Source: http://www.google.fr/patents/US8920487
Timestamp: 2017-10-17 07:56:41
Document Index: 785360121

Matched Legal Cases: ['Application No. 61', 'Application No. 04806450', 'Application No. 01104468', 'Application No. 01125340', 'Application No. 02019615', 'Application No. 02019616', 'Application No. 02019617', 'Application No. 02019618', 'Application No. 08001226', 'Application No. 12178317', 'Application No. 10012406', '§41', '§41', 'Application No. 200100915', 'Application No. 02733009', 'Application No. 02767765', 'Application No. 02733008', 'Application No. 101']

Brevet US8920487 - Longitudinally flexible stent - Google Brevets
An intravascular stent especially suited for implanting in curved arterial portion. The stent retains longitudinal flexibility after expansion. The stent is formed of intertwined meander patterns forming triangular cells. The cells are adapted to provide radial support, and also provide longitudinal...http://www.google.fr/patents/US8920487?utm_source=gb-gplus-shareBrevet US8920487 - Longitudinally flexible stent
Numéro de publication US8920487 B1
Numéro de demande US 12/842,292
Autre référence de publication US9161849
Numéro de publication 12842292, 842292, US 8920487 B1, US 8920487B1, US-B1-8920487, US8920487 B1, US8920487B1
Citations de brevets (99), Citations hors brevets (38), Classifications (14), Événements juridiques (1)
US 8920487 B1
An intravascular stent especially suited for implanting in curved arterial portion. The stent retains longitudinal flexibility after expansion. The stent is formed of intertwined meander patterns forming triangular cells. The cells are adapted to provide radial support, and also provide longitudinal flexibility after expansion. The cells also provide increase coverage of a vessel wall. Loops in the stent are disposed and adapted to cooperate, so that after expansion of said stent within a curved lumen, the stent is curved and cells on the outside of the curve open in length, but narrow in width, whereas cells on the inside of the curve shorten in length, but thicken in width to maintain a density of the stent element area which is much more constant than otherwise between the inside and outside of the curve. The stent also minimizes flaring out by eliminating free loops of the radially supporting circumferential bands of loops. The stent includes widened struts, wherein one or more of the widened struts have at least one reservoir for the delivery of an agent to a vessel site. The reservoir may be a fenestration or a recess that opens towards either the vessel wall or the lumen.
a plurality of first loop containing sections arranged generally in a circumferential direction and spaced apart from one another, loops in said first loop containing sections occurring at a first frequency and having a first width, said first loop containing sections including widened struts having a second width greater than said first width, wherein adjacent widened struts are joined by one loop of said first loop containing section having said first width, wherein at least one said widened strut has a reservoir;
a plurality of second loop containing sections arranged generally in a circumferential direction having struts, each strut having a length extending generally in a longitudinal direction of the stent, loops in said second loop containing sections occurring at a second frequency that is higher than said first frequency, said second loop containing sections consecutively alternating with said first loop containing sections along a longitudinal axis of the stent, said second loop containing sections alternately intersecting with longitudinally neighboring first loop containing sections at every third loop of each of said second loop containing sections around the circumference of the stent; and
wherein said first loop containing sections provide radial support upon expansion of the stent and said second loop containing sections provide longitudinal flexibility of the stent.
2. The stent according to claim 1, wherein said widened struts have more than one reservoir.
3. The stent according to claim 1, wherein each widened strut has at least one reservoir.
4. The stent according to claim 1, wherein at least one said reservoir is a fenestration extending in the radial direction of the widened strut.
5. The stent according to claim 1, wherein at least one said reservoir is a recess in the widened strut.
6. The stent according to claim 5, wherein the recess opens inward from the stent.
7. The stent according to claim 1, wherein said second loop containing sections intersect with longitudinally offset loops of adjacent first loop containing sections.
8. The stent according to claim 1, wherein said first loop containing sections and said second loop containing sections form a plurality of triangular cells.
9. The stent according to claim 8 further comprising square cells, each said cell comprising a plurality of flexible connectors, each said flexible connector having a first end and a second end, said first end connected to a first loop containing section and said second end connected to an adjacent first loop containing section.
10. The stent according to claim 8, wherein a first triangular cell has a different size than a second triangular cell.
11. The stent according to claim 1, wherein at least one loop of a first loop containing section is shorter than another loop of said first loop containing section.
12. The stent according to claim 1, wherein the loops of a first loop containing section are arranged in-phase with the loops of an adjacent first loop containing section.
13. The stent according to claim 1, wherein every other loop of at least one first loop containing section is staggered along the circumference of the stent.
a plurality of radially supporting first sinusoidal bands arranged generally in a circumferential direction having first widened struts and second widened struts extending generally in a longitudinal direction and spaced apart from one another, at least one widened strut having a reservoir, wherein each said first widened strut is connected to an adjacent second widened strut by a single curved connector to form a loop, wherein said curved connectors have a first width and said widened struts have a second width greater than said first width;
a plurality of flexible second sinusoidal bands arranged generally in a circumferential direction having loops formed by curved members and struts, each strut having a length extending generally in a longitudinal direction of the stent, each second sinusoidal band arranged between each pair of adjacent first sinusoidal bands along the longitudinal axis of the stent, said curved members of said second sinusoidal bands intersecting with said curved connectors of said first sinusoidal bands to form overlap portions, said overlap portions also having said first width.
15. The stent according to claim 14, wherein each widened strut has at least one reservoir.
16. The stent according to claim 14, wherein at least one said reservoir is a fenestration extending in the radial direction of the widened strut.
17. The stent according to claim 14, wherein at least one said reservoir is a recess in the widened strut.
18. The stent according to claim 17, wherein the recess opens inward from the stent.
19. A stent comprising a plurality of flexible cells, each said cell comprising:
a first widened strut having a first corner and a second corner,
a second widened strut having a first corner and a second corner,
a first curved connector having a first end and a second end, wherein said first curved connector has a first width and said first and second widened struts have a second width greater than said first width, wherein the first end of the first curved connector is joined to the first corner of the first widened strut and the second end of the first curved connector is joined to the first corner of the second widened strut, said first widened strut, second widened strut and first curved connector forming a first loop facing the inside of the cell;
a first strut, a second strut, a third strut, a fourth strut, a fifth strut and a sixth strut,
a first curved member, a second curved member, a third curved member, a fourth curved member and a fifth curved member, wherein
the first strut is connected to the second strut by the first curved member, said first strut, second strut and first curved member forming a second loop facing the inside of the cell;
the second strut is connected to the third strut by a second curved member;
the third strut is connected to the fourth strut by a third curved member, said third strut, fourth strut and third curved member forming a third loop facing the inside of the cell;
the fourth strut is connected to the fifth strut by a fourth curved member; and
the fifth strut is connected to the sixth strut by a fifth curved member, said fifth strut, sixth strut and fifth curved member forming a fourth loop facing the inside of the cell;
and wherein at least one widened strut of at least one cell has a reservoir.
20. The stent of claim 19 wherein the first widened strut forms part of a first cell adjacent to a second cell, said second cell comprising said first widened strut and a second curved connector.
21. The stent of claim 20 wherein said second curved connector of said second cell comprises a curved portion wherein said curved portion connects the second corner of the first widened strut with said first strut of said first cell.
This application is a continuation-in-part application of application Ser. No. 12/042,470 filed on Mar. 5, 2008, which is a continuation-in-part of application Ser. No. 10/757,805 filed on Jan. 14, 2004, which is a continuation-in-part of application Ser. No. 09/864,389 filed on May 25, 2001, which is a continuation-in-part of application Ser. No. 09/795,794 filed on Feb. 28, 2001, which is a non-provisional application of provisional application 60/202,723 filed May 8, 2000 and a continuation-in-part of application Ser. No. 09/516,753 filed on Mar. 1, 2000. This application also claims the priority of Provisional Application No. 61/332,416 filed on May 7, 2010. The disclosures of the above-identified related applications are hereby incorporated by reference.
The present invention relates generally to stents, which are endoprostheses implanted into vessels within the body, such as, but not limited to, blood vessels, to support and hold open the vessels, or to secure and support other endoprostheses in the vessels. In particular, the invention relates to a stent which is longitudinally flexible before and after expansion and which has at least one reservoir.
In addition to flexibility and vessel wall support, stents have been designed with the goal of delivering agents to a site for a variety of purposes, e.g. addressing the problem of restenosis and/or thrombosis. Thus, for example, stents may be coated or filled with various compounds and therapeutic agents to enhance their effectiveness.
Various methods have been employed to apply coatings to stents. U.S. Pat. No. 5,464,650 to Berg, for example, describes a method of applying a solution to the tissue-contacting surface of the stent that includes a solvent, a polymer and a therapeutic substance. The solvent evaporates once the solution is applied to the stent, leaving behind the polymer and the therapeutic agent for the treatment of the vessel wall of the lumen upon deployment of the stent. Other coating processes known in the art include, for example, U.S. Pat. No. 6,120,847 to Yang and U.S. Pat. No. 7,604,831 to Pacetti. However, such coating processes may result in surface imperfections, including uneven coating, dripping and cracking of the coating, which may cause adverse effects such as the delivery of ineffective or toxic doses of drugs at the treatment site. Moreover, stent coating increases the effective stent thickness and may increase trauma to the vessel lumen during implantation while reducing the flow cross-section of the lumen after implementation.
Other methods for drug delivery via the stent are known in the art. For example, U.S. Pat. No. 7,208,010 to Shanley describes a stent having widened struts with through-openings containing beneficial agents. The widened struts form substantially rigid segments connected to one another by ductile hinges, resulting in an articulated stent design that suffers from limited flexibility during delivery and upon deployment of the stent. Another disadvantage of such an articulated stent design is lack of treatment uniformity across the length of the stent between rigid segments and regions of flexibility.
Thus, it is desired to have a stent capable of delivering such agents without increasing the effective wall thickness of the stent, and without adversely impacting the maneuverability before expansion or flexibility, uniformity of vessel wall coverage or radial support upon deployment.
Yet another object of the invention relates to providing a flexible drug delivery stent containing one or more reservoirs that are spaced evenly along the stent to uniformly deliver therapeutic agents yet avoid the pitfalls of drug coatings
FIG. 3 shows a pattern for a stent constructed according to the principles of the present invention;
FIG. 5 shows a pattern for a stent constructed according to the principles of the present invention;
FIG. 7 shows a pattern for a stent constructed according to the principles of the present invention;
FIG. 16 shows the ability to compensate for foreshortening of a triangular cell according to the principles of the invention;
FIGS. 17A-F show other patterns for a stent constructed according to the principles of the invention;
FIG. 22 shows a pattern for a stent having reservoirs constructed according to the principles of the invention, the pattern shown reflecting an expanded state of the stent;
FIG. 23A shows an enlarged view of a first widened strut of FIG. 22;
FIG. 23B shows an enlarged view of a second widened strut of FIG. 22;
FIG. 24 shows an enlarged view of a first loop containing section of the stent pattern of FIG. 22;
FIG. 25 shows as enlarged view of a second loop containing section of the stent pattern of FIG. 22; and
FIG. 26 shows an enlarged view of a cell of the stent pattern of FIG. 22.
A meander pattern 301 is a vertical sinusoid having a vertical center line 302. It will be recognized that this is not a perfect sinusoid, but only an approximation thereof. Thus, as used herein, the term sinusoid refers to a periodic pattern which varies positively and negatively symmetrically about an axis; it need not be an exact sine function. A meander pattern 301 has two loops 304 and 306 per period wherein loops 304 open to the right while loops 306 open to the left. Loops 304 and 306 share common members 308 and 310, where member 308 joins one loop 304 to its following loop 306 and member 310 joins one loop 306 to its following loop 304. The vertical sinusoid of meander pattern 301 has a first frequency. The meander pattern 301 is characterized in that it is expandable in the vertical (circumferential) direction, without placing constraints on its exact direction or the direction of its loops.
A meander pattern 312 (two of which have been shaded for reference) is a horizontal pattern having a horizontal center line 314. A horizontal meander pattern 312 also has loops labeled 316, 318, 320, 322, and between the loops of a period is a section labeled 324. Looked at it in another way, these loops are part of a vertical sinusoid 303 having a vertical center line 305, which has a higher frequency than that of the meander patterns 301. Vertical sinusoids 301 alternate with vertical sinusoids 303. Vertical sinusoids 303 have a second frequency higher than the first frequency of the vertical meander patterns, i.e., vertical sinusoids 301. These meander patterns are characterized in that they are expandable horizontally (longitudinally). Other non horizontal meander patterns can be drawn using the same loops but all remain expandable in the horizontal direction (see meander pattern 411 in FIG. 3).
The horizontal meander pattern 312 may also be provided in odd and even forms. The straight sections 324 of the horizontal meander pattern 312 e intersect with every third common member 310 of the even vertical meander pattern 301 e. The straight sections 324 of the horizontal meander pattern 312 o also intersect with every third common member 310 of the odd vertical meander pattern 301 o. Viewed as vertical sinusoids 303, alternating vertical sinusoids 303 are intermittently coupled to the meander patterns 301. For example, between points 315 and 317, where vertical meander pattern 303 a is coupled to vertical meander pattern 301 e, there are two loops 304 and one loop 306 of vertical meander pattern 301 e and three loops 322 and two loops 320 of vertical meander pattern 303.
This corresponds to two cycles of meander pattern 301 e and three cycles of meander pattern 303. Similarly, between two points of coupling between vertical meander pattern 301 o and vertical meander pattern 303 a are two loops 306 and one loop 304, again making two cycles. There will be three loops 320 and two loops 322, again equal to three cycles of pattern 303.
Since this embodiment of the stent is preferably made of NiTi, and it is reboundable, it typically will be self-expanding. Upon expansion of the stent, the vertical meander patterns 301 open up in the vertical direction. This causes loops in the vertical meander pattern to shorten in the horizontal direction. The horizontal meander pattern 312 open up in the horizontal direction, compensating for the shortening of the loops of the vertical meander patterns. The loops in the horizontal meander open both in the vertical and the horizontal direction.
It should be noted that the loops of the horizontal meander pattern 312 or any other meander containing those loops such as 411, which are also the loops of the vertical meander pattern 303 in the present invention, compensate for foreshortening in a self-expanding stent in a particularly effective manner. A self-expanding stent formed of a shape-memory alloy must be compressed from an expanded position to a compressed position for delivery. As shown in FIG. 14, because of the configuration of the loops 320 and 322 of the horizontal meander pattern 312, when the stent is compressed from an expanded position 602 to a compressed position 604, the length 606 of the horizontal meander pattern (alternatively described as the width of the vertical pattern 303) naturally shrinks Consequently, when the stent expands, the loops 320 and 322 elongate and compensate for the shortening of the vertical meander patterns 301 e and 301 o as the vertical meander patterns 301 e and 301 o expand. In contrast, a horizontal meander pattern with such shapes as N-shapes will not naturally shrink longitudinally when the stent is compressed from an expanded position 608 to a compressed position 610, as illustrated in FIG. 14. As one skilled in the art would readily recognize, FIG. 14A has been included to better illustrate the actual resulting configuration of loops 320 and 322.
FIG. 4 is an expanded view of one flexible cell 500 of the pattern of FIG. 3. Each flexible cell 500 includes: a first member 501 having a first end 502 and a second end 503; a second member 504 having a first end 505 and a second end 506; a third member 507 having a first end 508 and a second end 509; and a fourth member 510 having a first end 511 and a second end 512. The first end 502 of the first member 501 is joined to the first end 505 of the second member 504 by a first curved member 535 to form a first loop 550, the second end 506 of the second member 504 is joined to the second end 509 of the third member 507 by a second curved member 536, and the first end 508 of the third member 507 is joined to the first end 511 of the fourth member 510 by a third curved member 537 to form a second loop 531. The first loop 550 defines a first angle 543. The second loop 531 defines a second angle 544. Each cell 500 also includes a fifth member 513 having a first end 514 and a second end 515; a sixth member 516 having a first end 517 and a second end 518; a seventh member 519 having a first end 520 and a second end 521; an eighth member 522 having a first end 523 and a second end 524; a ninth member 525 having a first end 526 and a second end 527; and a tenth member 528 having a first end 529 and a second end 530. The first end 514 of the fifth member 513 is joined to the second end 503 of the first member 501 at second junction point 542, the second end 515 of the fifth member 513 is joined to the second end 518 of the sixth member 516 by a fourth curved member 539 to form a third loop 532, the first end 517 of the sixth member 516 is joined to the first end 520 of the seventh member 519 by a fifth curved member 548, the second end 521 of the seventh member 519 is joined to the second end 524 of the eighth member 522 at first junction point 540 to form a fourth loop 533, the first end 523 of the eighth member 522 is joined to the first end 526 of the ninth member 525 by a sixth curved member 549, the second end 527 of the ninth member 525 is joined to the second end 530 of the tenth member 528 by a seventh curved member 541 to form a fifth loop 534, and the first end 529 of the tenth member 528 is joined to the second end 512 of the fourth member 510 at a third junction point 538. The third loop 532 defines a third angle 545. The fourth loop 533 defines a fourth angle 546. The fifth loop 534 defines a fifth angle 547.
The first, second, third, fourth and fifth loops 550, 531, 532, 533, 534 are loops directed to the inside of the cell. The loops 550, 531, 532, 533 and 534 of a cell 500 are connected to each other either by curved members 536, 548 and 549 or by junction points 542 and 538.
In the embodiment shown in FIG. 4, the first member 501, the third member 507, the sixth member 516, the eighth member 522, and the tenth member 528 have substantially the same angular orientation to the longitudinal axis of the stent and the second member 504, the fourth member 510, the fifth member 513, the seventh member 519, and the ninth member 525 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 and fourth members 501, 504, 507, 510 are substantially equal. The lengths of the fifth, sixth, seventh, eighth, ninth and tenth members 513, 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. It can be seen that each cell includes two cycles of the lower frequency vertical pattern and three cycles of the higher frequency vertical pattern.
The embodiments of FIGS. 3 and 5 can also be viewed as being made up of high frequency and low frequency vertical sinusoidal patterns or vertical loop containing sections which are arranged generally in the circumferential direction and which are periodically interconnected. Thus, there is a first loop containing section with loops occurring at a first frequency extending along line 302 and a second loop containing section with loops also occurring at said first frequency extending along line 302. A third loop containing section 303 extending along line 305 has loops occurring at a second frequency that is higher than said first frequency. It is disposed between the first and second loop containing sections and alternately joined to the first and second loop containing sections on their respective adjacent edges. In the illustrated embodiment, the high frequency is in a ratio of 3:2 to the low frequency. As noted above, the higher frequency loop containing elements are smaller in width. The relative widths can be selected so that the high frequency elements are crimpable to the same diameter as the lower frequency elements and the flexibility they provide is as desired.
Furthermore, the high frequency vertical patterns of smaller width result in elements having a lower maximal strain. Specifically, the lower maximal strain may be below the maximum strain without nonelastic deformation for the material the stent is made of. In this embodiment, where the stent is made of stainless steel, the lower maximal strain is below approximately 0.4%, even for a repeated bend of about 1 degree per mm length, as confirmed by finite element analysis. On the other hand, in a '303 type stent, for an equivalent amount of bending, a maximum strain of 8% is observed. Thus, the increased flexibility of the stent of the present invention means that, in addition to conforming better to the curved lumen, it will bend with each beat of the heart and its fatigue resistance will be substantially improved.
When curved stent is expanded while inside a lumen, also in the case of the cells 50, cells on the outside of the curve open in length, but narrow in width whereas the cells on the inside of the curve shorten in length, but increase in width to provide a density of the members per unit of surface area that remains more constant between the inside and outside of the curve.
The second type of cell 700 in FIG. 7 is illustrated in FIG. 9 and the same reference numerals are used to indicate generally corresponding areas of the cell. The apices 100, 104 of the second type of cell are offset circumferentially. Also, each flexible compensating member 67, 71 includes: a first portion or leg 79 with a first end 80 and a second end 81; a second portion or leg 82 with a first end 83 and a second end 84; and a third portion or leg 85 with the first end 86 and a second end 87, with the second end 81 and the second end 84 being joined by a curved member and the first end 83 and the first end 86 being joined by a curved member. The first end of a flexible compensating member 67, 71 is the same as the first end 80 of the first portion 79, and the second end of a flexible compensating member 67, 71 is the same as the second end 87 of the third portion 85. A first area of inflection 88 is disposed between the second end 81 of the first portion 79 and the second end 84 of the second portion 82, where the curved portion joining them lies. A second area of inflection 89 is disposed between the first end 83 of the second portion 82 and the first end 86 of the third portion 85 where the curved portion joining them lies.
As illustrated in FIG. 7, the cells 700 in each band of cells 706 are arranged with an identical orientation (i.e. the flexible compensating members of the cells 700 are each oriented in the same direction). The cells 700 may also be arranged so that the flexible compensating members in one band 706 are arranged in a different orientation from the flexible compensating members in another band 706. The same holds true for the orientation of the flexible compensating members of the cells 50. One skilled in the art can easily make these modifications.
FIG. 10 is a schematic representation comparing the cells 804 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, with cells 802 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 of vertical meander patterns 806, 826 are joined by members 808, 810, 812 (which are sections of horizontal meander patterns) to form a plurality of three cornered or triangular cells 804. By triangular cell, it is meant that there are three sections 810, 812, 814, each having loop portions and three associated points 816, 818, 820 of their joining, forming each cell.
Although two bands of '303 type cells are shown at each end in FIG. 12, this is not a requirement; there can be more or fewer, nor do the numbers of bands need be the same at both ends. Also, although twelve bands of cells 500 are shown in FIG. 13, a different number may be provided.
The ability to compensate for foreshortening is further illustrated by FIG. 16. This shows how the loop containing sections 901, which are part of the horizontal meander patterns, and have a higher frequency, compensate for foreshortening of the sections 903, which have a lower frequency when the stent expands. In the upper portion of FIG. 16, both the high frequency loop containing section 901 and the low frequency loop containing section 903 are shown in the compressed condition. The width of the section 903 is from line 905 to line 907. The width of the high frequency section extends from line 907 to line 909. The lower portion of the figure shows the stent expanded. The width of the low frequency section 903 is foreshortened and now extends only from line 905 to line 911. However, in expanding the high frequency section 901 has compensated for this foreshortening. It has a width that now extends from line 911 to line 909, providing compensation for foreshortening without any friction. As noted above, this is particularly advantageous for self expanding stents, e.g. those made of austenitic NiTi, also known under the name Nitinol, that expand to a memorized shape.
The further embodiments presented in FIGS. 17A-F share all the design and functional features of the previously presented embodiments. The additional feature is that the connections between first meanders and second meanders, or between low frequency bands and high frequency bands is such that no free loops of the low frequency band are present. The resulting ratio of frequency is 3:1, as described above, and the first meanders do not have odd and even first meanders. The loops of the high frequency band may be of uneven length and arranged to facilitate manufacturing and smoothness, as presented in FIGS. 17D and 17E. It is clear to one skilled in the art that other arrangements for this purpose could be designed and would be analogous to those presented. The presence of meanders of two types in two different directions in this design is demonstrated in FIG. 17F. It should be understood that an important feature of this embodiment of the invention is the fact that all loops of the first frequency ring are connected. The ratio of frequencies may be different from 3:1, and the phase relations between rings may be anywhere between in-phase and 180 degrees out of phase.
Elaborating further, FIGS. 17A-F (wherein like reference numbers refer to like parts) illustrate embodiments which eliminate free radially-supporting loops, and can provide increased smoothness along the length of the stent in a bent configuration. In the stent embodiments of FIGS. 17A-F, three cycles of a second vertical sinusoid 1010 are interconnected by a single cycle of a first vertical sinusoidal band 1001 to form a cell. This corresponds to three loops 1016, 1017 and 1018 or 1019 of the second sinusoidal band 1010 for each single loop 1004 or 1006 of the first sinusoidal band 1001, for a loop ratio of 3:1 in forming a cell.
The amplitude of any sinusoidal band may be generally constant (as generally shown in FIG. 17B), or may vary (as shown in FIGS. 17C-E) so as to provide loops 1016-1019 having members of varying lengths or varying patterns. The free loops 1016 and 1017 of the second sinusoids 1010 may, for example, have a combination of longer and shorter members such as, for example, member 1014 a and 1014 b respectively. Those skilled in the art will appreciate, therefore, in light of the foregoing, the specific heights, shapes, linearity, nonlinearity, curvature, geometric disposition, angular relation of the strut members 1014 a-c with respective intervening connective curved segments forming loops 1016-1019 may be modified in any number of ways and still carry out the spirit of the present invention.
The cells 2000 that form band 1901 are further illustrated in FIG. 20, Detail 1. Cell 2000 includes: a first member 2001 and a second member 2002 having a first loop 2005 there between, a third member 2003 and a fourth member 2004 having a second loop 2006 there between, a first connector 2008 joining respective ends of first member 2001 with fourth member 2004, and a second connector 2007 joining respective ends of second member 2002 with third member 2003. Preferably, as shown, the lengths of connector 2007 and connector 2008 are different, and the connectors alternate circumferentially around band 1901. The connectors 2007 and 2008 of each cell 2000 may be misaligned circumferentially from the neighboring connector, but connectors of the same type may be substantially aligned in the circumferential direction. As shown, connectors 2007 and 2008 serve to separate circumferentially adjacent cells 2000. Each cell 2000 may be formed so that each member of the cell is of a different length and/or each cell 2000 has a different total area. Further, FIG. 20 illustrates that members (2001, 2002, 2003, and 2004), loops (2005 and 2006), and connectors (2007 and 2008) may have an undulating form which can reduce any strain resulting from stent expansion. The degree of undulation may vary depending upon the desired stent characteristics. These same elements of cell 2000 may also have varying widths and/or areas of varying material thickness. Thus, for example, members (2001, 2002, 2003, and 2004), loops (2005 and 2006), and connectors (2007 and 2008) may each have the same or different width and/or material thickness. Alternatively, a sub-group of elements forming cell 2000 may have the same width and/or material thickness while the remaining subgroup of elements forming cell 2000 has a different width and/or material thickness. It will be understood that any suitable combination or variation of material width and thickness can be utilized for each of the cell elements depending on the desired characteristics of the stent. These structural variations can serve to transfer the stress/strain distribution to more suitable parts of the stent. This concept is described in published U.S. Pat. App. No. 2005/0273157, the entirety of which is incorporated herein by reference.
FIG. 21 is Detail 2, cell 2100, that forms band 1902. The structure of cell 2100 is substantially similar to cell 500 shown in FIG. 6. The lengths of members 2110, 2111, 2112 and 2113 can be equal or the lengths may be different so that the loops are circumferentially offset from each other thereby allowing better crimpability. If desired, loops 2108, 2109, 2119, 2120, and 2121 may be misaligned circumferentially. The radii of loops 2115, 2122, and 2114 may be reduced to improve stent securement and reduce crimping profile. As members 2103 and 2104 approach loop 2119, their respective ends can be connected to form a “keyhole” 2118 if desired. Members 2101, 2102, 2103, 2104, 2105, 2106, 2110, 2111, 2112 and 2113, loops 2108, 2109, 2114, 2115, 2119, 2120, 2121 and 2122, and junction points 2116 and 2117, which may all have an undulation to reduce any strain resulting from stent expansion. As previously explained, the degree of undulation may vary. These same elements of cell 2100 may also have varying widths and/or areas of varying material thickness. As noted above, these structural variations assist to appropriately distribute stress and strain within the stent.
FIG. 22 illustrates a pattern of a stent 2210 according to further principles of the invention. The stent 2210 comprises a plurality of first loop containing sections 2260, each first loop containing section comprising first widened struts 2220 and second widened struts 2225 arranged such that first widened struts 2220 alternate with second widened struts 2225. As illustrated in FIGS. 23A and 23B, which show an enlarged view of one embodiment of widened struts 2220 and 2225, each first widened strut 2220 has a first end 2221, a first side 2222, a second end 2223 and a second side 2224; and each second widened strut 2225 has a first end 2226, a first side 2227, a second end 2228 and a second side 2229. Each first widened strut 2220 further has a first corner 2291 where first side 2222 and second end 2223 meet, as well as a second corner 2292 where second side 2224 and first end 2221 meet. Likewise, each second widened strut 2225 further has a first corner 2297 where first side 2227 and second end 2228 meet, as well as a second corner 2298 where second side 2229 and first end 2226 meet. The first and second ends of the widened struts 2220, 2225 may be rounded, as shown in FIGS. 22 and 23A/23B, but any suitable configuration may also be employed. Each widened strut 2220, 2225 is characterized by width in the circumferential direction, a depth in the radial direction, and a length in the longitudinal direction of the stent. As such, each widened strut 2220, 2225 provides radial support upon deployment of the stent and has sufficient dimensions to have at least one and possibly more reservoirs 2215 extending in the radial direction and one or more widened struts that is sufficiently large to include an adequate supply of an agent without sacrificing the structural integrity or radial support of the widened strut. In this embodiment, the first side 2222, 2227 and second side 2224, 2229 are substantially straight with a length that is greater than the width of first end 2221, 2226 and second end 2223, 2228, i.e. greater than the width of the widened strut 2220, 2225; however, the invention contemplates any suitable dimensions for widened struts 2220, 2225 that provide sufficient space for at least one reservoir 2215.
Reservoirs may be of any shape or size suitable to contain an agent to the vessel site. Each reservoir individually may extend through the entire radial depth of the widened strut in the form of a fenestration or alternatively extend partially inward in the form of a recess opening either towards the internal or external side of the widened strut. In this manner, an agent contained in the reservoir may interact with the vessel site in either (1) the direction facing the vessel wall, (2) the direction facing the lumen, or (3) in both directions upon deployment of the stent. The invention contemplates that reservoirs may have a uniform or non-uniform distribution and/or configuration in any one widened strut of a stent as compared with the reservoirs occurring on other widened struts of the stent. For example, a subset of widened struts may have no reservoirs and/or a different number of reservoirs and/or one or more reservoirs in the form of a recess opening in a direction that is different from the reservoirs of one or more other widened struts of the same stent. The agent contained in one or more of the reservoirs may be a therapeutic agent, a polymer, or a combination of therapeutic agent(s) and a biocompatible matrix or polymer(s). The term “therapeutic agent” is meant to include any drug or compound, including biologics, having any intended activity, e.g., pharmacologic activity. The term “polymer” is meant to include materials that may facilitate, delay or modify release of the therapeutic agent from the reservoir, or facilitate depositing the therapeutic agent or composition into the reservoir and/or containing it in the reservoir until released. The invention contemplates that different agents may be deposited into different reservoirs of the same stent.
As shown in the embodiment of FIG. 22, widened struts 2220, 2225 are arranged such that, upon expansion of the stent in a straight vessel, all first widened struts 2220 are oriented in a first angle 2232 relative to a longitudinal axis “x” of the stent and all second widened struts 2225 are oriented in a second angle 2233 that, in the embodiment shown, is the mirror image of first angle 2232 relative to the longitudinal axis “x”. Further, in this embodiment, each first widened strut 2220 is substantially parallel to every other first widened strut 2220 in the same first loop containing section 2260, each second widened strut 2225 is substantially parallel to every other second widened strut 2225 in the same first loop containing section 2260, and every first widened strut 2220 is arranged at an angle 2231 relative to each circumferentially adjacent second widened strut 2225 in the same row 2230 wherein a curved connector 2240, 2250 of the first loop containing section 2260 joins each first widened strut 2220 to an adjacent second widened strut 2225. When the stent is in a crimped state for delivery, the widened struts 2220, 2225 in each first loop containing section are arranged so that they abut one another, i.e. the widened struts 2220, 2225 are stacked substantially parallel to one another and also substantially parallel to a longitudinal axis “x” of the stent. When the stent is expanded in a curved vessel, the orientation of the widened struts relative to each other may vary to accommodate the angles in the vessel.
FIG. 24 illustrates an enlarged view of one embodiment of the first loop containing section 2260 of FIG. 22. Each first curved connector 2240 has a first end 2241 and a second end 2242, and each second curved connector 2250 has a first end 2251 and a second end 2252. The first and second end of each curved connector are defined by points of connection with a first widened strut or a second widened strut. In the embodiment shown in FIG. 24, first widened struts 2220 and second widened struts 2225 occurring in the same loop containing section 2260 are connected to each other by first curved connectors 2240 and second curved connectors 2250. Each first widened strut 2220 is joined to the first end 2241 of a first curved connector 2240 at a second corner 2292 of the first widened strut 2220. Each first widened strut 2220 is also joined to the second end 2252 of a second curved connector 2250 at a first corner 2291 of the first widened strut 2220 located at the opposite corner from the second corner 2292. Thus, the first curved connector 2240 and the second curved connector 2250 are joined to the first widened strut 2220 at opposite corners from each other in the embodiment shown in FIG. 24. Likewise, each second widened strut 2225 is joined to the second end 2242 of a first curved connector 2240 at a second corner 2298 of the second widened strut 2225. Each second widened strut 2225 is also joined to the first end 2251 of a second curved connector 2250 at a first corner 2297 of the second widened strut 2225 located at the opposite corner from the second corner 2298. Thus, the first curved connector 2240 and the second curved connector 2250 are joined to the second widened strut 2225 at opposite corners from each other in the embodiment of FIG. 24.
Curved connectors 2240, 2250 have a width that optionally may be less than the width of widened struts 2220, 2225 such that curved connectors 2240, 2250 may provide increased flexibility between widened struts 2220 and 2225 both in the unexpanded and expanded states for radial expansion and/or bending in embodiments where such increased flexibility is desired. Alternatively, curved connectors of the first loop containing section may be made of more flexible materials than widened struts. Preferably, the configuration of the curved connectors conform with the curvature of the first and second widened struts 2220, 2225 to which the curved connectors are attached. This cooperation between the curved connectors and the widened struts enables the widened struts to stack tightly alongside each other around the circumference of the stent and parallel to a longitudinal axis “x” of the stent when crimped.
In the embodiment of FIG. 22, as further illustrated in FIG. 24, widened struts 2220 and 2225 occur in an alternating sequence, and in the embodiment of FIG. 22 alternating one with another, in a first loop containing section 2260, with first curved connectors 2240 and second curved connectors 2250 connecting them. As described above, a first widened strut 2220 is joined at a second corner 2292 to the first end 2241 of a first curved connector 2240. The same first widened strut 2220 is joined at a first corner 2291 to the second end 2252 of a second curved connector 2250, which in turn is joined at the second end 2251 to a first corner 2297 of a second widened strut 2225. The same second widened strut 2225 is joined at a second corner 2298 to the second end 2242′ of a circumferentially adjacent first curved connector 2240′, which has a first end 2241′ joined to a circumferentially adjacent first widened strut 2220′ at a second corner 2292′. This first widened strut 2220′ is joined to the second end 2252′ of a circumferentially adjacent second curved connector 2250′ at a first corner 2291′. This pattern continues in a repeating sequence to form a first loop containing section 2260 that extends around the entire circumference of the stent in a closed ring. As shown in FIG. 24, the curved members together with the widened struts form loops, such that a first loop L1 having an angle 2315 is formed by a first widened strut 2220, a second widened strut 2225′ and the first curved connector 2240 that connects the widened struts to each other. Likewise, a second loop L2 having an angle 2325 is formed by a second widened strut 2225, a first widened strut 2220 and the second connector member 2250 that connects the widened struts to each other. A cycle of a first loop containing section 2260 therefore includes a first widened strut 2220, a second widened strut 2225 and either a first or second curved connector 2240, 2250, forming one loop L1 or L2, respectively, per cycle as so described. As shown in FIG. 22, the first loop containing section 2260 includes peaks 2261 formed by first curved connectors 2240 opening in a first direction and troughs 2262 formed by second curved connectors 2250 opening in a second direction that is opposite to the first direction. Preferably, first loop containing sections 2260 are arranged in-phase with one another such that the peaks 2261 of adjacent first loop containing sections 2260 are aligned along a longitudinal axis “x” of the stent, and the troughs 2262 of adjacent first loop containing sections 2260 are also aligned along a longitudinal axis “x” of the stent.
Adjacent first loop containing sections 2260 are connected to one another by second loop containing sections 2280, each of which is formed by a series of substantially linear struts connected by curved members. FIG. 25 shows an enlarged portion of the stent of FIG. 22, a second loop containing section 2280 includes struts 2270 a-f connected to one another by curved members 2275 a-f to form loops. Thus, a loop L3 is formed by struts 2270 a and 2270 b together with curved member 2275 a; a loop L4 is formed by struts 2270 b and 2270 c together with curved member 2275 b; a loop L5 is formed by struts 2270 c and 2270 d together with curved member 2275 c; a loop L6 is formed by struts 2270 d and 2270 e together with curved member 2275 d; a loop L7 is formed by struts 2270 e and 2270 f together with curved member 2275 e; and a loop L8 is formed by struts 2270 f and 2270 a′ together with curved member 2275 f. A cycle of a second loop containing section 2280 therefore includes two adjacent struts (e.g. 2270 a and 2270 b) and a curved member joining them together (e.g. 2275 a) to form a loop (e.g. L3), thus having one loop cycle as so described.
A second loop containing section 2280 intersects with curved connectors 2240, 2250 of adjacent first loop containing sections. The intersection may be a point, a strut or a curved member. In the embodiment shown in FIG. 25, the intersection is a curved member 2275 d, 2275 f, which forms part of a second loop containing section 2280 as well as forming a portion of a curved connector 2240, 2250 of a first loop containing section 2260 along the overlap between the first and second loop containing sections. Thus, there is a first overlap portion 2244 defined by a first point of intersection 2296 and second point of intersection 2293 between the first curved connector 2240 of a first loop containing section and a curved portion 2275 c of a second loop containing section, and a second overlap portion 2245 defined by a first point of intersection 2294 and a second point of intersection 2295 between the second curved connector 2250 of a first loop containing section and the curved member 2275 f of a second loop containing section. As shown in FIG. 25, the second loop containing section 2280 in this embodiment intersects with a curved connector 2240, 2250 of a first loop containing section, such that a second loop containing section 2280 intersects with a first curved connector 2240 of a first loop containing section and with a second curved connector 2250 of an adjacent first loop containing section at every third loop of the second loop containing section 2280 in an alternating pattern (i.e. the loop L5 formed by struts 2270 c and 2270 d together with curved member 2275 c, and the loop L8 formed by struts 2270 f and 2270 a′ together with curved member 2275 f). The stent 2210 may be described as comprising first loop containing sections 2260 alternating with second loop containing sections 2280, such that a second loop containing section 2280 occurs between every two adjacent first loop containing sections 2260 and connects them to each other, with a first loop containing section 2260 preferably occurring at either or both ends of the stent. In this configuration, second loop containing sections 2280 provide longitudinal flexibility and compensate for foreshortening of the stent 2210 caused by the first loop containing sections 2260 upon expansion of the stent
The stent 2210 may also be understood as formed of a plurality of interlocking closed cells 2290 formed by a portion of a first loop containing section 2260 including a pair of widened struts 2220, 2225 and a curved connector 2240, 2250, as well as a portion of a second loop containing section 2280. FIG. 26 shows an enlarged view of one embodiment of a cell 2290, which includes two widened struts 2220, 2225 connected together at one end by a second curved connector 2250. In this embodiment, the first widened strut 2220 is joined to the second curved connector 2250 at first corner 2291 and the second widened strut 2225 is joined to the second curved connector 2250 at a first corner 2297. Thus, as described above, the cell 2290 includes one loop L2 of a first loop containing section, the loop L2 opening toward the inside of the cell 2290. As shown in FIG. 22, the first widened strut 2220 is linked to the second loop containing section 2280 via a first curved portion 2243 of a first curved connector 2240 defined by the portion between the second corner 2292 of the first widened strut 2220 and the point of intersection 2293 between the first curved connector 2240 and the strut 2270 d. The second widened strut 2225 is connected to the second loop containing section 2280 via a first curved portion 2245′ of a first curved connector 2240 defined by the portion between the point of intersection 2296′ between the strut 2270 c′ of the second loop containing section 2280 and the first curved connector 2240′ and the second corner 2298 of the second widened strut 2225. In this way, the first widened strut 2220 and the second widened strut 2225 are connected to each other by a portion of a second loop containing section 2280 that includes three loops L3, L5 and L7. A cell thus formed may be described as having one loop L1 or L2 formed by a first widened strut 2220 and a second widened strut 2225 connected by either a first curved connector 2240 or a second curved connector 2250, respectively, as well as three loops L4, L6, L8 or L3, L5, L7, respectively, formed by the struts 2270 a-f and curved members 2275 a-f of a second loop containing section 2280.
When the expanded stent according to this embodiment is bent while inside a lumen, the cells on the outside of the curve increase in longitudinal length, but decrease in circumferential width, whereas the cells on the inside of the curve decrease in longitudinal length, but increase in circumferential width, so that the area of the cell and the density of the struts remains much more constant than otherwise. This results in maintaining a more constant density of stent elements in contact with the lumen, irrespective of location on the inside or outside of a curved section. In turn, when the stent includes reservoirs filled with therapeutic agents, a more even dose is applied to the wall of the vessel, avoiding the possibility that a toxic dose be supplied at one area and/or a less than effective dose is applied to another area.
The stent thus described incorporates a first loop containing section having loops that occur at a first frequency alternating with a second loop containing section having loops that occur at a second frequency that is different than the first frequency, with at least one loop containing section including widened struts with sufficient dimensions to include at least one reservoir as described above. Adjacent loop containing sections are joined directly to each other either by points of connection or overlapping portions such that no additional material is needed to form the stent. One skilled in the art will recognize that the adjacent loop containing sections may be joined at any desired interval, thus resulting in cells that may have variable loop ratios between the loops of the first loop containing section and the loops of the second loop containing section. FIG. 3 shows a stent having cells with a 3:2 loop ratio whereas FIG. 22 shows a stent having cells with a 3:1 loop ratio. The widened struts having reservoirs and curved connectors shown in FIG. 22 may be incorporated into the stent shown in FIG. 3, as well as any other stent providing longitudinal flexibility and radial support upon expansion according to the principles described above. Furthermore, the first loop containing sections and/or second loop containing sections in the stent shown in FIG. 22 may have staggered loops as shown in FIGS. 18A/18B. A stent having widened struts with reservoirs as shown in FIG. 22 also may incorporate first loop containing sections and/or second loop containing sections having undulating members as shown in FIGS. 19-21.
One skilled in the art will recognize that a stent designed according to the principles of the invention may be modified to accommodate the particular needs of a vessel site; for example, individual widened struts or curved members may be removed in order to accommodate the particular needs of a treatment site. Likewise, one or more components of the stent may be provided with increased width, length or depth to modify the relative flexibility and radial support of that component. In addition, the radius of the stent may be increased or decreased along the longitudinal axis of the stent by modifying the circumferential width of any given first loop containing section 2260 or second loop containing section 2280, either by increasing the width of individual components thereof or adding additional widened struts of a first loop containing section or struts of a second loop containing section, for example.
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38 Translated German Office Action, Application No. 101 09 508.2-43, 1 page, dated Feb. 18, 2003
Classification aux États-Unis 623/1.15, 606/108, 606/198
Classification coopérative A61F2/856, A61F2/82, A61F2250/0068, A61F2/915, A61F2/91, A61F2002/91558, A61F2002/91525, A61F2002/91508, A61F2002/91533
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:RICHTER, JACOB;REEL/FRAME:025118/0258