Expandable Interatrial Shunt with Anchoring Flange

Solution Overview

Problem

Current interatrial shunt devices for treating heart failure have limitations, including fixed diameters that fail to accommodate changing patient physiology, lack of adjustability, and limited clinical effectiveness over time, particularly for patients with elevated left atrial pressure.

Innovation Solution

The development of interatrial shunting systems with anchoring mechanisms, such as inflatable flanges, expandable structures, and adjustable shunting elements, which can be implanted between the left and right atria to facilitate blood flow and securely anchor within the septal wall, allowing for size adjustment based on individual patient needs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed diameter annular passage is used in percutaneous shunt devices, then the device structure is simple and easy to manufacture, but it fails to accommodate changing patient physiology and condition over time

Engineering Contradiction:

Improveadaptability to changing patient physiologyVSAvoiddevice structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The shunt device incorporates an expandable structure that transitions from a compressed delivery configuration to an expanded operational configuration. The shunt element includes an expandable portion with multiple struts that can be radially expanded using a balloon catheter, allowing the device to adapt its diameter to match the patient's anatomical requirements and changing physiology over time.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device enables changeable parameters by allowing the shunt element diameter to be adjusted from a fixed value to a variable value. The expandable structure permits the diameter to be modified post-implantation through balloon inflation, and the device can be adjusted to different diameters (e.g., 6mm, 8mm, 10mm) to accommodate varying patient needs and physiological changes.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If a single size shunt device is used, then the device is easier to manufacture and deploy, but it may not work well for all patients with different anatomical requirements

Engineering Contradiction:

Improvesize adjustability for different patientsVSAvoidmanufacturing complexity

Core Design Contradiction:

Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The shunt device incorporates an expandable structure that transitions from a compressed delivery configuration to an expanded operational configuration. The shunt element includes an expandable portion with multiple struts that can be radially expanded using a balloon catheter, allowing the device to adapt its diameter to match the patient's anatomical requirements and changing physiology over time.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device enables changeable parameters by allowing the shunt element diameter to be adjusted from a fixed value to a variable value. The expandable structure permits the diameter to be modified post-implantation through balloon inflation, and the device can be adjusted to different diameters (e.g., 6mm, 8mm, 10mm) to accommodate varying patient needs and physiological changes.

Inventive Principle:

Principle #35Parameter changes

3Productivity

If the shunt diameter is increased to improve blood flow, then the shunting effect is enhanced, but the risk of device dislodgement or instability increases

Engineering Contradiction:

Improveshunting effectivenessVSAvoiddevice stability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The shunt element is divided into multiple segments or struts that form a mesh-like structure. This segmentation allows the device to achieve a large overall diameter for effective shunting while maintaining flexibility and stability through the distributed strut configuration. The segmented structure can expand to provide adequate shunt area while anchoring securely in the septal wall.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device incorporates different structural characteristics in different portions. The shunt element has an expandable portion with multiple struts for achieving large diameter and effective shunting, while other portions may have different structural properties for stability and anchoring. The flange portion provides local stability against the septal wall while the expandable portion provides the necessary shunt capacity.

Inventive Principle:

Principle #3Local quality

4Reliability

If percutaneous shunt devices are used to reduce left atrial pressure, then the clinical effect is initially effective, but the shunt typically closes or reduces in size over time

Engineering Contradiction:

Improvedurability of shunt effectVSAvoidduration of shunt effectiveness

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The shunt device incorporates an expandable structure that transitions from a compressed delivery configuration to an expanded operational configuration. The shunt element includes an expandable portion with multiple struts that can be radially expanded using a balloon catheter, allowing the device to adapt its diameter to match the patient's anatomical requirements and changing physiology over time.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device enables changeable parameters by allowing the shunt element diameter to be adjusted from a fixed value to a variable value. The expandable structure permits the diameter to be modified post-implantation through balloon inflation, and the device can be adjusted to different diameters (e.g., 6mm, 8mm, 10mm) to accommodate varying patient needs and physiological changes.

Inventive Principle:

Principle #35Parameter changes

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

These systems provide a more effective and durable solution for managing elevated left atrial pressure by allowing for perioperative or post-implant size selection and adjustment, improving clinical outcomes and extending the therapeutic effect beyond the limitations of existing devices.

Implementation Method 1

an inflatable flange configured to be expanded to a expanded configuration, wherein the expanded inflatable flange secures the shunting element to the septal wall

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

an expandable structure configured to transform from a compressed configuration to an expanded configuration, wherein the expanded expandable structure secures the shunting element to the septal wall

Methodology Applied

Scientific EffectElastic Recovery: Elastic Recovery

Data Source

PatentUS20230042011A1Interatrial shunts with anchoring mechanisms and associated systems and methods

Publication Date: 2023.02.09 SHIFAMED HLDG LLC

AI summary

The present technology relates to interatrial shunting systems and methods. In some embodiments, the present technology includes interatrial shunting systems that include a shunting element having a lumen extending therethrough that is configured to fluidly couple the left atrium and the right atrium when the shunting element is implanted in a patient. The system can also include an anchoring mechanism coupled to the shunting element and configured to secure the shunting element within the patients heart.