Extravascular Nerve Cuff Pocket for Leadless Stimulator Stability
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Solution Overview
Problem
Existing implantable neural stimulation systems face challenges in stabilizing leadless integral devices on nerves, which can lead to movement and potential damage to surrounding tissues, and require complex surgery with potential mechanical damage to leads.
Innovation Solution
The use of extravascular nerve cuffs with a pocket to securely position and stabilize leadless microstimulators near nerves, such as the vagus nerve, while shielding surrounding tissues from unwanted stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If leadless integral devices are used to eliminate leads and reduce surgery time, then reliability is improved by eliminating mechanical damage to leads, but device stability deteriorates because the rigid device is difficult to stably position on the nerve
Solution Approach 1:
The system is divided into two separate components: a stable nerve cuff that remains on the nerve and a removable leadless stimulator. The nerve cuff includes a retention mechanism that secures the stimulator in place during operation, while allowing for future removal and replacement. This segmentation resolves the contradiction by providing long-term stability through the cuff while maintaining the benefits of leadless design.
Solution Approach 2:
The leadless stimulator is positioned within a pocket or cavity formed by the nerve cuff structure. The cuff acts as a containing structure that holds the stimulator in a stable, fixed position relative to the nerve. This nesting arrangement provides stability for the rigid device while maintaining the leadless configuration.
2Reliability
If leads are used to connect IPG to electrodes, then electrical connection is established, but device complexity and surgery time increase due to tunneling requirements and mechanical vulnerability
Solution Approach 1:
The lead component is completely removed from the system. Instead of using leads to connect the IPG to electrodes, the patent employs a leadless stimulator with integral electrodes that directly contact the nerve. This extraction of the lead element eliminates the need for tunneling and reduces mechanical vulnerability while maintaining electrical connection functionality.
Solution Approach 2:
The electrodes are merged with the stimulator body to form an integral, leadless unit. This combination eliminates the separate lead component and simplifies the overall device architecture. The stimulator and electrodes function as a single unified structure that can be directly positioned on the nerve without requiring external leads.
3Reliability
If electrodes and IPG are implanted in separate areas connected by leads, then electrical stimulation is achieved, but surgery time and mechanical damage risk increase
Solution Approach 1:
The electrodes, stimulator, and retention mechanism are merged into a single integrated unit that can be implanted as one piece. This eliminates the need for separate implantation of electrodes and IPG, and removes the requirement for lead tunneling surgery. The integrated design achieves electrical stimulation capability while significantly reducing surgery time and mechanical damage risk.
Data Source
AI summary
An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.