CED Device Tissue Compression Seal Backflow Reduction

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Solution Overview

Problem

Convection-enhanced delivery (CED) systems face challenges with fluid backflow during drug infusion, particularly in brain tissue due to its poroelastic nature, which affects the distribution and penetration of drugs, and there is a need for improved systems and methods for extended drug delivery and monitoring.

Innovation Solution

The development of CED devices with a tissue-receiving space that compresses tissue to form a seal, reducing backflow, and includes features like a bullet-shaped nose for better tissue engagement, along with an implantable delivery system that includes percutaneous access, trunk lines, manifold, and skull anchors for long-term implantation, and integrated sensors for monitoring various parameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If infusion velocity is increased to enhance drug penetration into target tissue, then drug distribution improves, but fluid backflow along the insertion pathway increases

Engineering Contradiction:
Improvedrug penetration rateVSAvoidfluid backflow
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The patent applies preliminary action by pre-compressing the tissue around the catheter insertion site before drug infusion begins. This creates a sealed environment that prevents backflow before the infusion process starts, allowing higher infusion velocities to be used without compromising drug distribution or causing fluid loss through reflux.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the physical state of the tissue by compressing it to alter its poroelastic properties. This compression reduces tissue porosity and increases resistance to fluid flow, thereby preventing backflow while maintaining the ability to deliver drugs at optimized velocities for effective penetration.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If flexible microcatheter design is used to reduce backflow, then device adaptability improves, but sealing effectiveness against backflow remains insufficient in poroelastic tissue

Engineering Contradiction:
Improvecatheter flexibilityVSAvoidbackflow prevention
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent uses preliminary action by pre-compressing the tissue around the catheter before infusion begins. This creates a sealed environment that prevents backflow before the infusion process starts, allowing higher infusion velocities to be used without compromising drug distribution or causing fluid loss through reflux.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the physical state of the tissue by compressing it to alter its poroelastic properties. This compression reduces tissue porosity and increases resistance to fluid flow, thereby preventing backflow while maintaining the ability to deliver drugs at optimized velocities for effective penetration.

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 effectively reduces fluid backflow, enhances drug penetration and distribution, and allows for extended periods of drug delivery and monitoring, improving the efficacy of CED treatments by maintaining a consistent delivery profile and providing real-time feedback for adjusting treatment parameters.

Implementation Method 1

Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 3

In convection-enhanced delivery (CED), drugs are infused locally into tissue through a needle, cannula, or microcatheter inserted into the tissue. Transport of the infused material is dominated by convection, which enhances drug penetration into the target tissue compared with diffusion-mediated delivery or systemic delivery.

Methodology Applied
Scientific EffectConvection: Convection

Implementation Method 4

The system can include one or more inline filters disposed in the branch lines and configured to remove air, gas, bacteria, or particulates from fluid flowing through the branch lines.

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS11534592B2Systems and methods for drug delivery, treatment, and monitoring
Publication Date: 2022.12.27 NEELA THERAPEUTICS INC
  • US11534592B2 patent drawing
  • US11534592B2 patent drawing
  • US11534592B2 patent drawing

AI summary

Systems and methods for delivering a drug or other therapy over an extended period of time (e.g., several hours, days, weeks, months, years, and so forth) are disclosed herein, as are systems and methods for monitoring various parameters associated with the treatment of a patient. Systems and methods are also disclosed herein that generally involve CED devices with various features for reducing or preventing backflow.