Pre-shaped Template for Heart Valve Annulus Reshaping
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Solution Overview
Problem
Current less invasive surgical and percutaneous devices for heart valve repair are often large, complex, and have limited efficacy across various anatomical configurations, failing to effectively address valve regurgitation and device migration, particularly in open heart surgical procedures.
Innovation Solution
A pre-shaped template with a tissue-engaging surface and rotatable anchors is used to reshape the valve annulus, allowing for adjustable expansion and contraction to address valve regurgitation, minimize device migration, and accommodate diverse valve configurations through coupling mechanisms that exert radial forces to stabilize the annulus and improve leaflet coaptation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If less invasive surgical and percutaneous devices are used for heart valve repair, then patient recovery time and invasiveness are improved, but device size and complexity increase while efficacy decreases
Solution Approach 1:
The device is divided into multiple segments including a delivery catheter, an implantable frame with struts, and separate anchoring mechanisms. This segmentation allows the complex device to be delivered through a minimally invasive percutaneous approach while maintaining the functional complexity needed for effective valve repair.
Solution Approach 2:
The implantable frame and components are nested within a delivery catheter in a compressed state during delivery. Once positioned at the target valve site, the frame is deployed and expanded from the catheter, allowing the complex device structure to be delivered through a small percutaneous access point.
2Ease of operation
If less invasive surgical and percutaneous devices are used for heart valve repair, then patient recovery time and invasiveness are improved, but device efficacy and applicability to various anatomical configurations decrease
Solution Approach 1:
The device incorporates expandable and adjustable components including struts that can be deployed to different configurations and anchoring mechanisms that can be adjusted to accommodate various anatomical geometries. This dynamic adaptability allows the device to effectively treat different valve types and anatomical configurations through a single minimally invasive delivery approach.
Solution Approach 2:
The device allows for parameter adjustments including expansion ratio, anchoring depth, and frame geometry to match specific patient anatomy. These parameter changes enable the same minimally invasive device to be effectively applied across a broad range of anatomical configurations while maintaining high efficacy.
3Reliability
If expansion and contraction features are used to adjust valve diameter, then valve regurgitation is addressed, but device migration increases
Solution Approach 1:
The device merges the expansion/contraction mechanism for treating regurgitation with integrated anchoring features including barbs, hooks, or interlocking components that engage with the valve annulus or surrounding tissue. This combination allows the device to adjust valve diameter while remaining securely positioned, preventing migration during and after the procedure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution enables effective reshaping of the valve annulus, reducing valve regurgitation, minimizing device migration, and improving the applicability of less invasive techniques to a broader range of patient populations with varying valve configurations, while maintaining the benefits of minimally invasive procedures.
Implementation Method 1
at least one rotatable anchor configured to penetrate tissue when rotated
Implementation Method 2
the pre-shaped template is configured to draw at least one segment of a valve annulus into the concave region
Data Source
Figure 1~2
Figure 3~4
Figure 5A~5B
AI summary
A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coapting of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.