RESEARCH ARTICLE


Design of Medical Devices That Meet Contradictory Requirements



Len Malinin 1, *, Alexey Borovkov2, Alexandr Mikhaylov2
GEN3 Partners, 20 Winthrop Square, Boston, MA 02110, USA.


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© Malinin et al.;

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Correspondence: * Address correspondence to this author at the GEN3 Partners, 20 Winthrop Square, Boston, MA 02110, USA. Tel: 617 728-7013; Fax: 617 728-7500; E-mail: leonid.malinin@gen3partners.com


Abstract

Background:

Today vitally important medical devices are expected to meet diverse and increasingly stringent requirements, in order to ensure their dependability in scenarios which can be life-critical. These requirements can often be contradictory in nature, presenting additional challenge to the designer.

Method of Approach:

In this article, discussed are two approaches to address contradictory requirements to medical devices: resolving contradictions and advanced Finite Element Analysis (FEA) modeling. First, it is shown how the contradictions can be resolved by separating the contradictory requirements in space, in time, and amongst the elastic parameters of the material. The generated designs still need be validated first by advanced modeling. Two factors make FEA modeling of medical devices especially important: risks or difficulties in producing experimental data and unknown sensitivity of the design characteristics to different parameters of the device and factors in the human body. Discussed are the selection of the material models and boundary conditions and sensitivity of the results to the parameters of the model.

Results and Conclusions:

These approaches were applied to the development of peripherally inserted central catheters (PICC) and retrievable blood clot filters. The generated novel designs were protected by US patent applications. The results obtained in LS-DYNA and other packages are compared with the available experimental data for the kink test and material response.

Resolving contradictions and FEA modeling should not be contraposed to each other; they work more effectively in tandem.

The presented approaches can be used in the design and optimization of medical devices subject to stringent requirements or with enhanced properties.

Keywords: Contradictory Requirements, Medical Devices, FEA Modeling, Central Catheters, Retrievable Blood Clot Filters..