Hydraulic Delivery Catheter with Dual Pathways for Valve Alignment
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Solution Overview
Problem
Existing delivery systems for prosthetic heart valves struggle with precise alignment and control during percutaneous deployment, particularly in transitioning from a sheathed to an unsheathed state, lacking the ability to pause and evaluate the alignment of the valve during expansion.
Innovation Solution
A hydraulically driven delivery system with a dual fluid pathway mechanism that allows controlled transitions between containment, partial deployment, and full deployment configurations, using a stop pin to switch fluid pathways and pause the expansion process for evaluation and recapture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a prosthetic heart valve is sheathed within a capsule for percutaneous delivery, then the device can be delivered through a catheter with small cross-sectional dimension, but the valve cannot be evaluated for alignment during the delivery process
Solution Approach 1:
The deployment process is segmented into distinct phases (containment, partial deployment, full deployment) with the ability to pause at intermediate stages. The stop pin mechanism divides the continuous expansion into controllable segments, allowing evaluation at each stage.
Solution Approach 2:
The system performs preliminary alignment evaluation during the partial deployment phase before complete expansion. The stop pin allows the operator to pause the expansion process at an intermediate state where alignment can be assessed using imaging techniques before final deployment.
2Productivity
If the prosthetic heart valve is expanded fully at the target site, then the valve is deployed for treatment, but the alignment cannot be evaluated and corrected before final implantation
Solution Approach 1:
The expansion process is made periodic rather than continuous. The stop pin creates intermediate pause points where expansion halts, allowing for alignment evaluation and potential correction before proceeding to the next phase of expansion or final deployment.
Solution Approach 2:
Alignment evaluation is performed preliminarily during the partial deployment phase before final implantation. The stop pin mechanism enables this preliminary check by allowing the operator to pause expansion at an intermediate state where the valve is partially deployed but can still be recaptured if misaligned.
3Device complexity
If a single fluid pathway is used for hydraulic deployment, then the system is simpler, but the ability to control and pause the expansion process is limited
Solution Approach 1:
The fluid pathway system is segmented into multiple independent pathways (first and second fluid pathways) that can be controlled separately. This segmentation allows selective delivery of deployment fluid to different chambers, enabling precise control over the expansion process and the ability to pause at intermediate stages.
Solution Approach 2:
The system transitions from a static single-pathway design to a dynamic multi-pathway system where fluid can be directed differently based on operational needs. The stop pin mechanism dynamically switches between pathways, allowing the operator to control the pace and stages of expansion.
4Loss of time
If the prosthetic heart valve is deployed without the ability to pause, then the implantation process is faster, but recapture is difficult if misalignment occurs
Solution Approach 1:
The deployment process is segmented into reversible stages. The stop pin creates intermediate pause points where the valve is partially deployed but can still be recaptured. This segmentation provides multiple opportunities to assess alignment and recapture if needed, before final irreversible deployment.
Solution Approach 2:
The system performs preliminary deployment actions that are reversible. The stop pin allows pausing at an intermediate state where recapture is still possible, enabling the operator to verify alignment before committing to final deployment. This preliminary phase acts as a safety check.
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 precise control over the deployment process, allowing for improved alignment and evaluation of prosthetic heart valves during expansion, facilitating easier recapture if necessary, and enhancing the overall implantation procedure.
Implementation Method 1
a delivery system configured such that hydraulic delivery of a deployment fluid along a first fluid pathway drives a delivery system from the containment configuration towards a first partial deployment configuration
Implementation Method 2
drives a stop pin from a first pin position in which the deployment fluid flows along the first fluid pathway to a second pin position in which the deployment fluid is blocked from flowing along the first fluid pathway
Implementation Method 3
when a stop pin is in a second pin position, the deployment fluid is directed via a valve through a second flow pathway
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
A delivery system for prosthetic medical devices. The delivery system may include a delivery system configured to be driven between a containment configuration and a deployment configuration. The delivery system may be configured to cause relative motion between a delivery capsule and a prosthetic device within the delivery capsule. The delivery system may include a first fluid pathway and a second fluid pathway and may be configured to switch between the first fluid pathway and the second fluid pathway as the delivery system transitions toward a deployment configuration. The delivery system may include a recapture circuit configured to enable the delivery system to recapture a prosthetic device using the delivery capsule.