Impact case studies - Institute of Medical and Biological Engineering (iMBE)

Ceramic-on-metal hip joints

We are all living longer, and for a young person with a hip joint replacement “fifty active years after fifty” means another one hundred million steps.

In young active patients current hip replacements  may fail due to wear and adverse reactions to wear debris.

We need lower wearing bearings for hip joints. Current joints comprise of a hard femoral head on a soft polyethylene that wears or  combinations of harder but similar materials.

In 2000 we researched and patented a novel differential hardness hard on hard bearing , the ceramic on metal hip, which demonstrated substantially reduced wear in the laboratory. This was assigned to DePuy  Johnson and Johnson for development.  It entered clinical trials in 2005, and has shown reduced wear in patients. It was launched in 2007 and is now sold world wide. It is estimated that between 5 and 10000 have now been implanted in patients, and it is now awaiting approval by FDA for sale in USA.

Decellularised biological scaffolds

As we live longer there is considerable interest in approaches to tissue substitution that can self repair and regenerate with patients own cells. This is particularly important for functional tissue engineering in the cardiovascular and musculoskeletal systems, where it is necessary to replace biomechanical and biological function.

In 2000 we embarked on a basic research programme to develop biological scaffolds derived from human or animal tissues, which deliver tissue specific functionality and have ability to self repair.

We have developed and patented novel tissue specific bioprocesses that remove cells and cell fragments from tissue, making them biocompatible and able to self repair when implanted. Uniquely these tissue specific biological scaffolds, provide macroscopic function and multi scale composite structure and architecture which is able to translate macroscopic forces to micro scale strains which control cell differentiation.

These patents have been licensed to AIM listed University spin out Tissue Regenix Group TRG, to NHS Blood and Tissue services NHSBT and have been used by clinical collaborators in Brazil. Collaborators in Brazil have published four year clinical results for the pulmonary valve, TRG are undergoing clinical trials on vascular patch and developing a meniscus dCELL product and NHSBT are developing decellularised dermis and amnion.  Other tissue specific processes and biological scaffolds are in the research pipeline.

Strategic technology partnership with DePuy

iMBE is recognised world-wide for its distinctive research and simulation of wear in total joint replacements, hip, knee ankle spine, and has worked strategically with Depuy Johnson and Johnson in partnership for over a decade to under take basic and applied research into longer lasting joint replacements.

As part of this partnership we have defined new scientific relationships to describe wear under different conditions in hip, knee and ankle, have developed  simulation methods to predict wear under a wider range of clinical conditions, and have applied this scientific understanding to support the development of longer lasting, lower wearing hip knee and ankle joints.

Examples include use of ceramic matrix composite bearings in hip, the new relationships of wear and head size in hip, reduced wear with rotating platform mobile bearing knee, reduced wear with high flexion fixed bearing knee, reduced wear with low conforming partial knee replacement and definition of wear in the ankle joint for first time.

This research has impacted on and benefited hundreds of thousands of patients world wide. iMBE continues to support the clinical adoption and use of these developments world wide through professional education, as well as supporting development of next generation of hip and knee products.

Spin out collaboration in biomaterials and tissue engineering (BITECIC)

iMBE is a world leader in studies of tribology of joint replacement. It has unique capability and intellectual assets that are extremely valuable to a range of orthopaedic joint replacements manufacturers.

In 2003 we received support from Yorkshire forward to set up a centre for industrial collaboration CIC in biomaterials and tissue engineering (BITECIC), the aim being to act as a professional services interface to industry. This formed a spin out company in 2006 which has grown to ten people and turn over of £500k in 2010.

Through BITECIC, research support for product development in orthopaedic implants has been delivered to over twenty companies in area of biomaterials, tissue engineering, hip,  knee and ankle joints as well cardiovascular products.  Key customers include, Ceramtec, Mathys, JRI, Vascutec, Gaitec, Covidien.  The work supports products used in hundreds of thousands of patients world wide.

Additionally the research through this route has identified failure modes in products under development in pre clinical studies, so preventing them ever reaching patients, hence making a significant contribution to safety and reliability. The model also provides support for further development of previously licensed technology, for example fro Vascutec who acquired previously  licensed  bioprosthetic heart valve technology.

BITECIC  is providing a sustainable novel approach to applying research to  supporting product  development in industry.

Collaboration with NHS

iMBE has two formal partnerships with National health service,  with Leeds teaching hospital trust , through NIHR funded Leeds Musculoskeletal Biomedical Research centre and through the National blood and Tissue services, both being nationally funded centres of excellence.

We have collaborated with National blood and tissue services for over a decade, undertaking collaborative research which is now delivering clinical impact through adoption of new tissue processing methods for tissue transplantation and introduction into clinic of decellularised biological scaffolds derived from human donor tissue.

The Leeds musculoskeletal Biomedical research Unit, (Fisher – co director) funded by NIHR, provides pathways to impact and adoption of our musculoskeletal research as well as clinical research facilities such as imaging and gait. The unit benefits from early adoption of our research findings, such as low wearing knees, and allows us to undertake post market clinical studies on wear of prostheses, patient gait and function post operatively, so allowing clinical practice to evolve.

The implant retrieval bank allows us to study both well functioning and failed implants, so allowing us to identify conditions of failure and clinical contra-indications and to feed that back into clinical practice, one recent example being the importance of acetabular cup position in the hip.

Innovation and knowledge centre in regenerative therapies and devices (IKC RTD)

Supported by WELMEC centre of excellence in medical engineering. Established in  2009 and a public  launch in 2010, the IKCRTD and WELMEC integrate research innovation and impact across ten departments in the university and trust.  Uniquely integrating medical technologies and regenerative therapies, focusing on biological scaffolds, minimally manipulated stem cells, hybrid diagnostic and advanced devices, reducing the translation gap and uncertainty in innovation, accelerating translation and reducing risk in  technology development.

In the first two years it has 64 collaborative projects with 26 different companies. Current research and innovation turnover rising in excess of £10 million per year, with approximately 50% directed to collaborative projects and innovation support.