Soro-tymp: Soft Robot Assistance In Transtympanic Drug Delivery

Research question In-the-ear injections offer a promising method for treating both acute ailments like sudden sensorineural hearing loss and chronic conditions, pending new treatments. The current need for specialist otolaryngologists for administration limits accessibility. We propose developing Soro-tymp, a soft robotic system, to facilitate safe, precise inner ear therapeutic delivery. Background Despite substantial efforts to develop novel therapeutics for hearing loss, there are currently no devices on the market that support drug delivery. We have devised our soft robotic device to stabilize an injection needle and steer it to a desired point of insertion on the tympanic membrane. We have produced a research prototype which, by the time of commencing the project, will have been trialled in human cadavers. Aims and Objectives The aim of the project is to further the technological and translational development of Soro-tymp. Particularly, to develop an easy-to-manufacture, scalable and reproducible design for the soft robot and compile the technical documentation required for first-in-human evaluation of our technology. integrate an advanced imaging solution for visualizing the tympanic cavity and develop safe controls according to visual feedback. determine the best use of the technology in clinical workflows, estimate its economic value and establish pathways for commercialization. Methods and Timelines for delivery The work is divided into six interleaved workpackages, running across 36 months (12 quarters), which are detailed below. WP1(Q1–Q12): Hardware development and documentation of an improved soft, expandable robot, with improved manufacturability and workspace with a verification pipeline for standardized testing of our device. Additionally, we will produce a technical file for submission to the MHRA. WP2(Q3–Q10): A computer vision-based pipeline will be created to estimate robot motion and needle insertion depth. Accordingly, a remote centre-of-motion based controller will be devised to perform needle steering behind the tympanic membrane. WP3(Q3–Q10): We will investigate the usability of the Soro-tymp prototypes while producing supporting clinical information, e.g. in form of risk documentation and use specifications, for producing our technical file. WP4(Q3–Q10): Shortwave infrared imaging provides the possibility of visualizing the middle ear cavity through the semi-opaque ear drum. We will develop a fibre-based imaging probe to be integrated into our soft robot. A cadaveric study will be conducted for first validation of the system. WP5(Q7–Q10): The newly developed features, including computer vision-guided control and shortwave infrared imaging, will be integrated in a revised prototype, which will be trialled in healthy volunteers without needle insertion. WP6(Q1–Q12): Through stakeholder engagement and health economics analyses we will produce a go-to-market strategy and identify routes for commercialization of our technology. Anticipated Impact and Dissemination The project will conclude with a validated soft robotic ear injection device ready to be trialled in patients, able to deliver higher dose treatments than currently possible without surgery while making procedures accessible to less specialized clinical staff. The novelty of our approach will enable high impact dissemination, while PPI and clinical inputs will ensure clinical viability. Finally, we will have established a path for commercializing our technology to bring it to the patient.