Patent Document

CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a divisional of application Ser. No. 09/855,918, filed May 15, 2001, which is a divisional of application Ser. No. 08/999,583, filed Dec. 22, 1997, now U.S. Pat. No. 6,264,684, which is a continuation-in-part of three applications: 1) International Application No. PCT/US95/16497, filed Dec. 8, 1995, which was nationalized as Ser. No. 09/077,533, filed May 28, 1998, now U.S. Pat. No. 6,053,943; 2) Ser. No. 08/833,797, filed Apr. 9, 1997, now U.S. Pat. No. 6,451,047, which is a continuation-in-part of application Ser. No. 08/508,033, filed Jul. 27, 1995, now U.S. Pat. No. 5,749,880, which is a continuation-in-part of application Ser. No. 08/401,871, filed Mar. 10, 1995, now U.S. Pat. No. 6,124,523; and 3) Ser. No. 08/794,871, filed Feb. 5, 1997, now U.S. Pat. No. 6,039,755. This application expressly incorporates by reference the entirety of each of the above-mentioned applications as if fully set forth herein. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates generally to implantable intraluminal devices, particularly intraluminal grafts. Intraluminal stents are implanted in order to maintain luminal patency, typically after interventional methods have been employed to restore luminal patency from a diseased state, exclude an aneurysmal condition, bypass an occluded or obstructed anatomical region or to shunt body fluids. Surgically implantable prosthetics, particularly vascular prostheses, have been employed for many years. Expanded polytetrafluoroethylene (ePTFE) vascular grafts have been used as biocompatible implants for many years and the use of ePTFE as a bio-inert barrier material in intraluminal applications is well documented. Conventional ePTFE vascular grafts, however, typically lack sufficient diametric mechanical rigidity to maintain luminal patency in intraluminal applications.  
           [0003]    Conventional externally supported ePTFE vascular grafts, such as the IMPRA Flex-Graft or the Gore Ring Graft, have an external beading of helically wound non-expanded or solid polytetrafluoroethylene, or of solid fluorinated ethylene-propylene co-polymer (FEP). Non-expanded or solid polytetrafluoroethylene is significantly more rigid than the ePTFE material due to its higher density and absence of interstitial voids. These externally supported ePTFE vascular grafts are not well-suited to interventional intraluminal procedures due to their inability to assume a reduced profile suitable for percutaneous delivery using a catheter and their inability to recover an enlarged diametric dimension in vivo.  
           [0004]    Most intraluminal stents are formed of an open lattice fashioned either to be elastically deformable, such as in the case of self-expanding stainless steel spring stents, plastically deformable, such as in the case of balloon-expandable stainless steel PALMAZ stents, or thermally expandable such as by employing shape memory properties of the material used to form the stent. A common problem of most conventional intraluminal stents is re-occlusion of the vessel after stent placement. Tissue ingrowth and neointimal hyperplasia significantly reduces the open diameter of the treated lumen over time, requiring additional therapies.  
           [0005]    The present invention makes advantageous use of the known biocompatible and material properties of ePTFE vascular grafts, and adds an abluminal supporting structure capable of being diametrically reduced to an intraluminal delivery profile and self-expanding in vivo to conform to the anatomical topography at the site of intraluminal implantation. More particularly, the present invention consists of an ePTFE substrate material, such as that described in U.S. application Ser. No. 08/794,871, filed Feb. 5, 1997, now U.S. Pat. No. 6,039,755, as a carrier for a helically wound, open cylindrical support structure made of a shape memory alloy.  
           [0006]    The inventive intraluminal stent-graft device may be implanted either by percutaneous delivery using an appropriate delivery system, a cut-down procedure in which a surgical incision is made and the intraluminal device implanted through the surgical incision, or by laparoscopic or endoscopic delivery.  
           [0007]    Shape memory alloys are a group of metal alloys which are characterized by an ability to return to a defined shape or size when subjected to certain thermal or stress conditions. Shape memory alloys are generally capable of being plastically deformed at a relatively low temperature and, upon exposure to a relatively higher temperature, return to the defined shape or size prior to the deformation. Shape memory alloys may be further defined as one that yields a thermoelastic martensite. A shape memory alloy which yields a thermoelastic martensite undergoes a martensitic transformation of a type that permits the alloy to be deformed by a twinning mechanism below the martensitic transformation temperature. The deformation is then reversed when the twinned structure reverts upon heating to the parent austenite phase. The austenite phase occurs when the material is at a low strain state and occurs at a given temperature. The martensite phase may be either temperature induced martensite (TIM) or stress-induced martensite (SIM).  
           [0008]    When a shape memory material is stressed at a temperature above the start of martensite formation, denoted M s , where the austenitic state is initially stable, but below the maximum temperature at which martensite formation can occur, denoted M d , the material first deforms elastically and when a critical stress is reached, it begins to transform by the formation of stress-induced martensite. Depending upon whether the temperature is above or below the start of austenite formation, denoted A s , the behavior when the deforming stress is released differs. If the temperature is below A s , the stress-induced martensite is stable, however, if the temperature is above A s , the martensite is unstable and transforms back to austenite, with the sample returning to its original shape. U.S. Pat. Nos. 5,597,378, 5,067,957 and 4,665,906 disclose devices, including endoluminal stents, which are delivered in the stress-induced martensite phase of shape memory alloy and return to their pre-programmed shape by removal of the stress and transformation from stress-induced martensite to austenite.  
           [0009]    Shape memory characteristics may be imparted to a shape memory alloy by heating the metal at a temperature above which the transformation from the martensite phase to the austenite phase is complete, i.e., a temperature above which the austenite phase is stable. The shape imparted to the metal during this heat treatment is the shape “remembered.” The heat treated metal is cooled to a temperature at which the martensite phase is stable, causing the austenite phase to transform to the martensite phase. The metal in the martensite phase is then plastically deformed, e.g., to facilitate its delivery into a patient&#39;s body. Subsequent heating of the deformed martensite phase to a temperature above the martensite to austenite transformation temperature, e.g., body temperature, causes the deformed martensite phase to transform to the austenite phase and during this phase transformation the metal reverts back to its original shape.  
           [0010]    The term “shape memory” is used in the art to describe the property of an elastic material to recover a pre-programmed shape after deformation of a shape memory alloy in its martensitic phase and exposing the alloy to a temperature excursion through its austenite transformation temperature, at which temperature the alloy begins to revert to the austenite phase and recover its preprogrammed shape. The term “pseudoelasticity” is used to describe a property of shape memory alloys where the alloy is stressed at a temperature above the transformation temperature of the alloy and stress-induced martensite is formed above the normal martensite formation temperature. Because it has been formed above its normal temperature, stress-induced martensite reverts immediately to undeformed austenite as soon as the stress is removed provided the temperature remains above the transformation temperature.  
           [0011]    The present invention employs a wire member made of either a shape memory alloy, preferably a nickel-titanium alloy known as NITINOL, spring stainless steel or other elastic metal or plastic alloys, or composite material, such as carbon fiber. It is preferable that the wire member have either a generally circular, semi-circular, triangular or quadrilateral transverse cross-sectional profile. Where a shape memory alloy material is employed, pre-programmed shape memory is imparted to the wire member by helically winding the wire member about a cylindrical programming mandrel having an outer diametric dimension substantially the same, preferably within a tolerance of about +0 to −15%, as the ePTFE substrate and annealing the programming mandrel and the wire member at a temperature and for a time sufficient to impart the desired shape memory to the wire member. After annealing, the wire member is removed from the programming mandrel, straightened and helically wound about the abluminal wall surface of an EPTFE tubular member at a temperature below the A s  of the shape memory alloy used to form the wire member.  
           [0012]    In order to facilitate bonding of the wire member to the EPTFE tubular member, it is preferable that a bonding agent capable of bonding the support wire member to the ePTFE tubular member be used at the interface between the wire member and the ePTFE tubular member. Suitable biocompatible bonding agents may be selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, silicone fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone. The bonding agent may constitute an interfacial layer intermediate the wire member and the ePTFE tubular member, or may be a polymeric cladding at least partially concentrically surrounding the wire member.  
           [0013]    Where a cladding is provided, the cladding is preferably a polymeric material selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, silicone fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone. The cladding may be either co-extruded with the wire member, extruded as a tube into which the wire member is concentrically inserted after annealing the wire member, or provided as an elongate member which a longitudinal recess which co-axially receives the wire member. Where the bonding agent employed is a melt thermoplastic which has a melt point below the crystalline melt point of polytetrafluoroethylene, the melt thermoplastic bonding agent and the wire member are wound about the ePTFE tubular member, and constrained thereupon, such as by application of circumferential pressure, then the assembly is then exposed to the melt temperatures without longitudinally supporting the assembly.  
           [0014]    However, where the bonding agent is polytetrafluoroethylene, bonding of the wire member to the ePTFE tubular member requires exposing the assembly to temperatures above the crystalline melt point of polytetrafluoroethylene in order to effectuate bonding of the wire member to the ePTFE. This is preferably accomplished by introducing the assembly into a sintering oven while the assembly is on a mandrel and the assembly secured to the mandrel by an external helical wrapping of TEFLON tape applied to opposing ends of the assembly to longitudinally constrain the assembly and reduce or eliminate the tendency of the assembly to longitudinally foreshorten during sintering.  
         BRIEF SUMMARY OF THE INVENTION  
         [0015]    It is a primary objective of the present invention to provide a self-supporting, self-expanding stent-graft device which is capable of being delivered to an anatomical position within a human body in a first constrained configuration, positioned in vivo at a desired anatomical site, and the constraint released to permit the stent-graft device to transform to a radially enlarged second configuration.  
           [0016]    It is another primary objective of the present invention to provide a stentgraft device which consists generally of tubular member fabricated of a biocompatible polymer selected from the group of microporous expanded polytetrafluoroethylene (“ePTFE”), polyethylene, polyethylene terepthalate, polyurethane and collagen, and at least one winding of a elastically self-expanding wire coupled to either the abluminal or luminal surfaces of the ePTFE tubular member or interdisposed between concentrically positioned ePTFE tubular members.  
           [0017]    It is a further objective of the present invention to couple the at least one winding of the elastically self-expanding wire to the ePTFE tubular member by cladding a support wire in a polymeric material which has a melt point less than or equal to that of the ePTFE tubular member and below the A, temperature of the shape memory alloy metal wire.  
           [0018]    It is a further objective of the present invention to provide an adhesive interlayer for bonding the shape memory alloy metal wire to the tubular member, the adhesive interlayer being selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone.  
           [0019]    It is another objective of the present invention to provide a method for making a -expanding stent-graft device comprised generally of an ePTFE tubular member and at least one winding of a shape memory alloy metal wire coupled to the abluminal surface of the ePTFE tubular member.  
           [0020]    These and other objects, features and advantages of the present invention will be better understood by those of ordinary skill in the art from the following more detailed description of the present invention taken with reference to the accompanying drawings and its preferred embodiments. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]    [0021]FIG. 1 is a side elevational view of a supported intraluminal graft in accordance with a preferred embodiment of the present invention.  
         [0022]    [0022]FIG. 2 is a cross-sectional view taken along line  2 - 2  of FIG. 1.  
         [0023]    [0023]FIG. 3 is a cross-sectional view taken along line  3 - 3  of FIG. 1.  
         [0024]    [0024]FIG. 4A is a side elevational cross-sectional view of a graft member mounted onto a mandrel in accordance with a preferred embodiment of the method of the present invention.  
         [0025]    [0025]FIG. 4B is a side elevational cross-sectional view of FIG. 4A with a support member wrapped about an abluminal surface of the graft member.  
         [0026]    [0026]FIG. 4C is a side elevational cross-sectional view as in FIGS. 4A and 4B illustrating an abluminal covering concentrically superimposed over they support member and the graft member.  
         [0027]    [0027]FIG. 5 is a perspective view of a ribbon member clad in a polymeric covering in accordance with the present invention.  
         [0028]    [0028]FIG. 6 is a cross-sectional view taken along line  6 - 6  of FIG. 5.  
         [0029]    [0029]FIG. 7 is a perspective view of a wire member clad in a polymeric covering in accordance with the present invention.  
         [0030]    [0030]FIG. 8 is a cross-sectional view taken along line  8 - 8  of FIG. 7.  
         [0031]    [0031]FIG. 9 is a diagrammatic cross-sectional view of a first embodiment of a support member encapsulated in a shaped polymeric cladding covering.  
         [0032]    [0032]FIG. 10 is a diagrammatic cross-sectional view of a second embodiment of a support member encapsulated in a shaped polymeric cladding covering.  
         [0033]    [0033]FIG. 11 is a diagrammatic cross-sectional view of a third embodiment of a support member encapsulated in a shaped polymeric cladding covering.  
         [0034]    [0034]FIG. 12 is a diagrammatic cross-sectional view of a fourth embodiment of a support member coupled to a shaped polymeric cladding covering.  
         [0035]    [0035]FIG. 13 is a perspective view of an alternative preferred embodiment of the supported intraluminal graft in accordance with the present invention.  
         [0036]    [0036]FIG. 14 is a cross-sectional view taken along line  14 - 14  of FIG. 13.  
         [0037]    [0037]FIG. 15 is a process flow diagram illustrating the process steps for making the supported intraluminal graft in accordance with the method of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0038]    The shape memory alloy supported intraluminal graft  10  of the present invention consists generally of a tubular substrate  12  having a central lumen  13  passing through an entire longitudinal extent of the tubular substrate. The tubular substrate  12  has a luminal wall surface  15  adjacent the central lumen  13  and an abluminal wall surface  17  opposing the central lumen  13 . A support member  14  is provided and is preferably at least partially covered by a polymeric cladding  11 . The polymeric clad support member  14  is circumferentially disposed about and joined to the abluminal wall surface  17  of the tubular substrate  12 , such as by helically winding the polymeric clad support member  14  about the abluminal surface  17  of the tubular substrate  12 . Optionally, a second tubular substrate  19 , having an inner diameter sufficiently dimensioned to be concentrically engaged about the abluminal wall surface  17  of the tubular substrate  12  and the polymeric clad support member  14 , may be provided.  
         [0039]    In accordance with a first preferred embodiment of the present invention, and with particular reference to FIGS.  1 - 3 , there is provided the inventive supported intraluminal graft  10  comprised of a tubular  12  made of a biocompatible polymeric material, such as expanded polytetrafluoroethylene (“ePTFE”), polyethylene terepthalate (“PET”) such as that marketed and sold under the trademark DACRON, polyethylene, or polyurethane. Expanded PTFE substrate materials are preferably made by ram extruding an admixture of polytetrafluoroethylene resin and a hydrocarbon lubricant to form a tubular extrudate, drying off the hydrocarbon lubricant, longitudinally expanding the dried tubular extrudate, then sintering the longitudinally expanded dried tubular extrudate at a temperature above the crystalline melt point of polytetrafluoroethylene.  
         [0040]    The resulting tubular ePTFE material has a microporous microstructure which is composed of spaced-apart nodes interconnected by fibrils, with the fibrils being oriented parallel to the longitudinal axis of the ePTFE tube and parallel to the axis of longitudinal expansion. U.S. Pat. Nos. &#39;390 and &#39;566, both issued to Gore, teach processes for making ePTFE tubular substrates and are hereby incorporated by reference as teaching processes to make ePTFE tubular and planar materials. A tubular substrate may also be made by weaving yarn, made of either polyester or ePTFE, into a tubular structure as is well known in the art. Additionally, the tubular substrate  12  may have a cylindrical profile having a substantially uniform internal diameter along its longitudinal axis, or may have a tapered sidewall in which the tubular substrate  12  assumes a generally frustroconical shape in which the internal diameter of the tubular substrate  12  increases or deceases along the longitudinal axis of the tubular substrate  12 . Alternatively, the tubular substrate  12  may have at least one region of stepped diameter in which the internal diameter of the tubular substrate changes at a discrete longitudinal section of the tubular substrate  12 .  
         [0041]    In accordance with a first preferred embodiment of the present invention, the tubular substrate  12  is an extruded, longitudinally expanded and sintered ePTFE tubular member which has been radially expanded from an initial luminal inner diameter of between about 1.5 mm to about 6 mm to a final luminal inner diameter of between about 3 mm to about 18 mm. Thus, tubular substrate  12  is initially fabricated at a first relatively smaller diametric dimension, dried of the hydrocarbon lubricant, and sintered, then radially expanded by application of an radially outwardly directed force applied to the luminal wall surface  15  of the tubular substrate  12 , which radially deforms the wall of the tubular substrate  12  from an initial luminal inner diameter, denoted D 1 , to a second, enlarged luminal inner diameter, denoted D 2 . Alternatively, tubular substrate  12  may be provided as an extruded, longitudinally expanded and sintered ePTFE tubular member having an inner diameter equivalent to the final inner diameter of the supported intraluminal graft, e.g., extruded to a luminal diameter of between about 3 mm to about 18 mm, and a wall thickness sufficient to acceptably minimize the delivery profile of the supported intraluminal graft. Suitable wall thicknesses for the non-radially expanded ePTFE tubular member are considered less than or equal to about 0.3 mm for delivery to peripheral anatomic passageways.  
         [0042]    The tubular substrate  12  is preferably radially expanded by loading the tubular substrate  12 , in its fully or partially sintered state, onto an inflation balloon such that the tubular substrate  12  is concentrically engaged upon the inflation balloon, introducing the inflation balloon and tubular substrate  12  into a tubular housing defining a generally cylindrical cavity having an inner diameter corresponding to the maximum desired outer diameter of the final shape memory alloy supported graft, and applying a fluid pressure to the inflation balloon to inflate the inflation balloon and radially deform the tubular substrate  12  into intimate contact with the generally cylindrical cavity. Pressure is maintained within the inflation balloon for a period of time sufficient to minimize the inherent recoil property of the ePTFE material in the tubular substrate  12 , then the pressure is relieved and the inflation balloon permitted to deflate. The radially deformed tubular substrate, now having an inner luminal diameter D 2 , is removed from the generally cylindrical cavity for subsequent processing.  
         [0043]    During radial expansion of the tubular substrate  12  from D 1  to D 2 , the node and fibril microstructure of the ePTFE tubular substrate is deformed. The nodes, which have an orientation perpendicular to the longitudinal axis of the tubular substrate  12  and parallel to the radial axis of the tubular substrate  12 , deform along the longitudinal axis of each node to form elongated columnar structures, while the length of the fibrils interconnecting adjacent pairs of nodes in the longitudinal axis of the tubular substrate  12 , remains substantially constant. The fibril length is also referred to herein as the “internodal distance.” 
         [0044]    A support member  14 , which is preferably made of an elastic wire material selected from the group of thermoelastic or shape memory alloys, spring stainless steel, elastic metal or plastic alloys, or composite materials, such as woven carbon fibers. Where a shape memory alloy is employed, it is important that the shape memory alloy have a transition temperature below human body temperature, i.e., 37 degrees Celsius, to enable the shape memory alloy to undergo transformation to the austenite phase when the shape memory alloy wire member is exposed to human body temperature in vivo. In accordance with the best mode currently known for the present invention, the preferred shape memory alloy is a near equiatomic alloy of nickel and titanium.  
         [0045]    To facilitate attachment of the elastic or thermoelastic wire member  14  to the tubular substrate  12 , it is contemplated that a polymeric cladding  11  be provided to at least partially cover the support wire member  14  and facilitate adhesion between the support wire member  14  and the abluminal wall surface  17  of the tubular substrate  12 . In accordance with the best mode for practicing the present invention, it is preferable that the polymeric cladding  11  be selected from the group of biocompatible polymeric materials consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone.  
         [0046]    As will hereinafter be described more fully, the polymeric cladding  11  may be coupled to the support wire member  14  by any of a variety of known methodologies. For example, the polymeric cladding  11  may be co-extruded with the support wire member  14 , the polymeric cladding  11  may be extruded with an opening passing through the polymeric cladding  11  along its longitudinal axis and dimensioned to receive the support wire member  14  there through, the polymeric cladding  11  may have a longitudinally extending recess dimensioned to receive and retain the support wire member  14  therein, or the polymeric cladding  11  may be applied onto the support wire member  11  in dispersion form, such as by dipcoating or spraying, and the solvent or aqueous vehicle dried thereby forming a covering on the support wire member  11 .  
         [0047]    The support wire member  14  in its polymeric cladding  11  is circumferentially joined to the abluminal wall surface  17  of the tubular substrate  12 , such as by helically winding at least one length of polymeric clad support wire member  14  in a regular or irregular helical pattern, or by applying the polymeric clad support wire member  14  as a series of spaced-apart circumferential rings, along at least a portion of the longitudinal axis of the abluminal wall surface  17  of the tubular substrate  12 . It is preferable that the tubular substrate  12  be mounted onto a supporting mandrel [not shown] having an outer diameter closely toleranced to the inner diameter of the tubular substrate  12  to permit the tubular substrate  12  to be placed thereupon and secured thereto without deforming the tubular substrate  12 .  
         [0048]    A second tubular member  19  may, optionally, be concentrically engaged about the tubular member  12  and the polymeric clad support wire member  14 . As more clearly depicted in FIGS.  2 - 3 , where the second tubular member  19  is employed and disposed circumferentially about the tubular member  12  and the polymeric clad support wire member  14 , the tubular member  12  and the second tubular member  19  encapsulate the polymeric clad support wire member  14 . Where the tubular member  12  and the second tubular member  19  are both made of longitudinally expanded ePTFE, each will have a microporous microstructure in which the fibrils are oriented parallel to the longitudinal axis of each of the tubular member  12  and the second tubular member  19 , throughout their respective wall thicknesses. The encapsulation of the polymeric clad support wire member  14  is best accomplished by providing both the tubular member  12  and the second tubular member  19  as unsintered or partially sintered tubes.  
         [0049]    After wrapping the polymeric clad support wire member  14  about the abluminal surface of the tubular member  12 , and circumferentially engaging the second tubular member  19  thereabout, it is preferable to apply a circumferential pressure to the assembly, while the assembly is on the supporting mandrel [not shown]. Circumferential pressure may be applied to the assembly by, for example, helically wrapping tetrafluoroethylene film tape about the abluminal surface of the second tubular member  19  along its longitudinal axis, or by securing opposing ends of the assembly on the supporting mandrel, and rolling the assembly to calendar the assembly. After the circumferential pressure is applied to the assembly, the assembly is then introduced into either a convention or radiant heating oven, set at a temperature above the melt point of the material used to fabricate the tubular member  12 , the second tubular member  19  and/or the polymeric cladding  11 , for a period of time sufficient to bond the tubular member  12 , the second tubular member  19  and the polymeric cladding  11  into a substantially monolithic, unitary structure. Where polytetrafluoroethylene is used, it has been found that it is preferable to heat the assembly in a radiant heating oven.  
         [0050]    FIGS.  4 A- 4 C depict the method steps for making the inventive shape memory alloy supported intraluminal graft  10 . With a first step  20 , tubular member  12  is concentrically engaged onto a supporting mandrel  22  such that the supporting mandrel  22  resides within the lumen of the tubular member  12 . A helical winding of polymeric clad support wire member  14  is applied about the abluminal wall surface  17  of the tubular member  12  at step  25 . The helical windings have an interwinding distance  27  which is preferably at least one times the distance  29  which represents the width of the polymer cladding  11 , in the case of a planar polymer cladding  11 , or the diameter, in the case of a tubular polymer cladding  11  having a circular transverse cross-section.  
         [0051]    The helical winding of the polymeric clad support wire member  14  contacts the abluminal wall surface  17  of the tubular member  12  at an interfacial region  28 . According to one preferred embodiment of the present invention there is provided an adhesive material  23  selected from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamides, polyimides, polyesters, polypropylenes, polyethylenes, polyfluoroethylenes, silicone, fluorinated polyolefins, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, and polyvinylpyrolidone. The adhesive material is preferably applied to the interfacial region  28  of the polymeric clad support wire member  14 , but may also be applied in a pattern directly to a surface of the tubular substrate and the SMA wire member  14  brought into contact with the adhesive material. In this manner, as the polymeric clad support wire member  28  is helically applied to the abluminal wall surface  17  of the tubular member  12 , the adhesive material  23  forms an interlayer intermediate the polymeric clad support wire member  28  and the abluminal wall surface  17  of the tubular member  12 .  
         [0052]    Where the selected adhesive material  23  has a melt point less than the crystalline melt point of polytetrafluoroethylene, i.e., about 327 degrees Centigrade, the resulting assembly of step  25  may be introduced into a heating oven set at the melt temperature of the selected adhesive material  23 , for a period of time sufficient to melt the adhesive material  23  and impart an adhesive bond between the polymeric clad support wire member  14  and the tubular member  12 . On the other hand, where the selected adhesive material  23  is polytetrafluoroethylene, an external covering of a second tubular member  26  may be concentrically engaged about the assembly resulting from step  25 , a circumferential pressure exerted to the second tubular member  26 , thereby bringing the second tubular member  26 , the polymer clad support wire member  11  and the tubular member  12  into intimate contact with one another, and the entire assembly introduced into a sintering oven set at a temperature above the crystalline melt point of polytetrafluoroethylene and for a period of time sufficient to meld the second tubular member  26  and the tubular member  12  to one another to form a resultant substantially monolithic structure which is substantially devoid of interfacial demarcations between the second tubular member  26  and the tubular member  12 , with the polymer clad support wire member  14  residing intermediate there between.  
         [0053]    Turning now to FIGS.  5 - 12 , there is depicted numerous alternate configurations of the polymer clad support wire member  14 . FIGS. 5 and 6 depict a first embodiment of the polymer clad support wire member  34  in which the support wire member is formed as a planar ribbon wire  38  a generally tubular box-like polymer cladding  36  provided about the outer surfaces of the planar ribbon wire  38 . In the transverse cross-sectional view of FIG. 6 it will be seen that both the planar ribbon wire  38  and the polymer cladding  36  have generally quadrilateral cross-sectional configurations.  
         [0054]    FIGS.  7 - 8  depict a second embodiment of the polymer clad support wire member  40  in which the support wire member is formed as a cylindrical wire  44  having a generally tubular polymer cladding  42  provided about the outer circumference of the planar ribbon wire  44 . In the transverse cross-sectional view of FIG. 8 it will be seen that both the cylindrical wire  44  and the polymer cladding  42  have generally circular cross-sectional configurations.  
         [0055]    FIGS.  9 - 12  are provided in the transverse cross-sectional views only, it being understood that like FIGS. 5 and 7, each of the embodiments depicted in FIGS.  9 - 12  have corresponding perspective configurations. FIG. 9 depicts a third embodiment of the polymer clad support wire member  46  in which the support wire member is formed as a cylindrical wire having a generally triangular-shaped polymer cladding  48 , with a central longitudinal cylindrical bore to accommodate the cylindrical wire  49  therein, which is provided about the outer surfaces of the cylindrical wire  49 . A fourth embodiment of the polymer clad support wire member  50  is depicted in FIG. 10. Polymer clad support wire member  50  consists generally of a polymer cladding  52  having a plurality of planar surfaces and having a generally quadrilateral transverse cross-sectional shape, while the support wire member  54  is generally cylindrical with a generally circular transverse cross-section.  
         [0056]    As depicted in FIG. 11, a fifth embodiment of the polymer clad support wire member  60  is depicted. Here, the support wire member  54  has a generally cylindrical shape with a generally circular transverse cross-section, while the polymer cladding  62  has a main body portion having a generally circular transverse cross-section, but has additional projections extending radially outward from the generally circular main body portion to increase the bonding surface area of the polymer clad support wire member  60 . Finally, as depicted in FIG. 12, the sixth embodiment of the polymer clad support wire member  70  is depicted. In accordance with this sixth embodiment there is provided a generally cylindrical support wire member  76  having a generally circular transverse cross-section, while the polymer cladding  72  is provided with a generally triangular cross-sectional shape, with hemispherical recess  74  formed in an apex of the generally triangular cross-sectional shape. The hemispherical recess  74  subtends at least a 180 degree arc and extends along a substantial longitudinal extent of the polymer cladding  72 . The generally cylindrical support wire member  76  is engaged in the hemispherical recess  74  and retained therein by an interference fit, or by other suitable means, such as an adhesive.  
         [0057]    It will be understood by those skilled in the art, that each of the foregoing embodiments of the polymer clad support wire member may be made by pulltrusion methods in which the shape memory alloy wire member, having a preprogrammed austenite phase, is fed into an extruder during extrusion of the polymer cladding, or by extruding the polymer cladding with a central lumen, dimensioned appropriately to permit engagement of the shape memory alloy wire, then threading the support wire member into the central lumen of the polymer cladding.  
         [0058]    Finally, an alternative embodiment of a shape memory alloy supported intraluminal graft  80  is depicted in FIGS. 13 and 14. The inventive shape memory alloy supported intraluminal graft  80  may be formed by helically wrapping a length of polymer clad  84  shape memory alloy wire  86  about a supporting winding mandrel, such that the polymer cladding  84  has overlapping regions  88  which form seams. The resulting assembly is then heated above the melt point of the polymer cladding  84  to join and seal the overlapping regions  88  to one another.  
         [0059]    The inventive method  100  for making the inventive wire supported intraluminal graft, described above, is illustrated with reference to FIG. 15. An elastic or thermoelastic wire member is provided at step  102  along with a shaping mandrel  104 . The shaping mandrel  104  is preferably a solid cylindrical or tubular cylindrical stainless steel member capable of withstanding annealing temperatures of shape memory alloys. At step  106 , the wire member provided at step  102  is wound onto the shaping mandrel provided at step  104 . The wire member is preferably helically wound about the shaping mandrel such that adjacent windings are substantially uniformly spaced from one another. It is also contemplated that the wire member may be wound about the shaping mandrel in any of a wide number of configurations, including non-uniformly spaced windings long portions of the shaping mandrel, such that certain regions of the winding have higher and lower frequency windings than other regions, that the winding be shaped as adjacent circumferential loops such as that shape disclosed in Gianturco, U.S. Pat. No. 4,907,336 or Wiktor, U.S. Pat. No. 4,969,458, both hereby incorporated by reference as teaching a shape of winding suitable for use with the present invention, or virtually any other shape which is capable for forming an open tubular structural skeleton, including, without limitation, a helical winding having a plurality of sinusoidal bends along a length thereof, as taught by Wiktor, U.S. Pat. No. 4,886,062 or Pinchuck, U.S. Pat. No. 5,019,090, both hereby incorporated by reference as teaching alternative configurations of helical windings of wire members.  
         [0060]    Where a thermoelastic shape memory alloy (SMA) wire member is utilized, the SMA wire member is wound about the shaping mandrel, the shape of the wound SMA wire member is programmed at step  108  by annealing the SMA wire member at a temperature and for a time sufficient to impart shape memory properties to the SMA wire member. At step  110 , the preprogrammed SMA alloy wire member is then exposed to temperature conditions below the M f  temperature of the SMA alloy. While it is maintained below the M f  temperature of the SMA alloy, the wire member is removed from the shaping mandrel and straightened to a linear shape at step  112 . If the SMA alloy wire member is to be covered with a cladding, a polymeric tubular cladding is provided at step  118  and the SMA alloy wire member is threaded into the lumen of the tubular cladding at step  120 .  
         [0061]    It is preferable that steps  118  and  120  be performed while the SMA alloy wire member is maintained at a temperature below the M f  temperature of the SMA alloy to prevent shape recovery of the SMA alloy wire member. Alternatively, if no polymeric cladding is to be employed, but the SMA alloy wire member from step  112  is to be adhered, an adhesive material may be applied to the SMA alloy wire member at step  122 . Step  122  may be conducted while the SMA alloy wire member is at a temperature below the M f  temperature, however, due to the fact that most adhesives may not adhere to the SMA alloy wire member at such temperatures, the adhesive is preferably applied to the SMA alloy wire member while it is in the austenite state. Where an elastic wire member, such as a support structure made from stainless steel spring wire, is employed, the shape programming described in the preceding paragraph may, of course, be omitted.  
         [0062]    After application of the polymeric cladding at steps  118  and  120 , or after the adhesive is applied at step  122 , or where step  122  is conducted at a temperature below the M f  temperature of the SMA alloy, the SMA wire is then exposed to a temperature excursion to above the A f  temperature of the SMA alloy at step  114  so that the SMA alloy wire member recovers its programmed shape at step  116 . Where an elastic wire member is employed, it is not sensitive to temperature excursions and the temperature excursion step may be omitted.  
         [0063]    A tubular substrate, made of, for example, extruded ePTFE, preferably extruded ePTFE which has been radially deformed from its nominal extruded diameter to an enlarged diameter, or woven polyester, is provided at step  123 . The wire member in its enlarged shape, which in the case of an SMA wire member is its programmed shape, or in the case of an elastic wire member, in its unstressed state, is concentrically engaged about the tubular substrate at step  124 , and joined to the tubular substrate at step  126  by thermally bonding the adhesive or the polymeric cladding to the abluminal or luminal surface of the tubular substrate. It is preferable that step  126  be conducted while the tubular substrate is supported by a support mandrel and that the SMA alloy wire member is retained in intimate contact with a surface of the tubular substrate with at least a portion of the wire member. The wire member, either in its clad or unclad state, may be retained in intimate contact against either by tension wrapping the wire member or by an external covering wrap of a release material, such as polytetrafluoroethylene tape, to cover at least a portion of the wire member.  
         [0064]    After the wire member is joined to the tubular substrate, the assembly may optionally be sterilized at step  128 , such as by exposure to ethylene oxide for a time and under appropriate conditions to sterilize the assembly. Where an SMA alloy wire member is employed, the assembly is then exposed to a temperature below the A s  temperature of the SMA alloy wire member at step  130  and the assembly is mechanically deformed to a smaller diametric profile at step  132 . Where an elastic wire member is employed, the assembly is mechanically deformed to a smaller diametric profile at step  132  largely independent of temperature conditions. Step  132  may be performed by any suitable means to reduce the diametric profile of the assembly, such as by drawing it through a reducing die, manually manipulating the assembly to a reduced diametric profile, or folding the device.  
         [0065]    The reduced profile assembly is then loaded onto a delivery catheter and covered with a restraining sheath at step  134 . Once loaded onto a delivery catheter and covered with a restraining sheath to prevent shape recovery. In the case where the wire member is an SMA alloy, loading the assembly onto a delivery catheter and covering with a restraining sheath requires that step  134  be performed at a temperature below the A s  temperature of the SMA alloy wire in order to prevent thermoelastic recovery of the SMA alloy wire member. Where, however, the wire member is fabricated of an elastic material, the loading step  134  is not largely temperature sensitive and may be performed at room temperature. While the wire member will exert shape recovery forces at room temperature, e.g., above the A s  temperature of the SMA alloy wire employed, the restraining sheath of the delivery catheter will prevent the SMA alloy wire member from recovering its programmed shape and carrying the tubular substrate to the programmed shape of the SMA alloy wire member. Optionally, the sterilization step  128  may also be performed after the assembly is loaded onto the delivery catheter at step  134 .  
         [0066]    While the present invention has been described with reference to its preferred embodiments and the best mode known to the inventor for making the inventive shape memory alloy supported intraluminal graft, it will be appreciated that variations in material selection for the polymer cladding, for the shape memory alloy, or process variations, such as the manner of winding the polymer clad support wire member about either a winding mandrel or a tubular member, or times and conditions of the manufacturing steps, including material selection, may be made without departing from the scope of the present invention which is intended to be limited only by the appended claims.

Technology Category: 1