|Publication number||US7122049 B2|
|Application number||US 10/803,392|
|Publication date||17 Oct 2006|
|Filing date||18 Mar 2004|
|Priority date||19 Mar 2003|
|Also published as||CA2519226A1, CA2519226C, CN1787793A, CN100558320C, DE602004030671D1, EP1610724A2, EP1610724A4, EP1610724B1, EP2289464A1, US7980289, US20040186554, US20070088430, WO2004084764A2, WO2004084764A3|
|Publication number||10803392, 803392, US 7122049 B2, US 7122049B2, US-B2-7122049, US7122049 B2, US7122049B2|
|Inventors||Christopher E. Banas, David G. Rosenbaum|
|Original Assignee||Advanced Bio Prosthetic Surfaces, Ltd.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (88), Non-Patent Citations (1), Referenced by (21), Classifications (13), Legal Events (10)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application claims priority to currently pending U.S. Provisional Application Ser. No. 60/455,783 filed Mar. 19, 2003.
The present invention relates generally to endoluminal stents, covered stents and stent-grafts designed for delivery into an anatomical passageway using minimally invasive techniques, such as percutaneous intravascular delivery using a delivery catheter passed over a guidewire. More particularly, the present invention relates to endoluminal stents having a scaffold structure and structural geometry which is particularly well-suited for providing physiologically acceptable radial or hoop strength and longitudinal flexibility, while also presenting a luminal surface thereof which presents less obstruction to longitudinal shear forces during fluid flow across the luminal surface of the inventive device while maximizing fatigue life and corrosion resistance. Additionally, the inventive endoluminal stent is characterized by a geometry that uniquely has a negative coefficient of longitudinal foreshortening upon radial expansion. Thus, a unique aspect of the inventive endoluminal stent is that it elongates upon radial expansion.
Endoluminal stents are generally tubular scaffolds fabricated from implantable biocompatible materials. Stents have a generally tubular geometry characterized by a central lumen, a longitudinal axis, a circumferential axis and a radial axis. Conventional endoluminal stents fall within three general classifications: balloon expandable, self-expanding and shape-memory. Balloon expandable stents require mechanical intervention, such as by using a balloon catheter, to apply a positive pressure radially outward from a central lumen of the stent to mechanically deform the stent and urge it to a larger diameter. Self-expanding stents utilize inherent material mechanical properties of the stent material to expand the stent. Typically, self-expanding stents are fabricated of materials that rebound when a positive pressure is exerted against the material. Self-expanding stents are fabricated such that their zero-stress configuration conforms to the second larger diameter. The self-expanding stents are drawn down to the first smaller diameter and constrained within a delivery catheter for endoluminal delivery. Removal of the constraint releases the constraining pressure and the self-expanding stent, under its own mechanical properties, rebounds to the second larger diameter. Finally, shape-memory stents rely upon unique alloys that exhibit shape memory under certain thermal conditions. Conventional shape-memory stents are typically nickel-titanium alloys known generically as nitinol, which have a transition phase at or near normal body temperature, i.e., 37 degrees Centigrade.
The prior art is replete with various stent designs across all stent classifications. One of the difficulties with many conventional stent designs arises due to the conflicting criteria between the desired properties of circumferential or hoop strength of the stent, longitudinal or column strength, longitudinal flexibility, fish-scaling of individual structural members of the stent, fatigue life, corrosion resistance, corrosion fatigue, hemodynamics, radioopacity and biocompatibility and the capability of passing the stent through an already implanted stent. Typically, stents that are designed to optimize for hoop strength typically sacrifice either column strength and/or longitudinal flexibility, while stents that are designed to optimize for column strength often compromise longitudinal flexibility and/or hoop strength.
Most conventional stents exhibit longitudinal foreshortening upon radial expansion of the stent. Longitudinal foreshortening is a well-known property that results from the geometric deformation of the stent's structural members as the stent radially expands from a contracted state to a diametrically expanded state. Several prior art stents have been invented that claim a lack of appreciable foreshortening of the stent as a novel feature of the stent. Heretofore, however, a stent that longitudinally elongates upon radial expansion from a contracted state to a diametrically expanded state is unknown in the art.
It has been found desirable to devise an endoluminal stent which employs a series of first and interconnecting members arrayed in geometrical patterns which achieve a balance between hoop strength, column strength and longitudinal flexibility of the endoluminal stent. Many conventional stents employ a series of circumferential structural elements and longitudinal structural elements of varying configurations. A large number of conventional stents utilize circumferential structural elements configured into a serpentine configuration or a zig-zag configuration. The reason underlying this configuration is the need for radial expansion of the stent. Of these conventional stents which employ serpentine or zig-zag circumferential structural elements, many also employ longitudinal structural elements which join adjacent circumferential structural elements and provide a modicum of longitudinal or column strength while retaining longitudinal flexibility of the device. Additionally, many conventional stents require welds to join mating surfaces of the stent.
Heretofore, however, the art has not devised a unibody stent structural element geometry which achieves a balance between hoop strength, column strength and longitudinal flexibility, degree of longitudinal foreshortening, circumferential strength or hoop strength of the stent, longitudinal strength or column strength, longitudinal flexibility, fish-scaling of individual structural members of the stent, fatigue life, corrosion resistance, corrosion fatigue, hemodynamics, radioopacity, biocompatibility and the capability of passing the stent through an already implanted stent. The term “fish-scaling” is used in the art and herein to describe a condition where some stent structural elements extend beyond the circumferential plane of the stent during either radial expansion, implantation or while passing the stent through a bend in the vasculature. Those of ordinary skill in the art understand that fish-scaling of stent structural elements may cause the stent to impinge or snag upon the anatomical tissue either during endoluminal delivery or after implantation. The term “unibody” as used herein is intended to mean a stent that is fabricated without the use of welds and as an integral body of material.
The inventive endoluminal stent may be, but is not necessarily, fabricated by vapor deposition techniques. Vapor deposition fabrication of the inventive stents offers many advantages, including, without limitation, the ability to fabricate stents of complex geometries, the ability to control fatigue life, corrosion resistance, corrosion fatigue, bulk and surface material properties, and the ability to vary the transverse profiles, Z-axis thickness and X-Y-axis surface area of the stent's structural elements in manners that affect the longitudinal flexibility, hoop strength of the stent and radial expansion profiles.
Endoluminal stent, covered stent and stent-graft design inherently attempts to optimize the functional aspects of radial expandability, i.e., the ratio of delivery diameter to expanded diameter, hoop strength, longitudinal flexibility, longitudinal foreshortening characteristics, column strength, fish-scaling of individual structural members of the stent, fatigue life, corrosion resistance, corrosion fatigue, hemodynamics, biocompatibility and the capability of stent-through-stent delivery. Conventional stent designs have had to compromise one or more functional features of a stent in order to maximize a particular functionality, e.g., longitudinal flexibility is minimized in order to achieve desirable column strength or high hoop strengths are achieved at the expense of small ratios of radial expandability. It is an objective of the present invention to provide designs for endoluminal unibody stents that achieve balances between the ratio of radial expandability, hoop strength, longitudinal flexibility and column strength, with biocompatibility, hemodynamics, radioopacity, minimal or no fish-scaling and increased capacity for endothelialization.
In accordance with a preferred embodiment of the present invention, the inventive endoluminal stent is formed of a single piece of biocompatible metal or pseudometal and having a plurality of circumferential expansion members co-axially aligned along a longitudinal axis of the stent and a plurality of interconnecting members interconnecting adjacent pairs of circumferential expansion members. Each of the plurality of circumferential expansion members comprises a generally sinusoidal ring structure having successive peaks and valleys interconnected by stent strut members. Each of the interconnecting members interconnects adjacent pairs of circumferential expansion members at approximate mid-points of stent strut members on the adjacent pairs of circumferential expansion members. In order to enhance longitudinal flexibility of the inventive stent, it has been found desirable to include minor terminal regions of each interconnecting member that are narrower in width than a major intermediate region of the interconnecting member. The minor terminal regions are positioned at both the proximal and distal end of each interconnecting member and are narrower in width to enhance flexion at the junction region between the stent strut member and the interconnecting member. Additionally, it has been found desirable to form each of the minor terminal regions of the interconnecting members in the form of generally C-shaped sections extending proximally or distally from the intermediate region of each interconnecting member.
In accordance with all embodiments of the present invention, each of the plurality of circumferential expansion members and the plurality of interconnecting members may be fabricated of like biocompatible materials, preferably, biocompatible metals or metal alloys. In this manner, both the plurality of circumferential expansion elements and the plurality of interconnecting members have like physical material properties, e.g., tensile strength, modulus of elasticity, plastic deformability, spring bias, shape memory or super-elastic properties. Alternatively, the plurality of circumferential expansion members and interconnecting members may be fabricated of biocompatible materials, preferably, biocompatible metals or metal alloys which exhibit different physical or material properties. In this latter case, the plurality of circumferential expansion elements may, for example, be fabricated of a plastically deformable material, such as stainless steel, while the plurality of interconnecting members are fabricated of a shape memory or super-elastic material, such as nickel-titanium alloys, or of a spring biased material, such as stainless steel.
Heretofore, joints between discrete sections of endoluminal stents required welds in order to join sections of the stent. One particular advantage of the present invention is that by forming the stent using vapor deposition techniques, not only are discrete sections atomically joined without the use of welds, but different materials may be employed in different and discrete sections of the stent in order to impart distinct material properties and, therefore, functionality, to the discrete sections.
Finally, the present invention also includes a self-supporting endoluminal graft. As used herein the term “graft” is intended to indicate any type of tubular member that exhibits integral columnar and circumferential strength and which has openings that pass through the thickness of the tubular member. The inventive self-supporting endoluminal graft preferably consists of a member formed of at least one of a plurality of layers, each layer being comprised of a plurality of first and interconnecting members which intersect one another, as described above, to define a plurality of open regions between intersecting pairs of the first and interconnecting members. A web region subtends at least a portion of the open region to at least partially enclose each of the plurality of open regions. Successive adjacent layers of the plurality of layers are positioned such that the open regions are staggered in the Z-axis transverse through the wall of the self-supporting endoluminal graft. By staggering the open regions, interlamellar spaces are created to facilitate endothelialization of the endoluminal graft.
In accordance with the present invention there is provided several preferred embodiments. In each of the preferred embodiments of the present invention, the general configuration of the inventive endoluminal stent is substantially the same. Specifically and with particular reference to
Additionally, a plurality of terminal flange members 11, shown in phantom, may be provided in order to provide affixation points for mounting a graft covering (not shown) onto the stent 10. The terminal flange members 11 may be positioned at the distal end, the proximal end or both ends of the stent 10 and preferably are formed generally linear projections from either peak 12 p or a trough 12 t of a terminal circumferential expansion element 12 at either or both of the proximal or distal ends of the stent 10. Each of the plurality of flange members 11 may further include a rounded distal or proximal end region to facilitate affixation of a graft covering.
With reference to
Additionally, it has been found desirable, in accordance with the best mode for the present invention, to provide strain-relief sections 18 and 20 at opposing ends of each of the plurality of interconnecting members 14. The strain-relief sections 18 and 20 comprise terminal sections of the interconnecting member 14 and have a width Wt that is less than the width Wi of the interconnecting member 14. In accordance with one embodiment of the present invention, the strain-relief sections 18 and 20 each have a generally C-shaped configuration and traverse a radius in connecting the interconnection member 14 with the struts 16 of adjacent circumferential expansion members 12. Alternate geometric configurations of the C-shaped terminal strain-relief sections 18 and 20 are also contemplated by the present invention, such as S-shaped, V-shaped, M-shaped, W-shaped, U-shaped, or merely generally I-shaped extensions projecting co-axially along the longitudinal axis of each interconnecting member 14.
In accordance with the preferred embodiment for stent 30, it has been found desirable to employ a 2:1 ratio of peaks l2 p or troughs 12 t to interconnecting members. Thus, as depicted, there are six peaks 12 p and six troughs 12 t in each of the plurality of circumferential expansion elements 12 and three interconnecting members 14 interconnect each pair of adjacent circumferential expansion elements 12. Similarly, between adjacent pairs of circumferential expansion elements 12, the interconnecting members 14 are circumferentially offset one peak 12 p and one trough 12 t from the interconnecting members 14 in an adjacent pair of circumferential expansion elements 12. Thus, interconnecting elements in groups 14 a, 14 c and 14 e interconnect circumferential expansion element pairs 12 a–12 b, 12 c–12 d, 12 e–12 f, 12 g–12 h and 12 i–12 j, interconnecting elements in groups 14 b, 14 d and 14 f interconnect circumferential expansion element pairs 12 b–12 c, 12 d–12 e, 12 f–12 g, 12 h–12 i. With the interconnecting elements in group 14 a, 14 c and 14 e each being offset by one peak l2 p and one trough 12 t along the circumferential axis of each circumferential expansion element 12.
In stent 40, each of the interconnecting elements 14 are also angularly offset from the longitudinal axis of the stent by an angle β, except that the plurality of interconnecting elements 14 are not all parallel relative to each other. Rather, the interconnecting elements in interconnecting element groups 14 a and 14 c are parallel to each other and the interconnecting elements in interconnecting elements groups 14 b and 14 d are parallel to each other, with the interconnecting elements in groups 14 a and 14 c being offset from the longitudinal axis of the stent by an angle β− which is alternate to the angle β, also denoted angle β+, forming the offset from the longitudinal axis L′ for the interconnecting elements in groups 14 b and 14 d. The designation angle β+ and angle β− is intended to denote that these angles represent the substantially the same angular offset from the longitudinal axis L′, but have alternate orientations relative to the circumferential axis of the stent 40.
Turning now to
Finally, turning to
For each adjacent pair of circumferential expansion elements 12, the interconnecting elements 14 have different orientations of angular offset from the longitudinal axis L′ of the stent 50. For example, for circumferential expansion element pair 12 a–12 b, the interconnecting elements of group 14 b and group 14 c are offset by angle β− and by angle β+, respectively. In the adjacent circumferential expansion element pair 12 b–12 c, the interconnecting elements of group 14 a and 14 d are offset by angle β+ and by angle β−, respectively. Thus, between adjacent pairs of circumferential elements 12, the interconnecting elements are out of phase, in that they have different angular orientations of angle β. Additionally, between adjacent pairs of circumferential elements 12, the interconnecting elements are circumferentially offset by a single peak 12 p, with interconnecting element group 14 a being circumferentially offset from interconnecting element group by a single peak 12 p, and interconnecting element group 14 c being circumferentially offset from interconnecting element group 14 d by a single peak 12 p. Furthermore, there are different circumferential offsets between interconnecting element group pairs 14 b–14 c and 14 a–14 d within individual pairs of adjacent circumferential expansion elements 12. The circumferential offset between interconnecting element group pair 14 b–14 c is two peaks 12 p and three troughs 12 t, while the circumferential offset between interconnecting element group pair 14 a–14 d is four peaks 12 p and three troughs 12 t.
Those skilled in the art will appreciate that the foregoing embodiment of stents 10, 20, 30, 40 and 50 describe various geometries all comprised of common structural elements, namely, circumferential expansion elements 12 having a plurality of peaks 12 p and troughs 12 t and struts 16 interconnected by hinge elements 22. Furthermore, those skilled in the art will understand that variations on the number of and positioning of the interconnecting members 14 between adjacent pairs of circumferential expansion elements 12 and along the circumferential axis of the stent are also contemplated by the present invention and that the specific embodiments illustrated and described with reference to the figures is exemplary in nature.
During radial expansion of the stent 40 from its first constrained smaller diameter, i.e., 1.4 mm, to its second enlarged radially expanded diameter, i.e., 5.8 mm, the stent 40 exhibited no foreshortening characteristic of many stent geometries known in the art. In contrast to foreshortening the stent 40 unexpectedly elongated by 2.5%. Heretofore a stent that elongates upon radial expansion is unknown in the art.
The plurality of circumferential expansion elements 12 and interconnecting members 14, and components sections thereof, are preferably made of materials selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, and nitinol and stainless steel. The plurality of circumferential expansion elements 12 and the plurality of interconnecting members 14 may be made of the same material or of different materials and have the same material properties or have different material properties. The term “material properties” is intended to encompass physical properties, including without limitation, elasticity, tensile strength, mechanical properties, hardness, bulk and/or surface grain size, grain composition, and grain boundary size, intra and inter-granular precipitates. Similarly, the materials selected for the plurality of circumferential expansion elements 12 and the plurality of interconnecting members 14 may be selected to have the same or different chemical properties. The term “chemical properties” is intended to encompass both any chemical reaction and change of state that the material may undergo after being implanted into a body and the physiological response of the body to the material after implantation.
While the inventive stents may be fabricated by chemical, thermal or mechanical ablative methods known in the art, such as chemical etching, laser cutting, EDM or water jet processes, it is envisioned that a preferred method for fabricating the inventive stents is by physical vapor deposition techniques. Physical vapor deposition techniques afford the ability to tightly control both the tolerances of the stent geometries as well as the physical and chemical properties of the stent and the stent materials. The inventive stents 10, 30, 40, 50 and 60, including each of their elements, namely the plurality of circumferential expansion elements 12 and interconnecting members 14 and component sections thereof, are preferably made of a bulk material having controlled heterogeneities on the luminal surface thereof. As is described in co-pending, commonly assigned, U.S. patent application Ser. No. 09/754,304 filed Dec. 22, 2000, which is a divisional of U.S. Pat. No. 6,379,383 issued Apr. 30, 2002, which is hereby incorporated by reference, heterogeneities are controlled by fabricating the bulk material of the stent to have defined grain sizes, chemical and intra- and intergranular precipitates and where the bulk and surface morphology differ, yielding areas or sites along the surface of the stent while maintaining acceptable or optimal protein binding capability. The characteristically desirable properties of the inventive stent are: (a) optimum mechanical properties consistent with or exceeding regulatory approval criteria, (b) minimization of defects, such as cracking or pin hole defects, (c) a fatigue life of 400 MM cycles as measured by simulated accelerated testing, (d) corrosion and/or corrosion-fatigue resistance, (e) biocompatibility without having biologically significant impurities in the material, (f) a substantially non-frictional abluminal surface to facilitate atraumatic vascular crossing and tracking and compatible with transcatheter techniques for stent introduction, (g) radiopaque at selected sites and MRI compatible, (h) have a luminal surface which is optimized for surface energy and microtopography, (i) minimal manufacturing and material cost consistent with achieving the desired material properties, and (j) high process yields.
In accordance with the present invention, the foregoing properties are achieved by fabricating a stent by the same metal deposition methodologies as are used and standard in the microelectronics and nano-fabrication vacuum coating arts, and which are hereby incorporated by reference. The preferred deposition methodologies include ion-beam assisted evaporative deposition and sputtering techniques. In ion beam-assisted evaporative deposition it is preferable to employ dual and simultaneous thermal electron beam evaporation with simultaneous ion bombardment of the substrate using an inert gas, such as argon, xenon, nitrogen or neon. Bombardment with an inert gas, such as argon ions serves to reduce void content by increasing the atomic packing density in the deposited material during deposition. The reduced void content in the deposited material allows the mechanical properties of that deposited material to be similar to the bulk material properties. Deposition rates up to 20 nm/sec are achievable using ion beam-assisted evaporative deposition techniques.
When sputtering techniques are employed, a 200-micron thick stainless steel film may be deposited within about four hours of deposition time. With the sputtering technique, it is preferable to employ a cylindrical sputtering target, a single circumferential source that concentrically surrounds the substrate that is held in a coaxial position within the source. Alternate deposition processes which may be employed to form the stent in accordance with the present invention are cathodic arc, laser ablation, and direct ion beam deposition. When employing vacuum deposition methodologies, the crystalline structure of the deposited film affects the mechanical properties of the deposited film. These mechanical properties of the deposited film may be modified by post-process treatment, such as by, for example, annealing, high-pressure treatment or gas quenching.
Materials to make the inventive stents are chosen for their biocompatibility, mechanical properties, i.e., tensile strength, yield strength, and their ease of deposition include the following: elemental titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, such as zirconium-titanium-tantalum alloys, nitinol, and stainless steel.
During deposition, the chamber pressure, the deposition pressure and the partial pressure of the process gases are controlled to optimize deposition of the desired species onto the substrate. As is known in the microelectronic fabrication, nano-fabrication and vacuum coating arts, both the reactive and non-reactive gases are controlled and the inert or non-reactive gaseous species introduced into the deposition chamber are typically argon and nitrogen. The substrate may be either stationary or moveable, either rotated about its longitudinal axis, or moved in an X-Y plane within the reactor to facilitate deposition or patterning of the deposited material onto the substrate. The deposited material may be deposited either as a uniform solid film onto the substrate, or patterned by (a) imparting either a positive or negative pattern onto the substrate, such as by etching or photolithography techniques applied to the substrate surface to create a positive or negative image of the desired pattern or (b) using a mask or set of masks which are either stationary or moveable relative to the substrate to define the pattern applied to the substrate. Patterning may be employed to achieve complex finished geometries of the resultant stent, both in the context of spatial orientation of the pattern as well as the material thickness at different regions of the deposited film, such as by varying the wall thickness of the material over its length to thicken sections at proximal and distal ends of the stent to prevent flaring of the stent ends upon radial expansion of the stent.
The stent may be removed from the substrate after stent formation by any of a variety of methods. For example, the substrate may be removed by chemical means, such as etching or dissolution, by ablation, by machining or by ultrasonic energy. Alternatively, a sacrificial layer of a material, such as carbon or aluminum, may be deposited intermediate the substrate and the stent and the sacrificial layer removed by melting, chemical means, ablation, machining or other suitable means to free the stent from the substrate.
The resulting stent may then be subjected to post-deposition processing to modify the crystalline structure, such as by annealing, or to modify the surface topography, such as by etching to affect and control the heterogeneities on the blood flow surface of the stent.
A plurality of microgrooves may be imparted onto the luminal and/or abluminal surface of the stent 10, as is more fully described in International Publication No. WO 99/23977, published 20 May 1999, which is commonly assigned with the present application and is hereby incorporated by reference. The plurality of microgrooves may be formed either as a post-deposition process step, such as by etching, or during deposition, such as by depositing the stent-forming material onto a mandrel which has a microtopography on the surface thereof which causes the metal to deposit with the microgroove pattern as part of the deposited material.
Each of the preferred embodiments of the present invention are preferably fabricated by employing a vapor deposition technique which entails vapor depositing a stent-forming metal onto a substrate. The substrate may be planar or cylindrical and is either pre-patterned with one of the preferred geometries of first and interconnecting members, in either positive or negative image, or the substrate may be un-patterned. Where the substrate is un-patterned, the deposited stent-forming metal is subjected to post-deposition patterning to pattern the deposited stent-forming metal into one of the preferred geometries of the first and interconnecting members. In all embodiments of the present invention fabricated by vapor deposition techniques, the need for post-deposition processing of the patterned endoluminal stent, e.g., modifying the surface of the stent by mechanical, electrical, thermal or chemical machining or polishing, is eliminated or minimized.
Vapor deposition fabrication of the inventive endoluminal stents offers many advantages, including, for example, the ability to fabricate stents of complex geometries, ultrafine dimensional tolerances on the order of Angstroms, the ability to control fatigue life, corrosion resistance, corrosion fatigue, inter- and intra-granular precipitates and their effect on corrosion resistance and corrosion fatigue, bulk material composition, bulk and surface material properties, radioopacity, and the ability to vary the transverse profiles, Z-axis thickness and X-Y-axis surface area of the stent structural elements in manners that affect the longitudinal flexibility, hoop strength, and radial expansion behavior and profile of the stent. Bulk material composition may be adjusted to employ elemental fractions in alloy compositions that are not feasible when using conventionally formed metals. This results in achieving the ability to tailor the alloy compositions in a manner that optimizes the alloy composition for a desired material or mechanical property. For example, nickel-titanium tubes exhibiting shape memory and/or superelastic properties were made employing in excess of 51.5 atomic percent nickel, which is not achievable using conventional working techniques due to high plateau stresses exhibited by the material. Specifically, the present inventors have fabricated nickel-titanium alloy tubes employing the method of the present invention that contain between 51.5 and 55 atomic percent nickel.
Vapor deposition of the inventive endoluminal stent, in accordance with a preferred embodiment of the present invention, significantly reduces or virtually eliminates inter- and intra-granular precipitates in the bulk material. It is common practice in the nickel-titanium endoluminal device industry to control transition temperatures and resulting mechanical properties by altering local granular nickel-titanium ratios by precipitation regimens. In the present invention, the need to control precipitates for mechanical properties is eliminated. Where nickel-titanium is employed as the stent-forming metal in the present invention, local nickel-titanium ratios will be the same or virtually identical to the nickel-titanium ratios in the bulk material, while still allowing for optimal morphology and eliminating the need for employing precipitation heat treatment. The resulting deposited stent-forming metal exhibits superior corrosion resistance, and hence, resistance to corrosion fatigue, when compared to conventional wrought nickel-titanium alloys.
The plurality of circumferential expansion elements 12 and the plurality of interconnecting members 14 may be conformationally configured during vapor deposition to impart a generally rectangular, ovular or elliptical transverse cross-sectional profile with either right angled edges or with chamfered or curved leading and trailing luminal and abluminal surface edges in the longitudinal axis of the stent in order to provide better blood flow surface profiles.
While the present inventions have been described with reference to their preferred embodiments, those of ordinary skill in the art will understand and appreciate that a multitude of variations on the foregoing embodiments are possible and within the skill of one of ordinary skill in the vapor deposition and stent fabrication arts, and that the above-described embodiments are illustrative only and are not limiting the scope of the present invention which is limited only by the claims appended hereto.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US4733665||7 Nov 1985||29 Mar 1988||Expandable Grafts Partnership||Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft|
|US4739762||3 Nov 1986||26 Apr 1988||Expandable Grafts Partnership||Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft|
|US4776337||26 Jun 1986||11 Oct 1988||Expandable Grafts Partnership||Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft|
|US5421955||17 Mar 1994||6 Jun 1995||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US5514154||28 Jul 1994||7 May 1996||Advanced Cardiovascular Systems, Inc.||Expandable stents|
|US5569295||31 May 1995||29 Oct 1996||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US5603721||13 Nov 1995||18 Feb 1997||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US5728158||14 Jan 1997||17 Mar 1998||Advanced Cardiovascular Systems, Inc.||Expandable stents|
|US5733303||31 May 1995||31 Mar 1998||Medinol Ltd.||Flexible expandable stent|
|US5735893||14 Jan 1997||7 Apr 1998||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US5759192||15 Jan 1997||2 Jun 1998||Advanced Cardiovascular Systems, Inc.||Method and apparatus for direct laser cutting of metal stents|
|US5766238||24 Mar 1997||16 Jun 1998||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US5772864||23 Feb 1996||30 Jun 1998||Meadox Medicals, Inc.||Method for manufacturing implantable medical devices|
|US5776161 *||16 Oct 1995||7 Jul 1998||Instent, Inc.||Medical stents, apparatus and method for making same|
|US5780807||15 Jan 1997||14 Jul 1998||Advanced Cardiovascular Systems, Inc.||Method and apparatus for direct laser cutting of metal stents|
|US5807404||19 Sep 1996||15 Sep 1998||Medinol Ltd.||Stent with variable features to optimize support and method of making such stent|
|US5817126||17 Mar 1997||6 Oct 1998||Surface Genesis, Inc.||Compound stent|
|US5843120||24 Jun 1997||1 Dec 1998||Medinol Ltd.||Flexible-expandable stent|
|US5843164||19 Aug 1996||1 Dec 1998||Advanced Carrdiovascular Systems, Inc.||Intraluminal stent for attaching a graft|
|US5853419||17 Mar 1997||29 Dec 1998||Surface Genesis, Inc.||Stent|
|US5868782||24 Dec 1996||9 Feb 1999||Global Therapeutics, Inc.||Radially expandable axially non-contracting surgical stent|
|US5876432||28 Mar 1995||2 Mar 1999||Gore Enterprise Holdings, Inc.||Self-expandable helical intravascular stent and stent-graft|
|US5919225||14 Jul 1997||6 Jul 1999||Gore Enterprise Holdings, Inc.||Procedures for introducing stents and stent-grafts|
|US5938682||22 Sep 1997||17 Aug 1999||Cordis Corporation||Axially flexible stent|
|US6015429||12 Mar 1996||18 Jan 2000||Gore Enterprise Holdings, Inc.||Procedures for introducing stents and stent-grafts|
|US6033433||25 Apr 1997||7 Mar 2000||Scimed Life Systems, Inc.||Stent configurations including spirals|
|US6042597||23 Oct 1998||28 Mar 2000||Scimed Life Systems, Inc.||Helical stent design|
|US6056776||17 Aug 1998||2 May 2000||Advanced Cardiovascular System, Inc.||Expandable stents and method for making same|
|US6059808||10 Apr 1997||9 May 2000||Laboratoires Nycomed Sa||Implantable device and delivery system to reestablish or maintain a bodily canal|
|US6059810||27 Jan 1997||9 May 2000||Scimed Life Systems, Inc.||Endovascular stent and method|
|US6063101||20 Nov 1998||16 May 2000||Precision Vascular Systems, Inc.||Stent apparatus and method|
|US6066167||26 May 1998||23 May 2000||Advanced Cardiovascular Systems, Inc.||Expandable stents|
|US6066168||6 Apr 1998||23 May 2000||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US6066169 *||2 Jun 1998||23 May 2000||Ave Connaught||Expandable stent having articulated connecting rods|
|US6103320||9 Jun 1998||15 Aug 2000||Shincron Co., Ltd.||Method for forming a thin film of a metal compound by vacuum deposition|
|US6120847||8 Jan 1999||19 Sep 2000||Scimed Life Systems, Inc.||Surface treatment method for stent coating|
|US6124523||10 Mar 1995||26 Sep 2000||Impra, Inc.||Encapsulated stent|
|US6129755||9 Jan 1998||10 Oct 2000||Nitinol Development Corporation||Intravascular stent having an improved strut configuration|
|US6270524||14 Aug 1998||7 Aug 2001||Medtronic, Inc.||Flexible, radially expansible luminal prostheses|
|US6293966||20 Apr 1998||25 Sep 2001||Cook Incorporated||Surgical stent featuring radiopaque markers|
|US6309412||28 Apr 2000||30 Oct 2001||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US6309414||4 Nov 1997||30 Oct 2001||Sorin Biomedica Cardio S.P.A.||Angioplasty stents|
|US6312463||1 Feb 2000||6 Nov 2001||Endotex Interventional Systems, Inc.||Micro-porous mesh stent with hybrid structure|
|US6325821||29 Apr 1998||4 Dec 2001||Sorin Biomedica Cardio S.P.A.||Stent for angioplasty|
|US6325826||4 Jun 1999||4 Dec 2001||Advanced Stent Technologies, Inc.||Extendible stent apparatus|
|US6331190||14 Jan 2000||18 Dec 2001||Endologix, Inc.||Endoluminal vascular prosthesis|
|US6334870||3 Sep 1999||1 Jan 2002||Scimed Life Systems, Inc.||Stent configurations including spirals|
|US6334871||3 Sep 1996||1 Jan 2002||Medtronic, Inc.||Radiopaque stent markers|
|US6336938||25 May 1995||8 Jan 2002||William Cook Europe A/S||Implantable self expanding prosthetic device|
|US6355058||30 Dec 1999||12 Mar 2002||Advanced Cardiovascular Systems, Inc.||Stent with radiopaque coating consisting of particles in a binder|
|US6387123||13 Oct 1999||14 May 2002||Advanced Cardiovascular Systems, Inc.||Stent with radiopaque core|
|US6432133||16 Nov 2000||13 Aug 2002||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US6451049||1 Oct 1999||17 Sep 2002||Sorin Biomedica Cardio, S.P.A.||Stents for angioplasty|
|US6461380 *||28 Jul 1998||8 Oct 2002||Advanced Cardiovascular Systems, Inc.||Stent configuration|
|US6475236||17 Aug 2000||5 Nov 2002||Endosystems, Llc||Non-foreshortening intraluminal prosthesis|
|US6485508||13 Oct 2000||26 Nov 2002||Mcguinness Colm P.||Low profile stent|
|US6503272||21 Mar 2001||7 Jan 2003||Cordis Corporation||Stent-based venous valves|
|US6506211||13 Nov 2000||14 Jan 2003||Scimed Life Systems, Inc.||Stent designs|
|US6540774 *||31 Aug 1999||1 Apr 2003||Advanced Cardiovascular Systems, Inc.||Stent design with end rings having enhanced strength and radiopacity|
|US6605110 *||29 Jun 2001||12 Aug 2003||Advanced Cardiovascular Systems, Inc.||Stent with enhanced bendability and flexibility|
|US6613079 *||5 Feb 1999||2 Sep 2003||Medtronic, Inc.||Radially-expandable stent with controllable force profile|
|US6673106||5 Jun 2002||6 Jan 2004||Cordis Neurovascular, Inc.||Intravascular stent device|
|US6689159||1 May 2003||10 Feb 2004||Advanced Cardiovascular Systems, Inc.||Expandable stents and method for making same|
|US6699278||6 Jul 2001||2 Mar 2004||Cordis Corporation||Stent with optimal strength and radiopacity characteristics|
|US6709454||31 Jan 2000||23 Mar 2004||Advanced Cardiovascular Systems, Inc.||Self-expanding stent with enhanced delivery precision and stent delivery system|
|US6730116 *||16 Apr 1999||4 May 2004||Medtronic, Inc.||Medical device for intraluminal endovascular stenting|
|US20010037146||23 Feb 2001||1 Nov 2001||Lilip Lau||Expandable stents and method for making same|
|US20010037147||25 Jun 2001||1 Nov 2001||Lilip Lau||Expandable stents and method for making same|
|US20010047200||13 Oct 1999||29 Nov 2001||Raymond Sun||Non-foreshortening intraluminal prosthesis|
|US20010047201||7 Jun 2001||29 Nov 2001||Cox Daniel L.||Variable strength stent|
|US20010056298||21 Aug 2001||27 Dec 2001||Brown Brian J.||Longitudinally flexible expandable stent|
|US20020007209||6 Mar 2001||17 Jan 2002||Scheerder Ivan De||Intraluminar perforated radially expandable drug delivery prosthesis and a method for the production thereof|
|US20020016623||12 Oct 2001||7 Feb 2002||Kula John S.||Stent with variable wall thickness|
|US20020042649||9 Oct 2001||11 Apr 2002||Biotronik Mess-Und Therapiegeraete Gmbh & Co. Ingenieurbuero Berlin||Stent|
|US20020045935||24 Sep 2001||18 Apr 2002||Jang G. David||Intravascular stent apparatus|
|US20020055770||21 Sep 2001||9 May 2002||Doran Burns P.||Flexible and expandable stent|
|US20020072793||30 Oct 2001||13 Jun 2002||Sorin Biomedica Cardio S.P.A.||Angioplasty stents|
|US20020123798 *||2 Mar 2001||5 Sep 2002||Robert Burgermeister||Flexible stent|
|US20020156523||7 Jun 2002||24 Oct 2002||Lilip Lau||Exterior supported self-expanding stent-graft|
|US20020183831||31 May 2002||5 Dec 2002||Sorin Biomedica Cardio S.P.A.||Stents for angioplasty|
|US20030004567||11 Apr 2002||2 Jan 2003||Boyle Christopher T.||Endoluminal stent, self-supporting endoluminal graft and methods of making same|
|US20030083646||14 Dec 2001||1 May 2003||Avantec Vascular Corporation||Apparatus and methods for variably controlled substance delivery from implanted prostheses|
|US20030105515||14 Jan 2003||5 Jun 2003||Skubitz Sean P.||Stent designs|
|US20040054399||17 Sep 2002||18 Mar 2004||Roth Noah M.||Anti-galvanic stent coating|
|EP1212986A1||8 Dec 2000||12 Jun 2002||SORIN BIOMEDICA CARDIO S.p.A.||An angioplasty stent and manufacturing method thereof|
|FR2777771A1||Title not available|
|WO2001049212A1||18 Dec 2000||12 Jul 2001||Advanced Cardiovascular Systems, Inc.||Stent designs for use in peripheral vessels|
|WO2002038080A2||6 Nov 2001||16 May 2002||Advanced Bio Prosthetic Surfaces, Ltd.||Endoluminal stent, self-fupporting endoluminal graft and methods of making same|
|1||"Experimental studies: Are design differences relevant?" by Campbell Rogers, M.D., CardiacCatheterization Laboratory Brigham and Women's Hospital, pp. 1-21 (Sep. 24, 2002).|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7731746 *||4 Feb 2008||8 Jun 2010||Boston Scientific Scimed, Inc.||Stent|
|US7837726||13 Mar 2006||23 Nov 2010||Abbott Laboratories||Visible endoprosthesis|
|US8206432||7 Jun 2010||26 Jun 2012||Boston Scientific Scimed, Inc.||Stent|
|US8668731||22 Jun 2012||11 Mar 2014||Boston Scientific Scimed, Inc.||Stent|
|US8864811||25 Oct 2010||21 Oct 2014||Veniti, Inc.||Bi-directional stent delivery system|
|US8974514||13 Mar 2007||10 Mar 2015||Abbott Cardiovascular Systems Inc.||Intravascular stent with integrated link and ring strut|
|US8986367||23 Jan 2014||24 Mar 2015||Boston Scientific Scimed, Inc.||Stent|
|US8999364||25 May 2007||7 Apr 2015||Nanyang Technological University||Implantable article, method of forming same and method for reducing thrombogenicity|
|US9066825||12 Mar 2013||30 Jun 2015||C.R. Bard, Inc.||Uniformly expandable stent|
|US9173983||6 Apr 2009||3 Nov 2015||Cook Medical Technologies Llc||Surface structure of a component of a medical device and a method of forming the surface structure|
|US9233014||18 Nov 2010||12 Jan 2016||Veniti, Inc.||Stent with support braces|
|US9301864||8 Jun 2011||5 Apr 2016||Veniti, Inc.||Bi-directional stent delivery system|
|US9314360||16 Sep 2014||19 Apr 2016||Veniti, Inc.||Bi-directional stent delivery system|
|US20060235505 *||13 Mar 2006||19 Oct 2006||Oepen Randolf V||Visible endoprosthesis|
|US20070213810 *||13 Mar 2006||13 Sep 2007||Richard Newhauser||Segmented endoprosthesis|
|US20070255094 *||13 Mar 2006||1 Nov 2007||Oepen Randolf V||Crack/fatigue resistant endoprosthesis|
|US20080154354 *||4 Feb 2008||26 Jun 2008||Boston Scientific Scimed, Inc.||Stent|
|US20100010622 *||26 Aug 2009||14 Jan 2010||Abbott Laboratories||Hybrid segmented endoprosthesis|
|US20100241217 *||23 Sep 2010||Boston Scientific Scimed, Inc.||Stent|
|US20110060399 *||6 Apr 2009||10 Mar 2011||Steven J Charlebois||Surface structure of a component of a medical device and a method of forming the surface structure|
|USD723165||12 Mar 2013||24 Feb 2015||C. R. Bard, Inc.||Stent|
|U.S. Classification||623/1.15, 623/1.17|
|International Classification||A61F, A61F2/06, A61F2/90|
|Cooperative Classification||A61F2/915, A61F2002/91533, A61F2002/91583, A61F2230/0054, A61F2/91, A61F2250/0036|
|European Classification||A61F2/91, A61F2/915|
|18 Mar 2004||AS||Assignment|
Owner name: ADVANCED BIO PROSTHETIC SURFACES, LTD., TEXAS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BANAS, CHRISTOPHER E.;ROSENBAUM, DAVID G.;REEL/FRAME:015151/0660;SIGNING DATES FROM 20040317 TO 20040318
|24 May 2010||REMI||Maintenance fee reminder mailed|
|15 Oct 2010||FPAY||Fee payment|
Year of fee payment: 4
|15 Oct 2010||SULP||Surcharge for late payment|
|17 Apr 2014||FPAY||Fee payment|
Year of fee payment: 8
|18 Aug 2015||AS||Assignment|
Owner name: SPI DALLAS INVESTMENTS, LP, TEXAS
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:036384/0818
Effective date: 20150722
|24 Aug 2015||AS||Assignment|
Owner name: SPI DALLAS INVESTMENTS, LP, TEXAS
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:036434/0813
Effective date: 20150722
Owner name: LENNOX CAPITAL PARTNERS, LP, TEXAS
Free format text: CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF ASSIGNEE PREVIOUSLY RECORDED AT REEL: 036384 FRAME: 0818. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:036465/0091
Effective date: 20150722
|15 Feb 2016||AS||Assignment|
Owner name: PALMAZ, JULIO, CALIFORNIA
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:037820/0400
Effective date: 20150917
|16 Feb 2016||AS||Assignment|
Owner name: OAK COURT PARTNERS, LTD., NEVADA
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:037827/0568
Effective date: 20150917
Owner name: OAK COURT PARTNERS, LTD., NEVADA
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:037836/0646
Effective date: 20150917
|17 Feb 2016||AS||Assignment|
Owner name: OAK COURT PARTNERS, LTD., TEXAS
Free format text: SECURITY INTEREST;ASSIGNORS:PALMAZ SCIENTIFIC INC.;ADVANCED BIO PROSTHETIC SURFACES, LTD.;ABPS VENTURE ONE, LTD.;REEL/FRAME:037839/0278
Effective date: 20151230