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Publication numberUS20080288048 A1
Publication typeApplication
Application numberUS 11/860,805
Publication dateNov 20, 2008
Filing dateSep 25, 2007
Priority dateApr 29, 1997
Also published asDE69809114D1, DE69809114T2, DE69830520D1, DE69830520T2, EP0875215A1, EP0875215B1, EP1197188A2, EP1197188A3, EP1197188B1, US6325821, US20100241216
Publication number11860805, 860805, US 2008/0288048 A1, US 2008/288048 A1, US 20080288048 A1, US 20080288048A1, US 2008288048 A1, US 2008288048A1, US-A1-20080288048, US-A1-2008288048, US2008/0288048A1, US2008/288048A1, US20080288048 A1, US20080288048A1, US2008288048 A1, US2008288048A1
InventorsGiovanni Rolando, Paolo Gaschino
Original AssigneeSorin Biomedica Cardio S.R.L.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Stents for angioplasty
US 20080288048 A1
Abstract
This invention is a stent having a substantially tubular body defining a longitudinal axis comprising first and second adjacent annular segments, each segment defining a substantially sinusoidal shape having a plurality of peaks and valleys, the peaks of the first segment extending toward the second segment and being aligned longitudinally with the valleys of the second segment. The stent has a plurality of bridge elements having a U-shaped portion between first and second connector arms, the first connector arm of one bridge element being connected between a first peak and a first valley of the first segment and the second connector arm being connected between a first peak and a first valley of the second segment.
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Claims(12)
1. A stent having a substantially tubular body defining a longitudinal axis comprising:
first and second adjacent annular segments, each segment defining a substantially sinusoidal shape having a plurality of peaks and valleys, the peaks of the first segment extending toward the second segment and being aligned longitudinally with the valleys of the second segment;
a plurality of bridge elements having a U-shaped portion between first and second connector arms, the first connector arm of one bridge element being connected between a first peak and a first valley of the first segment and the second connector arm being connected between a first peak and a first valley of the second segment in a manner such that the U-shaped portion extends in the direction of the first peak of the first segment and the first valley of the second segment.
2. The stent of claim 1 wherein the U-shaped portions of the plurality of bridge elements are oriented in the same direction.
3. The stent of claim 1 further comprising a third annular segment connected to the second annular segment by a plurality of bridge elements, wherein the U-shaped portion of the plurality of bridge elements is oriented in one direction between the first and second annular segments and in the opposite direction between the second and third annular segments.
4. The stent of claim 1 wherein the connector arm of the bridge element joins the annular segment at a zero point of the sinusoidal shape.
5. The stent of claim 4 wherein each connector arm joins each annular segment at a zero point of the sinusoidal shape.
6. The stent of claim 1 further comprising a third annular segment connected by bridge elements to the second annual segment, wherein the bridge elements join zero points separated by 360 between the first and second adjacent segments, and further wherein the bridge elements join zero points separated by 720 between the second and third adjacent segments.
7. A method of preventing restenosis in a vessel comprising:
providing a stent having a substantially tubular body defining a longitudinal axis, the stent comprising first and second adjacent annular segments, each segment defining a substantially sinusoidal shape having a plurality of peaks and valleys, the peaks of the first segment extending toward the second segment and being aligned longitudinally with the valleys of the second segment, a plurality of bridge elements having a U-shaped portion between first and second connector arms, the first connector arm of one bridge element being connected between a first peak and a first valley of the first segment and the second connector arm being connected between a first peak and a first valley of the second segment in a manner such that the U-shaped portion extends in the direction of the first peak of the first segment and the first valley of the second segment;
advancing the tubular body in the contracted condition through the lumen of the vessel to an area of stenosis; and
deploying the tubular body within the lumen of the vessel by expanding the tubular body from the contracted to the expanded condition.
8. A method of making a stent comprising:
providing a tubular blank defining a longitudinal axis; and
forming the blank into first and second adjacent annular segments connected by a plurality of bridge elements, each segment defining a substantially sinusoidal shape having a plurality of peaks and valleys, the peaks of the first segment extending toward the second segment and being aligned longitudinally with the valleys of the second segment, the plurality of bridge elements having a U-shaped portion between first and second connector arms, the first connector arm of one bridge element being connected between a first peak and a first valley of the first segment and the second connector arm being connected between a first peak and a first valley of the second segment in a manner such that the U-shaped portion extends in the direction of the first peak of the first segment and the first valley of the second segment.
9. The method of claim 8 wherein the forming step is by a method selected from one of laser incision, photo-incision, and electroerosion.
10. A stent having a substantially tubular body defining a longitudinal axis comprising:
first and second adjacent annular segments, each segment having a substantially sinusoidal wave shape;
first and second bridge elements, the first bridge element having a first end connected to the first annular segment at a zero point of the sinusoidal wave shape and having a second end connected to the second annular segment at a zero point of the sinusoidal wave shape, the second bridge element having a first end connected to the first annular segment at a zero point of the sinusoidal wave shape spaced 360 from the connection of the first bridge element to the first annular segment and a second end connected to the second annular segment at a zero point of the sinusoidal wave shape spaced 360 from the connection of the first bridge element to the second segment, the first and second bridge elements and the portion of the first and second annular segments between the connection points of the bridge elements together defining a cell.
11. A stent having a substantially tubular body defining a longitudinal axis comprising:
a plurality of annular segments, each segment having a substantially sinusoidal wave shape;
a plurality of bridge elements, each bridge element having a first end connected to one annular segment at a zero point of the sinusoidal wave shape and a second end connected to an annular segment adjacent to the one annular segment at a zero point of the sinusoidal wave shape of the adjacent annular segment, the annular segments and bridge elements being configured such that when compression, flexure and torsion forces are applied to the stent they generate first maximum stress regions, second maximum stress regions, and third maximum stress regions, where the first, second, and third maximum stress regions do not overlap.
12. The stent of claim 11 wherein each bridge element includes a U-shaped portion between first and second connector arms and wherein the first maximum stress regions are located about the peaks and valleys of the annular segments, the second maximum stress regions are located about the apex of the U-shaped portion of the bridge element and the third maximum stress regions are located about the points of connection of the bridge elements and annular segments.
Description
  • [0001]
    This application is a continuation of patent application Ser. No. 10/159,969, filed May 31, 2002, now U.S. Pat. No. 7,273,494 B2, which is a continuation of patent application Ser. No. 09/410,303, filed Oct. 1, 1999, now U.S. Pat. No. 6,451,049 B2, which is a continuation-in-part of patent application Ser. No. 09/069,425, filed Apr. 29, 1998, now U.S. Pat. No. 6,325,821 B1, the contents of each of which are hereby incorporated by reference herein.
  • FIELD OF THE INVENTION
  • [0002]
    The present invention relates to stents for angioplasty. In particular, the invention relates to a stent having a cellular design.
  • BACKGROUND OF THE INVENTION
  • [0003]
    The term “stent” is intended to indicate devices useful for endoluminal insertion (for example, in a blood vessel), usually effected by means of catheterisation, with subsequent deployment in place so as to achieve local support of the lumen. The primary purpose of the stent is to eliminate and avoid the restenosis (i.e., narrowing or closure) of the treated area.
  • [0004]
    For a general review of vascular stents, reference is made to “Textbook of Interventional Cardiology” edited by Eric J Topol, W.B. Saunders Company, 1994 and, in particular, to section IV of volume II, entitled “Coronary Stenting”.
  • [0005]
    Many patents also provide a general review of stents, for example, U.S. Pat. Nos. 4,503,569; 4,768,507; 4,776,337; 4,800,882; 4,830,003; 4,856,516; 4,886,062; 4,907,336; and EP 0 201 466A.
  • [0006]
    Notwithstanding the extensive research and experimentation in the stent field, as documented in the patent literature, only a relatively small number of operative solutions have, until now, found practical application. This is due to various factors, which include the following problems or requirements:
  • [0007]
    while moving toward the treatment site, the stent should be capable of adapting to the path, which may include various curved sections;
  • [0008]
    distortion of the stent while it is being positioned should not be detrimental to the ability of the stent to provide an effective support when it is positioned and deployed;
  • [0009]
    the longitudinal shortening effect which occurs in many stents upon deployment should be limited, if not avoided;
  • [0010]
    maximum homogeneity and uniformity in the expansion of the stent should be achieved at the desired location;
  • [0011]
    an extensive support surface should be provided to the wall of the lumen which is being supported;
  • [0012]
    the origination of complex shapes and/or possible stagnation sites, especially in blood vessels, should be avoided, in order to avoid undesirable phenomena such as coagulation or thrombosis; and
  • [0013]
    the stents should be able to be simply and reliably produced using available technology and they should incorporate the requirements listed above.
  • [0014]
    A stent is subject to various forces, including compression, flexure, and torsion. These stresses often cause the stent to perform in an undesirable manner. Additionally, a significant disadvantage of current stent designs is their failure to distribute these stresses throughout the structure of the stent. Each of these stresses is maximized in a particular area of the stent. In current stent designs two or more of these areas of maximum stress overlap. This results in at least two problems. First, an overlap of the maximum stress areas may overly fatigue the stent and cause failure in an area of overlapped maximum stress. Second, the failure to distribute or discharge the maximum stress of these forces at different areas causes stress concentration on the vessel wall which may cause vessel wall injury. Thus what is needed in the art is a stent meeting the requirements listed above that will avoid stress concentration and elastic distortion as well as provide good elastic matching between the stent and the vessel into which it is placed.
  • SUMMARY OF THE INVENTION
  • [0015]
    This invention is a stent having a substantially tubular body defining a longitudinal axis comprising first and second adjacent annular segments, each segment defining a substantially sinusoidal shape having a plurality of peaks and valleys, the peaks of the first segment extending toward the second segment and being aligned longitudinally with the valleys of the second segment; a plurality of bridge elements having a U-shaped portion between first and second connector arms, the first connector arm of one bridge element being connected between a first peak and a first valley of the first segment and the second connector arm being connected between a first peak and a first valley of the second segment in a manner such that the U-shaped portion extends in the direction of the first peak of the first segment and the first valley of the second segment.
  • [0016]
    The U-shaped portion of the plurality of bridge elements may be oriented in the same direction. Alternately, they may be oriented in one direction between one pair of adjacent annular segments, and in the opposite direction between another pair of adjacent annular segments. Preferably, the connector arm of the bridge element joins the annular segment at the zero point of the sinusoidal wave shape. In one embodiment, each connector arm joins each annular segment at zero points of the sinusoidal wave separated by 360. Alternately, the connector arms may join zero points separated by 360 between one pair of adjacent segments, and zero points separated by 720 between another pair of adjacent segments.
  • [0017]
    In a second aspect, this invention is a method of preventing restenosis by providing the stent described above and deploying it within a body lumen.
  • [0018]
    In a third aspect, this invention is a method of making a stent by providing a tubular blank and forming the tubular blank into a stent having the geometry described above.
  • [0019]
    In a further aspect this invention is a stent having a substantially tubular body defining a longitudinal axis. The stent comprises first and second adjacent annular segments, each segment having a substantially sinusoidal wave shape. The stent further includes first and second bridge elements, the first bridge element having a first end connected to the first annular segment at a zero point of the sinusoidal wave shape and having a second end connected to the second annular segment at a zero point of the sinusoidal wave shape. The second bridge element has a first end connected to the first annular segment at a zero point of the sinusoidal wave shape spaced 360 from the connection of the first bridge element to the first annular segment and a second end connected to the second annular segment at a zero point of the sinusoidal wave shape 360 from the connection of the first bridge element to the second segment, the first and second bridge elements and a portion of the first and second annular segments between the connection points of the bridge elements together defining a cell.
  • [0020]
    In a further aspect, the invention is a stent having a substantially tubular body defining a longitudinal axis and having a plurality of annular segments, each segment having a substantially sinusoidal wave shape. The stent includes a plurality of bridge elements, each bridge element having a first end connected to one annular segment at a zero point of the sinusoidal wave shape and a second end connected to an annular segment adjacent to the one annular segment at a zero point of the sinusoidal wave shape of the adjacent annular segment, the annular segments and bridge elements being configured such that when compression, flexure and torsion forces are applied to the stent they generate first maximum stress regions, second maximum stress regions, and third maximum stress regions, where the first, second and third maximum stress regions do not overlap.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0021]
    The invention will now be described with reference to the accompanying drawings.
  • [0022]
    FIG. 1 is a plan view of the tubular stent of the present invention cut longitudinally and opened to lie within a single plane, the stent being in a radially contracted configuration.
  • [0023]
    FIG. 2 illustrates the stent of FIG. 1 in its radially expanded configuration.
  • [0024]
    FIG. 3( a) illustrates an expanded view of a single cell within the wall of the stent of FIG. 2 and FIGS. 3( b), 3(c), 3(d), 3(e) and 3(f) show the cross-sectional areas of portions of the stent.
  • [0025]
    FIGS. 4( a) to 4(f) illustrate the effects of compression, flexure, and torsion, respectively, on a cell of the stent of this invention.
  • [0026]
    FIGS. 5( a) to 5(f) illustrate various shapes of the wall of a continuous tubular blank used to make the stent of this invention.
  • [0027]
    FIGS. 6( a) and 6(b) illustrate the variation in cross section of a section of the stent of this invention.
  • [0028]
    FIG. 7 is a view similar to FIG. 1 of another embodiment of the stent of this invention.
  • [0029]
    FIG. 8 is a view similar to FIG. 1 of another embodiment of the stent of this invention.
  • [0030]
    FIG. 9 is a view similar to FIG. 1 of another embodiment of the stent of this invention.
  • [0031]
    FIG. 10 is a view similar to FIG. 1 of another embodiment of the stent of this invention.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • [0032]
    A stent is inserted into a lumen, such as a blood vessel, at a site where stenosis, i.e., narrowing or stricture, is to be corrected. The stent is a tubular envelope, tubular body, or cylinder having apertured walls, such as, for example, a mesh-like structure. The stent typically has dimensions between several millimeters and several tens of millimeters in length, and a wall thickness of the order of, for example, several hundredths of millimeters. The stent is normally positioned in situ by catheterisation through the vasculature followed by radial expansion from an introduction diameter of, for example, about 1.0 to 1.5 mm, to an expanded diameter of, for example, about 3 to 4 mm. In this expanded condition, the stent exerts a supporting force on the lumen, thereby avoiding or at least slowing restenosis of the vessel. In general, the external diameter of the stent in the radially-contracted condition is chosen to enable the introduction of the stent into a lumen, while the expanded diameter corresponds to the diameter required to be maintained in the lumen once the stenosis has been eliminated. It should also be remembered that, although the principle application of the stent described is in relation to the treatment of blood vessels, it may also be useful as a support element for any lumen present in the human or animal body.
  • [0033]
    The stent of this invention is a tubular body, i.e., a cylinder, with an open, or apertured, mesh-like structure. The stent is capable of being dilated from a radially-contracted position to a radially-expanded position. The tubular body is comprised of a wall having an inner surface and an outer surface defining a radial stent thickness therebetween. In one embodiment, the material making up the mesh-like structure of the stent varies in its cross-sectional shape and/or cross-sectional area. It has been discovered that this cross-sectional variation (and thus a variation in thickness and/or width in the stent wall) produces a particularly desirable stent because the strength, flexibility, and support of the stent may be varied in localized areas. In areas requiring flexibility, the width as measured along the circumference of the tubular body and/or the radial thickness are made smaller to enhance flexibility. In areas requiring strength, the width and/or thickness are made larger. In areas not requiring flexibility, the width is increased to provide added vascular support.
  • [0034]
    In the embodiments illustrated in the Figures, the stent is shown in planar views so that the geometry of the stent may be seen easily. The body of the stent extends longitudinally in the direction identified as the Z axis. It also lies in the Z plane, i.e., a plane coincident with the Z axis. During delivery and use of the stent, the stent may be flexed, bent or folded; thus good flexibility is one of the required characteristics of the stent. Another important characteristic of both the design and the material of the stent includes strength, i.e., the ability to withstand stresses due to compression, flexure, and torsion, as discussed further below.
  • [0035]
    FIG. 1 illustrates a plan view of the stent of this invention. The body of stent 1 is comprised of a plurality of successive segments 2 of generally annular form. FIG. 1 shows a stent comprising eight annular segments 2. Typically, the length of segments 2 measured in the longitudinal direction (i.e., along the Z axis) may range up to several millimeters (mm) but preferably is approximately 2 mm. That is, segments 2 are fairly “short” in comparison to the total length of the stent.
  • [0036]
    The various segments of stent 1 are joined together by bridge elements 8 (which are actually integral components of the stent wall) that connect adjacent segments 2 and enable stent 1 to flex or bend.
  • [0037]
    Radiopaque marker 13 optionally is provided. Marker 13 is integral with segments 2 and typically is located on the proximal and/or distal ends of the stent. “Proximal and distal ends” refers to the portion of the stent nearest and farthest, respectively, from the point of entry of the stent into the vasculature. Suitable radiopaque markers include metals such as platinum, tantalum, gold, and alloys of these metals. Such markers permit exact placement of a stent within the vasculature of a patient. During manufacture the radiopaque marker may be crimped into a hole in the stent wall.
  • [0038]
    The longitudinal flexibility of stent 1, necessary to assist in its delivery and location at the implantation site, is essentially due to bridge elements 8, while its structural strength, that is, its support of the lumen, is due primarily to the structure of segments 2. The desired characteristics of the stent can be obtained by adapting the arrangement and relationship of the bridge elements and the segments.
  • [0039]
    FIG. 1 shows a plan view of a stent which has been cut open and laid flat; that is, the stent is no longer in a tubular shape. FIG. 1 illustrates that each segment 2 has a serpentine or sinusoidal wave shape. Each segment comprises peaks 4 and valleys 6. Each annular segment is a mirror image of an adjacent annular segment about a plane perpendicular to the longitudinal axis of the stent. Thus, the peaks of one segment are aligned longitudinally with valleys of an adjacent segment. For purposes of this description the term 4“sinusoidal wave shape” means that the annular segments have an undulating repeating pattern similar to that of a sine wave. It is not intended to mean that the shape is limited to that of a sine wave.
  • [0040]
    Bridge elements 8 separate adjacent segments and maintain a distance between them in both the expanded and contracted conditions. Each bridge element 8 comprises a concave portion, or U-shape 10, having apex 12. The U-shape is adjoined to two connector arms 14 which extend from the U-shape and adjoin adjacent sinusoidal-shaped segments 2 at a zero point of the sinusoidal wave shape of each segment. The point of connection is between a peak and a valley of each segment such that the apex of the U-shape extends in the direction of the converging peak and valley that is nearest the attachment of the connector arm. These arms extend away from the U-shape and curve back to join the segments in the direction of the apex of the U-shape. Preferably these arms form an angle α of about 90 degrees with the U-shape. Bridge elements 8 are relatively flexible and change shape only slightly from the contracted to the expanded condition, as can be seen in FIGS. 1 and 2. Arms 14 adjoin adjacent sinusoidal wave shaped segments between a peak and a valley and preferably at zero-point 11 of the sinusoidal shape. (On a sine curve plotted on an X and Y axis, the “zero-point” is that point that intersects the X axis.)
  • [0041]
    FIGS. 1 and 2 illustrate an embodiment of the stent of this invention wherein the connector arms of each bridge element adjoin alternate zero points of each adjacent segment. That is, in terms of the sinusoidal wave shape of each segment, bridge elements are connected at zero points separated by 360. This results in even spacing of bridge elements between adjacent segments. In addition, the bridge elements are oriented in the same direction; that is, the U-shaped portion of each bridge element faces the same direction. It has been found that connection of the bridge elements at the zero points not only produces a very elastic joint but also results in the longitudinal length of the stent being the same in the contracted condition and the expanded condition and in all degrees of expansion therebetween.
  • [0042]
    A radially-contracted condition of the stent is illustrated in FIG. 1. This condition is slightly expanded from the stents fully contracted delivery condition so that the details of the stents structure may be more clearly shown. The radially-expanded condition of the stent shown in FIG. 2. FIG. 2 shows that a segment 2 is elongated compared to the same segment in FIG. 1. That is, the segments retain the sinusoidal shape, but the amplitude and the frequency of the sine wave is less in the expanded condition than in the contracted condition. FIGS. 1 and 2 also show that the connector arms 14 remain substantially parallel to the longitudinal axis of the stent in both the radially contracted position (FIG. 1) and radially expanded position (FIG. 2).
  • [0043]
    An alternative way of describing the structure of the stents of this invention is in terms of its substantially tubular surface which includes multiple cells. FIG. 3( a), is a view of one cell of the stent of FIG. 2. FIGS. 1 and 2 illustrate that the stent is made up of individual, interconnected cells, each cell having the same size and shape. FIGS. 3( b) to 3(f) illustrate that the cross sectional shape and area of the material making up the stent varies over the cell. The perimeter of a cell is formed from portions of adjacent sinusoidal segments (2 a and 2 b) and two bridge elements (8 a and 8 b). Sinusoidal segment portions 2 a and 2 b are 360 portions of the sinusoidal wave shape of the annular segments. Arms 14 a and 14 a′ extend from U-shape portion 10 a of bridge element 8 a. Apex 12 a of bridge 8 a is oriented in the same direction as apex 12 b of bridge 8 b. Bridges 8 a and 8 b adjoin adjacent segments 2 a and 2 b at zero points 11 of the sinusoidal shape; that is, between the peaks and valleys of the segments. Bridge element 8 b, having U-shape 10 b, apex 12 b, and arms 14 b and 14 b′, forms the remainder of the cell.
  • [0044]
    FIGS. 3( b), 3(c), 3(d), 3(e) and 3(f) show the shape and size of the cross-section of different portions of the cell taken along lines b-b, c-c, d-d, e-e and f-f respectively. It is preferred that the cross-sectional area of the material making up the stent vary. The cross-sectional shape may vary as well. An alternate way of describing this is that the width of the material making up the stent of FIGS. 1 and 2 (i.e., the width of any portion of a bridge or a sinusoidal segment in plane Z) may be different than the thickness of that portion (i.e., the dimension in a plane X, perpendicular to plane Z). It has been found that varying the cross-sectional area of different portions of the material of the stent produces optimum strength, flexibility, and support, enabling the stent to accommodate the differing stresses it encounters during use.
  • [0045]
    Through the use of stress analysis of the stent, it has been determined that during use, different areas of the cells are stressed, depending upon the forces acting on the stent. For example, when the stent is under compression, stress is maximized in the peaks and valleys of the sinusoidal segments. When the stent is flexed, the stress is maximized around the apex of the U-shape of the bridge elements. Under torsion, the stress is maximized at the ends of the connector arms of the bridge elements, i.e., where a bridge element connects to a sinusoidal segment.
  • [0046]
    FIGS. 4( a) to 4(f) illustrate the effects of compression, flexure, and torsion, respectively, on one cell of the stent of this invention. The arrows indicate the direction of the forces applied to the stent. The areas of the stent cell having the greatest stress concentration are indicated by solid lines. In FIG. 4( a), the stent is subjected to a compression force. FIG. 4( b) shows that the areas of greatest stress occurs at the peaks and valleys of the sinusoidal shaped segments. FIG. 4( c) shows s stent undergoing flexure. FIG. 4( d) indicates that the areas of greatest stress occur at the apex of the U-shape of the bridge. FIG. 4( e) shows a stent under torsion. FIG. 4( f) indicates that the maximum stress occurs at the areas where the bridge joins the sinusoidal shaped segments, i.e., at the zero point.
  • [0047]
    It is an advantage of the cellular design of the stent of this invention that the areas of maximum stress induced by compression, flexure and torsion forces do not overlap. This reduces the risk that a particular area of the stent cell structure will be overly fatigued and fail. It also reduces the risk of causing damage to the vessel wall which can result if there is a significant stress concentration at any portion of the cellular structure. In the stent of this invention maximum stresses from compression, flexure and torsion are distributed and discharged over three separate areas of the cellular structure thus reducing the risk of stent failure and damage to vessel walls.
  • [0048]
    In the stents of this invention, it is possible to alter the thickness and width of various portions of the stent during the manufacturing process. One way to do this is to form the desired wall geometry in a continuous tubular blank and then cut or machine the stent from this blank. For example, techniques such as laser incision, photo-incision, and electroerosion may be used to form a desired geometry. In this way, the stent bridges and sinusoidal segments are formed.
  • [0049]
    FIG. 5 a shows a continuous tubular blank from which stents can be formed. The tubular blank has outer surface 51 forming the outer diameter and inner surface 53 forming the inner diameter; surfaces 51 and 53 are separated by wall thickness 55. The characteristics of the stent including wall thickness and shape can be varied in accordance with the shape and surface configuration of inner and outer surfaces 53 and 51 of the tubular blank. Accordingly, the wall of the stent may be formed so that it has a variety of cross sectional shapes. FIGS. 5( b) to 5(f) show a section or slice of differently shaped tubular blanks between lines a-a′ and illustrate various wall shapes. The inner and outer surfaces of the tubular blank may be substantially parallel as in FIG. 5 b. This is consistent with the embodiment shown in FIGS. 3( a) to 3(f). Alternatively, the surface configuration of the outer and/or inner surfaces may be varied as in FIGS. 5( c) to 5(f). For example, the inner diameter of the tube may be constant and the outer diameter may vary, as in FIG. 5( c), or the converse, as in FIG. 5( d), may be used. FIGS. 5( e) and 5(f) illustrate tube walls having variable inside and outside diameters. Such tubular blanks are then machined to form the desired stent as described above. The result is that the desired thicknesses and widths can be provided to different portions of the stent.
  • [0050]
    FIGS. 6( a) and 6(b) show a further embodiment of the invention and illustrate how the shape of the wall of a continuous tubular blank corresponds to the stent of this invention. FIG. 6( a) shows a longitudinal cross-section of a portion of a tubular blank having a constant inner diameter but varying outer diameter. This blank is then used to form the sinusoidal segments and bridges of the stent. FIG. 6( b) shows that the regions of the bridges adjoining the sinusoidal shaped segments (i.e., at the zero point) may be made with a smaller thickness than the remaining portions of the stent.
  • [0051]
    Turning now to FIG. 7, various alternative embodiments of the stent of this invention are illustrated. This stent comprises bridge elements 78 adjoining sinusoidal shaped segments 72 at zero points 71 of the sinusoidal shape. The bridge elements are evenly spaced. In this case the bridge elements are spaced apart 720 along the sinusoidal shape of the segments. The apices of each bridge element face the same direction. As described above, when viewed as a cellular structure, the stent of FIG. 4 illustrates cells all having the same shape and size. In contrast to FIGS. 1 and 2, this stent has fewer connecting bridges and fewer cells.
  • [0052]
    The stent of FIG. 8 is a hybrid of FIGS. 1 and 6. Bridge elements 88 adjoin adjacent segments 82 at zero points 81 of the sinusoidal shape. All bridge elements are oriented similarly (i.e., face the same direction). The bridge elements adjoining adjacent segments are evenly spaced. However, the number and spacing of bridge elements is not the same for each pair of adjacent segments. This results in cells of unequal size and may produce regions of variable flexibility as well as strength. An advantage to having a greater number of bridge elements (and hence cells) at either end of the stent is that they provide additional stability and strength to the ends of the stent while having fewer cells in the middle portion of the stent provides additional flexibility.
  • [0053]
    Another variation of the stent is illustrated in FIG. 9. The bridge elements are evenly spaced throughout the stent, forming cells all of equal size and shape. However, apices (for example, 90 a and 90 b) of bridge elements 98 face opposite directions in adjacent pairs of segments 92.
  • [0054]
    FIG. 10 illustrates yet another variation of the stent, wherein U-shaped portions 100 a and 100 b of bridge elements 108 a and 108 b, respectively, are facing in opposite directions in adjacent pairs of segments 102 and wherein the cells formed at each end of the stent are of different size than those of the remaining cells. The bridge elements adjoining any pair of adjacent segments are evenly spaced, but the number and spacing of bridge elements is not the same for each pair of adjacent segments. This results in cells of unequal size, and, in similar fashion to FIG. 8, produces regions of greater strength at either end of the stent.
  • [0055]
    It is generally preferable to align the bridge elements between adjacent sinusoidal segments with the apices pointing in the direction of a converging peak and valley of the adjacent segments. This configuration provides a number of advantages. One advantage is that, in the expanded configuration, the stent cell structure is sufficiently open to permit access to the lumen. For example, it is possible to manipulate catheters through the stent wall into vessel bifurcations in order to treat those vessels. Another advantage is that the stent geometry provides a smooth profile for delivery when in the contracted position. In the stent design of this invention, the U-shape of the connecting bridges lies between a converging valley and peak of adjacent sinusoidal segments and acts as a bridge therebetween. This reduces the chance of snagging any cellular matter from the inside of the lumen. The peaks or valleys of some prior art stents protrude especially when the stent is bent during delivery. This protruding peak or valley can snag on a vessel wall or plaque, making delivery and positioning of the stent difficult. A further advantage is provided by the configuration of the bridge elements. The connector arms and U-shaped portion of the bridge elements act in cooperation with the segments to provide an effective support surface for the vessel wall while at the same time minimizing the amount of stent material which must be used.
  • [0056]
    As to deployment (that is, the in situ expansion) of the stent, currently the most widely used method is to use a balloon catheter, disposing the stent about the balloon of the catheter in the contracted condition and then expanding the balloon once the stent has been delivered to the deployment site. Different solutions are also possible, such as using superelastic materials that expand when the stent reaches the implantation site. Typically these materials are held in a contracted condition by means of a containment element that is released when the stent has reached the desired location and position. Materials having a “shape memory” that expand from a first configuration to a second expanded configuration when heated to a transition temperature (i.e., body temperature) also may be used in order to achieve the radial expansion in the implant position.
  • [0057]
    Usually the stent is made from a metal capable of satisfying two fundamental requirements: the ability to deform during the expansion phase and the ability to resist forces which could lead to contraction of the stent. That is, the stent retains the expanded shape. For example, the stents of this invention may comprise 316 stainless steel or a shape memory material known under the commercial designation “Nitinol”. “Nitinol” is a nickel-titanium alloy that has been shown to be successful due to its superelasticity as well as its shape memory. Stents also may comprise biodegradable and/or biocompatible polymers, as known to one of skill in the art.
  • [0058]
    These technological aspects will not be dealt with in detail in the present description in that they are not in themselves relevant to the comprehension and production of the invention. This also applies essentially to the technology for the production of the stent according to the invention. As described above, the stent of this invention comprises a tubular body with an apertured wall. Methods of making the stent include:
  • [0059]
    forming the stent from a continuous tubular blank intended to be segmented into individual stents, with the apertured parts being formed using techniques such as laser incision, photo-incision, electroerosion, and the like;
  • [0060]
    forming the stent from a strip-like body in which the apertured zones are formed, for example, using the techniques listed above, with the subsequent closure of the strip-like element into a tube; and
  • [0061]
    forming the stent from metal wire shaped by the subsequent attachment of wire loops, for example, using operations of micro welding, brazing, gluing, crimping, and the like.
  • [0062]
    The first arrangement described is the one currently preferred for producing stents of this invention. In particular, the use of laser beams to cut a continuous tubular blank has been shown to be the most flexible way to modify rapidly the characteristics of the stent during production.
  • [0063]
    Such methods may be used to produce a stent having either constant or variable wall thickness, and, in either case, with wall material having different cross-sections. These methods include making the stent from a continuous tubular blank and machining, grinding, chemically etching, or electron discharge machining the tube to produce the desired pattern and also obtain sections of desired cross-section. Alternatively, a tubular blank having constant or variable thickness down its length could be laser cut to form the desired arrangement of segments and bridges. A stent could be formed and then the inside surface could be turned or micro-etched.
  • [0064]
    The production method is not critical to the stents of this invention, as they may be formed by any desired method. This applies to the choice of the individual techniques and the order in which the various operations (the production of the apertured parts, segmentation, possible folding of the strip-like element, etc.) are performed.
  • [0065]
    Although particular embodiments have been disclosed herein in detail, this has been done for purposes of illustration only, and is not intended to be limiting with respect to the scope of the appended claims, which follow. In particular, it is contemplated by the inventor that various substitutions, alterations, and modifications may be made to the invention without departing from the spirit and scope of the invention as defined by the claims. For example, the frequency, number, and location of bridge elements and sinusoidal segments may be varied as necessary to obtain the desired characteristics of the stent.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4503569 *Mar 3, 1983Mar 12, 1985Dotter Charles TTransluminally placed expandable graft prosthesis
US4768507 *Aug 31, 1987Sep 6, 1988Medinnovations, Inc.Intravascular stent and percutaneous insertion catheter system for the dilation of an arterial stenosis and the prevention of arterial restenosis
US4776337 *Jun 26, 1986Oct 11, 1988Expandable Grafts PartnershipExpandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4800882 *Mar 13, 1987Jan 31, 1989Cook IncorporatedEndovascular stent and delivery system
US4830003 *Jun 17, 1988May 16, 1989Wolff Rodney GCompressive stent and delivery system
US4856516 *Jan 9, 1989Aug 15, 1989Cordis CorporationEndovascular stent apparatus and method
US4886062 *Oct 19, 1987Dec 12, 1989Medtronic, Inc.Intravascular radially expandable stent and method of implant
US4907336 *Sep 9, 1988Mar 13, 1990Cook IncorporatedMethod of making an endovascular stent and delivery system
US5421955 *Mar 17, 1994Jun 6, 1995Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5449373 *Mar 17, 1994Sep 12, 1995Medinol Ltd.Articulated stent
US5514154 *Jul 28, 1994May 7, 1996Advanced Cardiovascular Systems, Inc.Expandable stents
US5569295 *May 31, 1995Oct 29, 1996Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5591197 *Mar 14, 1995Jan 7, 1997Advanced Cardiovascular Systems, Inc.Expandable stent forming projecting barbs and method for deploying
US5603721 *Nov 13, 1995Feb 18, 1997Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5649952 *Jun 28, 1996Jul 22, 1997Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5681346 *Jan 6, 1997Oct 28, 1997Advanced Cardiovascular Systems, Inc.Expandable stent forming projecting barbs and method for deploying
US5695516 *Feb 21, 1996Dec 9, 1997Iso Stent, Inc.Longitudinally elongating balloon expandable stent
US5697971 *Jun 11, 1996Dec 16, 1997Fischell; Robert E.Multi-cell stent with cells having differing characteristics
US5718713 *Apr 10, 1997Feb 17, 1998Global Therapeutics, Inc.Surgical stent having a streamlined contour
US5725572 *Aug 8, 1997Mar 10, 1998Advanced Cardiovascular Systems, Inc.Radiopaque stent
US5728131 *Jun 12, 1995Mar 17, 1998Endotex Interventional Systems, Inc.Coupling device and method of use
US5728158 *Jan 14, 1997Mar 17, 1998Advanced Cardiovascular Systems, Inc.Expandable stents
US5733303 *May 31, 1995Mar 31, 1998Medinol Ltd.Flexible expandable stent
US5733330 *Jan 13, 1997Mar 31, 1998Advanced Cardiovascular Systems, Inc.Balloon-expandable, crush-resistant locking stent
US5735893 *Jan 14, 1997Apr 7, 1998Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5741327 *May 6, 1997Apr 21, 1998Global Therapeutics, Inc.Surgical stent featuring radiopaque markers
US5755776 *Oct 4, 1996May 26, 1998Al-Saadon; KhalidPermanent expandable intraluminal tubular stent
US5755781 *Feb 13, 1997May 26, 1998Iowa-India Investments Company LimitedEmbodiments of multiple interconnected stents
US5759174 *Jan 29, 1997Jun 2, 1998Cathco, Inc.Angioplasty balloon with an expandable external radiopaque marker band
US5759192 *Jan 15, 1997Jun 2, 1998Advanced Cardiovascular Systems, Inc.Method and apparatus for direct laser cutting of metal stents
US5766238 *Mar 24, 1997Jun 16, 1998Advanced Cardiovascular Systems, Inc.Expandable stents and method for making same
US5766239 *Oct 3, 1997Jun 16, 1998Advanced Cardiovascular Systems, Inc.Balloon-expandable, crush resistant locking stent and method of loading the same
US5769887 *Jan 17, 1997Jun 23, 1998Endotex Interventional Systems, Inc.Delivery catheter and graft for aneurysm repair
US5776161 *Oct 16, 1995Jul 7, 1998Instent, Inc.Medical stents, apparatus and method for making same
US5776183 *Aug 23, 1996Jul 7, 1998Kanesaka; NozomuExpandable stent
US5807404 *Sep 19, 1996Sep 15, 1998Medinol Ltd.Stent with variable features to optimize support and method of making such stent
US5827321 *Feb 7, 1997Oct 27, 1998Cornerstone Devices, Inc.Non-Foreshortening intraluminal prosthesis
US5913895 *Jun 2, 1997Jun 22, 1999Isostent, Inc.Intravascular stent with enhanced rigidity strut members
US5938697 *Mar 4, 1998Aug 17, 1999Scimed Life Systems, Inc.Stent having variable properties
US6027526 *Oct 3, 1997Feb 22, 2000Advanced Cardiovascular Systems, Inc.Stent having varied amounts of structural strength along its length
US6033433 *Apr 25, 1997Mar 7, 2000Scimed Life Systems, Inc.Stent configurations including spirals
US6193747 *Feb 17, 1998Feb 27, 2001Jomed Implantate GmbhStent
US6251142 *Dec 9, 1997Jun 26, 2001Sorin Biomedica Cardio S.P.A.Implantation device and a kit including the device
US6290719 *Jul 14, 1998Sep 18, 2001Sorin Biomedica Cardio S.P.A.Element for anchoring an implant device in place
US6309414 *Nov 4, 1997Oct 30, 2001Sorin Biomedica Cardio S.P.A.Angioplasty stents
US6325821 *Apr 29, 1998Dec 4, 2001Sorin Biomedica Cardio S.P.A.Stent for angioplasty
US6451049 *Oct 1, 1999Sep 17, 2002Sorin Biomedica Cardio, S.P.A.Stents for angioplasty
US7273494 *May 31, 2002Sep 25, 2007Sorin Biomedica Cardio S.R.L.Stents for angioplasty
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7931683Jul 27, 2007Apr 26, 2011Boston Scientific Scimed, Inc.Articles having ceramic coated surfaces
US7938855May 10, 2011Boston Scientific Scimed, Inc.Deformable underlayer for stent
US7942926Jul 11, 2007May 17, 2011Boston Scientific Scimed, Inc.Endoprosthesis coating
US7976915Jul 12, 2011Boston Scientific Scimed, Inc.Endoprosthesis with select ceramic morphology
US7981150Jul 19, 2011Boston Scientific Scimed, Inc.Endoprosthesis with coatings
US7985252Jul 30, 2008Jul 26, 2011Boston Scientific Scimed, Inc.Bioerodible endoprosthesis
US7998192Aug 16, 2011Boston Scientific Scimed, Inc.Endoprostheses
US8002821Aug 23, 2011Boston Scientific Scimed, Inc.Bioerodible metallic ENDOPROSTHESES
US8002823Jul 11, 2007Aug 23, 2011Boston Scientific Scimed, Inc.Endoprosthesis coating
US8029554Nov 2, 2007Oct 4, 2011Boston Scientific Scimed, Inc.Stent with embedded material
US8048150Apr 12, 2006Nov 1, 2011Boston Scientific Scimed, Inc.Endoprosthesis having a fiber meshwork disposed thereon
US8052743Aug 2, 2007Nov 8, 2011Boston Scientific Scimed, Inc.Endoprosthesis with three-dimensional disintegration control
US8052744Sep 13, 2007Nov 8, 2011Boston Scientific Scimed, Inc.Medical devices and methods of making the same
US8052745Nov 8, 2011Boston Scientific Scimed, Inc.Endoprosthesis
US8057534Sep 14, 2007Nov 15, 2011Boston Scientific Scimed, Inc.Bioerodible endoprostheses and methods of making the same
US8066763May 11, 2010Nov 29, 2011Boston Scientific Scimed, Inc.Drug-releasing stent with ceramic-containing layer
US8067054Nov 29, 2011Boston Scientific Scimed, Inc.Stents with ceramic drug reservoir layer and methods of making and using the same
US8070797Dec 6, 2011Boston Scientific Scimed, Inc.Medical device with a porous surface for delivery of a therapeutic agent
US8071156Mar 4, 2009Dec 6, 2011Boston Scientific Scimed, Inc.Endoprostheses
US8080055Dec 20, 2011Boston Scientific Scimed, Inc.Bioerodible endoprostheses and methods of making the same
US8089029Feb 1, 2006Jan 3, 2012Boston Scientific Scimed, Inc.Bioabsorbable metal medical device and method of manufacture
US8128689Sep 14, 2007Mar 6, 2012Boston Scientific Scimed, Inc.Bioerodible endoprosthesis with biostable inorganic layers
US8187620May 29, 2012Boston Scientific Scimed, Inc.Medical devices comprising a porous metal oxide or metal material and a polymer coating for delivering therapeutic agents
US8216632Jul 10, 2012Boston Scientific Scimed, Inc.Endoprosthesis coating
US8221822Jul 30, 2008Jul 17, 2012Boston Scientific Scimed, Inc.Medical device coating by laser cladding
US8231980Jul 31, 2012Boston Scientific Scimed, Inc.Medical implants including iridium oxide
US8236046Jun 10, 2008Aug 7, 2012Boston Scientific Scimed, Inc.Bioerodible endoprosthesis
US8267992Sep 18, 2012Boston Scientific Scimed, Inc.Self-buffering medical implants
US8287937Apr 24, 2009Oct 16, 2012Boston Scientific Scimed, Inc.Endoprosthese
US8303643Nov 6, 2012Remon Medical Technologies Ltd.Method and device for electrochemical formation of therapeutic species in vivo
US8353949Sep 10, 2007Jan 15, 2013Boston Scientific Scimed, Inc.Medical devices with drug-eluting coating
US8382824Oct 3, 2008Feb 26, 2013Boston Scientific Scimed, Inc.Medical implant having NANO-crystal grains with barrier layers of metal nitrides or fluorides
US8431149Apr 30, 2013Boston Scientific Scimed, Inc.Coated medical devices for abluminal drug delivery
US8449603May 28, 2013Boston Scientific Scimed, Inc.Endoprosthesis coating
US8574615May 25, 2010Nov 5, 2013Boston Scientific Scimed, Inc.Medical devices having nanoporous coatings for controlled therapeutic agent delivery
US8668732Mar 22, 2011Mar 11, 2014Boston Scientific Scimed, Inc.Surface treated bioerodible metal endoprostheses
US8715339Nov 21, 2011May 6, 2014Boston Scientific Scimed, Inc.Bioerodible endoprostheses and methods of making the same
US8771343Jun 15, 2007Jul 8, 2014Boston Scientific Scimed, Inc.Medical devices with selective titanium oxide coatings
US8808726Sep 14, 2007Aug 19, 2014Boston Scientific Scimed. Inc.Bioerodible endoprostheses and methods of making the same
US8815273Jul 27, 2007Aug 26, 2014Boston Scientific Scimed, Inc.Drug eluting medical devices having porous layers
US8815275Jun 28, 2006Aug 26, 2014Boston Scientific Scimed, Inc.Coatings for medical devices comprising a therapeutic agent and a metallic material
US8840660Jan 5, 2006Sep 23, 2014Boston Scientific Scimed, Inc.Bioerodible endoprostheses and methods of making the same
US8900292Oct 6, 2009Dec 2, 2014Boston Scientific Scimed, Inc.Coating for medical device having increased surface area
US8920491Apr 17, 2009Dec 30, 2014Boston Scientific Scimed, Inc.Medical devices having a coating of inorganic material
US8932346Apr 23, 2009Jan 13, 2015Boston Scientific Scimed, Inc.Medical devices having inorganic particle layers
US9284409Jul 17, 2008Mar 15, 2016Boston Scientific Scimed, Inc.Endoprosthesis having a non-fouling surface
US20100241216 *Sep 23, 2010Sorin Biomedica Cardio S.R.L.Stents for angioplasty
Classifications
U.S. Classification623/1.16, 623/1.11
International ClassificationA61F2/915, A61F2/91
Cooperative ClassificationA61F2002/91583, A61F2230/0013, A61F2/915, A61F2002/91541, A61F2/91
European ClassificationA61F2/915, A61F2/91