Segmented Annular Balloon with Apertures for TAVI Flow
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Solution Overview
Problem
Current inflatable medical devices, such as balloons used for trans-cutaneous heart valve implantation, face issues with blocking blood flow, poor dimensional control, and vulnerability to tear and puncture during procedures like Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI).
Innovation Solution
A novel inflatable medical device with a shell structure that includes a balloon fixed inside, featuring a central fluid passage and apertures for fluid communication, and a design with varying stiffness and pleating to maintain flow while resisting puncture and tear, allowing for precise control and extended use without blocking vital body lumens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a typical balloon is used for trans-cutaneous heart valve implantation, then the balloon can be inflated to open a stenosed aortic valve, but the balloon blocks the entire output of the heart causing pressure increase and may be ejected from the aortic valve
Solution Approach 1:
The balloon is divided into multiple segments with apertures between them, allowing blood to flow through the balloon structure while still providing sufficient inflation pressure for valve opening. This segmentation resolves the contradiction by permitting flow through strategic openings while maintaining structural integrity for effective valve dilation.
Solution Approach 2:
The balloon incorporates apertures that function as porous structures, enabling selective permeability to blood flow. The apertures are positioned and sized to allow adequate blood passage while maintaining the balloon's ability to generate sufficient inflation pressure for the procedure.
2Strength
If a typical balloon is used for BAV/TAVI procedure, then the balloon can be inflated to dilate the valve, but the balloon provides poor dimensional control and does not resist tear and puncture well
Solution Approach 1:
The balloon employs composite material construction combining different materials with complementary properties. One material provides high strength and puncture resistance, while another provides dimensional stability and control. This composite approach resolves the contradiction by integrating both toughness and precision dimensional control in a single structure.
Solution Approach 2:
The balloon incorporates pre-formed apertures and structural features during manufacturing that are optimized for both strength and dimensional control. The apertures are precisely positioned and sized in advance to ensure both puncture resistance and accurate dimensional performance during the procedure.
3Force
If rapid pacing is used during BAV/TAVI to minimize pressure buildup, then the forces on the balloon are reduced, but rapid pacing carries risk for the patient
Solution Approach 1:
The segmented balloon structure with apertures allows blood to flow through during inflation, reducing pressure buildup forces on the balloon without requiring rapid pacing. This eliminates the need for risky rapid pacing maneuvers while still achieving force reduction through the flow-permeable structure.
4Duration of action of moving object
If a typical balloon is used, then the balloon can be inflated for a few seconds, but the balloon must be withdrawn quickly due to blockage concerns
Solution Approach 1:
The apertured balloon structure functions as a porous medium that permits continuous blood flow through the balloon during inflation. This allows the balloon to remain inflated for extended durations without causing harmful blockage, resolving the contradiction between inflation time and flow obstruction.
Solution Approach 2:
The balloon design enables continuous blood flow through the apertures during the entire inflation period, maintaining uninterrupted circulation. This allows prolonged inflation times while eliminating the blockage concern that would otherwise require quick withdrawal.
Data Source
Figure 1A~1B
Figure 2A~3A
Figure 3B~4
AI summary
The present invention relates to a balloon for an inflatable structure apparatus, comprising a plurality of balloon segments arranged into an annular balloon structure and preferably attached to each other, wherein the plurality of balloon segments form one inflation/deflation volume and further an annular balloon structure for an inflatable structure apparatus, comprising a plurality of individual balloons arranged into an annular structure and preferably attached to each other. The present invention also describes a system, comprising the above balloon and a shell, preferably in the shape of a hollow cylinder, entirely or partially covering the balloon segments.