Closed-Loop Drug Delivery System for Cytokine Release Syndrome Management

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Solution Overview

Problem

Current drug delivery systems fail to effectively manage adverse side effects such as Cytokine Release Syndrome (CRS) induced by immunotherapy agents, requiring frequent monitoring and hospital visits for patients, which is burdensome and may delay timely medical intervention.

Innovation Solution

A closed-loop drug delivery system with integrated sensors and a controller that monitors biological conditions and adjusts drug administration in real-time, allowing for early detection of adverse effects and timely intervention, including the self-administration of counteractive drugs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If patients receive immunotherapy agents, then cancer treatment efficacy is improved, but adverse side effects like CRS occur

Engineering Contradiction:
Improvecancer treatment efficacyVSAvoidadverse side effects
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system pre-positions counteractive drugs in reservoirs and automatically administers them when adverse effects are detected, acting in advance to counteract CRS before it becomes severe

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

Sensors continuously monitor patient biological conditions and feed this information back to the controller, which automatically adjusts drug delivery to counteract adverse effects while maintaining treatment efficacy

Inventive Principle:
Principle #23Feedback

2Reliability

If patients are frequently monitored for adverse effects, then safety is improved, but patient burden and hospital visit requirements increase

Engineering Contradiction:
Improvepatient safety monitoringVSAvoidpatient burden
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system enables self-monitoring through integrated sensors that continuously track patient biological conditions and automatically trigger counteractive drug administration without requiring patient intervention or hospital visits

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Continuous feedback from sensors allows the system to autonomously monitor safety parameters and adjust treatment in real-time, eliminating the need for frequent manual monitoring and hospital visits

Inventive Principle:
Principle #23Feedback

3Measurement precision

If manual monitoring and hospital visits are used, then adverse effect detection is performed, but timely medical intervention is delayed

Engineering Contradiction:
Improveadverse effect detectionVSAvoidintervention delay
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system provides continuous monitoring through integrated sensors that operate without interruption, ensuring adverse effects are detected immediately and counteractive drugs are administered without delay

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system automatically detects adverse effects and administers counteractive drugs without requiring manual intervention, eliminating detection and intervention delays associated with hospital visits

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS20210346601A1Interventional dosing systems and methods
Publication Date: 2021.11.11 AMGEN INC
  • US20210346601A1 patent drawing
  • US20210346601A1 patent drawing
  • US20210346601A1 patent drawing

AI summary

Systems and methods for interventional dosing based on sensed feedback are disclosed. A system may include one or more reservoirs filled or fillable with, respectively, one or more drug products, an administration member, a fluid delivery system, one or more sensors, and optionally a controller. The administration member may be insertable into a patient and connected or connectable in fluid communication with the one or more reservoirs. The fluid delivery system may be operable to deliver the one or more drug products from the one or more reservoirs to the patient via the administration member. The one or more sensors may be operable to sense one or more biological conditions of the patient, including, but not limited to, a cytokine level and/or a biomarker indicative of cytokine release syndrome. The controller may be configured to control operation of the fluid delivery system based on output from the one or more sensors.