Lead insertion tool

Abstract

Disclosed herein is a lead insertion tool for inserting a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end. The tool includes a lead pathway and an engagement mechanism. The lead pathway extends through the tool and is configured to receive the implantable lead. The engagement mechanism includes an engaged state and a self-biasing non-engaged state. When the engagement mechanism is self-biased into the non-engaged state, the implantable lead is free to displace along the lead pathway. When the engagement mechanism is forced into the engaged state, the lead cannot displace along the lead pathway.

What is claimed is: 
     
         1 . A lead insertion tool for inserting a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end, the tool comprising:
 a clamshell structure including a first portion, a second portion coupled to the first portion via a hinge, an engagement mechanism, and a lead pathway configured to receive the implantable lead,   wherein each portion of the clamshell structure includes a central structure, a leading projection extending from the central structure, and a part of a lead pathway, the part of the lead pathway of the first portion combining with the part of the lead pathway of the second portion to form the lead pathway when the first portion and second portion are abutted together when the clamshell structure is in a closed state,   wherein the lead pathway extends through the central portion and the leading projection to a free end of the leading projection,   wherein the engagement mechanism is located on at least one of the portions of the clamshell structure and includes an engaged state and a self-biasing non-engaged state,   wherein, when the engagement mechanism is self-biased into the non-engaged state, the implantable lead is free to displace along the lead pathway, and when the engagement mechanism is forced into the engaged state, the lead cannot displace along the lead pathway.   
     
     
         2 . The tool of  claim 1 , wherein the first portion of the clamshell structure includes a first alignment feature and the second portion of the clamshell structure includes a second alignment feature, the alignment features interfacing with each other to facilitate proper alignment of the first and second portions of the clamshell structure when the first and second portions of the clamshell structure are abutted together. 
     
     
         3 . The tool of  claim 2 , wherein the first portion of the clamshell structure includes a first lock feature and the second portion of the clamshell structure includes a second lock feature, the lock features Interfacing with each other to maintain the first and second portions of the clamshell structure in a closed state. 
     
     
         4 . The tool of  claim 3 , wherein the engagement mechanism includes an engagement member on each of the portions of the clamshell structure, the implantable lead being compressed between the engagement members when the engagement mechanism is in the engaged state and the implantable lead is located in the lead pathway. 
     
     
         5 . The tool of  claim 4 , wherein at least one of the engagement members includes a stop that inhibits excessive compression of the implantable lead by the engagement members. 
     
     
         6 . The tool of  claim 5 , further comprising a trailing projection, and the lead pathway extends from a free end of the trailing projection to a free end of the leading projection. 
     
     
         7 . A lead insertion tool for inserting a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end, the tool comprising:
 a lead pathway through the tool that is configured to receive the implantable lead; and   an engagement mechanism including an engaged state and a self-biasing non-engaged state,   wherein, when the engagement mechanism is self-biased into the non-engaged state, the implantable lead is free to displace along the lead pathway, and when the engagement mechanism is forced into the engaged state, the lead cannot displace along the lead pathway.   
     
     
         8 . The tool of  claim 7 , wherein the tool includes a clamshell configuration that can be opened to allow the implantable lead to be loaded into the lead pathway, and wherein the clamshell configuration includes an alignment arrangement that facilitates proper alignment of the clamshell configuration when assuming a closed state. 
     
     
         9 . The tool of  claim 8 , wherein the clamshell configuration includes a lock arrangement that maintains the clamshell configuration in a closed state. 
     
     
         10 . The tool of  claim 9 , the tool further comprising a leading projection through which the lead pathway extends and wherein the leading projection has an outer diameter configured to be received in the lead receptacle. 
     
     
         11 . The tool of  claim 10 , wherein the leading projection includes a tapered free end. 
     
     
         12 . The tool of  claim 11 , further comprising a trailing projection, and the lead pathway extends from a free end of the trailing projection to a free end of the leading projection. 
     
     
         13 . The tool of  claim 12 , wherein the engagement mechanism, when in the engaged state, interacts with the implantable lead along the lead pathway between the free end of the trailing projection and the free end of the leading projection. 
     
     
         14 . The tool of  claim 13 , wherein the engagement mechanism includes at least one engagement member including an interior surface that compresses against the implantable lead when the engagement mechanism is forced into the engaged state. 
     
     
         15 . The tool of  claim 14 , wherein the engagement member is cantilevered from a surrounding structure of the tool. 
     
     
         16 . The tool of  claim 15 , wherein the engagement member is coupled to the surrounding tool via a living hinge. 
     
     
         17 . The tool of  claim 16 , wherein the engagement mechanism includes a pair of opposed engagement members that compress the implantable lead between the engagement members when the engagement mechanism is forced into the engaged state. 
     
     
         18 . The tool of  claim 17 , wherein at least one of the engagement members includes a hard stop that inhibits excessive compression of the implantable lead by the pair of engagement members. 
     
     
         19 . A method of using a lead insertion tool to insert a lead connector end of an implantable lead into a lead receptacle of a header of an implantable pulse generator, the implantable lead including a lead body extending distally from the lead connector end, the implantable lead extending through the tool such that the lead connector end projects out of a leading end of the tool and the lead body extends out of a trailing end of the tool, the method comprising: causing the lead connector end to enter the lead receptacle by causing an engagement mechanism of the tool to engage the implantable lead while displacing the tool towards the lead receptacle with a free end of the lead connector end aligned with the lead receptacle. 
     
     
         20 . The method of  claim 19 , further comprising: displacing the tool away from the lead receptacle and along the implantable lead with the engagement mechanism disengaged from the implantable lead and then again causing the engagement mechanism of the tool to engage the implantable lead while again displacing the tool towards the lead receptacle to further drive the lead connector end into the lead receptacle; and
 wherein the engagement mechanism self-biases out of engagement with the implantable lead.