Design for Mass Adaptation of the Neurointerventional Training Model HANNES with Patient-Specific Aneurysm Models

Abstract

A neurointerventional training model called HANNES (Hamburg ANatomical NEurointerventional Simulator) has been developed to replace animal models in catheter-based aneurysm treatment training. A methodical approach to design for mass adaptation is applied so that patient-specific aneurysm models can be designed recurrently based on real patient data to be integrated into the training system.HANNES’ modular product structure designed for mass adaptation consists of predefined and individualized modules that can be combined for various training scenarios. Additively manufactured, individualized aneurysm models enable high reproducibility of real patient anatomies. Due to the implementation of a standardized individualization process, order-related adaptation can be realized for each new patient anatomy with modest effort. The paper proves how the application of design for mass adaptation leads to a well-designed modular product structure of the neurointerventional training model HANNES, which supports quality treatment and provides an animal-free and patient-specific training environment.

Validation of the Design for Mass Adaptation Method – A Case for Higher Medical Treatment Quality

“…Mass individualization in DfMAd is conceived on a mass scale, i.e. for an entire market, and then implemented individually for each specific customer using the same process, the so-called standardized individualization process, as is used for in-theear hearing aids and also applied to the HANNES training model described above (Spallek et al, 2019). Mass individualization is particularly relevant in medical technology, where there are high patient similarities but nevertheless individual needs and anatomies.…”

“…This method was used in the development of a neurointerventional training model called Hamburg ANatomical Neurointerventional Simulator (HANNES), in which pathological blood vessel anatomies, for example with aneurysms, are simulated patient-specifically. Thanks to additive manufacturing technologies and the implementation of the standardized individualization process, HANNES replicates original patient data in a realistic way, so that the training of neuroradiologists and their experience with challenging interventions is increased, and the quality of treatment can be improved (Spallek et al, 2019). However, this design method needs to be validated to be accepted and used by product designers.…”

Novel synthetic clot analogs for in-vitro stroke modelling

“…Synthetically produced clots (n = 23) mainly composed of agarose (n = 12, A1-12) or silicone (n = 11, S1-11) were tested in a previously described neurovascular simulation model [4]. Different concentrations of these compounds were mixed with a 3:1 mixture of methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI) (C. Kreul GmbH & Co. KG, Hallerndorf, Germany) or/and micro-glass beads (MGB) (Carl Roth GmbH + Co KG, Karlsruhe, Germany) in different proportions in order to simulate different degrees of stiffness, elasticity, adhesion and fragmentation (Table 1).…”

“…Synthetic clot testing was performed in a neurovascular simulation environment (HANNES) [4,8] integrated on a monoplane angiography system (AlluraClarity FD 20, Philips Healthcare, Best,…”

“…Animal models used for medical training or device testing are associated not only with an ethical dilemma but also with high costs and a poor reproducibility of human anatomy [3]. In this study we use a fully animal-free experimental setting, comprised of a previously described neurointervention simulation model-HAmburg Anatomical NEurointerventional Simulator (HANNES) [4] and custom-designed 3D-printed models of intracranial vasculature as a realistic and cost-effective training environment for mechanical thrombectomy (MT).…”