An automated surgical device, the ventilator tube applicator (VTA), enables a grommet insertion surgery for patients with otitis media with effusion (OME) to be completed in a short time automatically and precisely, eliminating the use of general anesthesia (GA) typically required in such procedure. However, its current design limits the usefulness of the device as it is restricted by the properties of the tympanic membrane (TM), such as angle, thickness, and strength. Therefore, a novel design was conceptualized and the insertion control algorithm was improved to overcome the current challenges of the VTA. This innovative cover-cutter instrument design allows three-dimensional (3D) motion on an oblique surface using a single axis actuator. Experimental results on mock membranes showed great improvements in terms of robustness and success rate. The new design allowed the procedure to be performed on wider range of TM angles and hence increased the effectiveness of VTA. Grommet insertion force was reduced by an average of 66%, and the overall peak force reduced by an average of 14%. Finite element (FE) analysis on a cadaveric TM model further validated the usefulness of the cover-cutter instrument, and showed some interesting insights in the grommet insertion process.

References

References
1.
Paradise
,
J. L.
,
Rockette
,
H. E.
,
Colborn
,
D. K.
,
Bernard
,
B. S.
,
Smith
,
C. G.
,
Kurs-Lasky
,
M.
, and
Janosky
,
J. E.
,
1997
, “
Otitis Media in 2253 Pittsburgh-Area Infants: Prevalence and Risk Factors During the First Two Years of Life
,”
Pediatrics
,
99
(
3
), pp.
318
333
.
2.
Ilechukwu
,
G.
,
Ilechukwu
,
C.
,
Ubesie
,
A.
,
Ojinnaka
,
C.
,
Emechebe
,
G.
, and
Iloh
,
K.
,
2014
, “
Otitis Media in Children
,”
Open J. Pediatr.
,
4
(
01
), p.
47
.
3.
DiMaggio
,
C.
,
Sun
,
L. S.
,
Kakavouli
,
A.
,
Byrne
,
M. W.
, and
Li
,
G.
,
2009
, “
A Retrospective Cohort Study of the Association of Anesthesia and Hernia Repair Surgery With Behavioral and Developmental Disorders in Young Children
,”
J. Neurosurg. Anesthesiol.
,
21
(
4
), p.
286
.
4.
Tan
,
K. K.
,
Liang
,
W.
,
Pham
,
L. P.
,
Huang
,
S.
,
Gan
,
C. W.
, and
Lim
,
H. Y.
,
2014
, “
Design of a Surgical Device for Office-Based Myringotomy and Grommet Insertion for Patients With Otitis Media With Effusion
,”
J. Med. Devices
,
8
(
3
), p.
031001
.
5.
Gao
,
W.
,
Liang
,
W.
, and
Tan
,
K. K.
,
2016
, “
Development of an Intelligent Surgical Instrument for Otitis Media With Effusion
,”
ISA Trans.
,
65
, pp.
567
576
.
6.
Liang
,
W.
,
Huang
,
S.
,
Chen
,
S.
, and
Tan
,
K. K.
,
2017
, “
Force Estimation and Failure Detection Based on Disturbance Observer for an Ear Surgical Device
,”
ISA Trans.
,
66
, pp.
476
484
.
7.
Liang
,
W.
,
Gao
,
W.
, and
Tan
,
K. K.
,
2017
, “
Stabilization System on an Office-Based Ear Surgical Device by Force and Vision Feedback
,”
Mechatronics
,
42
, pp.
1
10
.
8.
Ng
,
C.
,
Liang
,
W.
,
Wu
,
W.
,
Gan
,
C. W.
, and
Tan
,
K. K.
,
2016
, “
Pain Mitigation Approach in Office-Based Procedure: Case Study
,”
42nd Annual Conference of the IEEE Industrial Electronics Society
(
IECON
), Florence, Italy, Oct. 23–26, pp.
601
606
.
9.
Fay
,
J. P.
,
Puria
,
S.
, and
Steele
,
C. R.
,
2006
, “
The Discordant Eardrum
,”
Proc. Natl. Acad. Sci.
,
103
(
52
), pp.
19743
19748
.
10.
Bluestone
,
C. D.
, and
Klein
,
J. O.
,
2007
,
Otitis Media in Infants and Children
,
PMPH-USA
,
Raleigh, NC
.
11.
Auinger
,
P.
,
Lanphear
,
B. P.
,
Kalkwarf
,
H. J.
, and
Mansour
,
M. E.
,
2003
, “
Trends in Otitis Media Among Children in the United States
,”
Pediatrics
,
112
(
3
), pp.
514
520
.
12.
Van der Jeught
,
S.
,
Dirckx
,
J. J.
,
Aerts
,
J. R.
,
Bradu
,
A.
,
Podoleanu
,
A. G.
, and
Buytaert
,
J. A.
,
2013
, “
Full-Field Thickness Distribution of Human Tympanic Membrane Obtained With Optical Coherence Tomography
,”
J. Assoc. Res. Otolaryngol.
,
14
(
4
), pp.
483
494
.
13.
Volandri
,
G.
,
Di Puccio
,
F.
,
Forte
,
P.
, and
Carmignani
,
C.
,
2011
, “
Biomechanics of the Tympanic Membrane
,”
J. Biomech.
,
44
(
7
), pp.
1219
1236
.
14.
Lai
,
E.
, and
Chang
,
C. D.
,
2011
, “
Determining a Suitable Material to Simulate the Tympanic Membrane Based on Quantitative Linear Elasticity
,”
Otolaryngol.-Head Neck Surg.
,
145
(
2_suppl
), p.
P207
.
15.
Wada
,
H.
,
Metoki
,
T.
, and
Kobayashi
,
T.
,
1992
, “
Analysis of Dynamic Behavior of Human Middle Ear Using a Finite-Element Method
,”
J. Acoust. Soc. Am.
,
92
(
6
), pp.
3157
3168
.
16.
De Greef
,
D.
,
Aernouts
,
J.
,
Aerts
,
J.
,
Cheng
,
J. T.
,
Horwitz
,
R.
,
Rosowski
,
J. J.
, and
Dirckx
,
J. J.
,
2014
, “
Viscoelastic Properties of the Human Tympanic Membrane Studied With Stroboscopic Holography and Finite Element Modeling
,”
Hear. Res.
,
312
, pp.
69
80
.
17.
Gan
,
R. Z.
,
Sun
,
Q.
,
Feng
,
B.
, and
Wood
,
M. W.
,
2006
, “
Acoustic–Structural Coupled Finite Element Analysis for Sound Transmission in Human Earpressure Distributions
,”
Med. Eng. Phys.
,
28
(
5
), pp.
395
404
.
18.
Wang
,
X.
,
Keefe
,
D. H.
, and
Gan
,
R. Z.
,
2016
, “
Predictions of Middle-Ear and Passive Cochlear Mechanics Using a Finite Element Model of the Pediatric Ear
,”
J. Acoust. Soc. Am.
,
139
(
4
), pp.
1735
1746
.
19.
Liu
,
Y.
,
Li
,
S.
, and
Sun
,
X.
,
2009
, “
Numerical Analysis of Ossicular Chain Lesion of Human Ear
,”
Acta Mech. Sin.
,
25
(
2
), pp.
241
247
.
20.
Cheng
,
T.
,
Dai
,
C.
, and
Gan
,
R. Z.
,
2007
, “
Viscoelastic Properties of Human Tympanic Membrane
,”
Ann. Biomed. Eng.
,
35
(
2
), pp.
305
314
.
21.
Gan
,
R. Z.
,
Feng
,
B.
, and
Sun
,
Q.
,
2004
, “
Three-Dimensional Finite Element Modeling of Human Ear for Sound Transmission
,”
Ann. Biomed. Eng.
,
32
(
6
), pp.
847
859
.
22.
Hüttenbrink
,
K.-B.
,
1988
, “
The Mechanics of the Middle-Ear at Static Air Pressures: The Role of the Ossicular Joints, the Function of the Middle-Ear Muscles and the Behaviour of Stapedial Prostheses
,”
Acta Oto-Laryngol.
,
105
(
sup451
), pp.
1
35
.
23.
Dirckx
,
J. J.
, and
Decraemer
,
W. F.
,
1991
, “
Human Tympanic Membrane Deformation Under Static Pressure
,”
Hear. Res.
,
51
(
1
), pp.
93
105
.
24.
Shino
,
A.
,
Ishii
,
T.
, and
Takayama
,
M.
,
1997
, “
Measurement of the Strength of Human Tympanic Membrane Using a Force-Sensing Myringotomy Knife
,”
Otology Jpn.
,
7
(
2
), pp.
97
101
.
25.
Gea
,
S. L.
,
Decraemer
,
W. F.
,
Funnell
,
R. W.
,
Dirckx
,
J. J.
, and
Maier
,
H.
,
2010
, “
Tympanic Membrane Boundary Deformations Derived From Static Displacements Observed With Computerized Tomography in Human and Gerbil
,”
J. Assoc. Res. Otolaryngol.
,
11
(
1
), pp.
1
17
.
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