Variable Diameter Microneedle for Ocular Drug Delivery

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Solution Overview

Problem

Current methods for delivering drugs to the posterior region of the eye, such as macular degeneration and diabetic retinopathy, face challenges due to the difficulty in accurately inserting needles to the desired depth and controlling the insertion force, leading to inefficiencies and potential damage to the eye.

Innovation Solution

A microneedle device with a variable diameter lumen and a hub portion that allows for precise control of insertion depth and reduced insertion force, featuring a beveled tip for easy penetration and a sealing surface to prevent leakage, facilitating targeted delivery to the suprachoroidal space.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a needle is used for direct injection into the eye, then effective drug delivery to the posterior region is achieved, but significant safety risks and potential damage to the eye occur

Engineering Contradiction:
Improvedrug delivery efficacyVSAvoideye damage risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a thin film ocular prosthesis that integrates drug delivery functionality. The prosthesis is made of a flexible, biocompatible material that conforms to the ocular surface, allowing for controlled drug release directly to the posterior region without the need for invasive needle injection, thereby maintaining efficacy while eliminating the risk of mechanical damage associated with needles.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The invention replaces the mechanical needle injection system with a passive or actively controlled drug delivery system embedded in the prosthesis. This substitution eliminates the need for forceful mechanical penetration, using instead controlled diffusion, osmosis, or programmed release mechanisms to achieve effective drug delivery to the target region.

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

2Productivity

If conventional needles are used for injection, then drug delivery is achieved, but controlling the depth and force of insertion becomes challenging

Engineering Contradiction:
Improvedrug delivery capabilityVSAvoidinsertion depth control
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The patent replaces the manual needle insertion mechanism with an integrated drug delivery system in the prosthesis. The drug delivery is achieved through controlled release mechanisms embedded in the prosthesis material, eliminating the need for manual depth control and force application during insertion.

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

Solution Approach 2:

The prosthesis is designed to self-deliver the drug through controlled release mechanisms. The drug delivery system within the prosthesis automatically regulates the release rate and depth of drug delivery without requiring external control, thereby simplifying the insertion and delivery process.

Inventive Principle:
Principle #25Self-service

3Measurement precision

If a variable diameter cannula is used, then precise control of insertion depth is achieved, but the device complexity increases

Engineering Contradiction:
Improveinsertion depth precisionVSAvoidcannula structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent uses a thin film prosthesis structure that inherently provides controlled depth of interaction with ocular tissues. The flexibility and conformability of the thin film allow it to naturally limit insertion depth to the appropriate tissue layer without requiring complex variable diameter structures or additional control mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS9956114B2Variable diameter cannula and methods for controlling insertion depth for medicament delivery
Publication Date: 2018.05.01 CLEARSIDE BIOMEDICAL INC
  • US9956114B2 patent drawing
  • US9956114B2 patent drawing
  • US9956114B2 patent drawing

AI summary

An apparatus includes a microneedle that defines a lumen therethrough. The microneedle has a proximal end portion a distal end portion and a hub portion between the proximal end portion and the distal end portion. The proximal end portion is configured to be coupled to a medicament container, such as, for example a syringe. The portion of the lumen within the proximal end portion has a first diameter. The distal end portion is configured to pierce a target tissue. The portion of the lumen within the distal end portion has a second diameter smaller than the first diameter. The hub portion includes a surface configured to contact the target tissue when the distal end portion is disposed with the target tissue.