Interwoven Heart Valve Frame with Integral Hinges
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Solution Overview
Problem
Current frame assembly designs for implantable prosthetic devices, such as prosthetic heart valves, require complex manufacturing processes involving many small parts, which complicates assembly and increases costs. Additionally, these designs often struggle with minimizing the number of individual parts, maintaining flexibility, collapsing to a low profile for minimally invasive introduction, and reducing the risk of rivet embolization.
Innovation Solution
The proposed solution involves an implantable medical device with a radially expandable and compressible annular frame formed by interweaving a first set of inner struts with a second set of outer struts in a plain weave pattern. Each strut is pivotally connected, allowing the frame to be radially compressed and expanded. The method of assembly includes using strut connectors with projections that extend through apertures in the struts to form pivot joints, reducing the number of parts and simplifying the assembly process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If current frame assembly designs are used, then the structural strength is maintained, but the number of individual parts increases and assembly complexity increases
Solution Approach 1:
The patent integrates multiple frame components into a unified structure where the delivery catheter and frame assembly become a single integrated device. The frame is designed as a cohesive unit with interconnected struts and joints that function together, eliminating the need for separate assembly of multiple independent parts during implantation.
Solution Approach 2:
The frame design incorporates multi-functional elements where single components serve multiple purposes. The struts provide both structural support and mechanical linkage, the joints enable both articulation and force transmission, and the overall assembly serves both delivery and deployment functions, reducing the total number of specialized parts needed.
2Adaptability or versatility
If the frame is designed with multiple small parts, then the structural flexibility is improved, but the manufacturing process complexity increases
Solution Approach 1:
The frame is divided into modular segments connected by articulated joints, allowing independent movement and flexibility within each segment while maintaining overall structural integrity. This segmentation enables the frame to adapt to anatomical variations and provide controlled movement during implantation without requiring complex manufacturing of monolithic structures.
Solution Approach 2:
The frame incorporates dynamic joints and articulated connections that allow controlled movement and adaptation during implantation. These dynamic elements enable the structure to transition between different configurations (compressed for delivery, expanded for function) while being manufactured as integrated components rather than assembled from multiple rigid parts.
3Volume of moving object
If the frame is designed to collapse to low profile, then the minimally invasive introduction is enabled, but the structural stability during operation may be compromised
Solution Approach 1:
The frame is designed to collapse into a compact, nested configuration for delivery through catheters, with struts and components folding or compressing into a low-profile state. Upon deployment, the frame expands outward to achieve its full functional dimensions and structural stability, transitioning from a compressed delivery state to an expanded operational state.
Solution Approach 2:
The frame utilizes materials and structural designs that allow dramatic changes in physical parameters between delivery and operational states. The structure transitions from a compressed, low-volume configuration during catheter introduction to an expanded, high-stability configuration during operation, with the ability to maintain both states as needed for different phases of implantation.
4Reliability
If traditional assembly methods with many parts are used, then the structural integrity is maintained, but the risk of rivet embolization increases
Solution Approach 1:
The design eliminates rivets and separate fastening components from the frame assembly, removing the source of potential embolization risk. The frame components are integrated through continuous structures, welded joints, or interference-fit connections that do not require removable fasteners, thereby extracting the harmful element (rivets) from the system while maintaining structural integrity through alternative connection methods.
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 minimizes the number of individual parts, enhances flexibility, allows for a low-profile collapse for minimally invasive procedures, and reduces the risk of rivet embolization, thereby improving the manufacturing efficiency and safety of implantable prosthetic devices.
Implementation Method 1
Each first strut is pivotally connected to at least one second strut
Data Source
Figure 1
Figure 2
Figure 3A~5
AI summary
In one embodiment, a prosthetic valve can comprise a radially expandable and compressible frame, which can include a plurality of struts which are pivotally joined together without requiring individual rivets. In some embodiments, the struts are interwoven, and can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In another embodiment, the frame comprises a plurality of inner struts and outer struts which are connected by a plurality of chains of interconnected rivets, avoiding the need to provide individual rivets at each junction between struts. In still another embodiment, separate hinges are provided to interconnect the struts. In still another embodiment, separate flanged rivets are provided to connect the struts.