Towards Bespoke Bio-Hybrid Prosthesis - Manufacturing bio-inductive interfaces in 3D

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

Abstract

There have been a number of exciting research developments in the field of bio-integrated and neural connected limb prosthetics. However, it has been shown that the range and lifetime of functionality is limited due to failures at both nerve and muscle interfaces, leading to signal loss and mechanical failure, respectively. Our vision is to challenge the mind-set of limb prosthesis being a disparate and mismatched entity to one where it may be truly interactive and integrated with the residual anatomy and physiology. Our envisaged prosthesis will respond to biological feedback via a tissue engineered abiotic/biotic conduit between the artificial prosthetic and remaining biological muscle and nerves. This will provide the natural and full range of communication and feedback with afferent and efferent connections to the neural system with an emphasis on integration and long-term reliability. This will be achieved through exploration and understanding the fundamental engineering and manufacture of bespoke 3D coupling constructs that encourage and facilitate the robust integration and interface with tissue-engineered skeletal muscle and nerves, and their ancillary structures. The researching will entail developing a new manufacturing process, and the associated sciences, through a multidisciplinary team comprising of manufacturing engineering, biological science and chemistry. Considerations for industrial scale-up, good manufacturing practice (GMP) and regulatory requirements are integrated throughout. The work will be conducted in partnership with a world-leading UK prosthetic manufacturing company along with clinical engagement.

Planned Impact

The proposed research is expected to generate significant clinical impact by addressing the key scientific and manufacturing challenges around interfacing biological components with electromechanical systems such as advanced limb prosthetics. The research will provide significant commercial, technological and scientific impact as it will enable, via a novel multi-systems manufacturing approach, new realms of functionality and personalisation in medical devices. Patient benefit will be allied with benefit to our industrial partner, Blatchford, and UK industry by developing new business models, innovative products and the creation of new supply chains. This proposal concerns limb prostheses, although several core technical accomplishments will be relevant to a myriad of other industrial areas.
This research will contribute to UK society and economy by benefitting the medical device industry, healthcare providers, medical professionals and patients. The resultant impact addresses the national priority areas of rehabilitation by facilitating superior forms of prostheses integration and performance. It will impact in a multitude of diverse ways by enhancing quality of life and health, raising the effectiveness of healthcare services and increasing economic competitiveness both directly, through device industry, and indirectly by allowing patients to more fully engage in occupational and social activity. Medium term benefits will be evident to those involved in the target areas of orthopaedics and rehabilitation, long term benefits will apply more broadly. Specific groups will include:
- Patients - Approximately 5000-6000 limb amputations occur in the UK every year, and an estimated 1 million globally which equates to one case every 30 seconds. Patients experiencing limb-loss or deficiency will be primary beneficiaries through increased function and capability, and resulting enhanced quality of life and health. Indirect economic advantages include a reduced tax burden, increased working capacity, less time off work and reduced travel to and from hospital.
- A wider range of medical conditions can also potentially benefit through the ability to create living tissue neural interfaces that can support the bidirectional flow of signalling between the body and external electrical mechanical and sensory devices. The ability to route signals in and out of the bodies neural networks or bypass damaged and severed nerve areas will open up new avenues for treatments and research. Potential conditions could include retinal eye implants, paraplegics, motor neuron disease, or other neurological disorders. Animal testing may be reduced by providing new methods to study neural interfaces.
- Healthcare Providers - our national health service will benefit economically from greater efficiency and reduced treatment costs helping them to meet the populations' growing expectations within ever tighter financial constraints. Surgical and clinical revision rates could be reduced. A significant current issue in prostheses, namely volume loss and muscle atrophy, may be reduced or eliminated due to the integration and utilisation of residual function. This can be an ongoing issue for prosthesis users, and results in significant further treatment and revision.
- Prosthetics industry will directly benefit from the increased scientific understanding and developments concerning interfacing the artificial with the residual biological elements. In particular, our project partner Blatchford, the UK's No.1 prosthetics company and our industrial project partner, view the fundamental research from this project as key to unlocking the future potential of prosthetics. Blatchford currently provide over 30% of all NHS prosthetic and orthotics services and also run the MOD clinic at Headley Court.

Publications

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Related Projects

Project Reference Relationship Related To Start End Award Value
EP/L02067X/1 15/12/2014 31/03/2016 £785,827
EP/L02067X/2 Transfer EP/L02067X/1 01/04/2016 30/06/2019 £525,896
 
Description We can summarise key findings to date as: We have formulated and engineered experimental apparatus that has permitted the design and manufacture of suitable micro-scale geometrical and topographical features onto substrates that enable both the attachment of precursor facings. Refining the controlled and variable freeform deposition is the subject of the ongoing manufacturing research.
Exploitation Route This is too early to determine
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description Our work and it's impact is being recognised through a number of invited activities. These include: - A opening talk (invited) at the Royal Society for Medicine. - A opening talk (invited) at the Henry Moore Institute. This was a weekend event open to the public and provided a culmination of a 3 month exhibit on prosthetics. - The Principal Investigator has spent a week (invited) in clinical departments.
First Year Of Impact 2017
Sector Healthcare,Manufacturing, including Industrial Biotechology,Culture, Heritage, Museums and Collections
Impact Types Cultural,Societal

 
Description Henry Moore institute - Opening talk at public discussion on Prosthetics 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact As part of the part of the Henry Moore Institute's event of 'The Body Extended: Sculpture and Prosthetics' (https://www.henry-moore.org/whats-on/2016/07/21/the-body-extended-sculpture-and-prosthetics) I provided the opening talk at the public event of '3DMe: Dialogues about prosthetic extensions, perceptions and representations' on Saturday 22nd October
Year(s) Of Engagement Activity 2016
URL https://www.henry-moore.org/whats-on/2016/07/21/the-body-extended-sculpture-and-prosthetics
 
Description Industry engagement event at Blatchford (world leading rehabilitation provider with clinical expertise in prosthetics, orthotics, special seating and wheelchairs) 
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 Professor Harris and Dr Kay visited Blatchford on 14th February 2018 to present their research in new manufacturing processes to management and engineering teams. This resulted in questions and discussion regarding how this related to current, emerging, and future devices for rehabilitation.
Year(s) Of Engagement Activity 2018
 
Description Invited presentation to a EPSRC programme grant project meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact I was invited to make a presentation on our research in new manufacturing processes to a large of researchers working on miniaturised ingestible devices in the EPSRC programme grant EP/K034537/1 / EP/K034537/2. Conducted 12th October 2017.
Year(s) Of Engagement Activity 2017