Hook-Shaped Catheter for His Bundle Lead Delivery
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Solution Overview
Problem
Existing catheters are not well-suited for delivering medical electrical leads to the His bundle in the right atrium, resulting in prolonged procedures, increased patient risk, and difficulty in attaching leads to cardiac tissue, as they are generally parallel to the heart surface and require protracted operating times.
Innovation Solution
A catheter with a hook-shaped distal portion that includes first and second segments with specific curvatures, allowing it to orient the distal tip perpendicular to the His bundle, facilitating precise placement and attachment of an electrical lead with a distal tip electrode that can penetrate up to 2 millimeters into the cardiac tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing catheters are used to deliver electrical leads to the His bundle, then the procedure can be completed, but the procedure time is prolonged and radiation exposure increases
Solution Approach 1:
The catheter incorporates a pre-formed curved distal portion with specific geometric characteristics (arc of 100-160 degrees, radius of curvature 8-15 mm) that enables direct engagement with the His bundle. This curvature allows the catheter to navigate the anatomical path to the His bundle more efficiently, reducing procedure time and radiation exposure while maintaining reliable lead delivery capability.
2Reliability
If existing catheters are used to deliver electrical leads to the His bundle, then the procedure can be completed, but radiation exposure to the patient increases
Solution Approach 1:
The pre-formed curved distal portion with optimized geometric parameters enables more direct access to the His bundle, reducing the time required for catheter manipulation and positioning under fluoroscopic guidance. This reduces the cumulative radiation exposure to the patient while ensuring reliable lead delivery to the target site.
3Reliability
If existing catheters reach the His bundle location, then lead delivery is possible, but the catheter is parallel to the heart surface making attachment difficult
Solution Approach 1:
The curved distal portion is designed with specific geometric characteristics (arc of 100-160 degrees, radius of curvature 8-15 mm) that position the catheter tip in optimal orientation relative to the His bundle. This curvature enables the catheter to approach the His bundle at an angle that facilitates perpendicular engagement and secure lead attachment, rather than approaching parallel to the heart surface as with straight catheters.
Solution Approach 2:
The catheter incorporates a specialized curved distal portion with specific geometric properties differentiated from the rest of the catheter body. This localized structural feature is designed specifically to engage the His bundle geometry, providing optimal orientation and contact for lead attachment while the remainder of the catheter maintains its delivery function.
4Ease of operation
If a catheter with curved distal portion is used, then lead attachment is facilitated, but the catheter structure becomes more complex
Solution Approach 1:
The curved distal portion is integrated as a seamless continuation of the catheter body rather than as a separate component. The curvature is formed with specific geometric parameters (arc of 100-160 degrees, radius of curvature 8-15 mm) that provide the necessary orientation for lead attachment while maintaining a relatively simple monolithic structure that minimizes manufacturing complexity.
Data Source
AI summary
A catheter used to deliver a medical electrical lead to a right atrium of a heart in close proximity to a His bundle. The catheter is adapted such that the distal tip confronts the His bundle generally perpendicularly. The catheter includes a proximal portion and a generally hook-shaped distal portion. The distal portion may include curves that direct the distal tip at an angle of over 180 degrees from the direction of the proximal portion.