Coronary Sinus Guide Segmentation and Nitinol Reinforcement
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Solution Overview
Problem
Current coronary access and delivery systems face challenges in advancing flexible medical devices, such as pacemaker leads, into the coronary sinus due to the heart's structure, difficulty in locating the sinus, and altered anatomy in cardiomyopathic hearts, which requires additional support and guidance.
Innovation Solution
The development of torqueable cores and coronary sinus guides with complementary shapes and reinforcement members to enhance pushability and torqueability, allowing for precise placement and navigation within the heart's vasculature, including the use of nitinol reinforcement for stiffness and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If flexible medical devices are used to access the coronary sinus, then the devices can navigate the heart's structure, but they lack sufficient support and guidance for precise placement
Solution Approach 1:
The patent introduces a coronary sinus guide as an intermediary device between the operator and the flexible medical device. The guide provides a structured pathway with reinforcement members that enable precise control and placement of the flexible device within the coronary sinus, solving the lack of guidance while maintaining navigability
Solution Approach 2:
The coronary sinus guide is divided into multiple segments including a proximal portion, medial portion, and distal portion with different curvature characteristics. This segmentation allows the guide to navigate complex heart structures while maintaining control for precise placement through differentiated structural properties in each segment
2Adaptability or versatility
If the coronary sinus guide is made more flexible to navigate altered anatomy, then it can adapt to cardiomyopathic hearts, but it loses torqueability and pushability
Solution Approach 1:
The guide incorporates reinforcement members at specific locations (proximal, medial, and distal portions) rather than uniformly throughout. This local reinforcement provides torqueability and pushability where needed while maintaining flexibility in other regions to adapt to altered anatomy in cardiomyopathic hearts
Solution Approach 2:
The coronary sinus guide uses composite construction combining flexible material with embedded reinforcement members. This composite structure enables the guide to simultaneously exhibit flexibility for navigating altered anatomy and sufficient stiffness for torqueability and pushability in specific segments
3Ease of operation
If reinforcement members are added to enhance stiffness, then pushability and torqueability improve, but the device becomes less flexible
Solution Approach 1:
The reinforcement members are strategically positioned in specific segments (proximal, medial, distal portions) rather than continuously throughout the entire guide. This segmentation allows enhanced pushability and torqueability in critical regions while preserving flexibility in other areas to navigate complex vasculature
Solution Approach 2:
Different portions of the guide have different levels of reinforcement based on their functional requirements. The proximal portion receives reinforcement for operator control, the medial portion for navigation, and the distal portion for tip stability, creating local quality variations that balance stiffness and flexibility
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
Enables effective introduction and placement of medical devices into the coronary sinus, even in hearts with altered anatomy, by providing the necessary stiffness and steerability to overcome structural and anatomical challenges.
Implementation Method 1
The development of torqueable cores and coronary sinus guides with complementary shapes and reinforcement members to enhance pushability and torqueability, allowing for precise placement and navigation within the heart's vasculature, including the use of nitinol reinforcement for stiffness and flexibility.
Data Source
Figure 1A
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AI summary
Coronary access and delivery systems are provided. A coronary access system can include a coronary sinus guide and a first core. A lateral vein delivery system can include a lateral vein introducer and a second core. The coronary sinus guide, the lateral vein introducer, and the first and second cores may be designed or shaped to access a predetermined position within a heart of a subject. For example, the coronary sinus guide, the lateral vein introducer, and/or the first and second cores can be used in combination to access the predetermined position within the heart of the subject.