We are excited about our first patent submission (June 2020) related to the soft robotic technology used to pump the blood. An excellent Search Report was received after 10 months, confirming that all the requirements are met to have an Italian patent granted. We are currently in process to extend it to an international PCT application, claiming the above Italian priority.
We are pleased to announce that ReinVAD will join the Hybrid Heart consortium! ReinVAD will focus on the development of the wireless transcutaneous energy and data transfer system that will be used to power the Hybrid Heart.
About ReinVAD: ReinVAD GmbH is a spin-off company from the RWTH Aachen founded in 2012 and located in the south of Aachen. The company’s goal is to develop a new Left Ventricle Assist Device (LVAD) that can save the life of patients with severe heart failure reviving them with a high quality of life.
On 21 January 2020, the British Heart Foundation (BHF) announced that Hybrid Heart is one of four finalists out of 75 initial submissions that will compete in the Big Beat Challenge to win a 30 million GBP award to explore and develop a radical new approach to treat cardiovascular diseases. With the World Health Organization (WHO) forecasting an increase in cardiovascular deaths worldwide, the Big Beat Challenge is a global initiative to encourage researchers and inspire transformational solutions to tackle the world’s biggest killer. As the next step, the Hybrid Heart team has to submit a full application in June 2020. The winner of the prestigious award will be announced by the end of 2020.
Hybrid Heart – Introducing a soft robotic heart
The Hybrid Heart project proposes a radical new concept for treating heart failure by replacing the diseased heart with a bioinspired and completely soft robotic heart, with in situ tissue-engineered inner lining (making it a hybrid heart), which can be wirelessly charged. The team, led by the Dutch cardiothoracic surgeon professor Jolanda Kluin (AMC, Amsterdam), roboticist/physicist dr. ir. Bas Overvelde (AMOLF, Amsterdam) and tissue-engineer professor Carlijn Bouten (TU/E, Eindhoven), strongly believes that Hybrid Heart can fully restore natural blood flow, can prevent limitations and complications inherent to current heart failure treatment, and will allow patients to move freely without a percutaneous driveline.
In the video below professor Jolanda Kluin introduces the Hybrid Heart project proposal. The video was recorded during the Big Beat Challenge event on 21 January 2020 in London.
Background – Eureka!
“On a Saturday morning back in 2016 I was reading a Dutch newspaper, I came across an interview with Bas Overvelde talking about soft robotics, illustrated by a picture of a soft robotic octopus”, Kluin says. “The picture didn’t show the typical robot with hinges and metal legs, but instead, it was made from a rubbery material that, when inflated, started to move seemingly organically. Kluin immediately connected the dots: “We should use this technology to build an artificial heart!”. She picked up the phone and called dr. ir. Bas Overvelde. This is when the project started. “I was immediately excited!”, says Overvelde. “I didn’t see any reason why we would not be able to make this work and the potential impact is huge”.
The video below shows a similar soft robotic device (a starfish instead of an octopus) as mentioned above. The soft robot was made in Overvelde’s research group (Soft Robotic Matter group) at AMOLF, Amsterdam.
The need for a new solution
For patients with advanced heart failure, current treatment options include intravenous inotropic drug support requiring hospitalization, donor heart transplantation and implantation of a long-term mechanical circulatory support device. With only 5000 heart transplantations per year globally and the high morbidity and mortality that accompany current mechanical devices, there is an urgent need for a new alternative. Current solutions mostly rely on pumps that only assist the left ventricle of the heart and carry a high risk of complications such as thrombosis, bleeding and infections. “Replacement of the failing heart with a bioinspired soft robotic heart with a tissue-engineered biocompatible surface and a wireless energy transfer has the potential to replace and match a healthy human heart,” Kluin conveys. “This will transform the treatment of end-stage heart failure.”
Credits: British Heart Foundation and Hybrid Heart consortium
Bas Overvelde: “Soft robotics have never before been used in artificial organ development nor has it ever been combined with in situ tissue-engineering, although during my PhD at Harvard University I collaborated on the development of a soft robotic sleeve to assist the heart.” Currently, none of the available mechanical circulatory support devices can function without a percutaneous driveline for the power source. As such, Hybrid Heart will transform the research and the clinical landscape. “This is an endeavour that relies on innovative collaborations across multiple disciplines, as illustrated by the diverse background of the members of the consortium. The efforts of this interdisciplinary and highly complementary consortium of global leaders in their respective fields of expertise, aim to cure the first patient using the Hybrid Heart by 2028.
Need for funding of this magnitude
“Our aim is to change the lives of heart failure patients within seven years. Whilst radical, our ambition is not completely science fiction”, says Kluin. In 2018, the Hybrid Heart project already started as a small consortium with a Horizon 2020 (FET OPEN) funded grant 3 million EUR) to explore the feasibility of the idea. “Based on our first results we are now convinced that we can achieve our ambitious goal by expanding our scientific and translational efforts to such a scale that is only possible with the proposed sponsorship of the British Heart Foundation”, Carlijn Bouten says. Additionally, to conquer the so-called ‘valley of death’ gap between scientific findings and clinical implementation and to enable viable translation to patients, the team will set up robust manufacturing and quality control. “Therefore, funding of this magnitude is absolutely essential to make this happen and give patients with heart failure a future”.
The international consortium
Besides the Dutch scientific trio, the research and development consortium consists of international partners spanning several countries, including dr. Matteo Cianchetti (SSSA, IT), assistant professor Ellen Roche (MIT, USA), professor Frans van de Vosse (TU/e, NL), professor Cathy Thornton (Swansea, UK), professor Bob Stevens (NTU, UK), Derek Williams-Wynn (PSTL, UK), Stefan Schätzl (Em-tec, DE), Praveen Sagar (OxDevice Ltd., UK), dr. Hadewych van Hauwermeiren (Medanex Clinical, BE), dr. Steven Tsui (Royal Papworth Hospital, UK), professor Victor Tsang (GOSH, UK), professor Hanneke Takkenberg (ErasmusMC, NL), professor Richard Huxtable (Bristol, UK), and dr. Rik Meijer (Factory-CRO, NL).
Every year worldwide 26 million people die because of heart failure. In Europe, 45% of the overall number of deaths is related to cardiovascular diseases. Despite all the technological advances, no final and optimal solution to the problem has been found yet. Indeed, heart transplantation is still the only way to guarantee a normal life to the end-stage patients. For these reasons, the HybridHeart project aims to develop an alternative solution to the already available ones, trying to combine the power of the soft robotics actuation, the advances in tissue engineering and the farsighted ideas of transcutaneous energy transfer systems, to guarantee biomimetism, biocompatibility and lower the risk of infections.
The main aim of this document is to integrate all the known physiological requirements, and all the expected technological constraints, that we consider to be needed decision-making factors during the development of an innovative generation of total artificial hearts. In every section. we tried to, not only present our main design goals, but also position them with respect to the ones characterizing the already developed, and sometimes commercialized, total artificial hearts.
The Hybrid Heart Consortium is organizing an internal seminar on the 29th of May 2019 at the TU Eindhoven in the Netherlands to bring together all partners and students involved in the project, and to share and discuss the progress of the development of soft robotics technology for cardiac support.
The day will start with presentations by all PhD students involved in the project. First, AMC and AMOLF will share the status of a systematic review of artificial heart technology that they are currently working on. After that, SSSA Pisa will present the status of their work on the soft McKibben actuators that, following a biomimetic approach, will be placed in a soft matrix to develop a soft pumping heart. Next, AMOLF will present their work on the robust soft sensing and control technology that they are developing using soft fluidic networks instead of electronic circuits. Following these presentations on the soft robotic technology, we will continue with presentations focusing on the anti-fouling and tissue-engineering coatings that are being developed at TU Eindhoven.
Additionally we host an invited talk about fluidics and fluid mechanics applied to cardiac support and transcutaneous energy systems, by prof Marcel Rutten, assistant professor at the TU/e department of Biomedical Engineering, research group Cardiovascular Biomechanics, which will be followed by a tour to show his lab and his custom-made mock circulation apparatus.
Importantly, we will ensure fruitful discussions during the day to streamline efforts between partners, and to identify missing links that need further attention. Next to creating room for debate, this will be achieved by organizing a hands-on practical anatomy session in the laboratory in order to get deeper understanding of cardiovascular physiology and pathophysiology, and by providing a specific session focusing on IP strategy hosted by dr. Marc Roelofs, IXA Amsterdam.
A news article was published on the frontpage of the Dutch newspaper Telegraaf, highlighting our effort to develop a fully artificial soft heart. See this link for the article.
We have had a fruitful consortium meeting @AMOLF on January 25th. Besides presentation of all work package leaders and a lab tour organised by the Soft Robotic Matter Group, we also enjoyed a visit from Nik de Bont discussing potential materials that can be used for our Hybrid Heart.
The HybridHeart consortium met at the The BioRobotics Institute Polo Sant’Anna Valdera (PSV), in Pontedera just outside Pisa, on the 5th September 2018 for the 1st Partner Meeting. All partners were present and the consortium was updated on progress made to date. The consortium were also given a tour of the BioRobotics Institute.
Dr. J. Kluin (1971) has been appointed professor of Translational Cardiothoracic Surgery at the University of Amsterdam’s (UvA) Faculty of Medicine.
Jolanda Kluin’s research focuses on translational research in cardiothoracic surgery. True translational cardiothoracic research involves the whole spectrum, from molecular biology, computational modelling, engineering, and preclinical animal studies to clinical studies and finally epidemiological follow-up studies. Besides fundamental research on the cellular and molecular level, collaboration between cardiac surgeons on one side and computational and engineering expertise on the other leads to innovations that improve the care of patients with heart disease. By planning and conducting the proper studies and trials, Kluin aims to translate laboratory findings to clinical practice.
As professor at the UvA, Kluin’s primary focus will be on regenerative medicine, congenital cardiac surgery, heart failure and valve surgery. This includes heart valve tissue engineering, the development of a soft robotics total artificial heart and long-term clinical follow-up studies on aortic valve repair surgery. She will build bench to bedside research lines on these topics. These lines are truly translational in the sense that they will include molecular biology, computational modelling and engineering, preclinical animal and clinical studies, as well as epidemiological follow-up studies.
About Jolanda Kluin
Kluin has been a staff member at the Amsterdam University Medical Center’s (Amsterdam UMC) department of Cardiothoracic Surgery since 2015, where she currently holds a post as congenital cardiothoracic surgeon. From 2006 to 2014, she was a staff member at Utrecht University Medical Center (UMC Utrecht). She was trained in Rotterdam where she obtained her doctorate cum laude.
Kluin is the recipient of, among others, prestigious grants from the European Union (Future and Emerging Technologies), the Netherlands Heart Foundation (CVON) and the Netherlands Organisation for Health Research and Development (ZonMw). She is the recipient of various awards and publishes extensively in international peer-reviewed journals. In addition, she is reviewer for many international journals and acts as adviser to the Ministries of Health of Great Britain, Ireland, Czech Republic, Germany and France on the awarding of grants. She has been a faculty member of many international meetings on cardiothoracic surgery and collaborates with scientists, engineers, cardiologists and cardiothoracic surgeons from around the world.
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