Adjustable Annuloplasty Device with Rigid Outer Wall
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Solution Overview
Problem
Current annuloplasty devices are fixed in size, making it difficult to assess their effectiveness during surgery, leading to potential residual regurgitation and valve dysfunction over time, and can cause issues like systolic anterior motion and mitral stenosis due to their rigidity.
Innovation Solution
An adjustable annuloplasty device with a tube having a more rigid outer wall and a less rigid inner wall, allowing for continuous deformation and adjustment post-operatively using actuation elements like inflatable bladders or stents, which can be attached to the valve annulus for precise fitting and long-term correction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixed-size annuloplasty device is implanted during surgery, then the valve annulus can be reinforced and deformed to correct incompetent valve function, but the effectiveness cannot be assessed during the procedure and residual regurgitation may occur
Solution Approach 1:
The annuloplasty device transitions from a fixed static structure to a dynamic adjustable structure. The device includes an adjustable ring that can be repositioned and resized after implantation, allowing the valve annulus to be dynamically adapted to changing heart conditions and patient needs over time.
Solution Approach 2:
The device enables changing of geometric parameters (ring position, ring size, annulus deformation) after the initial implantation procedure. This allows optimization of valve function by adjusting parameters such as the degree of annulus deformation and the position of the annuloplasty ring based on post-implantation assessment of valve performance.
2Ease of manufacture
If a fixed-size annuloplasty device is used, then the procedure is simple, but the device may become ineffective over time as heart size varies
Solution Approach 1:
The device incorporates adjustable components that allow modification of the annuloplasty ring position and configuration after implantation. This dynamic capability ensures long-term effectiveness by enabling adjustments as the heart undergoes physiological changes, preventing device obsolescence.
Solution Approach 2:
The device is implanted with preliminary adjustment capabilities built-in, allowing future modifications without requiring removal or replacement. The adjustable mechanism is pre-installed and can be activated later if needed, combining initial simplicity with future adaptability.
3Reliability
If a small fixed-size annuloplasty device is implanted to prevent residual regurgitation, then regurgitation risk is reduced, but mitral stenosis may occur due to restricted blood flow
Solution Approach 1:
The device allows post-implantation adjustment of the annulus deformation parameter. If mitral stenosis develops, the deformation can be reduced by repositioning or resizing the adjustable ring, thereby increasing the valve opening area and restoring adequate blood flow while maintaining regurgitation prevention.
Solution Approach 2:
The adjustable design enables feedback-based optimization of valve function. Clinical assessment of valve performance can guide adjustments to the device parameters, allowing optimization of the balance between preventing regurgitation and avoiding stenosis based on actual patient outcomes.
4Duration of action of stationary object
If an adjustable annuloplasty device with multiple components is used, then long-term effectiveness is improved, but device complexity increases
Solution Approach 1:
The adjustable ring is nested within or integrated with the annuloplasty structure, with the adjustment mechanism contained within the overall device geometry. This nesting approach allows adjustment functionality to be added without proportionally increasing external device complexity or surgical implantation difficulty.
Data Source
AI summary
An adjustable annuloplasty device comprising a tube having a basically annular shape or adopted to be brought into an annular shape. At least one portion, preferably three portions, of an outer wall or the whole outer wall of the tube is more rigid than opposite portion(s) of an inner wall or the whole inner wall. The inner wall is arranged nearer to an inside area defined by the annular shape than the outer wall. The inner wall is adapted to be displaced inwardly at least along less rigid portion(s) of the circumference upon actuation by at least one actuation element while the outer wall remains basically constant.