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Figure 15: Example Fluoroscopy View of the Lead Blank Extended Beyond the Surgical Introducer
Within the Pterygopalatine Fossa
•
Do not apply excessive force to the Lead Blank when advancing into the pterygopalatine fossa.
•
Do not advance the Lead Blank beyond the pterygopalatine fossa. Patient injury or poor
outcomes may result from further advancement of the Lead Blank.
•
Care should be taken to confirm that the distal tip of the Lead Blank has not entered the
inferior orbital fissure or nasal cavity.
•
NOTE: Surgical Introducer and Lead Blank placement may be confirmed using standard intra-
operative imaging (e.g., fluoroscopy).
If the Microstimulator size was chosen intra-operatively, then perform an impendence test and
bend the bone plate as detailed in Section C above. With the Surgical Introducer in place, and
the distal tip located at the pterygomaxillary fissure or just within the pterygopalatine fossa
(after the Lead Blank has been used to create an implant path), advance the Microstimulator
along the Insertion Groove on the Surgical Introducer. Using gentle pressure, advance the
Microstimulator beyond the distal tip of the Surgical Introducer into the pterygopalatine fossa.
Care should be taken to advance the Microstimulator in the same lead path or trajectory
created by the Lead Blank. This inferior to superior trajectory with a final distal lead location of
the superior medial PPF may be associated with better therapy. Lead trajectories that are
more lateral to medial or final distal lead location other than the superior medial PPF may
result in the inability to effectively stimulate the SPG by not having one or more electrodes in
close proximity to the SPG. Care should be taken to understand the surgical anatomy fully
prior to surgery.
Once the distal tip of the Microstimulator Lead is placed within the pterygopalatine fossa in
very close proximity to the sphenopalatine ganglion, slowly retract the Surgical Introducer,
leaving the Microstimulator inserted in the anatomy. Gently hold the Bone Fixation Plate
against the superior lateral zygomaticomaxillary buttress and slowly retract the Surgical
Introducer.
NOTE: Microstimulator placement may be confirmed using standard intra-operative imaging
(e.g., fluoroscopy).
