Ocular Delivery Device With Solid Separator For Subretinal Injection

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Solution Overview

Problem

Current methods for delivering therapeutic compositions to the subretinal space, such as retinitis pigmentosa and age-related macular degeneration, face challenges like localized distribution, risk of retina detachment, cataract development, and bleeding due to invasive procedures that fail to achieve uniform delivery to the macula.

Innovation Solution

A method and device using a solid separator that advances through the conjunctiva and sclera into the choroid, creating a separation without penetrating the sensory retina, allowing for the injection of fluid compositions into the suprachoroidal or subretinal space, ensuring uniform distribution and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If a sharp injection device is used to penetrate the sclera and deliver composition to the subretinal space, then the composition can be delivered to the subretinal space, but the composition remains localized near the injection site and does not reach the macula

Engineering Contradiction:

Improvecomposition deliveryVSAvoiddistribution uniformity

Core Design Contradiction:

Quantity of substanceVSManufacturing precision

Solution Approach 1:

The injection device is divided into separate functional components: a sharp probe for penetrating the sclera and a separate separator for creating the subretinal space. This segmentation allows each component to be optimized for its specific function while working together to achieve uniform distribution throughout the subretinal space including the macula

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A separator is introduced as an intermediary element between the injection site and the subretinal space. The separator creates a controlled separation that acts as a conduit, allowing the injected composition to flow uniformly throughout the subretinal space and reach the macula rather than remaining localized

Inventive Principle:

Principle #24Intermediary (Mediator)

2Quantity of substance

If a thin flexible catheter is inserted from the front sclera through the subretinal space to deliver composition near the macula, then the composition can reach the macula, but there is risk of severe detachment of the retina from the sclera and damage to the retina

Engineering Contradiction:

Improvecomposition delivery to maculaVSAvoidretina detachment and damage

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

Instead of inserting a catheter from the front sclera through the subretinal space toward the macula, the invention approaches the problem from the opposite direction by using a separator that creates the subretinal space from the rear, eliminating the need for front scleral incisions and reducing the risk of retinal detachment and damage

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The mechanical system of a thin flexible catheter that risks damaging the retina is replaced with a separator-based system that creates the subretinal space through controlled separation without requiring direct manipulation or insertion of delicate structures near the retina, thereby eliminating the risk of retinal detachment and damage

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Quantity of substance

If a sharp rigid cannula is inserted across the eye through the vitreous humor chamber to pierce the sensory retina and deliver composition to the subretinal space near the macula, then the composition can be delivered to the subretinal space, but there is increased chance of cataract development, high ocular pressure and bleeding

Engineering Contradiction:

Improvecomposition delivery to subretinal spaceVSAvoidcataract, ocular pressure, and bleeding

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The procedure is segmented into distinct steps: first creating the subretinal space using a separator, then injecting the composition through a separate passage. This segmentation avoids the need for a single complex vitrectomy-like procedure with rigid cannula, thereby reducing the risks of cataract development, high ocular pressure, and bleeding

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A separator is used as an intermediary to create the subretinal space without requiring direct piercing of the sensory retina or insertion of rigid cannula through the vitreous humor chamber. This intermediary approach eliminates the harmful effects of cataract development, high ocular pressure, and bleeding associated with traditional rigid cannula methods

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS11903879B2Method for delivery of compositions to the eye

Publication Date: 2024.02.20 TEL HASHOMER MEDICAL RES INFRASTRUCTURE & SERVICES LTD

AI summary

The present invention discloses a device suitable for delivery of a fluid composition to an eye, especially therapeutic compositions, comprising: a hollow needle with a bore having a proximal end and a distal end, said distal end configured to pass into a passage in a sclera of an eye, said bore configured to function as a conduit for a fluid from said proximal end to said distal end, and a solid separator having a distal tip, configured to move inside said bore of said hollow needle allowing said distal tip of said separator to protrude from said distal end of said needle.