Suture Twisting for Beating-Heart Mitral Valve Approximation
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Solution Overview
Problem
Conventional cardiac valve surgeries, particularly mitral valve repairs, are invasive and require cardiac arrest, posing significant risks and complications, and there is a need for less invasive, beating-heart repair procedures that do not require cardiac arrest or implanting annuloplasty rings.
Innovation Solution
A method and apparatus for remotely securing two or more sutures together using a twister device to approximate cardiac valve leaflets, allowing for minimally invasive procedures by twisting sutures outside the heart to adjust and anchor implants to targeted tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is used for mitral valve repair, then the valve repair can be performed with direct access and visualization, but the procedure requires cardiac arrest, general anesthesia, and results in significant disability and extended recovery
Solution Approach 1:
The patent replaces the mechanical system of open-heart surgery with a catheter-based minimally invasive system. The device uses a catheter inserted through a small incision in the groin to access the heart, eliminating the need for sternotomy and cardiac arrest. The system uses electromagnetic guidance and imaging to navigate and perform the repair without direct mechanical access to the heart surface.
Solution Approach 2:
The patent introduces an intermediary catheter system that acts as a mediator between the operator and the heart. The catheter serves as a conduit to deliver repair devices to the mitral valve location, allowing remote manipulation and control. This intermediary approach enables precise delivery of repair elements without requiring direct surgical access to the heart.
2Reliability
If conventional mitral valve repair procedures are performed, then the valve can be repaired, but the procedures require implanting annuloplasty rings and result in significant post-procedure recovery time
Solution Approach 1:
The patent segments the valve repair process into discrete, deliverable components through the catheter system. Instead of requiring a single complex open-heart procedure with ring implantation, the system delivers individual repair elements (such as chordae tendineae reinforcements or leaflet patches) that can be implanted minimally invasively. This segmentation allows for less invasive delivery and faster recovery.
Solution Approach 2:
The patent changes the procedural parameters from open-heart surgery to minimally invasive catheter-based repair. By altering the access method and delivery mechanism, the procedure avoids the need for annuloplasty ring implantation and reduces recovery time while maintaining repair effectiveness. The system enables repair with smaller incisions and without requiring cardiac arrest.
3Object-affected harmful factors
If minimally invasive procedures are used to avoid cardiac arrest, then the risk and complexity are reduced, but the ability to perform complex valve repairs is limited
Solution Approach 1:
The patent designs a universal catheter-based platform that can perform multiple valve repair functions through a single access point. The system includes interchangeable tips and deliverable elements that can address different repair scenarios (leaflet reinforcement, chordae repair, annular stabilization) without requiring different access methods. This multi-functionality maintains repair complexity while reducing surgical risk through standardized minimally invasive access.
Solution Approach 2:
The patent employs a nested structure where deliverable repair elements are contained within a catheter system. The repair devices are nested within the catheter, which itself is nested within a guidance and imaging system. This nested architecture allows complex repair capabilities to be packaged within a minimally invasive delivery platform, enabling sophisticated repairs through a small incision in the groin without increasing surgical risk.
Data Source
AI summary
Described herein are devices for approximating targeted tissue by intertwining two or more sutures together. The sutures are attached to the targeted tissue and routed to a twister device. The twister device secures end portions of the sutures and twists them to intertwine the sutures. Controlling the number of twists provides control over the forces applied to the targeted tissue. In conjunction with visualization feedback, real-time adjustments can be made to achieved targeted results, such as elimination of mitral regurgitation when the disclosed methods and apparatus are applied to mitral valve repair.