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.
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e-mail: satyajeetparakh@gmail.com
e-mail: bharatdalvi@hotmail.com
e-mail: jb@iitb.ac.in
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September 2011
Design Innovations
Evolution of a Novel Intraductal Patent Ductus Arteriosus Occlusion Device
Satyajeet Parakh,
Satyajeet Parakh
Department of Chemical Engineering,
e-mail: satyajeetparakh@gmail.com
Indian Institute of Technology Bombay
, Powai, Mumbai 400076, India
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Bharat Dalvi,
Bharat Dalvi
Consultant Cardiologist
e-mail: bharatdalvi@hotmail.com
Glenmark Cardiac Centre
, 10 Nandadeep, 209 D, Doctor Ambedkar Road, Matunga (E), Mumbai 400019, India
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Jayesh R. Bellare
Jayesh R. Bellare
Department of Chemical Engineering,
e-mail: jb@iitb.ac.in
Indian Institute of Technology Bombay
, Powai, Mumbai 400076, India
Search for other works by this author on:
Satyajeet Parakh
Department of Chemical Engineering,
Indian Institute of Technology Bombay
, Powai, Mumbai 400076, India
e-mail: satyajeetparakh@gmail.com
Bharat Dalvi
Consultant Cardiologist
Glenmark Cardiac Centre
, 10 Nandadeep, 209 D, Doctor Ambedkar Road, Matunga (E), Mumbai 400019, India
e-mail: bharatdalvi@hotmail.com
Jayesh R. Bellare
Department of Chemical Engineering,
Indian Institute of Technology Bombay
, Powai, Mumbai 400076, India
e-mail: jb@iitb.ac.in
J. Med. Devices. Sep 2011, 5(3): 035001 (6 pages)
Published Online: August 30, 2011
Article history
Received:
April 15, 2010
Revised:
October 7, 2010
Online:
August 30, 2011
Published:
August 30, 2011
Citation
Agrawal, M., Sonetha, V. A., Sharma, S., Parakh, S., Dalvi, B., and Bellare, J. R. (August 30, 2011). "Evolution of a Novel Intraductal Patent Ductus Arteriosus Occlusion Device." ASME. J. Med. Devices. September 2011; 5(3): 035001. https://doi.org/10.1115/1.4003674
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