Minimally Invasive Spinal Cord Stimulator (MI-SCS) for chronic pain treatment

Chronic pain represents the leading cause of disability worldwide. Eight million adults in the UK report chronic pain that is disabling, at a £10 billion cost to the UK economy. The proportion of the population experiencing chronic pain is increasing as the population ages. Existing treatments include pharmacological, non-pharmacological and surgical treatments. However, many patients continue to experience pain despite a variety of treatments. Alternative interventions are needed because current therapies are often ineffective. Spinal Cord Stimulation (SCS) is sometimes offered as a treatment for chronic pain, but current technology has several limitations. There are two SCS lead types: cylindrical, inserted percutaneously, and paddle requiring open spine surgery. The former carries little risk but is less effective or stable. Although very effective and stable, the latter carries a much higher risk, especially for frail and vulnerable people. Previous attempts have been made to develop percutaneous paddle electrodes, but these have not demonstrated equal effectiveness and, like cylindrical SCS, have high rates of electrode misplacement. This is because they are just a smaller version of current technology. Our innovation (Minimally Invasive SCS or MI-SCS) implants large paddles through standard Tuohy needles. We have developed a prototype, successfully tested it in in-vitro and human cadaveric spine models, and published our results in a high-impact journal [Science Advances 2021]. MI-SCS is an ultra-thin and flexible electrode, thinner than a human hair. Integrated within it is a set of channels, which can be filled with water or air, allowing a controllable change in the shape of the device (i.e., rolled to unrolled).MI-SCS is inserted with the same technique as a cylindrical SCS but then expands to cover as large a spinal cord area as a paddle SCS. MI-SCS will make available an effective treatment to older and frail patients. It will also increase the capacity of the NHS to deliver effective SCS by simplifying the insertion procedure so that paddle lead placement can be carried out as a simple day-case procedure. The primary aim and key measure of success of this proposal is to achieve the finalized MI-SCS prototype. We will finalize the design and manufacturing process by working with a leading medical device manufacturer. The manufactured prototypes will be tested in human cadaveric models, where the cerebrospinal fluid space has been reconstituted, and in laboratory models of the spinal column. We will demonstrate the long-term stability of the device using proven laboratory techniques. In parallel, we will work with patients and the public and incorporate their feedback across the grant duration. We will work with the University of Cambridge Technology Transfer Office and a Health Economy Agency to strategically plan clinical translation and commercialisation. The department of Clinical Engineering will oversee the regulatory process and interface with the MHRA to prepare for regulatory approval. The complete MI-SCS system will be ready to begin testing for regulatory approvals and first-in-human clinical trials by the end of the project. We intend the device to be in mass manufacture and available for use in five years.