Patent Publication Number: US-6981986-B1

Title: Longitudinally flexible expandable stent

Description:
This application is a continuation of U.S. application Ser. No. 09/122,431 filed on Jul. 24, 1998, now U.S. Pat. No. 6,348,065, which is a continuation of U.S. application Ser. No. 08/511,076, filed Aug. 3, 1995, now U.S. Pat. No. 6,818,014, which is a continuation-in-part of U.S. application Ser. No. 08/396,569, filed Mar. 1, 1995, now abandoned, the entire contents of all of which are incorporated herein in their entirety by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to an endoprosthesis device for implantation within a body vessel, typically a blood vessel. More specifically, it relates to a tubular expandable stent of improved longitudinal flexibility. 
     BACKGROUND OF THE INVENTION 
     Stents are placed or implanted within a blood vessel for treating stenoses, strictures or aneurysms therein. They are implanted to reinforce collapsing, partially occluded, weakened, or dilated sections of a blood vessel. They have also been implanted in the urinary tract and in bile ducts. 
     Typically, a stent will have an unexpanded (closed) diameter for placement and an expanded (opened) diameter after placement in the vessel or the duct. Some stents are self-expanding and some are expanded mechanically with radial outward force from within the stent, as by inflation of a balloon. 
     An example of the latter type is shown in U.S. Pat. No. 4,733,665 to Palmaz, which issued Mar. 29, 1988, and discloses a number of stent configurations for implantation with the aid of a catheter. The catheter includes an arrangement wherein a balloon inside the stent is inflated to expand the stent by plastically deforming it, after positioning it within a blood vessel. 
     A type of self-expanding stent is described in U.S. Pat. No. 4,503,569 to Dotter which issued Mar. 12, 1985, and discloses a shape memory stent which expands to an implanted configuration with a change in temperature. Other types of self-expanding stents not made of shape memory material are also known. 
     This invention is directed to stents of all these types when configured so as to be longitudinally flexible as described in detail hereinbelow. Flexibility is a desirable feature in a stent so as to conform to bends in a vessel. Such stents are known in the prior art. Examples are shown in U.S. Pat. No. 4,856,516 to Hillstead; U.S. Pat. No. 5,104,404 to Wolff; U.S. Pat. No. 4,994,071 to MacGregor; U.S. Pat. No. 5,102,417 to Palmaz; U.S. Pat. No. 5,195,984 to Schatz; U.S. Pat. No. 5,135,536 to Hillstead; U.S. Pat. No. 5,354,309 to Shepp-Pesch et al.; EPO. Patent. Application 0 540 290 Å2 to Lau; EPO. Patent. Application. No. 0 364 787 B1 to Schatz, and PCT. Application WO 94/17754 (also identified as German Patent Application 43 03 181). 
     Generally speaking, these kinds of stents are articulated and are usually formed of a plurality of aligned, expandable, relatively inflexible, circular segments which are interconnected by flexible elements to form a generally tubular body which is capable of a degree of articulation or bending. Unfortunately, a problem with such stents is that binding, overlapping or interference can occur between adjacent segments on the inside of a bend due to the segments moving toward each other and into contact or on the outside of a bend the segments can move away from each other, leaving large gaps. This can lead to improper vessel support, vessel trauma, flow disturbance, kinking, balloon burst during expansion, and difficult recross for devices to be installed through already implanted devices and to unsupported regions of vessel. 
     A diamond configuration with diagonal connections between each and every diamond of each segment is also known but such closed configurations lack flexibility. 
     It is an object of this invention to provide a longitudinally flexible stent of open configuration that avoids these problems and exhibits improved flexibility (radially and longitudinally) in the stent body segments thereof rather than in flexible joints between the segments. 
     SUMMARY OF THE INVENTION 
     To this end, the invention provides a tubular expandable stent, comprising: a plurality of cylindrical shaped open cylindrical segments aligned on a common longitudinal axis to define a generally tubular stent body, each segment being defined by a member formed in an undulating flexible pattern of interconnected substantially parallel struts with pairs thereof having alternating interconnecting end portions to define the periphery of the expandable stent segment, and in which the connected end portions of paired struts in each segment, before the stent is expanded, are positioned substantially opposite to connected end portions of paired struts in adjacent segments. The segments are interconnected by a plurality of interconnecting elements extending from some of the connected end portions on one segment to some of the connected end portions on adjacent segments in such a manner that there are three or more legs between points of connection from one side of each segment to its other side. Additionally, the connecting elements extend angularly from connecting end portion of one segment to connecting end portion of an adjacent segment, not to an opposite connecting end portion on an adjacent segment, whereby upon expansion of the stent the adjacent segments are displaced relative to each other about the periphery of the stent body to accommodate flexing of the stent within paired struts without interference between adjacent segments, rather than by means of articulating flexible connectors between segments. As a result, the connectors id between the segments are not intended to flex or bend under normal use. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  shows a flat view of an unexpanded stent configuration according to the invention. 
         FIG. 2  shows the pattern of  FIG. 1  in a tubular, unexpanded stent. 
         FIG. 3  shows an expanded stent of the configuration shown in  FIG. 1 . 
         FIG. 4  shows a flat view of an alternate unexpanded stent configuration according to the invention. 
     
    
    
     BEST MODE DESCRIPTION OF THE INVENTION 
     Turning to the Figures,  FIG. 1  and  FIG. 2  show a fragmentary flat view of an unexpanded stent configuration and the actual tubular stent (unexpanded), respectively. That is, the stent is shown for clarity in  FIG. 1  in the flat and may be made from a flat pattern  10  ( FIG. 1 ) which is formed into a tubular shape by rolling the pattern so as to bring edges  12  and  14  together ( FIG. 1 ). The edges may then joined as by welding or the like to provide a configuration such as that shown in  FIG. 2 . 
     The configuration can be seen in these Figures to be made up of a plurality of adjacent segments generally indicated at  16 , each of which is formed in an undulating flexible pattern of substantially parallel struts  18 . Pairs of struts are interconnected at alternating end portions  19   a  and  19   b . As is seen in  FIG. 1 , the interconnecting end portions  19   b  of one segment are positioned opposite interconnecting end portions  19   a  of adjacent segments. The end portions as shown are generally elliptical but may be rounded or square or pointed or the like. Any configuration of end portions is acceptable so long as it provides an undulating pattern, as shown. When the flat form  10  is formed into an unexpanded tube as shown in  FIG. 2 , the segments are cylindrical but the end portions  19  of adjacent segments remain in an opposed position relative to each other. 
     A more preferred method of manufacture begins with a thin walled tube which is then laser cut to provide the desired configuration. It may also be chemically etched or EDM&#39;d (electrical discharge machined) to form an appropriate configuration. 
     Interconnecting elements  20  extend from one end portion  19  of one segment  16  to another end portion  19  of another adjacent segment  16  but not to an oppositely positioned end portion  19  of an adjacent segment  16 . There are at least three struts included between the points on each side of a segment  16  at which an interconnecting element  20  contacts an end portion  19 . This results in the interconnecting elements  20  extending in an angular direction between segments around the periphery of the tubular stent. Interconnecting elements  20  are preferably of the same length but may vary from one segment to the other. Also, the diagonal direction may reverse from one segment to another extending upwardly in one case and downwardly in another, although all connecting elements between any pair of segments are substantially parallel.  FIG. 1 , for example shows them extending downwardly, right to left. Upwardly would extend up left to right in this configuration. 
     As a result of this angular extension of the interconnecting elements  20  between adjacent segments and loops, upon expansion of the stent as seen in  FIG. 3 , the closest adjacent end portions  19  between segments  16  are displaced from each other and are no longer opposite each other so as to minimize the possibility of binding or overlapping between segments, i.e., pinching. 
     The number of interconnecting elements  20  may vary depending on circumstances in any particular instance. Three per segment are satisfactory for the configuration shown and at least three will be used typically. 
     The alternate design shown in  FIG. 4  includes longer struts  18   a  in the two end segments  16   a  than in the intermediate segments  16 . This allows the end segments ( 16   a ) to have less compression resistance than the intermediate segments ( 16 ), providing a more gradual transition from the native vessel to the support structure of the stent. Otherwise, the configuration is the same as that shown in  FIG. 1 . 
     As already indicated, this invention is applicable to self-expanding configurations, mechanically expandable configurations and to a wide variety of materials, including both metal and plastic and any other material capable of functioning as an expandable stent. For example, the stent may be of metal wire or ribbon such as tantalum, stainless steel or the like. It may be thin-walled. It may be of shape memory alloy such as Nitinol or the like, etc. 
     The above Examples and disclosure are intended to be illustrative and not exhaustive. These examples and description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims attached hereto.