Methods of coating implantable leads

Abstract

An implantable cardiac lead, and/or subassembly includes an elongate sheath of insulative material including an insulative first layer and a protective second layer. The insulative first layer has at least one activated surface to which the protective second layer is coupled.

1 . A method comprising: 
 activating a surface of a first layer of material, the first layer of material forming a portion of an insulative lead body extending from a proximal end portion to a distal end portion and having an intermediate portion therebetween; and    coating a second layer of material on the activated surface of the first layer of material, including coating a layer of polyurethane along one or more portions of the first layer of material.    
     
     
         2 . The method of  claim 1 , wherein activating the surface of the first layer of material includes chemically treating the surface.  
     
     
         3 . The method of  claim 2 , wherein chemically treating the surface of the first layer of material includes using a plasma assisted vapor deposition process.  
     
     
         4 . The method of  claim 3 , wherein using the plasma assisted vapor deposition process includes treating the surface of the first layer of material with a monomer.  
     
     
         5 . The method of  claim 4 , wherein treating the surface of the first layer of material with the monomer includes treating the surface with at least one of acrylic acid, allyl amine, acrylamide, acrylonitrile, methacrylic acid, glycidyl methacrylate, N, N-dimethylacrylamide, or acetylene.  
     
     
         6 . The method of  claim 1 , further comprising cleaning the surface of the first layer of material with at least one of O 2 , Ar, N 2 , CH 3 OH, or CF 4 .  
     
     
         7 . The method of  claim 1 , wherein coating the second layer of material on the activated surface of the first layer of material includes at least one of dip coating or spray coating the second layer of material on the activated surface.  
     
     
         8 . The method of  claim 1 , wherein coating the second layer of material on the activated surface of the first layer of material includes using a melt process.  
     
     
         9 . The method of  claim 1 , wherein coating the second layer of material on the activated surface of the first layer of material includes coating an outer surface of the first layer of material along the one or more portions.  
     
     
         10 . The method of  claim 1 , wherein coating the second layer of material on the activated surface of the first layer of material includes transitioning from a layer of only silicone rubber at the lead body distal end portion to a layer of silicone rubber and polyurethane at the lead body proximal end portion or the lead body intermediate portion.  
     
     
         11 . The method of  claim 1 , wherein coating the layer of polyurethane along one or more portions of the first layer of material includes coating the lead body proximal end portion of the first layer of material.  
     
     
         12 . The method of  claim 1 , wherein coating the layer of polyurethane along one or more portions of the first layer of material includes coating the lead body intermediate portion and not the lead body distal end portion.  
     
     
         13 . A method comprising: 
 activating a surface of an insulative first layer of material, the insulative first layer of material extending form a proximal end portion to a distal end portion and having one or more recesses therein; and    coating a second layer of material on the activated surface of the insulative first layer of material forming a lead body, including disposing the second layer of material within a portion of the one or more recesses of the insulative first layer of material.    
     
     
         14 . The method of  claim 13 , wherein coating the second layer of material on the activated surface of the insulative first layer of material includes coating the activated surface with at least one of polyurethane or silicone.  
     
     
         15 . The method of  claim 13 , wherein coating the second layer of material on the activated surface of the insulative first layer of material includes coating the activated surface with an abrasion resistant material.  
     
     
         16 . The method of  claim 13 , wherein coating the second layer of material on the activated surface of the insulative first layer of material includes coating the activated surface with a protective layer of material.  
     
     
         17 . The method of  claim 13 , wherein coating the second layer of material on the activated surface of the insulative first layer of material includes coating the activated surface with a lubricious material.  
     
     
         18 . The method of  claim 13 , wherein coating the second layer of material on the activated surface of the insulative first layer of material includes coating the activated surface with a material having a greater stiffness than the insulative first layer of material.  
     
     
         19 . The method of  claim 13 , wherein disposing the second layer of material within a portion of the one or more recesses of the insulative first layer of material includes forming an isodiametric lead body.  
     
     
         20 . A method comprising: 
 activating a surface of an elongate first layer of material, the elongate first layer including at least one of silicone rubber, PTFE, or ePTFE, the elongate first layer extending from a proximal end portion to a distal end portion and having an intermediate portion therebetween; and    coating a second layer of material on the activated surface of the elongate first layer of material to form a lead body, including coating a layer of polyurethane along one or more portions of the elongate first layer.    
     
     
         21 . The method of  claim 20 , further comprising pre-forming the distal end portion of the elongate first layer of material and coupling the distal end portion to at least one of the proximal end portion or an intermediate portion of the elongate first layer of material or the second layer of material using, at least in part, the activated surface.  
     
     
         22 . The method of  claim 21 , wherein pre-forming the distal end portion of the elongate first layer of material includes forming a J-shape distal end portion.  
     
     
         23 . The method of  claim 21 , wherein pre-forming the distal end portion of the elongate first layer of material includes forming a spiral-shape distal end portion.  
     
     
         24 . The method of  claim 20 , further comprising fixing the elongate first layer of material with the second layer of material using energy.  
     
     
         25 . The method of  claim 20 , wherein coating the second layer of material on the activated surface of the elongate first layer of material includes transitioning from a combination of the first and second layer of materials to the first layer of material only.  
     
     
         26 . The method of  claim 20 , wherein activating the surface of the elongate first layer of material includes providing a non-adhesive based coupling surface.