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Research Papers

Design of a Surgical Device for Office-Based Myringotomy and Grommet Insertion for Patients With Otitis Media With Effusion

[+] Author and Article Information
Kok Kiong Tan

Department of Electrical and
Computer Engineering,
National University of Singapore,
117576, Singapore

Wenyu Liang

Department of Electrical and
Computer Engineering,
National University of Singapore,
117576, Singapore
e-mail: liangwenyu@nus.edu.sg

Le Phuong Pham

Department of Electrical and
Computer Engineering,
National University of Singapore,
117576, Singapore

Sunan Huang

Department of Bioengineering,
National University of Singapore,
117576, Singapore

Chee Wee Gan, Hsueh Yee Lim

Department of Otolaryngology,
National University of Singapore,
119228, Singapore

1Corresponding author.

Manuscript received June 8, 2013; final manuscript received March 13, 2014; published online July 21, 2014. Assoc. Editor: Carl Nelson.

J. Med. Devices 8(3), 031001 (Jul 21, 2014) (12 pages) Paper No: MED-13-1154; doi: 10.1115/1.4027247 History: Received June 08, 2013; Revised March 13, 2014

Otitis media with effusion (OME) is a very common ear disease occurring in adults and children alike when the middle ear is infected or the eustachian tube becomes dysfunctional, resulting in accumulation of fluid in the middle ear space. When medication as the first treatment fails, a grommet is commonly surgically inserted on the tympanic membrane (TM) of the patient to discharge the fluid. In this paper, a novel “all-in-one” device allowing office-based grommet insertion in an awake patient with OME is proposed, designed, fabricated, and tested. It utilizes a highly integrated structure encompassing key components of a mechanical system, a sensing system and a motion control system, all are synergized to enable the surgery to be completed in a short time automatically, precisely, effectively, and safely. The experimental results obtained with the device working on a mock membrane with characteristics representative of the TM are duly furnished, showing a success rate of up to 98%.

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Figures

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Fig. 3

Mechanical structure of the device

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Fig. 5

Design of hollow holder

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Fig. 6

Force measurement, stress and displacement distribution of the tool set

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Fig. 7

Design of cutter retraction mechanism

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Fig. 8

Schematic diagram of the build-in endoscope

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Fig. 9

Installation and force analysis of the force sensor

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Fig. 10

Measured output of the force sensor during the procedure on different mock membranes

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Fig. 11

Measured output and filtered output of the force sensor

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Fig. 12

Force-based supervisory controller

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Fig. 13

Motion sequences for incision

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Fig. 14

Motion sequences for insertion

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Fig. 15

Motion controller for USM stage

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Fig. 16

Proposed working process

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Fig. 17

System setup and system architecture

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Fig. 18

Program flow chart

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Fig. 19

Mock membrane before (left) and after (right) grommet insertion

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Fig. 20

Sensory information during the procedure

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Fig. 21

Half-head model and ear model

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Fig. 22

Ear model before (left) and after (right) grommet insertion

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Fig. 23

Fiberscope view before and after grommet insertion

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