Technical And Physical Description; Implantable Components - Synapse NeuRx Handbuch

6.0 TECHNICAL AND PHYSICAL DESCRIPTION

The NeuRx Diaphragm Pacing System (NeuRx DPS) is an intramuscular,
percutaneous, motor point diaphragm stimulation system. It is implanted using
standard laparoscopic surgical techniques.
diaphragm electrodes are connected to a four-channel external pulse generator at
a percutaneous exit site. The pulse generator provides a capacitively coupled,
charge-balanced, biphasic stimulation to each electrode with a common indifferent
electrode that is placed subcutaneously. The pulse generator controls the charge
delivered through clinician programmed parameters of pulse amplitude, pulse
duration, pulse frequency, pulse ramp, inspiration time, and respiratory rate. The
clinician uses a clinical station to evaluate electrode response to stimulation and
program the external pulse generator with the patient-specific parameters. The
user simply connects the device and turns it on for use; no other controls are
available or necessary for operation.
The locations for implantation are identified by electrically mapping the inferior
aspect of the diaphragm. Using the laparoscopic electrode delivery instrument,
the PermaLoc
muscle in proximity to branches of the phrenic nerve without making contact or
manipulating the nerve. The PermaLoc electrodes are tunneled, subcutaneously,
to a percutaneous exit site on the lateral chest region. An indifferent return
electrode (anode) is placed subcutaneously and exits at the same chest location.
These electrodes are connected to an external pulse generator (EPG) (stimulator)
that controls the timing and level of diaphragm pacing stimulation. Each electrode
may be controlled individually in terms of charge (pulse duration and pulse
amplitude) delivered and grouped together to recruit the diaphragm muscle to elicit
the desired level of inspiratory effort.
7.0

IMPLANTABLE COMPONENTS

7.1 Intramuscular Electrode (PermaLoc
The PermaLoc intramuscular electrode is a double helix wound lead with exposed
316LVM stainless steel stimulating surface and polypropylene reinforced core.
The PermaLoc also has a barb at the implanted end composed of 14 pieces of
polypropylene suture fused together. The body of the lead is insulated with PFA
(perfluoroalkoxy) fluoropolymer coating and terminated in a 316L stainless steel
pin with a silicon reinforcing sleeve. All of the materials have a history of long-term
implantable use as part of previously approved products. The lead is 59 - 63cm in
overall length, 0.75mm in diameter, and has a 9mm de-insulated stimulating tip.
The surface area of the stimulating tip is a minimum of 18.5mm2. The electrodes
are packaged in Tyvek packaging and sterilized by ethylene oxide exposure.
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intramuscular electrodes are surgically implanted in the diaphragm
The implanted intramuscular
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electrode)
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