Drug Delivery System Back Pressure Sensing

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Solution Overview

Problem

Parenteral drug delivery systems face challenges in ensuring precise delivery of drugs due to tissue back pressure, which can lead to incomplete dosing and leakage, especially with higher injection rates and viscous formulations, compromising drug efficacy and increasing the risk of adverse side effects.

Innovation Solution

A drug delivery system equipped with a pressure sensor to detect tissue back pressure during and after injection, allowing for adjusted operation to prevent leakage, including automatic actuation and retraction of the administration member, ensuring complete drug delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If higher injection rates are used to improve productivity, then injection speed increases, but tissue back pressure increases causing incomplete delivery and leakage

Engineering Contradiction:
Improveinjection speedVSAvoiddelivery completeness
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The pressure sensor provides real-time feedback on tissue back pressure during injection. The system monitors pressure levels and automatically adjusts the drive assembly operation or extends dwell time to ensure complete drug delivery even at higher injection rates, preventing both leakage and incomplete delivery.

Inventive Principle:
Principle #23Feedback

2Productivity

If faster injection is performed to reduce treatment time, then productivity improves, but drug leakage increases compromising dosing precision

Engineering Contradiction:
Improvetreatment timeVSAvoiddosing precision
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The pressure sensor monitors tissue back pressure throughout the injection process and during dwell time. This feedback enables the system to detect when injection is complete and when pressure has equalized, ensuring precise dosing delivery even when using faster injection rates to reduce overall treatment time.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system dynamically adjusts the injection profile based on real-time pressure feedback. The drive assembly can modify injection rate, pause for dwell time, and extend or reduce retention time based on pressure equalization, allowing optimized dosing precision with reduced treatment time.

Inventive Principle:
Principle #15Dynamics

3Reliability

If pressure monitoring is added to detect tissue back pressure, then delivery reliability improves, but device complexity increases

Engineering Contradiction:
Improvedelivery accuracyVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The pressure sensor replaces complex mechanical pressure indication systems with an electronic sensing and signaling system. This provides more reliable and precise pressure detection while integrating seamlessly with the electronic drive assembly control, overall reducing system complexity compared to pure mechanical approaches.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If dwell time is extended to allow pressure equalization and prevent leakage, then delivery reliability improves, but treatment time increases

Engineering Contradiction:
Improveleakage preventionVSAvoidtreatment time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The pressure sensor provides real-time feedback during the dwell time period, monitoring when tissue back pressure has equalized with reservoir pressure. This allows the system to determine the precise moment when the administration member can be safely removed without leakage, minimizing dwell time and treatment duration while ensuring complete drug delivery.

Inventive Principle:
Principle #23Feedback

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 reduces the risk of drug leakage and ensures precise dosing by monitoring tissue back pressure, maintaining the integrity of the drug delivery process and enhancing patient safety.

Implementation Method 1

a pressure sensor configured to detect tissue back pressure during use of the drug delivery system

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentUS11660391B2Drug delivery systems and methods with back pressure sensing
Publication Date: 2023.05.30 AMGEN INC
  • US11660391B2 patent drawing
  • US11660391B2 patent drawing
  • US11660391B2 patent drawing

AI summary

Systems and methods for injecting a drug and detecting tissue induced back pressure are disclosed. A drug delivery system may include a reservoir filled or fillable with a drug, an administration member connected or connectable in fluid communication with the reservoir, a drive assembly, and a pressure sensor. The administration member may be configured for insertion into and subsequently retraction from a patient. The drive assembly may be configured to urge the drug from the reservoir to deliver a dose of the drug to the patient via the administration member. The pressure sensor may be configured to detect tissue back pressure during use of the drug delivery system, including after dose completion and prior to retraction of the administration member. The drug delivery system may be controlled in a manner that accounts for the tissue back pressure measurement.