Single-piece lead fixation device with interference fit
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Solution Overview
Problem
Existing lead fixation devices for neurostimulation systems require neurosurgical screws and multiple components, which can complicate the implantation process and increase the risk of infection, while also being costly and potentially uncomfortable for patients.
Innovation Solution
A single-piece lead fixation device with a mushroom-like shape that uses an interference fit to secure medical leads in a burr hole without the need for neurosurgical screws, featuring a central bore and retention tracts for secure positioning and sealing, allowing for easy implantation and reduced material complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If neurosurgical screws and multiple components are used to secure the lead, then the lead fixation is reliable, but the device complexity increases and the implantation process becomes more complicated
Solution Approach 1:
The patent combines multiple separate components (fixation device, seal, and lead securing elements) into a single integrated unit. The fixation device includes a body with a bore for the lead, a seal portion that interfaces with the skull, and retention features all in one piece, eliminating the need for separate screws and multiple components while maintaining secure lead fixation
Solution Approach 2:
The single-piece fixation device performs multiple functions simultaneously: it secures the lead through the bore, seals the burr hole through the seal portion, and provides structural support. This multi-functional design replaces what would traditionally require separate specialized components, reducing overall device complexity while maintaining reliability
2Stability of the object's composition
If neurosurgical screws are used to secure the lead fixation device, then the fixation is stable, but the risk of infection increases
Solution Approach 1:
The patent extracts and removes the neurosurgical screws from the fixation system entirely. Instead of using external screws to attach the fixation device to the skull, the design uses an integrated seal portion that creates a barrier without requiring penetrating fasteners, thereby eliminating the infection risk associated with screw insertion while maintaining fixation stability through the interference fit and seal mechanism
3Reliability
If multiple components are used in the lead fixation system, then the lead can be securely fixed, but the implantation process becomes more time-consuming
Solution Approach 1:
By merging the fixation device, seal, and lead securing features into a single piece, the patent eliminates the time required to assemble multiple components during implantation. The surgeon can insert the complete fixation device as one unit through the burr hole, reducing implantation time while maintaining reliable lead fixation through the integrated design
4Reliability
If neurosurgical screws are used to secure the fixation device, then the fixation is secure, but the patient comfort decreases
Solution Approach 1:
The patent removes the uncomfortable neurosurgical screws from the patient's skull by using an integrated seal portion that creates fixation without requiring external fasteners. This eliminates the pressure points and irritation caused by screws against the skull, improving patient comfort while maintaining fixation security through the interference fit and seal mechanism
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 simplifies the implantation process, reduces the risk of infection, and provides improved patient comfort by eliminating the need for screws and multiple components, while ensuring secure lead fixation and sealing without neurosurgical screws.
Implementation Method 1
The at least one retention tract configured for retaining a portion of the body of the medical lead in the lead fixation device with an interference fit
Data Source
AI summary
A lead fixation device for securing a medical lead in a human patient includes: a single-piece structure comprising: a top surface; a bottom surface; an outer perimeter; and an inner perimeter, the inner perimeter comprising: a diameter approximately equal to or smaller than a diameter of a burr hole into which the lead fixation device is designed to be deployed; a central bore extending longitudinally from the top surface through to the bottom surface, a portion of the central bore being located in approximately a center of the lead fixation device and comprising a central bore diameter; and at least one retention tract formed in the top surface of a cap of the lead fixation device, the retention tract configured for retaining, with an interference fit, a portion of a body of the medical lead in the lead fixation device.