Mitomycin-C Reconstitution Kit with Sealed Absorbent Tray

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Solution Overview

Problem

Mitomycin-C, a chemotherapeutic agent used in cancer and ophthalmic treatments, is hazardous and highly unstable, making it difficult to handle and use effectively in ophthalmologic procedures due to its toxic nature and short shelf life.

Innovation Solution

A kit containing a vial of mitomycin-C, a syringe, and a diluent carrier with sterilized water, along with a mixing tray, where the drug is reconstituted and absorbed into absorbent pads within a sealed compartment, allowing for safe and simplified preparation and transient application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mitomycin-C is handled and prepared traditionally, then the drug can be used for treatment, but the hazardous and unstable nature of the drug makes it difficult to handle and use effectively

Engineering Contradiction:
Improvesafe handlingVSAvoiddifficulty to handle
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system divides the drug preparation process into separate, contained steps: the vial contains the powdered drug, the carrier contains the diluent, and the tray provides a sealed workspace. This segmentation isolates the hazardous drug from the operator until the moment of use, improving safety while maintaining ease of operation through predefined, simple steps.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The tray acts as an intermediary between the operator and the hazardous drug. It provides a sealed compartment that contains the reconstitution process, allowing the operator to work with the drug in a controlled environment without direct exposure. The tray mediates the interaction between the operator, the hazardous drug, and the disposal system.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If mitomycin-C is prepared in advance, then it can be used for treatment, but the drug is highly unstable with a brief shelf life

Engineering Contradiction:
Improvereadiness for useVSAvoidshelf life
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The system prepares everything except the actual drug reconstitution in advance: the vial is pre-filled with powder, the carrier is pre-filled with sterilized diluent, and the tray is pre-assembled with absorbent pads. This preliminary preparation eliminates the need for on-site drug preparation, ensuring the drug remains stable until the moment of use while maintaining immediate readiness for treatment.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The unstable drug substance is extracted from the preparation process and placed in a stable, sealed vial. The reconstitution process is extracted and contained within the sealed tray compartment. This separation allows the drug to maintain stability in its sealed form while enabling easy preparation when needed.

Inventive Principle:
Principle #2Taking out (Extraction)

3Ease of operation

If a complete reconstitution system is provided, then safe and simplified preparation is enabled, but the device complexity increases

Engineering Contradiction:
Improvesimplified preparationVSAvoidnumber of components
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The system merges multiple functions into integrated components: the tray combines the mixing surface, containment barrier, and disposal receptacle into a single unit. The vial and carrier are designed as integrated containers that work together as a single reconstitution system. This merging reduces the number of separate components while maintaining simplified operation through a cohesive, interconnected design.

Inventive Principle:
Principle #5Merging (Combining)

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

Enables safe and simplified preparation and application of mitomycin-C by providing a protective enclosure for the components, ensuring safe handling and disposal, and extending the drug's shelf life through reconstitution and absorption into absorbent pads.

Implementation Method 1

Withdrawing the plunger from the syringe creates a vacuum that exerts a suction force that is communicated through the tray second passageway, the compartment interior, and the tray first passageway to the interior of the diluent carrier. The reconstituted pharmaceutical in the diluent carrier is drawn by the suction force into the tray compartment interior

Methodology Applied
Scientific EffectSuction: Suction

Implementation Method 2

The reconstituted pharmaceutical in the diluent carrier is drawn by the suction force into the tray compartment interior where the reconstituted pharmaceutical is absorbed into the one or more absorbent pads contained in the tray compartment

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS8186511B2Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Publication Date: 2012.05.29 MOBIUS THERAPEUTICS LLC
  • US8186511B2 patent drawing
  • US8186511B2 patent drawing
  • US8186511B2 patent drawing

AI summary

An apparatus for preparing a pharmaceutical for transient application includes a tray having a sealed compartment, a vial of an ophthalmic formulation of mitomycin-C, a diluent carrier containing sterilized water, and a syringe that are all contained together in a single package. The component parts of the apparatus are used together to reconstitute the contents of the vial with the water in the diluent carrier, and then draw the reconstituted drug into the sealed compartment of the tray by a suction force produced by the syringe. In the tray compartment, the reconstituted drug is absorbed in an absorbent pad. The tray is opened to remove the pad and the absorbed drug from the tray compartment for use of the pad in transient application of the drug.