Aim of the client: Aferetica Srl, an innovative start-up specializing in apheretic blood purification therapies, wanted to conduct functional tests on a new medical device for ex vivo perfusion of the organs, kidney and liver taken and intended for transplantation.
Solution proposed by Coesum: For this project our experience in choosing the right technology and the materials to be used has been a winner. Furthermore, our contribution has been useful in co-design and engineering of some accessory parts of the organ’s container system.
Results: Aferetica was able to carry out the development of the different phases of the project with the technologies we proposed, arriving at the presentation of the system to the scientific medical community, first nationally, during the National Congress of the Italian Organ Transplant Society (November 2017) ) and subsequently, worldwide, during the 27th Congress of the International Society of Organ Transplants (July 2018).
Aferetica Srl is Start Up founded by operators and managers with decades of experience in the field of dialysis, intensive care, cardiology, medical devices in general. PerLife ™ is an integrated ex vivo organ perfusion system that incorporates the management of perfusion liquid purification, using specific apheretic devices, for the purpose of reconditioning and preservation of organs for transplantation. PerLife ™ is a successful project born from the teamwork that involved the entire Miriamese biomedical district, up to the synergic collaboration with the American CytoSorbents, with which Aferetica led the development of the PERSORB® device dedicated to the purification for adsorption of toxic molecules from the perfusion fluid and integrated into the PerLife ™ system.
COESUM also actively participated in the project. Already from the first meeting with Aferetica we have collected this new challenge and we were certain of the success thanks to the experience now more than established in the prototyping and rapid production technologies. After having identified the silicone mold replicas as the most appropriate technology for this first phase of the project, ie for the production of the first pre-series of the organs, kidney or liver containers, to which PerLife ™ system is perfused, it was started the real production process.
An initial phase of this process was characterized by the performance of the tests on the materials (polyurethane resins) used for the realization of the devices. This phase was necessary and fundamental for verifying the applicability of this type of technology in the biomedical field. Samples of material supplied by COESUM have been tested and, following the positive outcome of the checks, the process of casting from a silicone mold to the parts of the device continued. During this process COESUM has actively contributed to the re-engineering of some parts of the system, to make them achievable through the chosen production techniques.
The drawings were all provided by Aferetica, our contribution in the design concerned the redesign of the retina initially designed to be done entirely with soft material. The modifications made it possible to optimize the use of the tray and the housing of the organ by inserting a rigid frame anchored to the structure and the soft net that houses the organ, all engineered to be produced in co-molding.
The choice of transparent material was not random, but wanted to allow the operator to keep the organ always visible during the perfusion while the underlying part of the container is sandblasted.
The first productions have allowed to perform assembly and functional tests on the machine also with the other hardware and disposable components that have been positively overcome. All this led to the validation of the various development phases. At the moment, Aferetica is carrying out the necessary activities to start the production and marketing of the large-scale PerLife ™ system.