Stimulation Cuff with Longitudinal Opening for Nerve Contact
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Solution Overview
Problem
Existing implantable electrical stimulation systems face challenges in maintaining effective contact with target nerves, particularly in initiating and maintaining stimulation, due to difficulties in wrapping conventional leads around nerves and ensuring secure implantation.
Innovation Solution
The electrical stimulation lead features a stimulation cuff with a longitudinal opening and embedded cuff stiffeners, allowing for easier implantation and tissue ingrowth, along with a mount offset from the nerve channel axis, and a lead body with conductors electrically coupled to electrodes, facilitating secure nerve contact and selective stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional leads are used for nerve stimulation, then the basic electrical stimulation function is provided, but the ease of implantation and secure contact with target nerves deteriorates
Solution Approach 1:
The lead is segmented into a shaft portion and a cuff portion that can be independently positioned and secured around the nerve, allowing easier implantation while maintaining secure contact
Solution Approach 2:
The cuff acts as an intermediary structure between the lead shaft and the nerve, providing a secure interface that maintains reliable electrical contact while facilitating easier implantation
2Ease of operation
If the lead is made flexible for easy implantation, then the ease of operation improves, but the stability of electrode contact with the nerve deteriorates
Solution Approach 1:
The lead is divided into a flexible shaft for easy implantation and a stable cuff portion that maintains consistent electrode-nerve contact, resolving the contradiction between flexibility and stability
Solution Approach 2:
Different portions of the lead have different mechanical properties: the shaft is flexible for implantation while the cuff is more rigid to maintain stable electrode contact with the nerve
3Reliability
If electrodes are placed directly on the nerve, then the stimulation efficacy improves, but the risk of nerve damage and infection increases
Solution Approach 1:
The cuff serves as an intermediary structure that holds electrodes in close proximity to the nerve for effective stimulation while maintaining a protective barrier that reduces direct trauma and infection risk
Solution Approach 2:
The cuff is constructed as a flexible tubular structure that provides protection while allowing close electrode-nerve interaction, balancing efficacy with safety
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
This design enhances the ease of implantation, maintains effective nerve contact, and allows for selective stimulation of target nerves, improving the efficacy of electrical stimulation therapy.
Implementation Method 1
A plurality of electrodes are disposed on the interior surface of the cuff, wherein the plurality of electrodes is arranged into a plurality of rows... A plurality of conductors extend through the lead body, mount and cuff, with the plurality of conductors electrically coupled to the electrodes
Data Source
Figure 1
Figure 2A
Figure 2B
AI summary
An electrical stimulation lead includes a stimulation cuff having an exterior surface and an interior surface that defines a nerve channel having a nerve channel axis. A plurality of electrodes are disposed on the interior surface of the cuff. A longitudinal opening extends through the cuff and further extends along an entire length of the cuff, wherein the opening is operable to receive a target nerve from a region outside of the cuff to within the nerve channel. A mount is disposed on the exterior surface of the cuff and radially offset from the nerve channel axis. A lead body is radially offset from the nerve channel axis and a plurality of conductors extend through the lead body, mount and cuff, with the plurality of conductors electrically coupled to the electrodes. The electrical stimulation lead may include a plurality of slots to permit tissue ingrowth.