Motorized Suprachoroidal Injection Needle for Retinal Delivery

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Solution Overview

Problem

Current methods for treating macular degeneration, particularly in the subretinal layer, face challenges in accessing the macula due to its location at the back of the eye and under the delicate retina, making it difficult to deliver therapeutic agents effectively and safely.

Innovation Solution

A surgical instrument with a flexible cannula and slidable actuation assembly is designed to administer therapeutic agents from a suprachoroidal approach, featuring a nitinol needle that can be advanced obliquely to penetrate the choroid without damaging the retina, allowing for precise delivery between the sclera and choroid layers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle is inserted directly into the subretinal layer through the retina, then therapeutic agent delivery to the macula is achieved, but the risk of retinal damage and surgical complexity increases

Engineering Contradiction:

Improvesafety of retinal deliveryVSAvoidsurgical approach complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Instead of approaching the subretinal space from the retinal side (anterior to posterior), the invention approaches from the suprachoroidal space (posterior to anterior), effectively reversing the traditional surgical pathway. The needle is inserted through the sclera into the suprachoroidal space and then advanced to pierce the choroid and enter the subretinal layer, avoiding direct manipulation of the retina during insertion.

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The invention uses the suprachoroidal space as an intermediary pathway to reach the subretinal layer. By first accessing this intermediate space between the sclera and choroid, the surgeon can position the needle accurately before piercing the choroid to enter the subretinal space, providing a staged approach that reduces risk.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If manual actuation of the needle is used, then the device structure is simpler, but the precision and control of needle advancement deteriorates

Engineering Contradiction:

Improveneedle positioning accuracyVSAvoidactuation mechanism complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The invention replaces manual mechanical actuation with a motorized drive mechanism. A motor coupled to a lead screw advances the needle in a controlled manner, providing precise positioning through mechanical feedback and automated control, eliminating the imprecision of manual manipulation.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention incorporates feedback mechanisms where the motorized actuation system responds to positional information to control needle advancement. The system can detect needle position and adjust actuation accordingly, ensuring accurate delivery to the target subretinal location while preventing over-penetration.

Inventive Principle:

Principle #23Feedback

3Productivity

If the needle is advanced sharply to penetrate the choroid quickly, then the procedure time is reduced, but the trauma to the choroid and risk of retinal perforation increases

Engineering Contradiction:

Improvespeed of choroid penetrationVSAvoidtissue trauma and perforation risk

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The motorized lead screw mechanism provides periodic, controlled advancement of the needle rather than a single sharp thrust. The needle advances in controlled increments through the choroid, allowing for regulated penetration that minimizes tissue trauma while maintaining procedural efficiency.

Inventive Principle:

Principle #19Periodic 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 enables safe and precise delivery of therapeutic agents to the subretinal space, minimizing trauma and allowing for effective treatment of macular degeneration by accessing the target area with high accuracy and minimal risk of retinal perforation.

Implementation Method 1

the actuation member comprises an automated actuation assembly and an activation element configured to activate the automated actuation assembly

Methodology Applied

Scientific EffectAutomated actuation:

Implementation Method 2

a needle that is slidable relative to the cannula, wherein the needle comprises a distal sharp end configured to penetrate the choroid

Methodology Applied

Scientific EffectNeedle penetration:

Data Source

PatentEP3191033B1Motorized suprachoroidal injection of therapeutic agent

Publication Date: 2019.11.06 ORBIT BIOMEDICAL LTD

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AI summary

An apparatus for delivering therapeutic agent to an eye comprises a body, a cannula, a hollow needle, and an automated actuation assembly. The cannula extends distally from the body and is sized and configured to be insertable between a choroid and a sclera of a patient's eye. The actuation assembly is operable to actuate the needle relative to the cannula to thereby drive a distal portion of the needle along an exit axis that is obliquely oriented relative to the longitudinal axis of the cannula. The cannula may be inserted through a sclerotomy to position a distal end of the cannula at a posterior region of the eye, between the choroid and sclera. The needle may be advanced through the choroid to deliver the therapeutic agent adjacent to the potential space between the neurosensory retina and the retinal pigment epithelium layer, adjacent to the area of geographic atrophy.