Implantable Lead Affixation Structure for Nerve Stimulation to Alleviate Bladder Dysfunction and Other Indications

Abstract

Anchoring devices for affixing an implanted lead at a target location in a patient are provided herein. Such anchoring devices include a helical body having a plurality of tines extending laterally outward from the lead when deployed that engage tissue to inhibit axial movement of the implanted lead. The plurality of tines are biased towards the laterally extended deployed configuration and fold inward towards the lead to a delivery configuration to facilitate delivery of the lead through a sheath. The tines may be angled in a proximal direction or in both proximal and distal directions and may include various features to assist in visualization and delivery of the lead.

What is claimed is: 
     
         1 . An anchor for anchoring an implanted neurostimulation lead at a tissue location in a body of a patient, the anchor comprising:
 a helical body extending helically along a longitudinal axis thereof; and   a plurality of tines extending from the helical body, wherein each of the plurality of tines is biased toward a deployed configuration and resiliently deflectable for a delivery configuration,   wherein in the deployed configuration, the plurality of tines extend laterally away from the longitudinal axis of the helical body, and in the delivery configuration, the plurality of tines are folded inward toward the longitudinal axis of the helical body to facilitate delivery of a lead during implantation, and   wherein the anchor includes a proximal and a distal retention feature that are shaped to correspond to proximal and distal ends of a reduced diameter anchoring portion of the lead so as to facilitate retention of the anchor within the reduced diameter anchoring portion.   
     
     
         2 . The anchor of  claim 1 , wherein the proximal and distal retention features each comprise a cuff that extends, at least partly, circumferentially about the lead when the anchor is disposed thereon. 
     
     
         3 . The anchor of  claim 1 , wherein the proximal and distal retention features comprise a proximal facing edge and a distal facing edge, respectively, that extends along a plane perpendicular to the longitudinal axis of helical body. 
     
     
         4 . The anchor of  claim 3 , wherein the anchor is dimensioned so that the proximal and distal facing edges abut against the proximal and distal ends, respectively, of the reduced diameter anchoring portion of the lead when received therein. 
     
     
         5 . The anchor of  claim 1 , wherein the proximal and distal retention features are each shaped in a zig-zag, curve, or angled along a proximal and distal facing edge thereof so as to interlock with the corresponding shape of the proximal and distal ends of the reduced diameter anchoring portion of the lead. 
     
     
         6 . The anchor of  claim 1 , wherein the proximal and distal retention features are designed to abut against the corresponding proximal and distal ends of the reduced diameter anchoring portion of the lead in which the anchor is received so as to affix the anchor to the lead and prevent axial movement of the anchor along the lead. 
     
     
         7 . The anchor of  claim 1 , wherein the anchor is formed of a polyurethane. 
     
     
         8 . The anchor of  claim 7 , wherein the polyurethane has a shore hardness within a range between 50A and 80D. 
     
     
         9 . The anchor of  claim 1 , wherein the anchor is formed of a metal. 
     
     
         10 . The anchor of  claim 1 , wherein the body is formed from a single integral tube 
     
     
         11 . The anchor of  claim 1 , wherein the body comprises multiple sections adjacent each other. 
     
     
         12 . The anchor of  claim 11 , wherein adjacent sections of the multiple sections are attached to each other by any of: an adhesive, a mechanical coupling, a chemical coupling, and an oxidation coupling. 
     
     
         13 . An anchor for anchoring an implanted neurostimulation lead at a tissue location in a body of a patient, the anchor comprising:
 an anchor body extending along a longitudinal axis thereof; and   a plurality of tines extending from the anchor body and distributed both circumferentially and axially along the anchor body in a helical fashion, wherein each of the plurality of tines is biased toward a deployed configuration and resiliently deflectable for a delivery configuration,   wherein in the deployed configuration, the plurality of tines extend laterally away from the longitudinal axis of the anchor body, and in the delivery configuration, the plurality of tines are folded inward toward the longitudinal axis of the anchor body to facilitate delivery of a lead during implantation, and   wherein the anchor includes a proximal and a distal retention feature that are shaped to correspond to proximal and distal ends of a reduced diameter anchoring portion of the lead so as to facilitate retention of the anchor within the reduced diameter anchoring portion.   
     
     
         14 . The anchor of  claim 13 , wherein the proximal and distal retention features each comprise a cuff that extends, at least partly, circumferentially about the lead when the anchor is disposed thereon. 
     
     
         15 . The anchor of  claim 13 , wherein the proximal and distal retention features comprise a proximal facing edge and a distal facing edge, respectively, that extends along a plane perpendicular to the longitudinal axis of the lead. 
     
     
         16 . The anchor of  claim 15 , wherein the anchor is dimensioned so that the proximal and distal facing edge abut against the proximal and distal ends, respectively, of the reduced diameter anchoring portion of the lead when received therein. 
     
     
         17 . The anchor of  claim 16 , wherein the anchor is dimensioned with a total length between 10 and 30 mm. 
     
     
         18 . The anchor of  claim 13 , wherein the proximal and distal retention features are each shaped in a zig-zag, curve, or angled along a proximal and distal facing edge thereof so as to interlock with the corresponding shape of the proximal and distal ends of the reduced diameter anchoring portion of the lead. 
     
     
         19 . The anchor of  claim 13 , wherein the proximal and distal retention features are designed to abut against the corresponding proximal and distal ends of the reduced diameter anchoring portion of the lead in which the anchor is received so as to affix the anchor to the lead and prevent axial movement of the anchor along the lead. 
     
     
         20 . The anchor of  claim 13 , wherein the anchor is formed of a polyurethane. 
     
     
         21 . The anchor of  claim 20 , wherein the polyurethane has a shore hardness within a range between 50A and 80D. 
     
     
         22 . The anchor of  claim 13 , wherein the anchor is formed of a metal. 
     
     
         23 . The anchor of  claim 13 , wherein the anchor body is formed from a single integral tube. 
     
     
         24 . The anchor of  claim 13 , wherein the anchor body comprises multiple sections adjacent each other. 
     
     
         25 . The anchor of  claim 13 , wherein adjacent sections of the multiple sections are attached to each other by any of: an adhesive, a mechanical coupling, a chemical coupling, and an oxidation coupling.