Leadless Pacemaker Attachment Feature for Precise Torque Delivery
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Solution Overview
Problem
The delivery and retrieval of leadless cardiac pacemakers require precise manipulation to avoid damage to the pacemaker, cardiac tissue, and the venous system, due to the complexity of navigating catheters and sheaths through delicate anatomical structures, and existing systems lack sufficient control and precision in applying torque.
Innovation Solution
An attachment feature is introduced that is monolithically formed from a rigid material, mounted on the battery assembly of the leadless pacemaker, featuring a tether recess and a distal flange to reduce strain and thermal damage, allowing for precise engagement with delivery or retrieval systems and facilitating torque transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a leadless pacemaker is delivered via catheter-based delivery system through delicate anatomical structures, then the pacemaker can be implanted without subcutaneous pulse generator and leads, but precise manipulation is required to avoid damage to the pacemaker, cardiac tissue, and venous system
Solution Approach 1:
The attachment feature serves as an intermediary component between the delivery system and the pacemaker body. It provides a dedicated engagement interface that allows the delivery system to securely grasp and manipulate the pacemaker during delivery through delicate anatomical structures, thereby preventing damage while maintaining ease of operation.
Solution Approach 2:
The pacemaker is segmented into distinct functional components: the pacemaker body containing essential functions and the separate attachment feature designed specifically for delivery and retrieval operations. This segmentation allows the attachment feature to be optimized for mechanical engagement without compromising the pacemaker body's reliability.
2Ease of operation
If torque is applied to the leadless pacemaker during delivery or retrieval, then precise manipulation is achieved, but excessive strain may cause damage to the pacemaker or the venous system
Solution Approach 1:
The attachment feature acts as a mediator that receives and distributes torque from the delivery system. Its rigid material construction and specific geometry (including the distal flange and tether recess) enable controlled torque transmission while preventing excessive strain from being transmitted to the pacemaker body or the venous system.
3Strength
If the attachment feature is monolithically formed from rigid material, then torque transmission is effective and strain is reduced, but manufacturing complexity increases
Solution Approach 1:
The attachment feature integrates multiple functions into a single monolithic component: torque transmission, strain distribution, and engagement with both the delivery system and the pacemaker body. This merging eliminates the need for multiple separate parts and complex assembly procedures, actually simplifying manufacturing despite the rigid material requirement.
4Object-affected harmful factors
If the distal flange is positioned away from the battery assembly, then thermal damage to the battery is minimized, but the attachment feature's structural integrity must be maintained
Solution Approach 1:
The distal flange is extracted or positioned away from the battery assembly to isolate it from thermal effects. This spatial separation removes the heat-generating engagement interface from proximity to the temperature-sensitive battery, minimizing thermal damage while the rigid monolithic construction maintains structural integrity.
Data Source
AI summary
A leadless biostimulator including an attachment feature to facilitate precise manipulation during delivery or retrieval is described. The attachment feature can be monolithically formed from a rigid material, and includes a base, a button, and a stem interconnecting the base to the button. The stem is a single post having a transverse profile extending around a central axis. The transverse profile can be annular and can surround the central axis. The leadless biostimulator includes a battery assembly having a cell can that includes an end boss. A tether recess in the end boss is axially aligned with a face port in the button to receive tethers of a delivery or retrieval system through an inner lumen of the stem. The attachment feature can be mounted on and welded to the cell can at a thickened transition region around the end boss. Other embodiments are also described and claimed.