US20040106985A1 - Intravascular stent - Google Patents

Abstract

A stent comprises a first expansion strut column of first expansion strut pairs and a second expansion strut column of second expansion strut pairs. Each first expansion strut pair is connected to a second expansion strut pair by a connecting strut. Each connecting strut comprises at least one wrap portion, the at least one wrap portion being at least partially wrapped about at least one of the first joining portions of at least one of the first expansion strut column and the second expansion strut column.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation-in-part of U.S. application Ser. No. 10/206,432 filed Jul. 25, 2002 which is a continuation of U.S. application Ser. No. 09/574,077 filed May 18, 2000 which is a continuation of U.S. application Ser. No. 08/845,734 filed Apr. 25, 1997, now abandoned which is a continuation-in-part of U.S. application Ser. No. 08/824,142 filed Mar. 25, 1997, issued as U.S. Pat. No. 6,241,760 and which is a continuation-in-part of U.S. application Ser. No. 08/824,866 filed Mar. 26, 1997, issued as U.S. Pat. No. 5,954,743 and which is a continuation-in-part of U.S. application Ser. No. 08/824,865 filed Mar. 26, 1997, issued as U.S. Pat. No. 6,152,957 and which is a continuation-in-part of U.S. application Ser. No. 08/845,657 filed Apr. 25, 1997, issued as U.S. Pat. No. 5,922,021 and which claims benefit of U.S. Provisional Application No. 60/017,484 filed Apr. 26, 1996.[0001]
• The present application is also a continuation-in-part of U.S. application Ser. No. 10/123,883 filed Apr. 15, 2002 which is a continuation of U.S. application Ser. No. 09/839,442 filed Apr. 20, 2001, issued as U.S. Pat. No. 6,409,761 which is a continuation of U.S. application Ser. No. 08/824,142 filed Mar. 25, 1997, issued as U.S. Pat. No. 6,241,760 which also claims the benefit of U.S. Provisional Application No. 60/017,484 filed Apr. 26, 1996. U.S. application Ser. No. 10/123,883, from which the present application is a continuation-in-part, is also a continuation of U.S. application Ser. No. 09/839,287 filed Apr. 20, 2001 which is a continuation of U.S. application Ser. No. 09/237,537 filed Jan. 26, 1999, issued as U.S. Pat. No. 6,235,053 which claims benefit of U.S. Provisional Application No. 60/073,412 filed Feb. 2, 1998.[0002]
• This application is also continuation-in-part of U.S. application Ser. No. 10/321,005 filed Dec. 17, 2002 which is a continuation of U.S. application Ser. No. 09/839,287 filed Apr. 20, 2001 which is a continuation of U.S. application Ser. No. 09/237,537 filed Jan. 26, 1999, issued as U.S. Pat. No. 6,235,053 which claims benefit of U.S. Provisional Application No. 60/073,412 filed Feb. 2, 1998.[0003]
• The present application is also a continuation-in-part of U.S. application Ser. No. 09/960,861 filed Sep. 21, 2001 which claims benefit of U.S. Provisional Application No. 60/234,614 filed Sep. 22, 2000.[0004]
• This application is also a continuation-in-part of U.S. application Ser. No. 09/874349 filed Jun. 4, 2001 which claims priority to U.S. Provisional Application No. 60/209255 filed Jun. 5, 2000. The present application is also a continuation-in-part of U.S. application Ser. No. 10/297372 filed Dec. 5, 2002, which is a national stage application from International Application No. PCT/US01/18419 filed Jun. 5, 2001, which claims priority to U.S. Provisional Application No. 60/209255 filed Jun. 5, 2000.[0005]
• This application is also a continuation-in-part of U.S. application Ser. No. 09/942,077 filed Aug. 28, 2001 which claims benefit of U.S. Provisional Application No. 60/235,164 filed Sep. 23, 2000.[0006]
• The contents of all U.S. patents and applications cited above are incorporated herein by reference in their entirety.[0007]
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
• Not Applicable[0008]
BACKGROUND OF THE INVENTION
• Stents, grafts, stent-grafts, vena cava filters and similar implantable medical devices, collectively referred to hereinafter as stents, are radially expandable endoprostheses which are typically intravascular implants capable of being implanted transluminally and enlarged radially after being introduced percutaneously. Stents may be implanted in a variety of body lumens or vessels such as within the vascular system, urinary tracts, bile ducts, etc. Stents may be used to reinforce body vessels and to prevent restenosis following angioplasty in the vascular system. They may be self-expanding, mechanically expandable or hybrid expandable.[0009]
• Stents are generally tubular devices for insertion into body lumens. However, it should be noted that stents may be provided in a wide variety of sizes and shapes. Balloon expandable stents require mounting over a balloon, positioning, and inflation of the balloon to expand the stent radially outward. Self-expanding stents expand into place when unconstrained, without requiring assistance from a balloon. A self-expanding stent is biased so as to expand upon release from the delivery catheter. Some stents may be characterized as hybrid stents which have some characteristics of both self-expandable and balloon expandable stents.[0010]
• Due to the branching nature of the human vasculature it is not uncommon for stenoses to form at any of a wide variety of vessel bifurcations. A bifurcation is an area of the vasculature or other portion of the body where a first (or parent) vessel is bifurcated into two or more branch vessels. In some cases it may be necessary to implant multiple stents at the bifurcation in order to address a stenosis located thereon. Alternatively, a stent may be provided with multiple sections or branches that may be deployed within the branching vessels of the bifurcation.[0011]
• Stents may be constructed from a variety of materials such as stainless steel, Elgiloy, nickel, titanium, nitinol, shape memory polymers, etc. Stents may also be formed in a variety of manners as well. For example a stent may be formed by etching or cutting the stent pattern from a tube or section of stent material; a sheet of stent material may be cut or etched according to a desired stent pattern whereupon the sheet may be rolled or otherwise formed into the desired substantially tubular, bifurcated or other shape of the stent; one or more wires or ribbons of stent material may be woven, braided or otherwise formed into a desired shape and pattern.[0012]
• Typically, a stent is implanted in a blood vessel or other body lumen at the site of a stenosis or aneurysm by so-called “minimally invasive techniques” in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required through the patient's skin or by a “cut down” technique in which the blood vessel concerned is exposed by minor surgical means. When the stent is positioned at the correct location, the catheter is withdrawn and the stent is caused or allowed to expand to a predetermined diameter in the vessel.[0013]
• Despite the wide variety of stents presently available, there remains a desire to provide stents and stent designs which provide a more optimized combination of improved flexibility and good vessel coverage.[0014]
• All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.[0015]
• Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.[0016]
• A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.[0017]
BRIEF SUMMARY OF THE INVENTION
• In light of the above the present invention is directed to a variety of embodiments. In at least one embodiment a stent is provided that provides a more optimized combination of flexibility and vessel coverage. In some embodiments the stent is balloon expandable. In some embodiments the stent is self-expandable. In some embodiments the stent is hybrid expandable.[0018]
• In at least one embodiment the stent is provided with a smooth surface modulation that minimizes tulips.[0019]
• In at least one embodiment at least a portion of the stent is radiopaque.[0020]
• In at least one embodiment the stent is at least partially constructed from a shape memory alloy, polymer and/or other shape memory material.[0021]
• In at least one embodiment the stent is at least partially constructed from nitinol, stainless steel, or other metal.[0022]
• In at least one embodiment the stent is at least partially constructed from a polymer material and/or is at least partially coated with one or more polymer materials.[0023]
• In at least one embodiment the stent is provided with a biocompatible coating.[0024]
• In at least one embodiment of the invention the stent is provided with one or more of a variety of patterns or configurations of interconnected struts, connectors and/or stent members.[0025]
• In some embodiments the stent is provided with a desired stent pattern by cutting, ablating, shaping or otherwise modifying a substantially tubular member.[0026]
• In some embodiments the stent is provided with a desired stent pattern by cutting, ablating, shaping or otherwise modifying a sheet of suitable material. The sheet may then be rolled upon it itself and the edges of the rolled sheet may be engaged to one another in an abutting or overlapping configuration.[0027]
• In some embodiments the stent is formed from one or more moulds.[0028]
• In at least one embodiment the invention is directed to a stent comprising a first expansion strut column. The first expansion strut column is comprised of a plurality of adjacent first expansion strut pairs, wherein each first expansion strut pair has a first expansion strut and a second expansion strut. The first expansion strut column has a plurality of first joining portions. The first expansion strut is in communication with the second expansion strut at a first joining portion. The first expansion strut column has a plurality of second joining portions, wherein each first expansion strut pair is in communication with an adjacent first expansion strut pair at each second joining portion.[0029]
• The stent further comprises a second expansion strut column. The second expansion strut column is comprised of a plurality of adjacent second expansion strut pairs, wherein each second expansion strut pair has a first expansion strut and a second expansion strut. The second expansion strut column has a plurality of first joining portions. The first expansion strut is in communication with the second expansion strut at a first joining portion. The second expansion strut column has a plurality of second joining portions, wherein each second expansion strut pair is in communication with an adjacent second expansion strut pair at each second joining portion.[0030]
• The stent further comprises a first connecting strut column. The first connecting strut column comprises at least one connecting strut, wherein the at least one connecting strut is comprised of a first end region, a second end region and an intermediate region therebetween. The first end region is engaged to a portion of one of the first expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut. The intermediate region comprises a plurality of bend portions. At least a portion of the at least one connecting strut comprises at least one wrap portion, wherein the at least one wrap portion is at least partially wrapped about at least one of the first joining portions of at least one of the first expansion strut column and the second expansion strut column.[0031]
• In some embodiments the second end region of the at least one connecting strut is engaged to a portion of one of the second expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut.[0032]
• In some embodiments the second end region is engaged to a portion of one of the second expansion strut pairs at a location substantially equal in proximity to the first expansion strut than to the second expansion strut.[0033]
• In some embodiments the stent of claim further comprises a third expansion strut column and a second connecting strut column. The third expansion strut column is comprised of a plurality of adjacent third expansion strut pairs. Each third expansion strut pair has a first expansion strut and a second expansion strut. The third expansion strut column has a plurality of first joining portions. The first expansion strut is in communication with the second expansion strut at a first joining portion. The second expansion strut column has a plurality of second joining portions. Each third expansion strut pair is in communication with an adjacent third expansion strut pair at each second joining portion. The second connecting strut column comprises at least one connecting strut. The at least one connecting strut comprises a first end region, a second end region and an intermediate region therebetween. The first end region is engaged to a portion of one of the second expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut. The intermediate region comprises a plurality of bend portions. At least a portion of the at least one connecting strut comprises at least one wrap portion. The at least one wrap portion is at least partially wrapped about at least one of the second joining portions of the second expansion strut column and the first joining portions of the third expansion strut column.[0034]
• In some embodiments the second end region of the at least one connecting strut of the second connecting strut column is engaged to a portion of one of the third expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut.[0035]
• In some embodiments the second end region of the at least one connecting strut of the second connecting strut column is engaged to a portion of one of the second expansion strut pairs at a location substantially equal in proximity to the first expansion strut than to the second expansion strut.[0036]
• In some embodiments the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least one substantially linear portion to at least six substantially linear portions.[0037]
• In some embodiments the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least one substantially linear portion to at least six substantially linear portions.[0038]
• In some embodiments each substantially liner portion intersects an adjacent substantially linear portion at one of the bend portions.[0039]
• In some embodiments the at least one connecting strut comprises a single wrap portion, wherein the wrap portion is at least partially wrapped about at least one of the first joining portions of the first expansion strut column or one of the first joining portions of the second expansion strut column.[0040]
• In some embodiments the at least one connecting strut comprises a first wrap portion and a second wrap portion, the first wrap portion being at least partially wrapped about at least one of the first joining portions of the first expansion strut column, the second wrap portion is at least partially wrapped about at least one of the first joining portions of the second expansion strut column.[0041]
• In some embodiments the at least one wrap portion and the at least one first joining portion define a slot region, the slot region having a slot region width, the at least one connecting strut having a connecting strut width, the slot region width is less than the connecting strut width.[0042]
• In some embodiments the slot region width is about 0.0025 inch and the connecting strut width is about 0.0030 inch.[0043]
• In some embodiments the slot region width is about 0.0015 inches and the connecting strut width is 0.002 inch or greater[0044]
• In some embodiments the at least one wrap portion is substantially parallel to the first joining portion about which the at least one wrap portion is wrapped.[0045]
• In some embodiments the at least one wrap portion is an extension of at least one of the first expansion strut and the second expansion strut of the first expansion strut pair and/or the second expansion strut pair.[0046]
• In some embodiments the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column has a different shape from one another.[0047]
• In some embodiments the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column has a different length from one another.[0048]
• In some embodiments the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column has substantially the same length.[0049]
• In some embodiments the at least one connecting strut of the first connecting strut column has a first connecting strut width and the at least one connecting strut of the second connecting strut column has a second connecting strut width, the first connecting strut width and the second connecting strut width are different from one another.[0050]
• In some embodiments the at least one connecting strut of the first connecting strut column has a first connecting strut width and the at least one connecting strut of the second connecting strut column has a second connecting strut width, the first connecting strut width and the second connecting strut width are substantially the same.[0051]
• In some embodiments the intermediate region of the at least one connecting strut comprises at least two to at least six bend portions.[0052]
• In some embodiments the first end region of the at least one connecting strut is engaged to a first expansion strut pair at an intersection of the first expansion strut and the first joining portion of the first expansion strut pair.[0053]
• In some embodiments the first end region of the at least one connecting strut is engaged to a first expansion strut pair at an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.[0054]
• In some embodiments the first end region of the at least one connecting strut is engaged to the first expansion strut pair at a location adjacent to an intersection of the first expansion strut and the first joining portion of the first expansion strut pair.[0055]
• In some embodiments the first end region of the at least one connecting strut is engaged to the first expansion strut pair at a location adjacent to an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.[0056]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the first expansion strut of the first expansion strut pair to which the at least one connecting strut is engaged.[0057]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the first expansion strut pair to which the at least one connecting strut is engaged.[0058]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the second expansion strut of the first expansion strut pair to which the at least one connecting strut is engaged.[0059]
• In some embodiments the second end region of the at least one connecting strut is engaged to a second expansion strut pair at an intersection of the first expansion strut and the first joining portion of the second expansion strut pair.[0060]
• In some embodiments the second end region of the at least one connecting strut is engaged to a second expansion strut pair at an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.[0061]
• In some embodiments the second end region of the at least one connecting strut is engaged to a second expansion strut pair at a location adjacent to an intersection of the first expansion strut and the first joining portion of the second expansion strut pair.[0062]
• In some embodiments the second end region of the at least one connecting strut is engaged to a second expansion strut pair at a location adjacent to an intersection of the second expansion strut and the first joining portion of the second expansion strut pair.[0063]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the first expansion strut of the second expansion strut pair to which the at least one connecting strut is engaged.[0064]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the second expansion strut pair to which the at least one connecting strut is engaged.[0065]
• In some embodiments at least a portion of the at least one connecting strut is substantially parallel to the second expansion strut of the second expansion strut pair to which the at least one connecting strut is engaged.[0066]
• In some embodiments the at least one wrap portion of the at least one connecting strut extends longitudinally and circumferentially away from the first expansion strut pair to which the at least one connecting strut is engaged.[0067]
• In some embodiments the at least one wrap portion of the at least one connecting strut extends longitudinally and circumferentially away from the second expansion strut pair to which the at least one connecting strut is engaged.[0068]
• In some embodiments at least a portion of the first expansion strut and at least a portion of the second expansion strut of each first expansion strut pair are substantially parallel.[0069]
• In some embodiments at least a portion of the first expansion strut and the at least a portion of the second expansion strut are not parallel to a longitudinal axis of the stent.[0070]
• In some embodiments at least a portion of the first expansion strut and at least a portion of the second expansion strut of each second expansion strut pair are substantially parallel.[0071]
• In some embodiments at least a portion of at least one of the first expansion strut and the second expansion strut of each first expansion strut pair and/or second expansion strut pair are substantially parallel to a longitudinal axis of the stent.[0072]
• In some embodiments at least one of the first expansion strut and the second expansion strut of a first expansion strut pair and/or second expansion strut pair comprise at least one stepped notch.[0073]
• In some embodiments the first end region and/or the second end region of the at least one connecting strut is engaged to the at least one stepped notch.[0074]
• In some embodiments the first end region and the second end region of the at least one connecting strut have an ipsilateral orientation relative to one another.[0075]
• In some embodiments the first end region and the second end region of the at least one connecting strut have a contra-lateral orientation relative to one another.[0076]
• In some embodiments at least two connecting struts of the first connecting strut column and a first expansion strut pair and a second expansion strut pair respectively engaged each thereto form an asymmetrical cell space.[0077]
• In some embodiments at least two connecting struts of the first connecting strut column and a first expansion strut pair and a second expansion strut pair respectively engaged each thereto define a cell perimeter about the asymmetrical cell space. In at least one embodiment the cell perimeter is at least 5 mm in length. In at least one embodiment the cell perimeter is at least 7 mm in length. In some embodiments the cell perimeter is about 8 mm or more.[0078]
• In some embodiments the stent comprises at least one radiopaque marker.[0079]
• In some embodiments at least one of the first connecting strut pairs is configured to retain the at least one radiopaque marker.[0080]
• In some embodiments at least one of the second connecting strut pairs is configured to retain the at least one radiopaque marker.[0081]
• In some embodiments the at least one radiopaque marker is selected from at least one member of the group consisting of: at least one radiopaque rivet, at least one radiopaque band, at least one radiopaque coating and any combinations thereof.[0082]
• In some embodiments at least one of the first expansion strut and second expansion strut of a first expansion strut pair having at least one expansion strut bend.[0083]
• In some embodiments at least one of the first expansion strut and second expansion strut of a second expansion strut pair having at least one expansion strut bend.[0084]
• In some embodiments the first end region and/or the second end region of the at least one connecting strut is engaged to the at least one expansion strut bend.[0085]
• In some embodiments each first expansion strut pair of the first expansion strut column is both circumferentially and longitudinally offset relative to the second expansion strut pair of the second expansion strut column to which the first expansion strut pair is connected.[0086]
• In some embodiments each first expansion strut pair of the first expansion strut column is only longitudinally offset relative to the second expansion strut pair of the second expansion strut column to which the first expansion strut pair is connected.[0087]
• In some embodiments the at least one wrap portion of the at least one connecting strut has at least one substantially linear section.[0088]
• In some embodiments the at least one substantially linear section of the wrap portion is engaged to a stepped notch of one of the first expansion strut and second expansion strut.[0089]
• In some embodiments the at least one substantially linear section of the wrap portion and the first expansion strut or second expansion strut to which it is engaged are substantially parallel.[0090]
• In some embodiments the at least one substantially linear section of the wrap portion and the first expansion strut or second expansion strut to which it is engaged define an angle of about 180 to about 135 degrees. In at least one embodiment the angle is about 170 degrees or more.[0091]
• In some embodiments the at least one substantially linear section of the at least one wrap portion extends laterally away from the stepped notch.[0092]
• In some embodiments the at least one wrap portion of the at least one connecting strut comprises a first substantially linear section of the at least one connecting strut, the first substantially linear section extends longitudinally away from the first expansion strut pair to which it is engaged. A second substantially linear section of the at least one connecting strut extends from the first substantially linear section in a direction toward the first joining portion of the first expansion strut pair. In at least one embodiment a third section extends from the second substantially linear section in a direction toward the second expansion strut pair to which the at least one connecting strut is engaged. In at least on embodiment the first substantially linear section is engaged to a stepped notch of one of the first expansion strut and second expansion strut of the first expansion strut pair. In at least one embodiment the third substantially linear section is engaged to a stepped notch of one of the first expansion strut and second expansion strut of the second expansion strut pair.[0093]
• In some embodiments the intermediate portion of the at least one connecting strut is further comprised of at least two substantially linear sections, the at least two substantially linear sections intersecting at an intersection, the intersection of the at least two substantially linear portions defines a slant angle. In at least one embodiment the slant angle is obtuse.[0094]
• In some embodiments the intermediate portion of the at least one connecting strut is further comprised of at least two substantially linear sections, the at least two substantially linear sections intersecting at an intersection, the intersection of the at least two substantially linear portions defines a radius of curvature.[0095]
• In some embodiments the stent is configured to deliver at least one therapeutic agent. In at least one embodiment the at least one therapeutic agent is one or more coatings. In at least one embodiment the at least one therapeutic agent is a non-genetic agent, a genetic agent, cellular material, one or more polymer coatings, and or any combinations thereof.[0096]
• In some embodiments the stent is provided with a plurality of cavities. In at least on embodiment at least one of the plurality of cavities extend through at least one of the first expansion strut, the second expansion strut, the first joining portion, the second joining portion, and the at least one connecting strut. In at least one embodiment at least one of the plurality of cavities extends only partially through at least one of the first expansion strut, the second expansion strut, the first joining portion, the second joining portion, and the at least one connecting strut.[0097]
• In some embodiments the invention is directed to a stent delivery system comprising a stent delivery catheter for delivering the stent. In at least one embodiment the catheter comprises a balloon.[0098]
• In some embodiments the stent comprises a plurality of substantially serpentine bands including a first substantially serpentine band and a second substantially serpentine band. The first substantially serpentine band and the second substantially serpentine band are connected by at least one connection member. The first substantially serpentine band has a plurality of first end portions and a plurality of second end portions. The second substantially serpentine band has a plurality of first end portions and a plurality of second end portions. The at least one connection member comprising at least one wrap portion, wherein the at least one wrap portion extends away from one of the plurality first end potions and wraps around at least a portion of the first end potion from which it extends. The at least one connection member having a plurality of bends.[0099]
• These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described a embodiments of the invention.[0100]
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
• A detailed description of the invention is hereafter described with specific reference being made to the drawings.[0101]
• FIG. 1A is a side elevation view of the pre-expansion mode of an embodiment of the stent of the present invention.[0102]
• FIG. 1B is a cross sectional view of an embodiment of the stent of the present invention.[0103]
• FIG. 1C is a longitudinal cross sectional view of an embodiment of the stent of the present invention.[0104]
• FIG. 2A is a scale drawing of the strut pattern of an embodiment of the stent of the present invention.[0105]
• FIG. 2B is an expanded view of a section of the pattern of FIG. 2A.[0106]
• FIG. 3A is a schematic illustration of a pre-expansion mode of an embodiment of the stent of the present invention.[0107]
• FIG. 3B is a schematic illustration of the post-expansion mode of an embodiment of the stent of the present invention.[0108]
• FIG. 4A is a scale drawing including dimensions of an embodiment of the stent of the present invention.[0109]
• FIG. 4B is an enlarged section of the scale drawing of FIG. 4A.[0110]
• FIG. 5 is a scale drawing of an embodiment of the stent of the present invention with a tapered diameter in its post-expansion mode.[0111]
• FIG. 6A is a scale drawing of an embodiment of the stent of the present invention with reinforcement expansion columns.[0112]
• FIG. 6B is a perspective view of the embodiment of FIG. 6A.[0113]
• FIG. 7A is a scale drawing of an embodiment of the stent of the present invention including relief notches at strut joints to increase flexibility of the joints.[0114]
• FIG. 7B is an enlarged region of the embodiment of FIG. 7A.[0115]
• FIG. 7C is an enlarged view of a single connecting strut joining two expansion strut pairs in accordance with the embodiment of FIG. 7A.[0116]
• FIG. 8A is a side elevation view of an embodiment of the stent of the present invention.[0117]
• FIG. 8B is a side elevation view of an embodiment of the stent of the present invention, shown as if the stent struts and space there between were transparent.[0118]
• FIG. 8C is a scale drawing of an embodiment of the stent of the present invention.[0119]
• FIG. 8D is a variation of the embodiment of the stent of FIG. 8C.[0120]
• FIG. 8E is a perspective view of the embodiment of FIG. 8D.[0121]
• FIG. 8F is a drawing illustrating the post-expansion mode of the stent of the embodiment of FIG. 8D of the present invention.[0122]
• FIG. 8G is an enlarged view of a single connecting strut joining two expansion strut pairs in accordance with an embodiment of the present invention.[0123]
• FIG. 9A is a side elevation view of an embodiment of the stent of the present invention.[0124]
• FIG. 9B is a perspective view of the embodiment of FIG. 9A.[0125]
• FIG. 9C is a scale drawing of the embodiment of FIG. 9A.[0126]
• FIG. 9D is an enlarged region of the drawing of FIG. 9C.[0127]
• FIG. 9E is a scale drawing of an embodiment of the stent of the present invention.[0128]
• FIG. 9F is a scale drawing of an embodiment of the stent of the present invention.[0129]
• FIG. 9G is an enlarged view of a single connecting strut joining two expansion strut pairs in accordance with an embodiment of the present invention.[0130]
• FIG. 10A is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0131]
• FIG. 10B is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0132]
• FIG. 10C is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0133]
• FIG. 10D is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0134]
• FIG. 10F is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0135]
• FIG. 10F is a drawing of an alternate geometry of connecting struts and joining struts in accord with the present invention.[0136]
• FIG. 11 is a delivery balloon catheter, illustrating a method of deliver of a stent in accord with the present invention.[0137]
• FIG. 12 is a partial side view of an embodiment of the invention.[0138]
• FIG. 13 is a perspective view of an embodiment of the invention.[0139]
• FIG. 14 is a side view of the embodiment shown in FIG. 13.[0140]
• FIG. 15 is a side view of the embodiment shown in FIG. 13.[0141]
• FIG. 16 is a perspective view of an embodiment of the invention.[0142]
• FIG. 17 is a side view of the embodiment shown in FIG. 16.[0143]
• FIG. 18 is a side view of the embodiment shown in FIGS. 16 and 17.[0144]
• FIG. 19 is a side view of an embodiment of the invention.[0145]
• FIG. 20 is a side view of an embodiment of the invention.[0146]
• FIG. 21 is a side view of an embodiment of the invention.[0147]
• FIG. 22 is a side view of an embodiment of the invention.[0148]
• FIG. 23 is a side view of an embodiment of the invention.[0149]
• FIG. 24 is a side view of an embodiment of the invention.[0150]
• FIG. 25 is a perspective view of an embodiment of the invention.[0151]
• FIG. 26 is a side view of an embodiment of the invention.[0152]
• FIG. 27 is a side view of an embodiment of the invention.[0153]
• FIG. 28 is a perspective view of an embodiment of the invention.[0154]
• FIG. 29 is a side view of an embodiment of the invention.[0155]
• FIG. 30 is a perspective view of an embodiment of the invention.[0156]
• FIG. 31 is a side view of the embodiment of the invention shown in FIG. 30.[0157]
• FIG. 32 is a perspective view of an embodiment of the invention.[0158]
• FIG. 33 is a side view of an embodiment of the invention.[0159]
• FIG. 34 is a side view of an embodiment of the invention.[0160]
• FIG. 35A is a side view of an embodiment of the invention.[0161]
• FIG. 35B is a side view of an embodiment of the invention.[0162]
• FIG. 36A is an enlarged view of a portion of the embodiment shown in FIG. 35A.[0163]
• FIG. 36B is an enlarged view of a portion of the embodiment shown in FIG. 35B[0164]
• FIG. 37 is a perspective view of an embodiment of the invention.[0165]
• FIG. 38 is a side view of an embodiment of the invention.[0166]
• FIG. 39 is a side view of a configuration of the embodiment shown in FIG. 38.[0167]
• FIG. 40 is a partial side view of an alternative configuration of the embodiment shown in FIG. 38.[0168]
• FIG. 41 is a perspective view of an embodiment of the invention.[0169]
• FIG. 42 is a side view of the embodiment shown in FIG. 41.[0170]
• FIG. 43 is an enlarged side view of the embodiment shown in FIG. 41.[0171]
• FIG. 44 is a perspective view of an embodiment of the invention.[0172]
• FIG. 45 is a side view of the embodiment shown in FIG. 44.[0173]
• FIG. 46 is a partial side view of a configuration of the embodiment shown in FIG. 44.[0174]
• FIG. 47 is a partial side view of a configuration of the embodiment shown in FIG. 44.[0175]
• FIG. 48 is a perspective view of an embodiment of the invention.[0176]
• FIG. 49 is a side view of the embodiment shown in FIG. 48.[0177]
• FIG. 50 is an enlarged side view of the embodiment shown in FIG. 48[0178]
• FIG. 51 is a partial side view of a configuration of the embodiment shown in FIG. 48.[0179]
• FIG. 52 is a perspective view of an embodiment of the invention.[0180]
• FIG. 53 is a side view of an embodiment of the invention.[0181]
• FIG. 54 is a side view of an embodiment of the invention.[0182]
• FIG. 55 is a side view of an embodiment of the invention.[0183]
• FIG. 56 is a side view of an embodiment of the invention.[0184]
• FIG. 57 is a side view of an embodiment of the invention.[0185]
• FIG. 58 is a side view of an embodiment of the invention.[0186]
• FIG. 59 is a side view of an embodiment of the invention.[0187]
• FIG. 60 is a side view of an embodiment of the invention.[0188]
• FIG. 61 is an enlarged sectional view of the embodiment shown in FIG. 61.[0189]
• FIG. 62 is a side view of an embodiment of the invention.[0190]
• FIG. 63 is an enlarged sectional view of the embodiment shown in FIG. 62.[0191]
• FIG. 64 is a side view of an embodiment of the invention.[0192]
• FIG. 65 is an enlarged sectional view of the embodiment shown in FIG. 64[0193]
• FIG. 66 is a partial side view of an embodiment of the invention.[0194]
• FIG. 67 is a partial side view of an embodiment of the invention.[0195]
DETAILED DESCRIPTION OF THE INVENTION
• While this invention may be embodied in many different forms, there are described in detail herein embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.[0196]
• For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.[0197]
• An embodiment of the present invention is shown in FIGS. 1A, 1B,[0198]1C,2A and2B. Referring to FIG. 1A, an elongate hollowtubular stent10 in an unexpanded state is shown.
• It is understood that a stent may have a variety of expansion states which provide the stent with a variety of different stent diameters that will vary depending on the specific expansion state the stent is in. The term “unexpanded” as used herein refers to one or more of such configurations and/or diameters prior to implantation of the stent into a body lumen.[0199]
• A[0200]proximal end12 and adistal end14 define alongitudinal length16 ofstent10. Thelongitudinal length16 of thestent10 can be as long as 100 mm or longer. Aproximal opening18 and adistal opening20 connect to aninner lumen22 ofstent10.Stent10 can be a single piece, without any seams or welding joints or may include multiple pieces.
• [0201]Stent10 is constructed of two to fifty or more expansion columns or rings24 connected together by interspersed connectingstrut columns26. The first column on theproximal end12 and the last column on thedistal end14 ofstent10 areexpansion columns24.
• [0202]Expansion columns24 are formed from a series of expansion struts28, and joiningstruts30. Expansion struts28 are elongate members arranged so that they extend at least in part in the direction of the longitudinal axis ofstent10. When an outward external force is applied tostent10 from the inside by an expansion balloon or other means, or when thestent10 is caused to self-expand, the expansion struts28 are reoriented such that they extend in a more circumferential direction, i.e. along the surface ofcylindrical stent10 and perpendicular to its longitudinal axis. Reorientation of expansion struts28causes stent10 to have an expanded circumference and diameter. In the embodiment shown in FIG. 1A, expansion struts28 ofunexpanded stent10 are seen to extend substantially parallel to the longitudinal axis ofstent10.
• Expansion struts[0203]28 are joined together by joiningstruts30 to form a plurality of expansion strut pairs32. Expansion strut pairs have aclosed end34 and anopen end36. Additional joiningstruts30 join together expansion struts28 of adjacent expansion strut pairs32, such that expansion struts28 are joined alternately at their proximal and distal ends to adjacent expansion struts28 to formexpansion columns24. Eachexpansion column24 contains a plurality, typically eight to twenty, twenty to sixty, or more of expansion struts28. Expansion columns are preferably continuous unbroken ring structures extending around the circumference of thestent10; however, broken structures in which individual struts or pieces of struts are removed from an otherwisecontinuous expansion column24 can also be used.
• Connecting[0204]struts38 connectadjacent expansion columns24 forming a series of interspersed connectingstrut columns26 each extending around the circumference ofstent10. Each connectingstrut38 joins a pair of expansion struts28 in anexpansion column24 to an adjacent pair of expansion struts28 in anadjacent expansion column24. Forstent10 of FIG. 1A, the ratio of expansion struts28 in anexpansion column24 to connectingstruts38 in a connectingstrut column26 is two to one; however, this ratio in general can be X to 1 where X is greater or less than two. Other ratios may also be utilized. Furthermore, since thestent10 of FIG. 1A begins with anexpansion column24 on theproximal end12 and ends with anexpansion column24 on thedistal end14, if there aren expansion columns24 with m expansion struts28 per column, there will be m−1 connectingstrut columns26, and n(m−1)/2 connectingstruts38.
• The reduced number of connecting[0205]struts38 in each connectingstrut column26, as compared to expansion struts28 in eachexpansion column24, allowsstent10 to be longitudinally flexibility. Longitudinal flexibility can be further increased by using a narrow width connecting strut, providing additional flexibility and suppleness to the stent as it is navigated around turns in a natural blood vessel. In some embodiments at least one portion of one or more the connectingstruts38 may have a width different than that of one or more adjacent portions.
• At least a portion of the open spaces between struts in[0206]stent10 formasymmetrical cell spaces40. A cell space or geometric cell is an empty region on the surface ofstent10, completely surrounded by one or a combination of stent struts, including expansion struts28, connectingstruts38, or joiningstruts30.Asymmetrical cell spaces40 are cell spaces which have no geometrical symmetry i.e. no rotation, reflection, combination rotation and reflection or other symmetry.Asymmetrical cell spaces40 have an asymmetrical geometric configuration.
• [0207]Asymmetrical cell spaces40 in FIG. 1A are surrounded by a firstexpansion strut pair32 in afirst expansion column24, a first connectingstrut38, a secondexpansion strut pair32 in anadjacent expansion column24, a first joiningstrut30, a second connectingstrut38, and a second joiningstrut30. Furthermore, expansion strut pairs32 ofasymmetrical cell space40 may be circumferentially offset i.e. have longitudinal axes that are not collinear and have their open ends36 facing each other. The space between two expansion struts of anexpansion strut pair32 is known as aloop slot42.
• FIG. 1B shows[0208]inner lumen22,radius44 andstent wall46 ofstent10.Stent wall46 is comprised of stent struts including expansion struts28, connectingstruts38 and joiningstruts30.
• FIG. 1C shows,[0209]proximal end12,distal end14,longitudinal length16,inner lumen22, andstent wall46 ofstent10.Inner lumen22 is surrounded bystent wall46 which forms the cylindrical surface ofstent10.
• Referring now to FIGS. 2A and 2B, joining[0210]struts30 ofstent10 are seen to extend at an angle to the expansion struts28, forming anarrow angle48 with oneexpansion strut28 in anexpansion strut pair32 and awide angle50 with theother expansion strut28 of anexpansion strut pair32.Narrow angle48 is less than ninety degrees, whilewide angle50 is greater than ninety degrees. Joining struts30 extend both longitudinally along the longitudinal axis ofstent10 and circumferentially, along the surface of thestent10 perpendicular to its longitudinal axis.
• [0211]Expansion strut spacing52 between adjacent expansion struts28 in a givenexpansion column24 are uniform instent10 of FIGS. 2A and 2B; however, non-uniform spacings can also be used.Expansion strut spacings52 can be varied, for example, spacings52 between adjacent expansion struts28 in anexpansion column24 can alternate between a narrow and a wide spacings. Additionally, spacings52 in asingle expansion column24 can differ fromother spacings52 inother columns24.
• It is noted that varying[0212]expansion strut spacings52 which form theloop slots42 results in variable loop slot widths. Furthermore, the longitudinal axis of theloop slots42 need not be collinear or even parallel with the longitudinal axis ofloop slots42 of anadjacent expansion column24. FIGS. 2A and 2B show an arrangement of expansion struts28 such that collinear, paralleladjacent loop slots42 are formed, but non-collinear andnon-parallel loop slots42 can also be used.
• Additionally the shape of[0213]loop slots42 need not be the same among loop slots of a single ormultiple expansion columns24. The shape ofloop slots42 can be altered by changing the orientation or physical dimensions of the expansion struts28 and/or joiningstruts30 which connect expansion struts28 of expansion strut pairs32 defining the boundaries ofloop slots42.
• Connecting[0214]struts38 coupleadjacent expansion columns24, by connecting the distal end of an expansion strut pair in oneexpansion column24 to the proximal end of an adjacentexpansion strut pair32 in asecond expansion column24. Connecting struts38 of FIGS. 2A and 2B are formed from two linear sections, a firstlinear section54 being joined at its distal end to a secondlinear section56 at its proximal end to form afirst slant angle58.
• The first[0215]linear section54 of a connectingstrut38 is joined toexpansion strut28 at the point where joiningstrut30 makesnarrow angle48 withexpansion strut28. Firstlinear section54 extends substantially collinear to joiningstrut30 continuing the line of joiningstrut30 into the space betweenexpansion columns24. The distal end of the firstlinear section54 is joined to the proximal end of the secondlinear section56 formingslant angle58. Secondlinear section56 extends substantially parallel to expansion struts28 connecting at its distal end to joiningstrut30 in anadjacent expansion column24. The distal end of secondlinear section56 attaches toexpansion strut28 at the point where joiningstrut30 makesnarrow angle48 withexpansion strut28. Further, joiningstrut30 can have a second slant angle with a width that can be the same or different from the width of the first slant angle.
• FIGS. 2A and 2B show connecting struts[0216]38 and joiningstruts30 slanted relative to the longitudinal axis ofstent10, with the circumferential direction of the slanted struts alternating from column to adjacent column. Circumferential direction refers to the handedness with which the slanted struts wind about the surface of thestent10. The circumferential direction of the slant of connecting strut firstlinear sections54 in a connectingstrut column26 is opposite the circumferential direction of the slant of connecting strut firstlinear sections54 in an adjacent connectingstrut column26. Similarly, the circumferential direction of the slant of joiningstruts30 in anexpansion column24 is opposite the circumferential direction of the slant of joiningstruts30 in anadjacent expansion column24. Alternating circumferential slant directions of connectingstruts38 and joiningstruts30 prevents axial warping ofstent10 during deliver and expansion. Other non-alternating slant direction patterns can also be used for connectingstruts38 or joiningstruts30 or both.
• FIGS. 3A and 3B show a schematic illustration of a stent design according to the present invention in an unexpanded and expanded state respectively. The design is depicted as a flat projection, as if[0217]stent10 were cut lengthwise parallel to its longitudinal axis and flattened out. The connecting struts38 comprise first and secondlinear sections54 and56 formingslant angle58 atpivot point60. Anasymmetrical cell space40 is formed by expansion strut pairs32, connectingstruts38 and joiningstruts30. Multiple interlockingasymmetrical cell spaces40 make up the design pattern.
• As the stent is expanded, see FIG. 3B, the expansion strut pairs[0218]32 spread apart at their open ends36, shortening the length of expansion struts28 along the longitudinal axis of the cylindrical stent. The longitudinal shortening of expansion struts28 during expansion is countered by the longitudinal lengthening of connectingstruts38. The widening ofslant angle58 during expansion straightens connectingstruts38 and lengthens the distance between the coupled expansion strut pairs32. The widening of the slant angle of connectingstruts38 substantially compensates for the longitudinal shortening of expansion struts28. Thus, the stent has substantially constant unexpanded and expanded longitudinal lengths.
• When the stent is expanded, each[0219]expansion column24 becomes circumferentially stretched, enlarging the space between struts. The interlinking ofexpansion columns24 by connectingstruts38 that have been straightened through the expansion process gives the stent10 a high radial support strength. Theentire stent10 when expanded is unitized into a continuous chain mesh of stretchedexpansion columns24 and connectingstrut columns26 forming an asymmetrical interlocking cell geometry which resists collapse both axially and radially. When the stent is expanded it has increased rigidity and fatigue tolerance.
• In addition, efficient bending and straightening of connecting[0220]struts38 at pivot points60 allows increased longitudinal flexibility of the stent. For the stent to bend longitudinally, at least some of connectingstruts38 are forced to bend in their tangent plane. The tangent plane of a specific connectingstrut38 refers to the plane substantially tangent to the cylindrical surface of the stent at that connectingstrut38. The width of connectingstruts38 can be twice as wide as a thickness. In some embodiments a one-to-one ratio may be provided for, however other configurations and ratios of thickness to width may be utilized. However, pivot points60 in connectingstruts38 provide connecting struts38 a flexible joint about which to more easily bend increasing longitudinal flexibility of the stent.
• Referring to FIGS. 4A and 4B, an embodiment of the[0221]stent10 of the present invention is shown. In thisembodiment stent10 has alength16 of 33.25 mm and an uncrimped andunexpanded circumference88 of 5.26 mm. Fifteenexpansion columns24 are interspersed with connectingstrut columns26. Eachexpansion column24 is comprised of twelve expansion struts28 joined alternately at their proximal and distal ends by joiningstruts30 forming six expansion strut pairs32. Expansion struts28 are aligned parallel to the longitudinal axis ofcylindrical stent10. Joining struts30 form anarrow angle48 and awide angle50 with the respective expansion struts28 of expansion strut pairs32.Adjacent expansion columns24 employ alternating circumferential slant directions of joiningstruts30.
• In this embodiment[0222]expansion strut width62 is 0.20 mm,expansion strut length64 is 1.51 mm, and connectingstrut width66 is 0.13 mm.Distance68 from the outer edge of afirst expansion strut28 to the outer edge of a secondadjacent expansion strut28 in thesame expansion column24 is 0.64 mm, leaving aloop slot width70 of 0.24 mm.
• In this embodiment, connecting[0223]struts38 is comprised of a slanted firstlinear section54 joined to a secondlinear section56 at aslant angle58. Firstlinear section54 is slightly longer than secondlinear section56 and is attached at its proximal end to anexpansion strut28 in anexpansion column24. The attachment of the proximal end of firstlinear section54 toexpansion strut28 is at the point where joiningstrut30 makesnarrow angle48 withexpansion strut28. Firstlinear section54 extends substantially collinear to joiningstrut30 attaching at its distal end to the proximal end of secondlinear section56 to formslant angle58. Secondlinear section56 extends substantially collinear to expansion struts28, attaching at its distal end to anexpansion strut28 in anadjacent expansion column24. The attachment occurs at the point where expansion strut28 forms narrowangle48 with joiningstrut30. Joining struts30 and connecting strut firstlinear sections54 slant in alternating circumferential directions from column to adjacent column.
• The joining of connecting[0224]struts38 and expansion struts28 at the point wherenarrow angle48 is formed aids smooth delivery ofstent10 by streamlining the surface of the unexpanded stent and minimizing possible catching points. Bare delivery ofstent10 to the target lesion in a vessel will thus result in minimal snagging or catching as it is navigated through turns and curvatures in the vessel.Stent10 behaves like a flexible, tubular sled as it is moved forward or backward in the vessel on the delivery catheter, sliding through tortuous vessels and over irregular bumps caused by atherosclerotic plaques inside the vessel lumen.
• When fully expanded the[0225]stent10 of FIGS. 4A and 4B has an internal diameter of up to 5.0 mm or more, while maintaining an acceptable radial strength and fatigue tolerance. The crimped stent outer diameter can be as small as 1.0 mm or less depending on the condition of the underlying delivery balloon profile; a small crimped outer diameter is especially important if stent delivery is to be attempted without predilation of the target site. When the stent is optimally crimped over the delivery balloon, the surface of the crimped stent is smooth allowing for no snagging of the stent struts during either forward or backward movement through a vessel.
• FIG. 5 shows an embodiment of the present invention in which the[0226]stent10 in its expanded form has a gradual taper fromproximal end12 todistal end14. The shadedsegments72,74,76,78,80,82 and84 of expansion struts28 represent regions of expansion struts28 to be removed. Removal of the shadedsegments72,74,76,78,80,82 and84 providesstent10 with a gradual taper when expanded withdistal end14 having a smaller expanded diameter thanproximal end12. The degree of shortening of the expanded diameter of thestent10 at a givenexpansion column24 will be proportional to the length of the removedsegment72,74,76,78,80,82, or84 at thatexpansion column24. In the expandedstent10 the shortened expansion struts28 will have a shortened component along the circumference of the stent resulting in a shortened circumference and diameter. The tapered diameter portion can be positioned anywhere along the length ofstent10, and the tapering can be made more or less gradual by removing appropriately larger or smaller portions of the expansion struts28 in a givenexpansion column24.
• Tapering may be especially important in long stents, longer than 12 mm, since tapering of blood vessels is often more pronounced over longer lengths. Thus in some embodiments it is desirable to have a stent with a tapered expanded diameter.[0227]
• Another way to achieve a tapered expanded stent is to change the stiffness of the stent struts, expansion struts, connecting struts or joining struts such that the stiffness of the struts varies along the length of the stent. The stiffness of the struts can be changed by altering length, width or thickness, adding additional stiffening material, using a chemical or mechanical means to alter the physical properties of the stent material, or applying one or a series of elastic elements about the stent.[0228]
• Along with the use of a tapered diameter stent, a matching tapered balloon catheter would ideally be made for delivery and deployment of the tapered diameter stent. The method of using a tapered matching balloon catheter with a tapered diameter stent is within the scope of the present invention.[0229]
• Using a tapered balloon to expand a non-tapered stent will also achieve a tapered expanded stent; however, since no metal is removed from the stent, the stent is tapered as a result of incomplete expansion. The stent will therefore have increased metal fraction at the tapered end resulting in increased risk of acute thrombosis. Metal fraction is the proportion of the surface of the expanded stent covered by the stent strut material. Shortening the expansion struts as shown in FIG. 5 allows for a tapered expanded stent with substantially constant metal fraction along its length.[0230]
• Another embodiment of the present invention shown in FIGS. 6A and 6B has multiple[0231]re-enforcement expansion columns86 placed along the length of thestent10. There-enforcement columns86 are placed along the stent length to provide additional localized radial strength and rigidity tostent10. Additional strength and rigidity are especially important at the ends of the stent to prevent deformation of the stent both during delivery and after placement. During delivery the stent ends can catch on the vessel wall possibly deforming the unexpanded stent and altering its expansion characteristics. After the stent has been placed it is important that the stent ends are rigid so that they set firmly against the vessel wall; otherwise, during a subsequent catheter procedure, the catheter or guidewire can catch on the stent ends pulling the stent away from the vessel wall and possibly damaging and/or blocking the vessel.
• A variation of the embodiment of[0232]stent10 depicted in FIGS. 6A and 6B has alength16 of 20.70 mm and an uncrimped andunexpanded circumference88 of 5.26 mm. Thestent10 may comprise sixexpansion columns24 and threere-enforcement expansion columns86, each comprising respectively of twelve expansion struts28 or re-enforcement expansion struts90. There-enforcement expansion columns86 are positioned one at either end, and one along the length of thestent10.
• In some embodiments the[0233]expansion strut width62 is 0.15 mm, re-enforcementexpansion strut width92 is 0.20 mm, and the connectingstrut width66 is 0.10 mm. Thenarrow angle48 formed by joiningstrut30 andexpansion strut28 is 75 degrees, and thenarrow angle94 formed byre-enforcement joining strut96 andre-enforcement expansion strut90 is 60 degrees.
• Other arrangements of[0234]re-enforcement expansion columns86, such as providingre-enforcement expansion columns86 only on the ends of the stent, only on one end, or at multiple locations throughout the length of the stent can also be used and fall within the scope of the present invention. A taper can also be programmed into there-enforced stent10 by shortening expansion struts28 and re-enforcement expansion struts90 inappropriate expansion columns24 and86.
• Yet another embodiment of the present invention, shown in the FIGS. 7A, 7B and[0235]7C, is similar to the embodiment shown in FIGS. 6A and 6B but has the added feature ofrelief notches98 and100. A relief notch is a notch where metal has been removed from a strut, usually at a joint where multiple struts are connected. Relief notches increase flexibility of a strut or joint by creating a thinned, narrow region along the strut or joint.Relief notch98 is formed at the joint formed between firstlinear section54 of connectingstrut38 andexpansion strut28.Relief notch100 is formed at the joint between secondlinear section56 of connectingstrut38 andexpansion strut28. The positioning of the relief notches gives added flexibility to the unexpanded stent and prevents warping at the joints when the stent is expanded. This results in a smooth surface modulation to the expanded stent frame. Relief notches can be placed at other joints and can be included in any of the previously mentioned embodiments.
• FIGS. 8A and 8B show a side elevation view of a variation of an embodiment of the stent of the present invention. In this embodiment a four piece slanted connecting[0236]strut38 is used to couple the corner of anexpansion strut pair32 in oneexpansion column24 to the joiningstrut30 of a circumferentially offsetexpansion strut pair32 in anadjacent expansion column24. The expansion struts28, joiningstruts30,expansion columns24, re-enforcement expansion struts90,re-enforcement joining struts96, andre-enforcement expansion columns86 are substantially similar to the fourth embodiment of FIG. 6A. Connecting struts38 in connectingstrut columns26, however, have an altered geometry and connectivity, described in more detail below.
• FIG. 8A shows only the stent struts on the front half of the stent surface. The stent struts on the rear half of the stent surface are not shown. The stent appears as it would if the stent struts and space there between were opaque. FIG. 8B shows all stent struts from both the front and rear halves. The stent appears as it would if the stent struts and the space there between were transparent.[0237]
• Another variation of the embodiment shown in FIGS. 8A and 8B is depicted in FIG. 8C wherein the[0238]stent10 is provided with twelveexpansion columns24, fourre-enforcement expansion columns86, and fifteen connectingstrut columns26. In this variation, thestent10 has alength16 of 31.96 mm, and anunexpanded circumference88 of 5.26 mm.
• Connecting[0239]struts38 shown in an enlarged view in FIG. 8G are made up of four linear sections, aproximal end section162, first and secondintermediate sections164 and166 respectively and adistal end section168 forming threeslant angles170,172 and174. The proximal end ofproximal section162 is attached to acorner176 of anexpansion strut pair32 of anexpansion column24.Corner176 is formed where joiningstrut30 makesnarrow angle48 withexpansion strut28. Asecond corner178 ofexpansion strut32 is formed where joiningstrut30 makeswide angle50 withexpansion strut28.Corners176 and178 can have an angular shape formed by joining linear expansion struts28 and joiningstruts30, or preferablycorners176 and178 are rounded to remove sharp edges and provide increased flexibility. Additionally rounded corners providestent10 with greater expandability and reduce stress in the stent strut material at the corners in the expanded stent.
• [0240]Proximal end section162 of connectingstrut38 extends fromcorner176 and is attached at its distal end to firstintermediate section164 formingslant angle170. Firstintermediate section164 extends fromproximal end section162 such that firstintermediate section164 is parallel to expansion struts28 and is connected at its distal end to the proximal end of second intermediate section166 formingslant angle172.
• Second intermediate section[0241]166 extends in a slanted orientation relative to the longitudinal axis ofstent10, extending both longitudinally along and circumferentially aboutstent10. Preferably, second intermediate section166 is parallel to joiningstrut30 of the circumferentially offsetexpansion strut pair32 inadjacent expansion column24.
• Second intermediate section[0242]166 attaches at its distal end to the proximal end ofdistal end section168 formingslant angle174.Distal end section168 extends from second intermediate section166 attaching at its distal end to joiningstrut30 of circumferentially offsetexpansion strut pair32 ofadjacent expansion column24. The attachment is at a pointintermediate corners176 and178, where joiningstrut30 forms narrowangle48 andwide angle50 respectively with expansion struts28.
• The connection point of[0243]distal end section168 to joiningstrut30 is closer to corner176 thancorner178. Preferably the connection point is one to two or more expansion strut widths fromcorner176. Offsetting the connection point ofdistal end section168 to joiningstrut30 fromcorner176 to a pointintermediate corner176 andcorner178 reduces warping of the expandedstent10, resulting in a smooth surface modulation and reduced risk of thrombosis. Additionally, this design provides a longer total straightened length of connectingstrut38, which further reduces foreshortening ofstent10 during expansion.
• Another variation of the stent described above is shown in an unexpanded form in FIGS. 8D, 8E and in an expanded form in FIG. 8F comprises a[0244]stent10 with sixexpansion columns24, twore-enforcement expansion columns86, and seven connectingstrut columns26. In this variation, thestent10 has alength16 of 15.04 mm, and anunexpanded circumference88 of 5.26 mm. Thestent design10 is substantially similar to the design of the embodiment of FIG. 8C with a reduced number of expansion columns, re-enforcement expansion columns, and connecting strut columns.
• FIG. 8F illustrates a portion of the expanded[0245]stent10. After expansion ofstent10 by balloon or other means, the expansion struts28 are spread apart circumferentially, increasing the separation at theopen end36 of expansion strut pairs32 resulting in an increase in the circumference of thestent10. The spreading of the expansion struts28 causes a longitudinal shortening of theexpansion columns24, which is compensated by a straightening of the connectingstruts38. During the expansion process, the slant angles170,172 and174 widen straightening the connectingstruts38, and causing an increase in the separation distance betweenadjacent expansion columns24. The asymmetrical interlocking cell geometry of the expanded stent is illustrated in FIG. 8F.
• FIGS. 9A, 9B,[0246]9C,9D,9E,9F and9G illustrate another embodiment of the stent of the present invention. In this embodiment a three piece slanted connectingstrut38 is used to couple the joiningstrut30 of anexpansion strut pair32 in oneexpansion column24 to the joiningstrut30 of a circumferentially offsetexpansion strut pair32 in anadjacent expansion column24. The joints between segments of connectingstrut38 are curved forming a smooth rounded shape. The expansion struts28, joiningstruts30,expansion columns24, re-enforcement expansion struts90,re-enforcement joining struts96, andre-enforcement expansion columns86 are substantially similar to the fourth embodiment of FIG. 8A. Connecting struts38 in connectingstrut columns26, however, have an altered geometry and connectivity, described in more detail below.
• In the present embodiment shown in FIGS. 9A, 9B and[0247]9C the stent comprises eightexpansion columns24, threere-enforcement expansion columns86, and ten connectingstrut columns26. In this variation, thestent10 has alength16 of 20.32 mm.
• [0248]Relief notches204 are utilized at the joints between re-enforcement expansion struts90 andre-enforcement joining struts96 in there-enforcement expansion columns86 at the stentproximal end12 anddistal end14.Relief notches204 reduce the width of the joints between re-enforcement expansion struts90 andre-enforcement joining struts96, which reduces stress in the metal at the joints during and after expansion of the stent.Relief notches204 are particularly important at the stent ends since the stent ends are especially susceptible to warping during and after expansion. In someembodiments relief notches204 reduce the joint widths, such that the joint widths are substantially the same as the thickness of stent wall46 (see FIGS. 1B and 1C).
• Connecting[0249]struts38 shown in an enlarged view in FIG. 9D are made up of three linear sections, aproximal end section194, anintermediate section196 and adistal end section198 forming twoslant angles200,202. The connecting struts38 have wide radii of curvature at the joints between connectingstrut sections194,196 and198.
• The shape of connecting[0250]strut38 is thus curved or wavy rather than jagged and angular.
• The slant angles[0251]200 and202 are defined by linearly extrapolatingproximal end section194,intermediate section196 anddistal end section198, as shown by the dotted lines in FIG. 9D.
• FIG. 9E shows a variation of the connecting strut design of an embodiment of the invention. The connecting[0252]strut38 of FIG. 9E has smaller radii of curvature at the joints betweenproximal end section194,intermediate section196 anddistal end section198. Connectingstrut38 of FIG. 9E is thus more jagged and angular than that of FIG. 9D.
• Referring to the connecting[0253]struts38 of FIGS. 9D and 9E, the proximal end ofproximal section194 is attached to joiningstrut30 ofexpansion strut pair32intermediate corners176 and178.Proximal end section194 of connectingstrut38 extends from joiningstrut30 and is attached at its distal end tointermediate section196 forming slant angle200.Intermediate section196 extends fromproximal end section194 in a slanted orientation relative to the longitudinal axis ofstent10, extending both longitudinally along and circumferentially aboutstent10.Intermediate section196 is preferably parallel to joiningstruts30 of coupled expansion strut pairs32.
• [0254]Intermediate section196 is connected at its distal end to the proximal end ofdistal end section198 formingslant angle202.Distal end section198 extends from secondintermediate section196 attaching at its distal end to joiningstrut30 of circumferentially offsetexpansion strut pair32 ofadjacent expansion column24. The attachment is at a pointintermediate corners176 and178, where joiningstrut30 forms narrowangle48 andwide angle50 respectively with expansion struts28.
• The connection point of[0255]proximal end section194 anddistal end section198 to joiningstruts30 is closer to corner176 thancorner178. Preferably the connection point is one to two or more expansion strut widths fromcorner176. Offsetting the connection point ofdistal end section198 to joiningstrut30 fromcorner176 to a pointintermediate corner176 andcorner178 reduces warping of the expandedstent10, resulting in a smooth surface modulation and reduced risk of thrombosis. Additionally, this design provides a longer total straightened length of connectingstrut38, which further reduces foreshortening ofstent10 during expansion.
• The connecting[0256]strut38 of at least one embodiment has one hundred and eighty degree rotational symmetry about its center. The symmetry of the connectingstrut38 does not, however, result in a symmetrical cell space as the width ofloop slots42 connected in each cell space are different.Adjacent loop slots42 in each expansion column have alternating narrow and wide widths, preserving the asymmetry of the cell spaces. Introduction of one or many symmetrical cell spaces can be achieved in this design e.g. by providing uniform loop slot width to loop slots inadjacent expansion columns24 contained in the same cell space. Additionally completely non-uniform cell space patterns utilizing symmetric or asymmetric cell spaces can be achieved e.g. by providing non-uniform variations in the widths ofloop slots42.
• In another embodiment shown in FIG. 9F, the[0257]stent10 is shown in an unexpanded form and comprises sixexpansion columns24, threere-enforcement expansion columns86, and eight connectingstrut columns26. In this variation, thestent10 has alength16 of 16.00 mm, and anunexpanded circumference88 of 5.26 mm. Thestent design10 is substantially similar to the design of the embodiment of FIGS. 9A, 9B and9C with a reduced number ofexpansion columns24 and connectingstrut columns26.
• In the embodiment shown in FIG. 9G comprises a[0258]stent10 with twelveexpansion columns24, fourre-enforcement expansion columns86, and fifteen connectingstrut columns26. In this variation, thestent10 has alength16 of 30.01 mm, and anunexpanded circumference88 of 5.26 mm. Thestent design10 is substantially similar to the design of the embodiment of FIGS. 9A, 9B and9C with an increased number ofexpansion columns24re-enforcement expansion columns86 and connectingstrut columns26.
• FIGS. 10A, 10B,[0259]10C,10D,10E and10F illustrate some examples of alternate connecting strut designs which can be used in any of the previously discussed embodiments. FIG. 10A shows a roundedloop connecting strut38 which joins two circumferentially offset expansion strut pairs32 in adjacent expansion columns. Expansion struts28 in eachexpansion strut pair32 are joined by adjoiningstrut30. Joining struts30 are slanted such as to form anarrow angle48 and awide angle50 with the expansion struts28 they connect. The roundedloop connecting strut38 connects expansion struts28 at the point wherenarrow angle48 is formed between expansion struts28 and joiningstruts30. The slopes of the rounded connectingstrut38 at itsproximal end102 and distal end104 substantially match the slopes of the joiningstruts30 connecting the pairs of expansion struts28. The roundedloop connecting strut38 thus blends smoothly into the joiningstruts30. Additionally the roundedloop connecting strut38 has a first radius ofcurvature106 and a second radius ofcurvature108.
• In the embodiment shown in FIG. 10B a rounded[0260]loop connecting strut38 joins two circumferentially offset expansion strut pairs32 in adjacent expansion columns. Expansion struts28 in eachexpansion strut pair32 are joined by a joiningstrut30. Joining struts30 are at right angles to the expansion struts28 they connect. The roundedloop connecting strut38 connects to expansion struts28 at the same point as joiningstruts30. The rounded connectingstrut38 has a first radius ofcurvature106 and a second radius ofcurvature108 such that it connects circumferentially offset expansion strut pairs32.
• In the embodiment of FIG.[0261]10C connecting strut38 joins two circumferentially offset expansion strut pairs32 in adjacent expansion columns. Expansion struts28 in eachexpansion strut pair32 are joined by adjoiningstrut30. Joining struts30 are slanted such as to form anarrow angle48 and awide angle50 with the expansion struts28 they connect. The connectingstrut38 connects expansion struts28 at the point wherenarrow angle48 is formed betweenexpansion strut28 and joiningstrut30.
• The connecting[0262]strut38 is made up of threelinear sections110,112, and114 forming twoslant angles116 and118. The proximal end ofsection110 is attached toexpansion strut28 at the point where joiningstrut30 forms narrowangle48 withexpansion strut28.Section110 extends substantially collinear to joiningstrut30 and is attached at its distal end tointermediate section112 formingslant angle116.
• [0263]Intermediate section112 extends at an angle tosection110 such thatintermediate section112 is substantially parallel to expansion struts28 and is connected at its distal end to the proximal end ofdistal section114 formingslant angle118.Distal section114 extends at an angle such that it is substantially collinear to joiningstrut30 of the adjacentexpansion strut pair32.Distal section114 attaches at its distal end toexpansion strut28 of the adjacentexpansion strut pair32, at the point where joiningstrut30 forms narrowangle48 withexpansion strut28.
• In the embodiment of FIGS. 10D and 10E a connecting[0264]strut38 joins two circumferentially offset expansion strut pairs32 in adjacent expansion columns. Expansion struts28 in eachexpansion strut pair32 are joined by a joiningstrut30. Joining struts30 are at right angles to the expansion struts28 they connect. The connectingstrut38 connects to expansion struts28 at the same point as joiningstruts30.
• The connecting struts[0265]38 of FIGS. 10D and 10E are made up of multiple connecting strut sections connected end to end to form a jagged connectingstrut38 with multiple slant angles, couplingexpansion strut pair32 to adjacentexpansion strut pair32. The connecting strut of FIG. 10D is made up of three connecting strut sections, aproximal section120, anintermediate section122 and adistal section124 defining twoslant angles126 and128, while the connecting strut of FIG. 10E comprises of four connecting strut sections, aproximal section130,intermediate sections132 and134, and adistal section136 defining threeslant angles138,140 and142. In addition, connectingstrut section134 can be modified by replacing connectingstrut section136 by the dotted connectingstrut section144 to give another possible geometry of connectingstruts38.
• In the embodiment of FIG.[0266]10F connecting strut38 joins two circumferentially offset expansion strut pairs32 in adjacent expansion columns. Expansion struts28 in eachexpansion strut pair32 are joined by a joiningstrut30. Joining struts30 are slanted such as to form anarrow angle48 and awide angle50 with the expansion struts28 they connect.
• Connecting[0267]strut38 is made up of four linear sections, aproximal end section180, first and secondintermediate sections182 and184 respectively and adistal end section186 forming threeslant angles188,190 and192. The proximal end ofsection180 is attached to corner176 at the point where joiningstrut30 forms narrowangle48 withexpansion strut28.Proximal end section180 extends at an angle to joiningstrut30 and is attached at its distal end to firstintermediate section182 formingslant angle188. Firstintermediate section182 extends at an angle toproximal end section180 such that firstintermediate section182 is substantially parallel to expansion struts28 and is connected at its distal end to the proximal end of secondintermediate section184 formingslant angle190. Secondintermediate section184 is substantially longer than the firstintermediate section182. Secondintermediate section184 extends at an angle such that it is substantially collinear to joiningstrut30 of the adjacentexpansion strut pair32. Secondintermediate section184 attaches at its distal end to the proximal end ofdistal end section186 formingslant angle192.Distal end section186 extends in a slightly sloping orientation relative to expansion struts28, attaching to corner176 ofexpansion strut pair32 where joiningstrut30 forms narrowangle48 withexpansion strut28.Relief notches206 are formed at the joint betweendistal end segment186 of connectingstrut38 andcorner176 ofexpansion strut pair32 to increase flexibility of the unexpanded stent and prevent warping when the stent is expanded.
• One skilled in the art will recognize that there are many possible arrangements of connecting struts and joining struts consistent with the present invention; the above examples are not intended to be an exhaustive list. In particular, it is noted that (a) connecting strut sections need not be linear but may contain one or many radii of curvature, (b) connecting strut sections may each have a different longitudinal axis, (c) the joint between connecting strut sections need not be jagged or sharp, but rather can be smooth containing one or multiple radii of curvature, and (d) relief notches may be present at any of the strut joints.[0268]
• The stent of the present invention is ideally suited for application in coronary vessels although versatility in the stent design allows for applications in non-coronary vessels, the aorta, and nonvascular tubular body organs.[0269]
• Typical coronary vascular stents have expanded diameters that range from 2.5 to 5.0 mm. However, a stent with high radial strength and fatigue tolerance that expands to a 5.0 mm diameter may have unacceptably high stent metal fraction when used in smaller diameter vessels. If the stent metal fraction is high, the chances of acute thrombosis and restenosis potential will increase. Even with the same metal fraction a smaller caliber vessel is more likely than a larger one to have a high rate of thrombosis. It is, therefore, preferred to have at least two different categories of stents for coronary application, for example, small vessels stents for use in vessels with diameters from 2.5 mm to 3.0 mm, and large vessel stents for use in vessels with diameters from 3.0 mm to 5.0 mm. Thus, both small vessels and large vessels when treated with the appropriate sized stent will contain stents of similar idealized metal fraction.[0270]
• The stent of the present invention can be made using a CAM-driven laser cutting system to cut the stent pattern from a stainless steel tube. The rough-cut stent is preferably electro-polished to remove surface imperfections and sharp edges. Other methods of fabricating the stent can also be used such as, water/laser-jet, EDM, photo-electric etching technology, or other methods. Any suitable material can be used for the stent including other metals and polymers so long as they provide the essential structural strength, flexibility, biocompatibility and expandability.[0271]
• In some embodiments at least a portion of the stent is plated or otherwise provided with a radiopaque material such as metals including gold, platinum, tantalum or other suitable metal. It is preferred to provide one or both ends of the stent with a radiopaque material by localized plating or other mechanisms; however, the entire stent or other regions can also be plated or otherwise provided with radiopaque material. When plating both ends, one to three or more expansion columns on each end of the stent are plated to mark the ends of the stent so they can be identified under fluoroscopy during the stenting procedure. By plating the stent only at the ends, interference of the radiopaque plating material with performance characteristics or surface modulation of the stent frame is minimized. Additionally the amount of plating material required is reduced, lowering the material cost of the stent.[0272]
• In some embodiments one or more expansion struts or other portions of the stent are provided with one or more radiopaque fasteners such as a crimped sleeve of radiopaque material, a rivet of radiopaque material or other device(s).[0273]
• After plating, the stent is cleaned, typically with detergent, saline and ultrasonic means that are well-known in the art. The stents are then inspected for quality control, assembled with the delivery balloon catheter, and properly packaged, labeled, and sterilized.[0274]
• [0275]Stent10 can be marketed as stand alone or as a pre-mounted delivery balloon catheter assembly as shown in FIG. 11. Referring to FIG. 11, thestent10 is crimped over a foldedballoon146 at thedistal end148 of a deliveryballoon catheter assembly150. Theassembly150 includes aproximal end adapter152, acatheter shaft154, aballoon channel156, aguidewire channel158, aballoon146, and aguidewire160.Balloon146 can be tapered, curved, or both tapered and curved from a proximal end to a distal end in the expanded state. Additionallystent10 can be non-tapered or tapered in the expanded state.
• Typically the[0276]guidewire160 is inserted into the vein or artery and advanced to the target site. Thecatheter shaft154 is then forwarded over theguidewire160 to position thestent10 andballoon146 into position at the target site. Once in position theballoon146 is inflated through theballoon channel156 to expand thestent10 from a crimped to an expanded state. In the expanded state, thestent10 provides the desired scaffolding support to the vessel. Once thestent10 has been expanded, theballoon146 is deflated and thecatheter shaft154,balloon146, and guidewire160 are withdrawn from the patient.
• The stent of the present invention can be made as short as less than 10 mm in length or as long as 100 mm or more. If long stents are to be used, however, matching length or preferably slightly longer delivery catheter balloons will typically be needed to expand the stents into their deployed positions. Long stents, depending on the target vessel, may require curved long balloons, tapered long balloons or curved and tapered long balloons for deployment. Curved and/or tapered balloons which match the natural curve and taper of a blood vessel reduce stress on the blood vessel during and after stent deployment. This is especially important in many coronary applications which involve stenting in curved and tapered coronary vessels. The use of such curved and/or tapered balloons is within the scope of the present invention.[0277]
• In some embodiments of the invention such as those depicted in FIGS.[0278]1A,2A-8E,8G,10A-10F and12-67, thestent10 may be characterized as having a firstexpansion strut column24acomprised of a plurality of adjacent first expansion strut pairs32a, each of which in turn have afirst expansion strut28aand asecond expansion strut28b. The firstexpansion strut column24afurther comprises a plurality of first joining portions or struts30a. Thefirst expansion strut28ais in communication with thesecond expansion strut28bvia the first joiningportion30a. The firstexpansion strut column24aalso comprises a plurality of second joiningportions30b, each firstexpansion strut pair32ais in communication with an adjacent firstexpansion strut pair32avia a second joiningportion30b.
• Adjacent to the first[0279]expansion strut column24ais a secondexpansion strut column24bthat is comprised of a plurality of adjacent second expansion strut pairs32b, wherein each second expansion strut pair comprises afirst expansion strut28aand asecond expansion strut28b. The second expansion strut column further comprises a plurality of first joiningportions30a, wherein thefirst expansion strut28ais in communication with thesecond expansion strut28bat a first joiningportion30a. The second expansion strut column further comprises a plurality of second joiningportions30b. Each secondexpansion strut pair32bis in communication with an adjacent secondexpansion strut pair32bvia a second joiningportion30b;
• Between the first[0280]expansion strut column24aand the secondexpansion strut column24bis positioned a first connectingstrut column26a. The first connectingstrut column26acomprises at least one connectingstrut38. The connectingstrut38, comprises afirst end region302, asecond end region304 and anintermediate region306 therebetween.
• The[0281]first end region302 extends from a portion of one of the first expansion strut pairs32aat a location in closer proximity to thefirst expansion strut28athan to thesecond expansion strut28b. Thesecond end region304 extends from a portion of one of the second expansion strut pairs32b. In some embodiments, such as for example in the embodiment shown in FIG. 34, thesecond end region304 is engaged to a portion of the secondexpansion strut pair32bat a location substantially equal in proximity to thefirst expansion strut28aand thesecond expansion strut28b. In other embodiments, such as for example those depicted in FIGS.12-33 and35A-67, thesecond end region304 is engaged to a portion of the secondexpansion strut pair32bat a location in closer proximity to thefirst expansion strut28athan to thesecond expansion strut28b.
• At least one of the connecting struts comprise a[0282]wrap portion308. Thewrap portion308 is at least partially wrapped about at least one first joiningportions30aof either or both the firstexpansion strut column24aand the secondexpansion strut column24b. Thewrap portion308 of theconnector38 may comprise one or more portions of the connector or alternatively theentire connector38 may be characterize as awrap portion308 or one or moreinterconnected wrap portions308.
• In the embodiments shown in FIGS.[0283]12-67 theintermediate region306 further comprises at least twobend portions310aand310b.
• In some embodiments, such as those illustrated in FIGS.[0284]16-18 and21-67 the connectingstruts38 each have a connectingstrut width66. Thewrap portion308 of one or more of the connectingstruts38 and at least one first joining portion of either or both of the firstexpansion strut column24aand the secondexpansion strut column24bdefine aslot region320, wherein theslot region320 defines aslot region width322, theslot region width322 being no greater than the connectingstrut width66. In some embodiments theslot region width22 is the point at which the connectingstrut38 and the first or second joiningportion30aor30brespectively are at their closest proximity but not touching.
• In some embodiments such as are depicted in FIGS.[0285]34-65 thewrap portion308 of at least one of the connectingstruts38 is characterized as an extension314 of one or both of thefirst expansion strut28aand thesecond expansion strut28bof either or both the firstexpansion strut column24aand the secondexpansion strut column24b. At least a portion of the extension314 runs parallel to at least a portion of the first joiningportion30aof at least one of the firstexpansion strut column24aand secondexpansion strut column24b.
• In various embodiments of the invention depicted in FIGS.[0286]12-67 thestent10 is provided withexpansion strut columns24 that may be characterized as substantially serpentine bands wherein the firstexpansion strut column24ais a first substantially serpentine band and the second expansion strut column is a second substantially serpentine band. The first substantiallyserpentine band24aand the second substantiallyserpentine band24bare connected by at least one connectingmember38. The at least one connecting member has a connectingmember width66. The first substantiallyserpentine band24ahas a plurality offirst end portions30aand a plurality ofsecond end portions30b. The second substantiallyserpentine band24bhas a plurality offirst end portions30aand a plurality ofsecond end portions30b. The at least oneconnection member38 and at least onefirst end portion30aof at least one of the first substantiallyserpentine band24aand the secondserpentine band24bforming aslot region320, the slot region having aslot region width322, theslot region width322 is no greater than theconnection member width66.
• In some embodiments the at least one[0287]connection member38 comprises the at least onewrap portion308. The at least one wrap portion extends away from at least one of the pluralityfirst end potions326 and wraps around at least a portion of thefirst end potion326 from which it extends.
• In some embodiments, such as for example those depicted in FIGS. 12, 22,[0288]35,36,57,58,64 and65, thestent10 is provided with at least two distinctly different configurations of connecting struts ormembers38.Connectors38 of different configurations may be utilized in the same connecting strut column or different connectingstrut columns26aand26brespectively, as is shown.Connectors38 of different configurations may have different shapes, lengths, components, widths, angular orientations, compositions, etc., from one another.
• A[0289]first connector configuration350 of FIG. 12 has anintermediate region306 having three bend portions indicated at:310a,310b, and310c. While theintermediate region306 of asecond connector configuration354 comprises five bend portions indicated at:310a,310b,310c,310dand310e.
• In the embodiment of FIG. 12, the[0290]various configurations350 and354 of connecting struts orconnectors38 includes awrap portion308 that extends longitudinally and circumferentially away from thestrut pair32aof the firstexpansion strut column24ato engage astrut pair32bof the secondexpansion strut column24b. As is shown, in some embodiments thefirst end region302 of theconnector38 is engaged to thestrut pair32aat anintersection352 of thefirst expansion strut28aand a first joining strut orportion30a, while thesecond end region304 of the connector is engaged to thestrut pair32bat a point on a first joiningstrut30aof the second expansion strut column. It must be noted however, that different engagement configurations between the strut pairs32aand32band thefirst end region302 and thesecond end region304, respectively, may be utilized.
• In the embodiments shown in FIGS.[0291]13-15, the firstexpansion strut column24aof thestent10 is made of a plurality of adjacent first expansion struts28aand second expansion struts28bconnected by a plurality of first joiningstruts30ato form adjacent first strut pairs32a. A joiningstrut30aforms afirst intersection356 where the first joiningstrut30ajoins afirst expansion strut28aand asecond intersection358 is formed where the first joiningstrut30ajoins asecond expansion strut28bof the firstexpansion strut pair32a.
• The first and second expansion struts[0292]28aand28bin a firstexpansion strut column24aare aligned so that at least a portion of the first and second expansion struts28aand28bare parallel to each other. However, one or more portions of either or both of the first and second expansion struts28aand28bmay not be parallel to thelongitudinal axis17 of thestent10 and/or to the adjacent companion first orsecond expansion strut28aand28b.
• In some embodiments, the one or both of the[0293]first expansion strut28aand thesecond expansion strut28bof a givenexpansion strut pair32aand/or32bmay include a steppednotch360 on a distal or proximal end of the respective first orsecond expansion strut28aand/or28b. At least a portion of the steppednotch360 is an engagement site where thefirst end region302 orsecond end region304 of aconnector38 is engaged to the givenstrut pair32aand/or32b.
• The[0294]connector38 extends between the steppednotch360 of afirst strut pair32aof a firstexpansion strut column24ato a steppednotch360 of a longitudinally adjacentsecond strut pair32bof a secondexpansion strut column24b. In the embodiment shown in FIGS.13-15 thenotch360 of thefirst strut pair32ahas a contra-lateral position relative to thenotch360 of thesecond strut pair32bto which a givenconnector38 is in communication therebetween.
• In at least one embodiment, as best shown in FIG. 13, some first and/or second expansion struts[0295]28aand/or28bare provided with no steppednotches360. Whileother struts28aand/or28bare provided with at least two steppednotches360, indicated and360aand360b. Whileconnectors38 are depicted as extending from either or both of the proximal most notch and/or distal most notch, it should be recognized that aconnector38 may engage a given first or second strut pair at any point desired.
• The[0296]connectors38 shown in FIGS.13-15 are provided with fourbend portions310a,310b,310cand310d.
• As a result of the unique shape of the[0297]connectors38 and the longitudinally offset arrangement of adjacent first expansion strut pairs32aand second expansion strut pairs32b, as thewrap portion308 of eachconnector38 wraps about the first joiningstrut30aof the firstexpansion strut pair24ait also wraps about the first joiningstrut30aof the secondexpansion strut pair24b.
• A pair of circumferentially[0298]adjacent connectors38 and longitudinally adjacent firstexpansion strut pair32aand secondexpansion strut pair32bform anasymmetrical cell space40 as described above. In at least one embodiment, an example of which is shown in FIG. 15 theconnectors38 and the expansion strut pairs32aand32bwhich define thecell space40 have a cell perimeter of at least 5 mm, and may be at least 7 mm or more. In at least one embodiment the perimeter of thecell space40 is about 8.19 mm.
• Turning to the embodiments depicted in FIGS.[0299]16-18 the first and second expansion struts28aand28bmay be configured in any of the variety of manners describe in relation to the embodiments of FIGS.13-15.
• As to the[0300]connectors38 however, in the embodiments depicted in FIGS.16-18 theconnectors38 of the present embodiments are provided with at least 6bend portions310a,310b,310c,310d,310eand310f.
• Each bend portion, like all bend portions described herein may act as a pivot point about which the connector may bend and or flex as the[0301]stent10 is expanded or reduced in diameter.
• The[0302]first end region302 of theconnector38 is engaged to the firstexpansion strut pair32aand thesecond end region304 of theconnector38 is engaged to an adjacent secondexpansion strut pair32bin an ipsilateral arrangement as best shown in FIGS. 17 and 18.
• Like the embodiments shown in FIGS.[0303]13-18 the embodiments shown in FIGS. 19 and 20 are also provided with steppednotches360 in one or morefirst expansion strut28aand/orsecond expansion strut28b. Furthermore, in the embodiments depicted in FIGS. 19 and 20 one or more of the first expansion struts28aand/or second expansion struts28bare provided with one or more expansionstrut bend portions312. As is shown, each firstexpansion strut pair32aand secondexpansion strut pair32bis provided with afirst expansion strut28ahaving at least onebend portion312 and asecond expansion strut28bhaving at least one steppednotch360. This arrangement of alternating struts having at least onebend portion312 and struts having at least one steppednotch360, results in astent10 having first andsecond struts28aand28bwith no portion thereof being parallel to thelongitudinal axis17 of thestent10. However, in the embodiments shown in FIGS. 19 and 20, the distal most expansion strut column and the proximal most expansion strut column of thestent10 may be provided with expansion strut pairs wherein at least a portion of one or more expansion struts28aand/or28bis parallel to thelongitudinal axis17.
• The[0304]wrap portion308 of eachconnector38 wraps about both the first joiningstrut30aof the firstexpansion strut pair32aas well as the first joiningstrut30aof the secondexpansion strut pair32bas it extends between the firstexpansion strut pair32aand the secondexpansion strut pair32b.
• The[0305]first end region302 of theconnector38 is engaged to one of the first expansion struts28aor second expansion struts28bof the firstexpansion strut column24a. Thesecond end region304 of theconnector38 is engaged to one of the first expansion struts28aor second expansion struts28bof the secondexpansion strut column24b. Theconnectors38 haveend regions302 and304 that are contra-laterally engaged to opposing first expansion strut pairs32aand second expansion strut pairs32b.
• In the embodiment shown in FIG. 19 the[0306]intermediate region306 of each connector comprises at least fourbend portions310a,310b,310cand310d. In the embodiment shown in FIG. 20, at least some of theconnectors38 are provided with intermediate regions having at least 5bend portions310a,310b,310c,310dand310e.
• As indicated above, any of the[0307]stent10 described herein may be provided with one or more radiopaque markers, coatings or other mechanisms or devices for improving the radiopacity of at least a portion of the stent. In FIG. 20 one or more of afirst expansion strut28aorsecond expansion strut28bdefines aradiopaque marker housing362. Aradiopaque marker housing362 may be positioned anywhere on the stent including but not limited to a mid portion of the stent, one or more areas of the stent adjacent thereto, on or both end regions of the stent, etc. For example, in the embodiment shown, a pair of housings are provided with eachhousing362 positioned near theproximal end12 and thedistal end14 of thestent10. Aradiopaque marker363 of any type known in the art, including rivets, bands, etc may be positioned at least partially within, on, and/or about thehousing362.
• Turning now to the embodiment of FIG. 21, in the embodiment shown, each first[0308]expansion strut column24acomprises first expansion strut pairs32awhich are comprised of afirst expansion strut28aand asecond expansion strut28b, wherein one of thefirst expansion strut28aor thesecond expansion strut28bis parallel to thelongitudinal axis17 of thestent10. Similarly each secondexpansion strut column24bcomprises second expansion strut pairs32bwhich are comprised of afirst expansion strut28aand asecond expansion strut28b, wherein one of thefirst expansion strut28aor thesecond expansion strut28bis parallel to thelongitudinal axis17 of thestent10. Eachfirst expansion strut28aand eachsecond expansion strut28bof a first and secondexpansion strut pair32aand32bis respectively joined by a first joining strut.
• Where the[0309]first expansion strut28aof a given first or second expansion strut column is parallel to thelongitudinal axis17 of thestent10, eachfirst expansion strut28ais also parallel to every otherfirst expansion strut28aof the first or second expansion strut column of which it is a member. Similarly, where thesecond expansion strut28bof a given first or second expansion strut column is parallel to thelongitudinal axis17 of thestent10, eachsecond expansion strut28bis also parallel to every othersecond expansion strut28bof the first or second expansion strut column of which it is a member.
• In the embodiment shown in FIG. 21 at least a portion of each[0310]first expansion strut28aof eachexpansion strut pair32aand32bforms an acute angle with thesecond expansion strut28b. One of thefirst expansion strut28aorsecond expansion strut28bof eachexpansion strut pair32aand32bhas at least oneexpansion strut bend312.
• [0311]Connectors38 extend between a firstexpansion strut pair32aand an adjacent secondexpansion strut pair32b, wherein thefirst end region302 of theconnector38 is engaged to the at least one expansion strut bend of the firstexpansion strut pair32aand thesecond end region304 of theconnector38 is engaged to the at least one expansion strut bend of the secondexpansion strut pair32bin an ipsilateral configuration.
• The[0312]wrap portion308 of eachconnector38 wraps about only one of either the first joiningstrut30aof the respective firstexpansion strut pair32aand the secondexpansion strut pair32bto which anindividual connector38 is engaged.
• As is shown in the embodiment depicted in FIG. 21 the[0313]wrap portion308 and the joiningstrut30aor30bform theslot region320 as previously described. Theslot region width322, is no greater than theconnection member width66.
• In the embodiment shown in FIG. 21 the[0314]intermediate region306 of eachconnector308 comprises at least threebend portions310a,310band310c.
• In the embodiment shown in FIG. 22, a first connecting[0315]strut column26ais comprised ofconnectors38 of a substantially similar configuration to those described in the embodiments shown in FIGS.13-15. Theconnectors28 of the first connectingstrut column26ajoin longitudinally adjacent first expansion strut pairs32aand second expansion strut pairs32bin the contra-lateral orientation shown.
• In addition to the[0316]connectors38 of the first connectingstrut column26a, thestent10 is also provided with a second connectingstrut column26bwherein eachconnector38 of the second connectingstrut column26bjoin circumferentially and longitudinally offset second expansion strut pairs32aand third expansion strut pairs32cin the ipsilateral orientation shown. Theconnectors38 of the second connectingstrut column26bare substantially similar in configuration to the connectors described in relation to the embodiments depicted in FIG. 21.
• In other embodiments of the invention shown in FIGS. 23 and 24 the stent is provided with[0317]connectors38, wherein eachconnector38 comprises afirst wrap portion308aand asecond wrap portion308b. Thefirst wrap portion308aof theconnector38 wraps at least partially about the first joiningstrut30aof thefirst strut pair32ato which thefirst end region302 of the connector is engaged.
• The[0318]second wrap portion308bof theconnector38 wraps at least partially about the first joiningstrut30aof thesecond strut pair32bto which thesecond end region304 of theconnector38 is engaged.
• The[0319]first end region302 of eachconnector38 is engaged to one of thefirst expansion strut28aor thesecond expansion strut28bof a firstexpansion strut pair32aand thesecond end region304 of eachconnector38 is engaged to one of the first expansion strut or the second expansion strut of a secondexpansion strut pair32bin a contra-lateral orientation.
• Each[0320]connector38 in the embodiments shown in FIGS. 23 and 24 comprise at least fourbend portions310a,310b,310cand310d.
• In the embodiment shown in FIG. 23 the[0321]connectors38 have a more elongated configuration when compared to those shown in the embodiment of FIG. 24. In FIG. 24 at least a portion of theintermediate region306 of eachconnector38 is substantially parallel to thelongitudinal axis17 of thestent10, whereas in the embodiment of FIG. 23 eachconnectors38 is provided with anintermediate portion306 of which at least a portion forms anacute angle370 with thelongitudinal axis17 of thestent10 as well as anobtuse angle372 with thelongitudinal axis17 of thestent10.
• In the various embodiments shown in FIGS.[0322]25-33, thestent10 is comprised of alternating first and secondexpansion strut columns24aand24b, with the first and second expansion strut columns being in communication with one another via a connectingstrut column26a. The firstexpansion strut column24aincludes first expansion strut pairs32awherein at least one or both of thefirst expansion strut28aand thesecond expansion strut28bhave one or more steppednotches360 as previously described.
• In the various embodiments shown in FIGS.[0323]25-33 each of theconnectors38 include afirst end region302 which is engaged to and extends from the steppednotch360 of the firstexpansion strut pair24aand asecond end region304 which is engaged to and extends from a steppednotch360 of the second expansion strut pair.
• In some embodiments, such as for example those shown in FIGS. 25, 26,[0324]30-31, thefirst end region302 and thesecond end region304 are engaged respectively to a firstexpansion strut pair32aand a secondexpansion strut pair32bin a contra-lateral configuration. In other embodiments, for example those shown in FIGS.27-29 and32-33, thefirst end region302 and thesecond end region304 are engaged respectively to a firstexpansion strut pair32aand a secondexpansion strut pair32bin an ipsilateral configuration.
• In the various embodiments shown in FIGS.[0325]25-33, theconnectors38 are provided with aconnector width66 and the first and second expansion struts28aand28bwhich comprise the first and second expansion strut pairs32aand32bare provided with anexpansion strut width62. In many of the embodiments described herein, including those depicted in FIGS.25-33, theexpansion strut width62 is greater than theconnector width66. It is noted however that in some embodiments thestent10 may be provided withconnectors38 wherein at least a portion of aconnector width66 is equal to or greater than at least a portion of theexpansion strut width62.
• In some embodiments such as those depicted in FIGS. 42, 49 and[0326]53 within a given expansion strut column there may be differences in the width of the expansion struts relative to one another. Similarly within a given connecting strut column the width of the connectors may vary from one another.
• In the embodiments shown in FIGS.[0327]25-31 theconnectors38 share the common featured of having one or both offirst end region302 andsecond end region304 of each connector extend in a substantially linear manner from the steppednotch360 of either thefirst expansion strut28aor thesecond expansion strut28bof a respective firstexpansion strut pair32aor secondexpansion strut pair32b. In some embodiments a portion of theconnector38 adjacent to one or both of theend regions302 and304 may be substantially parallel to the expansion strut to which it is respectively engaged. In other embodiments one or more portions of theconnector38 adjacent to theend regions302 and304 may define an angle of about 180 degrees to about 135 degrees with the respective expansion strut28aor28bto which they are each respectively engaged. In some embodiment the angle thusly defined is about 135 degrees or greater.
• As is clear from the various embodiments shown, the[0328]intermediate region306 of theconnectors38 depicted in the embodiments of FIGS.25-33 may be provided with a diverse number of bend portions. For example in the embodiment shown in FIGS.25-29 theintermediate portion306 comprises twobend portions310aand310b. In the embodiments shown in FIGS. 30 and 31 the intermediate portion comprises at least fourbend portions310a,310b,310cand310d.
• In the embodiments shown in FIGS. 32 and 33 the[0329]connectors38 differ from those shown in FIGS.25-31 in that one or both of thefirst end region302 and thesecond end region304 of eachconnector38 extends laterally away from the steppednotch360 of either thefirst expansion strut28aor thesecond expansion strut28bof a respective firstexpansion strut pair32aor secondexpansion strut pair32bto which they are engaged.
• In the embodiments shown in FIGS.[0330]25-33 one or both of theend regions302 and304 may be substantially linear as previously described above. However, in some of the embodiments shown such as including the embodiments of FIGS.28-33 aconnector38 may initially extend longitudinally and/or circumferentially away from the expansion strut pair to which it is engaged and then change course back toward the strut pair before engaging the adjacent strut pair of the adjacent strut pair column. The combination of anend region302 and/or304 which extend away from the expansion strut pair to which it or they are engaged and anintermediate region306 of which at least a portion returns back toward the expansion strut pair to which the connector is engaged forms adistinctive wrap portion308 of theconnector38 which wraps about the first joiningstrut30aof at least one of the firstexpansion strut pair32aand secondexpansion strut pair32brespectively.
• In some embodiments described herein the[0331]intermediate section306 of a givenconnector38 may be further comprised of one or more substantially linear sections, such as for example: a first substantiallylinear section382, a second substantiallylinear section384 and/or a third substantiallylinear section386 depicted in FIGS. 26 and 27. A given connector may have only a single substantially linear section or any plurality of substantially linear sections. More typically however a connector may have between two and eight substantially linear sections. Some example embodiments having one or more substantially linear sections are shown in FIGS.25-33. Other embodiments described herein may also include one or more substantially linear sections.
• As is shown in various embodiments, and most clearly depicted in FIGS. 26 and 31, where a[0332]connector38 has intersecting substantially linear sections, such as for example a first and a second substantiallylinear sections382 and384, the intersection of the substantially linear sections is comprised of at least one bend or curved portion310a-f. The intersection of the substantially linear sections may define aslant angle58 as previously described. In some embodiments the intersections of the substantially linear sections may define a radius of curvature, which may vary between different intersections of different sections of the connector.
• In some embodiments, some examples of which are shown in the embodiments of FIGS. 26 and 31, at least two substantially linear sections, such as the first and third substantially[0333]linear sections382 and386, respectively, are substantially parallel to one another. In some embodiments, an example of which is shown in FIG. 29, the first substantiallylinear section382 and the second substantiallylinear section384 define aslant angle58 which is obtuse, and the second substantiallylinear section384 and the third substantiallylinear section386 define aslant angle58 that is also obtuse.
• Where a connector is comprised of one or more substantially linear sections as described, the individual sections may be substantially the same or different from one another in their various physical characteristics, such as length, width, thickness, cross-sectional shape, composition, angular orientation to one another, etc. For example in the embodiment shown in FIG. 27, each of the first, second and third substantially[0334]linear sections382,384 and386 respectively, have a different length.
• While in many of the embodiments described thus far, the[0335]end regions302 and304 are often respectively engaged to expansion strut pairs wherein the engagement of the end region is closer in proximity to one expansion strut verses the other of the given expansion strut pair, in some embodiments, such as for example the embodiment shown in FIG. 34, at least one of the end regions, in this example thesecond end region304 is engaged to a secondexpansion strut pair32bat a location substantially equivalent in proximity to thefirst expansion strut28aand thesecond expansion strut28b. As a result of this connector configuration, thewrap portion308 of the connector wraps only the first joiningstrut30aof thefirst strut pair32a.
• In some embodiments of the invention, some examples of which are depicted in the embodiments of FIGS.[0336]35A-65, theconnectors38 may be characterized as comprising afirst wrap portion308a, asecond wrap portion308b, and at least one substantiallylinear section382 therebetween.
• In the various embodiments shown in FIGS.[0337]35A-65, thefirst end region302 of aconnector38 is engaged to one of thefirst expansion strut28aor thesecond expansion strut28b, at or adjacent to a steppednotch360, of afirst strut pair32a. Thesecond end region302 of aconnector38 is engaged to one of thefirst expansion strut28aor thesecond expansion strut28b, at or adjacent to a steppednotch360, of a secondexpansion strut pair32b.
• The[0338]first wrap portion308aextends from thefirst end region302 and wraps at least partially around the first joiningstrut28aof the firstexpansion strut pair32a. The wrap portion is substantially parallel to the first joiningstrut28a. Thefirst wrap portion308aand the first joiningstrut28adefine aslot region320, wherein theslot region320 defines aslot region width322, theslot region width322 is no greater than the connectingstrut width66.
• The[0339]second wrap portion308bextends from thesecond end region304 and wraps at least partially around the first joiningstrut28aof the secondexpansion strut pair32b. The wrap portion is substantially parallel to the first joiningstrut28a. Thesecond wrap portion308band the first joiningstrut28adefine aslot region320, wherein theslot region320 defines aslot region width322, theslot region width322 is no greater than the connectingstrut width66.
• In at least one embodiment, such as for example in the embodiment shown in FIG. 36A, the[0340]slot region width322 may be about 0.0025 inch while the connecting strut width is about 0.0030 inch.
• As shown in the embodiments of FIGS.[0341]35A-40 and48-65, thewrap portions308aand308bare each in communication with a common substantiallyliner section382. At the intersection of the substantiallylinear section382 and therespective wrap portions308aand308bis abend portion310aand310brespectively present. Depending on the type ofconnector38 thebend portions310aand310bmay define a range of angles or radii of curvature.
• In some embodiments, including those depicted in FIGS. 35A, 36A, and[0342]41-47, the connectors comprise a plurality of interconnected substantiallylinear sections382,384 and386 respectively. At afirst bend portion310a, thefirst wrap portion308ais in communication with a first substantiallylinear section382. At asecond bend portion310b, the first substantiallylinear section382 is in communication with the second substantiallylinear section384. At athird bend portion310cthe second substantially linear section is in communication with the third substantiallylinear section386. At afourth bend portion310d, the third substantiallylinear section386 is in communication with thesecond wrap portion308b.
• In the embodiments shown in FIGS.[0343]35A-65, thevarious wrap portions308aand308b, and the various substantiallylinear sections382,384 and386 may be substantially the same or different from one another in their various physical characteristics, such as length, width, thickness, cross-sectional shape, composition, angular orientation relative to one another, etc.
• The various embodiments of the stents described herein may include one or more coatings and/or other delivery mechanisms which comprise one or more therapeutic agents, cellular materials, polymeric agents, drugs, etc.[0344]
• The therapeutic agent may be non-genetic or genetic. Suitable non-genetic therapeutic agents include anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone), anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine, antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors, anesthetic agents such as lidocaine, bupivacaine, and ropivacaine, anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides, vascular cell growth promoters such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters, vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin, cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms.[0345]
• Suitable genetic materials include anti-sense DNA and RNA, DNA coding for anti-sense RNA, tRNA or rRNA to replace defective or deficient endogenous molecules, angiogenic factors including growth factors such as acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factor α and β, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor α, hepatocyte growth factor and insulin like growth factor, cell cycle inhibitors including CD inhibitors, thymidine kinase (“TK”) and other agents useful for interfering with cell proliferation, the family of bone morphogenic proteins (“BMP's”), BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, and BMP-16. Any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7 are particularly desirable. These dimeric proteins can be provided as homodimers, heterodimers, or combinations thereof, alone or together with other molecules. Alternatively or, in addition, molecules capable of inducing an upstream or downstream effect of a BMP can be provided. Such molecules include any of the “hedgehog” proteins, or the DNA's encoding them.[0346]
• Suitable cellular materials include cells of human origin (autologous or allogeneic) or from an animal source (xenogeneic), genetically engineered if desired to deliver proteins of interest at the transplant site. The delivery media can be formulated as needed to maintain cell function and viability.[0347]
• Suitable polymer coating materials include polycarboxylic acids, cellulosic polymers, including cellulose acetate and cellulose nitrate, gelatin, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, polyanhydrides including maleic anhydride polymers, polyamides, polyvinyl alcohols, copolymers of vinyl monomers such as EVA, polyvinyl ethers, polyvinyl aromatics, polyethylene oxides, glycosaminoglycans, polysaccharides, polyesters including polyethylene terephthalate, polyacrylamides, polyethers, polyether sulfone, polycarbonate, polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene, halogenated polyalkylenes including polytetrafluoroethylene, polyurethanes, polyorthoesters, proteins, polypeptides, silicones, siloxane polymers, polylactic acid, polyglycolic acid, polycaprolactone, polyhydroxybutyrate valerate and blends and copolymers thereof, coatings from polymer dispersions such as polyurethane dispersions (BAYHDROL®, etc.), fibrin, collagen and derivatives thereof, polysaccharides such as celluloses, starches, dextrans, alginates and derivatives, hyaluronic acid, squalene emulsions. Desirably, polyacrylic acid, available as HYDROPLUS® (Boston Scientific Corporation, Natick, Mass.), and described in U.S. Pat. No. 5,091,205, the disclosure of which is hereby incorporated herein by reference, may be used. Also desirably, the polymer may be a copolymer of polylactic acid and polycaprolactone. Other materials include selected medical-grade biodegradable materials such as PGA-TMC, Tyrosine-Derived Polycarbonates and arylates, polycaprolactone co butyl acrylate and other co polymers, Poly-L-lactic acid blends with DL-Lactic Acid, Poly(lactic acid-co-glycolic acid), polycaprolactone co PLA, polycaprolactone co butyl acrylate and other copolymers, Tyrosine-Derived Polycarbonates and arylate, poly amino acid, polyphosphazenes, polyiminocarbonates, polydimethyltrimethylcarbonates, biodegradable CA/PO[0348]₄'s, cyanoacrylate, 50/50 DLPLG, polydioxanone, polypropylene fumarate, or polydepsipeptides.
• Other suitable coatings include macromolecules such as chitosan and Hydroxylpropylmethylcellulose. Surface erodible materials may also be used. Coatings may also comprise maleic anhydride copolymers, zinc-calcium phosphate and amorphous polyanhydrides.[0349]
• The inventive medical devices may also be provided with a sugar or more generally a carbohydrate and/or a gelatin to maintain the inventive medical devices on a balloon during delivery of the medical device to a desired bodily location. Other suitable compounds for treating the inventive medical devices include biodegradable polymers and polymers which are dissolvable in bodily fluids. Portions of the interior and/or exterior of the inventive medical devices may be coated or impregnated with the compound. Mechanical retention devices may also be used to maintain the inventive medical devices on the balloon during delivery.[0350]
• The inventive medical devices may also be provided in whole or in part with one or more of the above therapeutic agents, polymeric coatings or the like. Where multiple therapeutic agents are provided, different coatings and/or mechanisms may release the drugs at different rates. For example, one therapeutic agent may be released at a fast rate and another therapeutic agent may be released at a slow rate. Where multiple polymeric coatings are provided, the coatings may degrade or erode at different rates.[0351]
• In order to facilitate the retention and delivery of one or more therapeutic agents any of the stent embodiments described herein may be provided with a plurality of cavities or micro holes or slits[0352]27 other surface features, such as depicted in the examples illustrated in FIGS. 66 and 67. Thecavities27 increase or otherwise alter the surface area of the stent to provide thestent10 with a more optimum agent delivery mechanism. Thecavities27 may extend partially or entirely through the width of a given stent component. Any of the components of thestent10, including theconnectors38, first and second expansion struts28aand28b, first and second joiningstruts30aand30b, etc., may be provided with one ormore cavities27.
• The above disclosure is intended to be illustrative and not exhaustive. This 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 claims where the term “comprising” means “including, but not limited to”. 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.[0353]
• Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from[0354]claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.
• This completes the description of the preferred and alternate embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.[0355]

Claims (135)

What is claimed is:

1. A stent comprising:

a first expansion strut column, the first expansion strut column being comprised of a plurality of adjacent first expansion strut pairs, each first expansion strut pair having a first expansion strut and a second expansion strut, the first expansion strut column having a plurality of first joining portions, the first expansion strut in communication with the second expansion strut at a first joining portion, the first expansion strut column having a plurality of second joining portions, each first expansion strut pair in communication with an adjacent first expansion strut pair at each second joining portion;

a second expansion strut column, the second expansion strut column being comprised of a plurality of adjacent second expansion strut pairs, each second expansion strut pair having a first expansion strut and a second expansion strut, the second expansion strut column having a plurality of first joining portions, the first expansion strut in communication with the second expansion strut at a first joining portion, the second expansion strut column having a plurality of second joining portions, each second expansion strut pair in communication with an adjacent second expansion strut pair at each second joining portion;

a first connecting strut column, the first connecting strut column comprising at least one connecting strut, the at least one connecting strut comprising a first end region, a second end region and an intermediate region therebetween,

the first end region being engaged to a portion of one of the first expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut,

the intermediate region comprising a plurality of bend portions,

at least a portion of the at least one connecting strut comprising at least one wrap portion, the at least one wrap portion being at least partially wrapped about at least one of the first joining portions of at least one of the first expansion strut column and the second expansion strut column.

2. The stent ofclaim 1 wherein the second end region is engaged to a portion of one of the second expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut.

3. The stent ofclaim 1 wherein the second end region is engaged to a portion of one of the second expansion strut pairs at a location substantially equal in proximity to the first expansion strut than to the second expansion strut.

4. The stent ofclaim 1 further comprising a third expansion strut column and a second connecting strut column,

the third expansion strut column being comprised of a plurality of adjacent third expansion strut pairs, each third expansion strut pair having a first expansion strut and a second expansion strut, the third expansion strut column having a plurality of first joining portions, the first expansion strut in communication with the second expansion strut at a first joining portion, the second expansion strut column having a plurality of second joining portions, each third expansion strut pair in communication with an adjacent third expansion strut pair at each second joining portion;

the second connecting strut column comprising at least one connecting strut, the at least one connecting strut comprising a first end region, a second end region and an intermediate region therebetween,

the first end region being engaged to a portion of one of the second expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut,

the intermediate region comprising a plurality of bend portions,

at least a portion of the at least one connecting strut comprising at least one wrap portion, the at least one wrap portion being at least partially wrapped about at least one of the second joining portions of the second expansion strut column and the first joining portions of the third expansion strut column.

5. The stent ofclaim 4 wherein the second end region of the at least one connecting strut of the second connecting strut column is engaged to a portion of one of the third expansion strut pairs at a location in closer proximity to the first expansion strut than to the second expansion strut.

6. The stent ofclaim 4 wherein the second end region of the at least one connecting strut of the second connecting strut column is engaged to a portion of one of the second expansion strut pairs at a location substantially equal in proximity to the first expansion strut than to the second expansion strut.

7. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least one substantially linear section.

8. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least two substantially linear sections.

9. The stent ofclaim 8 wherein each substantially liner portion intersects an adjacent substantially linear section at one of the bend portions.

10. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least three substantially linear sections.

11. The stent ofclaim 10 wherein each substantially liner portion intersects an adjacent substantially linear section at one of the bend portions.

12. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least four substantially linear sections.

13. The stent ofclaim 12 wherein each substantially liner portion intersects an adjacent substantially linear section at one of the bend portions.

14. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut of the first connecting strut column further comprises at least five substantially linear sections.

15. The stent ofclaim 15 wherein each substantially liner portion intersects an adjacent substantially linear section at one of the bend portions.

16. The stent ofclaim 4 wherein the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least one substantially linear section.

17. The stent ofclaim 4 wherein the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least two substantially linear sections.

18. The stent ofclaim 17 wherein each substantially liner portion of the at least one connecting strut of the second connecting strut column intersects an adjacent substantially linear section at one of the bend portions.

19. The stent ofclaim 4 wherein the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least three substantially linear sections.

20. The stent ofclaim 19 wherein each substantially liner portion of the at least one connecting strut of the second connecting strut column intersects an adjacent substantially linear section at one of the bend portions.

21. The stent ofclaim 4 wherein the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least four substantially linear sections.

22. The stent ofclaim 21 wherein each substantially liner portion of the at least one connecting strut of the second connecting strut column intersects an adjacent substantially linear section at one of the bend portions.

23. The stent ofclaim 4 wherein the intermediate region of the at least one connecting strut of the second connecting strut column further comprises at least five substantially linear sections.

24. The stent ofclaim 15 wherein each substantially liner portion of the at least one connecting strut of the second connecting strut column intersects an adjacent substantially linear section at one of the bend portions.

25. The stent ofclaim 1 wherein the at least one connecting strut comprises a single wrap portion, the wrap portion being at least partially wrapped about at least one of the first joining portions of the first expansion strut column.

26. The stent ofclaim 1 wherein the at least one connecting strut comprises a single wrap portion, the wrap portion being at least partially wrapped about at least one of the first joining portions of the second expansion strut column.

27. The stent ofclaim 1 wherein the at least one connecting strut comprises a first wrap portion and a second wrap portion, the first wrap portion being at least partially wrapped about at least one of the first joining portions of the first expansion strut column, the second wrap portion being at least partially wrapped about at least one of the first joining portions of the second expansion strut column.

28. The stent ofclaim 1 wherein the at least one wrap portion and the at least one first joining portion define a slot region, the slot region having a slot region width, the at least one connecting strut having a connecting strut width, the slot region width being less than the connecting strut width.

29. The stent ofclaim 1 wherein the at least one wrap portion is substantially parallel to the first joining portion about which the at least one wrap portion is wrapped.

30. The stent ofclaim 28 wherein the at least one wrap portion is substantially parallel to the first joining portion about which the at least one wrap portion is wrapped.

31. The stent ofclaim 1 wherein the at least one wrap portion is an extension of at least one of the first expansion strut and the second expansion strut of the first expansion strut pair.

32. The stent ofclaim 1 wherein the at least one wrap portion is an extension of at least one of the first expansion strut and the second expansion strut of the second expansion strut pair.

33. The stent ofclaim 4 wherein the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column have a different shape from one another.

34. The stent ofclaim 33 wherein the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column have a different length from one another.

35. The stent ofclaim 33 wherein the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column have substantially the same length.

36. The stent ofclaim 4 wherein the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column have a different length from one another.

37. The stent ofclaim 4 wherein the at least one connecting strut of the first connecting strut column and the at least one connecting strut of the second connecting strut column have substantially the same length.

38. The stent ofclaim 4 wherein the at least one connecting strut of the first connecting strut column having a first connecting strut width and the at least one connecting strut of the second connecting strut column having a second connecting strut width, the first connecting strut width and the second connecting strut width being different from one another.

39. The stent ofclaim 4 wherein the at least one connecting strut of the first connecting strut column having a first connecting strut width and the at least one connecting strut of the second connecting strut column having a second connecting strut width, the first connecting strut width and the second connecting strut width being substantially the same.

40. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut comprises at least three bend portions.

41. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut comprises at least four bend portions.

42. The stent ofclaim 1 wherein the intermediate region of the at least one connecting strut comprises at least five bend portions.

43. The stent ofclaim 1 wherein the first end region of the at least one connecting strut is engaged to a first expansion strut pair at an intersection of the first expansion strut and the first joining portion of the first expansion strut pair.

44. The stent ofclaim 1 wherein the first end region of the at least one connecting strut is engaged to a first expansion strut pair at an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.

45. The stent ofclaim 1 wherein the first end region of the at least one connecting strut is engaged to a first expansion strut pair at a location adjacent to an intersection of the first expansion strut and the first joining portion of the first expansion strut pair.

46. The stent ofclaim 1 wherein the first end region of the at least one connecting strut is engaged to a first expansion strut pair at a location adjacent to an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.

47. The stent ofclaim 45 wherein at least a portion of the at least one connecting strut is substantially parallel to the first expansion strut of the first expansion strut pair to which the at least one connecting strut is engaged.

48. The stent ofclaim 47 wherein the at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the first expansion strut pair to which the at least one connecting strut is engaged.

49. The stent ofclaim 46 wherein at least a portion of the at least one connecting strut is substantially parallel to the second expansion strut of the first expansion strut pair to which the at least one connecting strut is engaged.

50. The stent ofclaim 49 wherein the at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the first expansion strut pair to which the at least one connecting strut is engaged.

51. The stent ofclaim 1 wherein the second end region of the at least one connecting strut is engaged to a second expansion strut pair at an intersection of the first expansion strut and the first joining portion of the second expansion strut pair.

52. The stent ofclaim 1 wherein the second end region of the at least one connecting strut is engaged to a second expansion strut pair at an intersection of the second expansion strut and the first joining portion of the first expansion strut pair.

53. The stent ofclaim 1 wherein the second end region of the at least one connecting strut is engaged to a second expansion strut pair at a location adjacent to an intersection of the first expansion strut and the first joining portion of the second expansion strut pair.

54. The stent ofclaim 1 wherein the second end region of the at least one connecting strut is engaged to a second expansion strut pair at a location adjacent to an intersection of the second expansion strut and the first joining portion of the second expansion strut pair.

55. The stent ofclaim 51 wherein at least a portion of the at least one connecting strut is substantially parallel to the first expansion strut of the second expansion strut pair to which the at least one connecting strut is engaged.

56. The stent ofclaim 55 wherein the at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the second expansion strut pair to which the at least one connecting strut is engaged.

57. The stent ofclaim 52 wherein at least a portion of the at least one connecting strut is substantially parallel to the second expansion strut of the second expansion strut pair to which the at least one connecting strut is engaged.

58. The stent ofclaim 57 wherein the at least a portion of the at least one connecting strut is substantially parallel to the first joining portion of the second expansion strut pair to which the at least one connecting strut is engaged.

59. The stent ofclaim 1 wherein the at least one wrap portion of the at least one connecting strut extends longitudinally and circumferentially away from the first expansion strut pair to which the at least one connecting strut is engaged.

60. The stent ofclaim 1 wherein the at least one wrap portion of the at least one connecting strut extends longitudinally and circumferentially away from the second expansion strut pair to which the at least one connecting strut is engaged.

61. The stent ofclaim 1 wherein at least a portion of the first expansion strut and at least a portion of the second expansion strut of each first expansion strut pair being substantially parallel.

62. The stent ofclaim 61 wherein the at least a portion of the first expansion strut and the at least a portion of the second expansion strut are not parallel to a longitudinal axis of the stent.

63. The stent ofclaim 1 wherein at least a portion of the first expansion strut and at least a portion of the second expansion strut of each second expansion strut pair being substantially parallel.

64. The stent ofclaim 63 wherein the at least a portion of the first expansion strut and the at least a portion of the second expansion strut are not parallel to a longitudinal axis of the stent.

65. The stent ofclaim 1 wherein at least a portion of at least one of the first expansion strut and the second expansion strut of each first expansion strut pair being substantially parallel to a longitudinal axis of the stent.

66. The stent ofclaim 1 wherein at least a portion of at least one of the first expansion strut and the second expansion strut of each second expansion strut pair being substantially parallel to a longitudinal axis of the stent.

67. The stent ofclaim 1 wherein at least one of the first expansion strut and the second expansion strut of a first expansion strut pair comprised at least one stepped notch.

68. The stent ofclaim 1 wherein at least one of the first expansion strut and the second expansion strut of a second expansion strut pair comprises at least one stepped notch.

69. The stent ofclaim 67 wherein the first end region of the at least one connecting strut is engaged to the at least one stepped notch.

70. The stent ofclaim 68 wherein the second end region of the at least one connecting strut is engaged to the at least one stepped notch.

71. The stent ofclaim 1 wherein the first end region and the second end region of the at least one connecting strut have an ipsilateral orientation relative to one another.

72. The stent ofclaim 1 wherein the first end region and the second end region of the at least one connecting strut have a contra-lateral orientation relative to one another.

73. The stent ofclaim 1 wherein the at least two connecting struts of the first connecting strut column and a first expansion strut pair and a second expansion strut pair respectively engaged each thereto form an asymmetrical cell space.

74. The stent ofclaim 73 wherein the at least two connecting struts of the first connecting strut column and a first expansion strut pair and a second expansion strut pair respectively engaged each thereto define a cell perimeter about the asymmetrical cell space, the cell perimeter is at least 5 mm in length.

75. The stent ofclaim 73 wherein the at least two connecting struts of the first connecting strut column and a first expansion strut pair and a second expansion strut pair respectively engaged each thereto define a cell perimeter about the asymmetrical cell space, the cell perimeter is greater than 7 mm in length.

76. The stent ofclaim 1 wherein the plurality of bend portions comprise at least six bend portions.

77. The stent ofclaim 1 wherein the stent further comprises at least one radiopaque marker.

78. The stent ofclaim 77 wherein at least one of the first expansion strut pairs is configured to retain the at least one radiopaque marker.

79. The stent ofclaim 77 wherein at least one of the second expansion strut pairs is configured to retain the at least one radiopaque marker.

80. The stent ofclaim 77 wherein the at least one radiopaque marker is selected from at least one member of the group consisting of: at least one radiopaque rivet, at least one radiopaque band, at least one radiopaque coating and any combinations thereof.

81. The stent ofclaim 1 wherein at least one of the first expansion strut and second expansion strut of a first expansion strut pair having at least one expansion strut bend.

82. The stent ofclaim 1 wherein at least one of the first expansion strut and second expansion strut of a second expansion strut pair having at least one expansion strut bend.

83. The stent ofclaim 81 wherein the first end region of the at least one connecting strut is engaged to the at least one expansion strut bend.

84. The stent ofclaim 82 wherein the second end region of the at least one connecting strut is engaged to the at least one expansion strut bend.

85. The stent ofclaim 1 wherein each first expansion strut pair of the first expansion strut column is both circumferentially and longitudinally offset relative to the second expansion strut pair of the second expansion strut column to which the first expansion strut pair is connected.

86. The stent ofclaim 1 wherein each first expansion strut pair of the first expansion strut column is only longitudinally offset relative to the second expansion strut pair of the second expansion strut column to which the first expansion strut pair is connected.

87. The stent ofclaim 1 wherein the at least one wrap portion of the at least one connecting strut has at least one substantially linear section.

88. The stent ofclaim 87 wherein the at least one substantially linear section of the wrap portion is engaged to a stepped notch of one of the first expansion strut and second expansion strut.

89. The stent ofclaim 88 wherein the at least one substantially linear section of the wrap portion and the first expansion strut or second expansion strut to which it is engaged are substantially parallel.

90. The stent ofclaim 88 wherein the at least one substantially linear section of the wrap portion and the first expansion strut or second expansion strut to which it is engaged define an angle of about 180 to about 135 degrees.

91. The stent ofclaim 88 wherein the at least one substantially linear section of the wrap portion and the first expansion strut or second expansion strut to which it is engaged define an angle of about 135 degrees or more.

92. The stent ofclaim 88 wherein the at least one substantially linear section extends laterally away from the stepped notch.

93. The stent ofclaim 1 wherein the at least one wrap portion of the at least one connecting strut comprises a first substantially linear section of the at least one connecting strut, the first substantially linear section extending longitudinally away from the first expansion strut pair to which it is engaged and a second substantially linear section of the at least one connecting strut extending from the first substantially linear section in a direction toward the first joining portion of the first expansion strut pair.

94. The stent ofclaim 93 wherein the at least one connecting strut further comprises a third section extending from the second substantially linear section in a direction toward the second expansion strut pair to which the at least one connecting strut is engaged.

95. The stent ofclaim 93 wherein the first substantially linear section is engaged to a stepped notch of one of the first expansion strut and second expansion strut of the first expansion strut pair.

96. The stent ofclaim 94 wherein the third substantially linear section is engaged to a stepped notch of one of the first expansion strut and second expansion strut of the second expansion strut pair.

97. The stent ofclaim 1 wherein the intermediate portion of the at least one connecting strut is further comprised of at least two substantially linear sections, the at least two substantially linear sections intersecting at an intersection, the intersection of the at least two substantially linear sections defining a slant angle.

98. The stent ofclaim 1 wherein the intermediate portion of the at least one connecting strut is further comprised of at least two substantially linear sections, the at least two substantially linear sections intersecting at an intersection, the intersection of the at least two substantially linear sections defining a radius of curvature.

99. The stent ofclaim 97 wherein the slant angle is obtuse.

100. The stent ofclaim 30 wherein the slot region width is about 0.0025 inch and the connecting strut width is about 0.0030 inch.

101. The stent ofclaim 1 wherein the stent is configured to deliver at least one therapeutic agent.

102. The stent ofclaim 1 wherein at least a portion of the stent is coated with at least one therapeutic agent.

103. The stent ofclaim 101 wherein the at least one therapeutic agent is at least one non-genetic therapeutic agent selected from at least one member of the group consisting of: anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone); anti-proliferative agents such as enoxaprin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid; anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine; antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin and thymidine kinase inhibitors; anesthetic agents such as lidocaine, bupivacaine and ropivacaine; anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet peptides; vascular cell growth promoters such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters, vascular cell growth inhibitors such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin; bifunctional molecules consisting of an antibody and a cytotoxin; cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vascoactive mechanisms, and any combinations thereof.

104. The stent ofclaim 101 wherein the at least one therapeutic agent is at least one genetic therapeutic agent selected from at least one member of the group consisting of: anti-sense DNA and RNA; DNA coding for anti-sense RNA, tRNA or rRNA to replace defective or deficient endogenous molecules; angiogenic factors including growth factors such as acidic and basic fibroblast growth factors, vascular endothelial growth factor, epidermal growth factor, transforming growth factor α and β, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor α, hepatocyte growth factor and insulin like growth factor; cell cycle inhibitors including CD inhibitors, thymidine kinase (“TK”) and other agents useful for interfering with cell proliferation; at least one of the family of bone morphogenic proteins (“BMP's”) such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, and BMP-16. Any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7; dimeric proteins such as homodimers, heterodimers, or combinations thereof, alone or together with other molecules; molecules capable of inducing an upstream or downstream effect of a BMP such as “hedgehog” proteins, or the DNA's encoding them and any combinations thereof.

105. The stent ofclaim 101 wherein the at least one therapeutic agent is at least one type of cellular material selected from at least one member of the group consisting of: cells of human origin (autologous or allogeneic); cells of non-human origin (xenogeneic) and any combination thereof

106. The stent ofclaim 101 wherein the at least one therapeutic agent comprises at least one polymer coating, the at least one coating selected from at least one member of the group consisting of: polycarboxylic acids; cellulosic polymers, including cellulose acetate and cellulose nitrate; gelatin; polyvinylpyrrolidone; cross-linked polyvinylpyrrolidone; polyanhydrides including maleic anhydride polymers; polyamides; polyvinyl alcohols; copolymers of vinyl monomers such as EVA; polyvinyl ethers; polyvinyl aromatics; polyethylene oxides; glycosaminoglycans; polysaccharides; polyesters including polyethylene terephthalate; polyacrylamides; polyethers; polyether sulfone; polycarbonate; polyalkylenes including polypropylene, polyethylene and high molecular weight polyethylene; halogenated polyalkylenes including polytetrafluoroethylene; polyurethanes; polyorthoesters; proteins; polypeptides; silicones; siloxane polymers; polylactic acid; polyglycolic acid; polycaprolactone; polyhydroxybutyrate valerate and blends and copolymers thereof; coatings from polymer dispersions such as polyurethane dispersions (BAYHDROL®, etc.), fibrin, collagen and derivatives thereof; polysaccharides such as celluloses, starches, dextrans, alginates and derivatives; hyaluronic acid; squalene emulsions; polyacrylic acid, a copolymer of polylactic acid and polycaprolactone; medical-grade biodegradable materials such as PGA-TMC, Tyrosine-Derived Polycarbonates and arylates; polycaprolactone co butyl acrylate and other co polymers; Poly-L-lactic acid blends with DL-Lactic Acid; Poly(lactic acid-co-glycolic acid); polycaprolactone co PLA; polycaprolactone co butyl acrylate and other copolymers; Tyrosine-Derived Polycarbonates and arylate; poly amino acid; polyphosphazenes; polyiminocarbonates; polydimethyltrimethylcarbonates; biodegradable CA/PO₄'s; cyanoacrylate; 50/50 DLPLG; polydioxanone; polypropylene fumarate; polydepsipeptides; macromolecules such as chitosan and Hydroxylpropylmethylcellulose; surface erodible material; maleic anhydride copolymers; zinc-calcium phosphate; amorphous polyanhydrides; sugar; carbohydrate; gelatin; biodegradable polymers; and polymers dissolvable in bodily fluids; and any combinations thereof.

107. The stent ofclaim 1 wherein the stent defines a plurality of cavities.

108. The stent ofclaim 107 wherein at least one of the plurality of cavities extend through at least one of the first expansion strut, the second expansion strut, the first joining portion, the second joining portion, and the at least one connecting strut.

109. The stent ofclaim 107 wherein at least one of the plurality of cavities extends only partially through at least one of the first expansion strut, the second expansion strut, the first joining portion, the second joining portion, and the at least one connecting strut.

110. The stent ofclaim 1 wherein the stent is at least partially constructed from a shape memory material.

111. The stent ofclaim 1 wherein the stent is at least partially constructed form nitinol.

112. The stent ofclaim 1 wherein the stent is in an expanded state.

113. The stent ofclaim 1 wherein the stent is in the unexpanded state.

114. The stent ofclaim 1 wherein the stent is self-expandable.

115. The stent ofclaim 1 wherein the stent is balloon expandable.

116. The stent ofclaim 1 wherein the stent is hybrid expandable.

117. The stent ofclaim 1 wherein the second end region is engaged to a portion of one of the second expansion strut pairs at a location in closer proximity to the second expansion strut than to the first expansion strut.

118. The stent ofclaim 4 wherein the second end region of the at least one connecting strut of the second connecting strut column is engaged to a portion of one of the third expansion strut pairs at a location in closer proximity to the second expansion strut than to the first expansion strut.

119. The stent ofclaim 1 wherein at least a portion of the intermediate region of the at least one connecting strut extends longitudinally and circumferentially away from the first end region of the same connecting strut.

120. The stent ofclaim 1 wherein at least a portion of the intermediate region of the at least one connecting strut extends longitudinally and circumferentially away from the second end region of the same connecting strut.

121. The stent ofclaim 4 wherein at least a portion of the intermediate region of the at least one connecting strut extends longitudinally and circumferentially away from the first end region of the same connecting strut.

122. The stent ofclaim 4 wherein at least a portion of the intermediate region of the at least one connecting strut extends longitudinally and circumferentially away from the second end region of the same connecting strut.

123. The stent ofclaim 1 wherein at least a portion of the first expansion strut and at least a portion of the second expansion strut of each first expansion strut pair are substantially not parallel.

124. The stent ofclaim 1 wherein at least a portion of the first expansion strut and at least a portion of the second expansion strut of each second expansion strut pair are substantially not parallel.

125. The stent ofclaim 77 wherein the at least one radiopaque marker is positioned at about a distal region of the stent.

126. The stent ofclaim 77 wherein the at least one radiopaque marker is positioned at about a proximal region of the stent.

127. The stent ofclaim 77 wherein the at least one radiopaque marker is positioned at about a middle region of the stent.

128. The stent ofclaim 30 wherein the slot region width is about 0.0015 inch and the connecting strut width is about at least 0.002 inch.

129. A system for delivering the stent ofclaim 1 into a body lumen comprising:

A stent delivery catheter, the stent in an unexpanded state be disposed about a portion of the catheter, the stent being expandable from the unexpanded state to an expanded state.

130. The system ofclaim 129 wherein the catheter further comprises a medical balloon, the stent being disposed about at least a portion of the medical balloon.

131. A stent comprising:

a first expansion strut column, the first expansion strut column being comprised of a plurality of adjacent first expansion strut pairs, each first expansion strut pair having a first expansion strut and a second expansion strut, the first expansion strut column having a plurality of distal joining portions, the first expansion strut in communication with the second expansion strut at a distal joining portion, the first expansion strut column having a plurality of proximal joining portions, each first expansion strut pair in communication with an adjacent first expansion strut pair at each proximal joining portion;

a second expansion strut column, the second expansion strut column being comprised of a plurality of adjacent second expansion strut pairs, each second expansion strut pair having a first expansion strut and a second expansion strut, the second expansion strut column having a plurality of proximal joining portions, the first expansion strut in communication with the second expansion strut at a proximal joining portion, the second expansion strut column having a plurality of distal joining portions, each second expansion strut pair in communication with an adjacent second expansion strut pair at each distal joining portion;

a first connecting strut column, the first connecting strut column comprising at least one connecting strut, the at least one connecting strut having a strut width, the at least one connecting strut comprising a first end region, a second end region and an intermediate portion therebetween, the first end region being engaged to a portion of one of the first expansion strut pairs, the second end region being engaged to a portion of one of the second expansion strut pairs, at least a portion of the intermediate region and at least a portion of at least one of the distal joining portions of the first expansion strut column defining a slot region, the slot region defining a width, the width of the slot region being no greater than the strut width of the at least one connecting strut, the intermediate region comprising at least two bend portions.

132. A stent comprising:

a first expansion strut column, the first expansion strut column being comprised of a plurality of adjacent first expansion strut pairs, each first expansion strut pair having a first expansion strut and a second expansion strut, the first expansion strut column having a plurality of first joining portions, the first expansion strut in communication with the second expansion strut at a first joining portion, the first expansion strut column having a plurality of second joining portions, each first expansion strut pair in communication with an adjacent first expansion strut pair at each second joining portion;

a second expansion strut column, the second expansion strut column being comprised of a plurality of adjacent second expansion strut pairs, each second expansion strut pair having a first expansion strut and a second expansion strut, the second expansion strut column having a plurality of first joining portions, the first expansion strut in communication with the second expansion strut at a proximal joining portion, the second expansion strut column having a plurality of second joining portions, each second expansion strut pair in communication with an adjacent second expansion strut pair at each second joining portion;

a first connecting strut column, the first connecting strut column comprising at least one connecting strut, the at least one connecting strut having a strut width, the at least one connecting strut comprising a first end region, a second end region and an intermediate region therebetween, the first end region being engaged to a portion of one of the first expansion strut pairs, the second end region being engaged to a portion of one of the second expansion strut pairs, at least a portion of the intermediate region and at least a portion of at least one of the first joining portions of at least one of the first expansion strut column and second expansion strut column defining a slot region, the slot region defining a width, the width of the slot region being no greater than the strut width of the at least one connecting strut, the intermediate region comprising at least two bend portions.

133. A stent comprising:

a plurality of substantially serpentine bands including a first substantially serpentine band and a second substantially serpentine band, the first substantially serpentine band and the second substantially serpentine band being connected by at least one connection member, the at least one connection member having a connection member width, the first substantially serpentine band having a plurality of first end portions and a plurality of second end portions, the second substantially serpentine band having a plurality of first end portions and a plurality of second end portions, the at least one connection member and at least one first end portion of at least one of the first substantially serpentine band and the second serpentine band forming a slot region, the slot region having a slot width, the slot width being no greater than the connection member width, the at least one connection member having at least two bend portions.

134. A stent comprising:

a plurality of substantially serpentine bands including a first substantially serpentine band and a second substantially serpentine band, the first substantially serpentine band and the second substantially serpentine band being connected by at least one connection member, the first substantially serpentine band having a plurality of first end portions and a plurality of second end portions, the second substantially serpentine band having a plurality of first end portions and a plurality of second end portions, the at least one connection member comprising at least one wrap portion, the at least one wrap portion extending away from one of the plurality first end potions and wrapping around at least a portion of the first end potion from which it extends, the at least one connection member having a plurality of bends.

135. A stent comprising:

a plurality of interconnected first expansion struts, the first expansion struts forming a first expansion column having a proximal end region and a distal end region, each first expansion strut in communication at a proximal end with one first expansion strut adjacent thereto and at a distal end with another first expansion strut adjacent thereto;

a plurality of interconnected second expansion struts, the second expansion struts forming a second expansion column having a proximal end region and a distal end region, each second expansion strut in communication at a proximal end with one second expansion strut adjacent thereto and at a distal end with another second expansion strut adjacent thereto;

a first connecting strut column comprising a plurality of first connecting struts, each first connecting strut having a first end region extending from the distal end region of the first expansion column at a location in closer proximity to one first expansion strut than to any other of the plurality of first expansion struts, a second end region extending from the proximal end region of the second expansion column at a location in closer proximity to one second expansion strut than to any other of the plurality of second expansion struts and an intermediate region between the first end region and the second end region, the intermediate region defining at least two bends of each first connecting strut, at least a portion of each first connecting strut comprising at least one wrap portion, the at least one wrap portion being at least partially wrapped about at least a portion of at least one of the distal end of one first expansion strut and the proximal end of one second expansion strut.

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