Expandable Annuloplasty Ring Structure for Valve-in-Ring Reoperation
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Solution Overview
Problem
Existing annuloplasty rings are rigid or semi-rigid and do not adequately accommodate the implantation of a subsequently implanted expandable valve, leading to issues such as regurgitation and the need for reoperations.
Innovation Solution
A mitral repair annuloplasty ring with a semi-rigid inner core and features that allow it to conform to the geometry of a transcatheter valve, featuring thick and thin regions or slits to enable different rates of bending, and optionally expansion joints or a sealing sleeve to minimize gaps and prevent regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous approach is used to deliver the annuloplasty ring, then the ring can be delivered through a small incision, but the risk of infection and tissue damage increases
Solution Approach 1:
The delivery system is divided into separate components: a delivery catheter and a self-expanding ring. The ring is compressed within the catheter during delivery, then deployed inside the heart, eliminating the need for percutaneous insertion through skin tissue and reducing infection risk.
Solution Approach 2:
A delivery catheter serves as an intermediary tool to transport the compressed ring through the vascular system to the heart, allowing the ring to be delivered without direct percutaneous access to the cardiac area, thus reducing tissue damage and infection risk.
2Ease of operation
If a percutaneous approach is used for ring delivery, then the procedure can be performed through a small incision, but the risk of vascular injury increases
Solution Approach 1:
The delivery system separates the ring from the delivery mechanism, allowing the ring to be compressed within a catheter and delivered through existing vascular access points without requiring additional percutaneous incisions that could cause vascular injury.
3Strength
If the annuloplasty ring is made of rigid material, then the ring provides structural support, but the ring cannot be compressed for delivery through catheter
Solution Approach 1:
The ring transitions from a rigid state (for providing structural support after deployment) to a compressible state (for delivery through catheter). This dynamic property allows the ring to be easily delivered while maintaining its structural function once deployed inside the heart.
Solution Approach 2:
The ring's physical parameters (rigidity/compressibility) are changed during the procedure. The ring is compressed to a small diameter for delivery, then expands to its functional diameter inside the heart, allowing it to provide structural support while being deliverable through catheter.
4Device complexity
If the annuloplasty ring is compressed to small diameter for delivery, then the ring can be delivered through catheter, but the ring cannot maintain its functional diameter during delivery
Solution Approach 1:
The ring is designed to dynamically change its diameter based on the operational requirement. During delivery, it maintains a compressed small diameter for catheter passage. Upon deployment inside the heart, it expands to its functional diameter and maintains this size through its elastic properties, ensuring reliability of function.
Solution Approach 2:
The ring's diameter parameter is changed from a small compressed state during delivery to a larger functional state after deployment. The elastic material properties enable the ring to maintain its functional diameter reliably once deployed, while allowing compression for delivery.
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 ring effectively accommodates a transcatheter valve, minimizing gaps and regurgitation by conforming to the valve's shape, thus reducing the need for reoperations and improving surgical outcomes.
Implementation Method 1
self-expanding annuloplasty ring...compressed to a small delivery diameter...expand to its functional diameter
Data Source
Figure 1
Figure 2A~2F
Figure 3A~3B
AI summary
A mitral repair annuloplasty ring that will accommodate implantation of a transcatheter valve therein for a valve -in-ring reoperation. The ring has a semi-rigid core with features that allow the ring to better conform to the cylindrical geometry of a transcatheter valve when implanted. The inner core defines a continuous peripheral D- shape with a substantially straight anterior side diametrically across from a more rounded posterior side with arcuate lateral sides therebetween. Segments of the ring core are subject to differing rates of bending due to variable radial thicknesses or radial slits opening to both inner and outer edges around the core periphery. One or more expansion joints may also be used to create the more circular final expanded shape. A plastically expandable sealing sleeve may surround the transcatheter valve for sealing gaps between the valve and annuloplasty ring.