Adjustable Annuloplasty Ring with Deployable Pressing Elements
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Solution Overview
Problem
Fixed-size annuloplasty rings used in cardiac valve repair are ineffective over time due to changes in heart size and geometry, leading to residual regurgitation and potential complications like systolic anterior motion, necessitating additional surgeries for adjustment or replacement.
Innovation Solution
An adjustable annuloplasty ring system with deployable pressing elements that can be adjusted peri- or post-operatively to customize the shape and size of the ring, using a support ring and adjustable ring assembly with features like deployable blades, fluid-deployable devices, and ratchets to ensure precise deformation and long-term treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed-size annuloplasty ring is implanted during classical annuloplasty procedure, then the valve annulus can be reinforced and deformed to correct incompetent valve function, but the ring becomes ineffective over time due to changes in heart size and geometry, leading to residual regurgitation and potential complications
Solution Approach 1:
The annuloplasty ring is designed with adjustable components that allow dynamic modification of the ring's shape and size after implantation. The pressing element can be repositioned along the ring to change the deformation pattern, and the ring itself can be resized by adjusting the pressing element's position, enabling adaptation to changing cardiac conditions over time
Solution Approach 2:
A pressing element is introduced as an intermediary component between the annuloplasty ring and the valve annulus. This pressing element can be repositioned to modify the ring's shape and deformation characteristics, serving as a mediator that enables adjustment of the ring's mechanical properties without requiring removal or replacement of the entire device
2Productivity
If a fixed-size annuloplasty ring is chosen during surgery, then the procedure can be completed in one operation, but the effectiveness cannot be assessed during the procedure since the heart is arrested, and a second operation may be needed if repair is unsuccessful
Solution Approach 1:
The adjustable annuloplasty ring allows preliminary adjustment and assessment of valve function before finalizing the implantation. The pressing element can be temporarily positioned to test different configurations, and valve function can be assessed during the procedure with the heart still beating, enabling optimization before committing to a final configuration
Solution Approach 2:
The ring's adjustability allows real-time modification during surgery to optimize valve function. The pressing element can be repositioned to achieve the desired ring shape and deformation, and the effectiveness can be assessed immediately during the procedure, eliminating the need for a second operation
3Reliability
If too small rings are implanted to overcome the risk of residual regurgitation, then residual regurgitation can be reduced, but mitral stenosis occurs due to too little blood flow through the mitral valve
Solution Approach 1:
The adjustable ring allows optimization of the balance between preventing regurgitation and maintaining adequate blood flow. The pressing element can be positioned to achieve the precise degree of annulus deformation needed to correct regurgitation without excessive reduction of the valve opening, and this can be fine-tuned during the procedure based on observed valve function
Solution Approach 2:
The pressing element creates localized deformation at specific positions around the annulus rather than uniform reduction. This allows targeted reinforcement of the valve annulus to prevent regurgitation while preserving adequate blood flow through the valve by maintaining appropriate dimensions in other areas
Data Source
Figure 1
Figure 2~3
Figure 4~5b
AI summary
An adjustable annuloplasty ring assembly (10) comprises a support ring (30), an adjustable ring (32) nested at least partly within the support ring, and at least one deployable pressing element (34) for deforming the adjustable ring using the support ring (30) as support. Plural pressing elements (34) may be used at different positions around rings. Each pressing element (34) may have a variable extents of deployment, to vary the extent of deformation of the adjustable ring at the position of the pressing element. Each pressing element may comprise a deflectable blade (40), and the state of the blade may be retained by a ratchet (50). The pressing elements may be operated in a predetermined controlled sequence.