Adjustable Heart-Chamber Passage 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 clinical procedures and tools, and do not effectively anchor within the tissue.
Innovation Solution
An adjustable passage device with expandable end regions and a plastically deformable middle region, allowing for in situ adjustment of passage diameters and angles to securely anchor within the heart wall, and accommodate different sized catheterization tools and medical devices.
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 size cannot be adjusted to accommodate various sized clinical procedures and tools
Solution Approach 1:
The shunt device incorporates an adjustable passage structure that can dynamically change its opening size from a first diameter to a second diameter. The passage includes a movable wall or expandable framework that allows in situ adjustment of the lumen size to accommodate different clinical procedure requirements while maintaining a relatively simple overall device architecture.
Solution Approach 2:
The device enables change of the passage diameter parameter from an initial state to an adjusted state through mechanical actuation. This parameter change allows the same device to serve multiple procedural needs with different tool size requirements without requiring multiple fixed-size devices.
2Reliability
If a shunt device is implanted to treat heart failure, then blood flow redistribution is achieved, but the device does not securely anchor within the heart wall tissue
Solution Approach 1:
The shunt device is divided into distinct functional segments including an anchoring portion with protrusions or barbs designed to engage with heart wall tissue, a middle region containing the adjustable passage, and end regions for sealing against the chambers. This segmentation allows the anchoring function to be optimized independently while maintaining manufacturing feasibility.
Solution Approach 2:
The anchoring structures feature asymmetric geometries with protrusions or barbs oriented to engage tissue in a specific direction, providing secure unidirectional anchoring that prevents device migration while maintaining symmetry in the overall device layout for balanced blood flow distribution.
3Adaptability or versatility
If the passage diameter is increased to accommodate larger tools, then procedural versatility improves, but blood flow control precision decreases
Solution Approach 1:
The passage diameter can be dynamically adjusted between a first smaller diameter for precise blood flow control and a second larger diameter for accommodating bigger clinical tools. This dynamic adjustability allows optimization of both flow control precision and procedural versatility depending on the specific clinical need at different times.
Solution Approach 2:
The device provides partial adjustment of the passage diameter rather than full expansion, allowing the passage to be enlarged just enough to accommodate the required tool size while maintaining adequate blood flow control. This partial action approach balances tool accommodation with flow precision.
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 various clinical procedures by adjusting passage sizes and angles, thereby improving treatment efficacy for heart conditions.
Implementation Method 1
the first end region being selectively deformable such that selected portions of the first end region are expandable to different angles relative to the longitudinal axis. In addition, the second end region may be delivered in the second heart chamber in a compressed delivery state and transitioned to a deployed state therein, the second end region being selectively deformable such that selected portions of the second end region are expandable to different angles relative to the longitudinal axis.
Implementation Method 2
An adjustable passage device with expandable end regions and a plastically deformable middle region, allowing for in situ adjustment of passage diameters and angles to securely anchor within the heart wall, and accommodate different sized catheterization tools and medical devices.
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.