Tricuspid Valve Support Device with Tilting Flow Optimizer

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Solution Overview

Problem

Current transcatheter therapies for tricuspid valve regurgitation face challenges due to the unique anatomical features of the tricuspid valve, including the risk of burdening adjacent cardiac structures and low hemodynamic pressure, which complicates safe and effective anchoring and blood flow management.

Innovation Solution

A tricuspid valve support device comprising a shaft, a flow optimizer, and an anchoring mechanism with a core and socket configuration that allows for tilting and locking of the flow optimizer to adjust its position relative to the anchoring mechanism, minimizing regurgitation during systole and allowing diastolic flow, while anchoring without traumatic interaction with surrounding tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If anchoring mechanism is used to secure the device in the tricuspid valve, then device stability is improved, but risk of burdening adjacent cardiac structures increases

Engineering Contradiction:

Improvedevice stabilityVSAvoidrisk of burdening adjacent cardiac structures

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The anchoring mechanism features arms with differentiated functional zones: distal portions with cushioning elements for tissue protection, intermediate portions for engagement, and proximal portions for structural support. This local differentiation allows stable anchoring while minimizing harm to adjacent cardiac structures.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The anchoring arms are equipped with cushioning elements at their distal portions that contact or approach cardiac structures before anchoring occurs. This beforehand cushioning prevents traumatic interaction with surrounding tissues during the anchoring process, addressing the contradiction between stability and tissue protection.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If flow optimizer is positioned to seal regurgitant orifice during systole, then tricuspid regurgitation reduction is improved, but risk of inducing atrioventricular pressure gradient increases

Engineering Contradiction:

Improvetricuspid regurgitation reductionVSAvoidatrioventricular pressure gradient

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The flow optimizer is designed with adjustable positioning capabilities through the ball-socket mechanism, allowing dynamic adjustment of the sealing surface orientation and position. This enables optimization of regurgitation sealing while minimizing pressure gradient induction by adapting to the specific anatomical and hemodynamic conditions of each patient.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device allows modification of key parameters including the angle of the flow optimizer relative to the anchoring mechanism, axial position, and rotational orientation. These parameter changes enable fine-tuning of the sealing function to achieve effective regurgitation reduction while maintaining acceptable pressure gradients.

Inventive Principle:

Principle #35Parameter changes

3Adaptability or versatility

If shaft is made adjustable to optimize flow optimizer position, then device adaptability is improved, but device complexity increases

Engineering Contradiction:

Improvedevice adaptabilityVSAvoiddevice complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The shaft is nested within the lumen of the ball, which itself is positioned within the socket of the anchoring mechanism. This nested configuration allows the shaft to be adjusted axially and rotated independently while maintaining a compact integrated structure, achieving high adaptability without proportionally increasing overall device complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The ball-socket joint introduces rotational freedom as an additional degree of freedom beyond axial adjustment. This dimensional addition enables the flow optimizer to be positioned in multiple orientations (angular and rotational) without requiring a completely separate adjustment mechanism, thereby improving adaptability with minimal complexity increase.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

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

The device effectively reduces tricuspid regurgitation by sealing the regurgitant orifice during systole and allowing unobstructed diastolic flow, enhancing the safety and efficacy of transcatheter therapy by maintaining a low atrioventricular pressure gradient and preventing thrombogenesis.

Implementation Method 1

The ball is configured to rotate within the socket so as to tilt the shaft relative to a central axis of the anchoring mechanism

Methodology Applied

Scientific EffectRotation:

Data Source

PatentUS20240058128A1Heart valve support device

Publication Date: 2024.02.22 TRIFLO CARDIOVASCULAR INC

AI summary

Devices for assisting with the functioning of a tricuspid valve of a heart include a shaft, a flow optimizer, and an anchoring mechanism. A tilting mechanism can be configured to tilt the shaft relative to a central axis of the anchoring mechanism. Leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and a rim, and the rim can have a higher stiffness than the membrane.