Percutaneous Heart Valve Reshaping Device
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Solution Overview
Problem
Heart valve incompetency due to dilation caused by heart disease leads to regurgitation and decreased cardiac output, which current treatments like open-heart surgical implantation of an annuloplasty ring are invasive and not always effective.
Innovation Solution
A device comprising a central ring with pivotable arms and attachment features that can be extended and contracted to reshape the heart valve by engaging with the valve tissue, reducing the valve annulus circumference and improving leaflet coaptation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgical implantation of an annuloplasty ring is performed, then the valve annulus is restored to its native circumference, but the treatment is highly invasive and carries significant surgical risks
Solution Approach 1:
The patent replaces the traditional open-heart surgical mechanical system with a minimally invasive percutaneous delivery system. The annuloplasty device is delivered through a catheter inserted via peripheral vessels, eliminating the need for thoracotomy, cardiopulmonary bypass, and direct surgical access to the heart, thus substituting a complex surgical mechanical system with a less invasive endovascular approach
Solution Approach 2:
The annuloplasty device is nested within a delivery catheter system for minimally invasive delivery. The contractile elements and frame are contained within the catheter lumen during delivery, then deployed at the target site, allowing the complex repair device to be delivered through a small percutaneous access point rather than requiring open surgical exposure
2Stability of the object's composition
If a rigid annuloplasty ring is implanted, then the valve annulus structure is stabilized, but the device cannot adapt to dynamic changes in valve geometry during the cardiac cycle
Solution Approach 1:
The patent employs contractile elements that can actively change the circumference of the valve annulus in response to varying pressure gradients and flow conditions during the cardiac cycle. The device transitions from a static rigid ring to a dynamic system that can adjust its geometry, allowing the annulus to maintain optimal shape under different hemodynamic conditions while preserving structural stability
Solution Approach 2:
The device changes physical parameters of the valve annulus by actively contracting or expanding the contractile elements to modify the annular circumference and geometry. This parameter adjustment allows the device to adapt to dynamic changes in valve shape and size during systole and diastole, maintaining effective leaflet coaptation across different cardiac phases
3Ease of operation
If the valve annulus is left dilated, then no invasive procedure is needed, but the valve leaflets fail to coapt properly causing regurgitation
Solution Approach 1:
The patent replaces open-heart surgical mechanical intervention with a percutaneous mechanical delivery system that achieves the same therapeutic effect of restoring annular geometry and improving leaflet coaptation without the need for thoracotomy, sternalotomy, or cardiopulmonary bypass, thus maintaining non-invasiveness while ensuring reliable valve function
Data Source
AI summary
The present disclosure includes a device for reshaping a heart valve. The device may include a central ring about a central axis and a plurality of arms coupled to the central ring, each of the arms coupled to the central ring at a pivot point at a first end of the arm, the arm comprising an attachment feature at a second point along the arm, the pivot point configured to allow movement of the arm about the pivot point through a plane extending radially from the central axis through the arm. Additionally, the plurality of arms may be contractable and may be extendable such that the hooks extend beyond a dilated heart valve. The present disclosure also includes associated methods and systems.