Shape-Memory Implant Anchors for Dynamic Mitral Leaflets
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Solution Overview
Problem
Existing treatments for mitral valve regurgitation, including pharmacological and surgical interventions, are invasive, costly, and dependent on skilled surgeons, while existing minimally invasive implants face challenges with sealing and fatigue failure due to significant tissue movement.
Innovation Solution
A system comprising an anchor with a proximal end and a distal end for engaging tissue, a suture coupled to the anchor, and a clip made of nitinol or other shape memory material, which is deployed using a delivery tool to enhance leaflet coaptation without disrupting native anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If existing minimally invasive implants are used to treat mitral valve regurgitation, then the need for invasive procedures and heart-lung machines is reduced, but the implants face sealing failures and fatigue due to significant tissue movement
Solution Approach 1:
The anchor is designed with flexible arms that can dynamically adapt to tissue movement during cardiac cycles. The arms are configured to flex and move with the tissue rather than resist it, maintaining sealing contact despite the significant tissue displacement that occurs during heartbeats. This dynamic adaptation prevents fatigue failure while preserving the minimally invasive nature of the procedure.
Solution Approach 2:
The anchor employs shape memory materials that change their physical parameters (such as stiffness and form) in response to environmental conditions like temperature or mechanical stress. This allows the anchor to transition between a deployable configuration during insertion and a locked, stable configuration after deployment, ensuring both ease of implantation and long-term reliability in the dynamic cardiac environment.
2Reliability
If traditional surgical interventions are used to treat mitral valve regurgitation, then reliable valve repair can be achieved, but the procedures are invasive, costly, and require skilled surgeons and heart-lung machines
Solution Approach 1:
The traditional single complex surgical procedure is segmented into multiple simpler steps: percutaneous anchor delivery, suture attachment, and clip application. Each component (anchor, suture, clip) performs a specific function that can be deployed and secured independently, reducing the overall procedural complexity while maintaining the reliability of valve repair. This segmentation allows less skilled operators to perform the procedure with standardized components.
Solution Approach 2:
The suture acts as an intermediary element that connects the anchor (implanted in tissue) to the clip (attached to the valve leaflet). This intermediary mechanism translates the anchoring force into effective valve coaptation without requiring complex direct attachment mechanisms, simplifying the overall system while ensuring reliable valve repair.
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
The system provides effective leaflet coaptation, minimizing backflow and reducing the need for invasive procedures, allowing deployment without a heart-lung machine and requiring less surgical expertise.
Implementation Method 1
a clip made of nitinol or other shape memory material, which is deployed using a delivery tool to enhance leaflet coaptation
Data Source
AI summary
The invention relates in some aspects to a device for use in anchoring an implant, including anchors, sutures, implants, clips, tools, lassos, and methods of anchoring among other methods. Anchors as disclosed herein could be utilized to secure a coaptation assistance device, an annuloplasty ring, an artificial valve, cardiac patch, sensor, pacemaker, or other implants. The implant could be a mitral valve ring or artificial mitral valve in some embodiments.