Abstract:
The invention provides for intra-luminal stents, especially stent having controlled fracture connection, as well as, methods of making and using the same. In one embodiment, a stent for implantation into a vessel has a plurality of annular segments collectively forming tubular shape, characterized by at least first and second adjacent annular segments each defined by a plurality of struts and at least one joint interconnecting respective struts of the first and second segments on a non-permanent basis.

Description:
RELATED APPLICATIONS 
     This application claims the benefit of PCT Application Serial No. PCT/US2006/015596, filed Apr. 25, 2006; which claims priority of U.S. Provisional Application Ser. No. 60/674,859, filed Apr. 25, 2005, the disclosures of all of which are incorporated herein by reference in their entirety as if fully set forth herein. 
    
    
     FIELD OF THE INVENTION 
     The invention relates generally to the field of prosthetic medical devices, and, more particularly to designs for intra-luminal stents. 
     BACKGROUND OF THE INVENTION 
     Stents are prosthetic devices implanted within a subject&#39;s vessel lumen to maintain the patency of the vessel. Typically stents are comprised of cylindrical members, which are capable of expanding from a smaller diameter to a larger diameter. The stent is typically implanted within a patient&#39;s vasculature by a minimally invasive procedure using a catheter and guide wire. The catheter serves as a delivery device to transport the stent to its implantation site, e.g. an occluded vessel lumen. Once delivered to the desired site, the stent is expanded from its smaller delivery diameter to its larger diameter. A balloon-expandable stent is caused to expand by inflating the underlying balloon located at the distal end of the catheter, and a self-expanding stent is allowed to expand by releasing it from a sheath located at the distal end of the catheter. Ultimately, the stent is deployed against the interior lining of subject&#39;s vessel wall. The expansion force of the expanded stent expansion opens up the vessel occlusion. The structural integrity of the stent operates as scaffolding to support the vessel lumen and maintain its patency. 
     A variety of vascular stents are known, such as U.S. Pat. No. 3,657,744 (Ersek), U.S. Pat. No. 3,868,956 (Alfidi), U.S. Pat. No. 4,441,216 (Ionescu), U.S. Pat. No. 4,503,569 (Dotter), U.S. Pat. No. 4,512,338 (Blako), U.S. Pat. No. 4,553,545 (Maass), U.S. Pat. No. 4,580,568 (Gianturco), U.S. Pat. No. 4,733,665 (Palmaz), U.S. Pat. No. 4,762,128 (Rosenbluth), U.S. Pat. No. 4,800,882 (Gianturco), U.S. Pat. No. 4,856,516 (Hillstead), U.S. Pat. No. 4,886,062 (Wiktor), U.S. Pat. No. 5,421,955 (Lau), U.S. Pat. No. 5,476,508 (Amstrup), U.S. Pat. No. 5,514,154 (Lau), U.S. Pat. No. 5,449,373 (Pinchasik), U.S. Pat. No. 5,695,516 (Fischell), U.S. Pat. No. 6,231,598 (Berry). 
     Because stents are usually deployed through a subject&#39;s vasculature, which can often involve navigating through both narrow and curved vessels, it is advantageous for the stent to be flexible along its longitudinal axis. Loading conditions generate significant amounts of stress on the stent involving torsion, extension, compression and flexion. Once deployed, the stent must have sufficient radial strength to resist compressive forces in order to maintain vessel patency. In addition, where the stent is deployed in a vessel, which undergoes regular stress such as by bending or where the vessel itself is curved, flexibility and resistance to fracture of the deployed stent may also be important. 
     A need exists for an improved stent design that will provide sufficient radial strength to maintain vessel patency while at the same time provides sufficient flexibility to facilitate easy deployment and accommodation of the particular physiological stress factors associated with the vessel in which it is deployed while also resisting fatigue fracture as a result of those same stress factors. Further, a need exists for a modular stent that is capable of separating at predetermined points in response to stress, in lieu of fracturing haphazardly. Embodiments of the invention described below meets these needs as well. 
     SUMMARY OF THE INVENTION 
     In certain embodiments the invention provides a stent which may be implanted in the vessel lumen of a subject in order to maintain or improve the patency of the vessel. Some embodiments of the invention provide a stent with improved resistance to fracture in certain implantation sites, as well as improved flexibility suitable for traversing through and deployment in tortuous vasculature. For example, certain stents of the invention may be used in the superficial femoral or iliac arteries. The stent may be expandable and thus have a first (smaller) and second (larger) diameter. The first diameter may be suitable for delivery of the stent to its implant site, while the second diameter, i.e., the deployed expanded diameter, is approximately the diameter of the vessel lumen at the implant site and is thus suitable for maintaining the vessel patency. According to a first aspect of the invention, a stent for implantation into a vessel comprising a plurality of annular segments collectively forming tubular shape, characterized by at least first and second adjacent annular segments each defined by a plurality of struts; and at least one joint interconnecting respective struts of the first and second segments on a non-permanent basis. In one embodiment, the interconnecting joint comprises a first male interlocking structure and a second female interlocking structure. In another embodiment, the respective struts of the first and second segments each comprise a hole and the interconnecting joint projects through the hole in the respective struts of the first and second segments. In still other embodiment, the interconnecting joint has a first end and a second end, and the first and second ends are each thicker than the diameter of one of the holes in the respective struts of the first and second segments. In other embodiments the interconnecting joint separates after the stent is deployed or at least a portion of the stent may comprise shape memory material such as nitinol or a shape memory polymer. 
     The invention also provides a method of treating a subject having at least a partially occluded vessel comprising implanting a stent of the invention thereby to maintain patency of the vessel. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above and further advantages of the invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which: 
         FIG. 1  is plan view of a flattened section of a stent comprising one embodiment of the invention; 
         FIG. 2  is plan view of a flattened section of a stent comprising another embodiment of the invention; 
         FIG. 3  is plan view of a flattened section of a stent comprising yet another embodiment of the invention; 
         FIG. 4  is plan view of a flattened section of a stent comprising one embodiment of the invention; 
         FIG. 5  is a plan view of a flattened section of a double strut stent segment; and 
         FIG. 6  shows another embodiment of a temporary joint. 
     
    
    
     DETAILED DESCRIPTION 
     The stents of the invention are designed comprising at least one controlled fracture location and, in certain embodiments, controlled timing of the fracture. As such, the connection design and materials are suitable to provide the stent with improved resistance to fatigue fractures at uncontrollable locations which can happen with stents presently in use. Fatigue fracture is a particular problem with stents deployed in tortuous vessels which stents are constantly subjected to torsion, twisting, bending and compression. Over time, the forces cause the stent to fatigue and break, sometime allowing jagged struts and end to pierce the adjacent vessel or hang into the lumen attracting thrombi. Such breakage can also compromise the support provided by the stent. Thus, the stents of the invention are designed to separate in such a manner so that when separation occurs the separation does not expose fragmented or jagged material and, importantly, the circumferential support provided by the stent does not become compromised. One method for accomplishing this is to provide for controlled separation or breakage at locations oriented at acute or greater angle relative to the circumference. The separation occurs at pre-determined locations via temporary joints. Several non-limiting examples are shown in the Figures to more clearly describe the features of the invention. Other designs of joints and connections can achieve the favorable outcomes of the invention. 
       FIG. 1  shows one embodiment of the invention. A flattened section of a stent is shown. The stent may be a hollow tube having a first end and a second end. The stent is comprised of two distinct patterns of alternating, circumferentially disposed segments. The terms “segment” and “section” are used herein to mean “one of several parts or pieces that fit with others to constitute a whole object”. A first circumferential segment is comprised of a plurality of struts which are disposed along a first portion of the longitudinal axis of the stent and, which form a plurality of circumferentially disposed closed cells defined by the struts. The struts form diamond shaped cells  110  in the particular embodiment shown in  FIG. 1 . However, other suitable cell shapes, including both open and closed cells are also contemplated. In this embodiment, the diamond shaped cells are comprised of a plurality of peaks and valleys. The circumferentially disposed cells alternate along the longitudinal axis with a second circumferential segment comprising sinusoidal segments  112 . The sinusoidal segments may be disposed in a partially circumferential manner. Disposed partially in a circumferential manner may mean, in some embodiments that the degree arc encompassed by the sinusoidal segment is less than 360°, less 270°, less than 180°, less than 90°, less than 60°, or less than 30°. Thus, because the sinusoidal segments are only partially disposed circumferentially, a plurality of sinusoidal segments is contemplated for each segment of the stent that alternates between the circumferentially disposed closed cells. The plurality of sinusoidal segments is thus sandwiched between circumferentially disposed closed cells. The circumferentially disposed closed cell segments thus lie adjacent to a plurality of sinusoidal segments traveling from one end of the stent, along the longitudinal axis to the other end. Both end positions along the longitudinal axis of the stent may be desirably occupied by circumferentially disposed cells. The sinusoidal segments are each joined to at least one circumferentially disposed cell of the first circumferential closed cell segment. In some embodiments the sinusoidal segment may be joined at a single position to one adjacent closed cell. In other embodiments the sinusoidal segment may be joined at more than one position to distinct adjacent cells, e.g., 2 distinct adjacent cells. The sinusoidal segments may desirably be joined at a peak position of one of the diamond shaped closed cells. 
     In certain embodiments the sinusoidal segments may expand independently of one another as the stent expands from its first diameter to its second diameter. Thus, the sinusoidal segments provide for a more flexible stent during deployment, while also providing for greater resistance to fatigue and fracture once the stent is deployed. The closed cells may be designed to provide for optimal radial strength. 
     An alternative embodiment of the invention is shown in  FIG. 2 . This embodiment is similar to the one described above for  FIG. 1 , except that a different closed cell structure is contemplated for the circumferentially disposed cells. In this embodiment a plurality of closed cells  210  are circumferentially disposed and are comprised of plurality of struts arranged in an undulating pattern forming a series of curved peaks and valleys. The closed cells are symmetrical about an axis orthogonal to the longitudinal axis of the stent. Individual cells are formed by joining points which exist at the valley formed between two adjacent cells. Valleys are located at positions closest to the circumferentially disposed axis which bisects the cell. Each cell is comprised of two peaks, each peak pointing towards an opposite end of the stent along the longitudinal axis of the stent. The open space comprising each of the peaks is narrower than the corresponding open center of the cell. The tips of the peaks are rounded and are radially disposed either inwardly, or outwardly, in an alternating pattern, in relation to the center of the hollow tube. Thus, cells radiating inwardly at the peak tips are separated from cells radiating outwardly at the peak tips by a plurality of sinusoidal segments  212  that are partially circumferentially disposed. A single connecting unit  209  which in this embodiment is sinusoidal is shown. A cell  210  in its pre-deployment position is also shown. For convenience, locations  201  through  204  are labeled to illustrate features of the invention when compared to presently available stents. Location  202  will enjoy similar radial strength, that is, the design will preserve the radial strength even after the controlled fracture. Certain embodiments will have locations  203  with a smaller profile which may be desirable in certain applications. Due to the design location  204  demonstrates improved flexibility. 
       FIG. 3  shows another embodiment of the invention. A flattened section of a stent is shown. The stent may be a hollow tube having a first and second end. The stent is comprised of a plurality of circumferentially disposed expandable segments. Each of these segments is comprised of a plurality of struts which may be circumferentially disposed in a zig-zag or Z pattern. The struts arranged in a zig-zag pattern form a plurality of peaks and valleys. Adjacent circumferentially disposed segments may be out of phase with each other (e.g. 180° out of phase). Thus, a valley on a first segment is proximal to a peak on an adjacent circumferentially disposed segment. 
     Adjacent circumferentially disposed segments may be joined at a plurality of proximal peaks and valleys by temporary joints  301 . In another embodiment, circumferentially disposed segments may be in phase. Thus, adjacent circumferentially disposed segments may be joined peak to peak. In this embodiment, a bridge  303  is marked which bridge connects the stent when it assumes its tubular form. 
     The temporary joint, however, may be strong enough to remain intact during deployment of the stent such that the stent has increased column strength and dimensional stability during loading of the stent on a catheter, as well as during the phases of delivery and deployment. The temporary joints may also be disposed to detach at different stress thresholds, such that adjacent circumferential segments remain interconnected at least one or more selected locations designed to withstand the higher stress conditions. The temporary joints may also help prevent the stent from elongating or shrinking axially when it is radially expanded during deployment. In certain embodiments two adjacent circumferential segments will have a temporary joint wherever a peak or valley is proximal to a corresponding peak or valley on an adjacent circumferential segment. In other embodiments two adjacent circumferential segments may have about 1-8 temporary joints connecting them. In yet other embodiments two adjacent circumferential segments may not have any temporary joints connecting them. The temporary joints may be spatially offset from each other such as in a helically disposed manner, to facilitate increased flexibility, and to accommodate crimping of the stent without compromising the stent at the crimping location 
     Referring to  FIG. 3 , the stent may thus be comprised of a first length (L 1 ) and a second length (L 2 ), where L 1  represents the length of a perpendicular drawn from a first temporary joint to a first peak, the first peak being connected by a strut to the first temporary joint and L 2  represents the length between a second temporary joint adjacent to the first temporary joint and a second peak, the second peak being connected by a strut to the second temporary joint. The stent may also be comprised of a plurality of connecting bridges. The connecting bridges may be struts which additionally join adjacent circumferential segments. The connecting bridge thus joins a first strut from a first circumferential segment to a second strut from a second circumferential segment. The connecting bridge may be joined to the first and second struts at a position encompassing at least one temporary joint. The connecting bridge struts may be disposed parallel with the longitudinal axis of the stent. Other methods for increasing column strength include coating and/or covering the stent with polytetrafluoroethylene and/or expanded polytetrafluoroethylene or other biocompatible polymers (on one or both the inner and/or outer surface). Preferably, the coating/covering is bioabsorbable. 
       FIG. 4  shows another embodiment of the invention. A flattened section of a stent is shown. The stent may comprise a hollow tube having a first and second end. The stent is comprised of a plurality of circumferentially disposed expandable segments. Each of these segments is comprised of a plurality of struts which may be circumferentially disposed in a zig-zag or Z pattern. The struts arranged in a zig-zag pattern form a plurality of peaks and valleys. Adjacent circumferentially disposed segments may be out of phase with each other. Thus a valley on a first segment is proximal to a peak on an adjacent circumferential segment. Adjacent segments may be joined at one point (e.g., locations  701 ,  702 ,  703 ) and thus the stent may be comprised of a plurality of contiguously attached struts that traverse the length of the stent from the first end to the second end in a staggered, alternating or spiral configuration. The circumferentially disposed segments may also be joined by a plurality of temporary joints  704 . Temporary joints may be comprised of weak linkages that will break over time as a result of physiological stress after the stent is deployed. The temporary joints, however, may be strong enough to remain intact during deployment of the stent such that the stent has increased column strength during loading of the stent on a catheter, as well as delivery and deployment of the stent. Disengagement of these temporary joints facilitates deployment in a curved vessel or in a vessel which undergoes a change in diameter at the deployment site. The temporary joints may also help prevent the stent from longitudinally elongating or shrinking axially when it is radially expanded during deployment. In certain embodiments two adjacent circumferential segments will have a temporary joint wherever a peak or valley is proximal to a corresponding peak or valley on an adjacent circumferential segment. In other embodiments two adjacent circumferential segments may have about 1-8 temporary joints connecting them. The temporary joints may be comprised of a first interlocking structure and a second interlocking structure. The interlock structure may be comprised of an elongated member that is contiguous with a strut.  FIG. 5  illustrates suitable location for a slotted connection. The first interlocking structure may comprise a male structure and the second interlocking structure may comprise a female structure adapted to receive the male structure. In  FIG. 5  a slotted interlock structure (female)  812  is adapted to interlock with the male interlock structure (not shown) of an adjacent segment.  816  shows a non-slotted location where two struts meet. The male and female interlock structures may be round or oval in shape or may assume other geometrically interlocking structures, such as hooks illustrated in  FIG. 6 . 
     The temporary joints or connections described in the various embodiments may be comprised of relatively weak linkages (e.g., reduced width or thickness) or mechanical joints bound by mechanical means, such as adhesive glue, epoxy, and other polymers that will break over time as a result of physiological stress once the stent is deployed. 
     In the various embodiments of the invention, the temporary connections can be thermally bonded/welded, molded or otherwise physically attached the stent. In other embodiments, for example where the connections form a loop, they may not be physically attached to the stent except to the extent that they loop through the segment holes. In some embodiments, the temporary joints or connections may be attached to other polymeric coatings on the stent. For example, the stent may be coated with expanded polytetrafluoroethylene (“ePTFE”) which can be bonded to the temporary joints and/or stent struts. 
     Any of the stents of the invention may be implemented with a double strut. Double strut stents have been previously described, see, e.g. U.S. Pat. Nos. 6,533,808, 6,132,461, 6,132,460 all of which are incorporated by reference in their entirety. Briefly, the double strut design provides for increased flexibility for ease of delivery and deployment, while maintaining optimal vessel support as well as radial (hoop) strength and column strength. The design provides for a plurality of slots in the struts comprising the stent. The slots are openings within the structure of the strut and may pass completely through the strut. In other embodiments, the slot is a groove or recess in the strut that does not extend completely through one dimension of the strut. Because the slots are contained within the strut they will have a length and a width that is less than the length and the width of the strut they are contained in. 
     Any method known in the art may be used to make the stents of the invention, e.g. chemical etching, electrochemical etching, electro-discharge machining (EDM), physical or chemical vapor disposition. The stent may be made from a hollow tube or from sheet materials. In certain embodiments the stent may be made by laser cutting the stent from a hollow tube. The hollow tube may be comprised of any biocompatible material. In one embodiment the hollow tube is comprised of shape memory polymer, shape memory alloy, or super elastic alloy, e.g. nitinol, or a Co—Cr alloy. Other suitable materials are well known in the art. 
     The skilled artisan will appreciate that the dimensions of the stent, as well as the dimensions of the struts comprising the stent may be varied to meet the needs of a particular application. For example in certain embodiments the number and length of the coiled segments may be varied depending on the flexibility desired for the particular application, as well as the length of the stent. The struts may be square or rectangular or circular in cross section. The strut thickness and width may vary along the length of the stent. In certain embodiments the strut thickness is in the range of about 0.002 inches to about 0.024 inches. In certain embodiments the struts may have a width in the range of about 0.002 inches to about 0.024 inches. The radial strength may vary along the length of the stent as well. In certain embodiments the radial strength may vary within the range of between about 5 and about-50 gram/mm. 
     The invention further provides a method of treating a subject having at least a partially occluded vessel comprising implanting a stent of the invention in the subject such that patency of the vessel is established or maintained. The vessel may include any vessel or duct within the subject, e.g. any portion of the circulatory system of the subject, including but not limited to the coronary arteries, carotid arteries and peripheral vasculature, as well as a biliary duct, a pancreatic duct and the like. The vessel may comprise a curved arterial lumen. 
     In certain embodiments the vessel stented may constitute a popiteal artery, a femoral artery, deep femoral artery, a brachial artery, a radial artery, an ulnar artery, a palmar arch, a posterior tibial artery, anterior tibial artery, external iliac artery, common iliac artery, internal iliac artery, descending genicular artery, and an axillary artery, as well as various venous vasculature. 
     The stent may be implanted in the subject using a minimally invasive procedure, e.g. by catheter and guide wire. The catheter may comprise a sheath and an elongated member. In certain embodiments the stent may be comprised of a shape memory material and thus be self expandable. In other embodiments a balloon catheter may be used to expand the stent upon deployment at the desired site. 
     Subject as used herein, refers to any animal. The animal may be a mammal. Examples of suitable mammals include, but are not limited to, humans, non-human primates, dogs cats, sheep, cows, pigs, horses, mice, rats, rabbits, and guinea pigs. 
     Treat, treatment, treating, as used herein means any of the following: the reduction in severity of a disease or condition; the reduction in the duration of a disease course; the amelioration of one or more symptoms associated with a disease or condition; the provision of beneficial effects to a subject with a disease or condition, without necessarily curing the disease or condition; the prophylaxis of one or more symptoms associated with a disease or condition. 
     Many modifications and variations of this invention can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. The specific embodiments described herein are offered by way of example only and are not meant to be limiting in any way. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.