Smart Manufacturing of Medical Devices for soft tissue fixation

Lead Research Organisation: University of Bradford
Department Name: Sch of Engineering Design and Technology

Abstract

We will research smart manufacturing routes, which impart controllable enhancement of properties and functionality of polymers and polymer composites whilst achieving precision geometry products. These will be relevant to a range of potential medical devices, selected with our industry partners, Zmith * Nephew, Wittman Battenfeld and Corbion Purac, particularly those exploiting shape memory functionality and surface feature control. The initial focus is for soft tissue fixation to bone (e.g. rotator cuff and anterior cruciate ligament (ACL) repairs); longer-term goals include fixations for fracture (including intermedullary nails) and knee joint replacements.

Solid phase orientation processing of polymers at temperatures above their glass transition point, but below their melting point, provides the major route to imparting a wide range of polymer molecular orientation, from low up to very high levels. This can be utilized to create dynamic devices which change shape in-situ on exposure to temperature or, potentially, body fluid, allowing the device to adapt to the surrounding bone topology. Protype devices will be manufactured from known resorbable or inert polymers, inorganic particles and suitable plasticisers all having known clinical history. The devices will be programmed to mechanically function and then degrade to expose known inorganic salts/scaffolds which can then be used to promote osteogenesis. In the case of medical implants such as tissue fixations, the recovery typically needs to take place at an appropriate temperature to avoid tissue damage (so less than ~50C), or (more challenging) be driven by exposure to body fluids, and to occur in an acceptable timescale to the operating clinicians (e.g. less than 15 s), and to retain fixation strength over required timescales (months for bioresorbables, permanent for non-resorbables).

In addition to the solid phase orientation processing route, a range of melt processing techniques can be used to obtain (in general) lower levels of orientation but which may have other advantages in terms of manufacturing, including net shape processing. Novel variants of these are explored in the Research Programme,including:
(a) micromoulding (single shot property gradient products, or over-moulded products, and surface feature control),
(b) micro-extrusion (for precision preforms for die drawing, or controlled surface continuous products), and
(c) hybrid processing, such as a novel injection-drawing process.

Manufacturing challenges to be addressed include (i) the overall goal of 'Smart Manufacturing', defined here as the effective control of property levels through processing, simultaneous with achieving precision geometry products at economic production rates for shape memory polymers; (ii) materials and additives suitability, combined with processability for the complex requirements for bioresorbable fixations; (iii) formation of starting materials suited to manufacturing routes, and (iv) refined modelling for developed understanding of solid and melt phase processing, vital in developing understanding of the processes and process design.

Planned Impact

The UK is generally recognised as having a strength in medical device technology and manufacturing. Our major collaborator, S&N is the largest medical device manufacturer in Europe and is UK-owned and head-quartered. Many of the other large medical device companies maintain manufacturing and/or R&D operations in the UK. Another driver of the UK medical device industry is the large number of SMEs that operate in this field. These companies are R&D oriented and frequently work in emerging areas of technology. The project therefore benefits both established large companies, leading to an immediate commercial impact, and has potential longer term impact on emerging industry through the creation of new product concepts enabled by the manufacturing techniques developed. The work can thus contribute to the success of the UK economy in both the short and longer term, and help to maintain the UKs lead in this strategically important area. The project addresses the key societal challenge of an ageing population as well as the needs of younger, active patients. Less invasive implants can lead to shorter hospital stays and faster rehabilitation, thus reducing pressure on the NHS. The programme addresses the EPSRC challenge theme of Healthcare Technologies, and more specifically the strategic priority areas within that theme of "Novel treatment and therapeutic technologies" (via development of novel SMP materials and implants) and "Design, manufacture and integration of healthcare technologies" (via innovative manufacturing methods).

Our process structuring research for polymer-related materials is at the heart of this proposal for 'smart manufacturing' of medical devices and has had significant impact in fundamental research results through to commercial spin outs, and has achieved high levels of academic and industrial collaboration, and a strong international cooperation platform. The current proposal will build upon these successes - in our university, regionally and nationally, and internationally, all to the clear benefit of the UK. The resourcing will be from a partnership of EPSRC, the University of Bradford, the supply chain in industry, and will also have international academic collaborators, in particular Sichuan University. It will have valuable synergy with the new Centre for Innovative Manufacturing in Medical Devices.

There is clear national and international value in the programme as our programme aims to focus on smart manufacturing (which we define here as the effective control of property levels through processing, simultaneous with achieving precision geometry products at economic production rates) exploiting advanced materials for development of medical device products aligned with strategic priorities of the British government in health delivery policies and associated industries - very much in line with EPSRC priorities in Manufacturing the Future, both in terms of novel, high value-added products from controlled, precision manufacturing routes which exploit our underpinning scientific knowledge, and doing this in a 'resource efficient' manner, by significantly enhancing the properties or functionality of specific polymers, creating significant added-value, and also EPSRC priorities in Healthcare Technologies.
Internationally, our project aligns with UK-China agreed strategic priorities for research collaboration. The international angle is of particular interest for impact, given the global nature of our sector and its supply chains, and the common demography issues related to aging populations. Such visibility attracts new collaborations with high level international companies as well as the excellent collaborations we have with the lead partner in this proposal, Smith & Nephew, so building capacity, and new funding streams, all contributing to increased engagement in research. Outputs will also include high quality journal publications, international conference presentations and joint IP.
 
Description A range of bioresorbable polymers suitable for shape memory behaviour for soft tissue fixations have been identified and used to make cementless fixations with good strength of connection.
Also, ultra precision microinjection moulding has been shown to provide some shape memory behaviour, opening up possibilities of net-shaped fixation devices. In addition, reversion moulding of shape memory devices has been further demonstrated. Die drawn shape memory sutures have been produced, with silver (antimicrobial) particles in collaboration with Nottingham Uni.
Exploitation Route potential development of bioresorbable soft tissue fixations including anchors and sutures; next step is the EPSRC HIP 3 year programme on Shape memory polymer bone and soft tissue fixations, in collaboration with Innovate Orthopaedics.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

 
Description 1. opened up discussions with other companies and surgeons for novel soft tissue fixation devices; 2. transfer of die drawing technology to an SME associated with our research; 3. support for a recent successful (top ranked) bid to EPSRC Healthcare Impact Partnerships; 4 research being directed towards other orthopaedic applications by Fortius Clinic surgeons for shape memory fixations.
First Year Of Impact 2017
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Societal

 
Description British Council Newton Researcher Links 'Healthcare Technologies for Aging Populations'
Amount £24,000 (GBP)
Funding ID 227337704 
Organisation British Council 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2016 
End 01/2017
 
Description EPSRC Healthcare Impact Partnership
Amount £904,074 (GBP)
Funding ID EP/R024324/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 07/2018 
End 06/2021
 
Description Oriented polymer processing - Sinopec BRICI
Amount £357,000 (GBP)
Organisation Sinopec Group 
Sector Private
Country China
Start 07/2018 
End 06/2021
 
Description Royal Academy of Engineering Fellowship
Amount £20,000 (GBP)
Funding ID 1314RECI013 
Organisation Royal Academy of Engineering 
Sector Learned Society
Country United Kingdom
Start 07/2014 
End 05/2015
 
Description Royal Society Newton Advanced Fellowship
Amount £111,000 (GBP)
Funding ID NA150222 
Organisation The Royal Society 
Sector Academic/University
Country United Kingdom
Start 09/2015 
End 08/2018
 
Description SelfGel technology: Polymer free and temperature independent bioadhesive in-situ gelling system UK ICURe Award
Amount £35,000 (GBP)
Funding ID IC1-20 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 07/2018 
End 09/2018
 
Description contract
Amount £5,000 (GBP)
Organisation JRI Orthapaedics 
Sector Private
Country United Kingdom
Start 04/2017 
End 04/2017
 
Description Aterius oriented polymer stents 
Organisation Arterius Limited
Country United Kingdom 
Sector Private 
PI Contribution precision small scale die drawing of bioresorbable polymers to make oriented tubes, used to laser cut stents. Shared IP with Arterius
Collaborator Contribution Original approach to us from Arterius, IP (shared), for use of our oriented polymer routes.
Impact the only British drug eluting, resorbable stent - currently close to commercialisation, in trials. Combination of engineering sciences and pharmaceutical science.
Start Year 2009
 
Description Innovate Orthopaedics - soft tissue and bone fixations 
Organisation Innovate Orthopaedics Ltd
PI Contribution Solid phase orientation of polymers for a range of soft tissue and bone fixation shape memory devices
Collaborator Contribution technical and market knowledge for fixations, and clinician connections
Impact new 3 year EPSRC HIP grant being announced, March 2018
Start Year 2017
 
Description Joint International Laboratory for Polymer Micro Processing 
Organisation Sichuan University
Country China 
Sector Academic/University 
PI Contribution Establishment of a micro moulding facility in Sichuan, to mirror the (more extensive) facilities in Bradford, to develop further our collaborative research. Joint IP for conducting polymer products.
Collaborator Contribution Materials engineering expertise, including polymer nano composite products, especially for electrically conducting products. Joint IP for conducting polymer products.
Impact Joint publications. Joint IP
Start Year 2010
 
Description Joint International Laboratory for Soft Matter Technologies 
Organisation Beijing University of Technology
Department College of Environmental and Energy Engineering
Country China 
Sector Academic/University 
PI Contribution Hosting Researcher Exchanges leading to joint publications; advisory role with respect to development of particular technologies
Collaborator Contribution sending researchers to our laboratory, leading to joint publications; Support (from Prof Zhang Liqun) for meetings with the Ministry of Science & Technology in Beijing
Impact joint publications
Start Year 2016
 
Description Joint Laboratory for Polymer Process Physics 
Organisation Changchun Institute of Applied Chemistry
Country China 
Sector Academic/University 
PI Contribution Royal Society Newton award, following Science Bridges China researcher exchanges (two way)
Collaborator Contribution High quality x-ray analysis of oriented polymers
Impact Journal papers (Macromolecules)
Start Year 2015
 
Description Sabic programme on micro needle manufacture 
Organisation Saudi Basic Industries Corporation
Country Saudi Arabia 
Sector Public 
PI Contribution research skills and facilities
Collaborator Contribution commercial opportunities and materials tailoring
Impact confidential to company
Start Year 2015
 
Description Sabic programme on solid phase orientation processing 
Organisation Saudi Basic Industries Corporation
Country Saudi Arabia 
Sector Public 
PI Contribution unique solid phase orientation processing research and facilities
Collaborator Contribution targeted products to exploit solid phase orientation
Impact confidential to company
Start Year 2015
 
Description Sinopec solid phase orientation project 
Organisation Sinopec Group
Country China 
Sector Private 
PI Contribution research skills and facilities for solid phase orientation processing of polymers
Collaborator Contribution materials manipulation and supply
Impact confidential to company
Start Year 2013
 
Description Smith & Nephew programmes 
Organisation Smith and Nephew
Country United Kingdom 
Sector Private 
PI Contribution solid phase processing of polymers and development of shape memory materials and products for tissue fixations. Joint IP on these materials and products.
Collaborator Contribution Development of shape memory materials and products for tissue fixations. Joint IP on these materials and products. Clinical challenges and assistance.
Impact extensive knowledge on shape memory materials for potential products in fixations. Combination of physics, mechanical engineering, biomedical engineering, biomaterials, medical technology.
 
Title Method of producing a tube for use in the formation of a stent, and such tube 
Description Development of bioresorbable oriented polymer arterial stents, based on Bradford's die drawing technology. European Patent App. 
IP Reference WO2014045068 
Protection Patent granted
Year Protection Granted 2014
Licensed Commercial In Confidence
Impact this is the only UK-based route to bioresorbable polymer stents, from a company set up in the University of Bradford incubator.
 
Title bioresorbable polymer arterial stent 
Description Arterius Ltd have previously secured InnovateUK funding with us, and have most recently undertaken in-animal trials which show a very successful performance of the stents compared with market leading metallic stents. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Initial development
Year Development Stage Completed 2017
Development Status Under active development/distribution
Impact die drawing technology transferred from the University to Arterius who now have a precision processing facility in a clean room in their company. 
URL http://arterius.co.uk
 
Title bioresorbable soft tissue fixation 
Description Discussions being held with companies to exploit the potential of shape memory fixations 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2016
Development Status Under active development/distribution
Impact still being developed 
 
Description Article in China Daily, 9 Jan 2018 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact China Daily article in Beijing, after the Award Ceremony for the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, presented by President Xi Jinping and other leaders. This is the top award in China for foreigners. Prof Phil Coates was one of the seven foreigners honoured with the award. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://www.chinadaily.com.cn/a/201801/09/WS5a53fa36a31008cf16da5d10.html
 
Description British Council Newton Researcher Links Workshop for Early Career Researchers 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact 13 UK-China Researcher Exchanges (funded separately from the Workshop) are being set up to run before Sep 2017
Year(s) Of Engagement Activity 2016
URL http://www.ukchina-amri.com
 
Description CCTV longer interview 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact CCTV mainstream news - my experience of the Golden Era through my research collaborations, and a celebration of the top award in China to a foreign scientist.
Year(s) Of Engagement Activity 2018
URL http://www.ukchina-amri.com
 
Description China Daily Europe article on top award in China made to Prof Phil Coates; 12 Jan 2018 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact China Daily article in Europe, after the Award Ceremony in Beijing for the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, presented by President Xi Jinping and other leaders. This is the top award in China for foreigners. Prof Phil Coates was one of the seven foreigners honoured with the award. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://europe.chinadaily.com.cn/a/201801/12/WS5a57acafa3102c394518ea1e.html
 
Description Chinese International Award 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Articles in China Daily - in English - in the UK and China; and other Chinese national newspapers concerning the Award to Prof Coates of the International Science & Technology Cooperation Award, the top award in China for a foreign scientist.
Year(s) Of Engagement Activity 2018
URL http://www.ukchina-amri.com
 
Description ECNS China article on top Chinese Award to Prof Phil Coates, 12 Jan 2018 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact ECNS article in Beijing, after the Award Ceremony for the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, presented by President Xi Jinping and other leaders. This is the top award in China for foreigners. Prof Phil Coates was one of the seven foreigners honoured with the award. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://www.ecns.cn/business/2018/01-12/288042.shtml
 
Description Interview for CCTV 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Interview of 3 leading UK people for opinion on developments in China, based on our experience - in my case research collaborations
Year(s) Of Engagement Activity 2017
 
Description SPE International Award in Plastics News (USA based publication, also in Europe and Asia) 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Announcement of the Society of Plastics Engineers Intenational award, the top award of the SPE, to Prof Phil Coates. This increases the visibility of the UK in the polymer engineering research area, where Prof Coates directs the world-leading Polymer IRC. The Award will be presented in May 2018 at the SPE major international conference, with a Plenary lecture.
Year(s) Of Engagement Activity 2018
URL http://www.plasticsnews.com/article/20180222/NEWS/180229963/spe-names-annual-award-winners-antec-spe...
 
Description Sichuan University article following top China Award to Prof Phil Coates in Jan 2018 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact Sichuan University article, after the Award Ceremony for the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, presented by President Xi Jinping and other leaders. This is the top award in China for foreigners. Prof Phil Coates was one of the seven foreigners honoured with the award. He is an Honorary Professor and High End Foreign Professor of Sichuan University, who are one of the main collaborators with Bradford and others in our ongoing Science Bridges China programme. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://www.scu.edu.cn/en/news/webinfo/2018/01/1514127424326967.htm
 
Description Xinhua article on China Award for Prof Coates 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Xinhua press article in Beijing, after the Award Ceremony for the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, presented by President Xi Jinping and other leaders. This is the top award in China for foreigners. Prof Phil Coates was one of the seven foreigners honoured with the award. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://www.xinhuanet.com/english/2018-01/08/c_136880680_10.htm
 
Description article in China Daily, 19 Jan 2018 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Interview of Prof Coates by China Daily in Beijing, after he received the International Science & Technology Cooperation Award of the People's Republic of China, Jan 2018, from President Xi Jinping and other leaders. This is the top award in China for foreigners. It increased the visibility of the UK in China (Prof Coates was only the sixth UK citizen to receive this award in over 20 years) and has given further momentum to the UK-China advanced materials for healthcare research community which he founded, and continues to lead, from the EPSRC-funded Science Bridges China platform. This top Award has very great significance for our key Chinese collaborators, and will promote and strengthen our research collaborations.
Year(s) Of Engagement Activity 2018
URL http://www.chinadaily.com.cn/a/201801/19/WS5a61c69fa3106e7dcc13562d.html