Paddle leads for neurostimulation and method of delivering the same

Abstract

Paddle lead including a lead body having a distal end, a proximal end, and a central axis extending therebetween. The lead body includes opposite first and second sides that extend between the distal and proximal ends. The paddle lead also includes electrodes disposed along the first side of the lead body that are configured to apply neurostimulation therapy within an epidural space of a patient. The electrodes are electrically coupled to conductive pathways that extend through the proximal end of the lead body. The lead body includes a flexible material a flexible material that is configured to flex when a fluid pressure is imposed on the lead body in the epidural space. The lead body is configured to have a non-planar contour that folds or curves about the central axis when experiencing the fluid pressure.

What is claimed is: 
     
         1 . A neurostimulating paddle lead comprising:
 a lead body having a distal end, a proximal end, and a central axis extending therebetween, the lead body including opposite first and second sides that extend between the distal and proximal ends;   electrodes disposed along the first side of the lead body and configured to apply a neurostimulation therapy within an epidural space of a patient, the electrodes being electrically coupled to conductive pathways that extend through the proximal end of the lead body;   wherein the lead body comprises a flexible material that is configured to flex when a fluid pressure in the epidural space is imposed on the lead body, the lead body configured to have a non-planar contour that folds or curves about the central axis when experiencing the fluid pressure.   
     
     
         2 . The paddle lead of  claim 1 , wherein the lead body has longitudinal edges that join the first and second sides, the longitudinal edges extending generally along the central axis, wherein the longitudinal edges partially close around a dura membrane when the fluid pressure is imposed. 
     
     
         3 . The paddle lead of  claim 2 , wherein the lead body is configured to flex such that the longitudinal edges move closer to each other within the epidural space. 
     
     
         4 . The paddle lead of  claim 1 , wherein the central axis extends along a geometric center of a cross-section of the lead body that is transverse to the central axis, wherein the lead body is configured such that the longitudinal edges and the central axis may not exist within a common plane when the lead body is in the epidural space and the fluid pressure is imposed. 
     
     
         5 . The paddle lead of  claim 1 , wherein the lead body is configured to flex within the epidural space when the fluid pressure is at least 15 cmH 2 0. 
     
     
         6 . The paddle lead of  claim 1 , wherein the lead body is configured to flex within the epidural space when the fluid pressure is at least 5 cmH 2 0. 
     
     
         7 . The paddle lead of  claim 1 , further comprising a tool receptacle coupled to the lead body along the second side, the tool receptacle having a receptacle cavity that is accessed through the second side or the proximal end. 
     
     
         8 . A lead-delivery assembly comprising:
 a paddle lead having a distal end, a proximal end, and a central axis extending therebetween, the paddle lead having opposite first and second sides that extend between the distal and proximal ends, the paddle lead including electrodes that are disposed along the first side of the paddle lead and are configured to apply a neurostimulation therapy within an epidural space of a patient;   a tool receptacle coupled to the paddle lead along the second side, the tool receptacle having a receptacle cavity that is accessed through the second side or the proximal end; and   a delivery tool having a leading end, the leading end being sized and shaped for insertion into the receptacle cavity to direct the paddle lead to a designated location in the epidural space.   
     
     
         9 . The lead-delivery assembly of  claim 8 , wherein the tool receptacle is integrally formed with the paddle lead. 
     
     
         10 . The lead-delivery assembly of  claim 8 , wherein the receptacle cavity is a lumina having an opening along the second side, the lumina extending from the opening toward the distal end. 
     
     
         11 . The lead-delivery assembly of  claim 8 , wherein the tool receptacle includes a pocket having the receptacle cavity, the receptacle cavity of the pocket having a width that is greater than half of a width of the lead body, the delivery tool having an edge at the leading end with a greatest dimension that extends along the width of the cavity when the delivery tool is disposed therein. 
     
     
         12 . A method of locating a paddle lead in an epidural space of a patient, the method comprising:
 inserting a delivery tool into a tool receptacle of a paddle lead, the paddle lead having opposite first and second sides that extend between distal and proximal ends of the paddle lead, the paddle lead including electrodes that are disposed along the first side and the tool receptacle along the second side;   directing the paddle lead into an epidural space of a patient; and   removing the delivery tool from the tool receptacle.   
     
     
         13 . The method of  claim 12 , wherein the tool receptacle is integrally formed with the paddle lead. 
     
     
         14 . The method of  claim 12 , wherein the tool receptacle has a lumina with an opening along the second side or the proximal end, the lumina extending from the opening toward the distal end. 
     
     
         15 . The method of  claim 12 , wherein the tool receptacle includes a pocket having a receptacle cavity, the receptacle cavity of the pocket having a width that is greater than half of a width of the lead body, the delivery tool having an edge at the leading end with a greatest dimension that extends along the width of the receptacle cavity when the delivery tool is disposed therein. 
     
     
         16 . A neurostimulating paddle lead comprising:
 a lead body having a distal end, a proximal end, and a central axis extending therebetween, the lead body including opposite first and second sides that extend between the distal and proximal ends;   electrodes disposed along the first side of the lead body and configured to apply a neurostimulation therapy within an epidural space of a patient, the electrodes being electrically coupled to conductive pathways that extend through the proximal end of the lead body;   wherein the lead body comprises a flexible material that is configured to flex when a fluid pressure in the epidural space is imposed on the lead body, the lead body configured to have a non-planar contour that folds or curves about the central axis when experiencing the fluid pressure; and   wherein at least some of the electrodes are arranged along the first side based at least on data obtained regarding an anatomical configuration of a target location for the paddle lead.   
     
     
         17 . The neurostimulating paddle lead of  claim 16 , wherein material that surrounds the electrodes conductors in the lead body consists essentially of at least one of polyimide, polyetheretherketone (PEEK), polyethylene terephthalate (PET) film, polytetrafluoroethylene (PTFE), parylene, polyether bloc amides, or polyurethane. 
     
     
         18 . The neurostimulating paddle lead of  claim 17 , wherein at least some of the electrodes are arranged in an irregular pattern along the first side.