RELATED APPLICATIONSThis application is a continuation of application Ser. No. 09/516,753, filed Mar. 1, 2000.[0001]
FIELD OF THE INVENTIONThe present invention relates generally to stents, which are endoprostheses implanted into vessels within the body, such as blood vessels, to support and hold open the vessels, or to secure and support other endoprostheses in the vessels. In particular, the present invention relates to a stent which is longitudinally flexible before after expansion.[0002]
BACKGROUND OF THE INVENTIONVarious stents are known in the art. Typically stents are generally tubular in shape, and are expandable from a relatively small, unexpanded diameter to a larger, expanded diameter. For implantation, the stent is typically mounted on the end of a catheter, with the stent being held on the catheter at its relatively small, unexpanded diameter. By the catheter, the unexpanded stent is directed through the lumen to the intended implantation site. Once the stent is at the intended implantation site, it is expanded, typically either by an internal force, for example by inflating a balloon on the inside of the stent, or by allowing the stent to self-expand, for example by removing a sleeve from around a self-expanding stent, allowing the stent to expand outwardly. In either case, the expanded stent resists the tendency of the vessel to narrow, thereby maintaining the vessel's patency.[0003]
U.S. Pat. No. 5,733,303 to Israel et al. (“'303”), which is expressly incorporated by reference, shows a unique stent formed of a tube having a patterned shape which has first and second meander patterns having axes extending in first and second directions. The second meander patterns are intertwined with the first meander patterns to form flexible cells. Stents such as this one are very flexible in their unexpanded state such that they can be tracked easily down tortuous lumens. Upon expansion, these stents provide excellent radial support, stability, and coverage of the vessel wall. These stents are also conformable, in that they adapt to the shape of the vessel wall during implantation.[0004]
One feature of stents with a cellular mesh design such as this one, however, is that they have limited longitudinal flexibility after expansion, which may be a disadvantage in particular applications. This limited longitudinal flexibility may cause stress points at the end of the stent and along the length of the stent. Conventional mesh stents like that shown in U.S. Pat. No. 4,733,665 may simply lack longitudinal flexibility, which is illustrated by FIG. 1, a schematic diagram of a[0005]conventional stent202 in acurved vessel204.
To implant a stent, it maybe delivered to a desired site by a balloon catheter when the stent is in an unexpanded state. The balloon catheter is then inflated to expand the stent, affixing the stent into place. Due to the high inflation pressures of the balloon—up to 20 atm—the balloon causes the[0006]curved vessel204 and even a longitudinally flexible stent to straighten when it is inflated. If the stent, because of the configuration of its mesh is or becomes relatively rigid after expansion, then the stent remains or tends to remain in the same or substantially the same shape after deflation of the balloon. However, the artery attempts to return to its natural curve (indicated by dashed lines)in FIG. 1 with reference to a conventional mesh stent. The mismatch between the natural curve of the artery and the straightened section of the artery with a stent may cause points ofstress concentration206 at the ends of the stent and stress along the entire stent length. The coronary vasculature can impose additional stress on stents because the coronary vasculature moves relatively significant amounts with each heartbeat. For illustration purposes, the difference between the curve of the vessel and the straightened stent has been exaggerated in FIG. 1.
U.S. Pat. No. 5,807,404 to Richter, which is expressly incorporated by reference, shows another stent which is especially suited for implantation into curved arterial portions or ostial regions. This stent can include sections adjacent the end of the stent with greater bending flexibility than the remaining axial length of the stent. While this modification at the end of the stent alleviates the stress at the end points, it does not eliminate the stress along the entire length of the stent.[0007]
Various stents are known that retain longitudinal flexibility after expansion. For example, U.S. Pat. Nos. 4,886,062 and 5,133,732 to Wiktor (“the Wiktor '062 and '732 patents”) show various stents formed of wire wherein the wire is initially formed into a band of zig-zags forming a serpentine pattern, and then the zig-zag band is coiled into a helical stent. The stents are expanded by an internal force, for example by inflating a balloon.[0008]
The coiled zig-zag stents that are illustrated in FIGS. 1 through 6 of the Wiktor '062 and '732 patents are longitudinally flexible both in the expanded and unexpanded condition such that they can be tracked easily down tortuous lumens and such that they conform relatively closely to the compliance of the vessel after deployment. While these stents are flexible, they also have relatively unstable support after expansion. Furthermore, these stents leave large portions of the vessel wall uncovered, allowing tissue and plaque prolapse into the lumen of the vessel.[0009]
Thus, it is desired to have a stent which exhibits longitudinal flexibility before expansion such that it can easily be tracked down tortuous lumens and longitudinal flexibility after expansion such that it can comply with the vessel's natural flexibility and curvature while still providing continuous, stable coverage of a vessel wall that will minimize tissue sag into the lumen.[0010]
OBJECTS AND SUMMARY OF THE INVENTIONAccordingly, an object of the invention is to provide a stent that is longitudinally flexible before expansion so that it can easily be tracked down tortuous vessels and remains longitudinally flexible after expansion such that it will substantially eliminate any stress points by complying with the vessel's flexibility and assuming the natural curve of the vessel.[0011]
Another object of the present invention is to provide a stent that is longitudinally flexible after delivery such that it flexes during the cycles of the heartbeat to reduce cyclic stress at the ends of the stent and along the stent.[0012]
Another object of the present invention is to provide a stent with a closed cell pattern such that it provides good coverage and support to a vessel wall after expansion.[0013]
Other advantages of the present invention will be apparent to those skilled in the art.[0014]
In accordance with these objects, the stent of the present invention is formed to be a tube having a patterned shape which has first and second meander patterns having axes extending in first and second direction wherein the second meander patterns are intertwined with the first meander patterns.[0015]
In accordance with one embodiment of the invention, the intertwined meander patterns form cells which have three points at which the first and second meander patterns meet each other, and which in this sense could be called triangular cells. These three cornered or triangular cells are flexible about the longitudinal axis of the stent after expansion. These triangular cells provide comparable scaffolding and radial strength to that of cells formed by intertwined meander patterns which have four points at which the first and second patterns meet each other, and which in this sense could be called square cells.[0016]
In another embodiment of the invention, bands of cells are provided along the length of a stent. The bands of cells alternate between cells adapted predominantly to enhance radial support with cells that are adapted predominantly to enhance longitudinal flexibility after expansion.[0017]
In another embodiment of the invention, the first meander patterns are adapted to prevent any “flaring out” of loops of the first meander patterns during delivery of the stent.[0018]
A stent according to the invention retains the longitudinal flexibility associated with the '303 cellular stent in its unexpanded state, and has increased longitudinal flexibility in the expanded state. The stent does so without sacrificing scaffolding—i.e. coverage of the vessel wall—or radial support.[0019]
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 shows a schematic diagram of a conventional rigid stent deployed in a curved lumen;[0020]
FIG. 2 shows a schematic diagram of a stent of the present invention deployed in a curved lumen;[0021]
FIG. 3 shows a pattern for a stent made in accordance with the present invention;[0022]
FIG. 4 shows an enlarged view of one cell of the pattern of FIG. 3;[0023]
FIG. 5 shows a pattern for a stent made in accordance with the present invention;[0024]
FIG. 6 shows an enlarged view of one cell of the pattern of FIG. 5;[0025]
FIG. 7 shows a pattern for a stent made in accordance with the present invention;[0026]
FIG. 8 shows an enlarged view of one cell used in the pattern of FIG. 7;[0027]
FIG. 9 shows an enlarged view of another cell used in FIG. 7;[0028]
FIG. 10 shows a schematic comparison of a four cornered or “square cell” and a three cornered or “triangular” cell of the present invention.[0029]
FIG. 11 shows a pattern for a stent constructed according to the principles of the invention which has variable geometry along its length.[0030]
DETAILED DESCRIPTION OF THE INVENTIONFIG. 2 shows a schematic diagram of a longitudinally[0031]flexible stent208 of the present invention. Thestent208 may be delivered to acurved vessel210 by a balloon catheter, and implanted in the artery by inflating the balloon. As described before, the balloon causes the artery to straighten upon inflation of the balloon. However, upon deflation of the balloon, thestent208 assumes the natural curve of thevessel210 because it is and remains longitudinally flexible after expansion. This reduces any potential stress points at the ends of the stent and along the length of the stent. Furthermore, because the stent is longitudinally flexible after expansion, the stent will flex longitudinally with the vessel during the cycles caused by a heartbeat. This also reduces any cyclic stress at the ends of the stent and along the length of the stent.
FIG. 3 shows a pattern of a stent according to the present invention. This pattern may be constructed of known materials, and for example stainless steel, but it is particularly suitable to be constructed from NiTi. The pattern can be formed by etching a flat sheet of NiTi into the pattern shown. The flat sheet is formed into a stent by rolling the etched sheet into a tubular shape, and welding the edges of the sheet together to form a tubular stent. The details of this method of forming the stent, which has certain advantages, are disclosed in U.S. Pat. Nos. 5,836,964 and 5,997,973, which are hereby expressly incorporated by reference. Other methods known to those of skill in the art such as laser cutting a tube or etching a tube may also be used to construct a stent which uses the present invention. After formation into a tubular shape, an NiTi stent is heat treated, as known by those skilled in the art, to take advantage of the shape memory characteristics of NiTi and its superelasticity.[0032]
The[0033]pattern300 is formed from a plurality of each of two orthogonal meander patterns which patterns are intertwined with each other. The term “meander pattern” is taken herein to describe a periodic pattern about a center line and “orthogonal meander patterns” are patterns whose center lines are orthogonal to each other.
A[0034]meander pattern301 is a vertical sinusoid having avertical center line302. Ameander pattern301 has twoloops304 and306 per period whereinloops304 open to the right whileloops306 open to the left.Loops304 and306 sharecommon members308 and310, wheremember308 joins oneloop304 to its followingloop306 andmember308 joins oneloop306 to its followingloop304.
A meander pattern[0035]312 (two of which have been shaded for reference) is a horizontal pattern having ahorizontal center line314. Ahorizontal meander pattern312 also has loops labeled316,318,320,322, and between the loops of a period is a section labeled324.
[0036]Vertical meander pattern301 is provided in odd and even (o and e) versions which are 180° out of phase with each other. Thus, eachleft opening loop306 of meander pattern301ofaces aright opening loop304 ofmeander pattern301eand aright opening loop304 of meander pattern301ofaces aleft opening loop306 ofmeander pattern301e.
The[0037]horizontal meander pattern312 is also provided in odd and even forms. Thestraight sections324 of thehorizontal meander pattern312eintersect with every thirdcommon member310 of the evenvertical meander pattern301e.Thestraight sections324 of the horizontal meander pattern312oalso intersect with every thirdcommon member310 of the oddvertical meander pattern301.
Upon expansion of the stent, the loops of the[0038]vertical meander patterns301 open up in the vertical direction. This causes them to shorten in the horizontal direction. The loops in thehorizontal meander pattern312 open up both in the vertical direction and the horizontal direction, compensating for the shortening of the loops of the vertical meander patterns.
A stent formed from the pattern of FIG. 3 and made of NiTi is particularly well suited for use in the carotid artery or other lumens subject to an outside pressure. One reason is that because the stent is formed of NiTi, it is reboundable, which is a desirable property for stents placed in the carotid artery. The other reason is that the stent of FIG. 3 offers excellent scaffolding, which is particularly important in the carotid artery. Scaffolding is especially important in the carotid artery because dislodged particles in the artery may embolize and cause a stroke.[0039]
FIG. 4 is an expanded view of one[0040]flexible cell500 of the pattern of FIG. 3. Eachflexible cell500 includes: afirst member501 having afirst end502 and asecond end503; asecond member504 having afirst end505 and asecond end506; athird member507 having afirst end508 and asecond end509; and afourth member510 having afirst end511 and asecond end512. Thefirst end502 of thefirst member501 is joined to thefirst end505 of thesecond member504 by a firstcurved member535 to form afirst loop550, thesecond end506 of thesecond member504 is joined to thesecond end509 of thethird member508 by a secondcurved member536, and thefirst end508 of thethird member507 is joined to thefirst end511 of thefourth member510 by a thirdcurved member537 to form asecond loop531. Thefirst loop530 defines afirst angle543. Thesecond loop531 defines asecond angle544. Eachcell500 also includes afifth member513 having afirst end514 and asecond end515; asixth member516 having afirst end517 and asecond end518; aseventh member519 having afirst end520 and asecond end521; aneighth member522 having afirst end523 and asecond end524; aninth member525 having afirst end526 and asecond end527; and a tenth member having afirst end529 and asecond end530. Thefirst end514 of thefifth member513 is joined to thesecond end503 of thefirst member501 atsecond junction point542, thesecond end515 of thefifth member513 is joined to thesecond end518 of the sixth member by acurved member539 to form athird loop532, thefirst end517 of thesixth member516 is joined to thefirst end520 of theseventh member519 by a fifth curved member548, thesecond end521 of theseventh member519 is joined to thesecond end524 of theeighth member522 atthird junction point540 to form afourth loop533, thefirst end523 of theeighth member522 is joined to thefirst end526 of theninth member525 by a sixthcurved member549, thesecond end526 of theninth member525 is joined to thesecond end530 of thetenth member528 by a seventhcurved member541 to form afifth loop534, and thefirst end529 of thetenth member528 is joined to thesecond end512 of thefourth member510. Thethird loop532 defines athird angle545. Thefourth loop533 defines afourth angle546. Thefifth loop534 defines afifth angle547.
In the embodiment shown in FIG. 4, the[0041]first member501, thethird member507, thesixth member516, theeighth member522, and thetenth member528 have substantially the same angular orientation to the longitudinal axis of the stent and thesecond member504, thefourth member510, thefifth member513, theseventh member519, and theninth member512 have substantially the same angular orientation to the longitudinal axis of the stent. In the embodiment shown in FIG. 4, the lengths of the first, second, third andfourth members501,504,507,510 are substantially equal. The lengths of the fifth, sixth, seventh, eighth, ninth andtenth members513,516,519,522,525,528 are also substantially equal. Other embodiments where lengths of individual members are tailored for specific applications, materials of construction or methods of delivery are also possible, and may be preferable for them.
Preferably, the first, second, third, and[0042]fourth members501,504,507,510 have a width that is greater than the width of the fifth, sixth, seventh, eighth, ninth, andtenth members513,516,519,522,525,528 in that cell. The differing widths of the first, second, third, and fourth members and the fifth, sixth, seventh, eighth, ninth, and tenth members with respect to each other contribute to the overall flexibility and resistance to radial compression of the cell. The widths of the various members can be tailored for specific applications. Preferably, the fifth, sixth, seventh, eighth, ninth, and tenth members are optimized predominantly to enable longitudinal flexibility, both before and after expansion, while the first, second, third, and fourth members are optimized predominantly to enable sufficient resistance to radial compression to hold a vessel open. Although specific members are optimized to predominantly enable a desired characteristic, all the portions of the cell interactively cooperate and contribute to the characteristics of the stent.
FIGS. 5 and 6 show a pattern and an expanded view of one cell of an embodiment of the present invention which is specially adapted for a stent made of stainless steel. The pattern is similar to the pattern of FIGS. 3 and 4, and the same reference numerals are used to indicate the generally corresponding parts.[0043]
In this embodiment of the invention, for example, the[0044]second loops531 are made stronger by shortening the third andfourth members507,510. This helps assure that the second loops do not “flare out” during delivery of the stent through tortuous anatomy. This “flaring out” is not a concern with NiTi stents which are covered by a sheath during delivery.
Furthermore, the length of the members in this embodiment may be shorter than the length of the corresponding members in the embodiment illustrated in FIGS. 3 and 4. Typically, the amount of strain allowed in a self-expanding NiTi stent may be around 10%. In a stainless steel stent, the amount of strain allowed typically may be 20% or greater. Therefore, to facilitate stents made of NiTi and stents made of stainless steel expanding to comparable diameters, the members of the NiTi stent may be longer than the members of a stainless steel stent.[0045]
FIG. 7 illustrates another aspect of the present invention. The stent of FIG. 7 is also constructed from[0046]orthogonal meander patterns301,302. The meander patterns form a series of interlockingcells50,700 of two types. The first type ofcell50 is taught by U.S. Pat. No. 5,733,303. These cells are arranged so that they form alternatingbands704 of first type ofcells50 andbands706 of the second type ofcells700.
As seen in FIG. 8 and particularly with respect to the cell labeled for ease of description, each of the '303[0047]cells50 has a firstlongitudinal apex100 and a secondlongitudinal end78. Eachcell50 also is provided with a firstlongitudinal end77 and a secondlongitudinal apex104 disposed at the secondlongitudinal end78. Eachcell50 also includes afirst member51 having a longitudinal component having afirst end52 and asecond end53; asecond member54 having a longitudinal component having afirst end55 and asecond end56; athird member57 having a longitudinal component having afirst end58 and asecond end59; and afourth member60 having a longitudinal component having afirst end61 and asecond end62. The stent also includes a first loop orcurved member63 defining afirst angle64 disposed between thefirst end52 of thefirst member51 and thefirst end55 of thesecond member54. A second loop orcurved member65 defining asecond angle66 is disposed between thesecond end59 of thethird member57 and thesecond end62 of thefourth member60 and is disposed generally opposite to thefirst loop63. A first flexible compensating member (or a section of a longitudinal meander pattern)67 having curved portion and two legs with afirst end68 and asecond end69 is disposed between thefirst member51 and thethird member57 with thefirst end68 of the first flexible compensatingmember67 joined to and communicating with thesecond end53 of thefirst member51 and thesecond end69 of the first flexible compensatingmember67 joined to and communicating with thefirst end58 of thethird member57. Thefirst end68 and thesecond end69 are disposed a variablelongitudinal distance70 from each other. A second flexible compensating member (or, a section of a longitudinal meander pattern)71 having afirst end72 and asecond end73 is disposed between thesecond member54 and thefourth member60. Thefirst end72 of the second flexible compensatingmember71 is joined to and communicates with thesecond end56 of thesecond member54 and thesecond end73 of the second flexible compensatingmember71 is joined to and communicates with thefirst end61 of thefourth member60. Thefirst end72 and thesecond end73 are disposed a variable longitudinal distance74 from each other. In this embodiment, the first and second flexible compensating members, and particularly the curved portion thereof,67 and71 are arcuate.
The second type of[0048]cell700 is illustrated in FIG. 9 and the same reference numerals are used to indicate generally corresponding areas of the cell. Theapices100,104 of the second type ofcell700 are offset circumferentially. Also, each flexible compensatingmember67,71 includes: a first portion orleg79 with afirst end80 and asecond end81; a second portion orleg82 with afirst end83 and asecond end84; and a third portion orleg85 with thefirst end86 and asecond end87, with thesecond end81 and thesecond end84 being joined by a curved member and thefirst end83 and thefirst end86 being joined by a curved member. The first end of a flexible compensatingmember67,71 is the same as thefirst end80 of thefirst portion79, and the second end of a flexible compensatingmember67,71 is the same as thesecond end87 of thethird portion85. A first area ofinflection88 is disposed between thesecond end81 of thefirst portion79 and thesecond end84 of thesecond portion82 where the curved portion joining them lies. A second area ofinflection89 is disposed between thefirst end83 of thesecond portion82 and thefirst end86 of thethird portion85 where the curved portion joining them lies.
While FIG. 7 illustrates a pattern of alternating bands of cells, the stent may be optimized for a particular usage by tailoring the configuration of the bands. For example, the middle band of the second type of[0049]cells700 may instead be formed ofcells50, or vice versa. The second type of cells in FIG. 7 may also utilize the cell configurations described with respect to FIGS. 4 and 6. The cell configurations of FIGS. 4 and 6 provide the advantage that they will not cause any torque of one portion of the cell relative to another portion of the cell about the longitudinal axis of the stent upon expansion, which may happen when the second type ofcells700 expand, a torque which could cause a stent to deform, and stick out.
As illustrated in FIG. 7, all of the flexible compensating members are arranged so that the path of the flexible compensating members, from left to right, travels in a generally downward direction. The[0050]cells700 can also be arranged so that the flexible compensating members in one band are arranged in a generally upward direction, and the flexible compensating members in an adjacent band are arranged in a generally downward direction. One skilled in the art can easily make these modifications.
FIG. 10 is a schematic representation comparing the[0051]cells804 of the present invention, which have three points where the intertwined first and second meander patterns meet and are in that sense three cornered or triangular cells, withcells802 of the '303 stent which have four points where the intertwined first and second meander patterns meet and are in that sense four cornered or square cells. More particularly, on the left side of FIG. 10, a pair ofvertical meander patterns806,826 are joined bymembers808,810,812 (which are sections of longitudinal meander patterns) to form a plurality of three cornered ortriangular cells804. By triangular cell, it is meant that there are threesections810,812,814, each having loop portions and three associatedpoints816,818,820 of their joining, forming each cell.
On the right side of FIG. 10, a pair of[0052]vertical meander patterns822,824 are joined together compensatingmembers828,830,832,834 (which are sections of a longitudinal meander) to form a plurality ofsquare cells804. By square cell, it is meant that there are four sections, each having loop portions, and four associated points of their joining, forming each cell. For example, theshaded cell802 is formed from foursections832,836,830,838, with four associated points of their joining840,842,844,846.
Both the square cell and the triangular cell have two kinds of sections with loops. The first kind of loop containing section is formed from a vertical meander pattern and is optimized predominantly to enable radial support. The second kind of loop containing section is optimized predominantly to enable flexibility along the longitudinal axis of the stent. Although each loop containing section is optimized predominantly to enable a desired characteristic of the stent, the sections are interconnected and cooperate to define the characteristics of the stent. Therefore, the first kind of loop containing section contributes to the longitudinal flexibility of the stent, and the second kind of loop containing section contributes to the radial support of the stent.[0053]
In the[0054]square cell802, it can be seen that the second kind ofloop containing sections830,832 each have oneinflection point848,850. In the triangular cell, theloop containing sections810,812 each have twoinflection point areas852,854,856,858. The higher number of inflection points allows more freedom to deform after expansion of the stent and distributes the deformation over a longer section, thus, reducing the maximal strain along these loop containing sections.
Furthermore, it can be seen that a[0055]square cell802 is generally more elongated along the longitudinal axis of the stent than atriangular cell804, which is generally more elongated along the circumference of the stent. This also contributes to higher flexibility after expansion.
If the[0056]first meander patterns806,822,824,826 of both types of cells are constructed identically and spaced apart by the same amount, the area of atriangular cell804 is the same as asquare cell802. This can be more readily understood with reference to a band of cells around the circumference of a stent. Each band will encompass the same area, and each band will have the same number of cells. Accordingly, the area of each cell in one band formed of square cells will be the same as the area of each cell in another band formed of triangular cells.
Although the areas of the cells are equal, the perimeter of the triangular cell is larger than the perimeter of the square cell. Therefore, in comparison to a square cell, a triangular cell offers increased coverage of a vessel wall.[0057]
In the particular embodiments described above, the stent is substantially uniform over its entire length. However, other applications where portions of the stent are adapted to provide different characteristics are also possible. For example, as shown in FIG. 11, a band of[0058]cells850 may be designed to provide different flexibility characteristics or different radial compression characteristics than the remaining bands of cells by altering the widths and lengths of the members making up that band. Or, the stent may be adapted to provide increased access to a side branch lumen by providing at least onecell852 which is larger in size then the remaining cells, or by providing an entire band ofcells854 which are larger in size than the other bands of cells. Or, the stent may be designed to expand to different diameters along the length of the stent. The stent may also be treated after formation of the stent by coating the stent with a medicine, plating the stent with a protective material, plating the stent with a radiopaque material, or covering the stent with a material.
Thus, what is described is a longitudinally flexible stent that utilizes a closed cell structure to provide excellent coverage of the vessel wall. The general concepts described herein can be utilized to form stents with different configurations than the particular embodiments described herein. For example, the general concepts can be used to form bifurcated stents. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention is defined by the claims which follow.[0059]