Implantable Shunt Conduit With Discrete Frames for Anatomical Conformability
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Solution Overview
Problem
Existing implantable medical devices for treating heart failure, such as heart shunts and occluders, face challenges in adaptability and efficacy, particularly in conforming to patient anatomy and maintaining fluid flow without causing thrombosis or erosion.
Innovation Solution
An implantable medical device with discrete frame components, including a conduit portion unsupported by frames, allows for conformability and fluid flow, featuring a membrane to prevent thrombosis and frame erosion, with adjustable tension for fluid regulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If catheter-based delivery systems are used to deliver occlusion devices to the heart, then minimally invasive delivery is achieved, but the devices become susceptible to damage from compression against bone structures and catheter manipulation
Solution Approach 1:
The occlusion device is nested within a delivery catheter system, allowing it to be transported through the vasculature in a protected state. The device is contained within the catheter lumen during delivery, shielding it from external mechanical damage while maintaining minimally invasive access.
Solution Approach 2:
The occlusion device incorporates shape memory alloy materials that allow it to dynamically change its structural state. The device transitions from a compressed delivery configuration to an expanded functional configuration upon reaching the target site, enabling it to withstand delivery stresses while maintaining structural integrity for its intended function.
2Reliability
If the occlusion device structure is made more robust to withstand delivery stresses, then device integrity during delivery is improved, but the ability to conform to irregular defect surfaces deteriorates
Solution Approach 1:
The occlusion device uses shape memory alloy materials that enable dynamic structural transformation. During delivery, the device maintains a robust compressed state for structural integrity, then transitions to an expanded conformable state at the target site to adapt to irregular defect surfaces, achieving both durability and adaptability through temporal structural changes.
Solution Approach 2:
The device exploits phase transition parameters of shape memory materials to change its mechanical properties. By controlling temperature and stress parameters, the device transitions between martensitic (soft, conformable) and austenitic (strong, rigid) phases, allowing it to be robust during delivery yet adaptable when deployed.
3Ease of operation
If self-expanding occlusion devices are used to simplify deployment, then ease of deployment is improved, but precise positioning and control during delivery deteriorate
Solution Approach 1:
The occlusion device is segmented into multiple expandable cells or struts that can be independently controlled during delivery. This segmentation allows the operator to maintain precise control over device positioning while preserving the self-expanding mechanism for simplified deployment at the target site.
Solution Approach 2:
The device incorporates controllable expansion mechanisms that allow it to transition from a compressed controlled state during delivery to a self-expanding state at deployment. Shape memory materials enable the device to remain dormant and controllable during navigation, then automatically expand when triggered, combining precise positioning with easy deployment.
Data Source
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AI summary
An implantable medical device comprising a first frame component. The first frame component including a first set of elongate elements configured to conform to an anatomy of a patient. The implantable medical device also comprising a second frame component including a second set of elongate elements configured to conform to an anatomy of a patient. The first frame component and the second frame component being discrete and separate from one another. The implantable medical device also comprising a conduit portion arranged between the first frame component and the second frame component. The conduit portion including a membrane connecting the first frame component and the second frame component.