Variable Wall Thickness Balloon for Reduced Valve Crimp Profiles
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Solution Overview
Problem
Existing prosthetic heart valves face challenges in achieving a reduced crimp profile and maintaining stable positioning during delivery, which can lead to increased tissue damage and difficulty in precise alignment during transcatheter procedures.
Innovation Solution
A balloon catheter system with a variable wall thickness, featuring a thinner central portion and thicker proximal and distal portions, designed to accommodate the prosthetic heart valve without covering it, ensuring stable positioning and reduced crimp profile through differential stretching and coating techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a uniform wall thickness balloon is used, then the manufacturing process is simple, but the crimp profile is larger and positioning stability is reduced
Solution Approach 1:
The balloon is designed with non-uniform wall thickness, featuring a thinner central portion (receiving portion) and thicker proximal and distal portions. This local variation in wall thickness allows the central portion to be more compliant for better valve conformability and reduced crimp profile, while the thicker end portions provide structural support and positioning stability during delivery and inflation.
2Volume of moving object
If a thinner wall thickness balloon is used, then the crimp profile is reduced, but the positioning stability during inflation deteriorates
Solution Approach 1:
The balloon incorporates localized wall thickness variations where the central portion has reduced thickness for compliance and smaller crimp profile, while the proximal and distal portions maintain greater thickness for structural integrity and axial positioning stability during the inflation process.
Solution Approach 2:
The balloon is functionally segmented into three distinct zones: a central receiving portion with thinner walls for valve conformability, and proximal and distal portions with thicker walls for positioning and structural support. This segmentation allows each zone to independently fulfill its specific function without compromising overall performance.
3Stability of the object's composition
If the balloon covers the prosthetic heart valve, then positioning is maintained, but the crimp profile increases and tissue damage risk increases
Solution Approach 1:
The thinner central portion of the balloon allows it to conform more closely to the contours of the crimped prosthetic heart valve without excessive coverage or protrusion, thereby reducing the overall crimp profile and minimizing potential tissue damage while maintaining adequate positioning support.
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 achieves a smaller crimp profile and maintains the prosthetic heart valve's stable axial position during inflation, enhancing precision and reducing the risk of tissue damage during delivery.
Implementation Method 1
The central portion may have a central wall thickness that is smaller than a proximal wall thickness of the proximal portion and smaller than a distal wall thickness of the distal portion
Implementation Method 2
designed to accommodate the prosthetic heart valve without covering it, ensuring stable positioning and reduced crimp profile through differential stretching and coating techniques
Data Source
AI summary
According to an example of the disclosure, a system for delivering a prosthetic heart valve includes a handle, a delivery catheter extending from the handle, and a balloon on a distal portion of the catheter, the balloon having a proximal portion, a distal portion, and a central portion positioned between the proximal portion and the distal portion, the central portion configured to receive the prosthetic heart valve in a crimped condition thereon. The proximal portion may have a proximal wall thickness, the distal portion may have a distal wall thickness, and the central portion may have a central wall thickness, the central wall thickness being smaller than the proximal wall thickness and smaller than the distal wall thickness.