IL135382A - Flexible expandable stent - Google Patents

Abstract

An expandable stent defining a longitudinal aperture, including: a plurality of flexible connected cells, each of said flexible cells comprising: (a) a first member having a longitudinal component having a first end and second end; (b) a second member having a longitudinal component having a first end and second end; (c) a third member (15) having a longitudinal component having a first end and second end; (d) a fourth member having a longitudinal component having a first end and second end; 1906 ז' באב התשס" ד - July 25, 2004 (e) a first loop (14) defining a first angle disposed between said first end of said first member and said first end of said second member; (f) a second loop (16) defining a second angle disposed between said second end of said third member and said second end of said fourth member, and disposed generally opposite to said first loop; (g) a first flexible compensating member or flexible link having a first end and a second end disposed between said first member and said third member, said first end of said first flexible compensating member of flexible link communicating with said second end of said first member and said second end of said first flexible compensating member of flexible link communicating with said first end of said third member, said first and said second ends disposed a variable longitudinal distance from each other; (h) a second flexible compensating member or flexible link having a first end and a second end disposed between said second member and said fourth member, said first end of said second flexible compensating member or flexible link communicating with said second end of said second member and said second end of said second flexible compensating member or flexible link communicating with said first end of said fourth member, said first and said second ends disposed a variable longitudinal distance from each other, said first and said second flexible compensating member or flexible links differentially extendible or compressible when said stent is bent in a curved direction away from the longitudinal axis of said aperture; and (i) said first, said second, said third, and said fourth members and said first and said second loops, and said first and said second flexible compensating member or flexible links disposed so that as said stent is expanded the distance between said first and said second flexible compensating member or flexible links increases and the longitudinal component of said first, second, third and fourth members decreases while said first and said second loops remain generally opposite to one another, the ends of said first and said second flexible compensating member or flexible links open so as to increase said variable longitudinal distance between said first and said second ends of said first flexible compensating member or flexible link so as to increase said variable longitudinal distance between said first and said second ends of said second flexible compensating member or flexible link so as to compensate for the decreasing of the longitudinal component of said first, second, third and fourth members and substantially lessen the foreshortening of said stent upon its expansion. 1907 ז' באב התשס" ד - July 25, 2004

Description

A FLEXIBLE EXPANDABLE STENT Eitan, Pearl, Latzer & Cohen-Zedek P-577-IL1 P-577-IL1 A FLEXIBLE EXPANDABLE STENT Henry Marshall Israel and Gregory Pinchasik FIELD OF THE INVENTION The present invention relates generally to stents for implanting into a living body.

BACKGROUND OF THE INVENTION Various stents are known in the art wherein, for the present application, the term "stent" indicates a device, made of body-compatible material, which is utilized to widen a blood vessel, or other orifice in the body, and to maintain the resultant size of the lumen. Typically, the stent is delivered to the desired location in the body with an inflatable balloon and, when the balloon is inflated, the stent expands, thereby widening the orifice. Other mechanical devices which cause expansion of the stent are also utilized.

Exemplary patents in the field of stents formed of wire are: U.S. 5,019,090 to Pinchuk, U.S. 5,161 ,547 to Tower, U.S. 4,950,227 to Savin, et al., U.S. 5,314,472 to Fontaine, U.S. 4,886,062 and U.S. 4,969,458 to Wiktor and U.S. 4,856,516 to Hillstead. Stents formed of cut stock metal are described in: U.S. 4,733,665 to Palmaz, U.S. 4,762,128 to Rosenbluth, U.S. 5,102,417 to Palmaz and Schatz, U.S. 5,195,984 to Schatz and WO 91 FR013820 to Meadox.

The stents described in U.S. 5,102,417 to Palmaz and Schatz have expandable tubular grafts connected together with a flexible connector. The grafts are formed of a plurality of slots disposed parallel to the longitudinal axis of the tube. The flexible connectors are helical connectors. Since the tubular grafts are relatively rigid, the flexible connectors are needed so that the stents can bend when being fed through a curved blood vessel. When the stents of U.S. 5,102,417 expand, the grafts expand radially and, consequently, shrink longitudinally. However, at the same time, P-577-IL1 the helical connectors twist. The twisting motion is most probably harmful to the blood vessel.

U.S. 5,195,984 to Schatz describes a similar stent but with one straight connector, parallel to the longitudinal axis of the tubular grafts, between tubular grafts. The straight member removes the twisting motion; however, it is not a very strong connector.

P-577-IL1 SUMMARY OF THE PRESENT INVENTION It is therefore an object of the present invention to provide a flexible stent which minimally shrinks, in the longitudinal direction, during expansion.

The stent of the present invention is formed of a tube having a patterned shape which has first and second meander patterns having axes extending in first and second directions wherein the second meander patterns are intertwined with the first meander patterns. The first and second directions can be orthogonal to each other.

In accordance with one embodiment of the present invention, the first meander patterns are formed into even and odd first meander patterns. The even and odd first meander patterns are 180° out of phase with each other and the odd patterns occur between every two even patterns. The second meander patterns can also be formed of even and odd patterns.

Additionally, in accordance with a preferred embodiment of the present invention, the second meander patterns have two loops per period and the even and odd first meander patterns are connected on first and second sides, respectively, of each loop of the second meander patterns.

Alternatively or in addition, the second meander patterns are formed of even and odd second meander patterns. In this embodiment, the even and odd first meander patterns have loops and the even and odd second meander patterns are connected to the even and odd first meander patterns so as to leave one full loop between each pair of even and odd second meander patterns.

Moreover, in accordance with a preferred embodiment of the present invention, the first and second meander patterns are formed from flat metal. Alternatively, they can be cut from wire. Further, they can be imbedded or covered with any body-compatible material.

P-577-IL1 BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: Fig. 1 is an illustration of a patterned stent, constructed and operative in accordance with a first preferred embodiment of the present invention; Fig. 2 is an illustration of the pattern of the stent of Fig. 1 ; Fig. 3 is an illustration of the stent of Fig. 1 in a bent position; Fig. 4 is an illustration of the stent of Fig. 1 in an expanded format; Figs. 5A and 5B are illustrations of the changes in the patterns of the stent of Fig. 1 due to expansion; Fig. 6 is a schematic illustration of a second embodiment of the pattern for a stent; Fig. 7 is an illustration of a third embodiment of the pattern for the stent; and Fig. 8 is an illustration of the pattern of Fig. 7 in an expanded format.

P-577-IL1 DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Reference is now made to Figs. 1 - 4 which illustrate a first embodiment of a stent, constructed and operative in accordance with the principles of the present invention. Fig. 1 illustrates the stent in its non-expanded form, Fig. 2 illustrates the pattern of the stent, Fig. 3 illustrates it in a partially bent position and Fig. 4 illustrates it in an expanded form.

The stent of the present invention is a tube whose sides are formed into 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 and "orthogonal meander patterns" are patterns whose center lines are orthogonal to each other.

In the stent of Figs. 1 - 4, the two meander patterns are labeled 1 1 and 12 and they are most easily seen in Fig. 2. Meander pattern 11 is a vertical sinusoid having a vertical center line 9. Meander pattern 11 has two loops 14 and 16 per period wherein loops 14 open to the right while loops 16 open to the left. Loops 14 and 16 share common members 15 and 17, where member 15 connects from one loop 14 to its following loop 16 and member 15 connects from one loop 16 to its following loop 14.

Meander pattern 12 is an horizontal pattern having an horizontal center line 13. Meander pattern 12 also has loops, labeled 18 and 20, but between loops of a period is an extended straight section labeled 22. Loops 18 open downwards and loops 20 open upwards. Vertical meander pattern 1 1 is provided in odd and even (o and e) versions which are 80° out of phase with each other. Thus, each left opening loop 16 of meander pattern 11o faces a right opening loop 14 of meander pattern 11e and a right opening loop 14 of meander pattern 11o faces a left opening loop 16 of meander pattern 1 e.

Horizontal meander pattern 12 is also provided in odd and even forms.

The straight sections 22 of horizontal meander pattern 12e intersect with every third common member 17 of vertical meander pattern 11e. The straight sections 22 of P-577-IL1 horizontal meander pattern 12o intersect with every third common member 15 of vertical meander pattern 11e, beginning with the common member 15 two after an intersected common member 17. The result is a full loop 14 between meander patterns 12e and 12o and a full loop 16 between meander patterns 12o and 12e.

Returning to Fig. 1 , the pattern of Fig. 2 is formed into a tube 30 of an easily deformable material, such as a metal. Due to the two meander patterns, the stent of Fig. 1 , when attached over a catheter balloon, is flexible and can therefore be easily dragged through curved blood vessels. An example of the way in which the stent of Fig. 1 bends is illustrated in Fig. 3.

In Fig. 3, the stent begins to bend at the point marked A in the direction marked by arrow 40. As the stent begins to curve, the section marked I becomes the inside of the curve while the section marked 0 becomes the outside of the curve. The inside of the curve I is shortened vis-a-vis the outside of the curve 0.

During bending, the loops 14 - 20 to the right of the point A change shape in order to compensate for the differences in length between the inside and outside curves. For example, loops 18i and 20i near the inside of the curve are closer together than loops 18o and 20o on the outside of the curve, which expand. Loops 14i and 16i near the inside I are compressed while the loops 14o and 16o closer to the outside O of the curve are expanded.

As can be seen, both meander patterns 11 and 12 are involved in the bending. Although not shown, it will be appreciated that the stent of Figs. 1 - 4 can bend in any direction and in more than one direction at any time.

Fig. 4 illustrates the stent of Fig. 1 in its expanded form. When the stent expands, both meander patterns 1 1 and 12 expand (i.e. all loops 14 - 20 open up). As can be seen, the expanded stent has two types of enclosed spaces, a large space 42 between meander patterns 12o and 12e and a small space 44 between meander patterns 12e and 12o. As can also be seen, each large space 42 has two loops 14 on its left side and two loops 16 on its right side. The large spaces between vertical meander patterns 1 1 e and 11 o, which are labeled 42a, have loops 18 at their tops and bottoms while the large spaces between vertical meander patterns 1 1o and 11e, which P-577-IL1 are labeled 42b, have loops 20 at their tops and bottoms. Similarly for small spaces 44a and 44b.

It is noted that, due to the orthogonal meander patterns 11 and 12, the stent of Fig. 1 does not significantly shrink during expansion. This is illustrated in detail in Figs. 5A and 5B to which reference is now made. Fig. 5A illustrates the movement, during expansion, of one vertical meander pattern 11 and Fig. 5B illustrates the movement, during expansion, of one horizontal meander pattern 12. The original patterns are shown with solid lines and the expanded patterns are shown with dashed lines.

The vertical meander pattern 11 of Fig. 5A expands by widening its loops 14 and 16. As a result, the vertical meander pattern 11 grows vertically by an amount 2*hi per loop. However, it also shrinks horizontally, by an amount 2*di. Similarly, the horizontal meander pattern 12 of Fig. 5B expands by widening its loops 18 and 20. As a result, the horizontal meander pattern 12 grows horizontally by an amount 2*d2 per loop. However, it also shrinks vertically, by an amount i2. Thus, the vertical growth of the vertical meander pattern 1 compensates, at least partially, for the vertical shrinkage of the horizontal meander pattern 12, and vice versa. It is noted that the end portions of any stent are only partially compensated and therefore, may shrink somewhat.

It will be appreciated that the two orthogonal meander patterns 11 and 12 and the compensation they provide to each other provides flexibility to the unexpanded stent of Fig. 1. However, when the stent is expanded, the changes in each of loops 14 and 16 provide rigidity to the resultant stent and thus, enable the stent to maintain a blood vessel at a desired inner diameter.

The stent of the present invention can be manufactured from flat metal which is etched into the pattern of Fig. 2. The etched metal is then bent to form the tube 30. Alternatively, the pattern of Fig. 2 can be manufactured from welded or twisted wire.

It will be appreciated that the stent of the present invention can be made from metal and/or wire. Additionally, it can be plated with a protective material, P-577-IL1 embedded with a medicine, and/or covered with a material which can fill in the spaces 42 and 44.

It will be appreciated that the present invention encompasses all stents manufactured with a pattern formed of two meander patterns, orthogonal or otherwise. Another exemplary pattern, also with orthogonal meander patterns, is provided herein wherein Fig. 6 is a schematic version and Fig. 7 is a more rounded version. Fig. 8 shows the pattern of Fig. 7 in an expanded format. The pattern of Figs. 6 and 7 is similar to that shown in Fig. 2 except that it has more horizontal meander patterns 12 and they are of one kind, rather than being even and odd as in Fig. 2.

As can be seen in both Figs. 6 and 7, there are two types of vertical meander patterns 11e and 11o which are 180° out of phase with each other. The horizontal meander patterns 12 connect with every line 15 of vertical meander pattern 11e.

Fig. 8 illustrates the pattern of Fig. 7 in an expanded format. Since there are no even and odd horizontal meander patterns, in the expanded format of Fig. 8, there are no large and small spaces. Instead, all spaces are of the same size.

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 hereinabove. Rather the scope of the present invention is defined by the claims which follow: P-577-IL1

Claims (13)

1. An expandable stent defining a longitudinal aperture, including: a plurality of flexible connected cells, each of said flexible cells comprising: a) a first member having a longitudinal component having a first end and second end; b) a second member having a longitudinal component having a first end and second end; c) a third member having a longitudinal component having a first end and second end; d) a fourth member having a longitudinal component having a first end and second end; e) a first loop defining a first angle disposed between said first end of said first member and said first end of said second member; f) a second loop defining a second angle disposed between said second end of said third member and said second end of said fourth member, and disposed generally opposite to said first loop; g) a first flexible compensating member or flexible link having a first end and a second end disposed between said first member and said third member, said first end of said first flexible compensating member or flexible link communicating with said second end of said first member and said second end of said first flexible compensating member or flexible link communicating with said first end of said third member, said first and said second ends disposed a variable longitudinal distance from each other; h) a second flexible compensating member or flexible link having a first end and a second end disposed between said second member and said fourth member, said first end of said second flexible compensating member or flexible link communicating with said second end of said second member and said second end of said second flexible compensating member or flexible link communicating with said first end of said fourth member, said first and said second ends disposed a variable longitudinal distance from each other, said first and said second flexible P-577-IL1 compensating member or flexible links differentially extendible or compressible when ) said stent is bent in a curved direction away from the longitudinal axis of said aperture; and i) said first, said second, said third, and said fourth members and said first 5 and said second loops, and said first and said second flexible compensating member or flexible links disposed so that as said stent is expanded the distance between said first and said second flexible compensating member or flexible links increases and the longitudinal component of said first, second, third and fourth members decreases while said first and said second loops remain generally 10 opposite to one another, the ends of said first and said second flexible compensating member or flexible links open so as to increase said variable longitudinal distance between said first and said second ends of said first flexible compensating member or flexible link so as to increase said variable longitudinal distance between said first and said second ends of said second flexible 15 compensating member or flexible link so as to compensate for the decreasing of the longitudinal component of said first, second, third and fourth members and substantially lessen the foreshortening of said stent upon its expansion.

2. The stent of claim 1 wherein the material of said first and said second 20 compensating members is provided with a width that is smaller than the width of the material of said first and said second loops.

3. The stent according to claim 2 wherein said compensating members define an area of inflection between said first end and said second end and said area of 25 inflection remains inflected after the expansion of said stent.

4. The stent of claim 3 in which the area of inflection enlarges during the expansion the stent. 30 5. The stent of claim 1 in which said members are generally straight.

5. P-577-IL1

6. The stent of claim 1 wherein said first flexible compensating member or flexible link is arcuate and said second flexible compensating member or flexible link is arcuate and said compensating members elongate in an amount substantially equal to the amount that the distance between the ends of said first and second members and said third and fourth members increases when said stent is expanded.

7. The stent of claim 1 wherein said cells define a uniform cellular structure.

8. The stent of claim 1 wherein said first flexible compensating member or flexible link and said second flexible compensating member or flexible link also serve to connect other cells which themselves have first and second compensating members.

9. The stent of claim 1 wherein said first and said second flexible compensating member or flexible links do not tend to project into or outside of said longitudinal aperture when said stent is expanded.

10. The stent of claim 1 wherein said first and said second flexible compensating member or flexible links do not tend to project into or outside of said longitudinal aperture when said stent is flexed.

11. An expandable stent having a longitudinal axis, which consists essentially of: a plurality of flexible cells having a longitudinal axis and a first longitudinal and a second longitudinal end, said cells disposed about the circumference of the stent, each of said cells comprising: a first pair of members connected by an area of inflection generally disposed at said first longitudinal end of said cell; a second pair of members connected by an area of inflection generally disposed at said longitudinal end of said cell, and P-577-IL1 a plurality of flexible links connecting said first and second pair of members and generally disposed between each neighboring cell about the circumference of said stent, wherein said flexible links have some area with a width smaller than the width of said areas of inflection.

12. The stent according to any of claims 1 - 11 , substantially as described hereinabove.

13. The stent according to any of claims 1 - 11 , substantially as illustrated in any of the drawings. P-577-IL1