Prosthetic Heart Valve Tether Securement Coupling

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Solution Overview

Problem

Current methods for delivering and deploying prosthetic heart valves, particularly for mitral valve replacements, face challenges in securing anchoring tethers and maintaining the valve's position within the heart, leading to higher morbidity and costs due to the need for open-heart surgery and extra-corporeal circulation.

Innovation Solution

A prosthetic heart valve design featuring a tether securement portion with a coupling mechanism that uses shape-memory materials and braided filaments, secured with sutures, and a positioning device for precise placement, allowing for transcatheter delivery and anchoring within the heart.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open-heart surgery is used for valve replacement, then the valve can be securely implanted, but the patient experiences high morbidity and requires extra-corporeal circulation

Engineering Contradiction:
Improvevalve implantation securityVSAvoidmorbidity from extra-corporeal circulation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses minimally invasive percutaneous access. The prosthetic valve is delivered through a catheter and deployed within the heart without requiring thoracic opening or heart-lung machine support, thereby eliminating the harmful effects of extra-corporeal circulation while maintaining secure valve implantation through specialized anchoring mechanisms

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the procedural parameters from open surgical access to percutaneous catheter-based access. By transforming the delivery approach from surgical incision to transluminal catheter insertion, the procedure achieves equivalent valve replacement outcomes with significantly reduced patient morbidity and elimination of extra-corporeal circulation requirements

Inventive Principle:
Principle #35Parameter changes

2Reliability

If anchoring tethers are used to secure the prosthetic valve, then the valve position is maintained, but the tether attachment to the valve presents technical challenges

Engineering Contradiction:
Improvevalve position stabilityVSAvoidtether securement mechanism
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the tether securement function into separate modular components: the tether itself, the securement portion with coupling features, and the frame structure. This segmentation allows each component to be optimized independently and simplifies the attachment process by providing dedicated coupling interfaces between the tether and valve frame, reducing overall system complexity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a tether securement portion as an intermediary component between the anchoring tether and the prosthetic valve frame. This intermediate structure provides specialized coupling features that facilitate reliable tether attachment while simplifying the integration with the valve assembly, thereby reducing the technical challenges of direct tether-to-valve attachment

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If a tether securement portion with coupling features is added to the prosthetic valve, then tether attachment is improved, but the device complexity increases

Engineering Contradiction:
Improvetether attachment easeVSAvoidvalve structure complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The patent merges the tether securement portion with the prosthetic valve frame structure, integrating the coupling features directly into the valve assembly. This combination eliminates the need for separate attachment hardware and simplifies the overall device by consolidating multiple functions into unified structural elements, thereby improving ease of operation without proportionally increasing complexity

Inventive Principle:
Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This solution enables secure anchoring and positioning of prosthetic heart valves, reducing the need for open-heart surgery and extra-corporeal circulation, thereby lowering morbidity and costs, while facilitating more efficient and minimally invasive mitral valve replacement procedures.

Implementation Method 1

The tether securement portion can include a shape-memory material and the coupling feature can be formed with the shape-memory material

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3675774B1Prosthetic heart valves with tether coupling features
Publication Date: 2023.06.21 TENDYNE HOLDINGS INC
  • EP3675774B1 patent drawingFigure 1
  • EP3675774B1 patent drawingFigure 2A~2B
  • EP3675774B1 patent drawingFigure 3

AI summary

Apparatus and methods are described herein for various embodiments of a prosthetic heart valve that have a tether securement feature that can be used to secure an anchoring tether to the prosthetic heart valve such that the tether can maintain the prosthetic heart valve in a desired position within the heart under high tensile forces applied to the tether during functioning of the heart. In some embodiments the tether securement feature can also include an engagement member that can be used to help position the prosthetic heart valve within a heart. Such an engagement member can be matingly engaged by a positioning device that can be used to help in radial positioning of the prosthetic heart valve during delivery and deployment of the prosthetic heart valve.