Adjustable Annuloplasty Ring for Cardiac Valve Regurgitation
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Solution Overview
Problem
Current cardiac valve insufficiency treatments, such as mitral and tricuspid valve replacement and repair, are time-consuming and often require repositioning or less-than-optimal annuloplasty due to the difficulty in accurately sizing and positioning annuloplasty rings to prevent regurgitation of blood flow.
Innovation Solution
An apparatus comprising a first annuloplasty ring and an elongate flexible body with an adjustable mechanism that can be inserted into the annuloplasty ring, allowing it to be tensioned to a smaller diameter, thereby modifying the cardiac valve annulus and reducing regurgitation, using mechanisms like cinching or electromagnetic wires for adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional suture techniques with annuloplasty rings are used, then valve repair can be performed, but the procedure is time-consuming and requires extensive repositioning or re-stitching
Solution Approach 1:
The patent employs adjustable mechanisms (cinching mechanisms, pull wires, expandable structures) that allow the annuloplasty ring to be dynamically adjusted in size and shape after implantation. This dynamic capability enables precise positioning and sizing without requiring removal and repositioning of the entire ring, thereby reducing surgical time while maintaining positioning precision.
Solution Approach 2:
The annuloplasty ring is divided into multiple segments or sections that can be independently adjusted or positioned. This segmentation allows for localized modifications and precise positioning of specific portions of the ring, reducing the need for extensive repositioning of the entire structure and thereby decreasing surgical time.
2Reliability
If annuloplasty ring is used to reduce annulus diameter, then regurgitation can be prevented, but the ring may be severely malpositioned requiring removal and repositioning
Solution Approach 1:
The adjustable mechanisms allow the annuloplasty ring to be dynamically resized and repositioned after initial implantation. If malpositioning occurs, the ring can be adjusted in situ rather than requiring removal and reimplantation, maintaining reliability of regurgitation prevention while improving ease of operation.
Solution Approach 2:
The patent utilizes mechanisms that allow changing of physical parameters (diameter, shape, tension) of the annuloplasty ring after implantation. This capability enables correction of malpositioning by adjusting parameters such as ring diameter or tension distribution, ensuring effective regurgitation prevention without requiring removal and repositioning.
3Manufacturing precision
If adjustable mechanisms are added to the annuloplasty ring, then positioning precision is improved, but device complexity increases
Solution Approach 1:
The patent introduces intermediary elements (pull wires, cinching mechanisms, delivery catheters) that mediate between the operator and the annuloplasty ring. These intermediaries provide controlled adjustability through simple external manipulation while maintaining relative simplicity of the ring structure itself, balancing positioning precision with device complexity.
Solution Approach 2:
The adjustment mechanism is partially extracted or separated from the main ring structure, allowing the ring to remain relatively simple while providing adjustability through external or separate components. This separation reduces the complexity burden on the ring itself while maintaining the precision benefits of adjustability.
Data Source
AI summary
An apparatus for modifying the annulus of a cardiac valve to reduce regurgitation of blood flow through the cardiac valve includes a first annuloplasty ring having a first diameter and being disposed about a first aspect of the annulus of the cardiac valve. The apparatus also includes an elongate flexible body having proximal and distal end portions and being insertable into the first annuloplasty ring. The elongate flexible body has an adjustable mechanism for selectively adjusting the elongate flexible body from a first relaxed configuration to a second tensioned configuration. The first annuloplasty ring is adaptable to obtain a second smaller diameter and to cause the annulus of the cardiac valve to be modified and reduce regurgitation of blood flow through the cardiac valve when the elongate flexible body obtains the second tensioned configuration.