Adjustable Repair Chords for Mitral Valve Regurgitation
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Solution Overview
Problem
Ischemic heart disease leads to mitral regurgitation due to papillary muscle dysfunction and mitral valve annulus dilation, causing leaflet tethering and decreased cardiac output, for which existing repair methods are inadequate in restoring normal valve function.
Innovation Solution
The development of adjustable repair chords with a spool assembly and delivery tool that allow for the implantation and adjustment of artificial chordeae tendineae to restore normal valve function by tensioning and relaxing the chords, using a spool mechanism to adjust the length of the longitudinal members between tissue portions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional open-surgery valve repair is performed, then the surgeon can directly visualize and estimate chord length, but the procedure requires open-heart surgery with cardiopulmonary bypass and the estimates may be incorrect after weaning
Solution Approach 1:
The patent applies preliminary action by performing chord length adjustment after the heart is weaned from cardiopulmonary bypass, when the heart is in its final physiological state. The adjustable chord allows measurement and adjustment to be performed at the appropriate time rather than estimating during arrested heart conditions, ensuring accuracy without requiring complex intraoperative adjustments
Solution Approach 2:
The patent implements dynamics by providing chords with adjustable length that can be modified after implantation. The chord includes a spool mechanism that allows the length to be adjusted post-implantation to achieve optimal leaflet coaptation, transforming a static estimation problem into a dynamic adjustment process that adapts to actual physiological conditions
2Adaptability or versatility
If adjustable repair chords with spool mechanism are used, then chord length can be adjusted to restore normal valve function, but the device structure becomes more complex
Solution Approach 1:
The spool assembly serves multiple functions: it acts as both the adjustment mechanism and an integral part of the chord structure. The spool can wind and unwind the chord material, providing length adjustment, while also serving as an attachment point for the chord ends. This multi-functionality reduces the need for separate adjustment devices and simplifies the overall structure
Solution Approach 2:
The patent applies nesting by placing the spool mechanism within the chord structure itself. The spool is positioned at one end of the chord, and the chord material passes through or around it, creating a compact integrated assembly. This nested arrangement minimizes the overall device footprint and reduces structural complexity compared to separate adjustment mechanisms
3Ease of operation
If percutaneous neochordea creation is performed, then the procedure is less invasive and adjustable in the beating heart, but it requires image-guidance and specialized delivery systems
Solution Approach 1:
The patent applies segmentation by dividing the delivery system into separate functional components: a catheter for percutaneous access, a delivery shaft for transporting the spool assembly, and the spool-chord assembly itself. This segmentation allows each component to be optimized for its specific function and facilitates percutaneous delivery while maintaining adjustability capabilities
Solution Approach 2:
The patent uses the delivery catheter and shaft as intermediaries to transport the spool-chord assembly to the target site without requiring open surgery. The catheter provides a pathway through the vascular system to the heart, allowing minimally invasive delivery of the adjustable chord while the spool mechanism remains accessible for post-implantation adjustment
Data Source
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AI summary
Apparatus is provided, including a delivery tool (20) including a handle portion (24) and a shaft (22) slidable with respect to the handle (24). A proximal portion (241) of the shaft (22) is slidable into a lumen (23) of the handle (24). A spool (46) is removably couplable to the delivery tool and is implanted in an intraventricular site (5) of a ventricle. At least one longitudinal member (60, 62) is coupled to the spool (46). A portion of the longitudinal member (60, 62) is configured to be coupled to a first portion of heart tissue (7) that surrounds the ventricular space. The longitudinal member (60, 62) is wound around the spool (46) in response to rotation of the spool (46), and, responsively, draws the second end portion of the longitudinal member and the first portion of heart tissue (7) toward the spool (46).