Adjustable Heart-Chamber Passage Device with Deformable Anchoring Ends
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Solution Overview
Problem
Existing shunt devices for treating heart conditions like heart failure and pulmonary arterial hypertension lack the ability to adjust the size of the passage in situ to accommodate various sized catheterization tools and maintain luminal patency for extended periods, and do not effectively anchor within tissue geometries.
Innovation Solution
An adjustable passage device with expandable end regions and a plastically deformable middle region, allowing for in situ adjustment of passage diameter and angles to secure anchoring within heart walls, and accommodate various clinical procedures and tools.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixed-size shunt device is implanted, then the device structure is simple and manufacturing is easy, but the passage diameter cannot be adjusted to accommodate various sized catheterization tools
Solution Approach 1:
The shunt device incorporates an expandable middle region that can dynamically change its diameter from a compressed delivery state to an expanded deployed state. This dynamic structure allows the passage diameter to be adjusted in situ to accommodate various sized catheterization tools while maintaining a relatively simple overall device structure that can be delivered percutaneously.
Solution Approach 2:
The device utilizes plastically deformable material in the middle region that allows permanent deformation from a smaller initial diameter to a larger final diameter. This parameter change enables the passage to be sized appropriately for different clinical procedures without requiring complex adjustable mechanisms.
2Reliability
If a shunt device is implanted to treat heart failure, then blood flow redistribution is achieved, but the device cannot maintain luminal patency for extended periods
Solution Approach 1:
The shunt device is divided into three distinct regions: a first end region, a middle region, and a second end region. Each region serves a specific function - the end regions provide anchoring while the middle region maintains luminal patency. This segmentation allows the middle region to be optimized specifically for maintaining open passage over extended periods.
Solution Approach 2:
The device employs different materials with distinct properties for different regions. The middle region uses plastically deformable material that maintains its deformed shape to keep the passage open, while the end regions use materials suitable for anchoring. This composite approach ensures long-term luminal patency while securing the device in place.
3Adaptability or versatility
If a shunt device is implanted to redistribute blood flow, then treatment of heart conditions is achieved, but the device cannot accommodate different surgical tools
Solution Approach 1:
The middle region of the device can be expanded to different diameters to accommodate various sized catheterization tools and surgical instruments. This dynamic sizing capability allows different surgical tools to pass through the shunt during clinical procedures without requiring multiple devices of different fixed sizes.
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
The device provides durable luminal patency and secure anchoring, enabling precise control of blood flow rates and accommodating different surgical tools, thus improving treatment efficacy for heart conditions.
Implementation Method 1
a middle region having first and second ends, a lumen extending therethrough, and a longitudinal axis aligned with the lumen... The middle region may be adjusted from a first state having a first diameter to a second state having a second diameter different from the first diameter... The middle region may be formed of a plastically deformable material
Data Source
AI summary
A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.


