SMART ACTIVE IMPLANTABLE MEDICAL DEVICES: A VISION FOR THE FUTURE
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1 SMART ACTIVE IMPLANTABLE MEDICAL DEVICES: A VISION FOR THE FUTURE Alain Ripart Senior Scientific Advisor Sorin Group September 27, 2012
2 Personalized medicine delivered by implanted devices is exploding WEI et al. Front. Energy Power Eng. China 2008
3 Very early pacemaker...
4 Heart rhythm disorders and associated therapy devices Bradycardia Pacemaker Atrial Arrhythmias Pacemaker/RF ablation Ventricular arrhythmias/ablation? ICD/RF ablation Congestive Heart Failure CRTD/Neuromodulation/ Hemodynamical support 4
5 Market Vision Today Population above 60 11%, 17% in billion Cardiovascular devices Market billion Cardiovascular devices Market 5
6 Smart, Powerful, Small M 10,573 CAGR, (%) M 7, CRT-D ICD 11,5 9,6 CRT-D Heart Failure CRT-P PM 0,2 Tachycardia Total 6,7% Bradycardia Market value PM 6
7 Active Cardiac Implantable Devices Titanium package Wireless Remote Monitoring RAM ROM High voltage Defibrillation RF communication Low power CPU Analog sensing & pacing Programming System Hermetic package MEMS Sensors 7
8 Fonctions uploaded in RAM 8
9 Fonctions uploaded in RAM 9
10 What s inside? Hybrid circuit 10
11 What s inside? Ovatio defibrillator 11
12 Heart failure 2005: up to 14 million Europeans currently suffer from heart failure. 2020: increasing to 30 million. Over 3.6 million new cases of heart failure are reported each year in Europe. First cause of cardiovascular mortality in Europe. Heart Failure is the most common cause of hospital admission in people over
13 Optimal Management of Heart Failure HF heart status change over time CRT settings must be repeatedly tailored to the individual patient Self-adjustment of CRT parameters Cardiac resynchronization is permanently tailored to the patient Replaces time-consuming echocardiographic assessment required with conventional CRT devices require Monitoring of the patient s status 13
14 Heart failure sensor Lead body (length=60cm) Lead Connections Distal End, with accelerometer inside Proximal end; connector fits into pacemaker receptacle Pacing Tip 14
15 Capteur SonR 15
16 e-brains RESEARCH in FP7: Leadless pacemaker Cap -Chip (Wafer) MEMS/NEMS Device possibly with TSV MetallisationSystem 2 IC Device 2 (Technology 2) with TSV MetallisationSystem 1 IC Device 1 (Technology 1) 24mm*15mm*5mm 9mm*7mm*3mm 8 cc 5mm*2mm*1mm 1 cc 0,5 cc 17
17 e-brains RESEARCH in FP7: Leadless pacemaker Cap -Chip (Wafer) MEMS/NEMS Device possibly with TSV MetallisationSystem 2 IC Device 2 (Technology 2) with TSV MetallisationSystem 1 IC Device 1 (Technology 1) Diameter: 6 mm Length: 24 mm 25mm 18
18 Acetylcholine Autonomous nervous system Noradrenaline 02/10/
19 Vagal nerve stimulation Technology close to CRM Vagus nerve Vagal nerve stimulation for refractory heart failure But neurostimulation is as its early stage evolution and innovations will follow CRM path Carotide Neurostimulation electrode Neurostimulator Cardiac electrode 20
20 Left Ventricular Assist devices : Hemodynamical support Bridge to transplant or contra-indication for heart transplant Sternotomy Thoratec (Heartmate), Micromed (Debakey), Jarvik (Jarvik 2000),Worldheart Micro pump : Patient indicated for LVAD but with risks. helps pumping to organs from LA to subclavian artery: 3l/min Minithoracotomy Endovascular for next generation Circulite (Synergy pocket micropump) Artificial heart : End stage biventricular failure replace both ventricles Sternotomy Cardiowast (Syncardia) - Abiomed (Abiocor) - Carmat (clinical 2013) 02/10/
21 Remote Follow-up of implanted Cardiac active devices Telemedecine was born a long time ago! 22
22 Sorin remote monitoring :a global solution Orange hosting centre Orange application service non emergency monitoring of device and patient Clinician access IMD Home monitor CRM patient Helpdesk Home Monitors and ICD deliveries home monitor inventory 23
23 Smart miniature low-power wireless microsystem for Body Area Networks RF & DSP SoC WBAN Hearing aids RF+IF+LF MEMS WiserBAN microsystem RADIO IC 65nm CMOS Cardiac implants Miniature antenna RF & LF MEMS 2.4GHz mw-level <4x4x1 mm 3 Cochlear implants Heterogenous SiP Insulin pumps 24
24 5 Years vision WiserBAN Switching from 400 MHz to 2.5 GHz is expected to bring: Smaller RF module (4 x 4 x 1 mm 3 ), More efficient antenna, Lower cost Higher data rate (up to 2 Mb/s), Lower overall power consumption (Lower duty cycle) New ETSI 2.56 GHz dedicated to Low Power Active Medical Implants (LP-AMI) EN Encryption bits & authentification mandatory EMC protection Potential products Today High end CRM devices To morrow any AIMD Watch / Pen / Badge relay Main risks to be assessed: Link budget at 2.5 GHz Diversity 25
25 Implants in 5 years Tab / Smartphone -Concentrate data - provide monitoring options - gateway to internet - USER INTERFACE BLUETOOTH NFC Proprietary RF GHz -400 MHz -HBC - Watch Concentrator Module - Powered via Body Energy Scavenging - Movement - Bio-fuel cell - Thermal exchanges - Also measure ECG and give time! - In 10 years: Brew coffee!!!! 26
26 THANK YOU FOR YOUR ATTENTION
27 Requirements for an implantable sensor Physiologic but simple Miniature Integration Low current consumption Reliable Hermetically sealed Biocompatible Leadless / Wireless 29
Technology Challenges for Active Cardiac Implantable Devices. Alain Ripart Senior VP and CSO
Technology Challenges for Active Cardiac Implantable Devices Alain Ripart Senior VP and CSO Heart rhythm disorders and associated therapy devices Bradycardia Pacemaker Atrial Arrhythmias Pacemaker Ventricular
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