Transcatheter Vena Cava Stent with Flap Valves for Tricuspid Insufficiency
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Solution Overview
Problem
Current treatments for tricuspid regurgitation, such as open heart surgery and medication, are either risky or ineffective, leaving many patients with significant tricuspid insufficiency untreated due to high mortality and morbidity rates associated with surgical interventions and inadequate management of the condition.
Innovation Solution
A tricuspid insufficiency treatment device featuring a tubular member with expandable stent and multiple valves configured for implantation within the vena cava, where each valve has a blocking member that opens and closes to manage blood flow during ventricular systole and diastole, preventing backflow and improving cardiac function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed for tricuspid valve replacement/repair, then the tricuspid insufficiency can be treated, but the mortality and morbidity rates are high
Solution Approach 1:
The patent replaces the mechanical open heart surgery approach with a transcatheter implantable device that uses a self-expanding stent and flap valves to treat tricuspid regurgitation. The device is deployed through catheter-based insertion via the vena cava, eliminating the need for open heart surgery while achieving effective valve replacement/repair through the implanted prosthesis.
Solution Approach 2:
The patent introduces an intermediary device (the implantable valve replacement prosthesis with stent and flap valves) that mediates between the diseased tricuspid valve and the venous system. This intermediary device is inserted through the vena cava and functions as a replacement valve, avoiding direct surgical intervention on the heart while still achieving therapeutic effect.
2Ease of operation
If medication is used to treat tricuspid regurgitation, then the treatment is less invasive, but the disease progresses and quality of life deteriorates
Solution Approach 1:
The patent employs dynamic flap valves that can open and close automatically in response to pressure differential changes during the cardiac cycle. The flaps are hinged to the stent structure and respond dynamically to blood flow conditions, providing adaptive valve function that maintains effectiveness throughout the cardiac cycle without requiring active control or medication adjustment.
Solution Approach 2:
The implantable valve device is designed to be self-regulating through its passive flap valve mechanism that automatically responds to hemodynamic conditions. The flaps open when pressure differential favors forward flow and close when pressure differential reverses, providing autonomous valve function without requiring external control systems or medication.
3Reliability
If a tubular member with multiple valves is implanted in the vena cava, then blood flow can be managed during ventricular systole and diastole, but the device complexity increases
Solution Approach 1:
The patent divides the valve function into multiple independent flap valves arranged circumferentially around the tubular stent member. Each flap valve operates independently to control blood flow at its specific location, allowing synchronized operation across multiple valves while maintaining simple individual valve structures. This segmentation enables effective blood flow control without requiring complex integrated mechanisms.
Solution Approach 2:
The patent employs thin, flexible flap valves made from biocompatible materials that can passively respond to pressure differential changes. These thin-film flaps are hinged to the stent and provide effective sealing and flow control through their flexible nature, avoiding the need for complex rigid mechanisms while achieving reliable blood flow management during cardiac cycle.
Data Source
AI summary
Embodiments of the present disclosure are directed to devices and methods for treating tricuspid valve insufficiency. For example, in some embodiments, a tricuspid insufficiency treatment device is provided, and includes a tubular member configured for implantation within a vena cava of a patient, where the tubular member is formed with a sidewall. The device also includes at least two (2) valves arranged circumferentially along the sidewall, where each valve comprises an opening formed in the sidewall, and a blocking member arranged to block and unblock a respective opening of the plurality of openings. Each blocking member comprises a flap or cover pivotally attached at or proximate a portion of a respective opening and arranged to block and unblock the opening during ventricular systole and ventricular diastole, respectively, such that the opening is unblocked in a direction opposite to the attachment of the flap or cover. The at least two valves are arranged along a first circumference at a first location between the ends of the tubular member.