Medical Lead Fixation via Deformable Radial Compression
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Solution Overview
Problem
Existing medical devices and lead extensions face challenges in securely fixing medical leads due to the limitations of using set screws, which require tools for tightening, can lead to fluid ingress, and do not provide adequate grip, leading to potential dislodgment and complications.
Innovation Solution
A fixation structure with a grip portion and a deformable portion that applies a radial compression force to the medical lead within a bore, allowing for secure fixation without the need for tools and providing a sealing function to prevent fluid ingress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If set screws are used to fix the lead within the bore, then the lead position is fixed, but the set screw requires tools to tighten and becomes countersunk within the set screw block
Solution Approach 1:
The fixation structure enables self-service operation by allowing the clinician to directly manipulate and tighten the fixation mechanism without requiring external tools. The structure is designed to be grippable and operable by hand, eliminating the need for countersinking and tool-based tightening procedures.
Solution Approach 2:
Instead of using a set screw that requires tightening from the outside (requiring tools), the invention inverts the approach by using a deformable portion that is compressed from the outside to create internal fixation pressure. This inversion allows direct manual operation while achieving the same fixation purpose.
2Stability of the object's composition
If set screws are used for lead fixation, then the lead is secured, but the set screw presents a connection that potentially exposes the interior of the header block to fluid ingress
Solution Approach 1:
The invention uses a deformable portion (such as an elastomeric component) that acts as a flexible sealing element. This deformable structure provides both mechanical fixation through compression and fluid sealing by conforming to the interface between the lead and header block, thereby preventing fluid ingress while maintaining lead stability.
Solution Approach 2:
The invention merges the fixation function and sealing function into a single integrated deformable portion. This unified structure simultaneously secures the lead through compression and prevents fluid ingress through its sealing capability, eliminating the separate set screw that created the fluid ingress risk.
3Length of moving object
If the distance from the medical device to the target site requires a lead extension, then the reach is extended, but the same fixation drawbacks are present at both connection points
Solution Approach 1:
The fixation structure is designed as a universal solution that can be applied at multiple connection points (device-to-extension and extension-to-lead). The same deformable portion-based mechanism provides consistent fixation and sealing performance at both interfaces, simplifying the overall system despite the extended configuration.
4Stability of the object's composition
If a set screw is tightened onto a metal ring on the proximal end of the medical lead, then the lead is fixed, but the set screw cannot be adequately gripped and becomes countersunk
Solution Approach 1:
The fixation structure is designed to be directly grippable by the clinician's fingers, enabling self-service operation without tools. The deformable portion is configured to be compressed manually, providing adequate grip and eliminating the countersinking issue associated with set screws.
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 proposed solution enables secure and tool-free fixation of medical leads and lead extensions, enhancing stability and preventing fluid ingress, thus improving the reliability and safety of medical device installations.
Implementation Method 1
a compression force is applied to the deformable portion of the fixation structure which then applies a radial force to the proximal end of the lead within a header bore
Implementation Method 2
the deformable portion or separate deformable structure may also provide a sealing function to prevent the ingress of fluids around the lead and into the header bore or extension connector block bore
Data Source
AI summary
Medical devices include fixation structures that include retained portions that provide medical lead fixation within the medical devices. Lead extensions include fixation structures that include retained portions that provide medical lead fixation within the lead extensions. A grip that a clinician may grasp and manipulate is engaged with a nose structure of a header block of the medical device or a connector block of a lead extension and manipulation of the grip causes compression of a deformable structure to ultimately create fixation of the lead or lead extension within the header block or the lead within the extension connector block. The deformable structure may be the retained portion of the fixation structure or alternatively may be separate from the fixation structure.