Expandable Sterile Enclosure with Integrated Fenestration

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Solution Overview

Problem

Current medical procedures face challenges in maintaining a sterile environment during surgeries, as existing methods require extensive setup and can compromise sterility due to the need for protective equipment and manual draping, leading to inefficiencies and potential contamination risks.

Innovation Solution

An expandable enclosure system with a patient-interfacing barrier and support system that creates a sterile environment by inflating with filtered air, featuring a fenestration for access and integrated gloves and supplies, which can be easily set up over a patient to maintain sterility without the need for additional protective gear.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional manual draping and protective equipment are used, then sterility can be maintained, but setup time increases and complexity increases

Engineering Contradiction:

Improvesterility maintenanceVSAvoidsetup time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent combines multiple sterile draping functions into a single pre-packaged enclosure system that includes the barrier, support system, and integrated gloves, eliminating the need for separate manual draping steps and reducing setup time while maintaining sterility

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The enclosure system is pre-assembled and pre-packaged in a sterile state before the procedure, with all components (barrier, support system, gloves) prepared in advance, allowing for rapid deployment without time-consuming manual setup in the operating room

Inventive Principle:

Principle #10Preliminary action

2Reliability

If traditional manual draping and protective equipment are used, then sterility can be maintained, but device complexity increases

Engineering Contradiction:

Improvesterility maintenanceVSAvoidsetup complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the barrier, support system, and gloves into a single integrated enclosure unit, reducing the number of separate components and steps required for setup, thereby simplifying the overall device complexity while maintaining sterile barriers

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The enclosure system serves multiple functions simultaneously: it provides the sterile barrier, structural support, and integrated gloves, eliminating the need for multiple separate protective equipment items and reducing the complexity of managing multiple separate components

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Adaptability or versatility

If the enclosure is expandable to fit different patients, then adaptability improves, but device complexity increases

Engineering Contradiction:

Improveenclosure adaptabilityVSAvoidenclosure structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The barrier is designed as an expandable structure that can be inflated or expanded to accommodate different patient sizes and anatomical positions, providing adaptability while using a simple mechanical expansion mechanism rather than complex adjustable components

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The enclosure volume and shape are adjusted by changing the inflation parameter of the expandable barrier, allowing it to adapt to different patients and procedural requirements through a single parameter change rather than multiple structural adjustments

Inventive Principle:

Principle #35Parameter changes

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 system effectively maintains a sterile environment during medical procedures by providing a controlled, filtered space that reduces the risk of contamination and streamlines setup, saving time and resources while ensuring patient safety.

Implementation Method 1

The enclosure further includes an inline high-efficiency particulate-arresting ("HEPA") air filter configured to prevent microbial contamination of the sterile environment inside of the enclosure

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

The air inlet is configured for introducing filtered air into the inside of the enclosure for inflating the expandable portion of the barrier from the unexpanded state to the expanded state

Methodology Applied

Scientific EffectGas pressure: Pressure Increase

Data Source

PatentUS12257191B2Enclosures including systems and methods thereof for establishing a sterile environment for a medical procedure

Publication Date: 2025.03.25 BARD ACCESS SYSTEMS INC

AI summary

A sterile environment system can include an enclosure and a support system. The enclosure can include a barrier separating a sterile environment inside of the enclosure from a non-sterile environment outside of the enclosure. The barrier can include an expandable portion configured to expand from an unexpanded state to an expanded state for working within the sterile environment, and a patient-interfacing portion including a fenestration configured for placement directly over an area of interest of a patient, the fenestration having a sealed state and an unsealed state for access to the area of interest from within the sterile environment. The support system can be coupled to the patient-interfacing portion of the barrier such that it is positioned on at least opposite sides of the fenestration.