His Bundle Lead Delivery via Anchor Wire
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Solution Overview
Problem
Current cardiac rhythm management systems face challenges in accurately and reliably delivering leads to the bundle of His for direct stimulation, due to the small and difficult-to-reach location beneath the tricuspid valve in the right ventricle, which complicates lead implantation and stabilization.
Innovation Solution
A system comprising an outer guide catheter with a preformed curve, an inner guide catheter, and an anchor wire with a fixation element, allowing for precise targeting and anchoring of the bundle of His, enabling the implantable lead to be advanced over the anchor wire for effective stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a conventional lead delivery system is used, then the lead can be delivered to the right ventricle, but the lead cannot accurately reach and stabilize at the bundle of His due to its small and difficult-to-reach location
Solution Approach 1:
The delivery system is divided into multiple components: an outer guide catheter, an inner guide catheter, and an anchor wire. Each component has a specific function - the outer catheter provides structural support and access, the inner catheter enables precise positioning, and the anchor wire ensures stable fixation at the target site. This segmentation allows the system to overcome the difficulties of reaching the bundle of His while maintaining ease of operation.
Solution Approach 2:
The anchor wire acts as an intermediary element that bridges the gap between the delivery catheters and the bundle of His target site. The wire with its fixation element first engages the tissue to establish a stable anchor, then serves as a rail over which the final lead is advanced. This intermediary approach enables accurate lead placement at the difficult-to-reach bundle of His location.
2Reliability
If the lead is advanced directly to the bundle of His, then stimulation can be achieved, but the lead cannot be reliably stabilized due to the small target area beneath the tricuspid valve
Solution Approach 1:
Before advancing the final lead, the system first deploys an anchor wire with a fixation element that penetrates and secures to the tissue at the bundle of His location. This preliminary anchoring action creates a stable foundation that ensures reliable lead positioning. Subsequently, the lead is advanced over the pre-positioned anchor wire, guaranteeing accurate and reliable stimulation while the added complexity is managed through systematic deployment steps.
3Stability of the object's composition
If the fixation element penetrates the tissue to anchor the wire, then stable positioning is achieved, but the risk of tissue damage increases
Solution Approach 1:
The fixation element is designed with localized penetrating capability - only the distal tip of the anchor wire has the sharp geometry needed for tissue penetration, while the proximal portion remains flexible and biocompatible. This local quality differentiation allows stable anchoring at the insertion point while minimizing tissue damage along the wire's path and ensuring patient safety during chronic implantation.
Data Source
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AI summary
Various embodiments concern implanting a lead to directly stimulate the bundle of His. Various embodiments can include introducing a curve of an outer guide catheter into the right ventricle, extending a curve of an inner guide catheter from a lumen of the outer guide catheter, extending a fixation element on a distal tip of an anchor wire from a lumen the inner guide catheter, and anchoring the anchor wire to target tissue within the right ventricle, the target tissue along the septal wall and proximate the tricuspid valve and the bundle of His. A distal tip of an implantable lead with a lumen can then be advanced over the anchor wire to the target tissue as the anchor wire guides the distal tip of the lead to the target tissue.