Curved His Bundle Lead Delivery for Precise Cardiac Placement
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Solution Overview
Problem
Existing methods for placing pacing leads or devices near the His bundle and other fast conduction pathways in the heart are inefficient and lack precision, often failing to achieve optimal physiologic conduction and ventricular coordination.
Innovation Solution
A sheath or catheter with a flexible distal portion having a predetermined curvilinear shape, allowing the distal tip to be oriented perpendicular to the heart wall, equipped with electrodes for structure identification and fixation elements for secure placement, facilitates precise delivery of leads to the His bundle or other conduction system regions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional lead placement methods are used, then the procedure can be performed with simple equipment, but the precision and accuracy of lead placement at the His bundle is insufficient
Solution Approach 1:
The delivery device incorporates a curved or angled distal portion that enables the lead to approach the His bundle at an optimal angle, improving placement precision by aligning the lead trajectory with the anatomical orientation of the conduction system
Solution Approach 2:
The delivery device is divided into functional segments including a navigation portion with electrodes for locating the His bundle, a delivery portion for transporting the lead, and a fixation portion for securing the lead. This segmentation allows each component to perform its specific function efficiently while maintaining overall device manageability
2Reliability
If pacing leads are placed to restore physiologic conduction, then ventricular coordination and pump function improve, but the difficulty of accurately identifying and accessing the His bundle increases
Solution Approach 1:
The delivery device includes electrodes that detect electrical signals from the His bundle, providing real-time feedback to guide the operator in positioning the lead at the correct location. This feedback mechanism enables accurate identification of the His bundle through characteristic electrogram patterns
Solution Approach 2:
The delivery device acts as an intermediary tool that bridges the gap between the operator and the deep anatomical structure of the His bundle, providing mechanical guidance and electrical signal detection capabilities that facilitate safe and accurate access to the target site
3Stability of the object's composition
If the distal tip is oriented perpendicular to the heart wall, then lead fixation stability is improved, but the complexity of positioning and manipulating the delivery device increases
Solution Approach 1:
The curved distal portion of the delivery device is designed with a specific radius of curvature that naturally orients the lead tip perpendicular to the heart wall upon deployment, achieving stable fixation geometry while maintaining ease of manipulation through the curve's inherent mechanical properties
Data Source
AI summary
Apparatus, systems, and methods are provided for placing pacing leads or other devices within a patient's heart. In an exemplary embodiment, the apparatus includes a tubular member comprising a flexible distal portion defining a curvilinear shape in a relaxed state including a curved first region defining a first radius lying within a first plane, a substantially straight second region extending from the first curved region defining a first length, and a curved third region extending from the second region defining a second radius smaller than the first radius.