OCT-Guided Subretinal Access to Reduce Surgical Morbidity
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Solution Overview
Problem
Existing minimally invasive surgical methods for accessing anatomical spaces, such as the subretinal space, are associated with high morbidity due to complications like cataract formation, retinal detachment, and retrograde reflux of therapeutic agents, necessitating the development of minimally invasive strategies that avoid vitrectomy and retinotomy.
Innovation Solution
The use of image-guided surgery (IGS) with fiber-optic distal sensor-based imaging, specifically optical coherence tomography (OCT), and a coaxial guide device comprising a vacuum channel and needle drive for precise access and delivery of therapeutic modalities to anatomical spaces, including the subretinal space, using a coaxial guide device with a needle drive and optical coherence tomography sensor for real-time visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvitreal ab interno approach with vitrectomy and retinotomy is used to access subretinal space, then access to anatomical space is achieved, but surgical morbidity increases due to complications like cataract formation, retinal detachment, and retrograde reflux of therapeutic agents
Solution Approach 1:
The patent inverts the conventional approach by using ab externo (from outside the eye) instead of ab interno (from inside the eye). The needle is inserted through the sclera and choroid to reach the subretinal space, avoiding vitrectomy and retinotomy. This inversion of the access route eliminates the need for vitreous cavity entry and retinal perforation, thereby preventing associated complications while maintaining effective subretinal access.
Solution Approach 2:
The patent employs optical coherence tomography (OCT) imaging to create real-time visual copies or representations of the anatomical structures during needle insertion. The OCT system provides cross-sectional images that allow the operator to visualize the needle's position relative to the retina and subretinal space without physical disruption of retinal tissue, enabling precise access while avoiding complications.
2Productivity
If vitrectomy and retinotomy are performed to deliver therapeutic agents to subretinal space, then therapeutic delivery is enabled, but retrograde reflux of agents into vitreous cavity occurs reducing therapeutic efficacy
Solution Approach 1:
By inverting the access route from ab interno to ab externo, the patent delivers therapeutic agents directly into the subretinal space through the sclera and choroid. This approach creates a direct delivery path that does not involve the vitreous cavity, thereby preventing retrograde reflux of therapeutic agents and ensuring complete retention of the delivered substance at the target site.
Solution Approach 2:
The patent uses the sclera and choroid as intermediary tissues through which the needle passes to reach the subretinal space. These tissues serve as a protective barrier and delivery conduit that allows direct access to the subretinal space without creating a communication pathway between the subretinal space and vitreous cavity, thus preventing agent reflux.
3Ease of operation
If conventional surgical approach with multiple surgical steps is used, then access to anatomical space is achieved, but surgical complexity and time increase
Solution Approach 1:
The patent segments the surgical procedure into minimal essential steps: (1) creating a small incision in the sclera, (2) inserting the needle through the sclera and choroid, (3) delivering the therapeutic agent, and (4) withdrawing the needle. This segmentation eliminates unnecessary steps such as vitrectomy and retinotomy, simplifying the overall procedure while maintaining effective access to the subretinal space.
Solution Approach 2:
The patent extracts and eliminates the complex intermediate steps of conventional surgery (vitrectomy, retinotomy, extensive dissection) from the procedural sequence. By taking out these unnecessary steps and retaining only the essential needle insertion and drug delivery components, the procedure becomes significantly simpler and faster while achieving the same therapeutic goal.
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
This approach minimizes surgical morbidity by providing precise, real-time access to anatomical spaces, ensuring accurate delivery of therapeutic agents while reducing complications and enhancing treatment efficacy.
Implementation Method 1
image-guided surgery (IGS) with fiber-optic distal sensor-based imaging, specifically optical coherence tomography (OCT)
Implementation Method 2
optical coherence tomography (OCT), and a coaxial guide device comprising a vacuum channel and needle drive for precise access and delivery
Implementation Method 3
the imaging component is stabilized via vacuum suction of the vacuum channel contacting the surface of the anatomical space
Data Source
AI summary
The present disclosure relates to methods for performing minimally invasive anatomical space access, e.g., minimally invasive subretinal access (MISA), in connection with the delivery of therapeutic modalities to an anatomical space of interest, e.g., the subretinal space, and system components adapted to facilitate such delivery.