Indexed Neochord Suture for Precise Heart Valve Leaflet Fixation
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Solution Overview
Problem
Current heart valve repair techniques face challenges in determining the precise length of replacement chords due to the soft and pliable nature of papillary muscle and leaflet tissues, leading to suture migration and inadequate immobilization, which results in imperfect neochord length and potential failure of the repair.
Innovation Solution
A suture construction with a central body having longitudinally spaced indexing openings, a papillary/tissue anchor structure, and a leaflet suturing structure, allowing for bi-directional stabilization and precise, adjustable fixation of the heart valve leaflet relative to the papillary muscle, using parallel strands or loops that can be temporarily or permanently secured.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional suture techniques are used to replace chordae, then the procedure can be performed with simple materials, but the sutures migrate or slide and cannot retain their intended position due to the soft and pliable nature of papillary muscle and leaflet tissues
Solution Approach 1:
The suture is divided into multiple segments with indexed openings at specific intervals. These segmented sections allow for precise positioning and adjustment while maintaining the overall integrity of the chord replacement. The indexing system creates discrete reference points that prevent migration.
Solution Approach 2:
An intermediary indexing system is introduced between the suture and the tissue. This indexing mechanism acts as a mediator that provides reference points for positioning the suture relative to the papillary muscle and leaflet, preventing direct slippage while allowing controlled adjustment.
2Productivity
If the surgeon attempts to determine the exact neochord length in a single step, then the procedure is quick, but the precision is insufficient because multiple iterations are needed to achieve the optimal length
Solution Approach 1:
The suture is pre-marked with indexing openings at predetermined intervals before implantation. This preliminary preparation allows the surgeon to quickly select the appropriate length during the procedure without needing to perform multiple iterative adjustments, combining speed with precision.
Solution Approach 2:
The indexing system provides dynamic adjustability during the procedure. The surgeon can selectively engage different indexing openings to achieve the optimal neochord length, allowing for precise adjustments while maintaining procedural efficiency through the pre-established reference points.
3Reliability
If clips are used to secure the suture position, then suture migration is limited, but clips can damage the suture, can be lost into the patient, and often fail to secure the position well
Solution Approach 1:
The harmful clip element is completely removed from the system. Instead of using external clips to secure the suture, the indexing openings are integrated directly into the suture structure itself, eliminating the need for separate securing components that could cause damage or be lost.
Solution Approach 2:
The securing function previously performed by separate clips is merged into the suture structure itself through the integrated indexing openings. This combination eliminates the need for additional components and reduces the risk of suture damage while maintaining position security.
4Manufacturing precision
If successive overlapped knots are tied along the suture to provide a defined fixed length, then an attempt is made to prevent migration, but the technique is not successful due to slippage and it is difficult to untie the knots to shorten the length when too long
Solution Approach 1:
The length definition is performed preliminarily through the pre-established indexing openings rather than through post-implantation knotting. This allows the correct length to be determined before final securing, eliminating the need for difficult-to-adjust knots while maintaining precision.
Solution Approach 2:
The complex mechanical knot-tying system is replaced with a simpler indexing mechanism. Instead of relying on friction and tension from successive knots, the system uses pre-defined geometric reference points that are easier to manipulate and adjust during the procedure.
Data Source
AI summary
A suture construction for adjustable fixation of a heart valve leaflet relative to a papillary muscle or other supporting heart tissue is defined by a central body portion having a plurality of longitudinally spaced indexing openings or loops, an anchor structure at a first end of the body portion, and a suturing structure at a second end of the body portion. The anchor structure is secured or coupled to the papillary muscle or supporting heart tissue and the suturing structure is passed through the heart valve leaflet where one of the indexing loops is selectively fixed to the heart valve leaflet to adjustably fix the heart valve leaflet in a desired functional position relative to the supporting heart tissue. The indexing loops of the suture construction prevent unwanted movement of the heart valve leaflet in both directions and are securable in very small incremental positions for proper functional spacing.