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

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)

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