hearrestore - nano-tera, 2016
TRANSCRIPT
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Hear Restore: Robotic Cochlear Implantation
Stefan Weber
University of Bern
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• Cochlea implants
• Robotic cochlear implantation
• From research to product
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45’000 im
plants p.a.
Deaf patients
Cochlear Implants
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But: Inconsistent preservation of residual hearing
• No treatment for patients with partly impaired hearing
• Re-implantation in children causes further deterioration
Solution: Robotic cochlear implantation
• Consistent hearing preservation
• More patients to benefit from CI technology
• Better individual implant performance
• Enable future treatments (i.e. drug delivery)
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Robotic cochlear implantation
1. Software based planning
2. Robotic Drilling
3. Insertion of array
4.
Completion of surgery
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Advantages
•
Minimally invasive
• Potentially atraumatic
• Consistent array insertion
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Stage 1
Plan a safe route, optimal for insertion
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Gerber N., Bell B., Gavaghan K., Weisstanner C., Caversaccio M., Weber S. (2013): Surgical planning tool for robotically assisted hearing aid implantation, InternationalJournal of Computer Assisted Radiology and Surgery, June 2013, Int J Comput Assist Radiol Surg. 2014 Jan;9(1):11-20
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Fiducial placement
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• Standard screws
1.5!3 mm
Medartis
• Percutaneous
• Placed before CT
• Local anaesthesia
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Preoperative imaging
• Resolution: 150 micron
• Available in current scanners
We use
• Siemens SOMATOM
• Temporal Bone protocol
• 0.156 ! 0.156 ! 0.2 mm3
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Identify facial nerve
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Plan trajectory
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Defining cochlea access
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Basal turn deviation
Wimmer et al. Semiautomatic Cochleostomy Target and Insertion Trajectory Planning for Minimally Invasive Cochlear Implantation. Biomed Res Int 2014
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Safety measures for drilling process
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6 – 10 mm
S
Pecking depth: 1 mm
S2
0.5 mmS3
1 mm
CT EMGTPE
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Stage 2
Drill along the safe route
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Setup & Drilling
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Intraoperative Imaging (for clinical trial)
Facialis Monitoring during drilling
Redundant tracking via analysis of bone density
Safety layers for facial nerve protection
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Heat minimization of drill process
High Precision Image Guidance
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High precision robotic guidance
Process accuracy (n=37 heads): 0.14 ± 0.07 mm
Recess: 2.5 ± 0.5 mm
Tunnel: 1.8 mm
Distance FN: 0.5 mm
Facial Nerve
Trajectory
External Auditory CanalOssicles
ChordaTympani
B Bell, T Williamson, N Gerber, K Gavaghan, W Wimmer, M Caversaccio, S Weber (2013) In Vitro Accuracy Evaluation of Image-Guided Robot System forDirect Cochlear Access Otology & Neurotology, Otol Neurotol. 2013 Sep;34(7):1284-90.
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Heat optimization of drill process
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Optimized drill geometry
• RPM 1000 s-1
• Pecking (1mm, 0.5mms-1)
• Integrated Irrigation
• Consistent chip removal
• Indirect Heat sensing
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Conventional surgical drill, no chip removal
Heat optimized drill, chip removal
A. Feldmann, J. Anso, B. Bell, T. Williamson, K. Gavaghan, N. Gerber, H. Rohrbach, S. Weber, P. Zysset: Temperature Prediction Model for Bone DrillingBased on Density Distribution and In Vivo Experiments for Minimally Invasive Robotic Cochlear Implantation, Annals of Biomedical Engineering
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Accuracy 0.29±0.14 mm
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Correlate bone density with drilling force
Williamson T, Bell B, Gerber N, Salas L, Zysset P, Caversaccio M, Weber S. (2013) Estimation of tool pose based on force-density correlation during robotic drilling.IEEE Trans Biomed Eng 2013 Apr;60(4):969-76.
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•
Neuromonitoring integrated in drill system• Specific multi-electrode probe
• Detect minimum current responses via various electrodes
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Determine safe / unsafe proximity
Facialis Monitoring (EMG) during drilling
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Drilling to access next measurement point
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Data analysis work flow
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Mastoid
MicroCT scan
FN
FN distance measurement Histopathology
-1 0 1
0 .10 .30 .5
1
1 .5
S t i m
u l u s
t h r e s h o l d
( m
A )
Ax ia l d is ta nc e (m m)
Sheep 2
Trajectory 7
LD = 0
d = 2
d = 4
d = 7
Mono
Stimulus threshold mapping Safe vs. unsafe?
D
FN Drill
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2
• Safe (>0.6mm, >95%)
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Uncertain
• Not safe (
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Intraoperative imaging (clinical trial)
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Stage 3
INSERTION
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Wimmer et al. Cochlear Duct Length Estimation: Adaptation of Escude’s Equation. CI2014 Munich, Germany
Selection of optimal electrode array
1. Define insertion depth
2. Estimate CDL
3. Select appropriate array Array length mm
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Array insertion using a guide tube
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Visualization
Endoscopic (future)Microscopic (clinical trial)
Wimmer et al. Cone beam and micro-computed tomography validation of manual array insertion for minimally invasive cochlear implantation. Audiol Neurotol 2014; 19:22-30
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• Full scala tympani insertion
• 25/26 cases
• Scala vestibuli insertion
• 1/26
• Unrelated to planning
Postoperative Assessment
Venail et al. Manual Electrode Array Insertion Through a Robot-assisted Minimal Invasive Cochleostomy: Feasibility and Comparison of Two Different Electrode Array Subtypes. OtolNeurotol 2015; 36:1015-22
Special flex28
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From Research to product
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Clinical trial (KEK and Swissmedic approved)
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Translation aspects
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First in man trial (KEK and Swissmedic approved)
• Build evidence base for clinical benefit
• International multi-center trials in preparation
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Health technology assessment (i.e. GB, GER, US)
• Create awareness among surgeons
• Development of sustainable business models
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Summary
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Concept: Robotic cochlea implantation
• Accurate: : 0.14 ± 0.07 mm
• Safe: EMG, Heat, Bone density
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Consistent: atraumatic insertion
• Approved: 13 patients for clinical trial
• Commercial development ongoing
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Thank You
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Prof. Marco Caversaccio, Inselspital Bern
• Teams at ARTORG, ISTB, CSEM...
• Clinical partners (CH, UK, GER)
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Industrial partners
... and of course the Nano-Tera Initiative