Leads with proximal stiffening and related methods of use and manufacture

Abstract

An electrical stimulation lead includes a lead body; electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body; terminals disposed along the proximal portion of the lead body; and conductors coupling the terminals to the electrodes. The lead also includes a conductor guide disposed within the lead body and extending from the proximal portion of the lead body. The conductor guide defines a central lumen and a plurality of conductor lumens disposed around the central lumen. The lead further includes a stiffening agent disposed within at least one of the conductor lumens. The stiffening agent includes a) a material formed from a granular particulate material, b) a polymeric material having a durometer at least 10% greater than the durometer of the conductor guide, or c) a continuous epoxy layer within which discrete epoxy particles are also disposed.

What is claimed as new and desired to be protected by Letters Patent of the United States is: 
     
         1 . An electrical stimulation lead, comprising:
 a lead body having a distal portion, a proximal portion, and a longitudinal length;   a plurality of electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body;   a plurality of terminals disposed along the proximal portion of the lead body;   a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;   a conductor guide disposed within the lead body and extending from the proximal portion of the lead body along the lead body, the conductor guide defining a central lumen and a plurality of conductor lumens disposed around the central lumen, the central lumen and conductor lumens extending longitudinally along the conductor guide, the conductor lumens having a proximal end and receiving the plurality of conductors within the conductor lumens; and   a stiffening agent disposed within at least one of the conductor lumens from the proximal end to at least a portion of the conductor lumen within which at least one of the conductors is disposed, wherein the stiffening agent comprises a material formed from a granular particulate material disposed within the conductor lumen.   
     
     
         2 . The electrical stimulation lead of  claim 1 , wherein the material of the stiffening agent is formed from the granular particulate material that has been melted within the conductor lumens. 
     
     
         3 . The electrical stimulation lead of  claim 1 , wherein at least a portion of the material of the stiffening agent and a portion of the conductor guide form a composite matrix. 
     
     
         4 . The electrical stimulation lead of  claim 3 , wherein the portion of the material of the stiffening agent and the portion of the conductor guide that form the composite matrix have been mixed by melting, reflowing, or any combination thereof 
     
     
         5 . The electrical stimulation lead of  claim 1 , wherein the granular particulate material comprises a ceramic particulate material. 
     
     
         6 . The electrical stimulation lead of  claim 1 , wherein the granular particulate material comprises a polymeric particulate material. 
     
     
         7 . The electrical stimulation lead of  claim 6 , wherein the granular particulate material further comprises a ceramic particulate material. 
     
     
         8 . The electrical stimulation lead of  claim 1 , wherein the stiffening agent is also disposed in a portion of the central lumen. 
     
     
         9 . An electrical stimulation lead, comprising:
 a lead body having a distal portion, a proximal portion, and a longitudinal length;   a plurality of electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body;   a plurality of terminals disposed along the proximal portion of the lead body;   a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;   a conductor guide disposed within the lead body and extending from the proximal portion of the lead body along the lead body, the conductor guide comprising a polymeric material and defining a central lumen and a plurality of conductor lumens disposed around the central lumen, the central lumen and conductor lumens extending longitudinally along the conductor guide, the conductor lumens having a proximal end and receiving the plurality of conductors within the conductor lumens; and   a stiffening agent disposed within at least one of the conductor lumens from the proximal end to at least a portion of the conductor lumen within which at least one of the conductors is disposed, wherein the stiffening agent is a polymeric material having a durometer at least 10% greater than a durometer of the polymeric material of the conductor guide.   
     
     
         10 . The electrical stimulation lead of  claim 9 , wherein the stiffening agent comprises monofilament. 
     
     
         11 . The electrical stimulation lead of  claim 9 , wherein the polymeric material of the stiffening agent has been melted or reflowed within the conductor lumen. 
     
     
         12 . The electrical stimulation lead of  claim 9 , wherein the stiffening agent is also disposed in a portion of the central lumen. 
     
     
         13 . The electrical stimulation lead of  claim 9 , wherein the durometer of the polymeric material of the stiffening agent is at least 25% greater than the durometer of the polymeric material of the conductor guide. 
     
     
         14 . An electrical stimulation lead, comprising:
 a lead body having a distal portion, a proximal portion, and a longitudinal length;   a plurality of electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body;   a plurality of terminals disposed along the proximal portion of the lead body;   a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;   a conductor guide disposed within the lead body and extending from the proximal portion of the lead body along the lead body, the conductor guide defining a central lumen and a plurality of conductor lumens disposed around the central lumen, the central lumen and conductor lumens extending longitudinally along the conductor guide, the conductor lumens having a proximal end and receiving the plurality of conductors within the conductor lumens; and   a stiffening agent disposed within at least one of the conductor lumens from the proximal end to at least a portion of the conductor lumen within which at least one of the conductors is disposed, wherein the stiffening agent comprises discrete epoxy particles and a continuous epoxy layer within which the epoxy particles are disposed.   
     
     
         15 . The electrical stimulation lead of  claim 14 , wherein the stiffening agent is formed by flowing a flowable epoxy material around the epoxy particles and then curing the flowable epoxy material to generate the continuous epoxy layer. 
     
     
         16 . The electrical stimulation lead of  claim 14 , wherein the stiffening agent is also disposed in a portion of the central lumen. 
     
     
         17 . A method of making the electrical stimulation lead of  claim 14 , the method comprising:
 disposing a plurality of conductor wires into a plurality of conductor lumens defined within a conductor guide, the conductor lumens extending longitudinally from a proximal end of the conductor guide, wherein at least one of the conductor lumens defines an open portion that extends distally from the proximal end of the conductor guide and does not contain any portion of the conductor wires;   disposing a plurality of terminals along the proximal portion of the conductor guide in a spaced-apart longitudinal arrangement;   electrically coupling each of the plurality of terminals to at least one of the conductors;   flowing epoxy material into the open portion of at least one of the conductor lumens;   curing the epoxy material;   breaking the cured epoxy material into discrete epoxy particles;   flowing additional epoxy material into the open portion of at least one of the conductor lumens and around the epoxy particles; and   curing the additional epoxy material to form a continuous epoxy layer having the epoxy particles disposed therein.   
     
     
         18 . The method of  claim 17 , wherein the conductor guide further defines a central lumen extending longitudinally from the proximal end of the conductor guide with the conductor lumens disposed circumferentially around the central lumen,
 wherein the method further comprises   flowing epoxy material into a proximal portion of the central lumen, and   curing the epoxy material in the proximal portion of the central lumen.   
     
     
         19 . The method of  claim 18 , further comprising
 breaking the cured epoxy material in the central lumen into discrete epoxy particles;   flowing additional epoxy material into the proximal portion of the central lumen and around the epoxy particles; and   curing the additional epoxy material to form a continuous epoxy layer having the epoxy particles disposed therein.   
     
     
         20 . The method of  claim 17 , wherein breaking the cured epoxy material comprises rolling the conductor guide over a tool having a desired radius to break the cured epoxy material disposed within the conductor lumens of the conductor guide.