Tether Termination Device for Minimally Invasive Cardiac Valve Repair
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Solution Overview
Problem
Current minimally invasive cardiac valve repair techniques face challenges in maintaining tension with sutures due to slippage issues, especially with small diameter sutures made of materials like metal or TEFLON, and existing fastening methods do not provide adjustable tension or secure locking mechanisms.
Innovation Solution
The development of devices and methods involving tissue anchors and tethers, where a first anchor is fixedly coupled to the tether, and a second anchor is slidably coupled to secure the tether to the tissue, allowing for adjustable tension application and secure locking using various mechanisms such as clamping, deformation, or adhesive methods, followed by cutting the excess tether.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If small diameter sutures made of metal or TEFLON are used, then the invasiveness is reduced and tissue damage is minimized, but the sutures are prone to slippage and cannot maintain tension reliably
Solution Approach 1:
The patent introduces a fastener as an intermediary component that couples to the suture and provides a secure locking mechanism. The fastener acts as a mediator between the thin suture and the tissue, allowing the suture to maintain tension without directly relying on its own structural integrity. The fastener's locking mechanism prevents slippage while the thin suture continues to minimize tissue damage.
Solution Approach 2:
The patent changes the physical state or properties of the suture system by introducing a fastener that can be deformed or activated to lock the suture in place. This parameter change transforms the system from a passive suture that relies on friction to an active locked system that maintains tension through mechanical engagement, thereby improving reliability without increasing invasiveness.
2Reliability
If traditional open-heart surgery is performed, then reliable valve repair can be achieved, but patient morbidity and mortality are high due to the invasive nature of the procedure
Solution Approach 1:
The patent extracts the critical function of secure suture anchoring from the context of open-heart surgery and implements it through a minimally invasive delivery system. The fastener and delivery device are introduced through small incisions or catheters, separating the anchoring function from the need for large incisions and heart-lung bypass, thereby reducing patient morbidity and mortality while maintaining repair effectiveness.
Solution Approach 2:
The patent replaces the complex mechanical system of open-heart surgery with a simplified delivery mechanism that can deploy fasteners through small incisions. The delivery device uses mechanical principles such as expansion, deployment, or self-actuation to position and activate fasteners without requiring the patient to undergo open-chest surgery, thus reducing harmful factors while maintaining repair reliability.
3Ease of operation
If deformable tubes or crimps are applied over sutures to maintain tension, then the need for knotting is eliminated, but the sutures may still slip through crimps and lose tension
Solution Approach 1:
The patent introduces a dynamic locking mechanism that transitions from an unlocked state (allowing suture adjustment) to a locked state (preventing slippage). The fastener can be activated after suture application to engage and secure the suture, providing both ease of operation during application and reliability during tension maintenance. This dynamic feature addresses the limitation of static crimps that cannot prevent slippage.
Solution Approach 2:
The fastener is designed to self-lock or self-secure the suture in place through its mechanical structure. Once deployed and activated, the fastener automatically maintains tension without requiring additional intervention or adjustment, thereby eliminating the need for knotting while ensuring reliable tension maintenance through its self-servicing locking mechanism.
4Ease of operation
If fusible collars are used to secure sutures, then knotting is avoided, but an external source of energy is required which may damage surrounding tissue
Solution Approach 1:
The patent replaces the thermal or chemical securing mechanism (fusible collars requiring external energy) with a purely mechanical locking system. The fastener uses mechanical deformation, expansion, or engagement to secure the suture, eliminating the need for external energy sources that could damage surrounding tissue. This mechanical substitution maintains ease of operation while removing the harmful effects of thermal or chemical exposure.
Data Source
AI summary
Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether in place and cutting excess tether are described.