Sterile Fluid Connector with Parallel Coupling

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Solution Overview

Problem

Existing connectors for fluid handling, particularly in non-sterile environments, fail to maintain fluid sterility and prevent contamination during connection, as they often require handling in non-sterile conditions and lack effective mechanisms for ensuring a sterile connection.

Innovation Solution

A connector system with a fluid leadthrough, a planar contact surface, and a sterile covering, along with a coupling device that engages with a complementary connector in a parallel direction, allowing for a fluid-tight and sterile connection using a single hand, and a locking mechanism to secure the connection against normal operating forces.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If connectors are used in non-sterile surroundings, then ease of operation is improved, but fluid sterility is compromised and contamination risk increases

Engineering Contradiction:
Improveease of operationVSAvoidcontamination risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The connector is provided with a sterile covering (sterile foil) that is applied in advance to the contact surface and fluid leadthrough opening before the connector is used. This preliminary protective action ensures that when the connector is handled in non-sterile surroundings, the critical fluid-contact surfaces remain sterile until the moment of connection, thus resolving the contradiction between ease of operation in non-sterile environments and maintenance of fluid sterility

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A sterile foil (thin film) is used to cover the contact surface and fluid leadthrough opening. This flexible thin film provides a sterile barrier that can be easily applied and removed, allowing the connector to be handled in non-sterile surroundings while maintaining sterility of the fluid path. The foil acts as a temporary protective barrier that is discarded after use, solving the contradiction between operational convenience and contamination prevention

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If a sterile connection is made using traditional methods, then fluid sterility is maintained, but device complexity and number of steps increase

Engineering Contradiction:
Improvefluid sterilityVSAvoidconnection complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sterile covering is integrated as a single component that simultaneously covers both the contact surface and the fluid leadthrough opening. This merged design allows one simple action (removing the sterile covering) to expose both sterile surfaces at once, enabling a sterile connection to be made in one straightforward step rather than requiring multiple separate operations, thus reducing device complexity while maintaining fluid sterility

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The connector is divided into a non-sterile outer portion (housing, coupling device) that can be handled freely, and a sterile inner portion (contact surface, fluid leadthrough opening) protected by the sterile covering. This segmentation allows the non-sterile parts to be manipulated easily while the sterile parts remain protected, simplifying the overall connection process while ensuring sterility where required

Inventive Principle:
Principle #1Segmentation

3Stability of the object's composition

If the coupling device engages perpendicular to the contact surface, then connection stability is improved, but ease of operation with single hand is reduced

Engineering Contradiction:
Improveconnection stabilityVSAvoidease of operation
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The coupling direction is changed from perpendicular (one-dimensional engagement) to parallel with the contact surface (two-dimensional engagement). The coupling device engages the complementary coupling device in a direction parallel to the contact surface, allowing the connection to be made by simply pushing the connectors together laterally. This dimensional change enables single-handed operation while maintaining connection stability through the planar contact surface geometry

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

4Ease of operation

If the contact surface is fully exposed, then ease of operation is improved, but fluid sterility is compromised

Engineering Contradiction:
Improveease of operationVSAvoidfluid sterility
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A flexible sterile foil is used to cover the contact surface and fluid leadthrough opening. This thin film can be easily applied over the exposed surfaces and removed just before connection, allowing the contact surface to remain geometrically exposed and accessible while being sterially protected. The foil provides a removable barrier that maintains sterility without interfering with the ease of operation or alignment during connection

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS9295825B2Connector, connector system and use thereof
Publication Date: 2016.03.29 SARTORIUS STEDIM BIOTECH GMBH
  • US9295825B2 patent drawing
  • US9295825B2 patent drawing
  • US9295825B2 patent drawing

AI summary

A connector assembly has a connector (10) with a fluid leadthrough (20) and a contact device (14). The contact device has an essentially planar contact surface (16) and a fluid leadthrough opening (18) passing through the contact surface (16). A sterile covering (64) sterilely covers at least part of the contact surface (16) and/or an end of the fluid leadthrough opening (20) adjacent the contact surface (16). A coupling device (22) is provided in proximity to the contact surface (16) outwardly from the fluid leadthrough opening (18). The connector assembly further includes a complementary connector (12) with a complementary coupling device (34) that can engage with the coupling device (22) along a coupling direction (40) that is essentially parallel to the contact surface (16).