Shaped reinforcing member for medical device and method for making the same

Abstract

Medical devices, medical device components, and methods of making the same. For example, one embodiment provides a method of shaping a reinforcing member through annealing. Another exemplary embodiment includes a method of making a medical device that includes such a shaped reinforcement member incorporated therein. Yet another exemplary embodiment provides a medical device including such a shaped reinforcing member therein.

What is claimed is:  
     
         1 . A method of shaping a reinforcing member adapted and configured for use in a medical device, the method comprising: 
 providing a reinforcing member;    applying a biasing force to the reinforcing member to bias the reinforcing member into a desired shape;    annealing the reinforcing member while it is biased in the desired shape; and    removing the biasing force from the reinforcing member.    
     
     
         2 . The method of  claim 1 , wherein the medical device is a catheter.  
     
     
         3 . The method of  claim 2 , wherein the catheter is an intravascular catheter.  
     
     
         4 . The method of  claim 1 , wherein the reinforcing member comprises a reinforcing braid.  
     
     
         5 . The method of  claim 4 , wherein the reinforcing braid comprises elongated metallic filaments, elongated polymeric filaments, or both elongated metallic filaments and elongated polymeric filaments.  
     
     
         6 . The method of  claim 1 , wherein the reinforcing member comprises a metallic material.  
     
     
         7 . The method of  claim 6 , wherein the annealing is performed at an annealing temperature in the range of about 500° F. to about 1000° F.  
     
     
         8 . The method of  claim 6 , wherein the annealing is performed over a time period in the range of about 0.25 to about 5 hours.  
     
     
         9 . The method of  claim 6 , wherein the reinforcing member comprises stainless steel, tungsten, nickel, titanium, gold, iridium, or an alloy or a combination thereof.  
     
     
         10 . The method of  claim 6 , wherein the metallic reinforcing member comprises stainless steel.  
     
     
         11 . The method of  claim 1 , wherein the reinforcing member comprises a polymer.  
     
     
         12 . The method of  claim 11 , wherein the annealing is performed at an annealing temperature in the range of about 280° F. to about 420° F.  
     
     
         13 . The method of  claim 11 , wherein the annealing is performed over a time period in the range of about 0.1 to about 2 hours.  
     
     
         14 . The method of  claim 11 , wherein the reinforcing member comprises a polymer selected from polyester, polyamide, acrylics or combinations or mixtures thereof.  
     
     
         15 . The method of  claim 11 , wherein the reinforcing member comprises polyamide.  
     
     
         16 . The method of  claim 1 , wherein the biasing force is applied by loading the reinforcing member onto a mandrel.  
     
     
         17 . The method of  claim 1 , wherein the biasing force is applied by loading the reinforcing member into a jig.  
     
     
         18 . The method of  claim 1 , wherein the metallic reinforcing member substantially maintains the desired shape when the biasing force is removed.  
     
     
         19 . The method of  claim 1 , wherein the reinforcing member includes a proximal portion, a distal portion, and the desired shape of the reinforcing member includes one or more curves in the distal portion of the reinforcing member.  
     
     
         20 . A method of making a catheter having a shaped reinforcement member, the method comprising: 
 providing the reinforcing member;    applying a biasing force to bias the reinforcing member into a desired shape;    annealing the reinforcing member;    removing the biasing force; and    incorporating the reinforcing member into the construction of the catheter.    
     
     
         21 . The method of  claim 20 , wherein the reinforcing member comprises a reinforcing braid comprising elongated metallic filaments, elongated polymeric filaments, or a combination thereof.  
     
     
         22 . The method of  claim 20 , wherein the reinforcing member comprises a metallic material comprising stainless steel, tungsten, nickel, titanium, gold, iridium, or an alloy or combinations thereof.  
     
     
         23 . The method of  claim 22 , wherein the metallic reinforcing member comprises stainless steel.  
     
     
         24 . The method of  claim 20 , wherein the reinforcing member comprises a polymer comprising polyamide, polyester, acrylics or combinations or mixtures thereof.  
     
     
         25 . The method of  claim 20 , wherein the reinforcing member substantially maintains the desired shape when the biasing force is removed.  
     
     
         26 . The method of  claim 20 , wherein the reinforcing member includes a proximal portion, a distal portion, and the desired shape of the reinforcing member includes one or more curves in the distal portion of the reinforcing member.  
     
     
         27 . The method of  claim 20 , wherein the catheter includes an elongated tubular body having a proximal portion, a distal portion, and a lumen extending therebetween, and the the tubular body of the catheter substantially conforms to the shape of the reinforcing member.  
     
     
         28 . A catheter comprising an elongated tubular body having a proximal portion, a distal portion, and a lumen extending therebetween, the tubular body comprising: 
 a polymer material; and    a reinforcing member annealed into a desired shape including at least one curve therein.    
     
     
         29 . A catheter comprising an elongated tubular body having a proximal portion, a distal portion, and a lumen extending therebetween, the catheter formed by the following process: 
 providing the reinforcing member;    applying a biasing force to bias the reinforcing member into a desired shape;    annealing the reinforcing member;    removing the biasing force; and    incorporating the reinforcing member with the catheter.    
     
     
         30 . A catheter comprising an elongated tubular member having a proximal portion, a distal portion, and a lumen extending therein, the catheter formed by the following process: 
 providing a reinforcing member;    applying a biasing force to bias the reinforcing member into the desired shape;    annealing the reinforcing member;    removing the biasing force;    disposing the reinforcing member over a portion of an inner catheter member; and    disposing an outer catheter member over a portion of the reinforcing member.