Heart Valve Folding Device for Accurate Delivery
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Solution Overview
Problem
Current methods for implanting heart valve prostheses are complex and time-consuming due to limited access and view during surgery, especially when using shape memory valves, which require cumbersome holders that obstruct the surgeon's view and are not adapted for valves with these characteristics.
Innovation Solution
A folding device and valve delivery system that includes a receptacle, handle, and retainer ring to assist in sizing, folding, holding, transferring, and delivering heart valve prostheses, allowing for consistent and accurate placement by reducing the size of the valve for delivery and using a handle to release it at the target site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional valve holders are used to position the valve during surgery, then the valve can be held and positioned, but the holder becomes large and cumbersome and obstructs the surgeon's view
Solution Approach 1:
The folding device is inserted within the valve delivery system, and the folded valve is nested within the folding device. This nested configuration allows the entire assembly to be delivered through a small aortic slit while maintaining valve positioning capability, eliminating the need for large external holders that obstruct the surgeon's view.
Solution Approach 2:
The valve is folded from its traditional three-dimensional expanded configuration into a compressed, compact form that can be delivered through a small incision. This dimensional transformation allows the valve to be positioned accurately without requiring large holding devices, thus improving the surgeon's visibility while maintaining positioning reliability.
2Device complexity
If the valve is folded to reduce size for delivery, then the delivery complexity is reduced, but consistent and accurate folding and delivery to the target site becomes challenging
Solution Approach 1:
The folding device is pre-configured with specific geometric features and constraints that guide the valve into the correct folded configuration before delivery. This preliminary folding action ensures that when the valve is compressed, it maintains a consistent and accurate shape that will properly expand at the target site, eliminating the need for complex manual folding procedures during surgery.
Solution Approach 2:
The folding device acts as an intermediary tool between the valve and the delivery system. It provides a controlled environment for folding the valve with precise geometric constraints, ensuring consistent folding accuracy. The folding device then serves as the mediator that transfers the folded valve to the delivery system for accurate placement at the target site.
3Productivity
If shape memory valves are used to simplify implantation, then the valve can be folded and re-expanded, but existing holders are not adapted for valves with shape memory characteristics
Solution Approach 1:
The folding device and delivery system are designed with universal adaptability to accommodate valves with shape memory characteristics. The device can hold the valve in a folded state during delivery and then release it to allow spontaneous expansion via shape memory effect. This multi-functional design eliminates the need for specialized holders for each valve type, enabling fast implantation while maintaining compatibility with shape memory materials.
Solution Approach 2:
The system exploits the parameter changes inherent in shape memory materials - specifically the temperature-dependent phase transformation that causes the valve to return to its original expanded configuration. The folding device is designed to maintain the valve in a constrained state during delivery, then release the constraints at the target site, allowing the shape memory effect to automatically expand the valve without requiring complex holding mechanisms.
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 system simplifies the implantation process by reducing the size of the valve for delivery, ensuring faster and more accurate placement, thereby minimizing surgery time and heart-lung bypass duration, and allowing for consistent folding and positioning of shape memory valves.
Implementation Method 1
The folding device is compressed to a reduced size to fit within the catheter
Implementation Method 2
New stented biological valves made from flexible material or from materials that exhibit shape memory characteristics promise less complicated and faster valve implant procedures
Data Source
AI summary
A folding device used to fold a cardiac valve is disclosed. Also shown are methods and system for holding and delivering a cardiac valve during implantation. The folding device facilitates folding either a stented or unstented prosthetic valve prior to insertion into a valve annulus. A delivery system is provided to allow a user to measure the patient annulus to select the prosthetic valve size and insert a folded prosthetic valve into a target site. Methods for using the folding device and delivery system are also disclosed.