Heart Valve Delivery Sequence for Accurate Annulus Anchoring

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Solution Overview

Problem

Conventional heart valve replacement surgeries are invasive and require lengthy recovery periods, and minimally invasive procedures face challenges in accurately positioning prosthetic valves due to imaging system limitations and heart movement, leading to issues like valve migration and tilted landings.

Innovation Solution

A sutureless cardiac valve prosthesis with a radially expandable support frame and a delivery device that includes a control unit, track wires, and sheaths for precise deployment, utilizing shape-memory materials and flexible leaflets to anchor the valve securely in the heart.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional open heart surgery is used for valve replacement, then the valve can be securely implanted, but the procedure becomes highly invasive with lengthy recovery periods

Engineering Contradiction:

Improvevalve implantation securityVSAvoidinvasiveness and recovery time

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The procedure is divided into separate phases: delivery through catheter, positioning at target site, and deployment. The valve prosthesis is segmented into compressed delivery state and expanded functional state, allowing minimally invasive access while maintaining secure implantation capability

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve prosthesis is nested within a delivery catheter system, which itself is nested within the patient's vasculature. The compressed valve fits within the catheter lumen, enabling percutaneous delivery without open chest surgery, thereby reducing invasiveness while preserving implantation security

Inventive Principle:

Principle #7Nested doll (Nesting)

2Object-affected harmful factors

If minimally invasive catheter-based delivery is used, then invasiveness is reduced, but positioning precision deteriorates due to imaging limitations and heart movement

Engineering Contradiction:

ImproveinvasivenessVSAvoidvalve positioning accuracy

Core Design Contradiction:

Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The delivery system includes pre-positioned markers and alignment features on the valve prosthesis and delivery catheter. These preliminary positioning elements are deployed before final valve release, enabling accurate alignment at the target site despite heart movement and imaging limitations

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system employs radiopaque markers and contrast elements that change visibility or appearance under imaging systems. These markers provide visual feedback for positioning verification, allowing operators to confirm accurate valve placement within the narrow 2-5mm tolerance range

Inventive Principle:

Principle #32Color changes

3Device complexity

If standard imaging systems are used for positioning, then the procedure remains simple, but positioning precision is limited with 2mm error margin

Engineering Contradiction:

Improveimaging system complexityVSAvoidvalve positioning accuracy

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

Radiopaque markers and imaging reference elements serve as intermediaries between the valve prosthesis and the imaging system. These markers amplify the visibility of positioning information, allowing standard imaging systems to achieve enhanced positioning accuracy without requiring complex advanced imaging equipment

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system replaces reliance on operator judgment and complex imaging adjustments with mechanical positioning features built into the delivery system. Pre-configured alignment mechanisms and stoppers provide physical constraints that ensure accurate valve placement, substituting mechanical precision for imaging-based estimation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 accurate and secure placement of prosthetic valves with reduced invasiveness, minimizing migration and recovery time, and improving the precision of minimally invasive procedures.

Implementation Method 1

utilizing shape-memory materials and flexible leaflets to anchor the valve securely in the heart

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentUS20260020954A1Devices and methods for delivery of valve prostheses

Publication Date: 2026.01.22 JC MEDICAL INC

AI summary

A heart valve prosthesis can be delivered within a native heart valve annulus using a delivery system that encases the heart valve prosthesis and sequentially permits expansion of a valve clasper and a lattice frame of the valve prosthesis. A sheath of the delivery system can be proximally retracted to permit the sinus locator to expand. Thereafter, a tubular member can be actuated to permit expansion of the lattice frame. Further, a clasper pusher of the delivery system, coupled to the tubular member, can be used to release a proximal portion of the sinus locator after release of the lattice frame. The delivery system can enable sinus locator engagement within the native annulus, sandwiching native valve leaflets between the expanded lattice frame and sinus locator, and thereafter permit disengagement of the sinus locator from the clasper pusher after the lattice frame expands.