Device having an electroformed pleated region and method of its manufacture

Abstract

A deflectable, flexible device includes an elongate body, a convoluted tip portion at a distal end of the elongate body, and a lumen to receive one or more wires. The convoluted tip portion includes an electroformed pleated region which is formed by electrodepositing a metal on a mandrel having a pleated region. The convoluted tip portion may be hermetically sealed to permit repeated sterilization. The electroformed pleated region may include one or more fluid emission orifices. The convoluted tip portion extends or bends in response to fluid pressure manipulation, contact with tissue, manipulation with an internal spring or wire, or by a user pushing, pulling, or twisting the catheter directly or via an introducer sheath or the like. The convoluted tip portion may further include an RF ablation element or other energy-driven technique to create continuous linear lesions or a sensing element.

1 - 20 . (canceled) 
     
     
         21 . A method of manufacturing an elastically deformable pleated section of a device, comprising:
 rendering a surface of a polymeric mandrel having a pleated region conductive, wherein adjacent pleats of the pleated region extend perpendicular to a longitudinal axis of the polymeric mandrel;   electrodepositing a metal onto the polymeric mandrel;   trimming the polymeric mandrel;   sacrificing only a portion of the polymeric mandrel, thereby forming an elastically deformable electroformed pleated section including a plurality of adjacent pleats extending perpendicular to a longitudinal axis of the pleated section, wherein the elastically deformable electroformed pleated section is formed to be longitudinally extendable, and further wherein the elastically deformable electroformed pleated region is electrically conductive; and   coupling the elastically deformable electroformed pleated section to the distal portion of an elongate body.   
     
     
         22 . The method of  claim 21 , wherein the step of electrodepositing a metal onto the polymeric mandrel comprises electrodepositing one or more of nickel, copper, or gold onto the mandrel. 
     
     
         23 . The method of  claim 21 , further comprising the step of overcoating the elastically deformable electroformed pleated region with gold or a gold alloy. 
     
     
         24 . The method of  claim 21 , further comprising the step of overcoating the elastically deformable electroformed pleated section with platinum or a platinum alloy. 
     
     
         25 . The method according to  claim 21 , further comprising coupling a proximal portion of the elongate body to a control handle. 
     
     
         26 . A method of manufacturing a catheter, comprising the steps of:
 electroforming, on a polymeric mandrel, an elastically deformable electroformed pleated region including a plurality of adjacent pleats extending perpendicular to a longitudinal axis of the pleated region, wherein the elastically deformable electroformed pleated region further comprises at least one fluid emission orifice, and further wherein the elastically deformable electroformed pleated region comprises an ablation element, and wherein at least a portion of the polymeric mandrel is retained;   coupling the elastically deformable electroformed pleated region to the distal portion of an elongate body; and   coupling the proximal portion of the elongate body to a control handle, thereby forming a catheter.   
     
     
         27 . The method of  claim 26 , wherein the step of electroforming, on a polymeric mandrel, an elastically deformable electroformed pleated region further comprises the steps of:
 providing the polymeric mandrel, wherein the polymeric mandrel comprises at least one pleated region and at least one interior lumen;   rendering the surface of the polymeric mandrel conductive; and   electrodepositing a metal onto the at least one pleated region.