Heart Valve Implant Delivery With Hub-Guided Rotational Positioning
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Solution Overview
Problem
Existing transcatheter techniques for delivering and deploying prosthetic heart valves face challenges in engaging, loading, translating, repositioning, resheathing, and deploying expandable stents within heart chambers efficiently.
Innovation Solution
The use of a self-expandable implant made from superelastic materials like nickel-titanium alloys, with a hub and swivel body mechanism, allows for precise deployment and repositioning of the implant within heart chambers, utilizing a delivery cable and pusher catheter system for controlled advancement and rotation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a self-expandable implant with superelastic materials is used, then deployment precision and repositioning capability are improved, but device complexity increases due to the hub and swivel body mechanism
Solution Approach 1:
The implant is divided into modular components including a hub, swivel body, and self-expandable stent sections. This segmentation allows independent optimization of each component's function while maintaining overall system precision and controllability during deployment.
Solution Approach 2:
The swivel body mechanism introduces dynamic rotational capability to the implant system, enabling controlled repositioning and orientation adjustment during deployment. This dynamic feature enhances deployment precision while the modular design manages the associated complexity.
2Measurement precision
If a delivery cable and pusher catheter system is used for controlled advancement, then positioning accuracy is improved, but the procedure time increases due to multiple manipulation steps
Solution Approach 1:
The implant is pre-loaded into the delivery catheter in a compressed state before the procedure begins. The delivery cable and pusher catheter are pre-positioned and connected to the implant hub, allowing immediate controlled advancement without time-consuming assembly steps during the procedure.
Solution Approach 2:
The delivery cable and pusher catheter system is designed to perform multiple functions including advancement, positioning, and deployment control through a unified mechanism. This multi-functionality reduces the number of separate manipulation steps required, thereby reducing procedure time while maintaining positioning accuracy.
3Ease of operation
If the implant is made self-expandable with superelastic materials, then ease of deployment is improved, but control over expansion timing becomes more difficult
Solution Approach 1:
The hub acts as an intermediary mechanism between the delivery system and the self-expandable stent. It provides a controlled interface that maintains the stent in a compressed state during delivery and enables precise timing of expansion through mechanical release, balancing ease of deployment with controlled expansion timing.
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 efficient and controlled delivery and positioning of prosthetic heart valves within heart chambers, enhancing the precision and effectiveness of transcatheter procedures.
Implementation Method 1
a self-expandable implant made from superelastic materials like nickel-titanium alloys
Data Source
AI summary
Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.