Protective Cap Mechanical Membrane Attachment

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Solution Overview

Problem

Existing protective injection devices for medical devices face challenges with production complexity and cost due to temperature-dependent ultrasonic welding of resilient barrier members, which requires precise tensioning and is prone to aging-related tension loss, leading to leakage issues.

Innovation Solution

A protective cap with a membrane holder using a resilient membrane made from medical-grade elastomeric polymers, where the membrane is mechanically attached and tensioned only upon application, eliminating the need for ultrasonic welding and reducing aging-related issues by maintaining a non-tensioned state during storage and transport.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ultrasonic welding is used to attach the resilient barrier member, then the membrane can be securely affixed, but the production process becomes complicated and costly due to temperature dependence and tight tolerances

Engineering Contradiction:
Improvesecure attachment of membraneVSAvoidproduction process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces the thermal ultrasonic welding process with a mechanical attachment system consisting of a holding flange and clamping structure. The membrane is mechanically clamped between the holding flange and the device body, eliminating the need for temperature-dependent welding processes and associated quality control complexities.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts the membrane attachment function from the complex ultrasonic welding process and implements it through a simple mechanical clamping mechanism. The holding flange structure separates the membrane securing function from the main device body, allowing for straightforward assembly without specialized equipment.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If the barrier member is highly tensioned during mounting, then the piercing site closes completely, but the piercing member may punch out a piece of the membrane

Engineering Contradiction:
Improvecomplete closing of piercing siteVSAvoidmembrane integrity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent implements a dynamic tensioning system where the membrane tension is adjusted based on the operational state. During storage and transport, the membrane is held in a relaxed state by the holding flange. When the device is activated and the piercing member is inserted, the membrane automatically tensions to provide complete sealing, preventing both premature punching and incomplete closure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The holding flange structure is designed to pre-position the membrane in a relaxed state during manufacturing and storage. The membrane is tensioned only when needed during actual use, after the piercing member has been inserted and begun to pull the membrane taut. This preliminary positioning prevents excessive tension during handling while ensuring adequate tension during operation.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If the barrier member is mounted with predetermined tensioning compression, then the membrane is ready for use, but the membrane loses tension over time due to aging

Engineering Contradiction:
Improvemembrane readiness for useVSAvoidtension maintenance over time
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent transitions from a static pre-tensioned mounting system to a dynamic tensioning system. The holding flange maintains the membrane in a relaxed state during storage and transport, preventing aging-related tension loss. When the device is activated, the membrane automatically tensions to the required level, ensuring consistent performance throughout the product lifecycle without degradation from prolonged tensioning.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If the piercing member is movable with respect to the sealing member, then the piercing can be performed, but the sealing member may not close completely after removal

Engineering Contradiction:
Improvepiercing capabilityVSAvoidsealing completeness after removal
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements a self-service sealing mechanism where the membrane automatically tensions and seals the piercing site without requiring additional components or complex mechanisms. The holding flange structure allows the piercing member to move freely during insertion, and the membrane's elastic properties enable it to automatically return to its sealed state after the piercing member is removed, ensuring complete closure.

Inventive Principle:
Principle #25Self-service

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 simplifies the assembly process, reduces production costs, and enhances the membrane's lifespan by applying tension only when needed, ensuring a reliable seal against leakage and contamination.

Implementation Method 1

a resilient membrane (18) arranged to cover the opening (15), the resilient membrane (18) comprising a piercing portion (20) and a sealing portion (22)

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the attachment means being an adhesive attachment means or a mechanical attachment means or a combination of an adhesive attachment means and a mechanical attachment means

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS9956138B2Protective cap
Publication Date: 2018.05.01 CARMEL PHARMA
  • US9956138B2 patent drawing
  • US9956138B2 patent drawing
  • US9956138B2 patent drawing

AI summary

A protective cap (1) for application on a medical device such as a medical vial (2) comprising a membrane holder (3) in which a resilient membrane (18) is mounted. The protective cap (1) is provided with connection means (10) for connecting the cap (1) to the medical device (2). The resilient membrane (18) comprises a piercing portion (20) and a sealing portion (22) and is mechanically and/or adhesively held in the protective cap (1) and is arranged to be brought into sealing contact with a receiving portion of the medical device (2) when the protective cap (1) is applied on the medical device (2).