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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - SensAtouch Grasper (Safe and Sensible Tissue Graspers for Pediatric and (Mini-)Laparoscopic Surgery)

Teaser

Summary

Laparoscopic surgery, a form of minimally invasive surgery (MIS), is the most common surgical intervention with over 15 million procedures performed annually worldwide. The benefits, as compared to open surgery, includes less scaring, less post-operative pain and shorter hospital stays; but, the risk remains that patient complications is 2-4% higher per operation.

State-of-the-art laparoscopic graspers lack force feedback capabilities, which is responsible for accidental tissue trauma, a primary factor of post-operative complications and patient fatalities. It is recorded that 38% of all grasper movements are unsuccessful, meaning the surgeon is unable to perform the desired action without repeated clamping, slip, or obvious tissue trauma. Surgeons continue to demand added force feedback capabilities for both patient and user benefits.

The trending market of Mini-Laparoscopy is driving the development of diametrically smaller graspers that further deteriorate force sensitivity due to the mechanical effects in smaller assemblies, which can lead to increased complication rates and costs. Simultaneously, the clinical demand for added sensitivity is driving the commercialisation of expensive electro-mechanical grasper systems that are increasing hospital costs, disrupting operating room dynamics, and adding unquantified patient risks.

Milton Medical Innovations is commercializing disruptive force feedback graspers to address this immediate clinical need. Our graspers are more sensitive, cost effective, and can be diametrically miniaturized without loss of performance. It operates on the same working principles as state-of-the-art instruments and is attachable onto the vast majority of commercially-available grasper handles.

Work performed

Work performed:
Assessment of the technical and commercial viability of our grasper portfolio.
Determined the optimal product offering(s) for commercialization.
Constructed a highly competitive entrance and pricing strategy.
Finalized business plan, investment plan, commercial plan, and financial feasibility study.
Results disseminated in two relevant conferences in the EU and US; Ranked 2nd place in a medical device innovation competition.

Final results

Currently, the market is flooded with over 150 companies manufacturing conventional stiff-hinged graspers. Over the past decade, research has been devoted to the development of mechanical-electrical systems (or mechatronic systems) that transmit force feedback information. Although feasibility studies validate their clinical benefits, these systems increase complexity, equipment costs, and training costs which continues to deter commercial implementation.
Our solution replaces the root technology of state-of-the-art (i.e., the tooltip), with a patented single-piece mechanism tooltip. The innovative tooltip uses material elasticity to amplify and notify surgeons of hazardous tissue forces. Its construction simplifies manufacturing, assembly and sterilization processes. This technology transforms any low-end to high-end commercially available grasper into an enhanced force feedback tissue manipulator. It can be procured at lower costs, while maintaining operating room dynamics, surgeons routines and preferences, and medical supply chains.