Compounding Junction Structure for Precise Small-Volume Mixing

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Solution Overview

Problem

Compounding devices face inefficiencies in setup time, downtime during ingredient replacement, and accuracy issues, particularly at small volumes, while also requiring improved usability and aseptic maintenance features to prevent errors and ensure precise fluid handling.

Innovation Solution

A pharmaceutical compounding device with a junction structure that combines fluids from multiple sources using a micro and macro pump mechanism, featuring a manifold with separate micro and macro channels, and a transfer set kit with distinct input lines and ports to enhance fluid isolation and accuracy, along with a user-friendly interface and occlusion sensors to minimize errors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional compounding devices use single-channel pumps and manifolds, then device complexity is reduced, but fluid isolation and measurement precision deteriorate at small volumes

Engineering Contradiction:
Improvefluid measurement accuracyVSAvoidpump and manifold structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent divides the fluid delivery system into separate micro-channel and macro-channel pumps, each handling specific fluid paths independently. This segmentation allows precise measurement of small volumes through the micro-channel while maintaining overall system functionality, resolving the contradiction between measurement precision and device complexity by organizing complexity into functional segments.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies different channel configurations to different fluid delivery needs - micro-channels for precise small-volume delivery and macro-channels for larger volumes. This local differentiation optimizes measurement precision where needed without unnecessarily complicating the entire system, as each channel type is tailored to its specific functional requirement.

Inventive Principle:
Principle #3Local quality

2Ease of manufacture

If compounding devices use integrated pump mechanisms, then device complexity is reduced, but ease of cleaning and disinfection deteriorates

Engineering Contradiction:
Improvedevice assemblyVSAvoidcleaning and disinfection
Core Design Contradiction:
Ease of manufactureVSEase of repair

Solution Approach 1:

The patent designs the pump system with separable micro-channel and macro-channel components that can be independently removed and cleaned. This segmentation maintains manufacturing efficiency through modular assembly while dramatically improving cleanability, as each channel can be accessed and disinfected separately without disassembling the entire pump mechanism.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent extracts the channel components from the integrated pump body, allowing them to be removed for cleaning while the main pump mechanism remains in place. This extraction approach preserves the benefits of integration for manufacturing while enabling thorough cleaning of previously inaccessible internal channels.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If traditional devices use single fluid paths, then device complexity is reduced, but reliability deteriorates due to potential cross-contamination

Engineering Contradiction:
Improvefluid isolationVSAvoidfluid path structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent creates completely separate micro-channel and macro-channel fluid paths that do not intersect, eliminating cross-contamination risks. This segmentation achieves superior fluid isolation and reliability while managing complexity through organized, non-interfering channel layouts that can be independently maintained.

Inventive Principle:
Principle #1Segmentation

4Productivity

If compounding devices minimize setup time, then productivity is improved, but measurement precision may deteriorate due to rushed calibration

Engineering Contradiction:
Improvesetup timeVSAvoidcalibration accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent incorporates pre-calibrated micro-channel and macro-channel components that are calibrated during manufacturing. This preliminary calibration eliminates the need for time-consuming on-site calibration procedures, allowing rapid setup while maintaining high measurement precision through factory-prepared calibration standards.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses pre-set calibration parameters stored in the device memory that can be quickly loaded without manual adjustment. This parameter-based approach maintains measurement precision by using validated calibration data while dramatically reducing setup time compared to manual calibration procedures.

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 reduces downtime and improves accuracy at small volumes, facilitates easier cleaning and disinfection, and prevents errors by ensuring precise fluid handling and intuitive operation, maintaining aseptic conditions and efficient compounding processes.

Implementation Method 1

variances in the pump tubing's material, length, elasticity, and diameter

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

Gravimetric devices generally use a peristaltic pump mechanism

Methodology Applied
Scientific EffectPeristalsis: Peristalsis

Implementation Method 3

The volume delivered is calculated by dividing the weight delivered by the specific gravity of the ingredient

Methodology Applied
Scientific EffectGravitation: Gravitation

Data Source

PatentUS11957864B2Compounding device, system, kit, software, and method
Publication Date: 2024.04.16 B BRAUN MEDICAL INC
  • US11957864B2 patent drawing
  • US11957864B2 patent drawing
  • US11957864B2 patent drawing

AI summary

An exemplary pharmaceutical compounding system and device for mixing materials from at least two distinct material sources can include a transfer set and junction structure that has a junction body, a first inlet port located at a first portion of the junction body, a second inlet port located at a second portion of the junction body, and an outlet port located at a third portion of the junction body. The junction structure can be configured to mix fluid received from both the first inlet port and second inlet port and to deliver the fluid to the outlet port. The junction structure can also include attachment structure located on the junction body and configured to attach the junction structure to the housing of the compounding device at a location downstream of a pump system.