Leaflet-Anchored Coaptation Repair for Valve Regurgitation
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Solution Overview
Problem
Existing cardiac valve repair procedures, such as surgical replacements and annuloplasty, are invasive, painful, and require long recovery periods, and often suffer from complications due to device durability issues and improper sizing, with success dependent on surgeon skill.
Innovation Solution
A cardiac valve repair device with a coaptation member and clip mechanisms that anchor to native leaflets and other heart anatomy, providing a new coaptation surface and securing the position, while minimizing disruption, and optionally using atrial and ventricular members to capture leaflets and fill regurgitant orifices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical replacement or annuloplasty procedures are used to treat valve regurgitation, then valve function can be restored, but the procedures are invasive, painful, and require long recovery periods
Solution Approach 1:
The device is divided into separate functional components including a positioning member with anchors and a coaptation member with clips, allowing minimally invasive delivery through catheter-based approaches while maintaining effective valve repair capability
Solution Approach 2:
The coaptation member acts as an intermediary structure positioned between the valve leaflets to provide a new coaptation surface, enabling effective valve closure without requiring direct surgical manipulation or replacement of the entire valve
2Reliability
If traditional annuloplasty rings or surgical repair procedures are used, then valve regurgitation can be treated, but device durability issues and improper sizing cause complications
Solution Approach 1:
The device incorporates adjustable and reconfigurable elements including deployable anchors and repositionable coaptation members, allowing optimization of device positioning and sizing after implantation to ensure long-term durability and effectiveness
Solution Approach 2:
The device allows for parameter adjustments including the positioning of anchors in the annulus, the orientation and position of the coaptation member, and the engagement of clips on the leaflets, enabling customization to patient-specific anatomy to prevent complications from improper sizing
3Reliability
If surgical repair procedures are used, then valve repair can be achieved, but success depends heavily on surgeon skill and improperly placed sutures may affect procedure success
Solution Approach 1:
The device incorporates self-aligning and self-positioning features including pre-configured anchor positions in the annulus and automated clip deployment mechanisms that engage leaflets at optimal locations, reducing dependence on surgeon skill for precise placement while maintaining repair effectiveness
Solution Approach 2:
The device replaces traditional suture-based mechanical repair with a clip-based system that can be deployed and secured with greater precision and consistency, reducing variability associated with manual suture placement by surgeons
Data Source
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Figure 1B
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AI summary
Cardiac valve repair devices and associated systems and methods are disclosed herein. A cardiac valve repair device configured in accordance with embodiments of the present technology can include, for example, a coaptation member configured to be positioned between one or more native leaflets of the cardiac valve to at least partially fill a space between the native leaflets. The cardiac valve repair device can further include one or more fixation mechanisms for securing the coaptation member in position between the leaflets. A cardiac valve repair device configured in accordance with additional embodiments of the present technology can include an atrial member and a ventricular member configured to sandwich one or more the native leaflets therebetween.