Adjustable Tensioning System for Mitral Valve Delivery
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Solution Overview
Problem
The growth of transcatheter mitral valve therapies is hindered by the complexity of mitral valve anatomy and physiology, leading to stresses and strains on delivery systems due to tortuous anatomical pathways, which affect the concordance between control mechanisms and the distal effectors, making precise implant expansion and positioning challenging.
Innovation Solution
An adjustable radial tensioning system and steering mechanisms are integrated into the delivery system to control implant expansion and positioning, featuring a rotor/stator assembly with tensioning members that maintain the implant in a collapsed configuration and facilitate expansion at the target location, along with steering assemblies for precise navigation and orientation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the delivery system navigates through tortuous anatomical pathways to reach the target location, then the implant can be delivered to the mitral valve, but stresses and strains on the delivery system affect the concordance between control mechanisms and distal effectors
Solution Approach 1:
The delivery system is divided into multiple segments including a catheter body, drive shaft, rotors, and tensioning members. Each segment performs a specific function: the catheter navigates the pathway, the drive shaft transmits rotational motion, the rotors convert rotation to linear tension, and the tensioning members directly control the implant. This segmentation allows each component to be optimized for its specific function while reducing the cumulative complexity of the entire system.
Solution Approach 2:
The patent introduces intermediate mechanisms between the proximal control and distal effector: the drive shaft acts as an intermediary to transmit rotational motion from the operator's hand to the rotors, while the rotors themselves serve as intermediaries that convert rotational input into linear tension output. These intermediaries decouple the control mechanism from the effector, allowing independent optimization and reducing the direct complexity of the control-pathway-effector linkage.
2Reliability
If tensioning members are contained within the distal region of the delivery system, then stretching or slippage over long distances is prevented, but the system requires more complex local structures at the distal end
Solution Approach 1:
The tensioning members are extracted from the long-distance transmission path and repositioned to be contained within the distal region of the delivery system, specifically within the implant delivery body. This extraction eliminates the stretching and slippage problems that would occur over long distances while concentrating the necessary structural complexity only where it is needed for reliable tensioning, rather than distributing complexity throughout the entire delivery system.
3Measurement precision
If steering mechanisms are added to facilitate final positioning and orientation of the implant, then positioning accuracy is improved, but the device complexity increases
Solution Approach 1:
The steering mechanisms are designed to be dynamically adjustable during the delivery procedure. The system allows for real-time modification of the catheter's orientation and position through adjustable steering components, enabling precise positioning without requiring a permanently complex rigid structure. The dynamic nature of the steering mechanisms allows them to adapt to anatomical variations while maintaining relatively simple baseline 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
The solution enables precise control over implant expansion and positioning, reducing stresses on the delivery system and improving the concordance between control mechanisms and effectors, thereby enhancing the accuracy and efficacy of transcatheter mitral valve therapies.
Implementation Method 1
The first rotor comprises at least one tension line attachment site, and the first tensioning member may be further wound around the first rotor, and may be wound around the first rotor at least three times
Data Source
AI summary
Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.