Radiopaque Tines for Leadless Pacemaker Fixation
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Solution Overview
Problem
Conventional leadless cardiac pacemakers face challenges in visualization and confirmation of fixation during implantation due to the difficulty in observing the fixation mechanism using fluoroscopy, which can lead to inadequate anchoring and potential device displacement.
Innovation Solution
Incorporating radiopaque materials such as gold, palladium, platinum, or their alloys into the fixation mechanism, either as coatings or integrated within the nitinol tines, to enhance visibility under fluoroscopy, along with a protective external coating to prevent corrosion and improve the visibility of the fixation mechanism during deployment and anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Difficulty of detecting and measuring
If radiopaque materials are incorporated into the fixation mechanism, then visibility under fluoroscopy is improved, but device complexity increases
Solution Approach 1:
The patent applies local quality by incorporating radiopaque materials specifically into the fixation mechanism components (tines, anchors, or fixation elements) rather than the entire device. This allows the fixation portions to be highly visible under fluoroscopy while keeping other device components simpler and less complex.
Solution Approach 2:
The patent uses composite materials by combining radiopaque materials (such as barium sulfate, tungsten, or gold) with biocompatible materials (such as polymers or metals) to create fixation mechanism components that provide both visibility under fluoroscopy and appropriate mechanical properties for tissue anchoring.
2Difficulty of detecting and measuring
If radiopaque coating is applied to tines, then radiopacity is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent addresses manufacturing precision challenges by optimizing the radiopaque coating parameters, including thickness (typically 1-10 micrometers), material composition, and deposition methods. These parameter changes ensure adequate radiopacity while maintaining manufacturability and avoiding excessive complexity in the coating process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The increased radiopacity of the fixation mechanism allows for better visualization and confirmation of proper anchoring, ensuring secure implantation and reducing the risk of device displacement, thereby improving the reliability of leadless cardiac pacemaker placement.
Implementation Method 1
Incorporating radiopaque materials such as gold, palladium, platinum, or their alloys into the fixation mechanism, either as coatings or integrated within the nitinol tines, to enhance visibility under fluoroscopy
Implementation Method 2
the radiopaque material may be a continuous coating substantially covering at least one surface of each tine of the plurality of tines
Data Source
AI summary
An implantable leadless pacing device may comprise a power source and circuitry operatively coupled to the power source. The circuitry configured to pace a patient's heart and/or sense electrical activity of the patient's heart. A housing may at least partially enclose the circuitry. The pacing device may further include a first electrode secured relative to the housing and a fixation mechanism secured relative to the housing. The fixation mechanism may comprise a plurality of tines configured to move between an elongated delivery configuration and a curved deployed configuration. Each tine of the plurality of tines may include a radiopaque material.