AU745664B2

AU745664B2 - A stent

Info

Publication number: AU745664B2
Application number: AU31246/99A
Authority: AU
Inventors: Henry M Israel; Gregory Pinchasik
Original assignee: Medinol Ltd
Current assignee: Medinol Ltd
Priority date: 1994-07-28
Filing date: 1999-05-25
Publication date: 2002-03-28
Anticipated expiration: 2015-07-26
Also published as: AU3124699A

Description

Regulation 3.2

AUSTRALIA

Patents Act 1952 COMPLETE SPECIFICATION FOR A STANDARD PATENT

(ORIGINAL)

*r 9*

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Name of Applicant: Actual Inventors: Address for Service: Invention Title: Medinol Ltd.

Kiryat Atidim, P.O. Box 58165, 61581 Tel Aviv, ISRAEL ISRAEL, Henry M.

PINCHASIK, Gregory DAVIES COLLISON CAVE, Patent Attorneys, 1 Little Collins Street, Melbourne, 3000.

A Stent The following statement is a full description of this invention, including the best method of performing it known to us: -1- IA A STENT 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 20 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 S. 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 =I Q:A)PER\GCP\31246c.doc-20/07101 -2expand, the grafts expand radially and, consequently, shrink longitudinally. However, at the same time, 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.

SUMMARY OF THE PRESENT INVENTION An object of the present invention is to provide an improved stent.

According to the present invention there is provided a stent formed of a tube having a patterned shape, the patterned shape comprising: a) even first meander patterns have axes extending in eeo a first direction; Sb) odd first meander patterns also having axes 20 extending in said first direction wherein, after expansion of said stent, said odd first meander patterns are out of phase with said even first meander patterns, and wherein said odd first meander patterns occur between every two even first meander patterns; c) second meander patterns having axes extending in a second direction, different than said first direction, **iwherein said second meander patterns intersect with said even and odd first meander patterns to form a distributed structure; d) wherein said first meander patterns have loops; e) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns i i i Q:\OPER\GC~31246c.doc-207/i01 -3between each pair of adjacent first meander patterns; and f) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns.

The invention also provides an expandable stent formed of an elongated cylindrical unitary tube suitable for insertion into a lumen or 5lood vessel in which it may be expanded, comprising: a plurality of first meanders extending in a first direction on the cylinder of the tube and a plurality of second meanders extending in a second direction, on the cylinder of the tube, wherein the first and second meanders are formed with loops and are interconnected such that at least one of the loops of each of the first meanders is disposed between each consecutive second meander, to which the first meander is connected, and at least one of the loops of each of the second meanders is disposed between each consecutive first meander to which it is connected; the first and second meanders defining a plurality of enclosed S 20 spaces.

The invention also provides a stent formed of a tube having a patterned shape, the patterned shape comprising: •c a) first meander patterns having axes extending in a o. first direction; 25 b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced \Ci apart to leave a portion of said second meander patterns i. i i 14- 2-02;11:33 ;Davies Collison Cave ;61 3 92542808 3/ 71 -3Abetween each pair of adjacent first meander patterns; e) wherein each of said second'meander patterns has at least one loop between at least one pair of adjacent first meander patterns.

The invention also provides a stent formed of a tube having a patterned shape, the patterned shape comprising: a) even first meander patterns having axes extending in a first direction; b) odd first meander patterns, also having axes 10 extending in said first direction, wherein said odd first meander patterns are 180° out of phase with said even first S• meander patterns and occur between every two even first meander patterns; c) second meander patterns having axes extending in a 15 second direction different than said first direction, "wherein said second meander patterns are intertwined with said even and odd first meander patterns;

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d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected on first and second sides, respectively, of each loop of said second meander patterns to said second meander patterns; f) wherein said second meander patterns are of one kind; and g) wherein said second meander patterns are connected to said even and odd first meander patterns so as to leave two loops of said first meander patterns between each pair of said second meander patterns.

The invention also provides a stent formed of a tube having a patterned shape, the patterned shape comprising: a) even first meander patterns having axes extending L 14- 2-uZ;11:33 ;uavies Collison Cave ;61 3 92542808 4/ 71 QrIOP TU 1RI24&CA.-I a2a -3Bin a first direction; b) odd first meander patterns, also having axes in said first direction, wherein said odd first meander patterns are 1800 out of phase with said even flat meander patterns and occur between every two even first meander patterns; c) second meander patterns having axes extending in a second direction different than said first direction, wherein said second meander patterns are intertwined with :K1 10 said even and odd first meander patterns; d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected on first and second sides, respectively, of i 15 each loop of said second meander patterns to said second meander patterns; f) wherein said second meander patterns are formed of even and odd second meander patterns and are connected to said even and odd first meander patterns so as to leave S" 20 three loops of said first meander patterns between each pair of said even and odd second meander patterns.

The invention also provides a stent formed of a tube having a patterned shape, comprising: a) even first meander patterns, having axes extending in a first direction; b) odd first meander patterns, also having axes extending in said first direction, wherein said odd first meander patterns are 180° out of phase with said even first meander patterns and occur between every two even first meander patterns; c) second meander patterns having axes extending in a second direction different from said first direction, -LII I- 14- 2-U2;11:33 ;Davies Collison Cave ;61 3 92542808 5/ 71 QAPorCI24.b,-J~uoado -3Cwherein said second meander patterns are intertwined with said even and odd first meander patterns to form a distributed structure; d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected to said second meander patterns so as to leave a loop of said second meander patterns between each odd and even first meander patterns; and f) wherein said second meander patterns are connected to said even and odd first meander patterns so as to leave *ooloops of said first meander patterns between each pair of S.second meander patterns.

The invention also provides a stent having a 15 longitudinal axis formed of a tube having a patterned shape, 9e the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a 20 second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops are disposed and adapted to cooperate so that upon the expansion of said stent the P~~'/rowth of some of said loops in the longitudinal direction I 3-iJ. ~I-CXI~:I 14- 2-02;11:33 ;Oavies Coglison Cave ;61 3 92542808 6/ 71 Q.~U'E\GCUI1IMCI4J1 -3Dof said tube compensates for the shrinkage of other of said loops in the longitudinal direction of said tube to eliminate any significant shrinkage of said stentin the length during expansion.

The invention also provides a stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, *wherein said second meander patterns intersect with said 9* first meander patterns; c) wherein said first meander patterns have loops; 15 d) wherein said first meander patterns are spaced ee apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent 20 first meander patterns; and f) wherein said meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said first meander patterns compensates for the vertical shrinkage of said second meander patterns to eliminate any significant shrinkage of said stent in length during expansion.

The invention also provides a stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a ~1 14- 2-02;11:33 ;Davies Coll ison Cave ;61 3 92542808 7/ 71 Qf\otWGC312«d<c-AIJ1MzA -3Esecond direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops and meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent the growth of some of said loops in the longitudinal direction of said tube compensates for the p 15 shrinkage of other of said loops in the longitudinal op direction of said tube to eliminate any significant shrinkage of said stent in the length during expansion.

The invention also provides a stent formed of a tube having a patterned shape, the patterned shape comprising: 20 a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent Sfirst meander patterns; and

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14- 2-U ;11!:33 ;Davies Col ison Cave ;61 3 92542808 8/ 71 Q'%oPEMlGM24cdoc-412m 2 -3F f) wherein said loops are disposed and adapted to cooperate so that upon the bending of said stent the inside curvature is shortened with respect to the outside curvature and said loops change shape to compensate for the difference in length between the inside and outside curvature.

The invention also provides a stent formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, ooooo. wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; 15 d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent 20 first meander patterns; and f) wherein said stent can bend in any direction and in more than one direction at any time prior to expansion and wherein changes in the shape of said loops upon expansion provides rigidity to said stent to enable said stent to maintain a blood vessel or a lumen at a desired inner diameter.

The invention also provides a stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a V V. 14- 2-02;11:33 ;Davies Coilison Cave ;61 3 92542808 9/ 71 -3Gsecond direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has :at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops are disposed and adapted to cooperate so that upon the expansion of said stent the *"vertical growth of said loops disposed on said first meander patterns substantially compensates for the vertical 15 shrinkage of said loops disposed on said second meander 4*ee patterns.

The invention also provides a stent having a 4*4* longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: 20 a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent 1 irst meander patterns; and r. 14- 2-02;11:33 ;Davies Collison Cave ;61 3 92542808 10/ 71 QiOPERmwjOl2Ac.ac-2m 2 -3H1f) wherein said first and said second meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said first meander patterns substantially compensates for the vertical shrinkage of said second meander patterns.

The invention also provides a stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: 0a) first meander patterns having axes extending in a 10 first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; 15 c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops disposed on said first meander patterns and said loops disposed on said second meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent said loops change shape to compensate for the tendency of said stent to foreshorten when said stent .is expanded.

The invention also provides a stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a s/RA first direction; 14- Z-U2;11:33 ;Davies Collison Cave ;61 3 92542808 11/ 71 Q.OPER\COU I24Gdo-fl2W 2 -31b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has 10 at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said first and said second meander patterns are disposed and adapted so that said stent prior to expansion is substantially uniformly flexible along said 'i 15 longitudinal axis and bendable in substantially any direction and in several directions at once without affecting the structural or functional integrity of said stent, said first and said second meander patterns disposed and adapted to cooperate so that upon the expansion of said 20 stent the vertical growth of said first meander patterns substantially compensates for the vertical shrinkage of said second meander patterns, said meander patterns further adapted to impart rigidity to said stent in an amount sufficient to support a lumen when said stent is expanded.

The invention also provides a stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, /wherein said second meander patterns intersect with said ii~ i-l~ 14- 2-UZ;ll: 33 ;Davies Collison Cave ;61 3 92542808 12/ 71 -3Jfirst meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and S: f) wherein said loops are disposed and adapted so 10 that said stent prior to expansion is substantially uniformly flexible along said longitudinal axis and bendable in substantially any direction and in several directions at once without affecting the structural or functional integrity of said stent, said loops disposed and adapted to i* 15 cooperate so that upon the expansion of said stent the 999^ *vertical growth of said loops disposed on said first meander patterns substantially compensates for the vertical shrinkage of said loops disposed on said second meander patterns, said loops further disposed and adapted to impart S• 20 rigidity to said stent in an amount sufficient to support a blood vessel or lumen when said stent is expanded.

The invention also provides a stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced I- -I'i i 14- 2-02;11:33 ;Davies Collison Cave ;61 3 92542808 13/ 71 Q.WVaMvML24k6ac.ID2.MV -3Kapart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said stent is adapted so that when it is expanded radially, its overall length remains substantially the same because some elements of said stent grow in said tube's longitudinal direction while some elements of said 10 stent shrink in said tube's longitudinal direction.

The invention also provides a stent formed of a tube @9*9 having a patterned shape, the patterned shape comprising: *i a) first meander patterns having axes extending in a first direction; S: 15 b) second meander patterns having axes extending in a :second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; 20 d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein at least one of said loops is provided with a width that is smaller than the width of the meander pattern on which said at least one of said loops is disposed.

I ;i i; 14- 2-02;11:33 ;Davies Collison Cave ;61 3 92542808 14/ 71 Q o91KcUlUi24c-daJ-4DoAJ2 -3L- 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

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of Fig. 1; 0 Fig. 3 is an illustration of the stent of Fig. 1 in a bent position; 5** Fig. 4 is an illustration of the stent of Fig. 1 in an S* expanded format; Figs. 5A and 5B are illustrations of the changes in the 15 patterns of the stent of Fig. 1 due to expansion; e* Fig. 6 is a schematic illustration of a second s. embodiment of the pattern for a stent; Fig. 7 is an illustration of a third embodiment of the pattern for the stent; and t I Fig. 8 is an illustration of the pattern of Fig. 7 in an expanded format.

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 about a center line and "orthogonal meander patterns" are patterns whose center lines are orthogonal to each other.

20 In the stent of Figs. 1 4, the two meander patterns are labeled 11 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 11 is provided in odd and even (o and e) versions which are 1800 out of phase with -4each other. Thus, each left opening loop 16 of meander pattern 11o faces a right opening loop 14 of meander pattern lie and a right opening loop 14 of meander pattern 11o faces a left opening loop 16 of meander pattern lie.

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 lie.

The straight sections 22 of horizontal meander pattern 120 intersect with every third common member 15 of vertical meander pattern lie. beginning with the common member 15 two after an intersected common member 17.

The result is a full loop 14 between meander patterns 15 12e and 120 and a full loop 16 between meander patterns 120 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 20 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 O.

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 180 and 200 on the outside of the curve, which expand. Loops 14i and 16i near the inside I are compressed while the II i I~ -il i- loops 140 and 160 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 tne 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 11 and 12 expand 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 120 and 12e and a small space 44 between meander patterns 12e and 120. 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 lle and Iio, which are labeled 42a, have loops 18 at their tops and bottoms while the large spaces between vertical meander 20 patterns iio and le, whicn 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 per loop. However, it also shrinks -6i- i horizontally, by an amount 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*d 2 per loop. However, it also shrinks vertically, by an amount h 2 Thus, the vertical growth of the vertical meander pattern 11 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 15 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 20 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, 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 i Q\OPER\GCP31246c.doc-20/07/01 -8rounded 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 lle and Ilo which are 1800 out of phase with each other. The horizontal meander patterns 12 connect with every line 15 of vertical meander pattern lle.

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 20 which follow.

S"The reference to any prior art in this specification is S not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

Throughout this specification and the claims which S.follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of S integers or steps.

Claims

2. A stent according to claim 1 and wherein said first and second directions are orthogonal.
3. A stent according to claim 1 and wherein said first and second directions are not orthogonal. Q:\OPER\GCPU 1246c.do-20/07/01
4. A stent according to claim 1 and wherein said first and second meander patterns are formed from wire. A stent according to claim 1 and wherein said first and second meander patterns are cut from flat metal.
6. A stent according to claim 1 and wherein said stent is finished in one of the following ways: plating with a protective material, embedding with medicine, and covering with a material.
7. The stent of claim 1, wherein said second meander patterns define a plurality of flexible arcuate compensating members adapted to elongate in said second direction to compensate for the tendency of said first meander patterns to foreshorten when said stent is expanded.
8. A stent according to claim 1 wherein each loop of said second meander patterns comprises at least two portions with 20 an area of inflection therebetweeen.
9. A stent according to claim 1, wherein each loop of said second meander patterns is rounded. 25 10. A stent according to claim 1, wherein said first meander patterns intersect with said second meander patterns so as to leave at least one loop of said second meander patterns between each pair of adjacent first meander patterns.
11. A stent according to claim 1 wherein said second f$ A eander patterns intersect with said first meander patterns Ic7\ -i i Q:AOPER\GCP31246c.doc-20/07101 -11- so as to leave at least one loop of said first meander patterns between each pair of adjacent second meander patterns.
12. A stent according to claim 1 wherein said second meander patterns intersect with said first meander patterns at common members which are shared by said first and said second meander patterns.
13. An expandable stent formed of an elongated cylindrical unitary tube suitable for insertion into a lumen or blood vessel in which it may be expanded, comprising: a plurality of first meanders extending in a first direction on the cylinder of the tube and a plurality of second meanders extending in a second direction, on the cylinder of the tube, wherein the first and second meanders are formed with loops and are interconnected such that at *least one of the loops of each of the first meanders is disposed between each consecutive second meander, to which S 20 the first meander is connected, and at least one of the loops of each of the second meanders is disposed between S• each consecutive first meander to which it is connected; the first and second meanders defining a plurality of enclosed spaces.
14. A stent according to claim 13, wherein the first and second meanders are connected together such that the loops eeo. :....thereof cooperate so that upon the expansion of the stent, the growth of some loops in the longitudinal direction of the tube compensates for the shrinkage of other loops in the longitudinal direction of the tube to substantially il. ~5 1: 1S__ Q:\OPER\GCP31246c.doc-20/07/01 12- eliminate any significant shrinkage of the stent in length during expansion. A stent according to claim 13 wherein the enclosed spaces of said stent are formed from interconnected circumferential and longitudinal meanders and wherein upon expansion the circumferential growth of the circumferential meanders compensates, at least partially, for the circumferential shrinkage of the longitudinal meanders and vice versa.
16. A stent according to claim 13, wherein the first and second meanders are connected together such that the loops thereof cooperate so that upon bending of the stents the loops change shape to compensate for the difference in length between the inside and outside curves.
17. A stent according to claim 13, wherein upon expansion .changes in the shape of the loops provides rigidity of the 20 stent to enable the stent to maintain a blood vessel or lumen at a desired inner diameter.
18. A stent according to claim 13, wherein the stent can bend in any direction and in more than one direction at any 25 time.
19. A stent according to claim 13, wherein the first meander patterns comprise even first meander patterns and odd first meanders and wherein the odd first meanders are 180° out of phase with the even first meanders and occur A between every two even first meanders. i: Q:QPER\GCP\3 1246&.do.-20A)7/0I 13 A stent according to claim 19 wherein the even and odd first meanders are connected to the second meanders on first and second sides of each loop of the second meanders.
21. A stent formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; C) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has *at least one loop between at least one pair of adjacent meander patterns. .9..20
22. A stent according to claim 21 wherein said first meander patterns comprise even and odd first meander patterns, said odd first meander patterns occur between every two even first meander patterns and, prior to expansion of said stent, said odd first meander patterns are out of phase with said even first meander patterns.
23. A stent according to claim 21 wherein said first 0. 0:meander patterns comprise even and odd first meander patterns, said odd first meander patterns occur between -~every two even first meander patterns and, after expansion wu of said stent, said odd first meander patterns are out of I U I I Q1 tVVI CU a0 .U VI I 1 3 VI I V gUI a VLQC U C iF l/ QA~O!'~aCPU O.I IDdO 14 phase with said even first meander patterns.
24. A stent according to claim 21 wherein each loop of said second meander patterns comprises at least two portions with an area of inflection therebetween. A stent according to claim 21 wherein each loop of said second meander patterns is rounded.
26. A stent according to claim 21 wherein said first meander patterns intersect with said second meander patterns so as to leave at least one loop of said second meander patterns between each pair of adjacent first meander patterns.
27. A stent according to claim 21 wherein said second :meander patterns intersect with said first meander patterns so as to leave at least one loop of said first meander patterns between each pair of adjacent second meander patterns.
28. A stent according to claim 21 wherein said second meander patterns intersect with said first meander patterns at common members which are shared by said first and said second meander patterns.
29. A stent according to claim 21 wherein said first and second meander patterns are cut from flat metal.
30. A stent formed of a tube having a patterned shape, the patterned shape comprising: 4,a) even first meander patterns having axes extending 7E 1- -ucii;ja u v i e o i i i son LdVe ;1 j YZb4Z UU 1b/ /1 QADOMGCpKia4llc.dtI4AJIMl in a first direction; b) odd first meander patterns, also having axes extending in said first direction, wherein said odd first meander patterns are 180° out of phase with said even first meander patterns and occur between every two even first meander patterns; c) second meander patterns having axes extending in a second direction different than said first direction, wherein said second meander patterns are intertwined with said even and odd first meander patterns; d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected on first and second sides, respectively, of 15 each loop of said second meander patterns to said second meander patterns; f) wherein said second meander patterns are of one kind; and g) wherein said second meander patterns are connected 20 to said even and odd first meander patterns so as to leave two loops of said first meander patterns between each pair of said second meander patterns.
31. A stent formed of a tube having a patterned shape, the patterned shape comprising: a) even first meander patterns having axes extending in a first direction; b) odd first meander patterns, also having axes in said first direction, wherein said odd first meander patterns are 180° out of phase with said even flat meander patterns and occur between every two even first meander patterns; I ti:. QAWPEA\GC L2460odc-t142Af -16- a) second meander patterns having axes extending in a second direction different than said first direction, wherein said second meander patterns are intertwined with said even and odd first meander patterns; d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected on first and second sides, respectively, of each loop of said second meander patterns to said second meander patterns; wherein said second meander patterns are formed of a:..:even and odd second meander patterns and are connected to Cesaid even and odd first meander patterns so as to leave three loops of said first meander patterns between each pair of said even and odd second meander patterns. :32. A stent according to claim 30 wherein said first and second directions are orthogonal.
33. A stent according to claim 30 wherein said first and second directions are not orthogonal.
34. A stent formed of a t-ube having a patterned shape, comprising: a) even first meander patterns, having axes extending in a first direction; b) odd first meander patterns, also having axes extending in said first direction, wherein said odd first meander patterns are 1800 out of phase with said even first meander patterns and occur between every two even first meander patterns; A c) second meander patterns having axes extending in a 1q VU4 1 1 t.)Q LJdVI~ t:.1 I11Q11fl d V~ eblI J S' 4Z2 U U Ul Q.%OAIPEGYUI24&GeCAM4V/2W -17- second direction differ-enit from said first direction, wherein said second meander patterns are intertwined with said even and odd first meander patterns to form a distributed structure; d) wherein said first and said second meander patterns comprise loops; e) wherein said even and odd first meander patterns are connected to said second meander patterns so as to leave :a loop of said second meander patterns between each odd and even first meander patterns; and wherein said second meander patterns are connected to said even and odd first meander patterns so as to leave loops of said first meander patterns between each pair of second meander patterns. 4*
35. A stent according to claim 34 wherein said second meander patterns are connected to said even and odd first meander patterns so as to leave two loops of said first meander patterns between each pair of second meander patterns.
36. A stent according to claim 34 wherein said second meander patterns are formed of even and odd second meander patterns and are connected to said even and odd first meander patterns so as to leave three loops of said first meander patterns between each pair of said even and odd second meander patterns.
37. A stent according to claim 34 wherein said first and second directions are orthogonal. l11.ao 1 uvavies tLoiiion t ve ;Ol J 3Z34ZtiU 1/ 11 L24&ea-I.cAV2 -18-
38. A stent according to claim 34 wherein said first and second directions are not orthogonal.
39. A stent according to claim 34 wherein said first and second meander patterns are formed from wire. A stent according to claim 34 wherein said first and second meander patterns are cut from flat metal. c. 10 41. A stent according to claim 34 wherein said stent is plated with a protective material embedded with medicine and covered with a material. 0 4
42. A stent having a longitudinal axis formed of a tube 15 having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; S: b) second meander patterns having axes extending in a second direction, different than said first direction, 20 wherein said second meander patterns intersect with said- first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops are disposed and adapted to cooperate so that upon the expansion of said stent the growth of some of said loops in the longitudinal direction of said tube compensates for the shrinkage of other of said C/T"\ L t VUC.I I -0 *UOaVI VZ 1.UVI I I lV ll LdVt eo .1 JZ4ZU 4 2U/ 11 -19- loops in the longitudinal direction of said tube to eliminate any significant shrinkage of said stent in the length during expansion.
43. A stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; C) whri.adfrs.ene aten aelos d) wherein said first meander patterns ae lps;e 15 apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said first meander patterns compensates for the vertical shrinkage of said second meander patterns to eliminate any significant shrinkage of said stent in length during expansion.
44. A stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, 77777 -777- T 14- Z-U ;ii:JJ ;uavies coiiison cave ;61 3 92542808 21/ 71 Q1O.VrCMIUlcrc-HI4JOaM wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops and meander patterns are
99.9.' disposed and adapted to cooperate so that upon the expansion :of said stent the growth of some of said loops in the longitudinal direction of said tube compensates for the shrinkage of other of said loops in the longitudinal 15 direction of said tube to eliminate any significant shrinkage of said stent in the length during expansion. .00. 45. A stent formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has JL, at least one loop between at least one pair of adjacent first meander patterns; and I ;i I,+-tZ-utiil.o ;uavies toiison tave ;bI J 2b42BUS 22/ 1 -21- if) wherein said loops are disposed and adapted to cooperate so that upon the bending of said stent the inside curvature is shortened with respect to the outside curvature and said loops change shape to compensate for the difference in length between the inside and outside curvature. 46. A stent formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes etnigi first direction; second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; C) wherein said first meander patterns have loops; aatd) wherein-said first meander patterns are spaced aatto leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and if) wherein said stent can bend in any direction and in more than one direction at any time prior to expansion and wherein changes in the shape of said loops upon expansion provides rigidity to said stent to enable said stent to maintain a blood vessel or a lumen at a desired inner-diameter. 47. A stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: A Ia) first meander patterns having axes extending in a 14- -u ;u av i eI l0 Lav e ;i o nZ3 'ZdU v j/ 1 Qi0P1a0C Vi44tdo oI4210 -22- first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has *o :-at least one loop between at least one pair of adjacent i first meander patterns; and f) wherein said loops are disposed and adapted to cooperate so that upon the expansion of said stent the 15 vertical growth of said loops disposed on said first meander patterns substantially compensates for the vertical 4 shrinkage of said loops disposed on said second meander patterns. 20 48. A stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns S between each pair of adjacent first meander patterns; I jl-- ri";r~;~e I- L-U ;i ;uavies o i i i son Lave ;b1 J b42UUU 24/ 71 QOVuIK\iC' U x.docIiuM 2 -23- e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said first and said second meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said first meander patterns substantially compensates for the vertical shrinkage of said second meander patterns. 49. A stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; 9 b) second meander patterns having axes extending in a 15 second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; 90009 c) wherein said first meander patterns have loops; O r d) wherein said first meander patterns are spaced 0.. 20 apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said loops disposed on said first meander patterns and said loops disposed on said second meander patterns are disposed and adapted to cooperate so that upon the expansion of said stent said loops change shape to compensate for the tendency of said stent to foreshorten when said stent is expanded. 7 -7 o 14- L-U;II:JJ ;uavies oiilison cave ;61 3 92542808 25/ 71 QAOhkCl 124tcdocd-1ibnuZ2 -24- A stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; o* 10 c) wherein said first meander patterns have loops; *eeoe d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has 15 at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said first and said second meander g0 patterns are disposed and adapted so that said stent prior to expansion is substantially uniformly flexible along said 20 longitudinal axis and bendable in substantially any direction and in several directions at once without affecting the structural or functional integrity of said stent, said first and said second meander patterns disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said first meander patterns substantially compensates for the vertical shrinkage of said second meander patterns, said meander patterns further adapted to impart rigidity to said stent in an amount sufficient to support a lumen when said stent is expanded. S 51. A stent having a longitudinal axis and a vertical axis formed of a tube having a patterned shape, the patterned i i. ;rr: 14- z-u ;i l:JJ ;uavies coii ison cave ;61 3 92542808 26/ 71 qCtDPEGCl)2c~c.AlJUT shape comprising: a) first meander patterns having axes extending in a first direction; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; c) wherein said first meander patterns have loops; wherein said first meander patterns are spaced 10 apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; I e) wherein each of said second meander patterns has .at least one loop between at least one pair of adjacent first meander patterns; and 15 f) wherein said loops are disposed and adapted so that said stent prior to expansion is substantially uniformly flexible along said longitudinal axis and bendable in substantially any direction and in several directions at once without affecting the structural or functional integrity of said stent, said loops disposed and adapted to cooperate so that upon the expansion of said stent the vertical growth of said loops disposed on said first meander patterns substantially compensates for the vertical shrinkage of said loops disposed on said second meander patterns, said loops further disposed and adapted to impart rigidity to said stent in an amount sufficient to support a blood vessel or lumen when said stent is expanded. 52. A stent having a longitudinal axis formed of a tube having a patterned shape, the patterned shape comprising: a) first meander patterns having axes extending in a i first direction; 14- Z-V4;11:JJ ;uavies coiiison cave ;51 3 92542808 27/ 71 Q V3PMrM L246CAC- t4ffiZIUZ -26- b) second meander patterns having axes extending in a second direction different than said first direction, wherein said second meander patterns intersect with said first meander patterns; C) wherein said first meander patterns have loops; d) wherein said first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent first meander patterns; and f) wherein said stent is adapted so that when it is expanded radially, its overall length remains substantially the same because some elements of said stent grow in said tube's longitudinal direction while some elements of said stent shrink in said tube's longitudinal direction. 53. A stent formed of a tube having a patterned shape, the OLD patterned shape comprising: 000: a) first meander patterns having axes extending in a first dir ection; b) second meander patterns having axes extending in a second direction, different than said first direction, wherein said second meander patterns intersect with said first meander patterns; C) wherein said first meander patterns have loops; d) wherein said'first meander patterns are spaced apart to leave a portion of said second meander patterns between each pair of adjacent first meander patterns; e) wherein each of said second meander patterns has at least one loop between at least one pair of adjacent A I V first meander patterns; and II i *U v i ,UaV 1ic ui u l I iave ;i 01 J ~LD4LdUb 2 1 QOEPRGCiW24c.dii-4l#2M2 -27- f) wherein at least one of said loops is provided with a width that is smaller than the width of the meander pattern on which said at least one of said loops is disposed. 54. A stent substantially as hereinbefore described with reference to the accompanying drawings. 6** 5. 0 S 0 *0 S 0 0 S. S 5t 05 S *555 5* 0 50 0@ 0 0 S *00~ @50555 0 DATED this 14th day of February, 2002 15 MEDINOL LTD. By its Patent Attorneys DAVIES COLLISON CAVE