Phrenic Nerve Electrode Placement With Ultrasound-Guided Neck Anchoring
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Solution Overview
Problem
Existing electrode assemblies for phrenic nerve stimulation in the neck face challenges such as movement relative to the nerve, potential damage to surrounding tissues, and invasiveness, leading to discomfort and reduced mobility, especially due to the complex anatomy of the neck region.
Innovation Solution
A minimally invasive surgical method is developed to implant an electrode assembly through the neck, utilizing the natural neck anatomy, with the electrode anchored to the anterior scalene muscle and prevertebral fascia, and utilizing diagnostic ultrasound for precise nerve location, ensuring stable positioning without cutting major muscles or vessels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a thoracic surgical approach is used to implant the electrode assembly, then the electrode can be securely positioned, but the surgery becomes more invasive requiring general anesthesia and creating an opening through the chest cavity
Solution Approach 1:
The surgical approach is segmented into a minimally invasive cervical component (small incision in the neck) and a separate access component (ultrasound guidance through the chest wall), avoiding the need for a single large invasive thoracic incision while maintaining secure electrode positioning through the cervical route
Solution Approach 2:
Diagnostic ultrasound serves as an intermediary tool that enables precise localization of the phrenic nerve through the chest wall without requiring direct surgical access to the thoracic cavity, allowing the electrode to be positioned securely while minimizing surgical invasiveness
2Object-affected harmful factors
If the electrode assembly is placed in the neck through a cervical approach, then surgical invasiveness is reduced, but the electrode may move relative to the phrenic nerve due to muscle and bone movement
Solution Approach 1:
The electrode assembly is preliminarily secured to the anterior scalene muscle and prevertebral fascia before final positioning is confirmed, ensuring stable attachment that prevents relative movement between the electrode and phrenic nerve during subsequent muscle and bone movement
Solution Approach 2:
The anterior scalene muscle and prevertebral fascia serve as intermediary anchoring structures that provide stable fixation for the electrode assembly, creating a reliable reference frame that maintains electrode-nerve contact despite movement of surrounding neck structures
3Stability of the object's composition
If the electrode assembly is anchored to surrounding tissues in the neck, then electrode stability is improved, but damage to surrounding vessels and tissue may occur
Solution Approach 1:
The electrode assembly is anchored locally to the anterior scalene muscle and prevertebral fascia at specific sites that provide stable fixation while being carefully selected to avoid damage to surrounding vessels and tissue, concentrating the anchoring force on appropriate structural elements
Solution Approach 2:
The anterior scalene muscle and prevertebral fascia act as intermediary anchoring structures that provide stable electrode fixation without directly damaging surrounding vulnerable tissues and vessels, distributing the mechanical stress through appropriate anatomical structures
4Ease of operation
If a minimally invasive cervical approach is used, then patient discomfort and range of motion are preserved, but the complex neck anatomy makes positioning challenging
Solution Approach 1:
Diagnostic ultrasound serves as an intermediary guidance tool that simplifies the positioning challenge by providing real-time visualization of the phrenic nerve location, allowing the surgeon to accurately place the electrode assembly despite the complex neck anatomy
Solution Approach 2:
The positioning process is segmented into distinct steps: ultrasound localization of the phrenic nerve, identification of the anterior scalene muscle and prevertebral fascia, and precise electrode placement at the identified landmarks, making the complex anatomy more manageable through systematic approach
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 method allows for safe, controllable phrenic nerve stimulation, reducing tissue damage and discomfort, and enabling outpatient treatment of sleep apnea with improved electrode stability and reduced invasiveness.
Implementation Method 1
The at least one pair of stimulation electrodes is configured to deliver current to activate the phrenic nerve through application of an electric field to a section of the phrenic nerve
Implementation Method 2
utilizing diagnostic ultrasound for precise nerve location
Data Source
AI summary
A delivery tool configured to surgically position an electrode assembly on a patient's anterior scalene muscle and phrenic nerve, the delivery tool including: an electrode carrying portion comprising a receiving space with at least one aperture in a floor of the receiving space, the receiving space being configured to hold an electrode assembly; a lead carrying portion extending from the electrode carrying portion, the lead carrying portion being configured to hold a lead connected to the electrode assembly; and a securing device configured to hold the electrode assembly in place relative to a stimulation target when the delivery tool is inserted into a patient's body, the securing device being further configured to allow the electrode to be repositioned after the electrode assembly has been held in place by the securing device.