Reinforced Valvuloplasty Balloon for Low-Profile Tissue Scoring
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Solution Overview
Problem
Existing valvuloplasty balloons are insufficient for treating severely diseased heart valves and often have a profile that hinders their passage through narrow pathways, necessitating improved designs that control folding mechanics and allow for the attachment of cutting members.
Innovation Solution
The development of valvuloplasty balloons with reinforced regions featuring braided filaments and polymer coatings, which enhance structural integrity while minimizing deflated profile, and include cutting members for tissue preparation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If valvuloplasty balloons are equipped with cutting members to treat severely diseased heart valves, then the therapeutic effectiveness is improved, but the device complexity and profile increase, hindering passage through narrow pathways
Solution Approach 1:
The balloon is divided into multiple reinforced regions spaced circumferentially around the body portion, with cutting members attached at specific locations. This segmentation allows the balloon to maintain structural integrity while enabling effective tissue scoring through the cutting members, resolving the contradiction between therapeutic effectiveness and device complexity.
Solution Approach 2:
Reinforced regions are created at specific locations on the balloon using braided filaments and polymer coatings, rather than uniformly reinforcing the entire balloon. This local reinforcement provides structural support where needed while maintaining flexibility and minimizing profile in other areas, allowing passage through narrow pathways.
2Ease of operation
If the balloon wall is made thinner to reduce profile for navigation, then ease of navigation through narrow pathways is improved, but the strength and structural integrity deteriorate
Solution Approach 1:
The balloon utilizes a thin polymer wall that provides flexibility for navigation through narrow pathways. The polymer wall acts as a flexible shell that can be compressed and folded during delivery, then expands at the target site to provide the necessary structural integrity for valvuloplasty and cutting operations.
Solution Approach 2:
The balloon combines multiple materials including polymer wall, braided filaments (such as silk or synthetic fibers), and polymer coatings to create a composite structure. This composite design provides both the flexibility needed for navigation and the strength required for effective tissue intervention.
3Strength
If reinforced regions with braided filaments are added to enhance structural integrity, then the strength is improved, but the profile when deflated increases, complicating passage through narrow pathways
Solution Approach 1:
Instead of uniformly reinforcing the entire balloon, braided filaments are concentrated in specific reinforced regions that are circumferentially spaced around the body portion. This localized reinforcement provides structural integrity where needed while minimizing the overall profile when the balloon is deflated, facilitating passage through narrow pathways.
Solution Approach 2:
The reinforced regions with braided filaments are designed to be dynamic in nature, allowing the balloon to compress and fold during delivery, then expand at the target site. The filaments provide structural support during expansion while being compact during deflation, enabling the balloon to adapt its profile to the delivery requirements.
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 reinforced design allows for effective expansion and symmetrical refolding, facilitating easier navigation through narrow pathways and efficient tissue scoring during valvuloplasty procedures.
Implementation Method 1
The balloon wall extending between the first and second reinforced regions includes a first elasticity and wherein the first and the second reinforced regions include a second elasticity less than the first elasticity
Implementation Method 2
the balloon is then inflated and the narrowed heart valve is expanded
Implementation Method 3
the balloon wall extending between the first and the second reinforced regions includes a first elasticity
Implementation Method 4
a first reinforced region including a first plurality of filaments and a polymer coating, a second reinforced region including a second plurality of filaments and a polymer coating
Data Source
AI summary
Example medical devices are disclosed. An example medical device includes an elongate shaft having a distal end region and a balloon coupled to the distal end region, the balloon including a wall, a distal waist, a proximal waist and body portion positioned between the distal waist and the proximal waist. The medical device also includes a first reinforced region positioned along the body portion, the first reinforced region including a first plurality of filaments and a second reinforced region positioned along the body portion, the second reinforced region including a second plurality of filaments. Further, the first reinforced region is circumferentially spaced from the second reinforced region such that the balloon wall extending between the first and the second reinforced regions is devoid of a filament.