Pinch-Actuated Cuff Electrode for Nerve Stimulation
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Solution Overview
Problem
Existing cuff electrode assemblies for implantable medical devices around nerves lack an efficient mechanism for secure and easy placement around target nerves, requiring improved designs for both functionality and ease of use.
Innovation Solution
A cuff electrode assembly with a resilient cuff body, arm members, and an electrode, configured to transition from a closed to an open configuration for placement around a nerve, utilizing a pinch hinge mechanism and stiffening members to ensure secure positioning and retention, made from flexible, electrically insulating polymers like silicone rubber with optional reinforcing materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cuff electrode assembly uses a pre-formed closed configuration with overlapping end portions, then the device achieves secure retention around the nerve, but the device complexity increases due to the helical structure and pinch hinge mechanism
Solution Approach 1:
The cuff body is divided into a first end portion and a second end portion that can be separately manipulated. The arm members are segmented from the cuff body, allowing independent actuation to open and close the cuff around the nerve, simplifying the implantation process while maintaining secure retention
Solution Approach 2:
The cuff electrode assembly transitions from a static pre-formed closed configuration to a dynamic structure that can open and close. The pinch hinge mechanism enables the cuff to dynamically adjust its state during implantation, reducing complexity by allowing simple manipulation rather than requiring complex pre-positioning mechanisms
2Ease of operation
If the cuff body is made from flexible electrically insulating polymer, then the ease of operation improves for nerve placement, but the manufacturing precision may be compromised due to material flexibility
Solution Approach 1:
The cuff body combines flexible electrically insulating polymer with reinforcing materials to create a composite structure. This maintains the flexibility needed for easy placement and manipulation around the nerve while the reinforcing materials provide structural integrity and manufacturing precision for the pre-formed closed configuration and helical structure
Solution Approach 2:
The material properties of the cuff body are optimized by selecting polymers with specific flexibility and insulating characteristics. The reinforcing materials are integrated to maintain dimensional stability during manufacturing while preserving the flexibility required for ease of operation during implantation
3Reliability
If the cuff body extends greater than 360 degrees about the target nerve, then the therapeutic efficacy improves through better nerve coverage, but the device complexity increases due to the extended helical configuration
Solution Approach 1:
The extended helical configuration is achieved through segmented arm members that can be independently actuated. This segmentation allows the cuff to extend greater than 360 degrees for improved nerve coverage while simplifying the implantation process by allowing sequential positioning rather than requiring complex pre-formed extended structures
Solution Approach 2:
The cuff body transitions from a compact closed configuration to an extended helical configuration during implantation. The pinch hinge mechanism enables this dynamic transformation, allowing the cuff to achieve greater than 360 degrees coverage for improved therapeutic efficacy while maintaining simplicity through mechanical actuation rather than complex pre-positioning
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
Enables secure, efficient, and easy implantation around target nerves, providing effective electrical stimulation while minimizing movement and ensuring long-term retention, thus improving the therapeutic efficacy of nerve stimulation systems.
Implementation Method 1
the cuff body is pre-formed to define a closed configuration... a force applied to urge the first and second arm members toward one another causes relative deflection of the second free end and the first free end so as to define an open configuration
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
The invention describes a cuff electrode assembly that includes a resilient cuff body configured to be disposed about a nerve. The cuff body includes a first end portion and a second end portion. The cuff body can be pre-formed to define a closed configuration having a generally annular cross-sectional shape such that, in the closed configuration, the cuff body extends helically with the first and second end portions overlapping on different planes. The cuff electrode assembly includes a first arm member and a second arm member, each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that force applied to urge the first and second arm members toward one another causes relative deflection of the first end portion and the second end portion to define an open configuration of the cuff body.