Implantable leads with topographic features for cellular modulation and related methods

Abstract

An implantable lead including a lead body, an electrode coupled to the lead body, and at least one cellular modulation segment. The lead body has a proximal end and a distal end. The lead body includes an outer layer defining a lumen. The outer layer has an outside surface. The electrical conductor is disposed within the lumen of the outer layer. The electrode is coupled to the lead body. The electrode is in electrical communication with the electrical conductor. The at least one cellular modulation segment is on the outside surface of the outer layer. The at least one cellular modulation segment includes topographic surface features configured to modulate cellular responses. The topographic surface features include a plurality of raised nodes and a plurality of raised ridges interconnecting the plurality of nodes and forming a lattice structure.

We claim: 
     
         1 . An implantable lead comprising:
 a lead body having a proximal end and a distal end, the lead body comprising an outer layer defining a lumen, the outer layer having an outside surface;   an electrical conductor disposed within the lumen of the outer layer;   an electrode coupled to the lead body, the electrode in electrical communication with the electrical conductor; and   at least one cellular modulation segment on the outside surface of the outer layer, the at least one cellular modulation segment including topographic surface features configured to modulate cellular responses, the topographic surface features including:
 a plurality of raised nodes; and 
 a plurality of raised ridges interconnecting the plurality of nodes and forming a lattice structure. 
   
     
     
         2 . The implantable lead of  claim 1 , wherein the plurality of raised nodes and the plurality of raised ridges are raised above an underlying basement layer by between 10 nm and 1,000 nm. 
     
     
         3 . The implantable lead of  claim 1 , wherein the plurality of raised ridges connect each of the plurality of nodes to the closest nodes, the closest nodes spaced from each other by between 10 nm and 1,000 nm. 
     
     
         4 . The implantable lead of  claim 3 , wherein the plurality of raised ridges further connect each of the plurality of nodes to the second-closest nodes. 
     
     
         5 . The implantable lead of  claim 1 , wherein the topographic surface features are configured to promote tissue growth in the area of the at least one cellular modulation segment by spacing the plurality of nodes from each other by between 10 nm and 250 nm. 
     
     
         6 . The implantable lead of  claim 1 , wherein the topographic surface features are configured to enhance cell migration over the area of the at least one cellular modulation segment by spacing the plurality of nodes from each other by between 750 nm and 850 nm. 
     
     
         7 . The implantable lead of  claim 1 , wherein the plurality of ridges have a polygonal shape in cross-section. 
     
     
         8 . The implantable lead of  claim 1 , wherein the at least one cellular modulation segment is integral with the outer layer. 
     
     
         9 . The implantable lead of  claim 1 , wherein the at least one cellular modulation segment is coupled to the outside surface of the outer layer. 
     
     
         10 . The implantable lead of  claim 1 , wherein the at least one cellular modulation segment includes two cellular modulation segments, a first cellular modulation segment and a second cellular modulation segment, the topographic surface features of the first cellular modulation segment different from the topographic surface features of the second cellular modulation segment. 
     
     
         11 . An implantable lead comprising:
 a lead body having a proximal end and a distal end, the lead body comprising an outer layer defining a lumen, the outer layer having an outside surface;   an electrical conductor disposed within the lumen of the outer layer;   an electrode coupled to the lead body, the electrode in electrical communication with the electrical conductor; and   at least one cellular modulation segment on the outside surface of the outer layer, the at least one cellular modulation segment including a plurality of pores.   
     
     
         12 . The implantable lead of  claim 11 , wherein the plurality of pores has an average pore diameter of between 20 nm and 120 nm. 
     
     
         13 . The implantable lead of  claim 11 , wherein the plurality of pores are randomly distributed. 
     
     
         14 . The implantable lead of  claim 11 , wherein the plurality of pores are uniformly distributed. 
     
     
         15 . The implantable lead of  claim 11 , wherein the at least one cellular modulation segment is integral with the outer layer. 
     
     
         16 . The implantable lead of  claim 11 , wherein the at least one cellular modulation segment is coupled to the outside surface of the outer layer. 
     
     
         17 . The implantable lead of  claim 11 , wherein the at least one cellular modulation segment includes two cellular modulation segments, a first cellular modulation segment and a second cellular modulation segment, the topographic surface features of the first cellular modulation segment different from the topographic surface features of the second cellular modulation segment. 
     
     
         18 . An implantable lead comprising:
 a lead body having a proximal end and a distal end, the lead body comprising an outer layer defining a lumen, the outer layer having an outside surface;   an electrical conductor disposed within the lumen of the outer layer;   an electrode coupled to the lead body, the electrode in electrical communication with the electrical conductor;   a first cellular modulation segment on the outside surface of the outer layer, the first cellular modulation segment including topographic surface features configured to enhance cellular adhesion, the topographic surface features including:
 a plurality of raised nodes; and 
 a plurality of raised ridges interconnecting the plurality of nodes and forming a lattice structure, the plurality of raised ridges connecting each of the plurality of nodes to all adjacent nodes, the adjacent nodes spaced from each other by between 10 nm and 1,000 nm; and 
   a second cellular modulation segment on the outside surface of the outer layer, the second cellular modulation segment including topographic surface features configured to reduce cellular adhesion.   
     
     
         19 . The implantable lead of  claim 18 , wherein the plurality of raised ridges further connect each of the plurality of nodes to all second-closest nodes. 
     
     
         20 . The implantable lead of  claim 18 , wherein the first cellular modulation segment is disposed within 10 cm of the distal end of the lead body.