Presentation is loading. Please wait.

Presentation is loading. Please wait.

Robotic Catheter Intervention: The Hansen Medical Sensei™

Similar presentations


Presentation on theme: "Robotic Catheter Intervention: The Hansen Medical Sensei™"— Presentation transcript:

1 Robotic Catheter Intervention: The Hansen Medical Sensei™
Robotic Catheter System Marvin J. Slepian, M.D. Professor of Medicine (Cardiology) Director, Interventional Cardiology Director, Tissue Engineering Lab Sarver Heart Center University of Arizona Tucson, Arizona 2010

2

3 Percutaneous endovascular intervention
remains limited by issues related to catheter access, positioning and stabilization Future therapies in coronary and peripheral intervention, electrophysiology and structural heart disease require greater catheter finesse and control Robotic control of catheter manipulation affords the means for greater finesse greatly expanding therapeutic options in the cath and EP lab

4 Catheter-Based Therapeutics: Limitations
Vascular access Vascular traverse - Tortuosity, calcification, stenosis, aneurysmal dilatation Endoluminal entry Intracardiac traverse - transeptal Intracardiac stabilization Coronary angulation, tortuosity Micropositioning Microdelivery

5 Robotic Catheter-Based Intervention:
Instinctive Motion Scaled Motion Vascular traverse (force-feedback) Variable Force sensing (Increased sensitivity, data) Precise navigation Difficult anatomy access Positional stability Microdelivery Reduction/Elimination radiation exposure Reduced operator fatigue Patient safety At-a-distance/telemetric operation

6 Sensei™ Robotic Catheter System
Work Station Console Displays Imaging modalities Hemodynamics Robotic Guide Remote Catheter Manipulator 1. Outter 2. inner Instinctive Motion Controller Brand X “Trans-Txic Catheter Patient

7 Sensei™ Robotic Catheter System: Components
Robotic Catheter Manipulator Artisan™ Control Catheter Physician Workstation

8 Instinctive Motion™ Controller (IMC)
Operator natural “instinctive” motion Motion recorded, digitized Proprietary control logic Scaling of motion 5 cm 1 cm

9 Remote Catheter Manipulator
Input from Instinctive Motion Controller Engages inner and outer catheter members Servo-motors continuously tensioning & re-tensioning pull wires Computer feedback loop (servo motors - position encoders)

10 Artisan Control Catheter
Steerable inner guide – 11 Fr. OD, 8.5 Fr. ID Off-the-shelf percutaneous catheter <8.5 Fr. Steerable outer guide – 14 Fr. OD, 12 Fr. ID Telescoping Seven Degrees of Freedom Tight bend radius (270o)

11

12 IntelliSense™ Fine Force Technology
Provides real-time measurement and display of the proximal force along the shaft of the percutaneous catheter Detects small variations in force and displays them in a clear visual format Early pre-clinical work suggests strong link between force and map quality1 Road Feel! 1. Okumura Y, Johnson S, Packer D. An analysis of catheter tip/tissue contact force induced distortion of three-dimensional electroanatomical mapping created using the Sensei robotic catheter system. Heart Rhythm 2007;4:S318.

13 CoHesion™ 3D Visualization Module = EnsiteTM + SenseiTM
Importation of the St. Jude Medical EnSite® 3D geometry, labels, and anatomical markers into the Sensei System’s main navigation window Localization of the percutaneous catheter tip within the EnSite ® 3D geometry Artisan catheter navigating from within Ensite model Labels are imported from EnSite system Artisan catheter navigating from within EnSite model 13

14 Robotic Catheter: Precise Navigation, Mapping & RFAblation

15 REMOTE: Remote Manipulation Of Intra-Cardiac Catheter Study
63 pts, 5 centers - Outside the U.S. Atrial Arrhythmias Robotic catheter system + Mapping Mapping of RA/LA Robotic catheter-assisted RF ablation End Points: 1. Navigation to Anatomical Targets 2. Targeting & delivery of RF Therapy 3. Safety

16 REMOTE: Results Intervention Success I. Navigation
Intracardiac targets 332/338 II. Ablation A flutter /6 A fib /34 Afib/flutter /7 AVNRT /6 III. Safety 1 pt. pericardial effusion manual transseptal puncture 1 pt. pericardial effusion during RF ablation

17 Approved Indication for Use
The Sensei Robotic Catheter System, and Artisan Control Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using pre-approved percutaneous mapping catheters. Europe Facilitate manipulation, precise positioning and control of percutaneous catheters within the atria of the heart. May 2, 2007

18 Clinical Cases by Arrhythmia Type Since Regulatory Clearance
U.S sites Europe - 10 sites 800+ clinical cases Afl (13%) AF (75%) Data as of June 30, 2008 The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias, including atrial fibrillation, have not been established.

19 Hansen Medical - SenseiTM
Stereotaxis - NiobeTM

20 Design Advantages Over Magnetic Technology
Sensei Robotic Catheter System Magnetic Navigation Catheter tip motion Instinctive motion allows for precise placement of catheter tip Indirect vector driving leads to variable placement Variable Force Can vary force as required for optimal therapy Constant weak force only, inadequate tissue contact Measurement of contact pressure Quantification of contact between catheter tip and heart wall allows clinician to vary treatment Indirect indication of contact, no quantification of force Control multiple catheters Key to enablement of future procedures Magnetic field limited to steering of one catheter

21 Sensei™ Robotic Catheter System: Universal Endovascular Platform
Proprietary Tools Structural Heart Disease (Potential future application) Ventricular therapy PFO closure Mitral valve repair Valve replacement 7 Fr. Catheter (compared with current 12 Fr. Artisan) Complex Vascular (Potential future application) Aortic aneurysms Carotid artery disease CAD/PCI Chronic total occlusions Lower extremities Venous applications 12 Fr. Artisan Catheter Electrophysiology Atrial flutter Ventricular tachycardia AVNRT, WPW Atrial fibrillation 22

22 Pre-clinical Renal Artery Cannulation: Tertiary Branch
7 Fr. OD Steerable Inner Guide 9 Fr. OD Steerable Outer Guide Investigational project, proof of principle, smaller Artisan catheter

23 In vitro cannulation of fenestrated aortic stent graft in aneurysmal model1
Movement was defined as change in position of the vector at the catheter tip per unit time along or outside the path trajectory. Taking into account forward, backward movement and rotation. 'Per unit time' as in the catheter stops and starts again in any given time. Rather than continuous movement Sensei™ Robotic Catheter System Conventional technique 1. The role of robotic endovascular catheters in target vessel cannulation. C. V. Riga, C. D. Bicknell, M. Hamady, N. J. W. Cheshire. The British Society of Endovascular Therapy (BSET), Birmingham June 2008

24 Robot-Assisted In-situ Stent Graft Fenestration
Swine model, Right renal artery Stabilization, Localization Puncture Wire advance Cutting balloon Balloon dilatation Stenting Wire advance Artisan inner Movement was defined as change in position of the vector at the catheter tip per unit time along or outside the path trajectory. Taking into account forward, backward movement and rotation. 'Per unit time' as in the catheter stops and starts again in any given time. Rather than continuous movement Artisan outter 1. Robot-assisted in situ fenestration of aortic stent grafts. Riga CV, Bicknell CD, Hamady M, Cheshire NJW. Multidisciplinary European Endovascular Therapy (MEET) Congress, Cannes July 2008

25 Future Capability: Two Handed Procedures
Although commonly used, the term structural heart disease in fact has no generic clinical meaning. Patients however with holes in the heart do fill the bill. The types of holes are primarily congenital - and are ASDs, VSDs, and PFOs. Patent foramen ovale (PFO) has been associated with cryptogenic stroke. Percutaneous closure of patent foramen ovale (PFO) for prevention of recurrent paradoxical embolism was first introduced in It is a catheter-based technique using atrial septal occlusion devices. Today, percutaneous closure of a PFO has become a common procedure in cardiac catheterization laboratories. PFOs have received a lot of lay press recently as many of you know with a causal relationship with migraines. This controversy is unresolved.

26 Universal Angiographic Catheter

27 Summary: Hansen SenseiTM system Integration of Robotic technology with Computational movement Integration of multiple imaging modalities to create a user friendly rotatable 3D cardiac “work space” Precise, instinctive motion, positioning and stabilization of a variety of diagnostic and therapeutic catheter systems/devices Ex vivo, In vivo and Clinical studies: Safe and effective for diagnostic and therapeutic access and delivery to multiple intra-cardiac and vascular locations The System continues to evolve with enhanced potential


Download ppt "Robotic Catheter Intervention: The Hansen Medical Sensei™"

Similar presentations


Ads by Google