis and interconnected to form the stent;

at least one link attaching each cylindrical ring to an adjacent cylindrical ring, the link having a curved portion extending substantially transverse to the stent longitudinal axis;

wherein the curved transverse portion of at least one link facing in an opposite circumferential direction from the curved transverse portion of another link;

wherein a proximal end of the stent is a mirror image of a distal end of the stent.

30. The stent ofclaim 29, wherein the curved portions of the links facing in the opposite circumferential direction are on the same cylindrical ring.

31. The stent ofclaim 29, wherein the curved portions of the links facing in the opposite circumferential direction are on the adjacent cylindrical rings or different cylindrical rings.

32. The stent ofclaim 29, wherein a plurality of struts define the rings and the link, at least a portion of one strut having a variable thickness.

33. The stent ofclaim 29, wherein a plurality of struts define the rings and the link, at least a portion of one strut having a variable width.

34-56. (canceled)

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