Transcatheter Valve Delivery for Controlled Recapture and Positioning
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing percutaneous transcatheter heart valve implantation systems face challenges in accurately positioning and repositioning self-expanding stented prosthetic heart valves due to difficulties in recapturing partially deployed valves and ensuring optimal placement, which can lead to complications such as leakage or dislodgment.
Innovation Solution
A delivery system with a shaft assembly and sheath assembly that allows for controlled expansion and contraction of the prosthetic heart valve through a coupling structure, enabling precise positioning and repositioning by manipulating the shaft assembly's longitudinal movement, facilitating evaluation and adjustment before full deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding transcatheter heart valve is deployed from the catheter, then the valve can be implanted in the native annulus, but it becomes exceedingly difficult to re-collapse or reposition the prosthetic
Solution Approach 1:
The delivery system employs a dynamic recapture mechanism where the outer sheath can be repositioned to recollapse the deployed valve. The coupling structure between the shaft assembly and outer sheath allows for controlled expansion and contraction of the valve, enabling the operator to recapture the prosthetic if positioning is incorrect. This dynamic control resolves the contradiction by making the valve deployment process reversible rather than irreversible.
2Reliability
If the prosthetic heart valve is incorrectly positioned relative to the native annulus, then serious complications such as leakage or dislodgment can result, but conventional delivery tools cannot facilitate repositioning
Solution Approach 1:
The outer sheath acts as an intermediary tool that enables recapture and repositioning of the deployed valve. By maintaining a coupling structure that allows controlled contraction, the sheath serves as a mediator between the deployed prosthetic and the operator, facilitating correction of positioning errors without requiring surgical intervention. This resolves the contradiction by providing a mechanism to correct positioning mistakes while ensuring proper sealing.
3Ease of manufacture
If conventional sewing of the prosthetic heart valve to the patient's native tissue is not necessary, then the procedure becomes less invasive, but accurate positioning and anchoring of the valve becomes more challenging
Solution Approach 1:
The delivery system incorporates feedback mechanisms through imaging guidance and controlled expansion/contraction capabilities. The operator can partially deploy the valve, evaluate its position using imaging, and then recapture or reposition it by manipulating the outer sheath and shaft assembly. This feedback loop enables accurate positioning without conventional sewing, resolving the contradiction between minimally invasive approach and positioning precision.
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
Enables controlled deployment and repositioning of self-expanding prosthetic heart valves, ensuring accurate anchoring and sealing against the native annulus, reducing the risk of complications and improving the success of minimally invasive procedures.
Implementation Method 1
a self-expanding prosthetic heart valve having a stent frame to which a valve structure is attached
Data Source
AI summary
A delivery system for use with a prosthetic heart valve having a stent frame to which a valve structure is attached, includes a shaft assembly including a distal end and a coupling structure disposed near the distal end and configured to be coupled to a distal end of the prosthetic heart valve. The system includes a sheath assembly defining a lumen sized to slidably receive the shaft assembly. The delivery system is configured to transition from a loaded state in which the sheath assembly encompasses the prosthetic heart valve to a deployed state in which the sheath assembly is withdrawn from the prosthetic heart valve. The coupling structure is configured to provide a controlled expansion or contraction of the distal end of the prosthetic heart valve based on longitudinal movement of the distal end of the shaft assembly.