Self-rolling Nerve Cuff with Beveled Edges
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Solution Overview
Problem
Existing implantable cuffs for vagus nerve stimulation face challenges during implantation, including nerve tissue stress, complexity in placement, and manufacturing reproducibility issues, particularly due to their design and material thickness.
Innovation Solution
A self-rollable cuff made from elastically deformable silicone sheets with beveled edges, allowing for easy wrapping around the nerve and reducing stress on the tissue, while maintaining electrode positioning and industrial reproducibility, is developed. The cuff features beveled edges that facilitate self-winding and reduce nerve distortion risks, with a crescent shape ensuring proper orientation and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional elastomeric cuff is used for vagus nerve stimulation, then the cuff provides good biocompatibility and flexibility, but the implantation procedure becomes complex and time-consuming with risks of nerve damage
Solution Approach 1:
The cuff is pre-formed with a specific geometry featuring two parallel longitudinal edges that facilitate proper positioning and wrapping around the nerve during implantation. This preliminary structural configuration eliminates the need for complex manual shaping or adjustment procedures, allowing surgeons to simply place and release the cuff for automatic wrapping.
Solution Approach 2:
The cuff structure is divided into distinct functional zones with two parallel longitudinal edges that create well-defined wrapping zones. This segmentation allows the cuff to be implanted as a single piece while automatically forming the correct wrapped configuration around the nerve, simplifying the surgical procedure.
2Object-affected harmful factors
If the cuff is made thinner to reduce nerve compression risk, then patient safety improves, but manufacturing precision becomes more difficult to control
Solution Approach 1:
The cuff is manufactured with a predetermined geometry including two parallel longitudinal edges and specific width dimensions before implantation. This pre-configured structure ensures that even thin cuffs maintain their structural integrity and proper wrapping geometry, allowing manufacturers to produce thinner, safer cuffs with controlled dimensions.
Solution Approach 2:
The invention utilizes thin elastomeric film structures with specific geometric features (parallel edges, controlled width) that maintain sufficient mechanical strength and wrapping capability while minimizing thickness. This allows the use of thinner materials that reduce nerve compression risk while remaining manufacturable with appropriate precision controls.
3Manufacturing precision
If the cuff implantation time is extended to ensure proper placement, then positioning accuracy improves, but nerve exposure to air and manipulation time increases causing potential damage
Solution Approach 1:
The cuff is pre-formed with two parallel longitudinal edges and appropriate width dimensions that automatically guide proper positioning and wrapping around the nerve. This preliminary structural preparation eliminates the need for time-consuming manual positioning adjustments, allowing rapid placement while ensuring accurate positioning.
Solution Approach 2:
The cuff's geometric design with parallel edges enables it to self-position and self-wrap around the nerve automatically upon release during implantation. This self-service capability eliminates the need for prolonged manual manipulation and positioning adjustments, reducing implantation time while maintaining positioning accuracy.
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 solution enables rapid and stress-reduced implantation, maintains anatomical integrity, and allows for thin, flexible cuffs with improved manufacturing reproducibility, reducing the risk of nerve damage and ensuring accurate electrode placement.
Implementation Method 1
a self-rollable cuff (26) to be wound around an elongate cylindrical body such as a nerve, and made from an elastically deformable material sheet
Data Source
AI summary
A cuff for use in nerve stimulation includes a sheet of elastomer having at least one electrode and being pre-stressed so as to allow its spiral self-winding to form a cuff around the nerve. The sheet is delimited by a first width defining an outer edge of the cuff after winding, a second width defining an opposite inner edge, a first length and a second opposite length. The first width is at both ends connected to the two lengths by a respective bevel edge forming an oblique angle relative to the direction of greatest dimension of the sheet.