Personalized prosthesis and methods of use

Abstract

A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration engages the personalized prosthesis with the treatment site. The mesh or membrane is personalized to match the treatment site in the expanded configuration, and has an outer surface that substantially matches the treatment site shape and size. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.

What is claimed is: 
     
         1 . A method for manufacturing a personalized implantable prosthesis in a manufacturing facility, said method comprising:
 providing one or more images of a treatment site in a patient;   creating a digital data set characterizing shape and volume of the treatment site based on the one or more images;   transforming the digital data set into machining instructions;   forming a mandrel using the machining instructions, wherein the mandrel has a shape that substantially matches the treatment site shape;   applying a mesh to the mandrel;   heat treating the mesh while the mesh is disposed over the mandrel so that the mesh is biased to return to a shape matching the shape of the treatment site thereby forming the personalized implantable prosthesis, the personalized implantable prosthesis having a contracted configuration and an expanded configuration,   wherein the personalized implantable prosthesis is adapted to be delivered to the treatment site in the contracted configuration, and   wherein the personalized implantable prosthesis is biased to return to the expanded configuration, the expanded configuration having a shape substantially matching the treatment site shape.   
     
     
         2 . The method of  claim 1 , wherein providing the one or more images comprises providing one or more computerized tomography (CT) images, one or more magnetic resonance images (MRI), one or more x-ray images, one or more ultrasound images, or one or more an angiography images of the treatment site. 
     
     
         3 . The method of  claim 1 , wherein transforming the digital data set into machining instructions comprises transferring the digital data set into a CAD/CAM system. 
     
     
         4 . The method of  claim 1 , wherein forming the mandrel comprises machining a piece of metal. 
     
     
         5 . The method of  claim 1 , wherein forming the mandrel comprises forming the mandrel so as to be undersized relative to the treatment site, the undersized mandrel accommodating for thickness of the mesh. 
     
     
         6 . The method of  claim 1 , wherein applying the mesh to the mandrel comprises slidably disposing a mesh over the mandrel. 
     
     
         7 . The method of  claim 1 , wherein applying the mesh to the mandrel comprises wrapping a filament around the mandrel. 
     
     
         8 . The method of  claim 1 , wherein applying the mesh to the mandrel comprises wrapping a preformed flat mesh therearound. 
     
     
         9 . The method of  claim 1 , wherein heat treating the mesh comprises heat treating a nitinol mesh. 
     
     
         10 . The method of  claim 1 , further comprising removing the mandrel from the mesh and recovering the mesh. 
     
     
         11 . The method of  claim 1 , further comprising forming at least one side aperture in the personalized implantable prosthesis, the at least one side aperture configured to be aligned with a side branch vessel in the treatment site. 
     
     
         12 . The method of  claim 1 , further comprising forming a membrane over the mesh thereby forming a cover over the personalized implantable prosthesis. 
     
     
         13 . The method of  claim 12 , wherein forming the membrane comprises attaching a polymer cover to the mesh. 
     
     
         14 . The method of  claim 12 , wherein forming the membrane comprises dip coating a polymer cover over the mesh. 
     
     
         15 . The method of  claim 1 , further comprising:
 mounting the implantable prosthesis on a delivery catheter;   cleaning the prosthesis and delivery catheter;   packaging the implantable prosthesis; and   terminally sterilizing the implantable prosthesis.   
     
     
         16 . The method of  claim 1 , further comprising requesting verification that the shape of the personalized implantable prosthesis is appropriate for implantation at the treatment site before shipping the personalized implantable prosthesis from the manufacturing facility. 
     
     
         17 . The method of  claim 16 , wherein the verification is performed by a physician. 
     
     
         18 . The method of  claim 16 , wherein the verification is performed over the Internet. 
     
     
         19 . The method of  claim 1 , further comprising shipping the personalized implantable prosthesis to a hospital. 
     
     
         20 . The method of  claim 1 , further comprising:
 mounting the personalized implantable prosthesis on a delivery catheter;   placing the personalized implantable prosthesis and the delivery catheter in packaging;   sterilizing the personalized implantable prosthesis and the delivery catheter in the packaging; and   requesting verification that the personalized implantable prosthesis is appropriate for implantation at the treatment site before opening the sterile packaging.   
     
     
         21 . The method of  claim 20 , wherein the verification is performed by a physician. 
     
     
         22 . The method of  claim 20 , wherein the verification is performed over the Internet. 
     
     
         23 . The method of  claim 1 , further comprising removing the implantable prosthesis from the mandrel so that a central lumen extends through the implantable prosthesis. 
     
     
         24 . The method of  claim 1 , wherein the treatment site is an aneurysm. 
     
     
         25 . A personalized prosthesis for implantation at a treatment site, said prosthesis comprising:
 a self-expanding mesh having a collapsed configuration and an expanded configuration, the collapsed configuration adapted to be delivered to the treatment site, and the expanded configuration adapted to expand the personalized prosthesis into engagement with the treatment site, wherein the mesh in the expanded configuration is personalized to match the treatment site, wherein the mesh has an outer surface that substantially matches the treatment site shape and size in the expanded configuration, and wherein the self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough.   
     
     
         26 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises a nitinol mesh. 
     
     
         27 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises one or more filaments in a helical pattern. 
     
     
         28 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises one or more filaments woven together to form overlapping regions with the one or more filaments overlapping one another at least once. 
     
     
         29 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises one or more filaments woven together to form a first overlapping region and a second overlapping region, wherein in the first overlapping region the filaments overlap with one another a first number of times, and wherein in the second overlapping region the filaments overlap with one another a second number of times different than the first number of times. 
     
     
         30 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises barbs or hooks adapted to engage tissue at the treatment site and anchor the personalized prosthesis. 
     
     
         31 . The personalized prosthesis of  claim 25 , wherein the self-expanding mesh comprises a plurality of overlapping filaments forming overlapping regions, and wherein the overlapping regions form raised surfaces adapted to engage tissue at the treatment site and anchor the prosthesis. 
     
     
         32 . The personalized prosthesis of  claim 25 , further comprising a membrane disposed over the mesh, wherein the membrane is elastic and conforms to the self-expanding mesh, and wherein the membrane has an outer surface that substantially matches the treatment site shape in the expanded configuration, and wherein the membrane forms the central lumen. 
     
     
         33 . The personalized prosthesis of  claim 32 , wherein the membrane comprises a resilient polymer. 
     
     
         34 . The personalized prosthesis of  claim 32 , wherein the polymer is impermeable to blood. 
     
     
         35 . The personalized prosthesis of  claim 32 , wherein the membrane comprises an elongated neck portion, and wherein invagination of the elongated neck into the personalized prosthesis forms the central lumen. 
     
     
         36 . The personalized prosthesis of  claim 25 , further comprising one or more radiopaque markers coupled to the membrane or the self-expanding mesh for facilitating implantation of the prosthesis at the treatment site. 
     
     
         37 . The personalized prosthesis of  claim 25 , further comprising one or more apertures extending through a sidewall of the prosthesis, the one or more apertures fluidly coupled with the central lumen to allow bloodflow or other fluids to flow between the central lumen and the one or more apertures, the one or more apertures configured to accommodate side branch vessels or other body passages such that the prosthesis does not obstruct blood flow or fluid flow therethrough. 
     
     
         38 . The personalized prosthesis of  claim 25 , wherein the treatment site has a shape, and wherein the lumen has a shape substantially matching the shape of the treatment site. 
     
     
         39 . The personalized prosthesis of  claim 25 , wherein the lumen does not substantially alter blood flow path across the treatment site. 
     
     
         40 . The personalized prosthesis of  claim 25 , wherein the lumen has a cylindrical shape. 
     
     
         41 . The personalized prosthesis of  claim 40 , wherein the cylindrically shaped lumen is formed from an invaginated portion of the personalized prosthesis. 
     
     
         42 . A personalized prosthesis for implantation at a treatment site of a patient, said prosthesis comprising:
 a self-expanding membrane having a collapsed configuration and an expanded configuration, the collapsed configuration adapted to be delivered to the treatment site, and the expanded configuration adapted to expand the personalized prosthesis into engagement with the treatment site,   wherein the membrane in the expanded configuration is personalized to match the treatment site, and   wherein the membrane has an outer surface that substantially matches the treatment site shape and size in the expanded configuration, and   wherein the membrane forms a central lumen configured to allow blood or other body fluids to pass therethrough.   
     
     
         43 . A method for treating damaged or diseased tissue at a treatment site, said method comprising:
 providing an implantable prosthesis having a central lumen, an expanded configuration and a collapsed configuration, and wherein the implantable prosthesis is biased to expand into the expanded configuration, and wherein the implantable prosthesis is personalized to match shape of the treatment site, and wherein the central lumen is configured to allow blood flow or other body fluids to pass therethrough;   advancing the implantable prosthesis in the collapsed configuration to the treatment site;   self-expanding the implantable prosthesis into the expanded configuration, wherein in the expanded configuration the implantable prosthesis has a shape that substantially matches the shape of the treatment site such that the implantable prosthesis expands substantially into engagement with tissue at the treatment site; and   reinforcing the tissue with the implantable prosthesis.   
     
     
         44 . The method of  claim 43 , wherein the implantable prosthesis comprises a self-expanding wire mesh surrounded by a polymer cover. 
     
     
         45 . The method of  claim 43 , wherein the implantable prosthesis comprises a self-expanding wire mesh. 
     
     
         46 . The method of  claim 43 , wherein the implantable prosthesis comprises a resilient polymer. 
     
     
         47 . The method of  claim 43 , wherein the treatment site has a shape, and wherein the lumen has a shape substantially matching the shape of the treatment site. 
     
     
         48 . The method of  claim 43 , wherein the lumen has a cylindrical shape. 
     
     
         49 . The method of  claim 48 , wherein the lumen is formed from an invaginated portion of the implantable prosthesis. 
     
     
         50 . The method of  claim 48 , wherein the cylindrically shaped lumen is disposed inside the implantable prosthesis. 
     
     
         51 . The method of  claim 43 , wherein the lumen does not substantially alter blood flow path across the treatment site. 
     
     
         52 . The method of  claim 43 , wherein advancing the implantable prosthesis comprises advancing the implantable prosthesis through a blood vessel. 
     
     
         53 . The method of  claim 43  wherein radially expanding the implantable prosthesis comprises retracting a sheath away from the implantable prosthesis, thereby allowing the implantable prosthesis to self-expand into the expanded configuration. 
     
     
         54 . The method of  claim 43 , wherein reinforcing the tissue comprises anchoring the implantable prosthesis to the tissue. 
     
     
         55 . The method of  claim 43 , wherein the treatment site comprises an aneurysm, and reinforcing the tissue comprises preventing the aneurysm from enlarging. 
     
     
         56 . The method of  claim 43 , wherein the treatment site comprises an aneurysm and reinforcing the tissue comprises excluding the aneurysm. 
     
     
         57 . The method of  claim 43 , wherein reinforcing the tissue comprises anchoring the implantable prosthesis with the tissue. 
     
     
         58 . The method of  claim 57 , wherein anchoring the implantable prosthesis comprises engaging barbs on the implantable prosthesis with the tissue. 
     
     
         59 . The method of  claim 43 , wherein reinforcing comprises constraining the tissue from moving radially outward or radially inward. 
     
     
         60 . The method of  claim 43 , wherein the implantable prosthesis comprises one or more radiopaque markers, the method further comprising aligning the one or more radiopaque markers with one or more anatomical features at the treatment site. 
     
     
         61 . The method of  claim 43 , wherein the implantable prosthesis comprises one or more apertures in a sidewall thereof, the method further comprising aligning the one or more apertures with one or more ostia of sidebranch vessels or body passages at the treatment site, thereby preventing obstruction of the one or more sidebranch vessels or the body passages. 
     
     
         62 . The method of  claim 43 , further comprising sealing the implantable prosthesis against the tissue at the treatment site to prevent bloodflow therepast.