CUSTOMISATION OF COSMETIC COVERS FOR ARTIFICIAL LIMBS

Lead Research Organisation: University of Strathclyde
Department Name: Design Manufacture and Engineering Man

Abstract

This proposal combines academic expertise in digital manufacturing and heterogeneous foams (University of Strathclyde, Department of Design, Manufacture and Engineering Management) with prosthetics practitioners (University of Strathclyde, National Centre for Prosthetics and Orthotics) and non-academic partners, manufacturers (Blatchford Ltd.) and service users (PACE Rehabilitation, an SME), to investigate the feasibility of revolutionising the functionality and appearance of prosthetic cosmoses. Currently, flexible polyurethane foam cosmoses are a widely used component of prostheses for limbs. In a very labour intensive process, cosmoses may be machined from slab stock to a semi finished form and then shaped further to match patient requirements. An ordinary covering stocking is often added to enhance the cosmetic appearance of the prosthesis. Amputees cover their metal orthopaedic limb (i.e. artificial leg, arm, etc) with a two-fold function cosmesis: it protects the expensive equipment and, in theory, it provides a better aesthetic appearance to the patient's orthopaedic prosthesis. The reality is that cosmetic covers underperform the artificial limb, attract dirt, are non-water proof or fire resistant, impede the normal functioning of joint(s) and have a poor visual finishing which hinders the patient's psychological recovery and acceptance of their new condition and appearance.Although widely used, the foam cosmesis neither deforms like human limbs nor withstands repeated flexure, and its appearance is far from resembling human skin. These problems have their root in the standardized nature of the foam used; with a homogeneous and uniform pore size throughout the material, the stiffness will also be constant and consequently it will bend in an 'unnatural' way. Ultimately the highly stressed areas will fail, and the foam will tear at the joints (especially on the knee). The mechanical properties of foams are determined by their cellular structure; so small cells with thicker walls create stronger, stiffer materials than large open pours. Traditional manufacturing methods have fabricated cosmoses from blocks of homogeneous foam resulting in objects that have uniform mechanical properties. However it is also well known that variation in cellular structure can produce impressive combinations of strength and flexibility. To date, no manufacturing process for mass production has existed capable of dynamically varying the cellular structure of foamed material. Consequently, a controlled variation of features in the cosmesis to suit patient's movements and needs is not available. This proposal seeks to enable the mass customization of functionally graded foams, so they can be fitted to orthopaedic limbs and replicate the movement of the existing (healthy) limb. Using recently reported advanced manufacturing techniques never used before in this field, (e.g. computational modelling and simulation of foamed materials' behaviour, rapid prototyping technologies, ultrasonic irradiation, etc), as well as cutting-edge technology in scanning and measurement of materials properties, we aim to provide end-users (both practitioner prosthetists and patients) with a method of influencing shape, appearance, function and behaviour of foam cosmoses for orthopaedic applications.This proposal envisages a 2 year work program during which the commercial partners will help with patient satisfaction interviews, will input directly into the specification of requirements, and assist with the assessment of results. Our intention with the outcomes of this project is to pave the way for our partners to apply the results and implement them in the production process, allowing them to take the work forward and exploit the benefits that the project's output will provide to the relevant industry, rehabilitation services, carers (i.e. orthotists), the National Health Service and, most importantly, the patient.

Planned Impact

This project will have an impact on the following: patients, healthcare professionals, relevant companies (especially on our industrial partners) and also on several academic disciplines. Patients: The prospect of getting better cosmoses, which are more durable, easier to maintain and clean, with a more realistic tactile feel and 'tailorable' to their specific needs (i.e. adjustable at the joint(s), different materials and finishes, etc) adds a vital ingredient of flexibility in the physical and psychological recovery process of amputees. Healthcare professionals (clinicians) and the NHS: The design of cosmoses will address improved functionalities and mechanical behaviour as well as methods for easy removal from the components for the clinician's manoeuvre. This will reduce numbers of visits and waiting periods and reduce the time a patient has to attend for maintenance and further adjustment to the prosthetic to accommodate changes in the foam stiffness. Relevant industry: specifically PACE and Blatchford, partners. Improving competitiveness in the market with higher quality cosmoses is a central interest in this research programme. The reduction of man hours and the automation of the production process is a major objective for the industry in the field. The investigators working on this project will obtain a direct benefit in terms of enhancement of skills, broader knowledge of the field and a better understanding on the supply chain in services for patients. As well as the aforementioned professionals in the field of prosthetics and orthopaedics, manufacturers of cosmoses and clinicians, academic beneficiaries will include other researchers working in the fields of (i) functionally graded materials, functionally tailored materials and foams; (ii) advanced manufacturing technologies; and (iii) multi-physics simulation and materials modelling. The modelling of the manufacture of enhanced cosmoses will have a positive impact for researchers working on heterogeneous systems, anisotropic materials and bio-inspired artefacts. This is a collaborative proposal among the University of Strathclyde (Department of Design, manufacture, Engineering Management; and the National Centre for Prosthetics and Orthotics), and the industrial partners PACE Rehabilitation and Blatchford. They will play an active role in the project as members of the consortium and also as fully involved executors of the project methodology in order to enhance exploitation of results and increasing impact for the benefit of the end-users. Blatchford is the manufacturer and supplier of the components used in orthopaedics, and PACE, an SME which works at the interface with patients providing prosthetic and orthotic clinical services, is a service user of these items. They bring to the project a synergistic collaboration and consultation on best practice and first-hand experience from the manufacture and servicing of the prosthetic components, ensuring appropriate exploitation of this project's outcomes. Together, the companies with the academics provide the project with a clear pipeline from concept, proof of principle, prototype and validation, scale-up and integration in their production process for further exploitation and commercialisation for the benefit of the end users (both patients and healthcare professionals). The dissemination mechanisms established in this project are (i) academic publications in journals covering the fields of Orthopaedics, Materials, Advanced Manufacture, and Health, as well as presentation at relevant Conferences, at least one national and one international; (ii) publicising on the university and partner's websites, (subject to any IP restrictions) (iii) a seminar at the end of the project to disseminate immediate results from the project which will bring together policy-makers, manufacturers, end users, clinicians (prosthetists, orthotists, orthopaedic and rehabilitation consultants, etc), and patients.

Publications

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Cairns N (2018) Rethinking the foam cosmesis for people with lower limb absence. in Prosthetics and orthotics international

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Nicola Cairns (Co-Author) (2011) What do lower limb amputees think of their cosmesis?

 
Description The appearance and life (i.e. length of service) of Cosmesis can be dramatically improved through a series of low cost modifications to the existing design.
Exploitation Route Karena Moore has been awarded an RSE fellowship to take the results of the project forward.
The RSE fellowship is funded by Scottish Enterprise, and designed to encourage and enable the development of a new Scottish based business, founded from a technological idea by the fellow and/or collaborators. Each fellow is assigned a mentor and expected to submit monthly reports plus attend scheduled workshops and programme of training.
In return the Fellowship provides 'upto' £37,000 salary support, plus National Insurance and pension costs over 12 months. A further allowance of 'upto' £10,000 is available for costs directly related to the Fellowship, such as equipment, consultancy, legal costs, and attendance at conferences and trade shows directly related to the Enterprise

2019 update : the company established in support of the RSE fellowship has been wound-up but the researcher involved has used the experience to found another start known as Kittiwig Ltd.
Sectors Healthcare

URL http://dx.doi.org/10.15129/b15474d6-ffa7-4f57-b0c3-ac9f08dda7cd
 
Description Outputs from this project were part of the case that lead to the award of an RSE fellowship to a research associated with IAA funded work arising from this project. -------------------------------------------- Karena Moore-Millar graduated as a product designer from DMEM in 2009 and has worked as an RA on various projects within the University since. She is currently writing up her mixed methods thesis, focusing on wig technology for people with alopecia (translating user requirements into product development) Recently Karena has been working on a collaborative project with Prof. Jonathan Corney (DMEM) & Dr Kevin Murray (NCPO), looking at the development of lifelike cosmetic covers for prosthetic limbs. The success of this project and development of working prototypes, led Karena and the team to pursue commercial opportunities to bring this product to market. In 2015, Karena and the team reached the qualifying stages of the Converge Challenge, and during this process Karena was encouraged to apply for the Royal Society of Edinburgh Fellowship (RSE fellowship). On the 13th January 2016, Karena stood before a panel of 12 expert judges to pitch her idea, (and dream!) of starting her own company, focusing on body image apparel. On the 1st April 2016, Karena will start her journey as an RSE fellow, looking to develop her ideas and incorporate as a company within 12 months. The RSE fellowship is funded by Scottish Enterprise, and designed to encourage and enable the development of a new Scottish based business, founded from a technological idea by the fellow and/or collaborators. Each fellow is assigned a mentor and expected to submit monthly reports plus attend scheduled workshops and programme of training. In return the Fellowship provides 'upto' £37,000 salary support, plus National Insurance and pension costs over 12 months. A further allowance of 'upto' £10,000 is available for costs directly related to the Fellowship, such as equipment, consultancy, legal costs, and attendance at conferences and trade shows directly related to the Enterprise For full details please see links below or contact the awards manager, Anne Fraser on 0131 240 5013 or by email, afraser@royalsoced.org.uk https://www.royalsoced.org.uk/636_ScottishEnterprise.html https://www.royalsoced.org.uk/cms/files/enterprise%20fellowships/RSEEFweb.pdf 2019 Update: the company start in support of the RSE fellowship has been wound-up but the researcher involved has built on the experience and now has a second start-up called Kittiwig Ltd.
First Year Of Impact 2010
Sector Healthcare
Impact Types Economic

 
Description Impact Acceleration Account
Amount £16,041 (GBP)
Funding ID Impact Acceleration Account - University Of Strathclyde 2012 / R120526-221 (Stefania Sansoni) 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2016 
End 03/2017
 
Description RSE/SE Enterprise Fellowship
Amount £40,738 (GBP)
Funding ID RSE/SE Enterprise Fellowship - Ms Karena Moore-Millar (University of Strathclyde acc no R151227) 
Organisation Royal Society of Edinburgh (RSE) 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2016 
End 03/2017
 
Title Rethinking the Foam Cosmesis for People with Lower Limb Absence 
Description Data relating to the development of a new design for the transfemoral foam cosmesis with improved appearance and functionality. This new design has the potential to significantly reduce patients' current dissatisfaction with the lifelike appearance of their foam cosmesis, resulting in improved self-confidence and body image. Mechanical testing revealed that the new design is 3 times more durable than the current standard model, demonstrating the potential to improve patient experience by reducing the need for clinical visits, while saving health service time and resources. The dataset comprises of a PDF file that describes in detail the process of creating and fitting the new style of cosmesis, a video file of one of the new cosmesis in use and a powerpoint file that summarizes the activities and outputs of the research project that lead to the creation of the new cosmesis" 
Type Of Material Database/Collection of data 
Year Produced 2016 
Provided To Others? Yes  
Impact Not Applicable 
 
Description Joint research with Heriot-Watt University 
Organisation Heriot-Watt University
Country United Kingdom 
Sector Academic/University 
PI Contribution University of Strathclyde researchers worked on this project with researchers from Heriot-Watt University
Start Year 2010
 
Description Project partnership with Chas A Blatchford & Sons Ltd 
Organisation Blatchford Clinical Services
Country United Kingdom 
Sector Private 
PI Contribution Chas A Blatchford & Sons Ltd worked with the research team and assisted/contributed to the project outcomes
Start Year 2010
 
Description Project partnership with PACE Rehabilitation Limited 
Organisation PACE Rehabilitation Limited
Country United Kingdom 
Sector Private 
PI Contribution PACE Rehabilitation Limited worked with the research team and assisted/contributed to the project outcomes
Start Year 2010
 
Company Name PellTek Ltd 
Description PELLTEK aims to create a product range of visually striking, medically certified, cosmetic covers for injured or artificial limbs. The company aims to expolit digital manufacturing techniques with 3D knitting and digital textile printing to create customised products for an attainable price. 
Year Established 2016 
Impact The award in 2016 of an RSE/SE fellowship to support the company MD (Karena Moore-Millar) has enabled the initial start-up phase of the company.
Website http://www.pelltek.com/