Inflatable Balloon With Reinforcing Strips For Shape Control

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Solution Overview

Problem

Current medical balloons, particularly high-compliance and low-compliance balloons, face issues such as inadequate pressure resistance, poor shape control, and vulnerability to punctures and tears, which can lead to complications during medical procedures like Balloon Aortic Valvuloplasty and Transcatheter Aortic Valve Implantation.

Innovation Solution

The development of an inflatable balloon design featuring a cylindrical section, a conical section, and circumferential fibers with reinforcing strips that include fibers extending at an angle, providing enhanced strength and shape control, along with a spherical reinforcement cap and a layered structure for improved durability and resistance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If high-compliance balloon material (urethane, latex, silicone) is used to allow easy expansion, then the balloon can expand several times in volume between zero and burst pressure, but the balloon walls have low tensile strength and thin out as the balloon expands, creating excessive risk of balloon failure

Engineering Contradiction:
ImproveexpandabilityVSAvoidtensile strength
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The balloon is constructed using composite materials combining an elastomeric base material with high-strength fiber reinforcement (aramid, carbon fiber, or glass fiber). This composite structure allows the balloon to achieve both high expandability and maintained tensile strength, as the fibers prevent wall thinning and provide structural support during expansion.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The reinforcement fibers are strategically positioned in specific regions of the balloon where stress concentrations occur during expansion. This localized reinforcement provides strength exactly where needed while maintaining the overall compliance and expandability of the balloon structure.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If traditional high-compliance balloon material is used, then the balloon can expand easily, but the balloon provides insufficient force to complete procedures and cannot reach high pressures

Engineering Contradiction:
Improveease of expansionVSAvoidexpansion force
Core Design Contradiction:
Ease of operationVSForce

Solution Approach 1:

The combination of elastomeric material with high-strength fibers creates a composite structure that maintains ease of expansion while significantly increasing the force the balloon can generate. The fibers reinforce the walls to withstand high pressures up to 300 psi or more while the elastomeric base provides flexibility and expandability.

Inventive Principle:
Principle #40Composite materials

3Stress or pressure

If PET material is used for low-compliance high-pressure balloons to provide strength, then the balloon can hold high pressures, but the balloon becomes fragile and prone to tears when pressed against hard surfaces

Engineering Contradiction:
Improvepressure resistanceVSAvoidpuncture resistance
Core Design Contradiction:
Stress or pressureVSStrength

Solution Approach 1:

The patent uses a composite of elastomeric material with flexible high-strength fibers (aramid, carbon fiber, or glass fiber) that provides both pressure resistance and puncture/tear resistance. The elastomeric base material provides flexibility and resistance to sharp surfaces, while the fiber reinforcement maintains structural integrity under high pressure.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The balloon structure is designed to maintain optimal wall thickness parameters during expansion, preventing the wall thinning that occurs in traditional balloons. The fiber reinforcement allows the balloon to withstand high pressures without requiring excessive wall thickness, maintaining a balance between pressure resistance and flexibility.

Inventive Principle:
Principle #35Parameter changes

4Volume of moving object

If PET material is used to create thin-walled balloons (5 μm to 50 μm) for low profile, then the balloon can be made very thin, but the balloon becomes difficult to pack or fold into small diameter and has poor trackability

Engineering Contradiction:
Improveballoon profileVSAvoidtrackability
Core Design Contradiction:
Volume of moving objectVSEase of operation

Solution Approach 1:

The fiber reinforcement allows the balloon to maintain structural integrity with optimized wall thickness, enabling the balloon to be packed and folded into small diameters while maintaining trackability. The fibers provide strength without requiring excessive wall thickness, allowing the balloon to conform to tortuous vessels.

Inventive Principle:
Principle #35Parameter changes

5Adaptability or versatility

If high-compliance balloon is used, then the balloon can expand easily, but the balloon has poor shape control and assumes shape dictated by environment rather than clinical goals

Engineering Contradiction:
ImproveexpandabilityVSAvoidshape control
Core Design Contradiction:
Adaptability or versatilityVSShape

Solution Approach 1:

The fiber reinforcement is strategically positioned in specific regions of the balloon to control shape in critical areas while allowing expansion in others. This localized reinforcement provides shape control where needed while maintaining overall expandability and compliance.

Inventive Principle:
Principle #3Local quality

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 balloon achieves higher burst pressure resistance, precise shape control, and improved puncture and tear resistance, ensuring safer and more effective medical procedures by maintaining structural integrity under high pressures.

Implementation Method 1

High-compliance, or highly elastic medical balloons typically cannot reach high pressures because their walls have a low tensile strength

Methodology Applied
Scientific EffectTensile strength: Tension

Implementation Method 2

High-compliance medical balloons can easily expand several times in volume between zero inflation pressure and burst. Once the pressure is reduced, the high-compliance medical balloon may return to its original shape

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS11471653B2Inflatable medical devices
Publication Date: 2022.10.18 LOMA VISTA MEDICAL INC
  • US11471653B2 patent drawing
  • US11471653B2 patent drawing
  • US11471653B2 patent drawing

AI summary

An inflatable balloon includes a base balloon having a cylindrical section and a conical section and at least one circumferential fiber extending circumferentially around the conical section. The inflatable balloon includes a plurality of reinforcing strips in the conical section over the at least one circumferential fiber. Each reinforcing strip includes a plurality of fibers extending at an angle relative to the at least one fiber. Each reinforcing strip is positioned a set circumferential distance away from a neighboring reinforcing strip.