Patient-Specific Optimization of Prosthetic Socket Construction and Fabrication Using Innovative Manufacturing Processes : A Project in Progress

Despite improved medical prevention and successful treatment of potential risk factors, the number of new amputations is constant over last years. According to the demographic changes and developments the number of amputations will increase and will cause considerable health care system costs. The current prosthetic socket construction and fabrication process does not take patient specific parameters into account, is based onto subjective estimations, competence and capabilities of the orthopedic technician and therefore causes a high rate of inappropriate prosthetic supplies. This essential drawback clearly shows that a substantial necessity exists to develop more objective planning systems and to gain a higher quality in the prosthetic socket construction. The central objective of the presented work is to improve the currently empirical process of prosthesis design in orthopedic technology with the aid of modern imaging techniques and computer technology by taking into account patient-specific consistence of the amputation stump. Based on patient-specific 3-D models, the 3-D visualization, quantification and simulation of the individual biomechanical tissue changes in the amputation stump in a static state, as well as under dynamic conditions during the interaction with the prosthetic socket will be evaluated using finite element analysis. The computeraided visualization and virtual simulation of soft tissue deformation and of the contact forces in the interface between the patient-specific deformable model and the amputation stump at the computer individually planned model of the prosthetic socket will serve as basis for a reproducible construction and fabrication of individually adjusted exoskeleton prosthetic socket systems as well as a computersimulated “virtual try-on” before construction and fabrication of the prosthesis even in the absence of the patients. The manuscript will present the aims on capturing and quantifying the complex process of tissue changes during the prosthetic treatment, in particular the effect of biomechanical changes in structure and load distribution within the amputation stump in the simulation. In the following we would like to present our implementation concept to optimize the current prosthetic socket construction and fabrication process by combining three existing powerful software products (Mimics, 3-matic and ANSYS) into one uniform software platform. Based on this virtual study of influencing factors and planned changes of the final result, it would be possible for the first time to verify the clinical efficiency of prosthesis assembly and to establish an objective quantifiable quality control.. Through the developed and optimized workflow the manufacturing process will be cheaper and enormous shorter. Through the use of telemedicine based analyse and supply systems even states where none or less specialists are available would benefit from the technology. An important market is therefore also seen in developing countries, where until now no efficient orthopaedic technology exists. Optimization of Prosthetic Socket Construction & Fabrication Kovacs et al.

[1]  H. Herr,et al.  Estimation of Ground Reaction Force and Zero Moment Point on a Powered Ankle-Foot Prosthesis , 2007, 2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[2]  Ming Zhang,et al.  Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. , 2006, Clinical Biomechanics.

[3]  A. Gefen,et al.  Real-Time Patient-Specific Finite Element Analysis of Internal Stresses in the Soft Tissues of a Residual Limb: A New Tool for Prosthetic Fitting , 2006, Annals of Biomedical Engineering.

[4]  F Lavaste,et al.  A Functional Evaluation of Prosthetic Foot Kinematics During Lower-Limb Amputee Gait , 2006, Prosthetics and orthotics international.

[5]  Mark Huang,et al.  Limb deficiency and prosthetic management. 3. Complex limb deficiency. , 2006, Archives of physical medicine and rehabilitation.

[6]  Mark Huang,et al.  Limb deficiency and prosthetic management. 4. Comorbidities associated with limb loss. , 2006, Archives of physical medicine and rehabilitation.

[7]  Mario C Faustini,et al.  The quasi-static response of compliant prosthetic sockets for transtibial amputees using finite element methods. , 2006, Medical engineering & physics.

[8]  Dr D. P. Reynolds,et al.  Interface load analysis for computer-aided design of below-knee prosthetic sockets , 1992, Medical and Biological Engineering and Computing.

[9]  A. Gefen,et al.  Real-time subject-specific monitoring of internal deformations and stresses in the soft tissues of the foot: a new approach in gait analysis. , 2006, Journal of biomechanics.

[10]  Zheng Shuxian,et al.  3D reconstruction of the structure of a residual limb for customising the design of a prosthetic socket. , 2005, Medical engineering & physics.

[11]  Xiaohong Jia,et al.  Finite element modeling of the contact interface between trans-tibial residual limb and prosthetic socket. , 2004, Medical engineering & physics.

[12]  P V S Lee,et al.  Stump/socket pressure profiles of the pressure cast prosthetic socket. , 2003, Clinical biomechanics.

[13]  A A Polliack,et al.  Laboratory and clinical tests of a prototype pressure sensor for clinical assessment of prosthetic socket fit , 2002, Prosthetics and orthotics international.

[14]  Peter K. L. Ng,et al.  Prosthetic sockets fabrication using rapid prototyping technology , 2002 .

[15]  M. Zhang,et al.  Comparison of computational analysis with clinical measurement of stresses on below-knee residual limb in a prosthetic socket. , 2000, Medical engineering & physics.

[16]  S E Solomonidis,et al.  Validation of a quantitative method for denning CAD/CAM socket modifications , 1999, Prosthetics and orthotics international.

[17]  S G Zachariah,et al.  Material properties of commonly-used interface materials and their static coefficients of friction with skin and socks. , 1998, Journal of rehabilitation research and development.

[18]  W D Spence,et al.  Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees—a preliminary study , 1997, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[19]  A L Hof,et al.  Gait analysis of transfemoral amputee patients using prostheses with two different knee joints. , 1996, Archives of physical medicine and rehabilitation.

[20]  R. H. Meier,et al.  Rehabilitation in limb deficiency. 4. Limb amputation. , 1996, Archives of physical medicine and rehabilitation.

[21]  T A Krouskop,et al.  Interface pressures in above-knee sockets. , 1987, Archives of physical medicine and rehabilitation.

[22]  J. Foort Socket design for the above-knee amputee∗ , 1979, Prosthetics and orthotics international.

[23]  C. W. Radcliffe,et al.  Some experience with prosthetic problems of above-knee amputees. , 1957, Artificial limbs.