Catheter Stability Device Using Expansion Members for Valve Delivery
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Solution Overview
Problem
Delivering and maintaining the position of balloon members and prosthetic devices within the native heart valve during heart valve procedures is challenging due to environmental conditions such as blood flow, pressure changes, and heart movement.
Innovation Solution
A delivery system that includes a catheter shaft with a tension member and expansion members to stabilize the catheter near the treatment location, utilizing features like adjustable tension, expandable balloon members, and pull wires to wedge the catheter within the aortic arch, ensuring precise positioning and stability during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the catheter shaft is made rigid to maintain position during heart valve procedures, then positioning stability is improved, but the ability to navigate through the aortic arch and deliver to the treatment location deteriorates
Solution Approach 1:
The catheter shaft is divided into multiple segments with different flexibility characteristics. The proximal portion has greater flexibility for navigation, while the distal portion maintains sufficient rigidity for stable positioning and device deployment at the treatment location.
Solution Approach 2:
Different portions of the catheter shaft are assigned different mechanical properties. The proximal section is designed with higher flexibility to navigate the aortic arch, while the distal section is designed with higher rigidity to maintain stable positioning during valve procedures.
2Ease of operation
If the catheter shaft is made flexible to navigate the aortic arch, then deliverability is improved, but positioning stability during procedures deteriorates
Solution Approach 1:
The catheter shaft is segmented into proximal and distal portions with differentiated flexibility. The proximal portion provides the flexibility needed for navigation through the aortic arch, while the distal portion provides the rigidity required for stable positioning during procedures.
Solution Approach 2:
The catheter shaft exhibits local quality variations where the proximal section has higher flexibility for navigation and the distal section has higher rigidity for stable positioning and device deployment.
3Stability of the object's composition
If the balloon member is expanded early to stabilize the catheter, then positioning stability is improved, but the ability to adjust position before final deployment deteriorates
Solution Approach 1:
The balloon member is inflated to a first, smaller diameter to provide preliminary stabilization of the catheter shaft during positioning, allowing the operator to adjust the position before final deployment. The balloon is then inflated to a second, larger diameter for final stable deployment of the heart valve device.
Solution Approach 2:
The balloon member provides dynamic stabilization by allowing incremental inflation. The balloon can be inflated to different diameters at different stages of the procedure, providing adjustable stabilization that maintains position adjustability during initial positioning while enabling stable final deployment.
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 enhances the stability and accuracy of balloon members and prosthetic devices within the heart valve, allowing for effective valvuloplasty and valve replacement procedures by maintaining position despite environmental challenges.
Implementation Method 1
By adjusting the tension in the tension member, the catheter shaft can be caused to flex between the first and second areas
Implementation Method 2
The at least one expansion member is moveable between a collapsed state and an expanded state and in its expanded state, the at least one expansion member is configured to stabilize the catheter shaft by contacting a wall of the aortic arch
Data Source
AI summary
A method of implanting a prosthetic heart valve includes advancing a distal end portion of a catheter shaft through a patient's vasculature. The distal end portion of the catheter shaft includes an expansion device. A prosthetic heart valve is mounted on the expansion device with the expansion device and the prosthetic heart valve in a compressed configuration. The method further includes positioning the distal end portion of the catheter shaft and the prosthetic heart valve to an implantation location and expanding the prosthetic heart valve and the expansion device to an expanded configuration. The expansion device includes a main body and a plurality of projections extending radially from the main body. The projections are spaced apart relative to each such that there are grooves extending between adjacent projections providing perfusion passageways between the expansion device and the prosthetic heart valve when the expansion device is in the expanded configuration.