Stent having helical elements

Abstract
An expandable stent comprised of a plurality of helical segments is disclosed. In one embodiment, the stent is generally cylindrical in shape having a cylindrical axis, and comprises a first and second set of helical segments. The helical segments in the first set are substantially parallel and have a first pitch forming a first helical angle with respect to the cylindrical axis. The helical segments in the second set are also generally parallel to each other and form a second pitch that differs from the first pitch, thereby forming a second helical angle with respect to the cylindrical axis. In an alternative embodiment, the stent comprises one set of helical segments and a plurality of circumferential elements that are joined together by the helical segments to form a plurality of cylindrical elements which are joined together to form a stent body. The stent may also have endzones.
Description
FIELD OF THE INVENTION

The present invention relates to prosthetic stents. In particular, the present invention relates to stents having helical elements and to methods for manufacturing the stents of the present invention.


BACKGROUND OF THE INVENTION

Stents are prosthetic devices that are implanted in the lumen of a vessel inside the body to provide support for the vessel's wall. Structural support from stents is particularly important in angioplasty procedures. Typically, stents are implanted within a vessel system to reinforce vessels that are partially occluded, collapsing, weakened, or abnormally dilated. More generally, stents can be used inside any physiological conduit or duct including, for example, arteries, veins, bile ducts, the urinary tract, alimentary tracts, the tracheobronchial tree, a cerebral aqueduct or the genitourinary system. Stents may be used in both humans and animals.


There are typically two types of stents: self expanding stents and balloon expandable stents. Self expanding stents automatically expand once they are released and assume a deployed, expanded state. A balloon expandable stent is expanded using an inflatable balloon catheter. The balloon is inflated to plastically deform the stent. Balloon expandable stents may be implanted by mounting the stent in an unexpanded or crimped state on a balloon segment of a catheter. The catheter, after having the crimped stent placed thereon, is inserted through a puncture in a vessel wall and moved through the vessel until it is positioned in the portion of the vessel that is in need of repair. The stent is then expanded by inflating the balloon catheter against the inside wall of the vessel. Specifically, the stent is plastically deformed by inflating the balloon so that the diameter of the stent is increased and remains at an increased state. In some situations, the vessel in which the stent is implanted may be dilated by the stent itself when the stent is expanded.


The Palmaz-Schatz™ stent, which is disclosed in the Handbook of Coronary Stents by Patrick W. Serruys et al. (Martin Dunitz, LTD 1998), is an example of a balloon expandable stent that had been implanted in hundreds of thousands of patients. The Palmaz-Schatz™ stent, like other known stents, has certain limitations. These include, but are not limited to: (i) low stent-to-vessel ratio uniformity, (ii) comparative rigidity of the stent in a crimped as well as deployed state, and (iii) limited flexibility making delivery and placement in narrow vessels difficult. Stent-to-vessel ratio generally refers to the degree that the vessel wall is supported by the stent in its expanded state and preferably should be uniform throughout the length of the stent. Furthermore because the Palmaz-Schatz™ stent consists of one or more bridges that connect a number of consecutively slotted tubes, there are a number of bare areas in the vessel after the expansion of the stent. These shortfalls are common to many stents. Id. at 36.


SUMMARY OF THE INVENTION

The present invention is directed to expandable stents that have relatively uniform stent-to-vessel ratios when expanded and other desirable properties, as well as methods for making these stents. The stents of the present invention comprise a generally cylindrically shaped main body having a plurality of expandable helical segments. The main body is comprised of a plurality of cylindrical main body elements that are joined together by the helical segments. The cylindrical elements have cylindrical axes that are collinear with the cylindrical axis of the main body. The cylindrical elements are formed from a plurality of circumferential elements that are joined together by the expandable helical segments. In some embodiments, the stent may comprise endzones that straddle the main body.


In one embodiment of the present invention, the stent may comprise a first non-helical endzone and a second non-helical endzone that straddle the main body. The main body is generally cylindrically shaped and has a cylindrical axis. A plurality of adjacent main body cylindrical elements are connected together to form the main body of the stent. Each main body cylindrical element may be comprised of a plurality of expandable first and second circumferential elements. In some embodiments, the second circumferential elements have a circumferential dimension less than the circumferential dimension of the first circumferential elements. In yet other embodiments, the first and second circumferential elements have the same circumferential dimensions and are substantially identical except that, with respect to the cylindrical axis of the stent, they are oriented differently. Each second circumferential segment in each main body cylindrical element is connected to two first circumferential segments. In addition, each second circumferential segment in each main body cylindrical element is connected to a second circumferential segment in an adjoining main body cylindrical element thereby forming a plurality of helixes in the main body of the stent.


In one embodiment, the main body may be comprised of a plurality of first helical segments each having a substantially identical first pitch and a plurality of second helical segments, each having a substantially identical second pitch. The first and second pitches are generally different. In at least one embodiment, the second pitch is twice that of the first, and at least one first helical segment crosses one of the second helical segments.


The stents of the present invention may be manufactured from a tubular member by removing material from the tube to form a first endzone region, a second endzone region, and a middle region. By removing material from the middle region a plurality of parallel helical segments will remain and a plurality of circumferential segments will remain connecting the helical segments. Alternatively, the stent may be formed from a tube by removing material such that at least two sets of helical segments remain with each set having a different pitch.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a three dimensional view of one embodiment of a stent according to the present invention in its unexpanded state.



FIG. 2 is planar view of a flattened portion of the circumference of the stent in FIG. 1.



FIG. 3 is an enlarged portion of FIG. 2.



FIG. 4 is another planar view of a flattened portion of the circumference of a stent according to the present invention in its unexpanded state.



FIG. 5 is an enlarged view of a portion of FIG. 4 showing a first circumferential element of the stent.



FIG. 6 is an enlarged view of a portion of FIG. 4 showing a second circumferential element of the stent.



FIG. 7 is a planar view of a flattened portion of the stent in FIG. 1 showing a plurality of sets of helical segments propagating through the stent's body.



FIG. 8 is a planar view of a flattened endzone that may be employed in a stent of the present invention.



FIG. 9 is a planar view of a flattened portion of part of the endzone shown in FIG. 8.



FIG. 10 is a planar view of a flattened portion of an expandable stent according to the present invention, after the stent has been deployed in a lumen.



FIG. 11 is three dimensional view of an alternative embodiment of the present invention.



FIG. 12 is a three dimensional view of an another stent according to the present invention.



FIG. 13 is a planar view of the stent shown in 12.



FIG. 14 is a detailed view of a portion of FIG. 13.



FIG. 15 is a detailed view of another portion of FIG. 13.





DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to an expandable stent, as well as a method of manufacturing the stent. In one embodiment, as is shown in FIGS. 1 and 2, the stent comprises a generally cylindrical shaped main body section 11 having a cylindrical axis 5 and a wall thickness 103. The wall thickness 103 may optionally be uniform throughout the stent. The main body section 11 is comprised of a plurality of helical segments 30 and 40 and a plurality of main body cylindrical elements 100, each having cylindrical axes (not shown) that are collinear with the main body cylindrical axis 5. The main body cylindrical elements 100 are each comprised of circumferential elements 50 that are joined together by the helical segments 30 and 40 to form individual cylinders 100.


The stent may also have a first endzone 10 and a second endzone 20 that straddle the body section 11. In some embodiments, such as the one shown in FIG. 1, the endzones 10 and 20 may advantageously provide the stent with square outer edges 8. The stent may be manufactured from stainless steel, or other suitable materials. In most embodiments, it is desirable that the material, or a portion of the material, be radiopaque and that the various segments that form the stent be contiguous. Although, in some embodiments, the various segments that make up the stent can be distinct elements that are joined together.


The main body 11, shown in FIGS. 1 and 2, may be formed in numerous ways. For example, the body 11 may contain two or more first helical segment 30 and 40 that are generally parallel to each other. In some embodiments they may be opposite each other by 180.degree. In general, the first helical segments 30 and 40 will be spaced equidistant along the circumference 110 of the main body 11. The first helical segments 30 and 40 are joined by a plurality of circumferential segments 50 to form a plurality of main body cylindrical elements 100, which may be only generally cylindrically shaped. In one embodiment, the circumferential segments 50 make up a majority of the circumference 110 of each cylindrical element 100. In addition to joining the circumferential elements 50 to form cylindrical elements 100, the helical segments 30 and 40 connect each cylindrical element 100 to an adjacent cylindrical element 100 to form the main body 11.


As is shown in FIGS. 2 and 3, the body of the stent 11 may comprise a plurality of main body cylindrical elements 100 formed from first circumferential segments 50 that are joined with second circumferential segments 60. The second circumferential segments 60 of each cylindrical element 100 may be joined with second circumferential segments 60 of adjacent cylindrical elements 100 to form a plurality of first helical segments 30 and 40 in the main body 11. (See FIG. 2). Each first circumferential segment 50 may have a circumferential dimension 55 and each second circumferential segments 60 may have a circumferential dimension 66′ (See FIG. 3). In some embodiments, it may be desirable for the circumferential dimension 55 of the first expandable element 50 to be larger than the circumferential dimension 66′ of the second expandable element 60.


The first circumferential segment 50 may be an expandable segment formed from plurality of segments joined together to form a pattern. The pattern, such as the one shown in the FIGS. 1-3, may be a repeating pattern that resembles a square wave form having curved peaks and valleys. Other patterns, both repeating and non-repeating, may be used. For example, and without limitation, the first circumferential segments 50 may resemble a triangle wave form, a sinusoidal wave form, other repetitious patterns, or any pattern that enables the segment to expand when a radial force is exerted on the stent from the inside or collapse radially when an external crimping force is applied.


The first circumferential elements 50 may have a filament width 420 (see FIG. 4). In one embodiment, the filament width may vary between 0.002 inches and 0.007 inches, but is preferably about 0.0050 inches. Other filament widths may be used depending on the parameters of the stent.


In the embodiment shown in FIGS. 1-5, the first circumferential elements 50 comprise linear portions 320 and curved portions 328 that join the linear portions 320 together to form a repeating pattern. In some, but not all, embodiments, the linear portion 320 may be parallel to the cylindrical axis of the stent. In other embodiments, the linear portion 320 lies at an angle of between 0-45 degrees with respect to the cylindrical axis. The first circumferential segment 50 has an amplitude 350 and a period 380. In one embodiment the amplitude may range from 0.5 mm to 2.0 mm and the period may range from 0.5 mm to 2.0 mm. In some embodiments, the amplitude is less than the period. Other amplitudes and periods may be used depending on the overall stent design and performance constraints.


The second circumferential element 60, which may be joined together in a helical pattern to form one or more helical segments 30 or 40, may also take numerous forms, in addition to the form shown in FIG. 6. In the embodiment shown in FIG. 6, the second circumferential element 60 comprises linear portions 412 and curved portions 414 having a filament width 407, and resembles generally an S-shaped structure. In addition, the second element circumferential segment 60 may have an angled portion 417 attached to the linear portion 412 at an end opposite that of the curved portion 414. The angled portion may be oriented to form an angle .alpha. relative to the cylindrical axis of the stent 5 in the range of 0-45 degrees. In at least one embodiment, the preferable angle .alpha. is about 10 degrees. In some embodiments, the linear portions 412 of the second circumferential element 60 lies at an angle .OMEGA. relative to the cylindrical axis of the stent, wherein .OMEGA. preferably ranges from 0 to 45 degrees. When viewed in a planar fashion as in FIG. 2, the linear portions 412 may, in some embodiments, form an angle .OMEGA., relative to the cylindrical axis of the stent. In some embodiments, .OMEGA. may be approximately equal to the helical angle of the first helical segments 30 and 40. In one embodiment, the second circumferential elements 60 may have an amplitude 300 (see FIGS. 3, 4, and 6) ranging from 0.5 mm to 2.0 mm and a period 310 ranging from 0.5 mm to 2.0 mm. Other ranges may be used depending on the particular stent size and design being employed. In one embodiment, the preferred period is about 0.82 mm and the preferred length of the linear portion 412 is about 0.5 mm and the amplitude 300 is about 0.38 mm. The amplitude of the second circumferential element 60 may be greater than, equal to, or less than the amplitude of the first circumferential element 50. In one embodiment, the circumferential contributions of the first circumferential elements 50 to the overall circumference of the main body 11 is greater than the circumferential contribution of the second circumferential element 60, in terms of either circumferential length or circumferential cylindrical surface area. In one embodiment, the stent may have an overall outer surface area of about 0.029 square inches.


As is shown in FIG. 7, the stent may have a main body 11 comprised of two or more first helical segments 30 and 40, as well as two or more second helical segments 200 and 210. The first and second helical segments 30, 40 and 200, 210, respectively, are joined together to form a generally cylindrically shaped body 11. In some, but not all embodiments, the first and second helical segments may share a common connecting element 250. In some embodiments, the common connecting element 250 may be H-shaped and the two generally parallel linear portions of the H-shaped connecting segment 250 may form an angle .delta. relative to the axis 5. (See FIG. 6) .delta. may, in one embodiment, be about 14 degrees. As is shown in FIG. 7, the first helical segments 30 and 40 and second helical segments 200 and 210 may have different pitches, i.e. number of spirals per unit length, which results in the first and second helical segments as having different helical angles (.theta. and .beta., respectively) i.e. the angle of the helical segment relative to the cylindrical axis 5 of the stent. In one embodiment, the second helical segments 200 and 210 have a pitch approximately twice that of the first helical segments. In one embodiment .theta. may vary from 0 to 45 degrees and is preferably about 40 degrees and .beta. is preferably about twice .theta. In other embodiments the angle .theta. may range from 0 to 90 degrees to the circumference 110 of each cylindrical element 100.


As is shown in FIGS. 2, 3, 4, and 6, the helical segments 30, 40 are circumferentially expandable (i.e. they expand along the circumference of the stent) and may be formed from a plurality of circumferential elements 60 that in turn are made up of linear 412 and/or curved 414 segments (see FIG. 6) that each have a filament width 407 (see FIG. 6) that is less than the circumferential dimension 66 of the circumferential element 60 (see FIG. 3). In some embodiments, each helical segment 30 or 40 will make a total contribution to the circumference of each cylindrical element 100 that is greater than the filament width 407. The circumferential contribution of each helical segment 30 or 40 to the overall circumference of the stent (110 in FIG. 1 or 105 in FIG. 11) may be greater than the circumferential contribution of the filament widths 407 of the segments (e.g. 412 and 414) making up the circumferential elements 60 that in turn make up the helical segments. (I.e., In some embodiments the circumferential contribution of the helical segments 30 and 40 to the circumference 110 of each cylindrical element 100 is more than just a function of the filament width 407, e.g., it may be a function of the geometry of the element 60.) For the embodiment shown in FIGS. 1 and 11, this is the case when the stent is in both the unexpanded and expanded state. The geometry of the helical segments 30 and 40 are a factor in determining their expandability.


Likewise, the helical segments 200, 210 are circumferentially expandable and may be comprised of other circumferential elements 50 that are in turn comprised of linear 320 and/or curved segments 328 (see FIGS. 3 and 5) that have a filament width 420 (see FIG. 4). The contribution of the helical segments 200, 210 to the overall circumferential dimension 110 of each cylindrical element 100 is greater than just the contribution of the filament widths 420 of the individual segments 320 and 328 that make up the elements 50 that in turn make up the helical segments 200, 210. The geometry of the elements 50 making up the helical segments 200, 210 may be a more important factor in determining the circumferential contribution of the helical segments 200 and 210 to the overall stent circumference than the filament width 420. Thus, in one embodiment of the present invention, the circumference of the stent 110 in its unexpanded state and the circumference 105 when the stent is expanded are primarily functions of the geometry of the elements 50 and 60 that make up the helical segments 30, 40 and 200, 210, respectively.


Some, but not all embodiments, of the present invention may employ endzones 10 and 20. (See FIGS. 1, 2, and 11). Stents that employ endzones will generally have two endzone regions straddling a central zone in the middle of the stent. The stents may also have a transition region between the endzone and the central zone. The transition region serves to help smoothly transition between the expanded middle region and portions of the end of the stent that remain unexpanded after the stent is implanted. The size and characteristics of the transition region are a function of the material and geometry of the stent. For example, the transition range properties vary as a function of, among other things, the helical angle of the first helical segments, the number of curved segments located in the endzones, and the angle .epsilon. of the linear portions of the segments forming the endzones. (See e.g. FIG. 8).


The endzones 10 and 20 may take numerous forms. In some embodiments, the endzones may be comprised of one or more rings 17. (See FIG. 8). The rings 17 may be generally cylindrically shaped, and in some embodiments, right cylindrically shaped. In one embodiment, the rings are formed from linear segments 28 joined together by curved segments 29 to form a pattern. The pattern, which is preferably—but not necessarily—a repeating pattern may take numerous forms, including the one shown. The endzones 10 and 20 may be comprised of a plurality of rings 17 attached together. Struts 15 may be used to attach the rings together to form the endzone and to attach the endzone to the main body 11. The struts, in some embodiments, act as cantilever springs and there stiffness, which is a function of their width and thickness, may define bending properties of the stent along its cylindrical axis 5.


In the embodiment shown in FIGS. 1, 7, 8, and 9, which is exemplary only, the linear segments 28 in the endzone 10, are oriented at an angle .epsilon. relative to the cylindrical axis of the stent. In one embodiment, the angle .epsilon. is greater than 0 degrees. In another embodiment, .epsilon. may range from 0 to 45 degrees and in still another embodiment is preferably about 10 degrees. The segments of the endzone may have a filament width 13 of between 0.002 and 0.007 inches. In one embodiment, the repeating pattern of the endzone has a period 2 of about 0.027 inches and an amplitude 21 of about 0.043 inches. Other values may be used. As is shown in FIG. 1, the struts 15, which are but one way to attach the endzones 10 and 20 to the main body 11, may, in one embodiment have a width of between 0.002 inches and 0.08 inches and preferably the width does not exceed the wall thickness, which typically—but not necessarily ranges from about 0.002 to 0.008 inches.


The stent of the present invention may, after insertion into a vessel, be expanded such that it plastically deforms from the unexpanded state to an expanded state having a diameter increase of about 400 to 500%, which results in a larger circumference 105. (See FIG. 11). FIG. 11 depicts the stent shown in FIG. 1 in an expanded state. Upon expansion the stent's outer diameter in one particular embodiment increases from 1.0 mm to 3.00 mm and maintains a stent-to-vessel ratio in the expanded state that is greater than on average 16%.


While endzones 10 and 20 may be used to provide square edge, not all stents according to the present invention require endzones. FIGS. 12-15 depict an endzoneless stent. Like the stent shown in FIG. 19, the stent of FIGS. 12-15 comprises a plurality of adjacent cylindrical elements 100. The cylindrical elements 100 are formed from a plurality of first circumferential elements 50′ and second circumferential elements 60. The first circumferential elements 50′ of the stent in FIGS. 12-15 are substantially identical to the second circumferential element 60 except that they are rotated to have a different orientation. The circumferential elements may be generally S-shaped having a linear portion 412, a curved portion 414 having a radius R, and an angled portion 417. R may vary widely depending on overall stent characteristics and in one embodiment varies between 0.001 and 0.02 inches and is preferably about 0.0083 inches. The angled portion 417 is spaced a distance 499 from the linear portion. In one particular embodiment, the distance 499 may vary from 0.002 to 0.020 inches and is preferably about 0.007 inches. The filament width 407 of the elements may, in one embodiment, be about 0.13 mm. The circumferential elements depicted in FIG. 14 and the expansion elements depicted in FIG. 15 are positioned about the cylindrical axis 5 as defined by angle K and may be generally S-shaped having a linear portion 412, a curved portion 414 having a radius R, and an angled portion 417. The angle K may vary widely depending on overall stent characteristics and range of radial compression or expansion about the axis 5.


Adjacent cylindrical elements 100 are joined together by connecting first circumferential elements 50′ in each cylindrical element 100 with first circumferential elements 50′ in an adjacent cylindrical element 100, such that the first circumferential elements 50′ in adjacent cylindrical elements 100 form helixes through the stent and such that second circumferential elements form helixes through the stent having an angle .theta. relative to the axis 5. In some embodiments, a connecting segment 250 (see FIG. 7) is used to connect first circumferential elements in adjacent cylindrical elements 100 and to connect second circumferential elements 60 in adjacent cylindrical elements 100. In addition, the connecting segment, connects first circumferential elements 50′ in each cylindrical element 100 with two second circumferential elements 60 in each cylindrical element 100. In one embodiment, the individual cylindrical elements 100 are adjacent to each other and are located a distance 666 apart. In one embodiment, the preferred may range between 0.002 and 0.020 inches, and is preferably about 0.009 inches.


The above description of the stent of the present invention is illustrative and not exhaustive. Various modifications may be made to the stent to change its overall characteristics without deviating from the scope and spirit of the invention as defined by the claims. For example and without limitation, the increasing the length of the linear segments and or increasing the arc of the second circumferential elements 60 will decrease the amount of radial force required to expand each circular section and will increase flexibility. Increasing the angle .OMEGA. of the second circumferential element 60 will: (i) increase the amount of radial force required for expansion, (ii) increase surface area, and (iii) decrease flexibility. Likewise, various modifications may be made to the struts 15. (See FIG. 2). Increasing strut width and wall thickness will: (i) increase surface area, (ii) increase radial strength, (iii) increase pressure required to expand the stent radially, (iv) decrease flexibility, and, in the case of increased wall thickness, (v) increase radiopacity.


The stent of the present invention may be manufactured in numerous ways. The stent may be formed from a metallic tube by removing various portions of the tube's wall to form the patterns described herein. The resulting stent will thus be formed from a single contiguous piece of material, eliminating the need for connecting various segments together. Material from the tube wall may be removed using various techniques including laser (YAG laser for example), electrical discharge, chemical etching, metal cutting, a combination of these techniques, or other well known techniques. See e.g. U.S. Pat. Nos. 5,879,381 to Moriuchi et al. and 6,117,165 to Becker, which are hereby incorporated in their entirety by reference. Forming stents in this manner allows for creation of a substantially stress-free structure where the helical segments are integral with the circumferential elements. In one embodiment, the tube from which the stent is formed may have an internal diameter of about 3.0 mm, a wall thickness of about 1.0 mm and a length of about 30 mm. Tubes having other dimensions may be used. In particular, the length may be adapted to that of the diseased part of the lumen in which the stent is to be placed. This may avoid using separate stents to cover the total diseased area.


Those skilled in the art will recognize that the stent and manufacturing method described above are illustrative and not exhaustive of the present invention and that modifications and variations may be made without deviating from the scope and spirit of the invention as defined by the following claims.

Claims
  • 1. An expandable stent, comprising: a plurality of adjacent non-helical cylindrical elements axially spaced along a cylindrical axis and joined together by a plurality of connecting segments, wherein each connecting segment is nonparallel with respect to a cylindrical axis;the cylindrical elements comprising a plurality of substantially linear portions joined together by a plurality of curved portions, wherein at least one cylindrical element includes a repeating pattern of a first segment alternating with a second segment, wherein each first segment is connected to exactly two connecting segments and consists of three substantially linear portions connected to each other by curved portions, wherein each second segment is connected to exactly two connecting segments and consists of five substantially linear portions connected to each other by curved portions; anda plurality of expandable helical segments consisting of a plurality of the first segments connected by the connecting segments.
  • 2. The stent of claim 1, wherein the stent is in an unexpanded state.
  • 3. The stent of claim 1, wherein the stent is in an expanded state.
  • 4. The stent of claim 1, wherein the curved portions of at least two adjacent cylindrical elements are circumferentially offset from one another.
  • 5. The stent of claim 1, wherein each cylindrical element is bounded by an upper plane and a lower plane parallel to the upper plane.
  • 6. The stent of claim 1, wherein at least one connecting segment includes a linear portion forming an angle of approximately 14 degrees with respect to the cylindrical axis.
  • 7. An expandable stent, comprising: a plurality of expandable helical segments, each helical segment consisting of a plurality of first circumferential elements alternating with a plurality of connecting segments, each first circumferential element bound by and connected to two consecutive connecting segments and consisting of three substantially parallel linear portions connected by curved portions, each connecting segment including a linear segment set at a first angle greater than 0 degrees with respect to a cylindrical axis; anda plurality of adjacent, non-helical cylindrical elements, each cylindrical element formed from a plurality of second circumferential elements alternating with the first circumferential elements, the cylindrical elements being attached to one another by the connecting segments.
  • 8. The stent of claim 7, wherein the second circumferential segments of at least two adjacent cylindrical elements are circumferentially offset from one another.
  • 9. The stent of claim 7, wherein at least one second circumferential segment consists of five linear portions joined together by curved portions.
  • 10. The stent of claim 7, wherein each cylindrical element forms an individual cylinder defining an upper planar boundary and a lower planar boundary parallel to the upper planar boundary.
  • 11. The stent of claim 7, wherein the first angle is at least approximately 14 degrees.
  • 12. The stent of claim 7, wherein each of the three linear portions of at least one of the first circumferential elements are nonparallel to the cylindrical axis.
  • 13. The stent of claim 7, wherein the stent is in an unexpanded state.
  • 14. The stent of claim 7, wherein the stent is in an expanded state.
  • 15. An expandable stent, comprising: a plurality of expandable helical segments, each helical segment consisting of a plurality of circumferential elements and a plurality of connecting segments, each circumferential element bound by and connected to two consecutive connecting segments and consisting of three linear portions joined by curved portions, and each connecting segment including a linear segment set at a first angle with respect to a cylindrical axis; anda plurality of adjacent cylindrical elements, each cylindrical element forming an individual cylinder defining an upper planar boundary and a lower planar boundary parallel to the upper planar boundary, each cylindrical element formed from a plurality of circumferential segments alternating with at least two of the circumferential elements, wherein at least one circumferential segment extends between two connecting segments and consists of five linear portions joined together by curved portions, wherein the circumferential segments of at least two adjacent cylindrical elements are circumferentially offset from one another, and wherein the cylindrical elements are attached to one another by the connecting segments.
  • 16. An expandable stent, comprising: a plurality of adjacent non-helical serpentine bands axially spaced along a cylindrical axis, the serpentine bands joined together by a plurality of connecting struts, wherein each connecting strut includes a substantially linear portion nonparallel with respect to a cylindrical axis;the serpentine bands comprising a plurality of straight portions joined together by a plurality of curved portions, wherein at least one serpentine band includes a repeating pattern of a first segment alternating with a second segment, the first segment extending between and connected to exactly two connecting struts and consisting of three straight portions alternating with curved portions, the second segment extending between and connected to exactly two connecting struts and consisting of five straight portions alternating with curved portions;a first helical segment consisting of a plurality of the first segments alternating with the connecting struts; anda second helical segment consisting of a plurality of the second segments alternating with the connecting struts.
  • 17. The stent of claim 16, wherein the curved portions of at least two adjacent serpentine bands are circumferentially offset from one another.
  • 18. The stent of claim 16, wherein each serpentine band is bounded by an upper plane and a lower plane parallel to the upper plane.
  • 19. The stent of claim 16, wherein the three straight portions are substantially parallel.
  • 20. The stent of claim 16, wherein the five straight portions are substantially parallel.
  • 21. The stent of claim 16, wherein the stent is in an unexpanded state.
  • 22. The stent of claim 16, wherein the stent is in an expanded state.
  • 23. The stent of claim 1, wherein the three substantially linear portions are substantially parallel.
  • 24. The stent of claim 1, wherein the five substantially linear portions are substantially parallel.
  • 25. The stent of claim 15, wherein the curved portions of at least two adjacent cylindrical elements are circumferentially offset from one another.
Priority Claims (2)
Number Date Country Kind
97201799 Jun 1997 EP regional
98201446 May 1998 EP regional
CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 12/027,382, filed on Feb. 7, 2008, which application is a continuation of U.S. patent application Ser. No. 10/014,705, filed on Dec. 11, 2001, now issued U.S. Pat. No. 7,329,277, which application claims the benefit of U.S. Provisional Application No. 60/254,688, filed on Dec. 11, 2000, all of which are hereby incorporated in their entirety by reference. U.S. patent application Ser. No. 10/014,705 is also continuation-in-part of U.S. patent application Ser. No. 09/511,481, filed on Feb. 23, 2000, now U.S. Pat. No. 7,108,714, which is a continuation of U.S. patent application Ser. No. 09/094,402, filed Jun. 10, 1998, now U.S. Pat. No. 6,117,165, all of which are hereby incorporated in their entirety by reference.

US Referenced Citations (151)
Number Name Date Kind
3657744 Ersek Apr 1972 A
4464722 Von Osten Aug 1984 A
5102417 Palmaz Apr 1992 A
5104404 Wolff Apr 1992 A
5133732 Wiktor Jul 1992 A
5158548 Lau et al. Oct 1992 A
5217483 Tower Jun 1993 A
5226913 Pinchuk Jul 1993 A
5304200 Spaulding Apr 1994 A
5354308 Simon et al. Oct 1994 A
5356423 Tihon et al. Oct 1994 A
5370683 Fontaine Dec 1994 A
5421955 Lau et al. Jun 1995 A
5443498 Fontaine Aug 1995 A
5449373 Pinchasik et al. Sep 1995 A
5507767 Maeda et al. Apr 1996 A
5514154 Lau et al. May 1996 A
5527354 Fontaine et al. Jun 1996 A
5545210 Hess et al. Aug 1996 A
5549663 Cottone, Jr. Aug 1996 A
5591230 Horn et al. Jan 1997 A
5630829 Lauterjung May 1997 A
5667523 Bynon et al. Sep 1997 A
5697971 Fischell et al. Dec 1997 A
5716396 Williams, Jr. Feb 1998 A
5725572 Lam et al. Mar 1998 A
5733303 Israel et al. Mar 1998 A
5741327 Frantzen Apr 1998 A
5755776 Al-Saadon May 1998 A
5755781 Jayaraman May 1998 A
5776161 Globerman Jul 1998 A
5800521 Orth Sep 1998 A
5810872 Kanesaka et al. Sep 1998 A
5824040 Cox Oct 1998 A
5824043 Cottone, Jr. Oct 1998 A
5843117 Alt et al. Dec 1998 A
5843120 Israel et al. Dec 1998 A
5843158 Lenker et al. Dec 1998 A
5843164 Frantzen et al. Dec 1998 A
5843175 Frantzen Dec 1998 A
5846246 Dirks et al. Dec 1998 A
5855597 Jayaraman Jan 1999 A
5860999 Schnepp-Pesch et al. Jan 1999 A
5876449 Starck et al. Mar 1999 A
5879381 Moriuchi et al. Mar 1999 A
5882335 Leone et al. Mar 1999 A
5895406 Gray et al. Apr 1999 A
5902317 Kleshinski et al. May 1999 A
5911732 Hojeibane Jun 1999 A
5911754 Kanesaka et al. Jun 1999 A
5913897 Corso et al. Jun 1999 A
5925061 Ogi et al. Jul 1999 A
5928280 Hansen et al. Jul 1999 A
5935161 Robinson et al. Aug 1999 A
5938697 Killion et al. Aug 1999 A
5948016 Jang Sep 1999 A
5964798 Imran Oct 1999 A
5972018 Israel et al. Oct 1999 A
5980552 Pinchasik et al. Nov 1999 A
6013854 Moriuchi Jan 2000 A
6017365 Von Oepen Jan 2000 A
6019789 Dinh et al. Feb 2000 A
6022370 Tower Feb 2000 A
6033433 Ehr et al. Mar 2000 A
6042597 Kveen et al. Mar 2000 A
6053940 Wijay Apr 2000 A
6059811 Pinchasik et al. May 2000 A
6083259 Frantzen Jul 2000 A
6099559 Nolting Aug 2000 A
6099561 Alt Aug 2000 A
6106548 Roubin et al. Aug 2000 A
6117165 Becker Sep 2000 A
6123721 Jang Sep 2000 A
6124523 Banas Sep 2000 A
6129755 Mathis et al. Oct 2000 A
6132460 Thompson Oct 2000 A
6132461 Thompson Oct 2000 A
6136023 Boyle Oct 2000 A
6171334 Cox Jan 2001 B1
6174326 Kitaoka et al. Jan 2001 B1
6179867 Cox Jan 2001 B1
6190403 Fischell et al. Feb 2001 B1
6200334 Jang Mar 2001 B1
6200337 Moriuchi et al. Mar 2001 B1
6203569 Wijay Mar 2001 B1
6231598 Berry et al. May 2001 B1
6238409 Hojeibane May 2001 B1
6241762 Shanley Jun 2001 B1
6245101 Drasler et al. Jun 2001 B1
6254628 Wallace et al. Jul 2001 B1
6254632 Wu et al. Jul 2001 B1
6261319 Kveen Jul 2001 B1
6264689 Colgan et al. Jul 2001 B1
6270524 Kim Aug 2001 B1
6309414 Rolando et al. Oct 2001 B1
6319277 Rudnick et al. Nov 2001 B1
6331188 Lau et al. Dec 2001 B1
6331189 Wolinsky et al. Dec 2001 B1
6340366 Wijay Jan 2002 B2
6348065 Brown et al. Feb 2002 B1
6350277 Kocur Feb 2002 B1
6355057 DeMarais et al. Mar 2002 B1
6364904 Smith Apr 2002 B1
6395020 Ley et al. May 2002 B1
6398805 Alt Jun 2002 B1
6423091 Hojeibane Jul 2002 B1
6432132 Cottone et al. Aug 2002 B1
6443982 Israel et al. Sep 2002 B1
6461381 Israel et al. Oct 2002 B2
6464722 Israel et al. Oct 2002 B2
6485508 McGuinness Nov 2002 B1
6506211 Skubitz et al. Jan 2003 B1
6508834 Pinchasik et al. Jan 2003 B1
6533809 von Oepen Mar 2003 B2
6551350 Thornton et al. Apr 2003 B1
6569193 Cox et al. May 2003 B1
6579314 Lombardi et al. Jun 2003 B1
6582461 Burmeister et al. Jun 2003 B1
6589276 Pinchasik et al. Jul 2003 B2
6602285 Von Oepen et al. Aug 2003 B1
6610086 Kock et al. Aug 2003 B1
6620201 Nadal Sep 2003 B1
6635084 Israel et al. Oct 2003 B2
6652579 Cox Nov 2003 B1
6682554 Von Oepen et al. Jan 2004 B2
6730116 Wolinsky May 2004 B1
6730117 Tseng May 2004 B1
6736844 Glatt May 2004 B1
6776793 Brown et al. Aug 2004 B2
6818014 Brown et al. Nov 2004 B2
6821292 Pazienza et al. Nov 2004 B2
6875228 Pinchasik et al. Apr 2005 B2
6929660 Ainsworth et al. Aug 2005 B1
6962203 Funchess Nov 2005 B2
6974475 Wall Dec 2005 B1
6981986 Brown et al. Jan 2006 B1
7204848 Brown et al. Apr 2007 B1
7329277 Addonizio et al. Feb 2008 B2
7404823 Gregorich et al. Jul 2008 B2
7682384 Addonizio et al. Mar 2010 B2
20010029397 Thompson Oct 2001 A1
20010056298 Brown et al. Dec 2001 A1
20020095208 Gregorich et al. Jul 2002 A1
20020116044 Cottone et al. Aug 2002 A1
20030225448 Gerberding Dec 2003 A1
20040243216 Gregorich Dec 2004 A1
20050049687 Yang et al. Mar 2005 A1
20070073384 Brown et al. Mar 2007 A1
20070100434 Gregorich et al. May 2007 A1
20080065195 Brown et al. Mar 2008 A1
20090024207 Addonizio et al. Jan 2009 A1
Foreign Referenced Citations (43)
Number Date Country
29702671 May 1997 DE
19717475 Sep 1998 DE
0565251 Oct 1993 EP
0645125 Mar 1995 EP
0686379 Dec 1995 EP
0734698 Oct 1996 EP
0800800 Oct 1997 EP
0801934 Oct 1997 EP
876806 Nov 1998 EP
0876806 Nov 1998 EP
0884029 Dec 1998 EP
0945107 Sep 1999 EP
945107 Sep 1999 EP
0968689 Jan 2000 EP
0970664 Jan 2000 EP
0983753 Mar 2000 EP
1008329 Jun 2000 EP
1025812 Sep 2000 EP
1123065 Nov 2006 EP
1852089 Nov 2007 EP
2204142 Jul 2010 EP
2758253 Jul 1998 FR
2281865 Mar 1995 GB
9417754 Aug 1994 WO
9526695 Oct 1995 WO
9626689 Sep 1996 WO
9721399 Jun 1997 WO
9726840 Jul 1997 WO
9732544 Sep 1997 WO
9740780 Nov 1997 WO
9820810 May 1998 WO
9830173 Jul 1998 WO
9840035 Sep 1998 WO
9856312 Dec 1998 WO
9912495 Mar 1999 WO
9939660 Aug 1999 WO
9949810 Oct 1999 WO
0013611 Mar 2000 WO
0030563 Jun 2000 WO
0045742 Aug 2000 WO
0071053 Nov 2000 WO
0158384 Aug 2001 WO
0189421 Nov 2001 WO
Non-Patent Literature Citations (6)
Entry
Notice of Opposition dated Jul. 28, 2011 re EP 1341482.
Notice of Opposition dated Aug. 5, 2011 re EP 1341482.
Simon H. Stertzer et al., AVE GFX Stent, Handbook of Coronary Stents, Second Edition, 1997, pp. 45-54, Martin Dunitz Ltd., The Livery House, London, United Kingdom.
Richard A. Schatz et al., Handbook of Coronary Stents, 1997, p. 24, Martin Dunitz Ltd., The Livery House, London, United Kingdom.
Home Medical Devices Products and Medical Procedures Device Approvals and Clearances, Medical Devices, Dec. 1997 PMA Approvals, http://www.fda.gov/medicaldevices/productsandmedicalprocedures/ deviceapprovalsandclearances/pmaaprovals/ucm115816.htm, 5-pages.
Jean Gregoire et al., Handbook of Coronary Stents, 1997, p. 72, Martin Dunitz Ltd., The Livery House, London, United Kingdom.
Related Publications (1)
Number Date Country
20100211152 A1 Aug 2010 US
Provisional Applications (1)
Number Date Country
60254688 Dec 2000 US
Continuations (3)
Number Date Country
Parent 12027382 Feb 2008 US
Child 12727567 US
Parent 10014705 Dec 2001 US
Child 12027382 US
Parent 09094402 Jun 1998 US
Child 09511481 US
Continuation in Parts (1)
Number Date Country
Parent 09511481 Feb 2000 US
Child 10014705 US