Concurrent TPN and Insulin Infusion via Segmented Lines

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Solution Overview

Problem

Current infusion systems for total parenteral nutrition (TPN) and insulin administration are complex and time-consuming, particularly in managing hyperglycemia, as they require manual modulation of insulin dosing and premixing of insulin with TPN solutions, increasing the risk of errors and complications.

Innovation Solution

A concurrent infusion system that uses a fluid administration set with separate lines for TPN and insulin solutions, a pump, and a flow controller to vary the ratio of TPN to insulin delivery based on glucose levels, allowing for simultaneous and controlled administration without premixing, and enabling ramping and tapering of infusion rates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If insulin is premixed in the same IV bag with TPN solution, then the administration process is simplified, but the risk of errors and complications increases

Engineering Contradiction:
Improveadministration processVSAvoidrisk of errors
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system divides the insulin and TPN solution delivery into separate independent lines (Line A for TPN, Line B for insulin) that converge at a common outlet. This segmentation allows each solution to be controlled separately through individual syringes and pumps, eliminating the need for premixing while maintaining administrative simplicity through integrated control.

Inventive Principle:
Principle #1Segmentation

2Adaptability or versatility

If manual modulation of insulin dosing is used, then flexibility in dosing is achieved, but the complexity and time consumption increase

Engineering Contradiction:
Improvedosing flexibilityVSAvoidmodulation complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system incorporates a glucose sensor that continuously monitors blood glucose levels and provides feedback to the controller. The controller automatically adjusts the insulin dosing rate based on this feedback, maintaining dosing flexibility while eliminating manual modulation complexity. The controller can also adjust TPN delivery rate in response to glucose levels.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system enables self-adjusting insulin and TPN delivery through automated control based on glucose sensor feedback. The controller automatically modulates the dosing rates without requiring manual intervention, reducing operational complexity while maintaining adaptability to changing glucose levels.

Inventive Principle:
Principle #25Self-service

3Reliability

If separate lines for TPN and insulin are used, then the risk of errors is reduced, but the device complexity increases

Engineering Contradiction:
Improveerror reductionVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system merges the control of separate TPN and insulin delivery lines into a single integrated pump and controller unit. While the fluid paths remain separate for safety, the control functions are combined, allowing centralized management of both infusions through one interface, thereby reducing operational complexity despite maintaining separate delivery lines.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The pump system is designed to handle multiple functions: it can independently control TPN delivery through Line A, insulin delivery through Line B, and automatically adjust both based on glucose sensor feedback. This multi-functionality is integrated into a single device, reducing the need for multiple separate devices while maintaining the safety benefits of separate lines.

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Reliability

If TPN delivery is tapered to 50% to minimize hyperglycemia, then glycemic control is improved, but the treatment effectiveness is reduced

Engineering Contradiction:
Improveglycemic controlVSAvoidtreatment effectiveness
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The glucose sensor provides continuous feedback on blood glucose levels, allowing the controller to dynamically adjust both TPN and insulin delivery rates. This eliminates the need for fixed 50% tapering, enabling full TPN delivery when appropriate while maintaining glycemic control through automated insulin adjustment and selective TPN modulation based on real-time glucose monitoring.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3233157B1Infusion system with concurrent TPN/insulin infusion
Publication Date: 2023.08.30 ICU MEDICAL INC
  • EP3233157B1 patent drawingFigure 1
  • EP3233157B1 patent drawingFigure 1A
  • EP3233157B1 patent drawingFigure 2~3A

AI summary

An infusion system to provide concurrent TPN/insulin infusion including: a fluid administration set having a primary line in fluid communication with the TPN source, a secondary line in fluid communication with the insulin source, and a common outlet line; a pump operable to removably receive the fluid administration set, the pump being operable to concurrently move the TPN solution through the primary line in response to a TPN solution flow rate signal and the insulin solution through the secondary line in response to an insulin solution flow rate signal; and a flow controller operable to provide the TPN solution flow rate signal and the insulin solution flow rate signal to the pump. The flow controller is further operable to vary the TPN solution flow rate signal and the insulin solution flow rate signal to vary a ratio of TPN solution to insulin solution provided to the common outlet line.