Percutaneous electrode assemblies, systems, and methods for providing highly selective functional or therapeutic neuromuscular stimulation

Abstract

Percutaneous electrode assemblies, systems, and methods make possible the providing of short-term therapy or diagnostic testing by providing electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments carried outside the body. The percutaneous electrodes include a flexible body having an electrically conductive region, a tissue penetrating region, and a percutaneous lead electrically coupled to the electrically conductive region. An anchoring element is positioned on the flexible body to resist movement of the electrically conductive region within tissue. An introducer is sized and configured to receive the flexible body and shield the anchoring element from contact with tissue while the electrically conductive region is placed to a desired position within tissue, and accommodates advancement of the anchoring element beyond the interior lumen for contact with tissue to resist movement of the electrically conductive region placed in the desired position.

1 . A method of providing a neurostimulation function comprising the steps of
 providing a percutaneous electrode, the percutaneous electrode comprising a flexible body including an electrically conductive region, a tissue penetrating region for implanting the electrically conductive region in tissue, a percutaneous lead electrically coupled to the electrically conductive region, and an anchoring element on the flexible body to resist movement of the percutaneous electrode within tissue,   inserting the percutaneous electrode within an introducer that shields the anchoring element from contact with tissue, the introducer including an electrically isolated area that correspond to the electrically conductive region of the flexible body,   implanting the percutaneous electrode while inserted within the introducer, to place the percutaneous electrode in a desired location within tissue,   withdrawing the introducer to place the anchoring element in contact with tissue, thereby resisting movement of the percutaneous electrode from the desired position,   providing a carrier sized and configured to be worn by the patient, the carrier also being sized and configured to hold a power source that can be released and replaced, the carrier including an electronics pod, the electronics pod including circuitry configured to generate a stimulation pulse,   providing instructions prescribing the release and replacement of the power source,   electrically engaging the percutaneous lead to the carrier to electrically couple the electrically conductive region to the electronics pod, and   activating the circuitry to generate a stimulation pulse to percutaneously apply the stimulation pulse to the tissue to provide the neurostimulation function.   
   
   
       2 . A method according to  claim 1   wherein the electrically isolated area is electrically coupled to a connector on the introducer to allow the electrically isolated area to be coupled to a stimulating circuit.   
   
   
       3 . A method according to  claim 2   further including, during the implanting step, a step of coupling the introducer to a stimulating circuit to provoke a tissue stimulation response to place the percutaneous electrode in the desired location.