Steerable Tricuspid Valve Delivery System

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Solution Overview

Problem

Developing a delivery system for replacement heart valves that can be compactly delivered and controllably expanded for precise placement within the body, while securely anchoring to intralumenal tissue without causing trauma, is challenging, especially for accessing and deploying valves like the tricuspid valve through tortuous vasculature.

Innovation Solution

A delivery system with an elongate shaft and deflection mechanisms, including bend portions and a deflection mechanism, allows for steerable deployment of a replacement heart valve to the tricuspid valve, featuring an implant retention area and support bodies that can bend and expand to secure the valve within the native valve annulus, using a capsule and tether for anchoring and stabilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a replacement heart valve is delivered through tortuous vasculature, then the valve can reach the tricuspid valve location, but the delivery system cannot maintain proper orientation and positioning

Engineering Contradiction:

Improvedeliverability through tortuous vasculatureVSAvoidpositioning accuracy at target site

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The delivery system is divided into multiple bendable sections with independent deflection capabilities. Each section can be controlled to bend in specific directions, allowing the distal end to navigate tortuous vasculature while maintaining overall system control for precise positioning at the target site.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The delivery system incorporates dynamic deflection mechanisms that allow real-time adjustment of the shaft's curvature and orientation. This enables the system to adapt to the complex geometry of tortuous vasculature while maintaining the ability to precisely position and orient the valve at the target location.

Inventive Principle:

Principle #15Dynamics

2Volume of moving object

If the prosthesis is compacted for delivery, then it can be delivered through minimally invasive procedures, but it cannot be securely anchored to intralumenal tissue

Engineering Contradiction:

Improvecompactness for deliveryVSAvoidanchoring security

Core Design Contradiction:

Volume of moving objectVSReliability

Solution Approach 1:

The prosthesis is designed with nested components that allow it to be compacted within the delivery system for minimally invasive delivery. Upon deployment, the components expand outward to engage with intralumenal tissue, providing secure anchoring while maintaining the initial compact form factor.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The prosthesis transitions from a compact, constrained state during delivery to an expanded, anchored state at the target site. This dynamic transformation allows the device to achieve both compactness for delivery and secure anchoring for reliability through controlled expansion mechanisms.

Inventive Principle:

Principle #15Dynamics

3Reliability

If open heart surgery is used to replace heart valves, then secure valve replacement can be achieved, but significant trauma is caused to the patient

Engineering Contradiction:

Improvevalve replacement securityVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical approach with a catheter-based delivery system. The prosthesis is delivered through the vasculature and deployed within the heart valve, achieving secure replacement without the need for sternotomy or cardiopulmonary bypass, thereby eliminating significant patient trauma while maintaining reliability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS20220287836A1Systems and methods for tricuspid valve treatment

Publication Date: 2022.09.15 EDWARDS LIFESCIENCES CORP

AI summary

Devices, systems and methods are described herein to provide improved treatment of a tricuspid valve. Such treatment may include tricuspid valve replacement, which may include providing a prosthetic tricuspid valve within the tricuspid valve annulus. Delivery systems for delivering the prosthetic tricuspid valve to the tricuspid valve annulus are disclosed herein. Treatment may also include repair of the tricuspid valve.