Spiral Fixation Device for Anchoring Medical Leads in Body Lumens
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Solution Overview
Problem
Current medical technologies face challenges in securely anchoring guidewires and electrical leads within body lumens, particularly in vasculature, leading to issues like dislodgement and lead migration due to inadequate fixation mechanisms, especially in tortuous anatomy and thin-walled veins.
Innovation Solution
An implantable medical elongated member with a fixation device that can be deformed into a spiral or helical shape using shape memory metals or expanding members to securely anchor the lead through friction, allowing for independent positioning and potential repositioning of the lead tip relative to the fixation structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional fixation structures (threaded fixation, mechanical friction devices) are used to anchor leads in vasculature, then anchoring capability is improved, but device complexity and risk of complications increase due to tortuous anatomy and thin-walled veins
Solution Approach 1:
The fixation structure is extracted from the lead tip and positioned as a separate, deployable component at the distal end of the lead. This allows the fixation mechanism to be independently optimized for vascular anchoring while keeping the lead shaft simple for navigation through tortuous anatomy.
Solution Approach 2:
The fixation structure transitions from a static tip-mounted design to a dynamic, deployable component that can be advanced through the vasculature in a compressed state and then expanded at the target location. This dynamic deployment allows adaptation to tortuous anatomy while providing stable anchoring.
2Stability of the object's composition
If fixation structures are permanently attached to the lead tip, then anchoring stability is improved, but adaptability for repositioning the lead tip is lost
Solution Approach 1:
The lead system is segmented into three independent components: the proximal lead shaft, the distal lead tip, and the separate fixation structure. This segmentation allows the fixation structure to remain stationary for stability while the lead tip can be repositioned independently for improved coupling with the treatment site.
Solution Approach 2:
A guide wire acts as an intermediary element that passes through the fixation structure, enabling the lead tip to be repositioned relative to the fixation structure without moving the fixation structure itself. The guide wire serves as a mediator between the stable fixation point and the repositionable lead tip.
3Productivity
If heavier devices are advanced over the guidewire, then treatment capability is improved, but unwanted movement and dislodgement of the guidewire increases
Solution Approach 1:
The fixation structure is deployed and anchored in the vasculature before advancing heavier treatment devices over the guidewire. This preliminary anchoring stabilizes the guidewire position, preventing unwanted movement during subsequent device advancement and treatment procedures.
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 provides stable anchoring of medical leads within body lumens, reducing dislodgement and migration, and enabling improved coupling between the lead and the treatment site, while allowing for potential repositioning without moving the fixation structure.
Implementation Method 1
a fixation device that can be deformed into a spiral or helical shape using shape memory metals
Implementation Method 2
securely anchor the lead through friction
Data Source
AI summary
An apparatus and method for anchoring an elongated object, for example a wire, in tubular body vessel, such as arteries, veins, the colon, bile ducts, etc. are disclosed. The wire may be a catheter, a guide wire, a tube or an electrical lead. In one embodiment, a fixation device is advanced over the wire and, upon external actuation, either deforms the wire or deploys an anchoring mechanism so as to secure the wire against the vessel wall. The anchoring mechanism can be easily removed from the vessel even in the presence of vessel occlusion. In another embodiment, a wire tensioned between two locations on a distal section of the wire deforms the wire and urges the wire into wall apposition.