Deflectable Shaft Delivery System for Cardiac Device Placement
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Solution Overview
Problem
Current delivery systems for implantable cardiac medical devices face challenges in navigation and deployment, particularly for compact devices, due to mechanical complications and MRI compatibility issues associated with elongate lead wires, necessitating more sophisticated systems for precise placement near the heart.
Innovation Solution
A delivery system assembly comprising an elongate outer tube, an inner member, and a deflectable shaft, allowing for longitudinal movement and deflection to navigate through the venous system, with a tether for secure attachment and repositioning of the device, facilitating precise deployment and fixation within the heart.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If elongate lead wires are used in traditional pacemakers, then the device can be implanted remotely in a subcutaneous pocket, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The invention extracts and removes the elongate lead wires from the pacemaker system, eliminating the source of mechanical complications and MRI compatibility issues. The pacemaker is delivered directly to the heart without lead wires, solving the reliability problem while maintaining implantation capability through a different delivery mechanism
Solution Approach 2:
The pacemaker device is nested within a delivery catheter system that guides it through the venous system to the heart. The compact pacemaker is contained within the lumen of the outer tube, allowing remote delivery without lead wires, thus maintaining implantation flexibility while improving reliability
2Volume of moving object
If a compact pacemaker is delivered through a standard guiding catheter, then the device size is reduced, but navigation and deployment precision is insufficient
Solution Approach 1:
The delivery system is segmented into multiple functional components: an outer tube for containing the pacemaker, an inner member for pushing and positioning, and a deflectable shaft for navigation. This segmentation allows each component to perform its specific function optimally, achieving both compact device delivery and precise navigation/deployment
Solution Approach 2:
The delivery system incorporates dynamic elements including a deflectable shaft that can change orientation, and an inner member that can move longitudinally within the outer tube. These dynamic capabilities enable precise navigation through the venous system and accurate deployment of the compact pacemaker at the target site
3Adaptability or versatility
If the outer tube and inner member are longitudinally moveable with respect to the deflectable shaft, then navigation flexibility is improved, but device complexity increases
Solution Approach 1:
The inner member serves multiple functions: it pushes the pacemaker forward, positions it accurately at the target site, and can be retracted to allow device deployment. The deflectable shaft provides both navigation capability and structural support. This multi-functionality reduces the need for additional components, managing complexity while maintaining navigation flexibility
Data Source
AI summary
A delivery system assembly includes an outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.


