Prosthetic Heart Valve Dual-Frame Coupling for Collapsible Delivery
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Solution Overview
Problem
Current prosthetic heart valves face limitations in collapsibility and expandability, which restricts their size reduction for minimally invasive delivery and increases periprocedural complications due to material volume, strength, and shape constraints.
Innovation Solution
A collapsible and expandable prosthetic heart valve design featuring a dual-frame structure with outer and inner frames, each composed of nickel-titanium alloy, where the outer frame includes atrial and ventricular portions with diamond-shaped cells and coupling arms, and the inner frame has diamond-shaped cells and commissure windows to support prosthetic leaflets, allowing for symmetric collapse and expansion to accommodate different patient anatomies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the implant is collapsed to a smaller size for minimally invasive delivery, then the access site size is minimized and periprocedural complications are reduced, but the material volume, strength, and shape constraints limit the degree of collapse
Solution Approach 1:
The implant is divided into multiple segments including an outer frame with atrial and ventricular portions, an inner frame, and multiple coupling arms. This segmentation allows each component to be optimized independently for collapse while maintaining overall structural strength during delivery and deployment
Solution Approach 2:
The inner frame is positioned within the outer frame, and the coupling arms connect the two frames. This nested configuration allows the implant to collapse to a smaller size for delivery while maintaining the necessary material volume and strength for proper function after deployment
2Ease of operation
If the implant is collapsed to a smaller size, then less invasive delivery is enabled, but the number of potential periprocedural complications increases due to material constraints
Solution Approach 1:
The implant is designed to be dynamically collapsible and expandable through the coordinated action of the outer frame, inner frame, and coupling arms. This dynamic capability enables minimally invasive delivery while maintaining reliability by ensuring the structure can properly expand and stabilize after deployment
Solution Approach 2:
The implant undergoes parameter changes from a collapsed state during delivery to an expanded state during deployment. The dual-frame structure with coupling arms controls these parameter changes to minimize complications while enabling less invasive delivery approaches
3Adaptability or versatility
If a dual-frame structure with multiple coupling arms is used, then the implant can be collapsed and expanded more effectively, but the device complexity increases
Solution Approach 1:
The complex dual-frame structure is segmented into modular components (outer frame, inner frame, coupling arms) that can be manufactured and assembled separately. This segmentation manages device complexity while maintaining the adaptability needed for effective collapse and expansion
Solution Approach 2:
The nested configuration of the inner frame within the outer frame, connected by coupling arms, provides an organized structure that manages complexity. This arrangement allows the implant to achieve versatile collapse and expansion capabilities while maintaining a manageable device architecture
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
This design enables a more durable and flexible prosthetic heart valve that can be effectively collapsed for minimally invasive delivery and expanded for proper function, reducing complications and strain during deployment and operation.
Implementation Method 1
A collapsible and expandable prosthetic heart valve design featuring a dual-frame structure with outer and inner frames, each composed of nickel-titanium alloy
Implementation Method 2
allowing for symmetric collapse and expansion to accommodate different patient anatomies
Data Source
AI summary
A prosthetic heart valve includes collapsible and expandable inner and outer frames. The outer frame engages native heart valve annulus tissue, with an atrial portion, a ventricle portion, and a narrowed waist portion between the two. The inner frame is positioned radially inward of the outer frame. The outer frame includes a plurality of outer coupling arms having a first end coupled to the outer frame and a second free end, and the inner frame includes a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end. A prosthetic valve assembly is disposed within the inner frame. The first end of the inner and outer coupling arms each include two struts. The coupling arms extend toward each other and the second free ends of the coupling arms are coupled to each other to couple the outer frame to the inner frame.