Compartmental Balloon Catheter for Controlled Vessel Dilation
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Solution Overview
Problem
Current angioplasty balloons cause significant trauma and dissections in blood vessels due to abrupt and uncontrolled inflation, leading to high rates of restenosis and delayed healing, especially in long lesions, as they apply uneven forces and lengthen during dilation, exacerbating injury and trauma.
Innovation Solution
A balloon catheter with a Constraining Structure (CS) that modulates inflation characteristics, creating compartmental zones with controlled topography to minimize trauma and promote plaque remodeling, preventing shear forces and axial tension, allowing for segmental dilation and controlled pressure distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If conventional angioplasty balloons are inflated to high pressure to overcome lesion resistance, then luminal expansion is achieved, but severe trauma to vessel walls occurs resulting in dissections, abrupt closure, and restenosis
Solution Approach 1:
The balloon is divided into multiple compartments separated by internal partitions. Each compartment can be inflated independently or in sequence, allowing controlled application of dilatation force to different segments of the lesion. This segmentation prevents sudden uniform expansion that causes vessel wall trauma, while still achieving adequate luminal expansion through progressive inflation of individual compartments.
Solution Approach 2:
The balloon employs sequential or alternating inflation of its compartments rather than simultaneous inflation. This periodic action allows the vessel wall to adapt gradually to expanding forces, reducing traumatic effects. The controlled sequence of inflation enables progressive plaque disruption while minimizing abrupt vessel wall stress that leads to dissections and restenosis.
2Object-affected harmful factors
If elastic or stretchable balloons are used to open radially without unfolding, then shear forces on vessel walls are reduced, but sufficient dilatation forces cannot be provided due to soft and compliant materials
Solution Approach 1:
The balloon structure incorporates internal partitions that create discrete compartments. These partitions provide structural rigidity to enable high dilatation forces while the overall balloon design maintains radial expansion without unfolding. The segmented structure allows forceful plaque disruption in the radial direction while minimizing tangential shear forces on the vessel wall.
Solution Approach 2:
The balloon employs composite construction combining elastic materials with internal rigid partitions. The elastic material provides flexibility and radial expansion capability without unfolding, while the internal partitions (made of stronger materials) provide the structural support necessary to generate sufficient dilatation forces against resistant lesions.
3Adaptability or versatility
If standard elastic balloons are inflated against inconsistent resistance, then the lesion can be opened, but increased pressure causes increased trauma and the elastic nature causes diameter to increase more at elastic areas causing further trauma
Solution Approach 1:
The internal partitions divide the balloon into multiple compartments that can be inflated independently. This allows targeted inflation pressure application to specific compartments facing different resistance levels. Each compartment can be adjusted to match the local lesion characteristics, providing consistent force distribution across areas of varying plaque density and vessel elasticity, thereby preventing concentrated trauma in compliant areas.
Solution Approach 2:
The balloon design allows different compartments to have different inflation pressures or volumes based on local lesion requirements. This local quality approach enables the balloon to adapt to inconsistent resistance by applying appropriate force to each segment, preventing over-expansion in elastic areas and ensuring adequate disruption in resistant areas, thus distributing trauma evenly.
4Productivity
If angioplasty balloons are used in long lesions requiring repeated inflation/deflation, then the occluded vessel can be treated, but balloon lengthening during dilation causes further damage to non-diseased areas
Solution Approach 1:
The partitioned compartment structure provides internal support that prevents balloon lengthening during inflation. Each compartment is constrained by the partitions, maintaining the balloon's longitudinal dimensions stable even as radial expansion occurs. This eliminates the lengthening effect that damages non-diseased areas during repeated inflation/deflation cycles required for treating long lesions.
Solution Approach 2:
The balloon design changes the mechanical parameters of inflation by decoupling radial expansion from longitudinal extension. The internal partitions constrain axial deformation, allowing the balloon to achieve full radial dilatation without lengthening. This parameter change enables safe treatment of long lesions through repeated inflation cycles without compromising adjacent healthy tissue.
Data Source
AI summary
A constraining structure for use with a balloon catheter includes multiple longitudinal struts and multiple expandable radial rings. The constraining structure can expand radially but may not expand substantially in the longitudinal direction. The constraining structure can have multiple compartments configured to expand independently of one another. Inflating the balloon catheter within the constraining structure can allow for dilation of the blood vessel in a pre determined topography.