Isolatable Drug Compounding System with Disposable Tubing

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Solution Overview

Problem

Medical drug compounding often requires preparation close to administration to ensure efficacy, but base ingredients can pose risks to personnel, necessitating specialized training and facilities to minimize exposure.

Innovation Solution

A low-cost drug compounding system that fits inside a fume hood, utilizing a single or multiple pumps for mixing, with a disposable mixing tube set and wireless operation, allowing compounding within a sealed environment to prevent exposure and contamination, featuring airtight seals, fume extraction, and remote operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If drug compounding is performed in a separate facility with specialized training requirements, then personnel exposure to drug ingredients is minimized, but device complexity and operational cost increase

Engineering Contradiction:
Improvepersonnel exposure to drug ingredientsVSAvoidfacility complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent extracts the hazardous compounding process from the general hospital environment by implementing a sealed containment system with negative pressure. The compounding chamber is isolated from personnel areas through physical barriers and controlled airflow, allowing drug preparation to occur in a contained space that protects personnel without requiring a completely separate facility.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces an intermediary containment chamber that acts as a buffer between the drug compounding process and personnel. This sealed environment with HEPA filtration and negative pressure serves as a mediator that allows necessary operations to occur while preventing direct exposure, eliminating the need for specialized training in general hospital staff.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If base ingredients are prepared in advance, then compounding efficiency increases, but risk of personnel exposure to concentrated ingredients increases

Engineering Contradiction:
Improvecompounding efficiencyVSAvoidpersonnel exposure to concentrated ingredients
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent enables preliminary preparation of drug ingredients within the sealed containment chamber. Base ingredients can be reconstituted, mixed, and stored in the containment environment before patient-specific compounding is required. This preliminary action occurs in a protected environment, eliminating exposure risk while maintaining readiness for efficient compounding when needed.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent creates an inert protective environment through negative pressure and HEPA filtration within the containment chamber. This controlled atmosphere allows ingredients to be prepared and stored without personnel exposure risk, as the containment system acts as an inert barrier that maintains separation between concentrated ingredients and hospital staff.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

3Object-affected harmful factors

If a disposable mixing tube set is used, then personnel exposure risk is reduced, but device complexity and waste generation increase

Engineering Contradiction:
Improvepersonnel exposure riskVSAvoiddisposable tubing waste
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The patent employs disposable mixing tube sets that are inexpensive and single-use. These tubes are discarded after a single compounding operation, eliminating the need for complex cleaning and sterilization procedures. The low cost of the disposable tubes makes the waste acceptable compared to the value of personnel safety and the complexity avoided by not requiring reusable component sterilization.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Ease of operation

If compounding is performed outside a sealed environment, then operational simplicity increases, but contamination and exposure risks increase

Engineering Contradiction:
Improveoperational simplicityVSAvoidcontamination and exposure risks
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent uses flexible membrane filters and sealed chambers that maintain containment while allowing necessary operations. The flexible nature of the containment components allows for easy setup and operation without complex rigid structures, maintaining simplicity while providing effective separation between the compounding environment and personnel areas.

Inventive Principle:
Principle #30Flexible shells and thin films

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 system effectively minimizes operator exposure to drug ingredients by enabling safe, contained compounding within a sealed environment, ensuring proper mixing and disposal without disconnection of tubing, while allowing remote operation and integration with fume extraction systems.

Implementation Method 1

a peristaltic pump held within the internal cavity; and where the first, second, and third shut off valves and the peristaltic pump are configured to receive a mixing tube assembly having a central tube section providing a compliant wall surrounding a lumen for receipt of the central tube section by the peristaltic pump for pumping material through the central tube section by flexure of the wall of the central tube section

Methodology Applied
Scientific EffectPeristalsis: Peristalsis

Data Source

PatentUS11148109B2Isolatable automatic drug compounding system
Publication Date: 2021.10.19 ZYNO MEDICAL LLC
  • US11148109B2 patent drawing
  • US11148109B2 patent drawing

AI summary

A low-cost drug compounding system that can practically fit inside of a fume hood or the like is provided. The system can use a single pump operable in forward and reverse directions (or multiple pumps) to compound complex mixtures particularly including those requiring the creation of solutions from dry or powdered ingredients. A wireless link allows operation of the system remotely. In one embodiment, the system uses a disposable mixing tube set that can be discarded after mixing while still attached to the base ingredient containers used for the compounding thereby minimize the chance of personnel exposure.