Compliant electrical stimulation leads and methods of fabrication

Abstract

In one embodiment, a neurostimulation lead for stimulating neural tissue of a patient, comprises: a lead body of insulative material; a plurality of electrodes; a plurality of terminals; a plurality of conductors, wherein the plurality of electrodes are electrically coupled to the plurality of terminals through the plurality of conductors; wherein the plurality of conductors are disposed in a helical manner in a repeating pattern of groups of conductors separated by gaps along a substantial length of the lead body, each gap being larger than an inter-conductor pitch within the groups of conductors; wherein the insulative material is a compliant material permitting elongation of the lead at low stretching forces and the insulative material of the lead body is fused through a substantial volume of the lead body and along a substantial length of the lead body.

1 . A neurostimulation lead for stimulating neural tissue of a patient, comprising: 
 a lead body of insulative material;    a plurality of electrodes;    a plurality of terminals;    a plurality of conductors, wherein the plurality of electrodes are electrically coupled to the plurality of terminals through the plurality of conductors;    wherein the plurality of conductors are disposed in a helical manner in a repeating pattern of groups of conductors separated by gaps along a substantial length of the lead body, each gap being larger than an inter-conductor pitch within the groups of conductors, wherein the gaps between adjacent groups are defined by one or more elastic filars that are fused with the insulative material of the lead body;    wherein the insulative material is a compliant material permitting elongation of the lead at low stretching forces and the insulative material of the lead body is fused through a substantial volume of the lead body and along a substantial length of the lead body.    
     
     
         2 . The neurostimulation lead of  claim 1  wherein the gaps are greater than two times the inter-conductor pitch within the groups of conductors.  
     
     
         3 . The neurostimulation lead of  claim 1  wherein the gaps are formed where the plurality of conductors are disposed in a partial longitudinal orientation relative to the lead body.  
     
     
         4 . (canceled)  
     
     
         5 . The neurostimulation lead of  claim 1  wherein the plurality of conductors are stranded wire conductors.  
     
     
         6 . The neurostimulation lead of  claim 1  wherein the insulative material of the lead body is substantially composed of a silicone urethane copolymer material.  
     
     
         7 . The neurostimulation lead of  claim 1  wherein the plurality of conductors are coated with a thin layer of perfluoroalkoxy polymer (PFA) material.  
     
     
         8 . The neurostimulation lead of  claim 1  wherein the lead stretches at least 25% when a stretching force of less than 3 lbs is applied to the lead.  
     
     
         9 . The neurostimulation lead of  claim 8  wherein the lead stretches at least 25% when a stretching force of less than 1 lb is applied to the lead.  
     
     
         10 . A method of fabricating a neurostimulation lead, comprising: 
 forming a lead body of insulative material, the insulative material being fused through a substantial volume of the lead body and along a substantial length of the lead body, wherein (i) a plurality of conductors are embedded within the insulative material, (ii) the plurality of conductors are disposed in a helical manner in a repeating pattern of groups of conductors separated by gaps along a substantial length of the lead body, each gap being larger than an inter-conductor pitch within the groups of conductors; and (iii) wherein the insulative material is a compliant material permitting elongation of the lead body at low stretching forces, winding the plurality of conductors and one or more elastic filars around an inner insulative layer or a mandrel, wherein the one or more elastic filars define the gaps between the groups along a substantial length of the lead body;    creating a plurality of electrodes on a distal end of the lead body;    creating a plurality of terminals on a proximal end of the lead body, wherein the plurality of electrodes are electrically coupled to the plurality of terminals through the plurality of conductors.    
     
     
         11 . The method of  claim 10  wherein the forming comprises: 
 subjecting the lead body to heat and pressure to fuse the compliant insulative material coating the plurality of conductors with other insulative material of the lead body.    
     
     
         12 . The method of  claim 10  wherein the forming comprises: 
 winding the plurality of conductors around an inner insulative layer or a mandrel by repetitively varying an angle to which the plurality of conductors are disposed relative to the inner insulative layer or mandrel to form the groups and the gaps between the groups along a substantial length of the lead body.    
     
     
         13 . (canceled)  
     
     
         14 . The method of  claim 10  wherein the forming comprises: 
 fusing the one or more elastic filars to other insulative material of the lead body.    
     
     
         15 . The method of  claim 10  wherein the gaps are greater than two times the inter-conductor pitch within the groups of conductors.  
     
     
         16 . The method of  claim 10  wherein the plurality of conductors are stranded wire conductors.  
     
     
         17 . The method of  claim 10  wherein the insulative material of the lead body is substantially composed of a silicone urethane copolymer material.  
     
     
         18 . The method of  claim 10  wherein the plurality of conductors are coated with a thin layer of perfluoroalkoxy polymer (PFA) material.  
     
     
         19 . The method of  claim 10  wherein the lead body stretches at least 25% when a stretching force of less than 3 lbs is applied to the lead.  
     
     
         20 . The method of  claim 10  wherein the lead body stretches at least 25% when a stretching force of less than 1 lb is applied to the lead.