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Development of the first fully biocompatible, soft actuated heart: combining in situ tissue engineering and soft robotics

Periodic Reporting for period 4 - HybridHeart (Development of the first fully biocompatible, soft actuated heart: combining in situ tissue engineering and soft robotics)

Reporting period: 2021-07-01 to 2022-07-31

The Hybrid Heart consortium envisions to develop and bring to the clinic soft biocompatible artificial organs. These will consist of a soft robotics shell with actuators (‘artificial muscles’) and sensors, enabling completely natural motion. The inner lining and structures will be made by in situ tissue engineering (TE), ensuring biocompatibility of blood-contacting surfaces.

As the first step, the consortium will develop the Hybrid Heart, which can completely replace a patient’s heart in a procedure similar to a heart transplant, to provide a cure for heart failure, which affects ~23 million people worldwide. Currently, patients with end-stage heart failure either receive a heart transplant, if available, or long-term mechanical circulatory support, which causes severe complications.

To achieve the ambitious goal of providing a permanent cure for these patients, the participants will, in parallel, develop the components of the Hybrid Heart: 1) a soft elastomeric robotics shell containing actuators and sensors, 2) scaffolds for in situ TE of inner lining, valves and vessels and 3) a wireless energy transfer system. These components together will form the full Hybrid Heart, which will be soft, adaptable, wireless and fully bio- and emo-compatible. Both functionality as well as biocompatibility of the HybridHeart will be shown in a Proof-of-Principle study in the chronic sheep model at the end of the project.

The Hybrid Heart project will be carried out by an interdisciplinary group of (academic) researchers and high-tech SMEs, with experience in cardiac surgery, TE, soft robotics and engineering. The technology underlying the Hybrid Heart is applicable to a range of soft robotics-based artificial organs, including the bowel, lung, or muscle structures (limbs). Replacing an entire organ with bioinspired robotic elements, TE biocompatible surfaces, artificial sensors, and an external power source allows for an off-the-shelf therapy for patients with organ failure.
During Period 1, work performed focused on knowledge exchange, defining requirements and prototype development.
The consortium had a kick-off meeting in Amsterdam and a second partner meeting in Pisa. In between the face to face meetings the consortium held teleconference calls to update on progress and to exchange knowledge. Various partners visited each other’s institution to further exchange knowledge and optimally align the work. Partners have also, where appropriate, expedited employing research staff to enable work within the work packages to be achieved on time and to budget.

In this first year of the project we designed and launched the Hybrid Heart logo and the Hybrid Heart website (www.hybridheart.eu). We wrote the data management plan and the dissemination and exploitation plan.

From the scientific point of view the partners at Amsterdam (Amolf), Pisa (SSSA) and Finning (Em-Tec) worked on prototype development of simple parts of the soft robotic part of Hybrid Heart. In the next years, these small parts will be adjusted and arranged to form Hybrid heart. Regarding the energy delivery of Hybrid Heart, requirements were defined and a prototype of the transcutaneous energy transfer system was developed.

Continuing on from Period 1, in Period 2 the Hybrid Heart consortium has made considerable progress in the development of a fully soft artificial heart powered by air pressure, fluidic networks to control the pumping behaviour of the heart, developing coatings for the soft materials to reduce risks related to the interaction between artificial tissue and blood, and wireless energy transfer to remove any unnecessary tethers and provide the internal fluidic pump with the required power. In the following period, we will start integration of all components to a fully soft heart that is fully bio- and hemo-compatible.
The Hybrid Heart Proof-of-Principle established in this project will set a baseline for the feasibility of novel artificial motile organ development based on soft robotics technology combined with TE and wireless energy transfer to follow. As such, this project will change the future of organ replacement, using the latest advancement and new applications of soft robotics and TE technologies, which will cause a foundational shift in transplantation research and medicine with unlimited availability of safe, biocompatible and off-the-shelf
solutions for all patients.
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