Login to Access Video or Poster Abstract: MP46-20
Sources of Funding: Precision Medical Devices

Introduction

PMD has developed a new Bluetooth controlled AUS designed to improve patient satisfaction and allow for physician telemetry. The FCD fluid-free device is composed of 3 solid components: 1)Control Pack 2) Valve assembly 3)Activator. The control pack consists of a printed circuit board, stepper motor and a nickel-cadmium cell in a titanium casing. The valve assembly consists of a cable link, plunger and urethral cuff. The control pack opens and closes the plunger via a drive assembly which adjusts the closure pressure magnitude, allowing post-implant adjustments (via telemetry) without the need for re-operation. The handheld activator communicates with the implanted control pack via Bluetooth technology. The activator allows for either the physician or patient to communicate with the FCD for daily operation or diagnostics. Daily operations of the device are recorded and remote tele-monitoring is available.

Methods

The newest FCD prototype was implanted into 11 female mongrel dogs. The study length began at 12 weeks of observation after implantation for the initial animal and is extended to a 1 year follow-up for the most recent implants. There was no attempt to make the animals incontinent. Evaluations include renal ultrasound for each animal as well as weekly CBC, BMP and UA. Software and device performance was evaluated by telemetrically acquired data. Histology of explanted devices at the end of protocol is performed for each implant.

Results

The successful surgical implantation of 32 previous devices has allowed the development of the newest Bluetooth controlled AUS. We have currently implanted 11 animals with the newest prototype. Successful telemetry has been established for all implants. No device infections or urethral erosions were seen. There was one cutaneous erosion of the control pack. 3 animals developed urinary retention. Two cases were related to tissue overgrowth in the valve cap resulting in urethral kinking and the remaining case was due to a software malfunction causing elevated closure pressure on the urethra with associated loss of communication with the device. This observation was identified through post hoc analysis of the telemetry data. The implanted devices have undergone over 3,560 activation cycles to date. The device has also generated over 1,100 status reports, allowing the investigator to monitor device function.

Conclusions

The successful development of a fluid-free remotely controlled AUS that allows for post-implant adjustable settings and remote tele-monitoring capabilities is possible. Further modifications to the prototype to reduce battery size and the risk of urinary retention are needed prior to human trials.

Funding

Precision Medical Devices