Medical devices including metallic films and methods for making same

Abstract

Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a metallic film comprising nickel, titanium, and chromium, wherein a ratio of a weight of chromium of the metallic film to a combined weight of nickel, titanium, and chromium of the metallic film is at least 0.001. The metallic film can include a shape memory alloy.

1 - 8 . (canceled) 
     
     
         9 . A method of manufacturing an endoprosthesis, comprising:
 forming a layer by depositing nickel and titanium on a substrate; and   irradiating at least some of the deposited nickel and titanium with particles having an energy of about 50 eV or more.   
     
     
         10 . The method of  claim 9 , further comprising releasing the layer from the substrate. 
     
     
         11 . The method of  claim 9 , wherein the substrate is a stent body or portion thereof. 
     
     
         12 . The method of  claim 9 , wherein irradiating comprises irradiating the deposited nickel and titanium with particles having an energy of at least 500 keV. 
     
     
         13 . The method of  claim 9 , wherein the depositing and the irradiating are combined and the particles having an energy of at least 50 eV comprise ions of nickel and titanium. 
     
     
         14 . The method of  claim 9 , wherein the layer has a density N of dislocations per cm 2 , the density N being at least 100 times larger than a density of dislocations in the absence of irradiating. 
     
     
         15 . The method of  claim 14 , wherein the density N is at least 1010 dislocations per cm 2 . 
     
     
         16 . The method of  claim 14 , wherein the layer comprises an amount of chromium, a ratio of a weight of chromium of the layer to a combined weight of nickel, titanium, and chromium of the layer is greater than or equal to 0.001 and less than or equal to 0.01. 
     
     
         17 . A method of manufacturing an endoprosthesis, comprising:
 forming a film by depositing constituents of the film on a substrate, the constituents including nickel and titanium, the film having a density N of dislocations per cm 2 ; and   increasing the density N of dislocations of at least a portion of the film by at least 100 times.   
     
     
         18 . The method of  claim 17 , wherein the deposited nickel and titanium has a surface area and increasing the density N of locations comprises increasing the density N of dislocations of at least 20% of the surface of the deposited nickel and titanium. 
     
     
         19 . The method of  claim 17 , wherein increasing the density N of dislocations is performed before releasing the film from the substrate. 
     
     
         20 . The method of  claim 17 , wherein increasing the density N comprises irradiating deposited nickel and titanium with particles having an energy of at least 50 eV. 
     
     
         21 . A method of manufacturing an endoprosthesis, comprising:
 depositing a film comprising nickel arid titanium and having a thickness of at least 2 μm; and   heating the film by using optical radiation having an intensity sufficient to modify a crystalline structure of the film without rupturing the film.   
     
     
         22 . A catheter-delivered filter medical device, comprising:
 a delivery catheter system; and   a film having one or more openings sized to allow fluid to flow selectively therethrough.   
     
     
         23 . The device of  claim 22 , where the film is a metal. 
     
     
         24 . The device of  claim 23 , where the film is a superelastic alloy. 
     
     
         25 . The device of  claim 24 , where the alloy is in a Martensitic state. 
     
     
         26 . The device of  claim 25 , where the alloy is a nickel-titanium alloy 
     
     
         27 . The device of  claim 26 , where the alloy is nitinol. 
     
     
         28 . The device of  claim 22 , where the film is a polymer. 
     
     
         29 . The device of  claim 22 , where the film is associated with a supporting structure. 
     
     
         30 . The device of  claim 29 , wherein the supporting structure is within the film. 
     
     
         31 . The device of  claim 29 , wherein the filter and supporting structure are collapsible. 
     
     
         32 . The device of  claim 29 , wherein the film is friction fit to the supporting structure. 
     
     
         33 . The device of  claim 29 , wherein the film is attached to the supporting structure. 
     
     
         34 . The device of  claim 22 , wherein the film has openings of about 25 to 500 micron. 
     
     
         35 . The device of  claim 22 , wherein the delivery catheter system includes a retractable sheath. 
     
     
         36 . The device of  claim 22 , wherein the catheter is delivered over a guidewire. 
     
     
         37 . The device of  claim 22  configured for clot removal or retrieval. 
     
     
         38 . The device of  claim 22  configured for use in the vascular system. 
     
     
         39 . A method of treatment, comprising:
 delivering the endoprosthesis of claim  1  in a body lumen; and   deploying the endoprosthesis at a desired treatment site.   
     
     
         40 . The method of  claim 39 , further comprising retracting a sheath to deploy the endoprosthesis. 
     
     
         41 . The method of  claim 39 , further comprising retrieving embolic material. 
     
     
         42 . A movable percutaneously delivered filter system comprising:
 a delivery system, including a sheath;   a filter section operatively associated with the delivery system having a proximal end and a distal end, the proximal end having at least one opening allowing fluid to flow therethrough and the distal end having a multiplicity of pores for allowing a fluid to flow therethrough and capturing particles of a predetermined size, the filter section being formed from a shape memory thin film material; and   a frame cooperatively associated with the filter section for adding radial strength.   
     
     
         43 . The removable percutaneously delivered filter system of  claim 42  wherein the frame is fully within the filter. 
     
     
         44 . A vascular filter system, comprising:
 a catheter delivery system, including a sheath; and   a collapsible filter; and   a collapsible frame adjacent the filter providing radial support thereto.   
     
     
         45 . The vascular filter system of  claim 44 , wherein the frame is fully within the filter. 
     
     
         46 . The vascular filter system of  claim 45 , wherein the filter further comprises:
 a proximal end having at least one opening therein; and   a distal end having a plurality of openings therein, wherein blood flow enters the filter through the at least one opening and exits the filter through the plurality of openings while capturing embolic materials in the distal end of the filter.   
     
     
         47 . The vascular filter system of  claim 46 , wherein a capture profile of the filter is determined according to a size of each of the plurality of openings at the distal end of the fiber. 
     
     
         48 . The vascular filter system of  claim 47 , wherein the size of each of the plurality of openings at the distal end of the filter ranges from 25 to 500 μm. 
     
     
         49 . The vascular filter system of  claim 45 , wherein the filter is further comprised of a thin film. 
     
     
         50 . The vascular filter system of  claim 49 , wherein the thin film is comprised of biocompatible Nitinol. 
     
     
         51 . The vascular filter system of  claim 49 , wherein the thin film is comprised of any of the group of biocompatible materials consisting of metals, metal alloys, polymers and composites. 
     
     
         52 . The vascular filter system of  claim 51 , wherein the filter is further comprised of a shape memory metal. 
     
     
         53 . The vascular filter system of  claim 52 , wherein the filter is further comprised of a super elastic or Martensitic shape memory metal. 
     
     
         54 . The vascular filter system of  claim 52 , wherein the frame is comprised of the shape memory metal. 
     
     
         55 . The vascular filter system of  claim 54 , wherein the filter slides over the frame. 
     
     
         56 . The vascular filter system of  claim 54 , wherein the frame and filter are connected. 
     
     
         57 . The vascular filter system of  claim 42 , wherein the filter and frame are attached to the catheter delivery system such that retracting the sheath deploys the filter and frame. 
     
     
         58 . A method of deploying a vascular filter system comprising:
 attaching a vascular filter and frame to a catheter delivery device, the catheter delivery device including a sheath;   inserting the catheter delivery device to an intended site through the vasculature of a patient;   refracting the sheath to deploy the filter and the frame; and   capturing embolic material in the filter.   
     
     
         59 . The method of  claim 58 , further comprising; radially supporting the filter opposite walls of the intended site by deployment of the frame. 
     
     
         60 . The method of  claim 59 , wherein the filter and frame are comprised of biocompatible shape memory materials.