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Parametric Design and Hybrid Fabrication of Above-Knee Prosthesis

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Indian Journal of Orthopaedics Aims and scope Submit manuscript

Abstract

Background

India has a large number of above-knee amputation patients who require a prosthetic leg that is affordable, conformal, functional, and durable. Available low-cost solutions, such as Jaipur foot, employ gypsum plaster in the process of fabricating a fitting socket. This has four shortcomings: (1) requirement of trained technicians, (2) high possibility of manual errors leading to rework, (3) long production time of several hours, and (4) difficulty in scaling up for widespread application.

Materials and Methods

An improved approach is presented here, which combines computer-aided parametric design and numerically controlled machining with manual thermoforming to overcome the above issues. The socket is semi-automatically designed based on 60 parameters, derived from 23 measurements obtained on the natural stump of a patient. The three-dimensional (3D) computer-aided design model of the socket can be used for additive manufacturing (3D printing), which was found to be accurate, but time-consuming and expensive. Hence, a hybrid process was evolved with the following three steps: computer numeric control machining of the stump and shank replica in polyurethane (PU) foam, followed by coating with suitable epoxy, and finally high-density polyethylene pipe thermoforming over the PU foam replicas.

Results

Three prostheses were fabricated using both conventional and hybrid processes and provided to volunteer patients. The hybrid process resulted in 28% reduction in overall fabrication time and improved satisfaction of patients due to better fit and comfort.

Conclusion

The proposed approach can be adapted for mass customization, required to meet the large gap in demand and supply, especially in resource-constrained settings.

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Acknowledgements

This project was carried out at Biomedical Engineering and Technology (incubation) Centre (BETiC) at IIT Bombay, funded by Rajiv Gandhi Science and Technology Commission, Government of Maharashtra, Mumbai, and Department of Science and Technology, Ministry of Science and Technology, New Delhi. The support provided by Mr. Rajiv Mehta, Trustee of RNCT, and his team including Ms. Nandini Thakkar, Mr. Salodkar (prosthetist), Mr. Buddha, Mr. Mane, Mr. Manoj, and Mr. Sawant is deeply acknowledged. Valuable insights about prosthesis design and patient rehabilitation were provided by Dr. Rajani Mullerpatan and her team at the Centre for Human Movement Science, MGM Institute of Health Sciences, Navi Mumbai, as well as Mr. Soikat Ghosh Moulic and Mr. Sanjoy Singh Oinam from Mobility India. Prof. Muhammad Salman, Civil Engineering Department, and Mr. Pratap Shingade at Structural Evaluation and Materials Testing Lab at IIT Bombay allowed access to their experimental facilities. Mr. Ashok Mawade, Industrial Design Centre, IIT Bombay, helped in evolving the coating process. BETiC researchers Mr. Shrishail Hamine and Dr. Trimbak Kawadikar helped in exploring 3D parametric modeling. The measurement templates were developed by two summer interns Arvind and Viren from Symbiosis Institute of Technology, Pune. Dr. Aayush Kant, IIT Bombay, helped in drafting and improving the paper. The project team is especially grateful to the three volunteer patients who tried out the prostheses and provided regular feedback. The project received the Google Impact Challenge for Disabilities Award, which is supporting the implementation of technologies described in this paper.

Funding

This project was carried out at Biomedical Engineering and Technology (Incubation) Centre at IIT Bombay, funded by Rajiv Gandhi Science and Technology Commission, Government of Maharashtra, Mumbai, and Department of Science and Technology, Ministry of Science and Technology, New Delhi. The support provided by Mr. Rajiv Mehta, Trustee of RNCT, and his team including Ms. Nandini Thakkar, Mr. Salodkar (prosthetist), Mr. Buddha, Mr. Mane, Mr. Manoj, and Mr. Sawant is deeply acknowledged.

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Authors and Affiliations

  1. Department of Mechanical Engineering, Bio-Medical Engineering and Technology Incubation Center/OrthoCAD Lab, Indian Institute of Technology Bombay, Near Power House, Hill-Side Road, Mumbai, Maharashtra, 400 076, India

    Lalitrao Amrutsagar, Gaurav Parit, Rupesh Ghyar & Ravi Bhallamudi

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  1. Lalitrao Amrutsagar
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  2. Gaurav Parit
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  4. Ravi Bhallamudi
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Correspondence to Lalitrao Amrutsagar.

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The authors declare that they have no competing interests.

Ethical standard statement

Detailed gait analysis of unilateral AK amputation patients receiving leg prosthesis fabricated using the conventional approach as well those fabricated using the proposed approach has been initiated after obtaining the approval of the Institutional Ethics Committee of MGM Institute of Health Sciences, Navi Mumbai. The initial study to establish the overall protocol is briefly described in this paper.

Informed consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published, and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

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Amrutsagar, L., Parit, G., Ghyar, R. et al. Parametric Design and Hybrid Fabrication of Above-Knee Prosthesis. JOIO 54, 381–390 (2020). https://doi.org/10.1007/s43465-020-00059-w

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