Surgery enabled by ultrasonics

Lead Research Organisation: University of Glasgow
Department Name: School of Engineering

Abstract

The range of surgical tools for interventional procedures that dissect or fragment tissue has not changed significantly for millennia. There is huge potential for ultrasonic devices to enable new minimal access surgeries, offering higher precision, much lower force, better preservation of delicate structures, low thermal damage and, importantly, enabling more procedures to be carried out on an out-patient or day surgery basis. To realise this potential, and deliver our vision of ultrasonics being the technology of choice for minimal access interventional surgery, a completely new approach to device design is required, to achieve miniaturisation and to incorporate both a cutting and healing capability in the devices. By integrating with innovative flexible, tentacle-like surgical robots, we will bring ultrasonic devices deep into the human body, along tortuous pathways to the surgical site, to deliver unparalleled precision.

Unsurpassed precision in challenging neurological, skull-base and spinal procedures as well as in general surgery is attainable through tailoring the robotic-ultrasonic devices to deliver the exact ultrasonic energy to the exact locations required to optimise the surgery. We will achieve this by quantifying the effects of the ultrasonic excitations typical of surgical devices in tissues, at and surrounding the site of surgery, in terms of precision cutting, tissue damage (mechanical damage, thermal necrosis, cavitation) but also the potential to aid regeneration. We will make world-leading advances in ultra-high speed imaging measurements and biophysical analysis, complementing advances in histology and clinical assessment, to develop a combined approach to the characterisation of both damage and regeneration of tissue. Through this holistic approach to device design, we will create integrated robotic-ultrasonic surgical devices tailored for optimised surgery.

Planned Impact

Societal impact will ultimately be the clinical use of the surgical devices we create. We will propose new complex surgeries (with minimal and difficult access) offering high precision. We will deliver semi-automation of many surgical tasks. The programme will therefore positively benefit patient care for the many millions of surgeries carried out annually world-wide. Resulting increases in out-patient procedures will impact health costs significantly. The clinicians in our team and our NHS partners will ensure patient care is at the heart of our research and will provide direct access to the operating theatre for the research team, to direct the innovations. We will partner with the NHS Medical Devices Unit to co-design the research towards translation to clinical uptake beyond the programme and to work with our clinician investigators and partners on clinical evaluations of our devices.

Our partner companies including Stryker, Dentsply, Intuitive Surgical, Kuka Robotics, Thales, CTS and several SMEs are our basis to ensure economic impact and a route to user engagement by embedding co-creation with their established user community networks. Our industrial partners will ensure we embed the regulatory frameworks into the research directions, and will also host our researchers for extended visits, ensuring a pipeline of highly skilled potential employees.

We plan for annual public engagement events, to include Science Festivals. We will organise a special session and workshop on ultrasonics in surgery during our hosting of the IEEE International Ultrasonics Symposium in Glasgow in 2019, attracting clinicians, engineers and companies, to disseminate our research widely. We will run similar and updated versions of the workshop annually at different venues, particularly to include robot-assisted minimal access ultrasonic surgery.

Academic impact will additionally be through publication of research and presentations at key international conferences and engineering and clinical society events.

Publications

10 25 50
 
Description Ministerial visit
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
URL https://www.leeds.ac.uk/forstaff/news/article/6984/universities_minister_visits_campus
 
Description UK-RAS White Paper on Surgical Robotics
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
URL https://www.ukras.org.uk/publications/white-papers/surgical-robotics-towards-measurable-patient-bene...
 
Description Autonomous multimodal implantable endoscopic capsule for the gastrointestinal tract
Amount € 3,992,860 (EUR)
Funding ID 952118 
Organisation European Commission H2020 
Sector Public
Country Belgium
Start 11/2020 
End 10/2024
 
Title FlapNet 
Description Dataset of labelled surgical images dedicated to tissue retraction 
Type Of Material Database/Collection of data 
Year Produced 2020 
Provided To Others? Yes  
Impact Dataset of labelled surgical images dedicated to tissue retraction 
URL https://github.com/Stormlabuk/dvrk_ULSTM
 
Description Brian Peterson, 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Supervision of PhD student
Collaborator Contribution Alternative cutting method
Impact Nil so far
Start Year 2020
 
Description Collaboration with the Surgical MIC 
Organisation National Institute for Health Research
Department NIHR Surgical MedTech Co-operative
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution We provide the Surgical MIC with our work as a case study to showcase their capabilities and areas of support.
Collaborator Contribution Expert advice and support for the clinical trials aspects of the project, including patient and public involvement. The latter includes access to patient and clinician networks, advice on engagement and other activities.
Impact This collaboration is in the early stages and will come into effect in the later parts of the project.
Start Year 2019
 
Description Oxford University 
Organisation University of Oxford
Department Department of Engineering Science
Country United Kingdom 
Sector Academic/University 
PI Contribution We provide continuing awareness of current developments in ultrasonic tools and robotic platforms
Collaborator Contribution Prof Robin Cleveland at University of Oxford is a member of the External advisory board for the Ultrasurge project. He has agreed to review project progress and provide independent advice.
Impact Prof Robin Cleveland continues to attend project's annual meetings, providing strategic direction. His feedback on the project progress is a valuable contribution for the project team to use it to make improvements in the research and development of the ultrasound miniature devices, as a potential candidate to be used as surgical instruments.
Start Year 2018
 
Description Partnership with Active Needle 
Organisation Active Needle Technology Ltd.
Country United Kingdom 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasound surgical tools
Collaborator Contribution Active Needle contributes to our annual meeting with the Industrial and Clinical impact Group, as well as general technology and market guidance
Impact None at this time
Start Year 2018
 
Description Partnership with CTS Corporation 
Organisation CTS Corporation
Country United States 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasound surgical tools, in particular the use of ultrasound materials which are lead-free
Collaborator Contribution CTS contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and market guidance. We also benefit from access to transducer materials.
Impact None to date
Start Year 2018
 
Description Partnership with Dentsply Sirona 
Organisation Dentsply Sirona
Country United States 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasound surgical tools and their application in dentistry
Collaborator Contribution Dentsply contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and market guidance. It is anticipated that there will also be visits to the company during the programme
Impact None to date
Start Year 2018
 
Description Partnership with Intuitive 
Organisation Intuitive Surgical Inc
Country United States 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasound surgical tools and their application on robotic platforms
Collaborator Contribution Intuitive contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and market guidance. In addition they provide support interfacing our tools onto their platforms and provided a full robotic da Vinci research kit.
Impact None to date
Start Year 2018
 
Description Partnership with KUKA Robotics 
Organisation KUKA Robotics
Country Germany 
Sector Private 
PI Contribution Contributed feedback on the use of the KUKA LBR Med robotic arm in our application, including any performance issues or general areas for improvement. Helped promote the KUKA LBR Med robotic arm by demonstrating it at the Medica trade show in Dusseldorf (2019) on behalf of KUKA and the University of Leeds.
Collaborator Contribution Extra assistance with the setting-up and maintenance of the KUKA LBR Med robotic arm. General advice and support, above and beyond that received by a typical customer, on the use of their product in our application. Expert feedback on our product and future development.
Impact Output: Public engagement at the Medica trade show in Dusseldorf (2019)
Start Year 2019
 
Description Partnership with NHS Medical Devices Unit 
Organisation NHS Greater Glasgow and Clyde (NHSGGC)
Country United Kingdom 
Sector Public 
PI Contribution Co-working on ultrasonic surgical devices and provision of data to meet medical devices requirements.
Collaborator Contribution Training and support to understand and meet requirements for technology development. The MDU contributes to our annual meeting with the Industrial and Clinical Impact Group
Impact We are working towards ultrasonic surgical device demonstrators as part of our pathway to impact.
Start Year 2018
 
Description Partnership with NPL 
Organisation National Physical Laboratory
Country United Kingdom 
Sector Academic/University 
PI Contribution We provide continuing awareness of current developments in ultrasonic surgical tools
Collaborator Contribution NPL contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and metrology guidance
Impact None to date
Start Year 2018
 
Description Partnership with Onscale 
Organisation OnScale
Country United States 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasonic surgical tools, specifically with respect to modelling and simulation
Collaborator Contribution OnScale contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as providing licenses to use their modelling software and engineering support in working with our simulations
Impact None to date
Start Year 2018
 
Description Partnership with Polytec 
Organisation Polytec
Country Germany 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasonic surgical tools, and measurement of them in manufacture and design
Collaborator Contribution Polytec contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and market guidance
Impact None to date
Start Year 2018
 
Description Partnership with SICCAS 
Organisation Shanghai Institute of Ceramics
Country China 
Sector Academic/University 
PI Contribution We provide continuing awareness of current developments in ultrasonic surgical tools, particularly in the use of ceramic transducers
Collaborator Contribution SICCAS contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as advice around the use of new ceramic transducer materials
Impact None to date
Start Year 2018
 
Description Partnership with Sonic Systems 
Organisation Sonic Systems Ltd
Country United Kingdom 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasonic surgical tools
Collaborator Contribution Sonic Systems contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as advice on power systems and driving units
Impact None to date
Start Year 2018
 
Description Partnership with Thales 
Organisation Thales Group
Department Thales Underwater Systems
Country United Kingdom 
Sector Private 
PI Contribution We provide continuing awareness of current developments in ultrasonic tools and robotic platforms
Collaborator Contribution Thales contributes to our annual meeting with the Industrial and Clinical Impact Group, as well as general technology and market guidance
Impact None to date
Start Year 2018
 
Description Stryker 
Organisation Stryker
Department Stryker Ireland
Country Ireland 
Sector Private 
PI Contribution We lead a strategic partnership with Stryker for their ultrasonics technical area. We collaborate on a range of ultrasonic interventional surgical devices, especially for bone cutting, and surgical navigation systems.
Collaborator Contribution Stryker have co-funded or fully funded 4 PhD students and an EPSRC IAA award. They are currently partners on our EPSRC Programme Grant (Surgery enabled by ultrasonics) and our EPSRC CDT FUSE (Future ultrasonic engineering). As well as direct funding, supervision and expertise, Stryker manufacture all the test samples and device components for our collaborative research. Stryker are co-funding a PhD studentship on the EPSRC Programme Grant - Surgery enabled by ultrasonics.
Impact Richards, D., Mathieson, A., Lucas, M. and Pretorius, N. (2015) An Ultrasonically Assisted Sagittal Saw for Large Bone Surgeries. In: IEEE International Ultrasonics Symposium (IUS), Taipei, Taiwan, 21-24 Oct 2015, pp. 1-4. ISBN 978147998182315 (doi:10.1109/ULTSYM.2015.0279) Li, X. , Stritch, T., Manley, K. and Lucas, M. (2021) Limits and opportunities for miniaturising ultrasonic surgical devices based on a Langevin transducer. IEEE Transactions on Ultrasonics, Ferroelectrics and Frequency Control, 68(7), pp. 2543-2553. (doi: 10.1109/TUFFC.2021.3065207)
Start Year 2014
 
Company Name NAMI SURGICAL LIMITED 
Description Nami Surgical Limited is a spin-out from the University of Glasgow. Postdoctoral researchers from the Centre for Medical and Industrial Ultrasonics (C-MIU, https://www.gla.ac.uk/research/az/cmiu/) working in the EPSRC Ultrasurge (Surgery enabled by Ultrasonics) Programme team (https://www.gla.ac.uk/research/az/ultrasurge/) have invented a solution to address a key ch. Ultrasound is used in the medical field for both diagnosis and therapy, the latter including surgery. Specifically, for therapeutic applications, high-intensity ultrasound (10 - 1000 Wcm-2) at frequencies between 20 - 100 kHz is used to permanently alter the tissue to which it is applied. Ultrasonic scalpels are handheld surgical devices that simultaneously cut and cauterise. Ultrasonic scalpels use the so-called thermal effect. Specifically, the tissue is heated to the point of denaturation. The tip of a device to generate this effect has a decoupled bifurcation, allowing the jaw to move and force the tissue onto the ultrasonic vibrating blade. The clamping pressure necessary to close the jaw is applied by the surgeon's hand through a mechanical lever. The induced friction causes the tissue to be heated, denaturated and cut in within few seconds, with no bleeding. The interaction between soft tissue and ultrasonic devices is complex, depending on the protein and water content of the tissue undergoing the surgical procedure. In general, tissue with high water content is easier to cut, whereas tissue with high protein content, such as blood vessels, nerves and connective tissue, requires more energy. The temperature can exceed 100 °C which is sufficient to denature proteins and, if the tissue is heated above its critical necrotic temperature, the damage is irreversible and beyond repair. The cutting and haemostatic effects are not independent and they happen simultaneously. 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. One of the most recent inventions in robotic surgery is represented by surgical instruments combined with articulated joints to enable a range of motions at the end effector similar to that of the human wrist, thus replicating the experience of open surgery. However, due to the technical characteristics and physical limitations of existing ultrasonic scalpels they cannot be used with articulated joints. In current ultrasonic cutting devices, only axial and rotation movements are permitted, as the transducers are too large to fit through the 5 - 10 mm trocar. The transducer is axially constrained to the robotic arm and the waveguide, which transfers the ultrasonic vibration from outside the human body to the end effector inside, cannot be bent. This represents a big disadvantage for surgical ultrasonic devices. In fact, although ultrasonic cutting has shown to be more precise and effective than other energy instruments, and with excellent coagulation speed, the latter are still preferred due to their dexterity. With current state-of the-art technology, ultrasonic transducer design, miniaturisation of an ultrasonic dissector cannot be achieved while still preserving device functionality and performance. Nami Surgical Ltd. 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.allenge for ultrasonic surgical devices. 
Year Established 2021 
Impact The company has so far raised the following funding: - £35k for market discovery. (Innovate UK - ICURe) - £15k for business model. (Innovate UK - ICURe) - £35k for the project: 'Fabrication and Validation of a functional miniaturized ultrasonic scalpel for robotic surgery'. (EPSRC-IAA) - £40k for company cashflow. (University Innovation Fund) - £300k 'Miniaturised ultrasonic scalpel for robotic surgical procedures'. (Innovate UK ICURe follow on funding: FY21 round 3)
 
Description Exhibited at the One Day in Leeds Event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Supporters
Results and Impact The event was to engage with donors and potential donors with the University to celebrate and highlight the research impact of the University. We presented our endoscopic technology to alumni and a guests, representatives from trusts and foundations and non-alumni who are interested in supporting the University.
Year(s) Of Engagement Activity 2019
 
Description Impact Festival 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Members of the Ultrasurge team in Glasgow (Richard Mosses, Xuan Li, Rebecca Cleary) participated in the Impact Festival showcasing the outcomes of EPSRC Impact Acceleration Account projects.
Year(s) Of Engagement Activity 2019
URL https://www.gla.ac.uk/myglasgow/ris/knowledgeexchange/knowledgeexchangefunding/impactaccelerationacc...
 
Description Invited speaker at a PPIE group meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Patients, carers and/or patient groups
Results and Impact The event was a focused group meeting arranged for patients and patient representatives to communicate the research that is on going in Leeds. We were invited to present our project and its impact for patients. We also had the opportunity to receive feedback from the PPI individuals
Year(s) Of Engagement Activity 2020
 
Description Invited talk at MedX event - Robotics in Healthcare 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Undergraduate students
Results and Impact The MedX society robotics in healthcare invited 'TED-style' talks on robotics and engineering in healthcare with the aim of engaging and inspiring. We presented our work in low-cost and endoscopic robotics and received positive feedback from the attendees.
Year(s) Of Engagement Activity 2019
URL https://surgicalmic.nihr.ac.uk/medtechfoundation/medx/
 
Description Operation Ouch exhibition 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact This was a family event is organised by the Bradford Science and Media Museum's with the CBBC series Operation Ouch during the half-term week. There were hands on exhibits as well as live science shows aimed at all ages. We have exhibited the ultra-low-cost flexible endoscope developed within this project.
Year(s) Of Engagement Activity 2019
URL https://www.scienceandmediamuseum.org.uk/whats-on/operation-ouch-half-term
 
Description Outreach at IEEE IUS 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Schools
Results and Impact We ran a Schools outreach event on ultrasonics at the Glasgow Science Centre during the IEEE International Ultrasonics Symposium that we Co-Chaired in Glasgow in 2019. 600 School pupils from the West of Scotland attended and got hands on experiences, including an image guided ultrasonic surgery device in a 3D printed skull.
Year(s) Of Engagement Activity 2019
 
Description Presentation of Research to the Minister of State for Universities, Science, Research and Innovation (Chris Skidmore) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact In the region as part of a fact-finding visit, the Minister of State for Universities, Science, Research and Innovation, was at our innovation hub, Nexus, to hear about internationally-important research and teaching undertaken at Leeds across these key areas. As part of this visit we presented our Ultra-low-cost endoscope and magnetic colonoscopy platforms which received positive feedback and extensive exposure through social and traditional media.
Year(s) Of Engagement Activity 2020
URL https://www.leeds.ac.uk/news/article/4526/sampling_world-leading_science
 
Description Presentation to the CRUK Trustees 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Third sector organisations
Results and Impact Our ultra-low-cost technologies for gastric cancer screening were presented to CRUK Trustees during their visit to the University of Leeds. This will potentially influence the charity's policy in funding more research in the space of global challenges.
Year(s) Of Engagement Activity 2020
URL https://www.leeds.ac.uk/news/article/4523/cancer_research_uk_delegation_visits_leeds
 
Description Research Insights - Arthritis - Pain that is 'Impossible to Ignore' 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact On line event with short talks and interactive discussion with the audience
Year(s) Of Engagement Activity 2021
 
Description Ultrasurge Project Team Meeting 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact This meeting was first one to be held between all the project partners after easing of COVID restrictions. The purpose of this meeting was to have face-to-face discussion on the project progress and next steps to be taken and strengthening the collaborative effort between all the players.

This meeting also also gave an opportunity for the new Ultrasurge project manager, who joined the project in November 2021, to be introduced to the entire Ultrasurge team.
Year(s) Of Engagement Activity 2021