Modular Percutaneous Valve Assembly with Pivot Points
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Solution Overview
Problem
Current artificial percutaneous prosthetic valves are bulky, making them difficult to deliver through small vessels and increasing the risk of vascular complications due to their large diameter and inflexibility, which also compromises the durability of the valve leaflets.
Innovation Solution
A modular percutaneous valve device comprising a valve module with a valve frame and a support module that can be assembled in situ, allowing for a smaller delivery diameter and improved flexibility, with features like pivot point connections and locking mechanisms to facilitate folding and assembly, reducing the need for thin materials and minimizing crimping damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current artificial percutaneous prosthetic valves are used, then valve function is restored, but the device is extremely bulky requiring large diameter catheters
Solution Approach 1:
The valve device is divided into multiple separate modules including a valve module with frame and leaflets, a support module with anchoring elements, and a delivery catheter. These modules are assembled in situ within the body lumen after delivery, allowing each component to be optimized independently and reducing the overall delivery diameter compared to pre-assembled bulkier designs.
2Volume of moving object
If the valve device is compressed for delivery, then delivery diameter is reduced, but the valve leaflet durability is compromised
Solution Approach 1:
The valve module is separated from the support module, allowing the valve leaflets to be delivered in a more protected configuration within the catheter while the support module provides structural integrity. This segmentation reduces the need for extreme compression of the leaflet material itself.
Solution Approach 2:
The valve module is pre-assembled with its frame and leaflets in a configuration that protects the leaflets during delivery, and the support module is prepared separately with anchoring elements. This preliminary preparation allows for controlled assembly at the implantation site rather than forcing the entire device through extreme compression.
3Volume of moving object
If a large diameter catheter is used, then the bulky valve can be delivered, but vascular complications increase
Solution Approach 1:
By dividing the valve device into smaller modular components that can be delivered separately and assembled in situ, the delivery catheter diameter is reduced to a size that can navigate tortuous vessels and the aortic arch without causing vascular damage, embolization, or other complications associated with large-bore catheters.
Solution Approach 2:
The modular valve components are designed to be nested within the delivery catheter in a compact configuration, with the valve module and support module arranged to minimize the overall profile. This nesting allows percutaneous delivery through smaller gauge catheters that can safely navigate the vascular system.
4Ease of operation
If the valve device is made flexible for delivery, then delivery through curved vessels is improved, but structural support is reduced
Solution Approach 1:
The device is segmented into a flexible valve module for navigation and a rigid support module for structural function. The valve module with its frame and leaflets can be flexed within the delivery catheter to navigate curved vessels, while the support module with its anchoring elements provides the necessary structural support once deployed and assembled.
Solution Approach 2:
The device transitions from a flexible, compressed state during delivery to a rigid, expanded state after deployment. The valve module can be flexed during delivery but expands to provide structural support when deployed, and the support module is designed to engage with the vessel wall to provide stable anchoring and structural integrity.
Data Source
Figure 1~2
Figure 3A~3B
Figure 4A~4B
AI summary
The invention provides a multi-component (modular) percutaneous valve device that includes a valve module having valve leaflets and a valve frame. The valve frame includes one or more, for example two, ring members and a plurality of masts. Also provided is a valve frame having specially designed pivot points at the connection between masts and first and second ring members to assist folding the valve module and minimizing delivery diameter. The valve frame may also include wire guides to facilitate combining the valve module with a support module. The masts or a ring of the valve frame may also include locking members, such as shafts for closing the valve module and securing the valve module to the support module. The support module includes corresponding locking members, such as spears that align with the shafts on the valve module for assembly and locking the valve module to the support module.