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, and increased ocular pressure due to invasive procedures.
Innovation Solution
A method and device utilizing a solid separator to create a separation in the choroid or RPE without penetrating the sensory retina, allowing for uniform distribution of fluid compositions into the suprachoroidal or subretinal spaces by advancing a distal tip through the conjunctiva and sclera, and injecting the composition into the created separation.
Engineering Contradictions & Design Principles
Engineering 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
Solution Approach 1:
A flexible catheter is introduced as an intermediary device to transport the composition from the injection site to the macula. The catheter extends through the subretinal space and delivers the composition to distant locations including the macula, solving the problem of localized distribution. The catheter acts as a mediator that bridges the gap between the injection site and the target area.
Solution Approach 2:
The delivery approach transitions from a point-based injection (0D) to a linear extension through the subretinal space (1D), allowing the composition to be transported along the catheter to distant locations. This dimensional change enables the composition to reach the macula and other remote areas that would otherwise be inaccessible from the injection site.
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 risk of damaging the retina
Solution Approach 1:
A channel is created in the sclera before inserting the catheter, providing a pre-formed pathway that guides the catheter safely through the tissue. This preliminary channel formation reduces the risk of retina detachment and damage during catheter insertion by establishing a controlled route that avoids random tissue disruption.
Solution Approach 2:
The flexible catheter serves as an intermediary that delivers composition to the macula while being guided through the subretinal space. The catheter's flexibility and the guiding channel work together to minimize mechanical stress on the retina, reducing the risk of detachment and damage while still achieving effective composition delivery.
3Quantity of substance
If a sharp rigid cannula is inserted across the eye through the vitreous humor chamber to pierce the sensory retina and enter the subretinal space near the macula, then the composition can be delivered to the subretinal space near the macula, but there is increased chance of cataract development, high ocular pressure and bleeding
Solution Approach 1:
The approach replaces the mechanical piercing action of a sharp rigid cannula through the vitreous humor with a different pathway: creating a channel in the sclera and inserting a flexible catheter through the subretinal space. This substitution eliminates the need to pierce the sensory retina and vitreous chamber, thereby reducing the risk of cataract development, high ocular pressure, and bleeding while still achieving effective composition delivery to the subretinal space.
4Quantity of substance
If repeated injections are performed to deliver composition to different areas, then comprehensive coverage can be achieved, but multiple incisions in the frontal part of the sclera are required
Solution Approach 1:
The flexible catheter enables dynamic delivery of composition to different areas including the macula and peripheral subretinal space from a single injection site. The catheter can be positioned and manipulated to reach various targets, eliminating the need for multiple fixed incisions and providing comprehensive coverage through a single access point.
Data Source
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.