Mapping Of The Diaphragm - Synapse NeuRx Handbuch

14.1 INCLUSION PRE-SCREENING
Candidates must have diaphragm dysfunction of neuromuscular origin who require
chronic ventilatory support because of diaphragm paralysis.
indicated in patients, such as high-level spinal cord injury, whose remaining
phrenic nerve, lung and diaphragm muscle function are sufficient to accommodate
electrical stimulation. The candidate must be in otherwise generally good health.
The laparoscopic surgical procedure for implantation of the NeuRx Diaphragm
Pacing System™ (DPS) is expected to take two hours. The patient is implanted
with four IM (Intra-Muscular) electrodes, two in each hemidiaphragm, using
laparoscopic techniques. Pre-operatives tests are obtained for patients based on
their needs prior to general anesthesia.
14.2 ESTABLISH LAPAROSCOPIC PORTS
The operation is done in the supine position with no neuromuscular blocking
agents. The patient's abdomen and chest is prepped and draped in the usual
sterile fashion. Four ports will need to be inserted into the abdominal cavity: one
for optics, two lateral working ports for the mapping probe and one epigastric port
for electrode insertion instruments and the exit site from the abdominal cavity for
the electrode lead wires. During this phase any abdominal adhesions are released
and gastrostomy tube tracts are removed if they are in the way of implantation of
the diaphragm pacing system. The falciform ligament is divided which allows
easier visualization of the medial aspect of the right diaphragm and easier exit of
the pacing electrodes through the epigastric port. Standard laparoscopic principles
are followed with a typical setup.

15.0 MAPPING OF THE DIAPHRAGM

Prior to mapping, a surface electrode is place around the thigh region and is
connected to the Clinical Station (see Clinical Station Operating Manual). Intra-
abdominal pressure during test stimulation (mapping) will be measured externally
through the insufflation port with tubing. This tubing will connect to a pressure
sensor to go to the clinical station. Mapping involves finding the point on the
abdominal side of the diaphragm where stimulation causes the greatest diaphragm
4 ports insertion
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The device is