Subretinal Delivery Piercer and Injector System for Macular Distribution
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Solution Overview
Problem
Current methods for subretinal delivery of therapeutic compositions in ophthalmic surgery face challenges such as localized distribution, risk of retinal detachment, and complications like cataract development and bleeding, particularly when targeting the macula, due to inadequate delivery techniques.
Innovation Solution
A method and device involving a piercer and injector system that makes a controlled incision through the sclera and retinal pigment epithelium to achieve a more homogeneous distribution of therapeutic compositions in the subretinal space, including the macula, with a guide assisting in precise incision and injection to minimize retinal damage and promote healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a sharp injection device is used to penetrate the sclera from outside the eye to the subretinal space, then the delivery of therapeutic composition is achieved, but the composition remains localized near the injection site and does not reach the macula
Solution Approach 1:
The delivery device is segmented into multiple functional components: a piercer for creating the initial incision, an injector for delivering the composition, and a guide for positioning. This segmentation allows each component to perform its specific function optimally, enabling the composition to be delivered uniformly throughout the subretinal space including the macula, while maintaining operational simplicity through coordinated action of the components.
Solution Approach 2:
A guide component is introduced as an intermediary between the injector and the subretinal space. The guide facilitates the formation of a fluid-tight seal and provides a stable platform for injection, enabling the therapeutic composition to be distributed uniformly throughout the subretinal space including the macula, while maintaining operational simplicity through the guide's mediating role.
2Quantity of substance
If a catheter is inserted from an incision site through the subretinal space to deliver composition near the macula, then the macular delivery is achieved, but severe detachment of the retina from the sclera occurs
Solution Approach 1:
The piercer creates the initial incision and establishes a fluid-tight seal before the injector is introduced. This preliminary action prepares the pathway and seal in advance, allowing the therapeutic composition to be delivered uniformly to the macula without causing severe retinal detachment, as the seal prevents unwanted fluid accumulation and tissue separation.
Solution Approach 2:
The guide serves as an intermediary structure that facilitates safe delivery of the therapeutic composition to the macula. It provides a stable platform for injection and maintains a fluid-tight seal, enabling macular delivery while preventing severe retinal detachment by avoiding direct manipulation and trauma to the retina during the procedure.
3Quantity of substance
If a sharp rigid cannula is inserted across the eye through the vitreous humor chamber to pierce the sensory retina, then the subretinal space is accessed, but increased chance of cataract development, high ocular pressure and bleeding occurs
Solution Approach 1:
The delivery system is segmented into distinct functional components: a piercer for creating the incision, an injector for delivering the composition, and a guide for positioning. This segmentation allows the piercer to create a controlled incision without requiring a rigid cannula to traverse the entire vitreous chamber, thereby reducing the risk of cataract development, high ocular pressure, and bleeding while still enabling effective therapeutic composition delivery.
Solution Approach 2:
The harmful elements (rigid cannula, need to traverse vitreous chamber, retinal piercing) are extracted from the delivery process. Instead, a piercer creates a localized incision in the sclera and retinal pigment epithelium, eliminating the need for a rigid cannula to cross the eye and reducing complications such as cataract development, high ocular pressure, and bleeding while maintaining effective therapeutic composition delivery.
4Quantity of substance
If repeated injections are made through the frontal part of the sclera, then the therapeutic composition is delivered, but multiple incisions are required increasing the complexity of the procedure
Solution Approach 1:
The guide component serves multiple functions: it guides the piercer to create the initial incision, provides a stable platform for repeated injections, and maintains a fluid-tight seal throughout the procedure. This multi-functionality allows repeated delivery of therapeutic composition through a single incision site, eliminating the need for multiple separate incisions and reducing procedural complexity while maintaining effective treatment delivery.
Data Source
AI summary
Disclosed are methods of subretinal delivery of therapeutic compositions to the eye of a mammal. Also disclosed are devices useful for the subretinal delivery of therapeutic compositions to the eye of a mammal.