Tip Assembly Locking Mechanism for Percutaneous Heart Valve Delivery
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Solution Overview
Problem
Current medical devices for delivering and implanting heart valves are invasive and require significant recovery times, with existing methods being inefficient for percutaneous delivery and deployment within the cardiovascular system.
Innovation Solution
A medical device system featuring a tip assembly with a nosecone and engagement members that attach securely to an inner shaft, allowing for percutaneous delivery and deployment of implantable heart valves, reducing invasiveness and improving delivery precision through a combination of locking mechanisms and a collar design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional invasive methods are used for heart valve delivery, then deployment capability is achieved, but recovery time increases and invasiveness increases
Solution Approach 1:
The device is divided into separate components: a delivery catheter with engagement members and a tip assembly with locking members. This segmentation allows the valve to be delivered through a percutaneous approach with reduced invasiveness, as the modular design enables precise positioning and secure attachment without requiring more invasive surgical exposure.
Solution Approach 2:
The locking members are designed to deflect from a first position to a second engaged position, providing dynamic attachment and detachment capabilities. This dynamic mechanism enables minimally invasive delivery by allowing the tip assembly to be securely attached during procedure and easily removed afterward, reducing recovery time compared to fixed invasive methods.
2Ease of operation
If percutaneous delivery method is used, then invasiveness is reduced, but delivery precision requirement increases
Solution Approach 1:
The distal end region of the inner shaft is inserted into the first lumen of the second engagement member, creating a nested configuration. This nesting arrangement provides precise alignment and positioning of the tip assembly relative to the delivery catheter, ensuring accurate delivery through the percutaneous approach while maintaining reduced invasiveness.
Solution Approach 2:
The engagement and locking mechanisms replace complex mechanical positioning systems with simpler, more reliable locking members that deflect into engaged positions. This substitution enables precise delivery through percutaneous access without requiring complex mechanical adjustment mechanisms, thus maintaining delivery precision while reducing invasiveness.
3Reliability
If locking members are added to secure tip assembly, then attachment reliability is improved, but device complexity increases
Solution Approach 1:
The locking members and engagement members are integrated into the tip assembly and inner shaft structures respectively, merging the attachment function into the existing structural components. This merging approach provides reliable attachment through the locking mechanism while minimizing additional complexity, as the locking members work in conjunction with the existing engagement member geometry rather than requiring entirely separate attachment systems.
Data Source
AI summary
Medical device delivery systems and methods for making and using medical device delivery systems are disclosed. An example delivery system for an implantable medical device includes an implantable heart valve including an inner shaft having a proximal end region, a distal end region and a first engagement member disposed along a portion of the distal end region and a tip assembly configured to attach to the inner shaft. The tip assembly includes a nosecone having a distal end region and a proximal end region, a second engagement member disposed within at least a portion of the nosecone, the second engagement member including a first locking member, the first locking member configured to deflect from a first position to a second engaged position. Further, attaching the tip assembly to the inner shaft includes deflecting the first locking member such that the locking member is coupled to the first engagement member.