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Research Papers

The Role of Simulation in the Design of a Semi-Enclosed Tubular Embolus Retrieval

[+] Author and Article Information
Xuelian Gu

Shanghai Institute for Minimally Invasive
Therapy,
University of Shanghai for Science
and Technology,
516 Jungong Road,
Shanghai 200093, China
e-mail: xuelianabowen@gmail.com

Yongxiang Qi, Zhonghua Li

MicroPort Endovascular (Shanghai) Co., Ltd.,
3399 Kangxin Road,
Shanghai 201318, China

Arthur Erdman

Department of Mechanical Engineering,
University of Minnesota,
111 Church Street SE #1100,
Minneapolis, MN 55455
e-mail: agerdman@umn.edu

1Corresponding authors.

2Y. Qi contributed equally to this work.

Manuscript received June 16, 2016; final manuscript received March 8, 2017; published online May 3, 2017. Assoc. Editor: Marc Horner.

J. Med. Devices 11(2), 021001 (May 03, 2017) (7 pages) Paper No: MED-16-1241; doi: 10.1115/1.4036286 History: Received June 16, 2016; Revised March 08, 2017

A numerical analysis of a semi-enclosed tubular mechanical embolus retrieval device (MERD) for the treatment of acute ischemic stroke (AIS) is presented. In this research, the finite element analysis (FEA) methodology is used to evaluate mechanical performance and provide suggestions for optimizing the geometric design. A MERD fabricated from nickel–titanium alloy (Nitinol) tubing is simulated and analyzed under complex in vivo loading conditions involving shape-setting, crimping, deployment, and embolus retrieval. As a result, the peak strain of the shape-setting procedure is proved to be safe for the device pattern. However, the MERD shows poor mechanical behavior after crimping into a catheter, because the peak crimping strain obtains a value of 12.1%. The delivery and deployment step demonstrates that the artery wall has little risk of serious injuries or rupture. In addition, the process of simulation of embolus retrieval and device system migration inside the cerebral artery lumen provides useful information during the design process.

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Figures

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Fig. 1

The numerical workflow of MERD after delivery to the targeted artery

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Fig. 2

Geometry model of MERD: (a) global planar sketch, (b) planar sketch of a single strut, and (c) 3D original pattern

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Fig. 3

Schematic view of MERD: (a) shape-setting and (b) crimping

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Fig. 4

Electromechanical test system of RX650 (MSI, Phoenix, AZ)

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Fig. 5

Radial supportive force versus MERD outer diameter for experimental and numerical results

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Fig. 6

MPS field contour plots of MERD during shape-setting step: global and detailed schematic views

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Fig. 7

FEA results for MERD during crimping step: (a) crimped MERD, (b) not crimped MERD, and (c) strain distribution into outer catheter

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Fig. 8

FEA results for MERD during deployment: (a) Von Mises stress (VMS) contour plots of the expanded blood vessel wall, (b) strain field contour plots of the tubular MERD, and (c) the schematic view of assembly

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Fig. 9

FEA results for MERD during migration step: (a) schematic of the strain distribution of the MERD during the MERD system, (b) strain distribution during embolus retrieval process, and (c) stress distribution of the captured plaque embolus

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