Research Papers

A New Vascular Coupler Design for End-to-End Anastomosis: Fabrication and Proof-of-Concept Evaluation

[+] Author and Article Information
Huizhong Li, Cody Gehrke, Himanshu Sant, Brittany Coats

Department of Mechanical Engineering,
University of Utah,
Salt Lake City, UT 84112

Bruce K. Gale

Department of Mechanical Engineering,
University of Utah,
50 S Central Campus Drive Rm 2110,
Salt Lake City, UT 84112
e-mail: bruce.gale@utah.edu

Jay Agarwal

Department of Surgery,
University of Utah,
Salt Lake City, UT 84132

1Corresponding author.

Manuscript received July 7, 2014; final manuscript received February 23, 2015; published online July 16, 2015. Assoc. Editor: John LaDisa.

J. Med. Devices 9(3), 031002 (Sep 01, 2015) (6 pages) Paper No: MED-14-1203; doi: 10.1115/1.4029924 History: Received July 07, 2014; Revised February 23, 2015; Online July 16, 2015

Traditional hand-suturing for vascular connection techniques is time consuming, expensive, and requires highly complex instruments and technical expertise. The aim of this study is to develop a new vascular coupler that can be used in end-to-end anastomosis surgery in an easier and more efficient way for both arteries and veins. The vascular coupler has four rotatable wings and one translatable spike in each wing. Prototypes were manufactured using polytetrafluoroethylene (PTFE) and high-density polyethylene (HDPE). A set of installation tools was designed to facilitate the anastomosis process. Proof-of-concept testing with the vascular coupler using plastic tubes and porcine cadaver vessels showed that the coupler should work as designed. A simplified finite element (FE) model assisted in the evaluation of the tearing likelihood of human vessels during installation of the coupler. Results of tests on the coupler showed that the vascular coupler could be efficiently attached to blood vessels, did not leak after the anastomosis was performed, had sufficient joint strength, and had little impact on flow in the vessel. The entire anastomosis process can be completed in 3 min when using the vascular coupler to join porcine cadaver vessels.

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Fig. 1

Image showing the coupler design and overview of the operation of the vascular coupler: (a) basic coupler design, (b) punctured vessel, (c) wings folded back with the couplers ready to be joined and (d) coupled vessel

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Fig. 2

HDPE coupler manufacturing process: (a) inner circle, outer circle, and spike holes are machined using CNC, (b) the through side cuts of the wing are made, and (c) the blind center cuts of the wing are made

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Fig. 3

The cam tool set showing the right base, cam, anvil, and wing closure tools

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Fig. 4

Basic FE model geometry: image (a) shows the initial state of the four wings, image (b) shows the final, idealized state when the four wings are closed and the end of blood vessel is stretched, and image (c) shows a ¼ radial symmetry model including one spike and the blood vessel

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Fig. 5

Vascular couplers made of (a) PTFE and (b) HDPE. The left coupler shows the initial state before the spikes are pushed in; the right couplers show the state after the spikes pushed in.

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Fig. 6

Composite photo shows the steps of the coupling process

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Fig. 7

Plot of the flow test data showing the relationship between pressure drop in the tubing and overall fluid pressure across the coupled and control tubing

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Fig. 8

Images (a)–(d) show the anastomosis process of two porcine cadaver vessels with the vascular couplers; image (e) shows the porcine cadaver vessel being stretched by four spikes

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Fig. 9

Simulation result images (a) and (b) show the top and side view of the stretching process of the vessel end and images (c) show the strain distribution at the vessel end



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