The learning curve for investigational surgery: lessons learned from laparoscopic diaphragm pacing for chronic ventilator dependence.

BACKGROUND: Electrical stimulation of the phrenic nerve motor point of the diaphragm through laparoscopic implantation of a pacing system is an option for high spinal cord-injured patients with chronic respiratory insufficiency. This study assesses the operative learning curve for the initial series of patients. METHOD: A series of six patients underwent laparoscopic placement of a diaphragm pacing system. The operative procedure was divided into the following four steps for analysis and rapid adjustment after each operation: exposure of the diaphragm, mapping of the phrenic nerve motor point, implantation of the pacing electrodes, and final routing of the wires to the external system. RESULTS: The first case required two operations, and the second case was unsuccessful because of a nonfunctioning phrenic nerve that led to a change in the preoperative screening criteria. The operative time decreased from 469 min for the first operation to 165 min for the sixth operation. The significant time decrease can be attributed to changes in the mapping and routing aspects of the operation. Key changes during this series that helped to reduce the operative time include abandonment of a software-dependent mapping technique, development of a grid algorithm for mapping, software improvement to increase the speed of stimulation and mapping, refinement of the mapping probe to maintain adequate suction on the diaphragm, shortening of the electrode lengths, and experience with the implantation of connections to the external electrodes. Presently, all five of the successfully implanted patients can be maintained on prolonged ventilatory support with the device. CONCLUSION: Analysis of every step of this investigational procedure enabled us to make rapid changes in surgical protocol, leading to decreases in operative times and expectant improvements in patient safety and efficacy. In this series, analysis was the key to developing a low-risk cost-effective outpatient diaphragm pacing system.

Cognitive feedback for use with FES upper extremity neuroprostheses.

This paper describes the development of two sensory substitutions systems that provide cognitive feedback for FES hand grasp restoration neuroprostheses. One system uses an array of five electrodes to provide machine status information and a spatially encoded representation of the command signal that a quadriplegic individual generates to achieve proportional grasp control. Only one electrode site is active at any given instant, and a second informational channel is superimposed on the spatial position channel by modulating the frequency of the stimulus pulses. The frequency modulated feedback channel signals six levels of force developed at the finger tips during prehension activities. The second sensory system is an integral part of an implanted FES system and utilizes a single subdermally placed electrode to display machine status information and a five-level frequency code for feedback of the user generated grasp control signal. The multielectrode feedback system was implemented for laboratory studies using surface mounted electrodes, although its design will ultimately incorporate subdermal electrodes to provide a highly cosmetic and unencumbering system. An evaluation of the effectiveness of grasp force and command signal feedback provided by this multielectrode system in assisting an FES hand system user to regulate grasp force during a laboratory task, showed increased consistency of performance and an economy of grasp effort between 25 and 30%. Alternative strategies for feedback information and coding algorithms are discussed.