Issn Print: 1058-2916
Publication Date: 2000/03/01
IN VIVO TESTING OF THE TOTALLY IMPLANTABLE JARVIK 2000® HEART SYSTEM
D. Tamez; J L Conger; G Jacobs; I Gregoric; R W Inman; B R Radovancevic; S M Moore; K Eya; H Eichstaedt; R K Jarvik; O H Frazier
Excerpt
The totally implantable Jarvik 2000 Heart system (J2000-TI) is undergoing in vivo testing to evaluate its packaging, ease of implantation, transcutaneous energy transfer (TET) capability, telemetric reliability, and overall efficiency. This study is being supported by the National Institutes of Health. The system's implantable components consist of an intraventricular axial-flow rotary blood pump (Jarvik 2000 Heart) with a dual-coil stator, a controller with a pacemaker-style header, and two secondary TET coils (main and backup), each with pacemaker-type connectors. The implantable controller contains lithium-ion batteries, electronic components, and an antenna embedded in the header. External components include an uninterruptable power source, a laptop computer, a radio-frequency communication link, a primary TET coil, and a TET oscillator. The blood pump was recently implanted in a 74-kg calf through a left thoracotomy. The secondary TET coils and controller were implanted subcutaneously over the animal's rib cage and abdominal area, respectively. The primary coil was secured on the skin, over the main secondary TET coil. The backup stator winding lead was exteriorized through the skin and was used to power the pump during surgery. Postoperatively, this lead can be used as an emergency backup. The J2000-TI was successfully implanted, and it has performed satisfactorily for 65 days. In this ongoing study, the blood pump is being operated at a programmable fixed speed of 9500±236 rpm, producing an average flow of 3 to 4 L/min. When telemetric measurements were compared to direct measurements (obtained with an exteriorized RS232 link), the resulting data sets did not vary by more than ±5%. Total J2000-TI power consumption, including TET utilization, has averaged 15.8±1.2 W. This study confirms the feasibility of implanting the J2000-TI in the calf model. The dual-coil stator and pacemaker-type packaging of the controller and leads should allow flexibility in case of component failure, either at implantation or postoperatively.
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