Mitral Valve Delivery System Segmented Expansion

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Solution Overview

Problem

Developing a delivery system for replacement heart valves that can be compactly delivered and controllably expanded for secure placement within the body, particularly challenging due to the need for minimal trauma and precise deployment in tortuous vasculature, and securing the prosthesis to intralumenal tissue without causing trauma.

Innovation Solution

A flexible delivery system comprising multiple layers, including ePTFE and nitinol hypotubes, with a distal segment configuration allowing for controlled expansion and anchoring mechanisms to secure the replacement mitral valve prosthesis, utilizing a transseptal approach for precise placement and deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the delivery system uses a compacted prosthesis design for delivery, then the device can be delivered through tortuous vasculature with minimal trauma, but the ability to controllably expand and secure the prosthesis at the desired location becomes more challenging

Engineering Contradiction:

Improvetrauma to patientVSAvoidcontrolled expansion and deployment

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The delivery system is divided into multiple segments including a guide catheter, expandable frame, and prosthesis assembly that can be independently controlled. The prosthesis itself is segmented into collapsible struts that can be selectively expanded at the target location while maintaining compact delivery profile through tortuous vasculature.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system transitions from a static compacted state during delivery to a dynamic expandable state at the target location. The prosthesis frame includes expandable elements that can be selectively deployed using controlled forces applied through the delivery system, allowing transition between compact and expanded configurations.

Inventive Principle:

Principle #15Dynamics

2Reliability

If the prosthesis is designed to be secured to intralumenal tissue, then stable placement is achieved, but the securing mechanism may cause trauma to the tissue

Engineering Contradiction:

Improvesecure placement of prosthesisVSAvoidtrauma to intralumenal tissue

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The delivery system acts as an intermediary that facilitates secure placement without direct tissue trauma. The expandable frame serves as a mediator between the prosthesis and the annulus, allowing controlled engagement with the tissue while the prosthesis itself remains protected during the securing process.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The securing mechanism utilizes changes in physical parameters such as radial expansion forces and contact pressures. The expandable frame can be controlled to apply gradual, controlled forces to engage with the annulus, transitioning from a non-contact delivery state to a secured implanted state without causing tissue damage.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If the delivery system is designed for percutaneous access through tortuous vasculature, then minimal invasive procedures are enabled, but precise control of prosthesis deployment at the target location becomes difficult

Engineering Contradiction:

Improvepercutaneous access and deliveryVSAvoidprecision of prosthesis deployment

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The delivery system incorporates feedback mechanisms including radiopaque markers and control systems that provide real-time information about the position and status of the prosthesis during deployment. This feedback allows precise control and adjustment of the expansion forces to ensure accurate placement at the target location despite the challenges of percutaneous access through tortuous vasculature.

Inventive Principle:

Principle #23Feedback

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

Enables the safe and effective delivery and secure anchoring of replacement mitral valves within the heart, minimizing trauma and ensuring proper blood flow, while accommodating complex anatomical paths and providing atraumatic deployment.

Implementation Method 1

The flexible delivery system can include an outer sheath assembly, a mid shaft assembly, and an inner assembly. The outer sheath assembly, the mid shaft assembly, and the inner assembly can be made of nitinol, a flexible metal, or a flexible polymer.

Methodology Applied

Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentUS20220331102A1Delivery system for replacement heart valve

Publication Date: 2022.10.20 EDWARDS LIFESCIENCES CARDIAQ LLC

AI summary

Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components, including a flexible nose cone, multi-layer sheath, and pre-compressed shaft, which can be moveable relative to each other.