INtegrated CAtheter Sheath having imaging capabilities – INCAS

In the field of cardio-vascular diseases, the last decade was marked by the development of percutaneous endocardiac and endovascular therapeutic solutions, leading to less invasive and cost effective strategies such as arrhythmia catheter ablation, transcatheter aortic valve implantation, mitral valve repair, septal defect and left atrial appendage closure, leadless pacemaker or endovascular prosthesis. All these procedures are performed under fluoroscopy and may require guiding using transthoracic or transesophageal echocardiography. In parallel, intracardiac echocardiography (ICE) was developed to provide surgeons and interventional cardiologists with visualization of structures and catheters or devices during procedures. This increased visualization inside the heart contributes to greater clinical confidence, fewer complications, expanded treatment capabilities, and improved workflow but require an additional, dedicated and costly tool.
The main objective of this project is to make the Proof of Concept of a multi-purpose smart sheath catheter equipped with advanced volumetric ultrasound imaging capabilities (elastography and ultrasensitive Doppler) that allow augmented visualization of the cardiac site in real time all along the delivery of the therapy. The proposed technical solution consists of integrating miniature ultrasound transducer arrays in the distal extremity of the steerable sheath catheter
The partners involved in the project, Centre Hospitalier Universitaire de Rennes, VERMON, CAIRDAC and Inserm U 1273 offer complementary competences to successfully develop a first prototype. VERMON has more than 30 years’ experience in the manufacturing of miniature ultrasound transducers for the medical industry. The transducers will be arranged in order to get a “forward looking” image. The ultrasound transducer arrays will be interfaced to the ultrasound machine by integrating the wired link inside the sheath catheter envelope. CAIRDAC team has a long experience in the design and manufacturing of cardiac lead catheters and is developing a second generation of a delivery tool catheter for leadless pacemakers. The software of image acquisition and post-processing which is specific to the ultrasound arrangement will be integrated to an high frame rate ultrasound console machine. Inserm U1273 “Physics for Medicine” has more than 10 years of experience in the design and development of custom hardware and software for medical imaging research projects.
These three separated developments (ultrasound transducer, smart catheter, ultrasound imaging software) will be coordinated by the “Centre Hospitalier Universitaire de Rennes” clinical team, project leader in charge of the clinical requirements and prototype validation.
The main technical challenges are related to the miniaturisation of the ultrasound transducer and its integration within a catheter sheath with small diameter and thickness. There is a trade-off between the miniaturisation level and the number of transducer arrays to be integrated into the sheath from which depends the image quality. However, the image quality could be further improved during the industrial development of the final product using more advanced manufacturing process. VERMON and CAIRDAC would be able to follow the project achievements within a product development phase to create with the INCAS partners this promising business area of the imaging sheath. Beyond the main project target, the technologies developed would also enable VERMON to address ultrasound ablation medical device for atrial fibrillation treatment which is an existing and very attractive market. A specific IP strategy will be started at the project beginning.
From the clinical point of view, the new product will facilitate “safe and easy to perform” procedures in the context of increasing indications. An added value may be the development of ambulatory procedures and the associated cost reduction for the health care system.