Thermoplastic Elastomer Port Welding for Biopharmaceutical Containers

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Solution Overview

Problem

Existing port attachment methods for containers in biopharmaceutical and medical applications are ineffective due to difficulties in gluing polyethylene tubes, leading to durability and leakage issues, as well as contamination risks.

Innovation Solution

A port comprising a rigid annular body with an overmolding member made of thermoplastic elastomer, which includes a sealing portion for needle traversal and an adhesion portion for direct welding to the container, enhancing fluidtightness and reducing contamination risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a polyethylene tube is used to attach the port to the container, then the port can be attached to the container, but the attachment is ineffective and causes durability issues and potential leakage

Engineering Contradiction:

Improveattachment durabilityVSAvoidgluing effectiveness

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces the chemical bonding method (gluing) with a mechanical/thermal bonding method (welding). The port is welded directly to the container using heat fusion, eliminating the need for polyethylene tubes and cyanoacrylate glue. This substitution resolves the contradiction by providing a more reliable attachment that is both easier to manufacture and more durable.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts and removes the polyethylene tube from the assembly. Instead of using a tube as an intermediate component, the port is welded directly to the container. This extraction eliminates the problematic gluing interface and improves both reliability and ease of manufacture.

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If cyanoacrylate glue is used to attach the port to the tube, then the port can be attached, but toxicity issues and contamination risks occur

Engineering Contradiction:

Improveattachment strengthVSAvoidcontamination risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the chemical bonding method (cyanoacrylate glue) with a thermal bonding method (welding). The port is welded directly to the container using heat fusion, eliminating the need for toxic adhesives. This substitution resolves the contradiction by providing strong attachment without the toxicity and contamination risks associated with glue.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If the port is welded directly to the container, then the attachment strength and fluidtightness are improved, but the manufacturing process becomes more complex

Engineering Contradiction:

ImprovefluidtightnessVSAvoidwelding process

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the bonding parameter from chemical (glue) to thermal (welding). By using heat fusion, the port and container are joined through localized melting and fusion of the polymer materials. This parameter change achieves superior fluidtightness and attachment strength while the welding process itself is a standard, well-established technique in the industry.

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 solution provides a strong and fluidtight attachment between the port and the container, reduces the risk of contamination, and ensures reliable sealing after needle withdrawal, improving the overall integrity and safety of the dispensing system.

Implementation Method 1

Because the thermoplastic elastomer constituting the overmolding member has a memory effect, after passage of the needle and its withdrawal during use, the pore opened in the overmolding member by the passage of the needle closes up again

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

the port can be welded directly to a container, significantly improving the strength and fluidtightness of the port with the container

Methodology Applied

Scientific EffectWelding: Welding

Data Source

PatentUS12295911B2Port, dispensing system comprising such a port, and manufacturing method

Publication Date: 2025.05.13 SARTORIUS STEDIM FMT SAS

AI summary

A port is suitable for attachment to a container and suitable for being traversed by a needle used to transfer content between the inside of the container and the outside of the container, and includes a rigid annular body extending in a direction including a side wall surrounding a channel extending between an inner end and an outer end, the inner and outer ends being at opposite ends along the direction, the body being open at the ends, an overmolding member of thermoplastic elastomer including a sealing portion suitable for being traversed by the needle in a direction close to the direction, the needle passing through the inner and outer ends, the overmolding member sealing the channel in a fluidtight manner after withdrawal of a needle and further including an adhesion portion suitable for attaching the port to the container.