The Apnex HGNS Therapy

The Apnex Hypoglossal Nerve Stimulation (HGNS™) System is intended to provide an alternative treatment option for people with clinically significant OSA by working in concert with the body’s natural neuromuscular physiology. It includes the following components:

• Apnex Implantable Neurostimulator
• Apnex Respiration Sensing Leads
• Apnex Stimulation Lead
• Apnex Programmer System
• Apnex Therapy Controller

Implanted Components
The implanted components are surgically implanted as generally shown in Figure 4. The Neurostimulator is implanted in a subcutaneous pocket inferior to the clavicle over the pectoralis fascia. A nerve cuff electrode on the distal end of the Stimulation Lead is implanted on a branch of the hypoglossal nerve (HGN) in the submandibular region. The proximal end of the Stimulation Lead is tunneled under the skin to the Neurostimulator. The Respiration Sensing Leads are tunneled under the skin from the Neurostimulator to the costal margins.



External Components
The Programmer System and Therapy Controller are wirelessly linked to the Neurostimulator. The Programmer System includes the following components: computer; programmer interface; and programmer head. The programmer system is used by the physician to control and program the Neurostimulator during surgery and therapy titration. The Therapy Controller is used by the patient to control limited aspects of therapy delivery, to meet their unique sleep needs. The external components are shown in Figure 5.



How It Works
The Apnex HGNS System (Figure 6) is intended to work by restoring neuromuscular activity to the genioglossus muscle by stimulating the hypoglossal nerve synchronous with inspiration to mitigate upper airway collapse during sleep. This is similar to how the body’s natural neuromuscular physiology functions in people without OSA. Stimulation is generated by the Neurostimulator, synchronized with inspiration as measured by the Respiration Sensing Leads using bio-impedance, and delivered to the hypoglossal nerve by the Stimulation Lead.