Dual-Frame Prosthetic Venous Valves for Transcatheter Deployment

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Solution Overview

Problem

Existing treatments for chronic venous insufficiency (CVI) do not effectively restore venous valve functionality and improve blood circulation from lower extremities to the heart, often requiring invasive procedures and are prone to thrombus formation.

Innovation Solution

A prosthetic venous valve assembly with a biocompatible, anti-thrombotic design, deployable via a minimally invasive transcatheter procedure, utilizing a dual or single valve frame with polymeric leaflets and a delivery catheter system for precise positioning and deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical treatments are used to treat chronic venous insufficiency, then symptom relief may be achieved, but the venous valve functionality is not restored and invasive procedures are required

Engineering Contradiction:

Improvevenous valve functionality restorationVSAvoidinvasiveness of procedure

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces traditional open surgical mechanical interventions with a transcatheter delivery system that deploys a prosthetic venous valve through a catheter. The valve is delivered percutaneously and deployed within the vein using a catheter-based mechanism, substituting the need for open surgical exposure and mechanical manipulation of the venous system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a catheter as an intermediary device to deliver the prosthetic venous valve to the target location within the vein. The catheter serves as a mediator that enables minimally invasive access to the deep venous system, allowing valve deployment without direct surgical exposure of the vein.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If traditional treatments are used, then some symptom relief may be achieved, but thrombus formation is prone to occur

Engineering Contradiction:

Improvethrombus formationVSAvoidsymptom relief effectiveness

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent changes the surface properties and material composition of the prosthetic valve and catheter system to reduce thrombogenicity. The device uses materials with modified surface characteristics that are less prone to inducing thrombus formation, and the design incorporates features that promote laminar flow and reduce stagnation zones where clots could form.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material construction for the prosthetic venous valve, combining materials with different properties to achieve both mechanical functionality and thromboresistance. The valve structure may incorporate biocompatible coatings and material combinations that reduce thrombus formation while maintaining valve performance.

Inventive Principle:

Principle #40Composite materials

3Measurement precision

If multiple separate procedures are performed to deploy individual valves, then each valve can be positioned precisely, but the treatment time and number of procedures increase

Engineering Contradiction:

Improvevalve positioning accuracyVSAvoidtreatment time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines multiple valve deployment capabilities into a single catheter system, allowing sequential deployment of multiple prosthetic valves through one continuous procedure. The catheter is designed with features that enable delivery and deployment of multiple valves without requiring withdrawal and reinsertion, merging what would traditionally be separate procedures into one continuous intervention.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent enables continuous deployment of multiple valves along the venous pathway without interrupting the procedural flow. The catheter system maintains continuous access to the venous system, allowing valves to be deployed sequentially at different locations while the catheter remains in place, eliminating the need for repeated punctures and insertions.

Inventive Principle:

Principle #20Continuity of useful action

Data Source

PatentUS20250275852A1Transcatheter Prosthetic Venous Valve Assemblies and Associated Catheter Delivery Systems and Methods

Publication Date: 2025.09.04 STRYKER CORP

AI summary

Single and dual frame prosthetic venous valve assemblies, and catheter delivery systems and methods, are disclosed. A representative dual frame venous valve assembly includes an outer valve frame having a lumen and a frame and venous valve assembly arranged within the lumen. The frame and venous valve assembly, which also may be a stand-alone prosthetic venous valve assembly, includes an inner valve frame having a frame matrix forming lateral valve supports and valve commissure supports; a polymeric frame coating encapsulating the frame matrix; and a one or more polymeric leaflets integrally formed with or coupled to the polymeric frame coating, with each leaflet moveable between an open or partially open state and a closed or partially closed state. A delivery catheter includes keys or slots for insertion of locking tabs of the outer valve frame, and a deployment control handle for controlling deployment of the venous valve assembly.