Public Funding for Nami Surgical Limited

Ultrasonic cutting instruments, widespread in surgical procedures today for operations on both soft and hard tissues, use high-energy ultrasonic oscillations in the 0.1 mm range to effectively remove soft tissue, seal vessels, or dissect bone tissue depending on the resonance frequency. Advantages of ultrasonic surgery include the ability to cut and dissect bone or soft tissue with precision and selectivity, with minimal damage to delicate tissue structures like nerves, muscles, blood vessels and ligaments. This results in improved patient outcomes, with evidence of lower levels of tissue necrosis and faster recovery times. However, there remain some key technology limitations of ultrasonic surgical devices which are limiting future development. The first is that these cutting devices tend to be single use, designed either for operations on soft tissues and coagulation procedures, or for the surgical cutting of harder mineralised tissue such as bone. Secondly, the supporting instrumentation required can be expensive, such as the power generators for the ultrasonic transducers, and the handpieces necessary to undertake the surgery. This project aims to address these technological shortcomings, and barriers to future innovation, to enable the development of a multifunctional tissue-selective ultrasonic instrument for cutting and coagulation of soft tissue, also able to undertake surgical cutting of bone. The prototype ultrasonic cutting device will incorporate a nickel-titanium, Nitinol, shape memory alloy, whose tuneable material properties can be used to actively adjust the dynamic performance of the transducer. This material will be additively manufactured, to provide flexibility in the design approach and to optimise the integration of the material with an ultrasonic transducer. It is anticipated that the prototype ultrasonic surgical device will be scalable to be inexpensive in comparison to the current requirement to acquire separate instruments for bone and soft tissue interventions.

Nami Surgical Ltd is a spin-out from the University of Glasgow. Two PhD graduates trained within the Centre for Medical and Industrial Ultrasonics have conceived a solution which meets a significant unmet healthcare challenge for ultrasonic surgical devices. Ultrasonic scalpels are handheld surgical devices that simultaneously cut and cauterise soft tissue. These devices are the gold standard energy instrument used in \>80% of minimally invasive surgeries. Feedback from surgeons is that they strongly prefer ultrasonic scalpels over conventional cutting tools or electrosurgical tools as they shorten operating times, length of patient stays, patient pain and overall chance of complications. In parallel, surgical robotic platforms are rapidly diffusing throughout the global healthcare system in response to the need for minimally invasive surgery approaches to combat the global rise in chronic disease and the growing ageing population. It is forecast that by 2025, close to 100% of US hospitals will have at least one surgical robot, up from about 25% in 2016\. However, due to the technical characteristics and physical limitations of existing ultrasonic scalpels, they cannot be used effectively with surgical robots. Existing scalpels have transducers that are too large to fit through laparoscopic ports and thus require long rods, "waveguides", to transfer energy to the surgical site. These waveguides cannot be bent or manoeuvred at the distal end, and generate heat that can damage tissue and smoke that reduces visibility. Nami's solution is a miniaturised ultrasonic scalpel that fits through a surgical port and is compatible with wristed robotic articulating joints, meeting an outstanding clinical need confining millions of procedures worldwide. Nami's patent-pending technology allows the ultrasonic scalpel to be mounted directly as the end effector of a wristed robotic arm, offering the surgeons the ability to perform complex procedures with dexterity mimicking the access of open surgery alongside the clinical benefits of minimally invasive surgery. This project will unlock the resources Nami requires to develop a driving system which can exploit the features of a first-of-a-kind miniaturised robotic ultrasonic technology, a surgical tool which can act both as an ultrasonic scalpel and a sensor. Fully unlocking this information, in combination with the digital ecosystem offered by surgical robotics, will enable surgeons to evaluate and analyse meaningful and actionable real-time surgical data. It represents a crucial advancement in modern ultrasonic surgical technology, allowing surgeons to perform complex procedures with greater confidence and improved patient outcomes.

Nami Surgical is a spin-out from the University of Glasgow. Biomedical engineers from the Centre for Medical and Industrial Ultrasonics (C-MIU) in the EPSRC Ultrasurge (Surgery enabled by Ultrasonics) Programme team ([www.gla.ac.uk/research/ultrasurge/][0]) have invented a solution to a complex problem in ultrasonic surgical devices. Ultrasonic scalpels are handheld surgical devices that simultaneously cut and cauterise. These devices are the gold standard energy instrument used in \>80% of minimally invasive surgeries. Feedback from surgeons is that they strongly prefer ultrasonic scalpels over conventional cutting tools. In parallel, surgical robotic devices are rapidly diffusing throughout the global healthcare system, with dozens of firms formed since 1999 to develop and manufacture these products. It is forecast that by 2025, close to 100% of US hospitals will have at least one surgical robot, up from about 25% in 2016\. However, due to the technical characteristics and physical limitations of existing ultrasonic scalpels they cannot be used with surgical robots. Existing scalpels have transducers that are too large for laparoscopic ports and thus require long end effector waveguides to transfer energy to the surgical site. These waveguides cannot be bent, lack manoeuvrability at the distal end, and generate heat (\>190C) that damages tissue and smoke that reduces visibility and is a biohazard. Our solution is a miniaturised ultrasonic scalpel that is compatible with robotic surgery. This patent-pending technology allows the ultrasonic scalpel to be mounted directly as the end effector of a wristed robotic arm so addressing a real clinical and market need. [0]: https://www.gla.ac.uk/research/az/ultrasurge/