The Injectrode: Changing the Business Case for Spinal Cord Stim to Treat Pain

The Injectrode: Changing the Business Case for Spinal Cord Stimulation to Treat Pain

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Non-invasive transcutaneous electrical stimulation (TES) therapies seek to directly manipulate neural activity to address disease. TES devices are low-cost and low-risk. While these completely non-invasive devices are able to engage deep nerves, they also activate more superficial neural structures that lie between the surface stimulation electrodes and the on-target deep nerve [Bucksot 2020]. Activation of superficial off-target neural structures leads to side effects including noxious sensation and uncomfortable muscular contractions, which limits the stimulation dose from being further increased to engage the deep on-target nerve.

An implantable device that directly interfaces with the nerve is able to achieve on-target neural engagement in a more specific manner. However, traditional implantable pulse generators (IPGs) consisting of an implanted battery, electronics, and stimulation lead are complex and costly. A traditional IPG requires invasive surgical placement, which adds to the cost of the therapy. The complexity of the IPG and the supply chain, where manufacturing procedures have to be tightly controlled across several suppliers, also adds to the cost of the therapy and is prone to multiple points of failure. Traditional IPGs also use stiff neural interfacing electrodes that do not conform around complex neural structures.

The Injectrode is a single-component minimally invasive neuromodulation electrode technology proposed as a ‘in between’ technology to combine the strengths of invasive and non-invasive stimulation fo the DRG for pain [Trevathan 2019]. It forms in-body around the neural structure to better isolate the target given individual anatomical difference. The pre-curing viscosity of Injectrode allows it to conform around complex neural structures, including nerve plexi found close to end-organs, which is not possible with conventional stiff neurostimulation electrodes. Additional Injectrode material is extruded as part of the injection to form a conductive conduit connecting the deep nerve target to just under the surface of the skin. Finally, more Injectrode is injected just under the skin to create a plate shaped ‘collector’. This collector couples with external non-invasive TES stimulation electrodes to transfer charge delivered from a non-invasive TES unit and route it to the deep nerve.

In this talk, Dr. Ludwig discusses the motivation for the Injectrode, the existing data to support its advantages, and next steps.

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