Retrievable Interatrial Shunt with Cinching Cord

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Solution Overview

Problem

Existing interatrial shunt devices lack effective in vivo adjustment and retrieval mechanisms, particularly for stents with flared ends, which limits their functionality in treating conditions like heart failure and pulmonary arterial hypertension.

Innovation Solution

A retrievable apparatus with a catheter and stent system that transitions between contracted and expanded states, featuring a cinching tube and cord for adjustable flow control and a biocompatible material for tissue protection, allowing for temporary and adjustable shunting across the atrial septum.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If existing interatrial shunt devices are used, then blood flow redistribution is achieved, but in vivo adjustment and retrieval mechanisms are lacking

Engineering Contradiction:

Improvein vivo adjustment capabilityVSAvoiddevice structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The stent incorporates a cinching mechanism with a cord that allows dynamic adjustment of the stent diameter in vivo. By pulling the cord through the delivery catheter, the stent can be cinched down to reduce its diameter and blood flow, or released to return to its expanded state, enabling real-time hemodynamic optimization without requiring device replacement

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device is divided into separable components: the stent portion with flared ends, the delivery catheter system, and the cinching mechanism. This segmentation allows the stent to be deployed independently while maintaining the ability to retrieve or adjust it through the catheter system, providing both functionality and control

Inventive Principle:

Principle #1Segmentation

2Reliability

If stents with flared ends are used, then anchoring and blood flow distribution are improved, but retrieval mechanisms are limited

Engineering Contradiction:

Improveanchoring stabilityVSAvoidretrieval capability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The stent transitions from a static structure to a dynamically adjustable one through the cinching mechanism. The flared ends provide stable anchoring when expanded, while the cinching cord allows the stent to be compressed back into a deliverable configuration for retrieval, combining secure placement with easy removal

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The stent with flared ends can be nested within the delivery catheter when cinched down. The flared portions that extend beyond the catheter during deployment can be recaptured by advancing the catheter over the stent after cinching, enabling complete retrieval without leaving foreign material in the body

Inventive Principle:

Principle #7Nested doll (Nesting)

3Stress or pressure

If shunting is performed to relieve atrial pressure, then acute relief is achieved, but precise flow control is limited

Engineering Contradiction:

Improveatrial pressure reliefVSAvoidflow adjustment precision

Core Design Contradiction:

Stress or pressureVSEase of operation

Solution Approach 1:

The cinching mechanism provides continuous feedback control of blood flow through the stent. By incrementally pulling the cord and observing hemodynamic response, clinicians can titrate the stent diameter to achieve optimal pressure relief and flow distribution, adjusting in real-time based on patient response

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The stent diameter is dynamically controllable through the cord tension mechanism. This allows precise modulation of the orifice size and corresponding blood flow, enabling fine-tuned pressure management rather than fixed-flow shunting

Inventive Principle:

Principle #15Dynamics

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 precise adjustment and retrieval of the shunt device, providing acute relief for excess atrial pressure and facilitating optimal blood flow, thereby improving treatment outcomes for heart failure and pulmonary arterial hypertension.

Implementation Method 1

movement of the first and second ends of the cinching cord relative to the cinching tube changes the tension in the cinching cord that is looped around the neck region of the stent. moving the first and second ends of the cinching cord proximally relative to the cinching tube causes the loop around the neck region of the stent to tighten, thereby causing the neck region of the stent to transition from the expanded deployed state to a more contracted state

Methodology Applied

Scientific EffectCompression: Compression

Implementation Method 2

shunting blood across the atrial septum via the stent between the atria responsive to a pressure differential across the atrial septum

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentUS20220387009A1Systems and methods for temporary shunting between heart chambers

Publication Date: 2022.12.08 WAVE LTD V

AI summary

The inventive device may include a delivery catheter that remains coupled to an expandable stent portion having an hourglass or “diabolo” shape. The temporary stent device is configured to lodge the shunt portion securely in the atrial septum, preferably the fossa ovalis, to function as an interatrial shunt, allowing blood flow between the left atrium to the right atrium responsive to a pressure differential across the atrial septum. Upon completion of the treatment, a delivery sheath may be used in conjunction with cinching cord coupled to the stent portion to retrieve and remove the temporary shunt device from the patient.