This research project is part of the iMIT program and funded by the Netherlands Organization for Scientific Research NWO. The iMIT Program, executed by a community of Dutch Universities, university medical centers, and companies, aims to develop instruments for minimally invasive interventions. The program will result in the development of interactive Multi-Interventional Tools (iMIT) that can adapt to their environment and integrate diagnostic and therapeutic functionalities, thus permitting effective single-procedure interventions.
The IGIT project focuses on increases the success rate of Percutaneous Coronary Interventions (PCI) of Chronic Total Occlusions (CTO). In the field on cardiovascular interventions, the CTO is a subset of lesion types that is the most challenging to treat, evidenced by the low procedural success (55%–80%) depending on the techniques and experience of the physician. In comparison, the procedural success rate of non-occluded lesions is approximately 90%. The most important reason for this lower success rate is the fact that the lesion cannot be crossed by the guidewire. Different techniques with extra equipment and additional guidewires are used to increase the rate of success. E.g., a support catheter can provide extra column strength, supporting the guidewire advancement through the occlusion while maintaining its flexibility. Consequences are an increase of complications such as false lumen creation or vessel dissection. Furthermore, these procedures may take hours leading to high irradiation exposure of patient andthe physician and use of large volumes of nefrotoxic contrast dye.
The aim of the IGIT project is to develop a support catheter with triple functionality: (1) imaging with an ultrasound transducer that does not only look sideways, but also in front, so that the CTO lesion can be visualized and information from the signal can be used to uncover the better accessible areas for crossing the CTO and avoid a dissection of the arterial wall or the creation of a false lumen (ErasmusMC); (2) accurate steering of the device based on the optimal use of the information already given by the location of the device, and the situation in front and around the device (TUDelft); (3) 3D visualization of the catheter without the use of X-ray by integrating a specially designed optical fiber into the support catheter (Philips). Next to these functionalities, several innovative crossing mechanisms that are able to cross heavily calcified CTOs without buckling and with ease will be developed.
In the BITE group we will focus on the design of the steerable catheter. Various methods of steering will be investigated. These include mechanical, electrical, or shape memory materials. A requirement is to leverage the limited space available in the catheter, especially since a part of the space is being used for ultrasound transducers.Furthermore, innovative crossing methods are investigated by looking into nature.
Designs related to IGIT:
- Pulze Hammer I
- Pulze Hammer II (coming soon)
- Accura (coming soon)
- Volt (coming soon)
- Wave Catheter (coming soon)
- Cradle Catheter (coming soon)
- Biopsy Needle (coming soon)
Publications related to IGIT:
- Sakes A., Van der Wiel, M., Dodou, D., Breedveld, P., Endovascular Crossing of Chronic Total Occlusions Using an Impulse: An Explorative Design Study. Cardiovascular Engineering and Technology.
- Sakes A., Dodou D., Breedveld P. (2017). Colliding with chronic total occlusions: development of an impulse crossing tool. Proc. 6th Dutch Conference of Biomedical Engineering, Jan. 26-27, Egmond aan Zee, The Netherlands, 1 p.
- Sakes A., Dodou D., Breedveld P. (2016). Bio-inspired Shooting Mechanism for Crossing Chronic Total Occlusions. Proc. 28th International Conference of Society for Medical Innovation and Technology (SMIT), Oct. 05-08, Delft, The Netherlands, 1 p.
- Sakes A., Regar E., Dankelman J., Breedveld P. (2016). Treating Total Occlusions: Applying Force for Recanalization. IEEE Reviews in Biomedical Engineering, Vol. 09, pp. 192-207.
- Sakes A., Wiel M. van der, Henselmans P.W.J., Leeuwen J.L. van, Dodou D., Breedveld P. (2016). Shooting mechanisms in nature: a systematic review. Plos One, Vol. 11, No. 7, 46 p.
- Sakes A., Dodou D., Breedveld P. (2016). Buckling prevention strategies in nature as inspiration for improving percutaneous instruments: a review. Bioinspiration and Biomimetics, Vol. 11, No. 2, 26 p..
- Sakes A., Regar E., Dankelman J., Breedveld P. (2016). Crossing total occlusions: navigating towards recanalization. Cardiovascular Engineering and Technology, Vol. 7, No. 2, pp. 102-117.
- Sakes A., Ali A., Henselmans P.W.J., Breedveld P. (2015). Design of a 2mm diameter 8 DOF steerable prototype for the treatment of chronic total occlusions. Proc. 5th Dutch Bio-Medical Engineering Conference, Jan. 22-23, Egmond aan Zee, the Netherlands, 1 p.
- Sakes A., Dankelman J., Breedveld P. (2014). Crossing CTO lesions: a review of the state of the art devices. Proc. ASME Design of Medical Devices Conference – Europe Edition 2014, Oct. 22-24, TU Aula Conference Centre Delft, Delft, the Netherlands, Abstract 38, 2 p.