An intrathoracic left ventricular assist system: utilization of results from a development program.
An intrathoracic, electrohydraulically actuated, left ventricular assist system (LVAS) was subjected to formal device readiness testing. Endurance testing was initiated on eight systems before testing was halted due to failure of four of the systems. Three failed due to environmental leakage. Solutions were straightforward, involving gasket changes and o-ring resizing. The fourth failure involved a magnetic coupling piston swelling and seizing. The failure was attributed, after long investigation, to hydrogen adsorption by the samarium-cobalt magnets. An unknown number of coupling magnets were affected in this fashion, necessitating complete replacement of magnets to resolve the problem. However, this was beyond the scope of the program, and no further endurance testing was accomplished. The test experience of the Nimbus/CCF LVAS has demonstrated all functional aspects of the complete LVAS, both in vitro and in vivo, and the endurance and reliability potential is indicated as well. Although the LVAS program is currently inactive, its legacy of technical innovations continue to drive the development of other medical devices.
Rintoul
T C
TC
Nimbus, Inc., Rancho Cordova, CA 95670.
Moise
J C
JC
Butler
K C
KC
Masterson
K
K
Emoto
H
H
Kiraly
R J
RJ
Navarro
R
R
Fujimoto
L
L
Massiello
A
A
Harasaki
H
H
D000818:Animals; D004867:Equipment Design; D004868:Equipment Failure; D006354:Heart, Artificial; D006353:Heart-Assist Devices; D006439:Hemodynamics / Q000502:physiology; D008955:Models, Cardiovascular