Head-and-Neck Microstimulation Device for Low-Trauma Airway Therapy
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Solution Overview
Problem
Existing treatments for sleep disordered breathing, such as obstructive sleep apnea, often require invasive implantation techniques that involve multiple incisions, larger surgical fields, and lead to patient discomfort and potential complications, particularly when using pectorally implanted pulse generators and leads, which also restrict MRI compatibility.
Innovation Solution
A minimally invasive implantable microstimulation therapy device is designed for subcutaneous placement in the head/neck region, with a small size and shape to secure directly against target nerves, using electrodes for nerve stimulation, and incorporates energy harvesting and wireless communication to minimize surgical impact and enhance patient comfort and MRI eligibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pectorally implanted pulse generators and leads are used, then nerve stimulation for airway patency is achieved, but surgical trauma and patient discomfort increase
Solution Approach 1:
The device is divided into separate functional components: a pulse generator implanted in the head/neck region and leads positioned at target nerves. This segmentation allows for smaller, less invasive implantation sites while maintaining effective nerve stimulation for airway patency.
Solution Approach 2:
The device transitions from a pectoral implant to a locally implanted device in the head/neck region where the nerve stimulation is needed. This local placement reduces the surgical field size and trauma while maintaining effective nerve stimulation for treating sleep disordered breathing.
2Reliability
If pectorally implanted pulse generators are used, then nerve stimulation is provided, but MRI compatibility is restricted
Solution Approach 1:
The device extracts the pulse generator from the pectoral region and relocates it to the head/neck region. This repositioning removes the large metallic implant from the chest area, making patients eligible for MRI scans while maintaining effective nerve stimulation capability.
3Power
If larger pulse generators are used, then sufficient power for nerve stimulation is achieved, but device bulkiness increases
Solution Approach 1:
The device employs dynamic pulse delivery with adjustable parameters including pulse width, frequency, and amplitude. This dynamic control allows a smaller device to deliver sufficient stimulation power by optimizing pulse characteristics rather than relying on a large battery and power amplifier.
Solution Approach 2:
The device utilizes advanced pulse generation techniques with variable parameters such as burst modes, ramp-up/ramp-down phases, and adaptive pulse widths. These parameter optimizations enable effective nerve stimulation with reduced power requirements, allowing for a more compact device design.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The microstimulation therapy device provides effective nerve stimulation for airway patency with reduced surgical trauma, improved patient comfort, and compatibility with MRI, minimizing the need for external charging and reducing bulkiness.
Implementation Method 1
In at least some examples, the power element includes an energy harvesting element
Data Source
AI summary
An apparatus includes an implantable stimulator to treat sleep disordered breathing (SDB) and at least one electrode associated with the stimulator.