Thermoplastic Ocular Insert Shape Memory Drug Delivery
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Solution Overview
Problem
Current ophthalmic drug delivery methods, such as eye drops and gels, face challenges including short residence time, low absorption rates, and frequent reapplication requirements, leading to inefficient drug delivery and potential side effects, with many patients failing to adhere to treatment regimens.
Innovation Solution
An ocular device configured to be positioned under the eyelids and outside the cornea, featuring a thermoplastic support structure that changes shape to conform to the eye's anatomy, allowing for sustained release of therapeutic agents over an extended period without frequent user application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If eye drops are used for drug delivery, then the drug can be easily administered, but the residence time is short (2-5 minutes) and absorption rate is low (5% or less)
Solution Approach 1:
The invention uses a flexible ocular insert made of elastomeric material that can be positioned in the cul-de-sac of the eyelid. The flexible shell structure maintains prolonged contact with the ocular surface, extending residence time from minutes to days while remaining easy to administer as a single-piece implantable device.
Solution Approach 2:
Instead of delivering drug continuously at low concentration like eye drops, the ocular insert delivers a controlled amount of drug over an extended period (days to weeks), providing excessive duration of action compared to conventional methods while maintaining therapeutic effectiveness.
2Reliability
If eye drops are reapplied frequently to maintain therapeutic levels, then adequate drug delivery can be achieved, but patient adherence decreases significantly
Solution Approach 1:
The ocular insert is pre-loaded with therapeutic agent and implanted once, then automatically delivers drug over an extended period without requiring repeated patient actions. This preliminary loading ensures consistent drug delivery while eliminating the need for frequent reapplication that compromises adherence.
Solution Approach 2:
The ocular insert serves itself by maintaining its position in the cul-de-sac and continuously releasing drug through diffusion or erosion mechanisms without requiring patient intervention. The device self-regulates drug delivery while remaining in place for days or weeks, ensuring reliable therapy independent of patient compliance.
3Duration of action of moving object
If gels are used to improve adherence to the eye, then residence time increases, but vision is blurred
Solution Approach 1:
The ocular insert is designed as a discrete, localized structure positioned in the cul-de-sac away from the visual axis. This segmentation separates the drug delivery function from the visual field, allowing prolonged residence time without interfering with vision, unlike gels that spread across the corneal surface.
Solution Approach 2:
The invention extracts the drug delivery function from the visual pathway by positioning the insert in the cul-de-sac and using a support structure that maintains spacing between the therapeutic agent and the cornea. This extraction allows extended residence time while preventing the vision-blurring effect of surface gels.
4Stability of the object's composition
If the ocular device is made with a support structure for shape stability, then the device maintains its form, but the material may cause irritation or foreign body reaction
Solution Approach 1:
The ocular insert uses a composite structure combining an elastomeric matrix containing the therapeutic agent with a separate support structure made of biocompatible material. This composite design provides shape stability while the elastomeric portion minimizes irritation and allows controlled drug release, resolving the conflict between structural integrity and biocompatibility.
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
The ocular device provides consistent and prolonged delivery of therapeutic agents, reducing waste and side effects, while maintaining comfort and minimizing irritation, allowing for tailored treatment based on anatomical fit and drug release profiles.
Implementation Method 1
The first structure is formed of a shape memory material and provides a first shape to the ocular device prior to positioning the ocular device on the surface of the eye. The first shape of the ocular device conforms to a second, different shape after positioning the ocular device on the surface of the eye.
Implementation Method 2
at least one therapeutic agent dispersed within the second material of the second structure
Data Source
AI summary
Disclosed is an ocular device including a first structure formed of a first material providing a first shape to the ocular device prior to positioning the ocular device on the surface of the eye, a second structure formed of a second, different material having a tubular structure and a lumen through which the first structure extends, and at least one therapeutic agent is dispersed within the second material of the second structure. The first shape of the ocular device conforms to a second, different shape after positioning the ocular device on the surface of the eye. Upon being removed from the eye, the ocular device retains the second shape or changes to a third shape different from both the first shape and the second shape. Related apparatus, systems and method are described.