Ocular Interlayer Injection Needle With Tissue Separator Access
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Solution Overview
Problem
Current treatments for posterior segment ocular diseases like AMD and DR are limited by the difficulty in delivering effective doses of drugs and gene therapy substances to the target posterior tissues due to tissue barriers such as the cornea, conjunctiva, and blood-retinal barrier.
Innovation Solution
A device with a needle and tissue separator is used to penetrate the outer layer of the eye, forming a passage into the interlayer region, allowing for the injection of substances like liquids, gels, or implants, while minimizing damage to underlying tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional injection methods are used to deliver drugs to posterior tissues, then the delivery system is simple, but the tissue barriers (cornea, conjunctiva, blood-retinal barrier) prevent effective drug delivery
Solution Approach 1:
The injection device is divided into multiple functional segments: an outer needle for penetrating the cornea and conjunctiva, an inner tissue separator for creating a subconjunctival pocket, and a fluid delivery system. This segmentation allows each component to perform its specific function while overcoming the tissue barriers to achieve reliable drug delivery to posterior tissues.
2Ease of operation
If a needle is used to penetrate outer tissue layers, then access to interlayer regions is achieved, but damage to underlying tissues occurs
Solution Approach 1:
The tissue separator acts as an intermediary element between the needle and the underlying tissues. It creates a subconjunctival pocket that separates the injection site from the sensitive retina and choroid, allowing drug delivery while minimizing direct contact and potential damage to these delicate posterior tissues.
Solution Approach 2:
The tissue separator is advanced first to create the subconjunctival pocket before the needle delivers the drug. This preliminary action establishes a safe pathway and containment space, preventing direct injection into vulnerable posterior tissues and reducing the risk of retinal detachment or other complications.
3Reliability
If the tissue separator is positioned proximally to the needle tip, then tissue separation is achieved, but the separator may protrude and cause issues
Solution Approach 1:
The tissue separator is designed with dynamic positioning capability, allowing it to be adjusted between a proximal position for effective tissue separation and a retracted position to prevent protrusion complications. This dynamic adjustment ensures the separator performs its function when needed while minimizing potential harm during drug delivery.
Data Source
AI summary
Provided is a device for injection into an interlayer of an organ of a subject. The device includes a needle having a size transitional portion terminating in a sharp needle distal tip. The device also includes an elongated tissue separator that is shiftable in the needle lumen. An actuator shifts the tissue separator in the needle lumen between a first position, in which the separator distal tip is fixedly positioned proximally to the needle distal tip, and a second position in which the separator distal tip is fixedly positioned a predetermined distance distally from the needle distal tip.


