Heart Valve Catheter Cartridge for Sequential Anchoring Release
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Solution Overview
Problem
Existing minimally invasive procedures for implanting prosthetic heart valves using self-expanding anchoring systems face challenges such as incorrect positioning, potential damage to the aortic vessel wall, and high risk of mortality due to unsatisfactory implantation or removal of non-functioning prostheses.
Innovation Solution
A catheter system with a flexible guide system and cartridge unit that allows for sequential release and expansion of anchoring support hoops, featuring a bendable region to navigate the aortic bend, and includes operating elements for controlled manipulation and a liquid coolant to maintain the anchoring support below the transition temperature, ensuring precise implantation and functionality check.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If self-expanding anchoring supports made from shape memory alloys are used to enable minimal invasion implantation, then the invasiveness of the procedure is reduced, but the risk of incorrect positioning and vessel wall damage increases
Solution Approach 1:
The patent applies preliminary action by providing a bendable region in advance along the guide system's longitudinal axis before the implantation procedure. This pre-configured bendable region allows the guide system to navigate the aortic bend smoothly, enabling the catheter to reach the correct implantation position without causing vessel wall damage, thus resolving the contradiction between minimal invasion and positioning accuracy.
Solution Approach 2:
The patent employs flexible shells by incorporating a bendable region constructed from flexible materials along the guide system. This flexible structure allows the catheter to conform to the aortic bend geometry, enabling smooth navigation through the vasculature while maintaining precise positioning capability, thereby reducing both invasiveness and positioning errors simultaneously.
2Ease of operation
If the anchoring support is designed to self-expand at body temperature using shape memory alloys, then the implantation process is simplified, but the control over expansion timing and positioning precision is reduced
Solution Approach 1:
The patent applies segmentation by dividing the anchoring support into multiple hoops that can be sequentially released and expanded. This segmented design allows controlled expansion at different stages, with the first hoop expanding to provide initial anchoring and the second hoop expanding subsequently to secure final positioning, thereby maintaining both operational simplicity and precise timing control.
Solution Approach 2:
The patent employs dynamics by designing the anchoring support with sequential expansion capability through controlled release mechanisms. The hoops are configured to expand in a specific sequence based on catheter manipulation, allowing dynamic control over expansion timing while maintaining the self-expanding property of the shape memory alloy, thus balancing ease of operation with precision control.
3Strength
If the guide system is made rigid to maintain structural integrity during insertion, then the strength and durability are improved, but the ability to navigate the aortic bend is reduced
Solution Approach 1:
The patent applies segmentation by dividing the guide system into multiple sections along its longitudinal axis, including a bendable region with adjustable curvature and rigid end portions. This segmented structure allows the middle section to flex and conform to the aortic bend while the end portions maintain structural integrity, thereby simultaneously achieving both navigability and strength.
Solution Approach 2:
The patent employs dynamics by designing the guide system with a bendable region that can dynamically adjust its curvature in response to the aortic anatomy. The bendable region can be actively manipulated to match the vessel's curvature during insertion, while the overall structural integrity is maintained through the rigid end portions and controlled flexibility of the intermediate section.
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
Reduces the risk of incorrect implantation and vessel damage by enabling precise positioning and functional verification of the prosthetic heart valve, allowing for safe retrieval if necessary, thus minimizing patient risk and improving procedural safety.
Implementation Method 1
a liquid coolant to maintain the anchoring support below the transition temperature
Implementation Method 2
self-expansion of such anchoring supports with a heart valve prosthesis attached to them is initiated, the intended result being a reliable anchoring and exact positioning of the heart valve prosthesis. Such anchoring supports have tended to be made from shape memory alloys, such as 'Nitinol' for example, and the alloy is selected so that its transition temperature is around 37° C., and self-expansion can be initiated on reaching the transition temperature.
Data Source
AI summary
The invention relates to a catheter for the transvascular implantation of prosthetic heart valves, in particular including self-expanding anchorage supports (10), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve with anchorage supports is temporarily housed in a folded form in a cartridge-type unit (4) during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system (1), which includes a flexible region (9) that can be guided through the aorta. Actuating elements (2, 3) run through the interior of the hollow guide system, said elements permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.