Flush DBS Cap with Adhesive Lead Fixation
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Solution Overview
Problem
Existing deep brain stimulation (DBS) cap designs fail to effectively prevent lead migration, leading to loss of therapeutic effect and complications such as scalp erosions and infections, due to their poor locking mechanisms and protrusion from the skull surface.
Innovation Solution
A DBS cap with a base ring and lead securing element that incorporates an adhesive to secure the DBS lead to the skull, ensuring stability and sitting flush with the skull surface to prevent migration and minimize cosmetic issues and complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing DBS cap designs are used with traditional locking mechanisms, then the device structure is simple, but the lead migration prevention is insufficient
Solution Approach 1:
The cap is divided into multiple functional components: a base ring that sits on the skull surface, a lead securing element with adhesive properties, and a top cover. This segmentation allows each component to perform its specific function - the adhesive layer provides reliable lead fixation while the modular structure maintains overall simplicity
Solution Approach 2:
An adhesive layer is introduced as an intermediary substance between the lead and the cap structure. This adhesive mediator creates a strong bonding interface that prevents lead migration without requiring complex mechanical locking mechanisms, thus improving reliability while maintaining structural simplicity
2Object-affected harmful factors
If DBS caps protrude from the skull surface, then the lead securing mechanism is easier to access, but cosmetic issues and scalp erosions occur
Solution Approach 1:
The cap design transitions from a protruding three-dimensional structure to a flush, planar configuration that sits level with the skull surface. This dimensional change eliminates the harmful protrusion that causes scalp erosions while the adhesive-secured lead ensures continued ease of access and secure fixation
3Reliability
If traditional DBS cap designs are used, then the manufacturing process is simple, but therapeutic effect is lost due to lead migration
Solution Approach 1:
The adhesive layer's bonding strength parameter is optimized to provide sufficient holding force for lead fixation. By changing the material parameter (adhesive properties) rather than the structural complexity, the design maintains ease of manufacture while ensuring reliable therapeutic effect through prevented lead migration
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 DBS cap effectively secures the lead, reducing migration and associated complications, improving aesthetic outcomes and preventing scalp erosions by using an adhesive to hold the lead in place and sitting flush with the skull, thus maintaining therapeutic efficacy and reducing the risk of infections.
Implementation Method 1
a DBS cap with a base ring and lead securing element that incorporates an adhesive to secure the DBS lead to the skull
Data Source
AI summary
Various examples are provided for securing deep brain stimulation (DBS) leads. In one example, among others, a DBS cap for securing a DBS lead includes a base ring adapted to be mounted within a counterbore opening formed in the skull, a lead securing element that mounts to the base ring, and. a top cover that mounts to the base ring. In another example, a method for securing a DBS lead includes forming a counterbore opening in the skull, securing a DBS cap within the counterbore opening, passing a DBS lead through the DBS cap and the counterbore opening and positioning a tip of the lead in brain tissue, and securing the DBS lead to the DBS cap using an adhesive. The skull opening includes a lower bore, a concentric upper bore, and a step positioned at the interface of the upper and lower bores.