Mitral Valve Edge-to-Edge Repair Using Implant Securing Device
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Solution Overview
Problem
Current cardiac valve repair procedures are invasive, requiring cardiac arrest and cardiopulmonary bypass, which pose significant risks and complications, and there is a need for less invasive methods that do not require stopping the heart.
Innovation Solution
A non-invasive method and apparatus for repairing mitral valves using an edge-to-edge procedure, employing an implant securing device with an outer and inner member to secure sutures and form half-hitch knots, allowing for mitral valve repair while the heart is still beating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open-heart surgery is performed for mitral valve repair, then the valve can be repaired effectively, but the patient faces significant risks including strokes and myocardial damage due to cardiac arrest and cardiopulmonary bypass
Solution Approach 1:
The procedure segments the repair process into two distinct phases: first, the implant is deployed on the atrial side of the valve leaflet while the heart continues to beat; second, the heart is stopped only briefly to tie knots on the ventricular side. This segmentation eliminates the need for prolonged cardiac arrest and cardiopulmonary bypass, reducing complications while maintaining repair effectiveness
Solution Approach 2:
The implant is preliminarily positioned and secured on the atrial side of the valve leaflet before the heart is stopped. This preliminary action allows the majority of the repair work to be completed while the heart is still beating, minimizing the time required for cardiac arrest and reducing associated risks
2Reliability
If traditional open-heart surgery is performed for mitral valve repair, then the repair can be completed, but the procedure is highly invasive and labor-intensive
Solution Approach 1:
A delivery catheter serves as an intermediary device to transport and deploy the implant on the atrial side of the valve leaflet while the heart is still beating. This intermediary approach enables minimally invasive access compared to traditional open-heart surgery, reducing surgical invasiveness while ensuring repair completion
Solution Approach 2:
The repair procedure is segmented into distinct steps performed at different times: implant deployment on the atrial side while the heart beats, followed by brief cardiac arrest for knot tying on the ventricular side. This segmentation simplifies each individual step, making the overall procedure less labor-intensive and technically challenging
3Strength
If the heart is stopped for mitral valve repair, then sutures can be tied securely, but the patient is exposed to prolonged risks from cardiac arrest and cardiopulmonary bypass
Solution Approach 1:
The implant is preliminarily positioned and secured on the atrial side of the valve leaflet before the heart is stopped. This preliminary action ensures that the implant is correctly positioned and ready for knot tying, allowing the heart to be restarted immediately after the brief knot-tying phase, thus minimizing the duration of cardiac arrest while maintaining suture security
Solution Approach 2:
The procedure segments suture securing into two phases: initial implant deployment on the atrial side while the heart beats, followed by brief cardiac arrest solely for knot tying on the ventricular side. This segmentation reduces the overall duration of cardiac arrest compared to traditional methods where the entire repair is performed during cardiac arrest
Data Source
AI summary
Apparatus and methods for performing a non-invasive procedure to repair a cardiac valve are described herein. In some embodiments, apparatus and methods are described herein for repairing a mitral valve using an edge-to-edge repair to secure the mitral valve leaflets. Implant securing devices are also described that can be used during a procedure to repair a mitral valve. In some embodiments, an implant securing device includes an outer member and an inner member movably disposed within the outer member. The inner member can be used to hold or secure a suture extending from an implant deployed on an atrial side of a leaflet of a mitral valve, and the outer member can be used to push or move a half hitch knot toward a ventricular side of the leaflet, which can be used to secure the implant in the desired position.