Balloon Deployment via Proximal Compression for Implant Positioning

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Solution Overview

Problem

Current balloon inflation patterns during medical procedures, such as heart valve deployment, can lead to dislodgement of implants due to uneven pressure distribution, limiting the ability to adjust the implant's position.

Innovation Solution

A method and device that compress the proximal region of the balloon to inflate the distal region first, creating a tapered shape at lower pressures, and then transition to inflating the proximal region, resulting in a shape with generally straighter sides, which anchors the implant and prevents dislodgement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the balloon is inflated using conventional inflation patterns, then the proximal portion inflates first due to fluid reaching it first, but this causes the implant to be dislodged distally by high pressure and limits the ability to adjust implant position

Engineering Contradiction:
Improveimplant position adjustment capabilityVSAvoidimplant dislodgement risk
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The distal portion of the balloon is inflated first before the proximal portion by using a covering that compresses the proximal region. This preliminary inflation of the distal portion creates a tapered shape that anchors the implant and prevents dislodgement before the proximal portion is inflated, thereby eliminating the risk of implant dislodgement and enabling position adjustment capability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The conventional inflation pattern inflates the proximal portion first, but this invention inverts the sequence by inflating the distal portion first. This reversal of the inflation sequence fundamentally changes the pressure distribution pattern, preventing the high pressure that causes implant dislodgement while maintaining the ability to adjust implant position

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If the proximal portion of the balloon is inflated first, then high pressure is generated in that region, but this pressure dislodges the implant distally and creates unstable inflation

Engineering Contradiction:
Improveinflation speedVSAvoidinflation stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The distal portion is inflated first as a preliminary action, creating a tapered shape that stabilizes the implant position. Only after this preliminary stabilization is achieved is the proximal portion inflated, which prevents unstable high-pressure inflation from dislodging the implant while maintaining efficient inflation productivity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The covering is designed to dynamically change its compression state on the proximal region during inflation. At lower inflation pressures, the covering maintains compression to prevent proximal inflation and ensure distal inflation first. As pressure increases, the covering progressively transitions from a compressed state to a less compressed state, allowing controlled proximal inflation while maintaining stability

Inventive Principle:
Principle #15Dynamics

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

This approach ensures controlled balloon inflation, preventing implant dislodgement and allowing for precise positioning and expansion of cardiovascular devices during transvascular procedures.

Implementation Method 1

flowing a fluid into the balloon causes a rise in an inflation pressure

Methodology Applied
Scientific EffectPressure increase: Pressure Increase

Implementation Method 2

flowing a fluid into the balloon

Methodology Applied
Scientific EffectFluid pressure: Pressure Gradient

Implementation Method 3

compressing a proximal region of the balloon by exerting pressure on the proximal region of the balloon with a covering

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 4

the balloon can be inflated into a shape with generally straighter sides than the tapered shape

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS20230149166A1Controlled balloon deployment
Publication Date: 2023.05.18 EDWARDS LIFESCIENCES CORP
  • US20230149166A1 patent drawing
  • US20230149166A1 patent drawing
  • US20230149166A1 patent drawing

AI summary

The methods and devices disclosed herein promote temporal control of balloon inflation patterns. The devices include a covering for a portion of the balloon that compresses the balloon portion during the inflation process. This enables the distal portion of a balloon to be inflated prior to the proximal portion of a balloon, creating a tapered shape at lower inflation pressures. This is especially useful during transvascular implantation procedures, as it prevents dislodgement of an implant mounted on the balloon. As inflation continues, pressure exerted on the balloon by the covering is overcome such that the proximal region of the balloon inflates, forming a shape with generally straighter sides than the tapered shape, thereby expanding the cardiovascular device.