Leaflet-Restraining Frame for Mitral Valve Prolapse Control
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Solution Overview
Problem
Existing treatments for heart valve leaflet prolapse, such as surgery and existing implants, do not effectively inhibit the movement of prolapsing leaflets into the atrium, leading to regurgitation and other complications.
Innovation Solution
Percutaneously-implantable devices comprising a flexible longitudinal member and linking members that are anchored to heart tissue to inhibit leaflet movement, with a support structure and leaflet-restraining frame to improve coaptation, using a catheter for deployment and tissue anchors for secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing implants are used to treat leaflet prolapse, then the treatment can be performed, but the implants do not effectively inhibit leaflet movement into the atrium
Solution Approach 1:
The implant is divided into multiple functional segments: a longitudinal member for structural support, linking members for anchoring to tissue, and a frame with leaflet-restraining portions for direct leaflet inhibition. This segmentation allows each component to perform its specific function optimally, with the frame specifically designed to prevent leaflet movement into the atrium while other components provide support and anchoring.
Solution Approach 2:
The implant extends into the atrium with leaflet-restraining portions that occupy the space where prolapsing leaflets would move. By adding this spatial dimension into the atrial chamber, the implant creates a physical barrier that prevents leaflet displacement without interfering with normal valve function during forward flow.
2Ease of operation
If percutaneous delivery is used, then surgical invasion is reduced, but the implant must be deliverable through a catheter in a compressed state
Solution Approach 1:
The implant transitions from a compressed, low-profile state during delivery through the catheter to an expanded, functional state after deployment. The longitudinal member and frame are designed to be flexible and compressible for delivery, then expand to their functional configuration to provide leaflet restraint. This dynamic transformation allows percutaneous delivery of a complex structure.
Solution Approach 2:
The implant components are nested within the catheter during delivery, with the frame and longitudinal member contained within the catheter lumen in a compressed state. The linking members are also stored within the catheter system. Upon deployment, these nested components are released and expand to their functional configurations, allowing the complex implant to pass through the relatively small catheter.
3Reliability
If the implant structure is made more complex to improve leaflet restraint, then coaptation improves, but the device becomes harder to deliver and implant
Solution Approach 1:
The longitudinal member serves multiple functions: it provides structural support for the frame, acts as a delivery conduit for the frame and linking members, and extends into both the ventricle and atrium to anchor the implant. The frame simultaneously provides leaflet restraint and defines the implant's functional geometry. This multi-functionality reduces the number of separate components needed while maintaining effective leaflet restraint.
Data Source
Figure 1A
Figure 1B
Figure 2A~2B
AI summary
An implant (240) for a native heart valve (10) of a heart (4) of a subject, the heart valve (10) having an annulus (16) defining an orifice between an atrium (6) and a ventricle (8), and a plurality of leaflets (12, 14), the implant (240) comprising: a plurality of tissue anchors (46) configured to penetrate into tissue of the heart (4); a support structure (242) configured to be anchored to an atrial side of the annulus by the plurality of tissue anchors (46); and a resilient frame (244) configured to be secured to the support structure (242), the frame (244) having a constrained state for delivery to the heart valve (10) and an expanded state, wherein when in the expanded state, the frame (244) defines a leaflet-restraining portion (250) that (a) extends away from the support structure (242) and at least partway across the atrial side of the orifice of the heart valve (10) and (b) inhibits atrially-directed movement of a leaflet (14) of the heart valve (10), while allowing ventricularly-directed movement of the leaflet (14).