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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

Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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Page 1: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 2: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Otologic Surgery

w Operating microscopew High dexterityw Constrained access

n Restricted range of motion

n Obstructed view

Page 3: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Ear Anatomy

wExternal earwMiddle earw Inner ear

Page 4: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

External Ear

w Auriclew External auditory canalw Tympanic membranew Canal dimensions

n 1 cm diametern 2.5 cm long

Page 5: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Middle Ear

w Tympanic membranew Ossicles

n Malleusn Incusn Stapes

w Oval windoww Round windoww Eustachian tube

Page 6: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Myringotomy and PE Tubes

w Recurrent otitis mediaw Most common ear

surgeryw Approximately 1.4

million tubes placed annually

Page 7: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Myringotomy and PE Tubes

Page 8: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Tympanoplasty (type I)

w Reconstruct eardrumw Secondary to chronic

middle ear infections and non-healing perforations

Page 9: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Tympanoplasty with Ossicular Reconstruction

w Replace malleus (type II) or malleus and incus (type III) with prosthesisw Eardrum repair (as

necessary)

Page 10: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Tympanoplasty withOssicular Reconstruction

w Replace all three ossicles (stapes, incus, malleus) with prosthesisw Type IV tympanoplastyw Repair eardrum (as

necessary)

Page 11: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Stapedotomy

w Otosclerosis with stapes footplate fixationw Prosthetic stapes

(piston prosthesis)

Page 12: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Inner Ear

w Cochleaw Semicircular

canalsw Utricle and

Saccule

Page 13: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Cochlear Implantation

w Sensorineural hearing lossw Electronic stimulation of the cochlea

Page 14: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Considerations in Otologic Surgery

Page 15: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Considerations in Ear Surgery

wAccessn Space versus invasiveness trade-off

wManipulationn Confined spacesn Micro-manipulations

Page 16: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Transmeatal Approach

w Most minimally invasive approachw Confined space

n Decreased range of motion

w Coaxialn Reduced depth

perceptionn Obstruction of view

Page 17: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 18: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 19: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Part I: Middle Ear Surgery

Stapedotomy

Page 20: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Part I:Stapedotomy

w Technically difficult operationw Clear variations in outcome based on surgeon

experiencew Potential complications

n Hearing lossn Vertigon Tinnitus

Page 21: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 22: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Steady Hand Robot

Page 23: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Steady Hand in Stapedotomy

Fenestration Trials

Page 24: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Force Scaling:

w Tactile feedbackw Test various robot

modes (vs. free-hand):n Unscaled force feedbackn Amplified force

feedback

Page 25: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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)

Page 26: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Forces at the Oval Window:Load Cell Measurements

w Max Force (N)

w Cumulative Force (Ns)

Page 27: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Steady Hand in Stapedotomy

Fenestration TrialsDATA

Page 28: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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)

Page 29: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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)

Page 30: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 31: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 32: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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)

Page 33: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 34: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 35: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 36: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 37: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 38: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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)

Page 39: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 40: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Part II: Inner Ear Surgery

Accessing the Scala Media of the Cochlea

Page 41: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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.

Page 42: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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.

Page 43: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 44: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Sensorineural Hearing Loss

w Loss of inner hair cellsw Located in

the scala media of the cochlea

Page 45: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Surgical Problem:Access the Scala Media

w Insert a needle in the Scala Median Deliver therapyn Hair cell

regenerationn Treat cause instead

of symptom

Page 46: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Defining the problem:Access the Scala Media

w Navigationn 20 micron

resolutionw Positioning

n 25 micron resolution

w Injectionn 1 nanoliter

Page 47: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Navigation:Imaging the Scala Media

Page 48: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

Navigation:Imaging the Scala Media

Page 49: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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

Page 50: Microsurgery in Otology 01 24 02 - Department of Computer Science · 2002-01-25 · Instruments wSawbones Corporation wDentsply Caulk Corporation wHarwick Chemical wJeneric / Pentron

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