Project: Advanced Intracardiac imaging Device.
_x000D_More than 10 million people in Europe are affected by Chronic Heart Failure (CHF) today and this number will increase to 30 million by 2020. Furthermore, cardiovascular diseases and cancers cause more than 70% of deaths in Europe. As the result, CHF related hospitalisations have doubled in the two last decades. Improved diagnosing and therapeutic methodologies and suitable equipments are urgently needed to reduce life threatening situation and healthcare expenditure._x000D__x000D_In CHF patients, reduction in the left ventricle stroke volume and cardiac output is COly caused by poor electrical conduction that desynchronizes the right and left ventricle contractions. Actually, the heart is a hollow muscle which acts as an electrically controlled pump for the blood. An electrical impulse generated for every heartbeat by specialised nerve node (sinoatrial node) spreads through the heart, activating muscle contraction in a regular and sophisticated pattern. This electrical conduction is a very complex process involving many special structures and mechanisms inside the heart and the study of these issues is known as ElectroPhysiology (EP) which is essential diagnosis for implantation of pacemakers and defibrillators or any intervention on conductivity abnormalities. The most relevant application for advanced electrophysiology concerns the "Atrial Fibrillation" which is due to the disorganised electrical activity in the atria and leading to irregular heartbeat. In this type of intervention, the EP physician creates a number of lesions (tissue damage) by local heating or freezing in the endocardial surface of the atrial wall, forming an isolation to stop the erratic pulse propagation and restore normal sinus rhythm. The creation of such lesions is complex three-dimensional (3D) task and therefore requires suitable 3D visualisation which is not available today (the heart is beating during the procedure and heart walls and catheters are moving fast!)._x000D__x000D_Because lack of proper visual guidance, EP operations are difficult, expensive, long and painful intervention with significant risk of procedure failure and serious complications for the patient. Current imaging modalities for EP operations are: X-Ray fluoroscopy, 3D magnetic navigation of the catheter tip (Stereotaxis Niobe System); the first tool allows seeing the catheter but not the atrial chambers and the heart walls while the second is very time consuming procedure and the motion of patient or breathing introduce large errors. The best option for realtime imaging is so far intracardiac ultrasound or intracardiac echography (ICE) since its can provide both images of catheter and tissue in high frame rate compatible with the intervention. Unfortunately, current ICE products (Siemens AcuNav, EPmed) can only provide single plane ultrasonic phased array visualisation._x000D__x000D_Realtime 3D ultrasound is today available for external applications such as gynecology/obstetrics and cardiology (from the chest wall), some demonstrators and announcements in 3D transesophageal echo have been disclosed but all show insufficient resolution and unsuitability for EP procedures. There is obviously a need to provide physicians with ICE products that are capable of making very accurate images of the heart tissue as well as enable realtime 3D scanning of the surrounding heart muscles and chambers in order to efficiently assist the surgeon in manipulating the EP cathethers. In extension, this new 3D capability of ICEs will further pave the way for the next generation of multifunctionnal surgical instruments which integrate higher sensor density and heterogeneous functionalities (RFID, wireless)._x000D__x000D_The AID project has objectives to develop a realtime 3D ultrasound ICE device which includes a miniaturised (7F-10F) high resolution multiplane phased array catheter which is accurately motorised and position controlled in the heart chambers. The project development strategy is organised in two CO sections including technological research and demonstrator realisation for validation. The development work will be undertaken by a strict necessary consortium composed by European leading companies: Vermon (FR), mymotors & actuators GmbH (DE) and Dr. Fritz Faulhaber GmbH&Co.KG (DE). The Pship has demonstrated their excellence respectively in medical devices, high precision motorisation and integration of miniaturised mechatronics. The clinic evaluation of final products will be managed by Vermon, in close co-operation with customers. _x000D__x000D_The AID's objectives will address the ever-demanding new ICE modalities so as to promote rapid market development and to reinforce the leading position of the involved Ps. Furthermore, the medical and technological progress and understanding expected in CHF diagnostic/treatment will advantageously impact current healthcare expenditure (reduction of hospitalisation and rehospitalisation) and patient's quality of life (see Healthcare Expenditures in Annexes p.1)._x000D_
| Acronym | AID (Reference Number: 4312) |
| Duration | 03/11/2008 - 03/12/2011 |
| Project Topic | The AID project aims at the development of intracardiac diagnosing product providing realtime 3D image capability while COtaining high resolution for 2D scans. AID's devices will open up new cardiac surgical modality in offering on-demand volume examination, essential in electrophysiology. |
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Project Results (after finalisation) |
AID project is aimed at the development of intracardiac catheter probe for 3D ultrasonic imaging (ICE device). The work has been carried out on one hand, the design and manufacture of motorized surgical endoscopic probe, and on the other hand new transducer for high resolution rotating image._x000D_The initial design of the probe having integrated and disposable motorisation has been abandoned since the manufacturing and assembly costs are far from those expected for the applications. An alternative design was developped to incorporate a reusable motor mounted in the handle of the endoscope, this design has been optimized and prototyped for performance assessment._x000D_What have been achieved during the project period:_x000D_* ICE catheter: material for catheter construction has been selected amongst numerous solutions available, the approved design of the catheter satisfies requirements for rotation functionnalities of the probe._x000D_* 3D ultrasonic sensor: a new sensor for accurate 3D imaging was designed. The structure and method of manufacturing include integrated reinforced material that helps improving the precision of the image as well as the detectability of the transducer through angiography; the cencept is patent pending._x000D_* Packaging and interconnect: we have developped a miniaturised interconnect method which allow the sensor to mounted onto the catheter at minimum encumbrance and sufficient reliability for the application._x000D_* Driving mechanism: Faulhaber and Vermon have achieved the endoscope mechanism with integrated motorisation located in the handle._x000D_* Implementation of the modules: the final functional prototype has been assembled and tested; the results show acceptable performance and the prototype will be test under medical environment requirements (drop, humidity and sterilisation) |
| Network | Eurostars |
| Call | Eurostars Cut-Off 1 |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 3 | Dr.Fritz Faulhaber GmbH & Co. KG | Partner | Germany |
| 3 | mymotors & actuators GmbH | Observer | Germany |
| 3 | Vermon SA | Coordinator | France |