Disposable Infusion Assembly with Pressure Sensing for Epidural Space Identification

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Solution Overview

Problem

Current epidural injection techniques face challenges in accurately identifying the fluid-filled epidural space due to subjective methods, leading to potential misplacement of the needle, excessive fluid administration into non-target tissues, and increased risk of tissue damage or nerve damage.

Innovation Solution

A method and device that utilize pressure measurements to control fluid flow, stopping injection when a predetermined pressure is reached and resuming when the pressure drops below a set value, ensuring accurate placement and minimizing fluid administration into non-target tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If pressure sensing is implemented to identify fluid-filled spaces, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improveidentification accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the pressure sensing capability with the existing fluid delivery system by integrating a pressure sensor into the syringe assembly. The sensor is positioned within the fluid pathway to detect pressure changes that indicate needle entry into the target fluid-filled space, merging diagnostic and therapeutic functions into a single integrated device.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system implements real-time pressure feedback by continuously monitoring fluid pressure during injection. When the pressure sensor detects a characteristic pressure pattern indicating needle entry into the target space, the system provides feedback to control the injection process, automatically adjusting or stopping fluid delivery to prevent over-injection into non-target tissues.

Inventive Principle:
Principle #23Feedback

2Productivity

If continuous fluid flow is used to identify fluid-filled spaces, then productivity is improved, but loss of substance increases

Engineering Contradiction:
Improveidentification speedVSAvoidfluid loss
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The patent employs periodic or pulsatile fluid flow instead of continuous flow to identify fluid-filled spaces. The system delivers fluid in controlled pulses, monitoring pressure responses between pulses. This periodic action maintains identification speed by systematically probing the tissue while significantly reducing total fluid consumption compared to continuous flow methods.

Inventive Principle:
Principle #19Periodic action

Solution Approach 2:

The system uses partial action by delivering only the minimum necessary fluid volume required to detect pressure changes indicating target space entry. Rather than using excessive continuous flow to ensure identification, the controlled pulsatile delivery provides just enough fluid to generate detectable pressure signals, minimizing waste while maintaining identification capability.

Inventive Principle:
Principle #16Partial or excessive action

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

This approach enhances the safety and accuracy of epidural injections by reducing tissue damage and fluid administration errors, providing real-time pressure feedback for precise needle placement and minimizing the risk of complications.

Implementation Method 1

A sensor, such as a pressure sensor, is provided within the disposable assembly for detecting fluid pressure

Methodology Applied
Scientific EffectPressure sensing:

Data Source

PatentUS10946139B2Disposable assembly for drug infusion with pressure sensing for identification of and injection into fluid-filled anatomic spaces
Publication Date: 2021.03.16 MILESTONE SCIENTIFIC INC
  • US10946139B2 patent drawing
  • US10946139B2 patent drawing
  • US10946139B2 patent drawing

AI summary

A disposable fluid flow assembly for operation in connection with a fluid pump configured to provide a flow of fluid to the disposable fluid flow assembly is provided. The disposable fluid flow assembly includes an elongated flexible tube, a needle hub connected with the flexible tube, a pressure sensor for sensing fluid pressure, and an identification circuit embedded connected with the pressure sensor. The identification is configured to provide a plurality of signals to the central controller of the fluid pump when the disposable needle assembly is connected with the fluid pump. The plurality of signals may include various signals, such as a signal to identify physical characteristics of the assembly, a signal to ensure that the assembly is authentic, a signal to ensure that the disposable assembly is not re-used, and/or a signal to ensure that the pressure signal is connected and operating properly.