Closed System Transfer Device Adaptor Sealing and Pressure Equalization

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Solution Overview

Problem

Closed system transfer devices (CSTDs) face challenges in preventing the inflow of contaminants and release of hazardous vapors during drug transfer, as they often lack effective pressure equalization systems, leading to the generation of fine aerosols that can expose environments and healthcare professionals to hazardous drugs.

Innovation Solution

A closed system transfer device is designed with a first and second adaptor that form a sealed fluid passage between reservoirs, featuring a carrier that displaces to seal or open the fluid path, and a releasable lock mechanism to secure the adaptors in place, ensuring a closed system is maintained during transfer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a closed system transfer device is used to transfer medication between reservoirs, then the potential for drug aerosolization and hazardous drug exposure is limited, but differences in pressure between reservoirs can lead to the generation of fine aerosols that escape into the air

Engineering Contradiction:
Improveprevention of hazardous drug exposureVSAvoidgeneration of fine aerosols
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The CSTD is divided into separate adaptors (first adaptor and second adaptor) that can be connected to different reservoirs. Each adaptor has its own sealing mechanism with septa that can independently manage pressure differentials, preventing aerosol generation at the interface between reservoirs while maintaining the closed system.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary fluid pathway with movable carriers that act as pressure-equalizing elements. These carriers move in response to pressure differentials and open/close fluid pathways accordingly, allowing pressure equalization between reservoirs without direct communication that would cause aerosolization.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If a sealed fluid passage is maintained between reservoirs, then contaminants are prevented from entering and hazardous vapors are prevented from releasing, but pressure equalization is compromised leading to aerosol generation

Engineering Contradiction:
Improveinflow of contaminantsVSAvoidpressure equalization
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent employs dynamic sealing elements (movable carriers with septa) that can change their position and sealing state in response to pressure differentials. When pressure equalization is needed, the carriers move to open positions that allow controlled pressure balancing while maintaining contamination barriers. When sealing is prioritized, the carriers return to sealed positions.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the physical state and position of movable carriers based on pressure parameters. The carriers transition between sealed positions (preventing contaminant inflow) and open positions (allowing pressure equalization), dynamically adjusting the system's sealing and pressure-balancing properties based on operational needs.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If adaptors are securely locked together to maintain a closed system, then the sealed fluid passage is maintained, but the device complexity increases with additional locking mechanisms

Engineering Contradiction:
Improvemaintenance of closed systemVSAvoidlocking mechanism structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The locking mechanism is designed to automatically engage and lock the first and second adaptors together when they are brought into proximity for connection. The system uses self-actuating features such as spring-loaded locking elements or snap-fit mechanisms that require no additional操作步骤 beyond the basic connection action, thereby maintaining reliability without significantly increasing operational complexity.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS20240216222A1Closed system transfer device
Publication Date: 2024.07.04 B BRAUN MELSUNGEN AG
  • US20240216222A1 patent drawing
  • US20240216222A1 patent drawing
  • US20240216222A1 patent drawing

AI summary

A closed system transfer device includes a first adaptor and a second adaptor that attach with one another in a coupled state to form a sealed fluid passage between two reservoirs. The first adaptor can be attached to a first reservoir, and the second adaptor can be attached to a second reservoir. One or both adaptors can include a septum that engages another septum during coupling and decoupling to prevent liquid or vapor from being released to the environment. The device can also include a vent line that equalizes pressure between the two reservoirs. The vent line can include at least one filter to filter gas in device. In addition, or in the alternative, the vent line can be connected in fluid communication with an inflatable membrane that stores gas inside the device and assists in equalizing pressure.