Cuff-Resistant Anchoring Balloon Design

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Solution Overview

Problem

Existing anchoring balloons for medical catheters and probes fail to effectively resist axial movement and provide clear tactile feedback during treatments, leading to potential misplacement and discomfort due to their conforming nature and lack of resistance to axial displacement.

Innovation Solution

A medical device featuring an inflatable balloon with a diamond-like configuration that transitions to a spherical shape upon inflation, providing tension and secure anchoring within the body, along with a support structure that includes a first-end portion with greater wall thickness than the middle-body portion, ensuring resistance to axial movement and clear tactile feedback.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conforming urologic bladder balloon is used that readily adapts to body structures, then the balloon can hold the catheter from falling out of the bladder, but the balloon allows axial displacement of the catheter relative to the balloon and does not provide sharp tactile feedback when low force is applied

Engineering Contradiction:
Improveprevention of catheter expulsion from bladderVSAvoidtactile feedback sharpness
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The balloon incorporates a distal flared portion with a larger diameter than the proximal portion, creating localized structural differentiation. This flared section provides rigid anchoring against bladder wall to prevent catheter expulsion, while the differentiated structure creates a mechanical stop that delivers sharp tactile feedback when the balloon reaches the bladder neck during insertion, even under low applied force

Inventive Principle:
Principle #3Local quality

2Reliability

If a conforming urologic bladder balloon is used that readily adapts to body structures, then the balloon can prevent urine leakage, but the balloon allows axial movement of the catheter within the urethra when axial force is applied

Engineering Contradiction:
Improveprevention of urine leakageVSAvoidresistance to axial catheter movement
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The balloon features a distal flared portion with increased diameter that creates a mechanical anchor point. This localized structural feature resists axial forces applied to the catheter by engaging the bladder neck or urethral wall, preventing catheter migration while the rest of the balloon maintains its conforming seal to prevent urine leakage

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The balloon has an asymmetric structure with a distal flared portion that is larger in diameter than the proximal portion. This asymmetry provides directional stability, with the flared end acting as a stop against retrograde movement into the bladder, while the narrower proximal portion allows forward insertion and maintains seal against the urethral wall

Inventive Principle:
Principle #4Asymmetry

3Reliability

If a balloon is made conforming and readily adaptable to body structures, then the balloon can secure the catheter in the bladder, but the feedback to the user is difficult to notice when low force is applied

Engineering Contradiction:
Improvesecuring of catheter in bladderVSAvoidtactile feedback detectability
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The distal flared portion creates a localized mechanical feature that produces a distinct tactile sensation when it contacts the bladder neck or urethral wall. This structural differentiation amplifies the tactile feedback signal during insertion, making it easily detectable by the operator even when minimal insertion force is applied, while the overall balloon structure remains conforming to secure the catheter

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 solution effectively minimizes axial translation of the catheter or probe, provides sharp tactile feedback at low force application, and maintains the desired position during treatments, reducing the risk of misplacement and deformation.

Implementation Method 1

The balloon is formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to a inflation pressure that is at least about ten percent greater than atmospheric pressure external to the balloon

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

The balloon is stretch-mounted to the support structure so as to be in tension relative to the support structure

Methodology Applied
Scientific EffectTension: Tension

Data Source

PatentEP3086832B1Cuff-resistant anchoring balloon for medical device
Publication Date: 2020.01.15 HOLOGIC INC
  • EP3086832B1 patent drawingFigure 1
  • EP3086832B1 patent drawingFigure 2
  • EP3086832B1 patent drawingFigure 3A~3D

AI summary

A medical device (100) having an elongate support structure (110) and an inflatable balloon (120) including a first-end portion (142) secured to the support structure at a first location, a second-end portion (144) secured to the support structure at a second location distal to the first location, and a middle-body portion (141), the first-end portion having a wall thickness greater than a wall thickness of the middle-body portion, the balloon defining a sealed interior through which the support structure extends. The balloon is stretch-mounted to the support structure in tension and formed in a diamond-like configuration that transitions to a substantially spherical configuration when the balloon is inflated to an inflation pressure at least about ten percent greater than atmospheric pressure, such that when inflated to the inflation pressure and anchored in an anatomical body region, the balloon resists movement of the support structure relative to the balloon.