Stimulation lead comprising internal flex film component and method of fabrication

Abstract

In one embodiment, a stimulation lead for applying electrical pulses to tissue of a patient, the stimulation lead comprises: a plurality of electrodes on a first end of the lead body; a plurality of terminals on a second end of the lead body; a lead body comprising a flex film component disposed within insulative material, wherein (i) the flex film component comprises a plurality of electrical traces, (ii) the plurality of electrical traces electrically couple the plurality of electrodes with the plurality of terminals, and (iii) the flex film component comprises a plurality of bends along a substantial length of the lead body; wherein the stimulation lead is adapted to elastically elongate under application of stretching forces to the lead body without disconnection of the electrical connections between the plurality of electrodes and the plurality of terminals through the electrical traces of the flex film component.

1 . A stimulation lead for applying electrical pulses to tissue of a patient, the stimulation lead comprising:
 a plurality of electrodes on a first end of the lead body;   a plurality of terminals on a second end of the lead body;   a lead body comprising a flex film component disposed within insulative material, wherein (i) the flex film component comprises a plurality of electrical traces, (ii) the plurality of electrical traces electrically couple the plurality of electrodes with the plurality of terminals, and (iii) the flex film component comprises a plurality of bends along a substantial length of the lead body;   wherein the stimulation lead is adapted to elastically elongate under application of stretching forces to the lead body without disconnection of the electrical connections between the plurality of electrodes and the plurality of terminals through the electrical traces of the flex film component.   
     
     
         2 . The stimulation lead of  claim 1  wherein the stimulation lead is capable of elongating more than 20% under a stretching force of less than 3 lbs. 
     
     
         3 . The stimulation lead of  claim 1  wherein the stimulation lead is capable of elongating more than 20% under a stretching force of less than 0.5 lbs. 
     
     
         4 . The stimulation lead of  claim 1  wherein the stimulation lead is capable of elongating more than 50% without damaging the plurality of electrical traces. 
     
     
         5 . The stimulation lead of  claim 1  wherein the flex film component comprises a plurality of conductive pads that each electrically interconnect one of the plurality of electrical traces and with a respective one of the plurality of electrodes and terminals. 
     
     
         6 . The stimulation lead of  claim 5  wherein the stimulation lead further comprises a plurality of vias, disposed underneath the plurality of electrodes and the plurality of terminals, electrically connected with the plurality of conductive pads. 
     
     
         7 . The stimulation lead of  claim 1  further comprising:
 a stylet tube within the insulative material of the lead body, the stylet tube is adapted to elastically elongate under application of stretching forces to the lead body. 
 
     
     
         8 . The stimulation of  claim 1  wherein the flex film component comprises a flat first end and flat second end in sections of the flex film component proximate to the plurality of electrodes and the plurality of terminals, respectively. 
     
     
         9 . The stimulation lead of  claim 1  wherein the flex film component comprises a plurality of layer with a first plurality of electrical traces in a first layer and second plurality of electrical traces in a second layer. 
     
     
         10 . The stimulation lead of  claim 8  wherein the second plurality of electrical traces extend past the first plurality of electrical traces at a first end and at a second end of the flex film component. 
     
     
         11 . A method of fabricating a stimulation lead for applying electrical pulses to tissues of a patient, the method comprising:
 providing a flex film component that includes a plurality of electrical traces extending from a proximal portion to a distal portion of the flex film component;   shaping the flex film component to comprise a plurality of bends along a substantial length of the lead body;   enclosing the flex film component in an elastic insulative material to form a lead body;   providing a plurality of electrodes on a first end of the lead body;   providing a plurality of terminals on a second end of the lead body, wherein the plurality of electrodes are electrically coupled to the plurality of terminals through the plurality of electrical traces of the flex film component,   wherein the stimulation lead is adapted to elastically elongate under application of stretching forces to the lead body without disconnection of the electrical connections between the plurality of electrodes and the plurality of terminals through the electrical traces of the flex film component.   
     
     
         12 . The method of  claim 11  wherein the shaping comprises:
 directing the flex film component through a plurality of gears to form a serpentine shape in the flex film component. 
 
     
     
         13 . The method of  claim 12  wherein at least one of the plurality of gears heats the flex film component. 
     
     
         14 . The method of  claim 13  wherein the flex film component is heated above its glass transition temperature. 
     
     
         15 . The method of  claim 13  further comprising:
 directly cooling the flex film component after shaping the flex film component with the at least one gear of the plurality of gears employed for heating the flex film component. 
 
     
     
         16 . The method of  claim 15  wherein the cooling comprising:
 operating one or more vents to providing cooling air over the flex film component upon exiting from the at least one gear. 
 
     
     
         17 . The method of  claim 11  wherein the flex film component comprises a plurality of conductive pads that each electrically interconnect one of the plurality of electrical traces and with a respective one of the plurality of electrodes and terminals. 
     
     
         18 . The method of  claim 17  wherein the stimulation lead further comprises a plurality of vias, disposed underneath the plurality of electrodes and the plurality of terminals, electrically connected with the plurality of conductive pads. 
     
     
         19 . The method of  claim 11  wherein the shaping leaves a flat first end and flat second end in sections of the flex film component proximate to the plurality of electrodes and the plurality of terminals, respectively. 
     
     
         20 . The method of  claim 11  wherein the second plurality of electrical traces extend past the first plurality of electrical traces at a first end and at a second end of the flex film component.