Cardiac Lead Delivery via Expandable Fixator Guidewire
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Solution Overview
Problem
Existing methods for implanting cardiac leads require slitting of catheters during lead delivery, which is skill-intensive, prone to user error, and restricts catheter design, making it difficult to navigate and secure leads in branching vessels effectively.
Innovation Solution
A lead delivery device using a guidewire with an expandable fixator that anchors in the vessel, allowing the lead to be advanced over the guidewire without removing the catheter, eliminating the need for slitting and enhancing navigation and fixation within the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If catheter slitting is used for lead delivery, then lead can be delivered to target site, but procedural complexity increases and user error risk increases
Solution Approach 1:
The invention extracts the lead from the catheter using a guidewire-based delivery system. The guidewire is advanced through the catheter to the target site, then the catheter is removed, leaving the guidewire in place to guide the lead to the final position. This eliminates the need for catheter slitting and simplifies the procedure.
Solution Approach 2:
The guidewire serves as an intermediary element between the catheter and the lead. It is first delivered through the catheter to the target site, then the catheter is removed, and finally the lead is advanced over the guidewire to the target site. This intermediary approach avoids the complexity of catheter slitting while achieving the same goal of lead delivery.
2Productivity
If catheter slitting is performed, then lead delivery is enabled, but skill-intensive operation is required
Solution Approach 1:
The guidewire system is designed to be self-guiding through the vasculature to the target site. The guidewire's inherent flexibility and trackability allow it to navigate the vascular system without requiring complex manual manipulation or slitting techniques, reducing the skill-intensive nature of the procedure.
Solution Approach 2:
The guidewire is advanced to the target site and positioned before the lead is delivered. This preliminary positioning establishes a stable track that simplifies subsequent lead advancement, eliminating the need for complex real-time manipulations during lead delivery.
3Ease of manufacture
If fixed catheter design is used, then manufacturing is simplified, but navigation in branching vessels is restricted
Solution Approach 1:
The delivery system is segmented into separate functional components: the catheter for initial access, the guidewire for navigation and positioning, and the lead for final implantation. This segmentation allows each component to be optimized independently - the catheter can be simple for manufacturing while the guidewire provides enhanced navigation capabilities through its flexible, trackable design.
Solution Approach 2:
The guidewire provides dynamic navigation capabilities that adapt to the vascular anatomy. Its flexible construction allows it to conform to branching vessel structures, while its trackability enables precise positioning at the target site, overcoming the limitations of fixed catheter designs.
Data Source
AI summary
A lead delivery apparatus and a method of delivering a medical lead to an anatomic target site. An elongated lead advancement member is coupled to a delivery shaft. The delivery shaft is inserted to the target site. The delivery shaft is temporarily attached to the target site using a fixator. A medical lead is inserted over the lead advancement member and pushed over the lead advancement member toward the target site.