ULTRASPINE: Ultrasound-Enabled Minimally Invasive Disc Replacement

Lead Research Organisation: University of Leeds
Department Name: Mechanical Engineering

Abstract

The aim of this programme of work is to develop a new minimally invasive treatment system for spinal disc degeneration, the condition responsible for the majority of low back pain. The treatment involves removal of degenerated tissue from the disc using a therapeutic ultrasound system and replacement with an injectable fast-setting gel that mimics the behaviour of the healthy disc. This work will combine engineering, basic science and clinical expertise at the Universities of Leeds and Oxford. We aim to design, build, optimise and test the system in readiness for clinical trials and commercialization by the end of the funding period.
Four out of five adults will suffer from low back pain during their lifetime and around 5% of sufferers become chronically disabled. This imposes a high economic and social burden on society because the disorder affects people of working age as well as the elderly, with the total cost being estimated to be over 1 % of the UK's GDP. Low back pain is strongly associated with degeneration of the intervertebral discs, the soft tissues that connect the spinal vertebrae and allow the spine to articulate. Current surgical treatments for low back pain are highly invasive and have relatively low long term success rates. The present work aims to develop a novel, minimally invasive therapy for disc replacement without the need for surgical incision. If successful, it has the potential to revolutionise clinical practice for the treatment of back pain, thus improving quality of life and reducing the economic impact of this major disease.
The work will include the development of a novel high intensity focussed ultrasound system for the removal of the degenerated tissue from a highly controllable location, employing the same system to visualise the procedure in real time. A new class of self assembling peptide gels will also be developed and optimised for minimally invasive insertion into the cavity to restore the disc's mechanical function. In parallel with these developments, a combined programme of computational and experimental modelling will be undertaken to evaluate the mechanical performance of the treatment and optimise its performance across the likely variance in disc properties seen in a typical patient population.
The programme of work is expected to yield a complete novel spinal therapy system ready for clinical trial and commercialization. The processes employed will have potential to be adapted for other spinal treatments as well as for orthopaedic interventions in other joints, adding further impact in the longer term and benefitting both healthcare providers and the patients themselves.

Publications

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Mengoni M (2016) Modelling the failure precursor mechanism of lamellar fibrous tissues, example of the annulus fibrosus. in Journal of the mechanical behavior of biomedical materials

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Mengoni M (2015) Derivation of inter-lamellar behaviour of the intervertebral disc annulus. in Journal of the mechanical behavior of biomedical materials

 
Description New methodologies have been developed for testing medical devices for the spine to evaluate their time-dependent performance. These laboratory tests and computer simulations allow devices to be examined and optimised before they are taken to clinical trial. These methods focus on assessing minimally invasive treatments for the intervertebral discs (the soft tissues between the vertebrae); disc degeneration is one of the main causes of back pain. The methods have been used to evaluate hydrogels developed in this project as well as tissues treated through therapeutic ultrasound developed in a joint grant at the University of Oxford.
The new hybrid peptide hydrogels were developed and evaluated in this project for intervertebral disc repair; these gels mimic the properties of the healthy tissue to draw in water and create a swelling pressure. The gels can be injected as liquids down very narrow gauge needles, reducing risk of damage to the surrounding tissue structures. We found the gels were able to restore healthy disc height and biomechanical performance in cyclic loading to the levels seen in healthy tissue.
Exploitation Route The methods developed are being used to evaluate a new treatment for disc degeneration. The methods are being used both internally and with external partners.
The hydrogels have been patented (granted in US, pending in EU) and further tests are ongoing in an in vivo model - if successful then commercial partners will be sought to develop the gels as a clinical product.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

 
Description Membership of Royal Academy of Engineering Panel for Biomedical Engineering
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact The panel has published a number of reports and briefing papers. Details are here: http://www.raeng.org.uk/policy/engineering-policy/panel-for-biomedical-engineering/publications
URL http://www.raeng.org.uk/policy/engineering-policy/panel-for-biomedical-engineering
 
Description Presented 'provocation' and participated in Wellcome Health Exchange - Wellcome Trust discussion on healthy aging research chaired by Eliza Manningham-Buller (Ruth Wilcox)
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description Provided evidence and represented RAEng at Royal College of Surgeons Commission on the Future of Surgery (Ruth Wilcox)
Geographic Reach National 
Policy Influence Type Participation in a national consultation
URL https://futureofsurgery.rcseng.ac.uk/?_ga=2.204377936.1302407628.1552062378-663961335.1547802634
 
Description Healthcare Technologies Programme Grant
Amount £3,962,447 (GBP)
Funding ID EP/N02480X/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 10/2016 
End 09/2021
 
Title intervertebral disc mechanical testing to assess nucleus augmentation 
Description New method developed to biomechanically test in vitro intervertebral disc tissue for the examination of nucleus augmentation devices 
Type Of Material Model of mechanisms or symptoms - in vitro 
Year Produced 2016 
Provided To Others? Yes  
Impact Outcomes from testing being used to inform and optimise the design of nucleus augmentation interventions internally and with external research groups. 
 
Title Data Associated with paper titled: Peptide:glycosaminoglycan hybrid hydrogels as an injectable intervention for spinal disc degeneration. 
Description Data Associated with paper titled: Peptide:glycosaminoglycan hybrid hydrogels as an injectable intervention for spinal disc degeneration. Data includes FTIR, TEM, optical micrographs, and processed numeric data used in the figures. 
Type Of Material Database/Collection of data 
Year Produced 2016 
Provided To Others? Yes  
Impact Database has been made openly available. It has been used internally by other researchers in the group and university. External access has not yet been cited. 
URL https://doi.org/10.5518/47
 
Title Mengoni and Wilcox Ovine FSU data 
Description 8 cervical functional spinal units from 5 ovine spines: CT scan images, mechanical compression (load, displacement, pressure and image information) and FE models 
Type Of Material Database/Collection of data 
Year Produced 2016 
Provided To Others? Yes  
Impact Database released with paper to enable other researchers to access and compare data. Greater impact likely in future once data has been used. 
URL http://archive.researchdata.leeds.ac.uk/id/eprint/22
 
Title Ovine annulus fibrosus interlamellar material model calibration data set 
Description Experimental data: microscopy images and geometrical data of unloaded and radially loaded samples of ovine lumbar annulus fibrosus tissue; Computational data: input file and raw results of load/extension FE models built from the experimental data; Results data: values of calibrated interlamellar behaviour 
Type Of Material Database/Collection of data 
Year Produced 2015 
Provided To Others? Yes  
Impact Data released to enable other researchers to apply or reuse for additional purposes. Great impact likely once data has been used and published. 
URL http://archive.researchdata.leeds.ac.uk/id/eprint/2
 
Title NOVEL PEPTIDE COMPLEXES 
Description The invention relates to novel self-assembling peptide complexes comprising a charged peptide and a polysaccharide, methods of producing them and uses therefor. The novel self-assembling peptide complexes of the present invention have particular utility in the restoration of biomechanical or biochemical function of a variety of biological tissues, for example and without limitation, in degenerated spinal discs, osteoarthritic joints, damaged cartilage, meniscus, ligaments, tendons, dental, ophthalmic and cardiovascular and blood vessel tissues. The invention provides inter alia methods of repairing and or restoring biomechanical or biochemical function of biological tissues and scaffolds for the support of cell growth. 
IP Reference US2016058871 
Protection Patent granted
Year Protection Granted 2016
Licensed No
Impact Follow on funding obtained for first in vivo study
 
Title Novel peptide complexes 
Description The invention relates to novel self-assembling peptide complexes comprising a charged peptide and a polysaccharide, methods of producing them and uses therefor. The novel self-assembling peptide complexes of the present invention have particular utility in the restoration of biomechanical or biochemical function of a variety of biological tissues, for example and without limitation, in degenerated spinal discs, osteoarthritic joints, damaged cartilage, meniscus, ligaments, tendons, dental, ophthalmic and cardiovascular and blood vessel tissues. The invention provides inter alia methods of repairing and or restoring biomechanical or biochemical function of biological tissues and scaffolds for the support of cell growth. 
IP Reference WO2014167310 
Protection Patent application published
Year Protection Granted 2014
Licensed No
Impact Follow-on funding obtained. Commercialisation workshop held as a demonstrator for JRI Ltd and used to map routes for future commercialisation/impact. Further applications being explored through PhD projects.
 
Title 2DImage2Mesh by Mengoni, M. A Python code to generate quadrangular meshes on images 
Description 2DImage2Mesh, a python code to generate quadrangular meshes on images: conversion of triangular shells from scanIP to quadrangular plane stress or strain in Abaqus 
Type Of Technology Software 
Year Produced 2015 
Open Source License? Yes  
Impact Software used internally to accelerate process of finite element model generation. 
URL https://github.com/mengomarlene/2DImage2Mesh/tree/0.2
 
Title opti4Abq, by Mengoini M. A generic Python code to run Abaqus in an optimisation loop 
Description An optimisation method via scipy.optimize that runs on a set of Abaqus finite element models to minimise the difference (in a least square sense) between the FEA output and the a corresponding set of data 
Type Of Technology Software 
Year Produced 2015 
Open Source License? Yes  
Impact Method used extensively internally to derive tissue material parameters in specimen-specific finite element models of different tissues to match to corresponding experimental data. 
URL https://github.com/mengomarlene/opti4Abq/tree/0.2
 
Description CONFERENCE ABSTRACT - ICCB - VII International Conference on Computational Bioengineering (2017) Fernando Zapata Cornelio 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact • Zapata-Cornelio F.Y., Mengoni M., Wijayathunga V.N. & Wilcox R.K. (Sept 2017) The use of 3D in-vitro intervertebral disc bulge in the validation of specimen-specific finite element models. Proceedings of ICCB - VII International Conference on Computational Bioengineering, Compiègne, France
Year(s) Of Engagement Activity 2017
 
Description CONFERENCE ABSTRACT - Global Spine Congress, Milano, Italy (Oluwasegun Kayode) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact • Kayode O., Sikora S.N.F., Wilcox R.K. & Mengoni M. (May 2017) Characterisation of the annulus fibrosus in-vitro mechanical behaviour requires a specimen-specific approach. Proceedings of the Global Spine Congress, Milano, Italy
Year(s) Of Engagement Activity 2017
 
Description CONFERENCE ABSTRACT - ISB - XXVI Congress of the Int. Society of Biomechanics (Australia) Fernando Zapata Cornelio 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact • Zapata-Cornelio F.Y., Mengoni M., Wijayathunga V.N. & Wilcox R.K. (July 2017) A new methodology for the validation of in-silico intervertebral disc models using CT imaging under load. Proceedings of ISB - XXVI Congress of the Int. Society of Biomechanics, Brisbane, Australia
Year(s) Of Engagement Activity 2017
 
Description CONFERENCE ABSTRACT 2 - ICCB - VII International Conference on Computational Bioengineering (2017) Fernando Zapata Cornelio 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact • Zapata-Cornelio F.Y., Sikora S.N.F., Gregory D.E., Wilcox R.K. & Mengoni M. (Sept 2017) On measuring pre-strain and functional extrafibrillar behaviour of the annulus fibrosus to reverse-engineer its fibrous behaviour. Proceedings of ICCB - VII International Conference on Computational Bioengineering, Compiègne, France
Year(s) Of Engagement Activity 2017
 
Description Exhibit at Big bang Fair 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Schools
Results and Impact Researchers developed 'We've got your back' stand to promote medical engineering to wider public. High levels of engagement from participants.

>3000 visitors over course of the event.
Year(s) Of Engagement Activity 2014
URL http://www.thebigbangfair.co.uk
 
Description Great Yorkshire Show 
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 Stand at Great Yorkshire Show showcasing research activities of group and their impact on healthcare. Visited by >4000 people over the course of the event.
Year(s) Of Engagement Activity 2016
 
Description Great Yorkshire Show 11th - 13th July - Ruth Wilcox 
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 iMBE regularly have an exhibit at the Great Yorkshire Show where the work conducted by all areas of the Institute is disseminated to the general public by displays, hands on models, computer screens and explanations by the participants.• Exhibit at Great Yorkshire Show, July 11-13 2017. Event attracts 130,000 with estimated 3,000 visitors to our exhibit which included 'build a knee' activity, cycling skeleton and examples of various medical devices for the knee. (organiser: Edwards; participating staff: Wilcox, Jennings, Jones, Liu)
Year(s) Of Engagement Activity 2017
 
Description Hosted laboratory visit for Leeds Biomedical Research Centre Patient Public Involvement group 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Patients, carers and/or patient groups
Results and Impact Hosted a laboratory tour and series of talks from academic members of the Institute of Medical and Biological Engineering for members of the Leeds PPI group
Year(s) Of Engagement Activity 2018
URL https://youtu.be/cKfs50-NxJQ
 
Description Invited Talk University of Iowa 2017 - Marlene Mengoni 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Capturing population variation in subject-specific FE models of the spine and the hip, U. Iowa, July 2017
Year(s) Of Engagement Activity 2017
 
Description Invited presentation University of Zaragoza - Marlene Mengoni 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Direct-controlled validation: towards capturing population variation in subject-specific Finite Element models of the spine. U. Zaragoza, March 2017
Year(s) Of Engagement Activity 2017
 
Description Invited talk 'On the concept of "context of use" in Finite Element models of the spine.' at U. Exeter by Marlene Mengoni 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Invited seminar at University of Exeter to raise awareness of computational modelling methods and issues to wider technical audience
Year(s) Of Engagement Activity 2018
 
Description Leeds Fesitval of Science and Be Curious Festival Leeds 
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 A number of activities were held during the 2016 Leeds Festival of Science including our Great Bones workshop and stands at the 'Be Curious' Festival. The Be Curious Festival is a free, interactive event suitable for everyone with an interest in health, wellbeing and the human body, held at the University of Leeds. It saw over 1000 members of the public attend, a third of them were young people and almost everyone rated the event as very good.
Year(s) Of Engagement Activity 2016
URL http://www.stem.leeds.ac.uk/events/lfos/lfos-public-programme/becurious/
 
Description Local engagement activities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach Local
Primary Audience Schools
Results and Impact Stands always very popular with large numbers of delegates attending and requests to hold follow-on activities with schools and exhibit at future events.

Extremely positive feedback from attendees, teachers and parents, leading to increasing requests to provide exhibits for other events
Year(s) Of Engagement Activity 2009,2010,2011,2012,2013
 
Description POSTER - MEDE2017 (Seb Sikora) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact Poster - Reducing variance of pre-clinical testing for inter-vertebral disc interventions.
Year(s) Of Engagement Activity 2017
 
Description POSTER MeDe 2017 - James Warren 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact • Development of a minimally invasive therapy for intervertebral disc degeneration using synthetic peptides.
Year(s) Of Engagement Activity 2017
 
Description Poster - MeDe 2017 - Marlene Mengoni 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Industry/Business
Results and Impact • in-silico evidence helps to understand variability in pre-clinical testing of spinal interventions.
Year(s) Of Engagement Activity 2017
 
Description Royal Academy of Engineering Panel for Biomedical Engineering 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Participants in your research and patient groups
Results and Impact Event promoted collaboration and career development for early-career medical engineers with advice from expert mentors and funders.

Feedback from delegates very positive with 100% rating the networking opportunities and quality of the speakers and mentors as good or excellent.
Year(s) Of Engagement Activity 2014
URL http://www.raeng.org.uk/publications/reports/young-researchers-futures-meeting-orthopaedic
 
Description Science for a Successful Nation 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Presented stand depicting our research highlights to illustrate the importance of sustained funding as part of the EPSRC Science for a Successful Nation event
Year(s) Of Engagement Activity 2015
URL https://www.epsrc.ac.uk/newsevents/news/sciencesuccessfulnation/
 
Description U3A Harrogate 10th July 2017 - Ruth Wilcox 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact U3A Harrogate - explanation and dissemination of activities of the Institute of Medical & Biological Engineering
Year(s) Of Engagement Activity 2017