US 11,745,011 B2
Apparatus and method for positioning, implanting and using a stimulation lead
Joseph W. Boggs, Chapel Hill, NC (US); Amorn Wongsarnpigoon, Chapel Hill, NC (US); Matthew G. deBock, Morrisville, NC (US); Meredith J. McGee, Cary, NC (US); Devin Sell, Brecksville, OH (US); and Robert B. Strother, Willoughby Hills, OH (US)
Assigned to SPR Therapeutics, Inc., Cleveland, OH (US)
Filed by SPR Therapeutics, Inc., Cleveland, OH (US)
Filed on Aug. 27, 2021, as Appl. No. 17/458,664.
Application 17/458,664 is a continuation of application No. 15/388,128, filed on Dec. 22, 2016, granted, now 11,103,697.
Application 15/388,128 is a continuation of application No. PCT/US2016/057267, filed on Oct. 17, 2016.
Prior Publication US 2021/0386995 A1, Dec. 16, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61N 1/05 (2006.01); A61N 1/36 (2006.01); A61B 17/34 (2006.01); A61N 1/372 (2006.01); A61N 1/378 (2006.01)
CPC A61N 1/0558 (2013.01) [A61B 17/3468 (2013.01); A61N 1/0502 (2013.01); A61N 1/0551 (2013.01); A61N 1/36017 (2013.01); A61N 1/36071 (2013.01); A61N 1/37205 (2013.01); A61N 1/3787 (2013.01); A61N 1/37211 (2013.01)] 13 Claims
OG exemplary drawing
 
1. An introducer system for positioning, testing, and deploying a lead for percutaneous peripheral nerve stimulation, the system comprising:
an electrical stimulus generator unit;
a needle assembly including an outer sheath having an outer circumference and defining a lumen, an inner sheath carried completely within the lumen during positioning and testing, and a plurality of test electrodes positioned along the outer circumference and electrically communicating with the stimulus generator unit;
a self-anchoring open-coiled helical stimulation lead carried within the inner sheath and having a conductive distal anchor, said anchor comprising an integrated electrode, and a proximal end in communication with the stimulus generator unit,
a deployment mechanism cooperating relative to the lead and the needle assembly to deploy the lead out of the needle assembly at a selected position identified by at least one of the plurality of test electrodes during positioning and testing of the system; and
wherein the self-anchoring lead remains confined within the needle assembly prior to deployment of the self-anchoring open-coiled helical stimulation lead and the distal anchor remains deployed in tissue after deployment of the self-anchoring open-coiled helical stimulation lead.