Manufacturers are constantly seeking to design new, better performing transvenous cardiac leads to prevent perforation of the heart by the lead tip. Currently, there is no standardized test method to measure the buckling load of leads, a major factor in the propensity of the lead to perforate the heart. This study further investigates the effect of boundary conditions on buckling loads at the lead tip of different transvenous cardiac leads achieved using different variations of our initial physiologically relevant test method. The goals of the test are to create the maximum buckling load with high repeatability and the simplest possible design. A buckling test was performed to capture maximum buckling load using three leads of each model (five currently available cardiac lead models) and were tested in each of six test setups. The buckling test methodology had a substantial effect on the load-displacement profiles, regardless of whether the lead was a pacemaker or defibrillator lead. By adding the right ventricular (RV) constraint, the buckling load more than doubled for most leads. The use of a lubricant reduced friction between the lead body and the RV surface, and thereby subsequently lowered the buckling load in those setups that used the RV constraint. In addition, the use of the lubricant reduced the variability in the results. The addition of both the RV constraint and the lubricant substantially influences the mechanical behavior of transvenous cardiac leads and is recommended for buckling testing of transvenous cardiac leads.
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June 2018
Research-Article
A Novel In Vitro Testing Approach for the Next Generation of Transvenous Cardiac Leads: Buckling Behavior
Donna L. Walsh,
Donna L. Walsh
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
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Ashok Williams,
Ashok Williams
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
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Oleg Vesnovsky,
Oleg Vesnovsky
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
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L. D. Timmie Topoleski,
L. D. Timmie Topoleski
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland—Baltimore County,
Baltimore, MD 21250
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland—Baltimore County,
Baltimore, MD 21250
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Nandini Duraiswamy
Nandini Duraiswamy
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903, New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: Nandini.duraiswamy@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903, New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: Nandini.duraiswamy@fda.hhs.gov
Search for other works by this author on:
Donna L. Walsh
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Ashok Williams
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Oleg Vesnovsky
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993
L. D. Timmie Topoleski
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland—Baltimore County,
Baltimore, MD 21250
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
Silver Spring, MD 20993;
Department of Mechanical Engineering,
University of Maryland—Baltimore County,
Baltimore, MD 21250
Nandini Duraiswamy
Office of Science and Engineering Laboratories,
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903, New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: Nandini.duraiswamy@fda.hhs.gov
Center for Devices and Radiological Health,
U.S. Food and Drug Administration,
10903, New Hampshire Avenue,
Silver Spring, MD 20993
e-mail: Nandini.duraiswamy@fda.hhs.gov
1Corresponding author.
Manuscript received September 15, 2017; final manuscript received February 8, 2018; published online April 2, 2018. Assoc. Editor: Xiaoming He.
J. Med. Devices. Jun 2018, 12(2): 021004 (6 pages)
Published Online: April 2, 2018
Article history
Received:
September 15, 2017
Revised:
February 8, 2018
Citation
Walsh, D. L., Williams, A., Vesnovsky, O., Timmie Topoleski, L. D., and Duraiswamy, N. (April 2, 2018). "A Novel In Vitro Testing Approach for the Next Generation of Transvenous Cardiac Leads: Buckling Behavior." ASME. J. Med. Devices. June 2018; 12(2): 021004. https://doi.org/10.1115/1.4039593
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