Telescoping Catheter Delivery System for Left Heart Device Placement
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Solution Overview
Problem
Current catheter systems for accessing the left ventricle of the heart are inadequate, particularly for patients who do not respond to traditional coronary sinus lead placement, necessitating improved systems for minimally invasive delivery and placement of medical devices.
Innovation Solution
A transseptal delivery system comprising an elongate first tubular member with an adjustable portion and a second tubular member with a curved portion, allowing for puncture creation and guide insertion into the left atrium and ventricle, facilitating the placement of leads and other medical devices with rotational capability for multiple site access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional transvenous approach through the right heart is used to access the left ventricle, then the procedure can be performed with existing catheter systems, but up to 40-50% of patients do not respond to CRT with this approach, indicating inadequate access or positioning capability
Solution Approach 1:
The delivery system is divided into multiple catheter components: a first catheter for transseptal access and a second catheter for left ventricular positioning. This segmentation allows each catheter to be optimized for its specific function, improving overall access capability and CRT response rate.
Solution Approach 2:
The system incorporates steerable and deflectable catheter portions that can dynamically adjust their curvature and orientation. This dynamic capability enables precise positioning at various left ventricular sites, improving adaptability and access for patients who fail traditional approaches.
2Reliability
If multiple separate catheter systems are used for transseptal access and left ventricular positioning, then each function can be optimized independently, but the procedure complexity and number of components increases
Solution Approach 1:
The patent combines transseptal access capability and left ventricular positioning capability into an integrated delivery system. The first and second catheters can be used together as a coordinated system, reducing the number of separate procedures and components while maintaining the reliability of each function.
Solution Approach 2:
The delivery system is designed to perform multiple functions: transseptal puncture, guide wire placement, and left ventricular lead positioning. This multi-functionality reduces device complexity by eliminating the need for separate specialized catheters for each step.
3Device complexity
If a rigid fixed-shape catheter is used, then the catheter structure is simple and stable, but the ability to access various anatomical sites and adapt to different patient geometries is limited
Solution Approach 1:
The catheter system incorporates steerable and deflectable portions that can dynamically change their shape and orientation. This dynamic capability allows the catheter to adapt to different patient anatomies and access various left ventricular sites while maintaining structural integrity.
Solution Approach 2:
Different portions of the catheter have different mechanical properties: some segments are rigid for stability, while others are flexible and steerable for adaptation. This local differentiation of properties allows the catheter to simultaneously maintain simplicity in its basic structure while achieving high adaptability at its working end.
4Reliability
If an invasive surgical approach is used to access the left ventricle, then direct access can be achieved, but patient trauma and recovery time increase
Solution Approach 1:
The patent uses a series of intermediary structures (guide wires, dilators, and flexible catheters) to progressively access the left ventricle through smaller incisions. This intermediary approach replaces direct surgical access with a stepwise minimally invasive procedure, reducing patient trauma while maintaining access reliability.
Solution Approach 2:
The system replaces aggressive mechanical surgical instruments with flexible, steerable catheters that can navigate through vascular and cardiac structures. This substitution of mechanical approaches enables reliable left ventricular access through minimally invasive routes, significantly reducing patient trauma and recovery time.
Data Source
AI summary
A transseptal catheter delivery system includes an elongate first tubular member and an elongate second tubular member receivable within the first tubular member. The first tubular member includes an adjustable portion adjacent a distal end. The second tubular member is adapted to receive an instrument to be placed in the left ventricle, and includes a curved portion adjacent its distal end in a relaxed state. The adjustable portion is deflectable toward the atrial septum to guide a puncturing tool and/or guide insertion of the second tubular member through a septal puncture into the left atrium. Within the left atrium, the curved portion is oriented toward the left ventricle to guide insertion of a guide wire, and subsequently the second tubular member, into the left ventricle. Methods of transvenously accessing a left ventricle are also provided.