Epicardial Anchor Tether Positioning and Load Monitoring

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Solution Overview

Problem

Existing prosthetic heart valves lack the ability to adjust or reposition themselves post-deployment and fail to monitor the tension of securing tethers effectively, leading to issues like tether slacking, over-tightening, and suboptimal angular configuration, which can result in valve misalignment and migration.

Innovation Solution

The development of an adjustable tether and epicardial anchor device system that allows for post-deployment adjustment of tether length and tension, using a positioning device with a locking pin mechanism and force sensor for precise tension measurement and adjustment, enabling secure anchoring and optimal valve positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a prosthetic heart valve is deployed with a securing tether, then the valve can be anchored to the heart wall, but the tether tension cannot be adjusted or monitored after deployment, leading to improper tensioning

Engineering Contradiction:
Improvevalve anchoring stabilityVSAvoidtether tension adjustment capability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies the dynamics principle by making the tether length adjustable after deployment. The tether can be extended or retracted using a pulling mechanism that allows dynamic adjustment of tether tension, transforming a static anchoring system into a dynamic one that can adapt to changing conditions post-deployment

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements feedback by incorporating a force sensor that continuously monitors tether tension and provides real-time feedback to the operator. This feedback mechanism enables precise control of tether tension during adjustment, allowing the operator to maintain optimal tension levels and prevent both over-tightening and slacking

Inventive Principle:
Principle #23Feedback

2Stability of the object's composition

If the tether is tensioned to secure the valve, then the valve position is fixed, but the tether may become slack or over-tightened over time, causing misalignment

Engineering Contradiction:
Improvevalve position stabilityVSAvoidpost-deployment adjustment capability
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The system enables dynamic adjustment of tether length post-deployment, allowing the operator to restore optimal tension if the tether becomes slack or over-tightened. The adjustable mechanism provides ongoing adaptability to maintain proper valve alignment and position stability throughout the device's service life

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The force sensor provides continuous monitoring of tether tension, enabling the operator to detect when tension deviates from the optimal range and make corrective adjustments. This feedback loop ensures the valve maintains stable positioning by preventing both slacking and over-tightening conditions

Inventive Principle:
Principle #23Feedback

3Reliability

If the anchor device is positioned during deployment, then the valve can be secured, but no adjustments can be made to the anchor position after initial placement

Engineering Contradiction:
Improveanchor securing strengthVSAvoidanchor repositioning capability
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies dynamics by enabling the anchor device to be repositioned after initial deployment. The anchor can be detached and re-attached at different locations on the heart wall, transforming a static anchoring system into one that allows post-deployment position adjustments to optimize valve alignment

Inventive Principle:
Principle #15Dynamics

4Ease of manufacture

If a simple anchor device is used, then the deployment is straightforward, but the device lacks measurement and monitoring capabilities for tether load

Engineering Contradiction:
Improvedevice simplicityVSAvoidtether load measurement capability
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent introduces a force sensor as an intermediary component between the tether and the anchor device. This sensor acts as a mediator that measures tether load and provides feedback without significantly complicating the overall device structure or deployment process, adding measurement capability while maintaining relative simplicity

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3116409B1Devices for positioning and monitoring tether load for prosthetic mitral valve
Publication Date: 2023.07.26 TENDYNE HOLDINGS INC
  • EP3116409B1 patent drawingFigure 1
  • EP3116409B1 patent drawingFigure 2
  • EP3116409B1 patent drawingFigure 3

AI summary

Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.