Leadless Pacemaker Attachment Feature for Precise Delivery Torque
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Solution Overview
Problem
Current leadless cardiac pacemakers face challenges in precise delivery and retrieval due to the complexity of navigating catheters and sheaths through delicate anatomical structures, leading to potential damage to the pacemaker, cardiac tissue, and the venous system, necessitating improved manipulation techniques.
Innovation Solution
An attachment feature with a one-piece construction, mounted on the battery assembly, featuring a tether recess and a distal flange, which reduces strain and thermal damage, allowing for precise torque transmission and improved docking mechanisms for delivery and retrieval systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a leadless pacemaker is delivered via catheter-based delivery system through delicate anatomical structures, then the pacemaker can be implanted minimally invasively, but the complexity of navigation increases the risk of damage to the pacemaker, cardiac tissue, and venous system
Solution Approach 1:
The attachment feature is pre-configured on the pacemaker with a rigid stem and torque transmission interface before implantation. This preliminary preparation ensures that when the pacemaker needs to be manipulated during delivery or retrieval, the torque transmission capability is already in place, reducing the risk of damage during these critical operations.
Solution Approach 2:
The attachment feature is designed as a distinct component with a rigid stem that separates the torque transmission function from the pacemaker housing. This segmentation allows the delivery system to apply torque to the pacemaker through the attachment feature without transmitting excessive stress to the delicate electronic components and battery assembly inside the pacemaker.
2Ease of operation
If torque is transmitted to the leadless pacemaker during delivery or retrieval operations, then precise manipulation is achieved, but the attachment feature may experience excessive strain and fail
Solution Approach 1:
The attachment feature incorporates a rigid stem specifically designed to handle torque loads, while the rest of the pacemaker housing maintains its sealed, hermetic construction. This local quality differentiation allows torque transmission at the attachment interface without compromising the overall integrity and waterproofing of the pacemaker device.
Solution Approach 2:
The attachment feature uses a rigid material construction that provides high strength-to-weight ratio and excellent torque resistance. The rigid stem is designed with material properties optimized for mechanical strength while maintaining compatibility with the biocompatible housing materials, creating a composite structure that withstands delivery and retrieval operations.
3Ease of manufacture
If the attachment feature is constructed with multiple components for flexibility, then assembly is easier, but the number of potential failure points increases
Solution Approach 1:
The attachment feature is designed as a one-piece, integrally formed component that combines the stem, torque transmission interface, and docking features into a single rigid structure. This merging eliminates potential failure points at component interfaces while maintaining manufacturability through techniques such as injection molding or precision machining of the single piece.
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.