Research Papers

Novel Design and Validation of a Micro Instrument in an Ear Grommet Insertion Device

[+] Author and Article Information
Cailin Ng

NUS Graduate School for Integrative
Sciences and Engineering,
National University of Singapore,
Singapore 119077
e-mail: cailin.ng@u.nus.edu

Wenyu Liang

Department of Electrical and
Computer Engineering,
National University of Singapore,
Singapore 119077
e-mail: liangwenyu@nus.edu.sg

Chee Wee Gan

Department of Otolaryngology,
National University of Singapore,
Singapore 119077
e-mail: entgcw@nus.edu.sg

Hsueh Yee Lim

Department of Otolaryngology,
National University of Singapore,
Singapore 119077
e-mail: lynne@drlynnelim.com

Kok Kiong Tan

Department of Electrical and
Computer Engineering,
National University of Singapore,
Singapore 119077
e-mail: kktan@nus.edu.sg

1Corresponding author.

Manuscript received December 8, 2017; final manuscript received April 11, 2018; published online July 13, 2018. Assoc. Editor: Carl Nelson.

J. Med. Devices 12(3), 031004 (Jul 13, 2018) (12 pages) Paper No: MED-17-1373; doi: 10.1115/1.4040185 History: Received December 08, 2017; Revised April 11, 2018

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.

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Fig. 1

Working process of the VTA: 1—system initialization, 2—touch detection, 3—tool set retraction and cutter extruded, 4—myringotomy (cutter incision), 5—cutter retract and VT insertion, 6—VT release and tool set withdrawal

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Fig. 2

VTA and its control system

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Fig. 3

Distal end of the instrument, the needle cutter

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Fig. 4

Experiment setup utilizing a flat mock membrane at 90 deg

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Fig. 5

Success rate of VTA on different membrane angles

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Fig. 6

Grommet insertion failed at oblique angles because of (a) over-insertion when the grommet is pushed in such that the outer flange is partially inserted (b) under-insertion when the inner flange is not completely inserted. Correct grommet insertion is shown in (c) where the TM is less oblique: (a) over insertion, (b) under insertion, and (c) correct insertion.

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Fig. 7

CAD model of the (a) cover-cutter instrument, with the cutter as the outer sheath and holder with conical tip (b) cover-cutter instrument with grommet loaded axially

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Fig. 8

CAD model of membrane with cover-cutter instrument. Sliding on the oblique surface, the grommet moves in the y-direction and tilts upward, while the actuator pushes the holder and the grommet forward in the z-direction, creating 3DOF, two translational and one rotational, motion.

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Fig. 9

Working process of VTA with cover cutter: (a) initialization, (b) touch detection, (c) myringotomy, (d) grommet insertion, and (e) grommet release

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Fig. 10

CAD model of the (a) normal holder with conical tip and (b) slanted holder with conical tip

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Fig. 11

Different setups according to (a) less oblique angles (70deg<θ≤90deg) with slanted holder angled in different direction as the slope of the membrane, S1, (b) normal angles (50deg≤θ≤70deg) with normal holder, and (c) very oblique angles (30deg≤θ<50deg) with slanted holder angled in same direction as the slope of the membrane, S2

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Fig. 12

Experimental setup showing VTA with cover cutter and 3D printed mock membrane holder mounted onto platform stage (holder shown in this picture is 40deg)

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Fig. 13

Force diagrams comparing (a) without motion control and (b) with motion control

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Fig. 14

Flowchart of adaptive insertion algorithm

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Fig. 15

Success rate comparison for the four types of membranes

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Fig. 16

Peak force comparison for the four types of membranes

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Fig. 17

TM coordinate system, and fixed support as highlighted in green

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Fig. 18

(a) Manual insertion model and its (b) coordinate system for insertion motion

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Fig. 19

(a) Angle between grommet and incision site, (b) needle-cutter insertion model, and its (c) coordinate system for insertion motion

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Fig. 20

(a) TM-grommet angle at the edge where the grommet first contacts the TM, (b) TM-grommet angle at the far end, and (c) cover-cutter holder S1 setup with blade rotated 40 deg from its original position

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Fig. 21

(a) Cover-cutter insertion model and its (b) coordinate system for insertion motion

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Fig. 22

Successful grommet insertion of (a) manual method and (c) cover-cutter method. Over-insertion occurs during (b) needle-cutter method.

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Fig. 23

Plots of force on TM for (a) manual insertion, (b) needle-cutter insertion and (c) cover-cutter insertion

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Fig. 24

Plots of malleus movement for (a) manual insertion, (b) needle-cutter insertion and (c) cover-cutter insertion

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Fig. 25

Deflection profile of malleus with the maximum deflection occurring on the head of the malleus (unit: mm)



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