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Otologic Surgery
Daniel L. Rothbaum, MD
Jaydeep Roy, PhD
Louis L. Whitcomb, PhD
Russell Taylor, PhD
Gregory Hager, PhD
Dan Stoi
John K. Niparko, MD
Howard Francis, MD
Otologic Surgery
w Operating microscopew High dexterityw Constrained access
n Restricted range of motion
n Obstructed view
Ear Anatomy
wExternal earwMiddle earw Inner ear
External Ear
w Auriclew External auditory canalw Tympanic membranew Canal dimensions
n 1 cm diametern 2.5 cm long
Middle Ear
w Tympanic membranew Ossicles
n Malleusn Incusn Stapes
w Oval windoww Round windoww Eustachian tube
Myringotomy and PE Tubes
w Recurrent otitis mediaw Most common ear
surgeryw Approximately 1.4
million tubes placed annually
Myringotomy and PE Tubes
Tympanoplasty (type I)
w Reconstruct eardrumw Secondary to chronic
middle ear infections and non-healing perforations
Tympanoplasty with Ossicular Reconstruction
w Replace malleus (type II) or malleus and incus (type III) with prosthesisw Eardrum repair (as
necessary)
Tympanoplasty withOssicular Reconstruction
w Replace all three ossicles (stapes, incus, malleus) with prosthesisw Type IV tympanoplastyw Repair eardrum (as
necessary)
Stapedotomy
w Otosclerosis with stapes footplate fixationw Prosthetic stapes
(piston prosthesis)
Inner Ear
w Cochleaw Semicircular
canalsw Utricle and
Saccule
Cochlear Implantation
w Sensorineural hearing lossw Electronic stimulation of the cochlea
Considerations in Otologic Surgery
Considerations in Ear Surgery
wAccessn Space versus invasiveness trade-off
wManipulationn Confined spacesn Micro-manipulations
Transmeatal Approach
w Most minimally invasive approachw Confined space
n Decreased range of motion
w Coaxialn Reduced depth
perceptionn Obstruction of view
Limitations of Microsurgery
uLimitations- Positional accuracy (15-20 microns)- Optical limitation of 10 microns
uReducing limitations will:- Increase surgical performance- Allow new surgical procedures- Make surgery better, safer, faster, cheaper
Conceptual Overview
Part I: Stapedotomy• Use stapedotomy as a model procedure to
develop a robotic-assist for otologic surgery• Improve existing surgeriesPart II: Accessing the Scala Media• Use robotic assistance to permit new surgical
approaches
Part I: Middle Ear Surgery
Stapedotomy
Part I:Stapedotomy
w Technically difficult operationw Clear variations in outcome based on surgeon
experiencew Potential complications
n Hearing lossn Vertigon Tinnitus
Applying the Steady Hand robot to Stapedotomy
w Fenestration of the stapes footplate with a micro-pick
w Crimping of the piston prosthesis to the incus
Steady Hand Robot
Steady Hand in Stapedotomy
Fenestration Trials
Force Scaling:
w Tactile feedbackw Test various robot
modes (vs. free-hand):n Unscaled force feedbackn Amplified force
feedback
Locating the Fenestration:Displacement
w Mark desired fenestration site
w Before and after images
w Measure difference between centers of desired and actual fenestrations
w Displacement (mm)
Forces at the Oval Window:Load Cell Measurements
w Max Force (N)
w Cumulative Force (Ns)
Steady Hand in Stapedotomy
Fenestration TrialsDATA
Free-Hand vs SH 1:1 vs SH 2:1Fellows & Attendings TOGETHER
1-way ANOVA0.0875.356.086.43Max Force
(N)
37.83
0.150
SH Robot1:1 Force Feedback
(mean)
0.081
0.648
P-value
1-way ANOVA
1-way ANOVA
Test
47.43
0.160
SH Robot2:1 Force Feedback
(mean)
69.93Cumulative Force (Ns)
0.178Displacement (mm)
Free-Hand(mean)
Free-Hand vs. SH Robot 2:1Adjusted for Fellow/Attending
0.04
0.08
0.032
R2
Robotic Assistance
Surgeon
Independent Variables:
0 = Free-Hand1 = SH Robot
with 2:1 Force Scaling
0 = Fellow (F)1 = Attending
(A)
0.17
0.04
0.60
P-value
-22.09Cumulative Force (Ns)
-1.08Max Force (N)
-0.017Displacement (mm)
Coefficient(Robotic
Assistance:0=FH; 1=SH
2:1)
Dependent variable
(multiple linear regression)
DisplacementGrouping SH 1:1 & SH 2:1 together
Independent Variables:
0.81-0.006
Dependent Variable:Displacement (mm)
-0.023
Coefficient Value(mm)
Robotic Assistance
Surgeon
0 = Free-Hand1 = SH Robot with
either 1:1 or 2:1 Force Scaling
0 = Fellow (F)1 = Attending (A)
0.40SurgeonCoefficient
Robotic Assistance Coefficient
P-Value
DisplacementFH vs SH 2:1
Independent Variables:
0.601-0.017
Dependent Variable:Displacement (mm)
-0.037
Coefficient Value(mm)
Robotic Assistance
Surgeon
0 = Free-Hand1 = SH Robot with
2:1 Force Scaling
0 = Fellow (F)1 = Attending (A)
0.251SurgeonCoefficient
Robotic Assistance Coefficient
P-Value
Fellows vs AttendingsFH, SH 1:1 & SH 2:1 TOGETHER
Student t-test for 2 samples0.845.895.97Max Force
(N)
57.99
0.166
Fellow(mean)
0.26
0.75
P-value
Student t-test for 2 samples
Student t-test for 2 samples
Test
44.66
0.159
Attending(mean)
Cumulative Force (Ns)
Displacement (mm)
Fellow vs. Attending:Free-Hand ONLY
Student T-test for 2 samples0.010.1000.236Displacement
(mm)
Student T-test for 2 samples
Student T-test for 2 samples
Test
0.92
0.72
P-value
71.53
6.60
Attending(mean)
68.76Cumulative Force (Ns)
6.30Max Force (N)
Fellow(mean)
Dependent variable
Fellow vs. Attending:SH 2:1 ONLY
Student T-test for 2 samples0.150.1860.135Displacement
(mm)
Student T-test for 2 samples
Student T-test for 2 samples
Test
0.36
0.72
P-value
39.46
5.22
Attending(mean)
54.87Cumulative Force (Ns)
5.46Max Force (N)
Fellow(mean)
Dependent variable
FH vs. SH 2:1:Fellows ONLY
Student T-test for 2 samples0.040.1350.236Displacement
(mm)
Student T-test for 2 samples
Student T-test for 2 samples
Test
0.55
0.25
P-value
54.87
5.46
SH 2:1(mean)
68.76Cumulative Force (Ns)
6.30Max Force (N)
FH(mean)
Dependent variable
FH vs. SH 2:1:Attendings ONLY
Student T-test for 2 samples0.010.1860.100Displacement
(mm)
Student T-test for 2 samples
Student T-test for 2 samples
Test
0.21
0.11
P-value
39.46
5.22
SH 2:1(mean)
71.53Cumulative Force (Ns)
6.60Max Force (N)
FH(mean)
Dependent variable
Fenestration Trial Summary:SH Robot (vs. Free-Hand)
w Applies less force at oval window (particularly at 2:1 force scaling)n Maximum force: decreases 17% from 6.4 to 5.4 N
l p-value = 0.04
n Cumulative force: decreases 32% from 70 to 47 Nsl p-value = 0.17
w No real difference in ability to target the fenestration
Fenestration Trial Summary:Fellows (vs. Attendings)
w DISPLACEMENT:n Free-Hand
l Worse at targeting the fenestrationn SH Robot
l Improved targeting of the fenestration using the SH Robotl In contrast to attendings who have decreased ability to target the
fenestration using the robot
w FORCE:n Free-Hand
l No difference in forces applied at oval window (Maximum and Cumulative Force)
n SH Robotl No significant difference in effect of SH Robot on forces applied at
oval window (Maximum and Cumulative Force)
Steady Hand in Stapedotomy:Future Directions
w Enhance Robot Capabilitiesn More sophisticated control algorithmsn Force Scalingn Better end effectors
w Better match robot strengths to appropriate tasksn For example, fenestration versus crimping
w Animal trialsn If demonstrate improved performance measures with the
robot
Part II: Inner Ear Surgery
Accessing the Scala Media of the Cochlea
Hearing Loss
w 28 million people in the United States1
w People losing hearing earlier in life2
w Age-related hearing loss n 30% of adults 65 years and older3
n 50% of adults 75 years and older4
1 National Institute on Deafness and Other Communication Disorde1 National Institute on Deafness and Other Communication Disorders (NIDCD). rs (NIDCD). National Strategic Research Plan:National Strategic Research Plan: Hearing Hearing and Hearing Impairment. and Hearing Impairment. Bethesda, MD: HHS, NIH, 1996.Bethesda, MD: HHS, NIH, 1996.
2 2 WallhagenWallhagen, M.I.; Strawbridge, W.J.; Cohen, R.D.; et al. An Increasing pre, M.I.; Strawbridge, W.J.; Cohen, R.D.; et al. An Increasing prevalence of hearing impairment and associated risk valence of hearing impairment and associated risk factors over three decades of the Alameda County Study. factors over three decades of the Alameda County Study. American Journal of Public HealthAmerican Journal of Public Health 87(3):44087(3):440--442, 1997.442, 1997.
3 Gates, G.A.; Cooper, Jr., J.C.;3 Gates, G.A.; Cooper, Jr., J.C.; KannelKannel, W.B.; et al. Hearing in the elderly: The Framingham Cohort, 19, W.B.; et al. Hearing in the elderly: The Framingham Cohort, 198383––1985. Part I. Basic 1985. Part I. Basic audiometric test results. audiometric test results. Ear and Hearing Ear and Hearing 11(4):24711(4):247--256, 1990.256, 1990.
44 CruickshanksCruickshanks, K.J.; Wiley, T.L.; Tweed, T.S.; et al. Prevalence of hearing l, K.J.; Wiley, T.L.; Tweed, T.S.; et al. Prevalence of hearing loss in older adults in Beaver Dam, Wisconsin: oss in older adults in Beaver Dam, Wisconsin: TheThe EpidemiologyEpidemiology of Hearing Loss Study. of Hearing Loss Study. American Journal ofAmerican Journal of EpidemiologyEpidemiology 148(9):879148(9):879--886, 1998.886, 1998.
Hearing Aids
w Only 25% of those who could benefit from a hearing aid actually use one1
w $1.5 billion market worldwide2
11 PopelkaPopelka, M.M.;, M.M.; CruickshanksCruickshanks, K.J.; Wiley, T.L.; et al. Low prevalence of hearing aid use am, K.J.; Wiley, T.L.; et al. Low prevalence of hearing aid use among older adults with hearing ong older adults with hearing loss: The Epidemiology of Hearing Loss Study. loss: The Epidemiology of Hearing Loss Study. Journal of the American Geriatrics SocietyJournal of the American Geriatrics Society 46(9):107546(9):1075--1078, 1998.1078, 1998.
2 2 Baker, S.; Palmer, A.T. Baker, S.; Palmer, A.T. A microchip in your ear: the Danes’ lead in miniature audio spaA microchip in your ear: the Danes’ lead in miniature audio spawns a slew of fresh applications: wns a slew of fresh applications: Business Week Online, Aug 9, 1999.Business Week Online, Aug 9, 1999.
Pathophysiology of Hearing Loss
w Conductive hearing lossn Problem in conduction of the
acoustic signaln Outer and Middle ear
w Sensorineural hearing lossn Problem in conduction and/or
processing of the neural impulse
n Inner Ear, Auditory Nerve, Brain
Sensorineural Hearing Loss
w Loss of inner hair cellsw Located in
the scala media of the cochlea
Surgical Problem:Access the Scala Media
w Insert a needle in the Scala Median Deliver therapyn Hair cell
regenerationn Treat cause instead
of symptom
Defining the problem:Access the Scala Media
w Navigationn 20 micron
resolutionw Positioning
n 25 micron resolution
w Injectionn 1 nanoliter
Navigation:Imaging the Scala Media
Navigation:Imaging the Scala Media
Academic Acknowledgements:
w MADLABn Eugene de Juann Patrick S. Jensenn Aaron Barnesn Sue L. Wun Terry Shelleyn Jay Burns
w ERCn Rajesh Kumarn Jason Wachs
w Surgeonsn John Niparkon Howard Francisn Lawrence Lustign Daniel Leen David Friedlandn Andre Haenggeli
w Materials testingn Robert Cammaratan Ingrid Shaon Han Seo Cho
Corporate Acknowledgements:
w Xomedn Tino Schulern George Bowen
w Storz Instrumentsw Smith and Nephew
Instrumentsw Sawbones Corporationw Dentsply Caulk
Corporation
w Harwick Chemicalw Jeneric / Pentron
Corporationw Kerr Corporationw Stryker Leibingerw Dow Corningw Ferro Corporation