Suture-securing device for heart valve repair
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current surgical techniques for treating functional tricuspid regurgitation are limited, with only a small percentage of affected patients undergoing tricuspid valve surgeries annually, and existing methods do not effectively address the pathophysiologic abnormalities causing tricuspid valve annular dilatation and leaflet tethering.
Innovation Solution
The development of a suture-securing device that automatically transitions from an unlocked to a locked configuration, allowing for the secure coupling of sutures to different parts of the heart valve annulus, and a system involving a support with leaflet-piercing elements and a securing element to sandwich valve leaflets, facilitating the repair of heart valves by reshaping the annulus and improving valve function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional surgical techniques are used for tricuspid valve repair, then the surgical procedure can be performed, but the number of patients treated remains very low (only 8,000 annually out of 1.6 million affected) and the pathophysiologic abnormalities are not effectively addressed
Solution Approach 1:
The surgical procedure is divided into distinct modular steps: delivering the support structure, deploying the securing element, piercing the leaflets, and coupling components. This segmentation allows for systematic treatment of the pathophysiologic abnormalities while increasing procedural standardization and treatability
Solution Approach 2:
The support structure is delivered and positioned on the valve annulus before the securing element is deployed to pierce the leaflets. This preliminary positioning ensures proper geometric relationships are established before the critical leaflet-piercing step, enabling effective treatment of annular dilatation and leaflet tethering
2Ease of operation
If a suture-securing device with automatic locking configuration is used, then suture coupling is simplified and automated, but the device complexity increases with multiple tubular elements and locking mechanisms
Solution Approach 1:
The suture-securing device automatically transitions from an unlocked to a locked configuration through its own mechanical properties. The biased configuration causes the second tubular element to rotate and engage the locking mechanism without requiring separate manual locking actions, making the device self-securing
Solution Approach 2:
The device incorporates a dynamic locking mechanism where the second tubular element can rotate relative to the first tubular element. This rotational movement transforms the device from an unlocked state (where sutures are slidable) to a locked state (where sutures are secured), providing operational flexibility
3Adaptability or versatility
If leaflet-piercing elements are delivered independently to the second side of the heart valve, then the delivery flexibility is improved, but the coordination and timing of delivery becomes more complex
Solution Approach 1:
The support structure acts as an intermediary component that receives the leaflet-piercing elements after they are independently delivered through the valve leaflets. The support structure's opening allows the piercing elements to pass through and couple to it, coordinating the independent delivery process with the final assembly
Data Source
AI summary
A suture-securing device includes a first tubular element, shaped to define a first lumen therethrough, and having first and second ends; and a second tubular element, shaped to define a second lumen therethrough, and having first and second ends. The suture-securing device is configured to have (a) an unlocked configuration in which the first end of the second tubular element is disposed closer to the first end of first tubular element than is the second end of the second tubular element, and the sutures are disposable within and slidable through the first and second lumens, and (b) a locking configuration in which the second end of the second tubular element is disposed closer to the first end of first tubular element than is the first end of the second tubular element, and the sutures are inhibited from sliding through the first and second lumens. Other embodiments are also described.