# Patent

## Title
Stent with dual support structure

## Abstract

A intraluminal stent comprises a reticulated tube having an un-deployed diameter and expandable to an enlarged diameter. The tube includes a structural beam extending between first and second ends. The structural beam changes from a first geometry to a second geometry when the tube changes from the un-deployed diameter to the enlarged diameter. The structural beam includes first and second longitudinal elements each extending at least partially between the first and second ends and with a spacing between the first and second elements. Each of said first and second elements changes from the first geometry to the second geometry when the tube changes from the un-deployed diameter to the enlarged diameter for the spacing to remain substantially unchanged as the tube changes from the un-deployed diameter to the enlarged diameter.

## Background
I. CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation of application Ser. No. 10/353,353, filed Jan. 28, 2003, now abandoned which is a continuation of application Ser. No. 09/545,246, filed Apr. 7, 2000, which issued as U.S. Pat. No. 6,533,808 on Mar. 18, 2003, which is a continuation of application Ser. No. 09/069,347, filed Apr. 29, 1998, which issued as U.S. Pat. No. 6,132,461 on Oct. 17, 2000, which is a continuation-in-part of application Ser. No. 09/049,486, filed Mar. 27, 1998, which issued as U.S. Pat. No. 6,132,460 on Oct. 17, 2000, which applications are incorporated herein by reference.


II. BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention pertains to stents for use in intraluminal applications. More particularly, this invention pertains to a novel structure for such stents.
2. Description of the Prior Art
Stents are widely used for numerous applications where the stent is placed in the lumen of a patient and expanded. Such stents may be used in coronary or other vasculature, as well as other body lumens.
Commonly, stents are cylindrical members. The stents expand from reduced diameters to enlarged diameters. Frequently, such stents are placed on a balloon catheter with the stent in the reduced-diameter state. So placed, the stent is advanced on the catheter to a placement site. At the site, the balloon is inflated to expand the stent to the enlarged diameter. The balloon is deflated and removed, leaving the enlarged diameter stent in place. So used, such stents are used to expand occluded sites within a patient's vasculature or other lumen.
Examples of prior art stents are numerous. For example, U.S. Pat. No. 5,449,373 to Pinchasik et al. teaches a stent with at least two rigid segments joined by a flexible connector. U.S. Pat. No. 5,695,516 to Fischell teaches a stent with a cell having a butterfly shape when the stent is in a reduced-diameter state. Upon expansion of the stent, the cell assumes a hexagonal shape.
In stent design, it is desirable for the stent to be flexible along its longitudinal axis to permit passage of the stent through arcuate segments of a patient's vasculature or other body lumen. Preferably, the stent will have at most minimal longitudinal shrinkage when expanded and will resist compressive forces once expanded.
III. SUMMARY OF THE INVENTION
According to a preferred embodiment of the present invention, an intraluminal stent is disclosed. The stent comprises a reticulated tube having an un-deployed diameter and expandable to an enlarged diameter. The tube includes a structural beam extending between first and second ends. The structural beam changes from a first geometry to a second geometry when the tube changes from the un-deployed diameter to the enlarged diameter. The structural beam includes first and second longitudinal elements each extending at least partially between the first and second ends and with a spacing between the first and second elements. Each of said first and second elements changes from the first geometry to the second geometry when the tube changes from the un-deployed diameter to the enlarged diameter for the spacing to remain substantially unchanged as the tube changes from the un-deployed diameter to the enlarged diameter.



IV. BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a first embodiment of a stent according to the present invention shown in a rest diameter state and showing a plurality of stent cells each having a major axis perpendicular to an axis of the stent;
FIG. 2 is a plan view of the stent of FIG. 1 as it would appear if it were longitudinally split and laid out flat;
FIG. 3 is the view of FIG. 2 following expansion of the stent to an enlarged diameter;
FIG. 4 is a view taken along line 4-4 in FIG. 2;
FIG. 5 is a view taken along line 5-5 in FIG. 2;
FIG. 6 is an enlarged view of a portion of FIG. 2 illustrating a cell structure with material of the stent surrounding adjacent cells shown in phantom lines;
FIG. 7 is the view of FIG. 2 showing an alternative embodiment of the present invention with a cell having five peaks per longitudinal segment;
FIG. 8 is the view of FIG. 2 showing an alternative embodiment of the present invention with a major axis of the cell being parallel to an axis of the stent;
FIG. 9 is the view of FIG. 5 following expansion of the stent to an enlarged diameter;
FIG. 10 is a plan view of a first prior art stent as it would appear if it were longitudinally split and laid out flat;
FIG. 11 is the view of FIG. 10 with the stent modified for support beams to include parallel, spaced elements in accordance with the present invention;
FIG. 12 is a plan view of a second prior art stent as it would appear if it were longitudinally split and laid out flat; and
FIG. 13 is the view of FIG. 12 with the stent modified for support beams to include parallel, spaced elements in accordance with the present invention.



V. DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the several drawing figures in which identical elements are numbered identically, a description of the preferred embodiment of the present invention will now be provided. Where several embodiments are shown, common elements are similarly numbered and not separately described with the addition of apostrophes to distinguish the embodiments.
As will be more fully described, the present invention is directed to a novel support beam for an expandable stent. The support beam is applicable to a wide variety of stent designs. In a preferred embodiment, the support beam will be used as a longitudinal segment in a stent as described in the aforementioned U.S. patent application Ser. No. 09/049,486 filed Mar. 27, 1998, entitled “STENT” and naming Paul J. Thompson as sole inventor. Therefore, such a stent will now be described with reference to FIGS. 1 to 9. Subsequently, the use of the novel beam will be described in use with other stent designs (i.e., those shown in U.S. Pat. No. 5,449,373 to Pinchasik et al. and U.S. Pat. No. 5,695,516 to Fischell) to illustrate the broad range of applicability of the novel support beam to a wide range of other stent designs.
FIG. 1 illustrates a stent 10 having a rest length Lr and an un-deployed or reduced diameter Dr. The stent 10 is of the design shown in the aforementioned U.S. patent application. The slot of the novel beam construction, as will be described, is not shown in FIG. 1.
For ease of illustration, the stent 10 is shown flat in FIG. 2 which illustrates a rest circumference Cr (Cr=πDr). In FIG. 2, locations A, B, C, D and E are shown severed from their normally integrally formed locations A1, B1, C1, D1 and E1. This permits the stent 10 to be shown as if it were severed at normally integrally formed locations A-A1, B-B1, C-C1, D-D1 and E-E1 and laid flat. FIG. 6 is an enlarged portion of the view of FIG. 2 to better illustrate a cell structure as will be described.
The stent 10 is a reticulated, hollow tube. The stent 10 may be expanded from the rest diameter Dr (and corresponding rest circumference Cr) to an expanded or enlarged diameter. FIG. 3 is a view similar to FIG. 2 (i.e., illustrating the expanded stent 10 as it would appear if longitudinally split and laid flat). Since FIG. 3 is a two-dimensional representation, the enlarged diameter is not shown. However, the enlarged circumference Ce is shown as well as a length Le following expansion. The expanded diameter is equal to Ce/π.
As will be discussed length Le is preferably not more than minimally smaller (e.g., less than 10% smaller) than length Lr. Ideally, Le equals Lr.
The material of the stent 10 defines a plurality of cells 12. The cells 12 are bounded areas which are open (i.e., extend through the wall thickness of the stent 10). The stent 10 may be formed through any suitable means including laser or chemical milling. In such processes, a hollow cylindrical tube is milled to remove material and form the open cells 12.
The cells 12 have a longitudinal or major axis XM-XM and a transverse or minor axis Xm-Xm. In the embodiments of FIGS. 1-3, the major axis XM-XM is perpendicular to the longitudinal cylindrical axis X-X of the stent 10. In the embodiments of FIGS. 8 and 9, the major axis XM′-XM′ is parallel to the longitudinal cylindrical axis X′-X′ of the stent 10′. The cell 12 is symmetrical about axes XM-XM and Xm-Xm.
The cell 12 is defined by portions of the tube material including first and second longitudinal segments or support beams 14. The beams 14 each have a longitudinal axis Xa-Xa (shown in FIG. 6). The beams' longitudinal axes Xa-Xa are parallel to and positioned on opposite sides of the cell major axis XM-XM.
Referring to FIG. 6, each of longitudinal beams 14 has an undulating pattern to define a plurality of peaks 17, 21, 25 and valleys 19, 23. The peaks 17, 21, 25 are spaced outwardly from the longitudinal axes Xa-Xa and the valleys 19, 23 are spaced inwardly from the longitudinal axes Xa-Xa. As used in this context, “inward” and “outward” mean toward and away from, respectively, the cell's major axis XM-XM.
Each of the peaks 17, 21, 25 and valleys 19, 23 is a generally semi-circular arcuate segment. The peaks 17, 21, 25 and valleys 19, 23 are joined by parallel and spaced-apart straight segments 16, 18, 20, 22, 24 and 26 which extend perpendicular to the major axis XM-XM. Linearly aligned straight end portions 16, 26 of opposing segments 14 are joined at first and second longitudinal connection locations 27 spaced apart on the major axis XM-XM. First and second transverse connection locations 28 are spaced apart on the minor axis Xm-Xm. The first and second transverse connection locations 28 are positioned at the apices of the center peaks 21 of the longitudinal beams 14.
Slots 30 are formed through the complete thickness of each of the beams 14. The slots 30 extend between first and second ends 31, 32. The first ends 31 are adjacent the longitudinal connection locations 27. The second ends 32 are adjacent the transverse connection locations 28. The slots 30 divide the beams 14 into first and second parallel elements 141, 142.
Except as will be described, the beams 14 have uniform cross-sectional dimensions throughout their length as illustrated in FIG. 4. By way of non-limiting example, the width W and thickness T of the straight line segments 16, 18, 20, 22, 24 and 26 are about 0.0065 inch (about 0.16 mm) and about 0.0057 inch (about 0.14 mm), respectively. The width W includes the widths (each of equal width) of the two elements 141, 142 plus the width WS of the slot 30. By way of a non-limiting example, the width WS is in the range of 0.001 to 0.0025 inch. By way of another non-limiting example, the width WS is less than 0.005 inch.
For reasons that will be described, the width W′ (FIG. 5) at the apices of the peaks 17, 21, 25 and valleys 19, 23 is narrower than width W (in the example given, narrow width W′ is about 0.005 inch or about 0.13 mm). The width of the peaks 17, 21, 25 and valleys 19, 23 gradually increases from width W′ at the apices to width W at the straight segments 16, 18, 20, 22, 24 and 26. At the longitudinal and transverse connection locations 27, 28, the width WC (shown in FIG. 2) is preferably equal to or less than the common width W. Preferably, the width WS of slot 30 remains constant throughout its length.
The combined lengths of segments 16-20 to the apex of peak 21 represent a path length 50 from longitudinal connection location 27 to transverse connection location 28. Similarly the combined lengths of the other arcuate and straight segments 22-26 to the apex of peak 21 represent identical length path lengths 51 of identical geometry from longitudinal connection locations 27 to transverse connection locations 28. Each of the path lengths 50, 51 is longer than a straight-line distance between the transverse and longitudinal connection locations 27, 28. As will be described, the straight-line distance between the traverse and longitudinal connection locations 27, 28 increases as the diameter of the stent 10 is expanded. The path lengths 50, 51 are sized to be not less than the expanded straight-line distance.
The stent 10 includes a plurality of identical cells 12. Opposite edges of the segments 14 define obliquely adjacent cells (such as cells 121, 122 in FIG. 2). Cells 12 having major axes XM-XM collinear with the major axis XM-XM of cell 12 are interconnected at the longitudinal connection locations 27. Cells having minor axes collinear with the minor axis Xm-Xm of cell 12 are interconnected at the transverse connection locations 28.
As mentioned, the stent 10 in the reduced diameter of FIG. 1 is advanced to a site in a lumen. The stent 10 is then expanded at the site. The stent 10 may be expanded through any conventional means. For example, the stent 10 in the reduced diameter may be placed on the balloon tip of a catheter. At the site, the balloon is expanded to generate radial forces on the interior of the stent 10. The radial forces urge the stent 10 to radially expand without appreciable longitudinal expansion or contraction. Plastic deformation of the material of the stent 10 (e.g., stainless steel) results in the stent 10 retaining the expanded shape following subsequent deflation of the balloon. Alternatively, the stent 10 may be formed of a super-elastic or shape memory material (such as nitinol—a well-known stent material which is an alloy of nickel and titanium).
As the stent 10 expands, the path lengths 50, 51 straighten to accommodate the expansion. During such change in geometry of the path lengths 50, 51, each of the elements 141, 142 similarly changes in geometry so that. At all times, the elements 141, 142 are mutually parallel and separated by spacing 30.
FIG. 3 illustrates the straightening of the path lengths 50, 51. In FIG. 3, the stent 10 has been only partially expanded to an expanded diameter less than a maximum expanded diameter. At a maximum expanded size, the path lengths 50, 51 are fully straight. Further expansion of the stent 10 beyond the maximum expanded size would result in narrowing of the minor axis Xm-Xm (i.e., a narrowing of a separation between the transverse connection locations and a resulting narrowing of the length Lr of the stent) or would require stretching and thinning of the stent material.
As shown in FIG. 3, during expansion of the stent 10, the straight segments 16, 18, 20, 22, 24 and 26 are substantially unchanged. The straightening of the path lengths 50, 51 results in bending of the arcuate peaks 17, 21, 25 and valleys 19, 23. Since the width W of the peaks 17, 21, 25 and valleys 19, 23 is less than the width W of the straight segments 16, 18, 20, 22, 24 and 26, the arcuate peaks 17, 21, 25 and valleys 19, 23 are less stiff than the straight segments 16, 18, 20, 22, 24 and 26 and, therefore, more likely to deform during expansion.
As the geometry of the beams 14 changes during expansion, the geometry of the first and second elements 141, 142 similarly changes so that the elements 141, 142 remain in mutually parallel relation both before and after expansion. As used in this application, the term “mutually parallel” means the spacing 30 between the elements 141, 142 is substantially constant throughout the length of the elements 141, 142. The elements 141, 142 and beam 14 may be curved or straight throughout their lengths.
As the stent 10 expands, the cells 12 assume a diamond shape shown in FIG. 3. Since the expansion forces are radial, the length of the major axis XM-XM (i.e., the distance between the longitudinal connection locations 27) increases. The length of the minor axis Xm-Xm (and hence the length of the stent 10) remains unchanged.
The stent 10 is highly flexible. To advance to a site, the axis X-X of the stent 10 must bend to navigate through a curved lumen. Further, for placement at a curved site in a lumen, the stent 10 must be sufficiently flexible to retain a curved shape following expansion and to bend as the lumen bends over time. The stent 10, as described above, achieves these objections.
When bending on its axis X-X, the stent 10 tends to axially compress on the inside of the bend and axially expand on the outside of the bend. The present design permits such axial expansion and contraction. The novel cell geometry 12 results in an accordion-like structure which is highly flexible before and after radial expansion. Further, the diamond shape of the cells 12 after radial expansion resists constricting forces otherwise tending to collapse the stent 10.
The dual support structure of the elements separated by the slots increases flexibility without reducing resistance to compression forces. Further, during expansion and during flexing of the stent on its axis, the use of parallel, spaced elements 141, 142 results in lower stress levels than would be experienced by a solid beam.
Numerous modifications are possible. For example the stent 10 may be lined with either an inner or outer sleeve (such as polyester fabric or ePTFE) for tissue growth. Also, the stent may be coated with radiopaque coatings such as platinum, gold, tungsten or tantalum. In addition to materials previously discussed, the stent may be formed of any one of a wide variety of previous known materials including, without limitation, MP35N, tantalum, platinum, gold, Elgiloy and Phynox.
While three cells 12 are shown in FIG. 2 longitudinally connected surrounding the circumference Cr of the stent, a different number could be so connected to vary the properties of the stent 10 as a designer may elect. Likewise, while each column of cells 12 in FIG. 2 is shown as having three longitudinally connected cells 12, the number of longitudinally connected cells 12 could vary to adjust the properties of the stent. Also, while each longitudinal segment 14 is shown as having three peaks 17, 21, 25 per longitudinal segment 14, the number of peaks could vary. FIG. 7 illustrates a stent 10′′ with a cell 12′′ having five peaks 117′′, 17′′, 21′′, 25′′ and 125′′ per longitudinal segment 14′′. Preferably, the longitudinal segment will have an odd number of peaks so that the transverse connection points are at an apex of a center peak. In FIG. 7, no slot is shown in the beams 14′′ for ease of illustration.
FIGS. 8 and 9 illustrate an alternative embodiment where the major axis XM′-XM′ of the cells 12′ are parallel with the cylindrical axis X′-X′ of the stent 10′. In FIG. 9, the expanded stent 10′ is shown at a near fully expanded state where the path lengths 50′, 51′ are substantially linear. In FIGS. 8 and 9, no slots are shown in the beams 14′ for ease of illustration.
FIGS. 10 and 12 illustrate prior art stent designs. FIG. 10 is a stent 10a as shown in U.S. Pat. No. 5,449,373 to Pinchasik et al. and FIG. 12 is a stent 10b as shown in U.S. Pat. No. 5,695,516 to Fischell. Stent 10a is shown flat as if longitudinally split at locations Aa-Aa1 through Pa-Pa1. Similarly, Stent 10b is shown flat as if longitudinally split at locations Ab-Ab1 through Eb-Eb1.
Both of the designs of FIGS. 10 and 12 include solid structural beams 14a, 14b. Beams 14a are curved when the stent 10a is in a reduced diameter state. The beams 14a cooperate to define cells 12a. The curved beams 14a straighten when the stent 10a expands. The beams 14b are straight and cooperate to define a butterfly-shaped cell 12b. Upon expansion, the beams 14b remain straight but pivot for the cell 12b to assume a hexagon shape upon expansion.
The dual support structure aspect of the present invention is applicable to prior art stents such as those shown in FIGS. 10 and 12. FIGS. 11 and 13 show the prior art stents of FIGS. 10 and 11, respectively, modified according to the dual support structure aspect of the present invention. Specifically, beams 14a′, 14b′ are provided with slots 30a, 30b to divide the beams into parallel, spaced first and second elements 14a1′, 14a2′ and 14b1′, 14b2′ having the benefits previously described.
From the foregoing, the present invention has been shown in a preferred embodiment. Modifications and equivalents are intended to be included within the scope of the appended claims.

## Claims

1. A stent comprising:
a reticulated tube having an undeployed diameter and an enlarged diameter, wherein the tube comprises a structural beam between a first end of the tube and a second end of the tube, said structural beam extending substantially perpendicular to a longitudinal axis of the tube in the undeployed diameter and the enlarged diameter,
wherein the structural beam comprises:
(a) a first longitudinal element and second longitudinal element extending substantially parallel to one another, said first and second longitudinal elements having an undulating pattern that defines a plurality of peaks and valleys extending at least partially between the first and second ends of the tube, each of the peaks and valleys being a semicircular arcuate segment and being separated by substantially parallel segments, the peaks having a width that is smaller than the width of the substantially parallel segments; and
(b) a slot between the first and the second longitudinal elements,

wherein the width of the slot remains substantially unchanged as the tube expands from the undeployed diameter to the expanded diameter and wherein the structural beam changes from a first geometry to a second geometry when the tube changes from the undeployed diameter to the enlarged diameter.

2. The stent of claim 1, further comprising a plurality of cells.

3. The stent of claim 2, wherein the cells are substantially identical.

4. The stent of claim 1 wherein the substantially parallel segments remain substantially parallel as the stent expands from the undeployed diameter to the expanded diameter.

5. The stent of claim 2, wherein the cells assume a diamond shape as the stent expands form the undeployed diameter to the expanded diameter.

6. The stent of claim 1, wherein the stent is a balloon expandable stent.

7. The stent of claim 1, wherein the stent is made of a shape memory material.

8. The stent of claim 7, wherein the shape memory material is nitinol.

9. A stent comprising:
a stent body expandable between an undeployed orientation and a deployed orientation,
the stent body having cell defining portions including first and second longitudinal segments which are fixedly attached to each other at opposite ends thereof, said cell defining portions extending substantially perpendicular to a longitudinal axis of the stent body in the undeployed orientation and the deployed orientation,
wherein the first and second longitudinal segments each comprise:
(a) a first longitudinal element and second longitudinal element extending substantially parallel to one another, said first and second longitudinal elements having an undulating pattern that defines a plurality of peaks and valleys extending at least partially between the first and second ends of the longitudinal segment, each of the peaks and valleys being a semicircular arcuate segment and being separated by substantially parallel segments, the peaks having a width that is smaller than the width of the substantially parallel segments; and
(b) a slot between the first and the second longitudinal element.

10. The stent of claim 9, further comprising a plurality of cells.

11. The stent of claim 10, wherein the cells are identical.

12. The stent of claim 9 wherein the parallel straight segments remain parallel as the stent expands from the undeployed diameter to the expanded diameter.

13. The stent of claim 10, wherein the cells assume a diamond shape as the stent expands form the undeployed diameter to the expanded diameter.

14. The stent of claim 9, wherein the stent is a balloon expandable stent.

15. The stent of claim 9, wherein the stent is made of a shape memory material.

16. The stent of claim 15, wherein the shape memory material is nitinol.

17. A stent comprising:
a stent body expandable between an undeployed orientation and a deployed orientation;
the stent body having cell defining portions with opposing surfaces defining an open cell bounded by the cell defining portions, the cell having a major axis and a minor axis;
the cell defining portions including first and second longitudinal segments each of which includes:
(a) a longitudinal axis extending parallel to the cell major axis, the longitudinal axis being positioned on opposite sides of the cell major axis; and
(b) an undulating pattern that defines a plurality of peaks and valleys spaced outwardly and inwardly, respectively, from the longitudinal axes;

the first and second longitudinal segments being interconnected at opposite ends thereof;
the stent body further including first and second longitudinal connection locations at interconnection points of the interconnected first and second longitudinal segments for connection of the cell to first and second longitudinally adjacent cells, respectively, and first and second transverse connection locations on the first and second longitudinal segments, respectively, for connection of the cell to first and second transversely adjacent cells, respectively;
the cell defining portions being symmetrical about both the major axis and the minor axis;
the first and second longitudinal connection locations being positioned on the major axis;
sets of substantially parallel portions that interconnect the peaks and valleys; and
wherein the peaks have a width that is smaller than the width of the substantially parallel portions.

18. The stent of claim 17, wherein the peaks include apices, and the width of the longitudinal segments decrease as said longitudinal segments extend toward said apices.

19. The stent of claim 17, wherein the stent is a balloon expandable stent.

20. The stent of claim 17, wherein the stent is made of a shape memory material.

21. The stent of claim 20, wherein the shape memory material is nitinol.

22. The stent of claim 17, wherein the first and second transverse connection locations are positioned on the minor axis.