Design Innovation

Evolution of a Novel Intraductal Patent Ductus Arteriosus Occlusion Device

[+] Author and Article Information
Megha Agrawal, Vaibhavi A. Sonetha, Smriti Sharma

Satyajeet Parakh

Department of Chemical Engineering,  Indian Institute of Technology Bombay, Powai, Mumbai 400076, Indiasatyajeetparakh@gmail.com

Bharat Dalvi

Consultant Cardiologist  Glenmark Cardiac Centre, 10 Nandadeep, 209 D, Doctor Ambedkar Road, Matunga (E), Mumbai 400019, Indiabharatdalvi@hotmail.com

Jayesh R. Bellare1

Department of Chemical Engineering,  Indian Institute of Technology Bombay, Powai, Mumbai 400076, Indiajb@iitb.ac.in


Corresponding author.

J. Med. Devices 5(3), 035001 (Aug 30, 2011) (6 pages) doi:10.1115/1.4003674 History: Received April 15, 2010; Revised October 07, 2010; Published August 30, 2011; Online August 30, 2011

Persistence of the ductus arteriosus (DA) after birth leads to the congenital heart disease known as patent ductus arteriosus (PDA). The objective of this study is to develop an evaluation protocol and to propose a new and innovative intraductal design for a PDA occluder in order to conform to the varied morphology of the DA and to overcome the problems associated with devices relying on the anchorage mechanism. The new design, an assembly of 36 planar thermally treated Nitinol wires called Novel Device 36 (ND36), is in the shape of a frustum of a cone with a larger diameter of 12 mm, smaller diameter of 6 mm, and length of 11 mm. In-vitro biomimetic evaluations, namely, hemolysis tests and platelet adhesion studies, were conducted to ascertain the biocompatibility of the thermally treated Nitinol wires. These tests were also conducted on two different dimensions of Dacron fibers, which were to be sutured onto the device to induce thrombogenesis while in the duct, thereby facilitating better occlusion. Flow dynamics tests, which help simulate the dynamic conditions prevalent in the duct, were carried out on the ND36 and a commercially used PDA occlusion device. An analysis of the scanning electronic microscopy images showed no platelet adhesion on the Nitinol wires. The tested wires also showed nearly 0% hemolysis. Dacron fibers 0.2 mm thick and having an area density of 77 GSM proved to be best suited. Comparative analysis carried out with the commercially available Amplatzer duct occluder during the flow dynamics tests showed that the ND36 was capable of effectively occluding the duct as well as remaining stable under the dynamic conditions encountered in the duct. The ND36 has the potential to efficiently serve as a simplistic and cost effective alternative for PDA occlusion.

Copyright © 2011 by American Society of Mechanical Engineers
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Figure 1

Different views of the proposed intraductal design: (a) top view and (b) isometric view

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Figure 2

Dimensions of the jig (in mm) used for shaping wires. The smaller circles are pins of diameter 1.5 mm and height 3 mm while the larger circles are screws for fixing the wires.

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Figure 3

The different steps for the fabrication of the device: (a) adhering the wire to the plate, (b) assembling the wire and closing the ends with an O-ring, and (c) immersion of the assembly in a hot-water bath

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Figure 4

(a) The final assembly of novel device and (b) the final assembly with Dacron fabric suturing

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Figure 5

The different materials that were subjected to biological tests: (a) thermally treated Nitinol wire, (b) medical grade stainless steel wire, (c) Dacron fiber 1, and (d) Dacron fiber 2

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Figure 6

Hemolysis results for thermally treated Nitinol wire and 316L stainless steel wire

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Figure 7

Hemolysis results for different GSM Dacron fibers

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Figure 8

SEM micrographs of (a) glass cover slip before platelet exposure and (b) after platelet exposure (c) thermally treated Nitinol before platelet exposure and (d) after platelet exposure (e) medical grade stainless steel before platelet exposure and (f) after platelet exposure

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Figure 9

SEM micrographs of (a) fiber 1 before platelet exposure and (b) after platelet exposure (c) fiber 2 before platelet exposure and (d) after platelet exposure

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Figure 10

Schematic of the flow dynamics setup



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