Overstretched TPE Balloon for Constant Cuff Pressure

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Solution Overview

Problem

Existing pressure equalization systems for medical cuffs, such as those used in respiration cannulas, face challenges in maintaining constant pressure despite volume changes, with electronic regulators being complex and expensive, and latex-based systems being cumbersome and allergenic.

Innovation Solution

A pressure equalization balloon produced from thermoplastic polymer (TPE) is overstretched beyond its intended maximum volume, altering its modulus of elasticity to maintain constant pressure within a predetermined range, using a protective case to prevent external damage and ensure air permeability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If electronic pressure regulators are used to maintain constant cuff pressure, then pressure control precision is improved, but device complexity and cost increase

Engineering Contradiction:
Improvepressure control precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces electronic pressure regulators with a purely mechanical solution - a latex equalization balloon that uses elastic deformation to automatically equalize pressure between the cuff and the balloon. The latex balloon's inherent elastic properties provide the pressure equalization function without requiring electronics, sensors, or power sources, thus reducing device complexity while maintaining pressure control capability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The equalization balloon system is self-regulating - when cuff pressure changes, the latex balloon automatically expands or contracts to equalize the pressure difference. This self-service mechanism eliminates the need for external control systems, motors, or electronic regulation, providing simple yet effective pressure maintenance through the balloon's intrinsic elastic behavior.

Inventive Principle:
Principle #25Self-service

2Ease of manufacture

If latex balloons are used as equalization balloons, then ease of manufacture and cost are improved, but allergenic potential and patient safety worsen

Engineering Contradiction:
Improveease of manufactureVSAvoidallergenic potential
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent uses composite construction by placing the latex equalization balloon inside a protective sheath made of non-allergenic material. This layered structure combines the manufacturing advantages of latex with the safety benefits of hypoallergenic materials, eliminating direct patient exposure to latex allergens while preserving the balloon's pressure equalization function.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The protective sheath acts as an intermediary barrier between the latex balloon and the patient environment. This intermediate layer prevents direct contact between potential latex allergens and the patient, while still allowing the balloon to perform its pressure equalization function through the sheath wall via gas permeability.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If the equalization balloon is made fragile to achieve constant pressure, then pressure regulation precision is improved, but reliability and resistance to damage worsen

Engineering Contradiction:
Improvepressure regulation precisionVSAvoidresistance to damage
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The protective sheath provides beforehand cushioning and protection for the fragile latex balloon. This outer shell shields the thin-walled balloon from mechanical damage, shocks, and handling stresses that would otherwise compromise its integrity, while still allowing the balloon to deform elastically for pressure equalization.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The protective sheath is designed as a flexible shell that can deform along with the latex balloon during pressure equalization. This flexible enclosure protects the fragile balloon from external damage while permitting the necessary volume changes and pressure equalization function through its compliant structure.

Inventive Principle:
Principle #30Flexible shells and thin films

4Reliability

If the protective sheath is made rigid to protect the balloon, then reliability is improved, but the balloon's ability to expand and contract for pressure equalization worsens

Engineering Contradiction:
Improveprotection from damageVSAvoidpressure equalization capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The protective sheath is specifically designed as a flexible rather than rigid structure. This flexible shell provides mechanical protection while simultaneously allowing the latex balloon to expand and contract freely for pressure equalization. The sheath's compliance ensures it does not constrain the balloon's volume changes needed for maintaining constant pressure.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The protective sheath is made air-permeable (porous) to allow gas exchange between the balloon interior and exterior. This porosity enables the balloon to equalize pressure with the surrounding environment while the sheath structure provides protective enclosure, combining protection with functional adaptability.

Inventive Principle:
Principle #31Porous materials

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 solution effectively maintains constant pressure in connected volumes, reducing the risk of damage and allergenic concerns, while allowing for controlled pressure adjustments and visibility of the balloon's condition, enhancing handling and safety in medical applications.

Implementation Method 1

the modulus of elasticity changes in dependence on the stretching in such a way that the pressure obtaining in the equalization balloon remains constant at least within a predetermined regulating volume range

Methodology Applied
Scientific EffectModulus of elasticity: Elasticity

Implementation Method 2

which is sufficiently stable to protect the balloon accommodated in the case in relation to shocks, damage or pressure exerted from the exterior, and it will be appreciated that the protective case must be air-permeable in order not to influence expansion or contraction of the equalization balloon

Methodology Applied
Scientific EffectAir permeability: Permeation

Data Source

PatentUS10238824B2Pressure equalization balloon and method for the production thereof
Publication Date: 2019.03.26 COLOPLAST AS
  • US10238824B2 patent drawing
  • US10238824B2 patent drawing
  • US10238824B2 patent drawing

AI summary

The volume of a pressure equalization balloon is connected to a further volume, the pressure of which is intended to remain as constant as possible. To keep the cuff pressure in the pressure range of between roughly 20 mbar and 30 mbar, the equalization balloon is produced from a thermoplastic polymer (TPE) and is overstretched past the maximum intended control volume before first use and is then relaxed to the range of the control volume.