Wireless monitoring and control for implantable rotary blood pumps.

A wireless biotelemetry system for the transfer of digital data through intact skin and tissue has been developed to provide a safe and noninvasive means of communication between implanted medical devices and the outside of the body. The system utilizes 2 miniature infrared transmitter/receiver modules. Data are transmitted through intact skin and subcutaneous tissue on an 890 nm infrared carrier signal. The system has been evaluated in human cadavers and during in vivo implantation of artificial hearts and ventricular assist devices for durations of up to 96 h. Acceptable data transfer (error rate < 10(-5)) through a typical tissue thickness of 5-25 mm has been demonstrated. The ability to monitor and control a device from a remote site using public communication systems such as telephone lines and asynchronous transfer mode (ATM) systems has also been demonstrated. Design optimization is currently ongoing in preparation for clinical utilization with artificial heart systems and other implantable devices (such as rotary blood pumps).

A remotely controlled and powered artificial heart pump.

An intrathoracic pulsatile artificial heart pump has been developed. Transcutaneous energy transfer and biotelemetry systems provide continuous power and remote monitoring and control, with no percutaneous connections required. The electrohydraulic system can be used either as a ventricular assist device or with modifications as a total artificial heart. The device uses a unidirectional axial flow pump coupled with a pressure activated one-way valve to allow hydraulic fluid to passively return to the volume displacement chamber during diastole. The transcutaneous energy transfer system provides power to the device and recharges the implantable battery pack. A wearable external controller and external battery pack provide the patient enhanced mobility and thus an improved quality of life. The biotelemetry system allows control and monitoring of the device after implantation, as well as an added capability to monitor and control the device remotely over public communication lines. Early prototypes have functioned failure free for up to 3 years in vitro. The device has sustained circulation in vivo for up to 4 days. Design optimization is continuing, and chronic in vivo evaluation is planned.

Transcutaneous energy transfer with voltage regulation for rotary blood pumps.

Rotary blood pumps often require a constant operating voltage. To meet this requirement and to eliminate the need for percutaneous leads, a voltage-regulated transcutaneous energy transfer (TET) system has been developed. Voltage regulation is achieved by using a transcutaneous infrared feedback control loop operating on a 890 nanometer (nm) wavelength. In vitro testing of the system developed has shown that output voltage can be maintained to within 0.2 V of nominal (14.5 V) for delivered powers up to 50 watts (W) and coil separations of between 3 and 10 mm. Power transfer efficiencies were determined to be from 68% to 72% over the tested range of coil separations and output currents from 1.5 to 3.6 amperes (A). This system has demonstrated acceptable performance in regulating output voltage while transferring power inductively without using percutaneous connections. By integrating this type of TET system with an implanted rotary blood pump, the quality of life for the device recipient could be improved.

A transcutaneous energy and information transfer system for implanted medical devices.

During the last four decades there has been a rapid increase in the development and usage of medical devices. Currently, there are more than 500,000 devices on the market and 25,000 new devices enter the market each year. Many medical devices are now designed to be implantable (pacemakers, defibrillators, circulatory assist devices, artificial hearts, cochlear implants, neuromuscular stimulators, biosensors, etc.). Almost all of the active devices (those that perform work) and many of the passive devices (those that do not perform work) require a source of power. In addition, these devices need to be monitored and controlled, which can be accomplished by utilizing remote communication methods. A transcutaneous energy transfer system combined with a remote communications system has been developed and evaluated in vitro and in vivo (bovine, porcine, and human cadaver experiments). The energy transfer system can deliver up to 60 W with power transfer efficiencies between 60 and 83%. An automatically tuned, resonant frequency tracking method is used to obtain optimum power transfer over a range of operating conditions. The remote communications system can transfer digital data bidirectionally through intact skin at rates up to 9600 baud. The system transmits information by frequency modulating an 890 nm infrared carrier signal. The system has demonstrated satisfactory performance during multicenter evaluation with ventricular assist and total artificial heart devices. Design improvements have been identified, which will be implemented to produce an optimized system for energy transfer to and remote communications with various implantable medical devices.