Nano Materials and Structures for Superior Implants (Nanoplants)

Lead Research Organisation: Loughborough University
Department Name: Materials

Abstract

Various RCUK funded projects at Loughborough University over the years have delivered significant foreground intellectual property and technology know-how related to the fabrication of nanostructured materials with outstanding properties, surpassing some of the commercial counterparts, relevant to the energy, electronic security and in particular healthcare sectors. Specifically it has been demonstrated that the hydrothermal ageing (HTA) resistance of zirconia based ceramics can be enhanced significantly by retaining a nano grain size below 180 nm even at low density components. This is highly relevant to the ~$5B hip replacement market where concerns about the toxicity / wear debris in metal and polymer components renders all-ceramic solutions increasingly attractive. HTA degradation (the unwanted conversion of tetragonal zirconia to a weaker monoclinic form in an aqueous environment) is the Achilles-heel for the use of zirconia ceramics in biomedical sector and was the reason behind the well-publicised failure of zirconia hip replacements around 2000. Thus, when HTA is countered, new opportunities open up. The proposed technology (involving novel nano-suspension control, granulation and then microwave assisted hybrid heating as well as flash sintering regimes; zirconia toughened alumina and zirconia ceramics will be considered) aims to deliver very small zirconia grain sizes that will both assist current compliance (e.g. ISO 13356, ISO 633-3) and open up novel all-ceramic hip replacements via multi-fold enhancement in HTA-resistance of porous and dense graded zirconia based structures. The methodology will be applicable to ceramic-metal graded implant structures also with suitable modifications. The retention of nano-size throughout all stages of ceramic component production is critical to delivering the target end properties that will assist the health and quality of life in a growing ageing population. This will be achieved via the development of implant structures (applicable for hip/knee prosthesis, finger joints and jaw & skull repairs) that deliver improved mobility over a longer time period thus reducing reliance on repeat surgery and in some cases confinement to use of wheelchair.

Planned Impact

2008 data estimates that the global hip replacement market is ~$5.6B. Knees and Spines account for a further $6.7B and 8.1B respectively and adding in trauma, extremity, sports segments create a total market of ~$31B. Between 1995 and 2008, it enjoyed a 10-15% per annum growth rate. Despite the recent economic down-turn, growth rates remain at >6%.The business opportunity addressed by this project is to create hip (and subsequently other bone) replacement components featuring a superior performance nano-ZTA or nano-zirconia and thus make in-roads firstly into the $5.6B world-wide hip replacement market and subsequently within the ~$31B world-wide orthopaedics market. Based on Hip and Knee market data, Europe has a 30 % share of the market, whilst the USA has a 50% share; it should also be noted that use of ceramics is increasing with an average 20% of implants using ceramics predicted for 2013 and above. Interestingly, Europe (up to 50% utilisation) is embracing ceramics more than the US (5% utilisation) meaning significant future export opportunities. A closer inspection of the market data also suggests that the USA, Europe and Japan account for 80% of the market, even though from a population perspective, these regions make up just 20% of the 6.7B world population. This illustrates the huge global growth potential in this area: As the standard of living in India, China, other countries rises, so will the demand for joint replacement operations.
The project partner foresees at least a doubling of their ~1M current hip markets by 2017. LU sees significant IP generation and licensing opportunities. MAM supplies components that are used in the final implant (femoral head, acetabular cup) assemblies ultimately implanted by surgeons. Companies supplying final assemblies include the following big companies (turnovers adjacent): Stryker $5.75B; J&J $4.93B; Zimmer $3.99B; S&N $2.93B. Though not part of this consortium, such companies will have a key role to play in commercialising any nano-ceramic component emerging from the project. From an environmental aspect, nano-zirconia and eco-friendly microwave and flash sintering offers the potential for lower sintering temperatures (~300-600C reduction in peak firing temperatures respectively). This will lead to significant energy savings and less CO2 emissions.
Currently 61% of joint replacements are for the 65+ age group and 36% are at 45-64, figures in both age categories are set to rise as people live longer and younger people are increasingly willing to pay for operations that allow them to enjoy sports that place a strain on joints for longer. Being able to offer patients just one hip replacement during their life can have a massive impact on quality of life and hospital costs. In 2008 there were nearly 74,000 hip replacements (50,500 NHS) in the UK. A mean stay of a week in hospital and a "cost per day in hospital" of £225 leads to £80M/year NHS cost. It can be seen that 1 instead of 2 hip replacements will bring significant benefits. The goal of achieving implant surface porosity opens up the option of having slow release anti-bacterial agents that could prevent the 2-3% rate of infections associated with hip and knee replacements annually, that further costs £5.2M to NHS. Alternatively, if impregnated with mechanically enhanced hydroxyapatite, the porous surface could provide anchorage points for live bone (see Case for Support). This could reduce the recuperation time and pressure on hospital beds.
Sale of products and a reduction in raw material consumption and recycling, or increased market share through sales of superior products that may also be more durable, will help assisting in waste minimisation. Production costs can also be lowered, raising UK competitiveness and encouraging growth in UK advanced ceramics production via development of innovative and sustainable high value products, something identified as critical in the face of low cost competition.

Publications

10 25 50
 
Description The ability to produce genuinely nanostructured ceramic components suitable for healthcare, defence, electronic and energy applications using both conventional and field assisted processing methods. For the first time these components were also demonstrated to be manufactured with nanostructure, high density and significant design freedom using additive manufacturing (3D printing) methods in combination with microwave/flash sintering techniques.
Exploitation Route The enormous design freedom provided by the digital manufacturing techniques and the significant time and energy reduction obtained through field assisted processing methods auger well for the fabrication of engineering ceramic components (both simple and complex shaped) for a number of application sectors viz., healthcare, electronic, defence, transport etc.
Through a spin-off project with one of the Nanoplants partner Morgan Advanced Ceramics - the hydrothermal testing protocols we developed have been adopted recently to perform accelerated tests to predict product lifetime of metal and ceramic reflective block sensors used in next generation ultrasonic smart flow meters - a trait that is extremely helpful to design them and reliably measure fluid flows in domestic as well as industrial situations (see press release: http://www.dpaonthenet.net/article/107091/Industry-and-Academia-go-with-the-flow.aspx ).
A Plenary lecture was presented in the International Conference on Biomaterials Innovation, India , December 2020.
Sectors Aerospace, Defence and Marine,Education,Electronics,Energy,Healthcare,Manufacturing, including Industrial Biotechology,Security and Diplomacy,Transport

URL https://www.researchgate.net/publication/346544643_Plenary_Lecture_on_Additive_Manufacturing_of_Nanostructured_Bioceramic_Implants_International_Conference_on_Biomedical_Materials_Innovation_December_2020
 
Description For the first time nanostructured zirconia and ZTA based ceramic components, femoral heads, acetabular cups, dental implants were manufactured using additive manufacturing and field assisted sintering techniques. This has opened up a huge potential for personalised healthcare options as well as highly complex shaped ceramics production with significant design freedom. This can be applied further to the development of highly efficient energy materials, electronic ceramics, armour systems as well as functionally gradient materials for demanding applications. Recently BBC4 invited LU's advanced ceramics group to feature in a Documentary (Oct 2018) on "The Secret Story of Stuff: Materials of the Modern Age" . This programme explored the world of material science, uncovering the innovations in manufacturing that are set to change the world we live in. The Consul General of India Visited Loughborough University on 15th February 2022 to help forge research, teaching and enterprise links with India. He visited the School of AACME and our world leading research and innovation labs on Advanced Ceramics and 3D printing along with Power Trains, EV/Unmanned Vehicles, LMCC, Caterpillar IRC, LMCC etc.
First Year Of Impact 2022
Sector Aerospace, Defence and Marine,Digital/Communication/Information Technologies (including Software),Education,Electronics,Energy,Environment,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology,Transport
Impact Types Cultural,Societal,Economic,Policy & public services

 
Description Grand Challenge
Amount £4,000,000 (GBP)
Funding ID EP/N010493/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 03/2016 
End 02/2021
 
Description Knowledge Transfer Partnership
Amount £232,234 (GBP)
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 06/2017 
End 06/2020
 
Description Rapid manufacture of solid-state battery structures by additive manufacturing and Flash sintering
Amount £240,264 (GBP)
Funding ID 10007480 
Organisation Innovate UK 
Sector Public
Country United Kingdom
Start 06/2021 
End 07/2022
 
Description Invited member of the advisory mentoring committee 
Organisation Indian Institute of Science Bangalore
Country India 
Sector Academic/University 
PI Contribution PI has been invited to be a member of the advisory committee for their Translational Centre of Excellence in Biomaterials
Collaborator Contribution They are also working in the area of ceramics and composites for biomedical applications and are keen for us to take part in the discussions, mentoring and guidance to achieve the CoE's vision.
Impact Not yet.
Start Year 2016
 
Description Invited to Ivoclar Vivadent Company to discuss possible collaboration 
Organisation Ivoclar Vivadent AG
Country Liechtenstein 
Sector Private 
PI Contribution The work developed under Nanoplants grant was responsible for this industrial invitation. The pioneering research conducted on 3D printing and flash sintering of bioceramic components at Loughborough by the team was instrumental for this collaboration.
Collaborator Contribution They contacted us for initiating the collaboration based on our reputation in this area.
Impact A meeting is planned to discuss possible future collaboration activities.
Start Year 2017
 
Title DEFORMABLE GRANULE PRODUCTION 
Description A method of forming granules, the method including forming a suspension of a nanopowder such as a nano zirconia powder containing yttria. The powder is formed from a suspension, and freon is added directly to the suspension as an additive. The suspension is then granulated by spray freeze drying, and the freon subsequently removed by heat treatment. The voids left by the vacated freon provide meso, micro and macro flaws or structural defects in the granules. 
IP Reference US2011241236 
Protection Patent application published
Year Protection Granted 2011
Licensed No
Impact This discovery that was originally developed for zirconia ceramics is successfully employed for a number of nanoceramic systems such as YAG, Alumina, Zirconia Toughened Alumina etc.
 
Title DEFORMABLE GRANULE PRODUCTION 
Description This is an EU patent related to the Spary Freeze Drying of flowable and crushable nanoceramic granules for producing engineering components. 
IP Reference EP2346951 
Protection Patent application published
Year Protection Granted 2011
Licensed Commercial In Confidence
Impact It has opened up a new collaborative opportunity with world leading dental component company in Liechtenstein. This is because this patent has covered that part of the globe also and got noticed.
 
Title DOPED ZIRCONIA CERAMIC 
Description The present invention provides the use of a doped zirconia ceramic having a mean grain size of about 190 nm or less and consisting of the tetragonal zirconia crystallographic phase as a hydrothermally stable material or in an application that requires the use of a hydrothermally stable material. The present invention also provides a doped zirconia ceramic having a mean grain size of about 190 nm or less and consisting of tetragonal zirconia which does not undergo detectable tetragonal to monocli 
IP Reference EP2364282 
Protection Patent application published
Year Protection Granted 2011
Licensed No
Impact This has open up a huge interest in the nanostructed zirconia and other ceramics developed at Loughborough University and many companies have shown keen interest to engage with the Advanced Ceramics group for project colloboration in their respective fields such as defence, electronics, energy and healthcare sectors.
 
Description BBC4 documentary on our nanostructured implants work 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact Our research work on 3D printing of nanostructured ceramics for healthcare applications had featured in a hour long BBC 4 documentary titled "The Secret Story of Stuff: Materials of the Modern Age." It explores the world of material science, uncovering the innovations in manufacturing that are set to change the world we live in. See: https://www.lboro.ac.uk/departments/materials/news/2018/materials-at-loughborough-featured-in-bbc-4-documentary.html

This was also reviewed as one of the best TV educational programmes by many newspapers of the country including Guardian. https://www.theguardian.com/tv-and-radio/2018/oct/31/secret-story-stuff-tv-review
Year(s) Of Engagement Activity 2018
URL https://www.lboro.ac.uk/departments/materials/news/2018/materials-at-loughborough-featured-in-bbc-4-...
 
Description Ceramics expo - press release 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Through a spin-off project from Nanoplants our collaborating partner Morgan Advanced Materials has developed the capability to produce complex ceramic acoustic reflectors used in ultrasonic flow meters, drawing on pioneering research carried out in conjunction with Loughborough University (UK), ensuring consistent measurement accuracy over a longer projected lifespan.
Year(s) Of Engagement Activity 2017
URL http://www.ceramicsexpousa.com/resources/news/2016/12/14/morgan-announces-ceramic-acoustic-reflector...
 
Description International Keynote Talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Industry/Business
Results and Impact Invited Keynote Presentation
Year(s) Of Engagement Activity 2022
URL https://magnusconferences.com/materials-science/speaker/bala-vaidhyanathan
 
Description Interview to Technopolis Limited 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Third sector organisations
Results and Impact An interview was given to Technopolis Limited on the outcomes of the Nanoplants HIP project funded by EPSRC. This will form part of the case study document.
Year(s) Of Engagement Activity 2020
 
Description Invited presentation in a prestigeous international congress 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Gave an invited presentation in the 7th International Congress on Ceramics held at Brazil (2018). This is a very important conference for the advanced ceramic materials practitioners and it was excellent to represent our pioneering work on 3D printing of ceramics and green processing. This has resulted in an invitation to write a book with one of the most famous book publishers.
Year(s) Of Engagement Activity 2018
URL http://www.icc7.com.br/
 
Description Keynote Presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presented a keynote lecture at the International Conference on Biomaterials, BioEngineering & BioTheranostics
(BioMET 2018), In Vellore, India. The talk was extremely well received and our institution was invited to take part in further collaborative initiatives and a mutual exchange visits have taken place.
Year(s) Of Engagement Activity 2018
 
Description Plenary Lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Prestigious Plenary lecture presented at the International Conference on Biomaterials Innovation, India on December 2020 to wider audience with mix of research students, academic and industry people, healthcare professionals etc
Year(s) Of Engagement Activity 2020
 
Description Plenary talk at 17th International AMPERE Conference, Spain 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A Plenary talk in 17th International Conference on Microwave and High Frequency Heating (APERE 17), at Valancia, Spain in September 2019. The talk was extremely well received and the PI received invites to present the findings in other conferences and new discussion on future collaboration ensued. One of the researcher attended has made a successful internship application to come and work in UK from Spain.
Year(s) Of Engagement Activity 2019
URL http://ampere2019.com/plenary-keynotes-speakers/
 
Description Press Release and Ceramics Expo 
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 Industry/Business
Results and Impact Through a spin-off project with one of the Nanoplants partner Morgan Advanced Ceramics - the hydrothermal testing protocols we developed have been adopted recently to perform accelerated tests to predict product lifetime of metal and ceramic reflective block sensors used in next generation ultrasonic smart flow meters - a trait that is extremely helpful to design them and reliably measure fluid flows in domestic as well as industrial situations (see press release: http://www.dpaonthenet.net/article/107091/Industry-and-Academia-go-with-the-flow.aspx ). This developed product also planned for showcase at Ceramics Expo 2017 in USA (see: http://www.ceramicsexpousa.com/resources/news/2016/12/14/morgan-announces-ceramic-acoustic-reflector-manufacturing-capability-for-flow-metering/ ).
Year(s) Of Engagement Activity 2015,2016
URL http://www.dpaonthenet.net/article/107091/Industry-and-Academia-go-with-the-flow.aspx
 
Description Visit by the Consul General of India to the Advanced Ceramics and 3D Printing labs in the School of AACME 
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 Policymakers/politicians
Results and Impact The Consul General of India Visited Loughborough University on 15th February 2022 to help forge research, teaching and enterprise links with India. He visited the School of AACME and our world leading research and innovation labs on Advanced Ceramics, 3D printing, Power Trains, EV/Unmanned Vehicles, LMCC, Caterpillar IRC etc.
Year(s) Of Engagement Activity 2022
URL https://www.lboro.ac.uk/internal/news/2022/february/visit-by-consul-general-of-india/