Stent-Valve Delivery for Beating-Heart Valve Replacement

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Solution Overview

Problem

Conventional cardiac valve replacement surgeries require invasive procedures, such as sternotomy and cardiopulmonary bypass, which increase risks for subsequent surgeries and are limited by the need for anti-coagulant treatment with synthetic valves or the short lifespan of biological valves.

Innovation Solution

A minimally-invasive surgical approach using stent-valves that can be implanted on a beating heart, featuring adjustable stent components and delivery systems for precise positioning without open-chest cavity access, including stent-valves with anchoring struts, locking elements, and fabric reinforcement for stability and sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional surgical approaches (sternotomy/thoracotomy) are used for cardiac valve replacement, then the surgeon can access the heart and perform the replacement, but the procedure becomes highly invasive requiring heart arrest and cardiopulmonary bypass

Engineering Contradiction:

Improvesurgical safety for first interventionVSAvoidsurgical procedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The replacement valve is nested within a delivery catheter system that guides it through the patient's vascular system to the implantation site. The valve is compressed within the catheter and then deployed at the target location, eliminating the need for open-chest surgery and heart arrest.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

A delivery catheter acts as an intermediary device to transport the replacement valve through the vascular system to the implantation site. This intermediary system enables minimally invasive access while maintaining the ability to deliver and position the valve accurately.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If synthetic valves are used for replacement, then the valve rarely fails, but the patient requires life-long anti-coagulant treatment which limits activities and causes complications

Engineering Contradiction:

Improvevalve durabilityVSAvoidanti-coagulant treatment side effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The replacement valve combines biological leaflets (for natural blood flow and no anti-coagulation requirement) with a synthetic stent framework (for structural support and durability). This composite structure provides the advantages of both materials while minimizing their disadvantages.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

Different parts of the valve have different material properties optimized for their specific functions: biological tissue for the valve leaflets where flexibility and blood compatibility are needed, and synthetic material for the stent framework where structural strength and durability are required.

Inventive Principle:

Principle #3Local quality

3Object-affected harmful factors

If biological valves are used for replacement, then no anti-coagulation treatment is required, but the valves typically fail within 10-15 years

Engineering Contradiction:

Improveanti-coagulation treatment requirementVSAvoidvalve lifespan

Core Design Contradiction:

Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The hybrid valve structure combines biological leaflets with a synthetic stent framework, providing both the immediate functionality of biological valves and the long-term durability of synthetic materials, potentially extending valve lifespan beyond 10-15 years.

Inventive Principle:

Principle #40Composite materials

4Device complexity

If percutaneous heart valve replacement therapies are used, then the surgical approach is less invasive, but the ability to ensure proper positioning and stability of the replacement valve is compromised

Engineering Contradiction:

Improvesurgical procedure invasivenessVSAvoidvalve positioning accuracy

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

The stent is designed with pre-formed anchoring structures (barbs, hooks, or interlocking elements) that engage with the native valve annulus or surrounding tissue upon deployment. This preliminary design ensures stable positioning without requiring complex adjustment mechanisms during the procedure.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The stent is designed to expand and conform dynamically to the implantation site geometry, with flexible struts that adapt to the native valve annulus shape while maintaining radial force for stable positioning. The stent can expand from a compressed state within the catheter to a deployed state that engages with surrounding tissue.

Inventive Principle:

Principle #15Dynamics

5Reliability

If multiple surgeries are performed for failed valve replacement, then the need for re-operation is met, but tissue adherences from the first surgery increase the risks associated with subsequent surgeries

Engineering Contradiction:

Improvesurgical safetyVSAvoidtime between surgeries

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The hybrid biological-synthetic valve combines the immediate biocompatibility of biological tissue with the long-term durability of synthetic materials, potentially extending valve lifespan and reducing the frequency of re-operations, thereby avoiding tissue adhesion complications from multiple surgeries.

Inventive Principle:

Principle #40Composite materials

Data Source

PatentEP3492043B1A replacement valve

Publication Date: 2025.09.24 BOSTON SCI LTD

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AI summary

Stent-valves (e.g., single-stent-valves and double-stent-valves) and associated methods and systems for their delivery via minimally-invasive surgery are provided.