Axially Movable Dual-Balloon Valve Delivery for Leaflet Opening
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Solution Overview
Problem
Existing methods for transcatheter aortic valve replacement, such as lacerating leaflets to mitigate coronary ostial obstruction, require high precision and can lead to aortic insufficiency and debris release, posing risks of vascular occlusion or stroke, especially when dealing with calcified leaflets.
Innovation Solution
A delivery assembly with an outer and inner balloon catheter system that allows for precise modification of host leaflets by forming a pilot puncture and expanding a guest prosthetic valve within the native or previously implanted valvular structure, minimizing the need for high precision and reducing debris risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If lacerating or severing a portion of host valve leaflets is performed to mitigate coronary ostial obstruction, then the risk of blocking coronary ostia is reduced, but the method requires high spatial precision and surgical skill, and increases the risk of aortic insufficiency and debris release
Solution Approach 1:
The delivery system is divided into two separate balloons (inner and outer) that can be independently controlled and positioned. The inner balloon performs leaflet modification while the outer balloon provides support and prepares the implantation site, allowing each component to specialize in its function and reduce overall procedural risk
Solution Approach 2:
The inner balloon is used to perform preliminary modification of the host leaflets (such as laceration or severing) before the guest valve is expanded. This preliminary action prepares the leaflets to be displaced away from coronary ostia, mitigating obstruction risk before the main valve replacement occurs
2Object-affected harmful factors
If lacerating existing leaflets is performed to mitigate coronary ostial obstruction, then the risk of blocking coronary ostia is reduced, but particulate or other debris may be released into the blood stream, making the patient susceptible to vascular occlusion or stroke
Solution Approach 1:
The inner balloon acts as an intermediary tool that modifies the leaflets through controlled laceration or severing. By using the balloon as the mediating instrument rather than direct mechanical cutting tools, the process can be more controlled and potentially reduce uncontrolled debris generation into the bloodstream
Solution Approach 2:
The delivery system extracts or removes the problematic host leaflets from their original position through controlled laceration, displacing them away from the coronary ostia. This extraction approach allows the leaflets to be removed from the critical area while minimizing disturbance to surrounding tissues and blood flow
3Object-affected harmful factors
If high spatial precision and surgical skill are used to lacerate leaflets, then coronary ostial obstruction is mitigated, but the procedure complexity and difficulty increase
Solution Approach 1:
Multiple functions are merged into a single integrated delivery system: the inner balloon performs leaflet laceration, the outer balloon provides structural support and defines the implantation zone, and both work together to achieve leaflet displacement. This merging reduces the need for multiple separate complex procedures and lowers the overall precision requirement compared to performing laceration as a standalone high-precision procedure
4Reliability
If a delivery assembly with inflatable balloons axially movable relative to each other is used, then controlled expansion of prosthetic valve is achieved while maintaining host leaflet integrity, but the device structure becomes more complex
Solution Approach 1:
The inner balloon catheter is nested within the outer balloon catheter, with the inner balloon positioned inside the outer balloon. This nested configuration allows both balloons to be delivered through the same access route and deployed in a coordinated manner, achieving complex functionality while maintaining a relatively compact delivery profile
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 effectively reduces the risk of coronary ostial obstruction and aortic insufficiency by allowing controlled expansion of the prosthetic valve while maintaining functional integrity of the host leaflets, thereby minimizing debris release and procedural complications.
Implementation Method 1
the inner balloon is inflated to modify a host leaflet of a host valvular structure
Implementation Method 2
the outer balloon is inflated to radially expand the guest prosthetic valve to its functional size
Data Source
AI summary
The present disclosure relates to delivery assemblies for implantation of a prosthetic valve within a valvular structure in which an opening was formed in a host leaflet. In an example, the delivery assembly comprises a guest prosthetic valve and a delivery apparatus that includes an outer balloon, and an inner balloon axially movable relative to the outer balloon. The delivery apparatus can be advanced towards the host leaflet structure with the inner balloon kept in a concealed position. The inner balloon can then be advanced relative to the outer balloon, so as to be positioned inside the host leaflet, and inflated to form a leaflet opening within the host leaflet. The inner balloon can then be deflated and the outer balloon can be advanced into the leaflet opening, and inflated with the guest prosthetic valve disposed thereover, so as to expand the guest prosthetic valve inside the leaflet opening.