Steerable Coaptation Implant for Precise Tricuspid Valve Alignment
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Solution Overview
Problem
Existing medical devices for treating tricuspid regurgitation (TR) either remodel fragile tissue or insert devices that risk causing new TR, lacking precise positioning and effective coaptation.
Innovation Solution
A self-expanding anchoring stent with a coaptation sail, delivered via a percutaneous system, allows multi-directional positioning and alignment with native leaflets, using a steering tube and adjustable coupler to ensure optimal coaptation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mechanical solution is used to remodel the TV annulus shape and size to force the leaflets closer together, then coaptation is improved, but the risk to fragile tissue increases
Solution Approach 1:
The patent introduces a coaptation device as an intermediary element between the native leaflets and the annulus. This device has a distal end that contacts the leaflets and a proximal end that contacts the annulus, serving as a mediator to achieve leaflet coaptation without directly forcing the fragile leaflet tissue together, thereby reducing mechanical stress on the native tissue while maintaining coaptation effectiveness.
2Reliability
If a device is inserted to close the gap and prevent TR via coaptation with native leaflets, then TR reduction is achieved, but the risk of causing new TR increases
Solution Approach 1:
The coaptation device incorporates a steerable shaft with multiple degrees of freedom that allows dynamic adjustment of the device's orientation and positioning after implantation. The steering mechanism enables the operator to fine-tune the device's angle and position to achieve optimal leaflet contact, ensuring that the device adapts to the patient's specific anatomy rather than forcing a fixed configuration, thereby preventing new TR while maintaining effective gap closure.
Solution Approach 2:
The device features a specifically designed distal end with a contact surface that is tailored to match the local geometry of the native leaflets. This localized adaptation ensures that the coaptation force is distributed appropriately across the leaflet tissue, preventing focal stress concentrations that could cause new TR while maintaining effective gap closure at the specific location where it is needed.
3Measurement precision
If the coaptation device is designed with multi-directional positioning capability, then positioning precision is improved, but device complexity increases
Solution Approach 1:
The device is divided into distinct functional segments: a proximal shaft portion, a distal shaft portion, and a separate steerable section with multiple degrees of freedom. This segmentation allows each portion to be optimized for its specific function while simplifying the overall control mechanism. The modular design enables independent adjustment of each segment, achieving high positioning precision without requiring a monolithically complex system.
Data Source
AI summary
An implantable prosthesis and delivery' system for treating tricuspid valve regurgitation (TVR). The system is configured for pre-loading into a percutaneous delivery 7 system. The system includes a self-expanding anchoring stem with an attached and positionable coaptation member. The stem is implanted in the inferior vena cava proximate the right atrium and is connected to the coaptation member with a. steering tube and a multi-directional coupler and gimbal assembly. The coaptation member is fabricated from a porous or semi-porous material formed over a wire frame and is configured, possibly with leaflet matching curvature, before implantation. When deployed, the coaptation member self-aligns, self-inflates, and takes shape over several cardiac cycles to conform to the patient's TV defects and to provide coaptation surfaces for native leaflets to reduce TVR.