Annuloplasty Ring Tether Adjustment for Beating-Heart Valve Repair
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Solution Overview
Problem
Existing surgical techniques for treating mitral regurgitation caused by ischemia or dilated cardiomyopathy, such as restrictive annuloplasty, fail to provide durable long-term results due to continued ventricular remodeling, and valve replacement in these patients has higher perioperative mortality.
Innovation Solution
An annuloplasty ring system with tethers attached to subvalvular structures like papillary muscles, allowing for on-pump implantation and off-pump adjustment of tether lengths while the heart is beating, ensuring optimal valve function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If restrictive annuloplasty is performed to treat mitral regurgitation, then short-term regurgitation is alleviated, but long-term results are poor due to continued ventricular remodeling
Solution Approach 1:
The patent applies dynamics by making the annuloplasty ring adjustable after implantation. The ring can be repositioned and reconfigured in the delivery system to change its shape and size, allowing it to adapt to ventricular remodeling over time rather than being fixed at implantation. This dynamic adjustment capability enables the ring to maintain effectiveness long-term despite changes in ventricular geometry.
Solution Approach 2:
The patent implements parameter changes by allowing modification of the annuloplasty ring's physical parameters (shape, size, configuration) after implantation through the delivery system. The ring's parameters can be adjusted to optimize mitral valve function as the ventricle remodels, transforming a static device into one that can adapt to changing physiological conditions.
2Reliability
If papillary muscles are relocated using sutures to treat mitral regurgitation, then durable repair is achieved, but it is difficult to determine optimal relocation distance
Solution Approach 1:
The patent applies feedback by using imaging modalities (fluoroscopy, echocardiography, or other imaging devices) to visualize the mitral valve and papillary muscles during the procedure. This real-time feedback allows the operator to adjust the annuloplasty ring position and tether length to achieve optimal papillary muscle relocation, ensuring precise positioning rather than relying on predetermined distances.
Solution Approach 2:
The patent implements dynamics by allowing continuous adjustment of the annuloplasty ring and tethers after implantation. The delivery system enables the operator to reposition the ring and adjust tether lengths to achieve the optimal papillary muscle relocation distance, transforming a static, predetermined procedure into a dynamic, adjustable process.
3Ease of manufacture
If annuloplasty ring is implanted on-pump to treat mitral regurgitation, then initial positioning is achieved, but final adjustment must wait until off-pump which delays optimization
Solution Approach 1:
The patent implements continuity of useful action by enabling adjustment of the annuloplasty ring and tethers while the heart is beating (off-pump). The delivery system maintains the ability to adjust ring position and tether lengths after initial implantation, allowing continuous optimization of mitral valve function without requiring a second surgical intervention or waiting for a future procedure.
Data Source
Figure 1A~1B
Figure 2A~2B
Figure 3
AI summary
An annuloplasty ring for repair of mitral and tricuspid valves including an inner core covered by an outer suture-permeable interface. The inner core defines a closed peripheral shape surrounding an orifice and at least one outwardly-projecting boss configured to provide a suture anchor, such as having a pair of apertures. A plurality of anchoring sutures pass through the interface and secure the annuloplasty ring to a native heart valve annulus, while at least one tethering suture ties to the suture anchor and extends to structure in a subvalvular chamber below the native heart valve annulus. The length of the tethering suture is adjusted while the heart is beating using a tensioning system to ensure proper valve functioning.