Dual-Layer Balloon Structure for Controlled Implant Expansion

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing expandable implants face challenges in controlled expansion and protection against puncture during deployment, with conventional balloons being vulnerable to puncture and fragments dispersing unpredictably when burst.

Innovation Solution

A dual-compliance inflatable device comprising an interior and exterior inflatable body, where the exterior body shields the interior from puncture, controls fluid release, and provides support during inflation, ensuring controlled expansion and retention of fragments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional single-layer balloon is used for implant expansion, then the device structure is simple, but the balloon is vulnerable to puncture and fragments disperse unpredictably when burst

Engineering Contradiction:

Improvepuncture resistanceVSAvoidballoon structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements a dual-layer balloon structure where an inner balloon is nested within an outer balloon. The inner balloon provides the primary expansion function while the outer balloon serves as a protective shell that contains fragments if the inner balloon bursts, thereby resolving the contradiction between puncture resistance and structural complexity.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The balloon system is segmented into two independent functional layers: the inner balloon responsible for expansion and the outer balloon responsible for containment and protection. This segmentation allows each layer to be optimized for its specific function while working together as an integrated system.

Inventive Principle:

Principle #1Segmentation

2Ease of operation

If an expandable implant is deployed percutaneously, then the procedure is minimally invasive, but controlled expansion is challenging and over/under expansion risks exist

Engineering Contradiction:

Improvecontrolled expansionVSAvoiddeployment safety

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The dual-balloon system provides inherent feedback control where the outer balloon's constraints prevent over-expansion of the inner balloon, while the inner balloon's expansion naturally inflates the outer balloon to provide containment. This mutual interaction ensures controlled expansion within safe parameters.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The outer balloon acts as a pre-positioned protective shell that cushions and constrains the inner balloon before expansion occurs. This beforehand protection prevents runaway expansion and contains any fragments if the inner balloon fails, addressing deployment safety concerns.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Object-affected harmful factors

If the interior inflatable body is punctured or bursts, then fluid release is uncontrolled and fragments disperse, but with the exterior body present, fluid release is controlled and fragments are retained

Engineering Contradiction:

Improvefragment dispersionVSAvoiddual-body structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The outer balloon transforms the potentially harmful effect of inner balloon rupture into a beneficial containment mechanism. When the inner balloon bursts, the outer balloon captures fragments and controls fluid release, converting a failure mode into a safety feature.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The outer balloon serves as an intermediary barrier between the inner balloon's contents and the external environment. This intermediate layer mediates the release of fluid and fragments, controlling their discharge rather than allowing uncontrolled dispersion.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 dual-compliance system ensures stable and controlled expansion of implants, reduces the risk of puncture, and facilitates controlled fluid release, enhancing safety and efficacy of implant deployment.

Implementation Method 1

The exterior inflatable body may shield the interior inflatable body from puncture and may provide support during inflation

Methodology Applied

Scientific EffectPhysical barrier protection:

Implementation Method 2

one or more openings at the distal portion configured to allow the fluid within the interior inflatable body to escape the exterior inflatable body when the interior inflatable body is punctured or bursts

Methodology Applied

Scientific EffectGravity-driven fluid flow: Gravitation

Data Source

PatentEP4237064B1Protected pressure-safe balloons

Publication Date: 2026.01.21 EDWARDS LIFESCIENCES CORP

Figure 1~2B
Figure 3A~4
Figure 5~6B

AI summary

The present embodiments relate generally to devices, systems, and methods for an inflatable device. A system may include an interior inflatable body configured to inflate in response to receiving fluid. The system may include an exterior inflatable body at least partially surrounding the interior inflatable body and configured to inflate when the interior inflatable body inflates and apply an expansion force to the surface to dilate the surface, the exterior inflatable body having a distal portion, a proximal portion, and one or more openings at the distal portion configured to allow the fluid within the interior inflatable body to escape the exterior inflatable body when the interior inflatable body is punctured or bursts.