Endoscopic Submucosal Depot Delivery for Localized Symptoms
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Solution Overview
Problem
Existing systemic drug delivery methods, such as intravenous, oral, and subcutaneous injections, struggle to effectively target localized symptoms in conditions like inflammatory bowel disorders, leading to poor drug bioavailability and increased side effects due to systemic distribution.
Innovation Solution
A delivery system for creating an intraintestinal or submucosal pocket within the gastrointestinal tract using a supply conduit and depot conduit, allowing localized administration of a depot through an endoscope, with features like a housing, extension, and fluidic connectors to secure and advance the conduits for precise drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic medications are administered to treat localized symptoms, then drug distribution is achieved, but drug bioavailability at the target site decreases and side effects increase
Solution Approach 1:
The patent implements local quality by transitioning from systemic drug distribution to localized submucosal drug delivery. The delivery system targets specific gastrointestinal tract locations, creating a concentrated drug depot at the disease site rather than distributing medication throughout the entire bloodstream. This localized approach increases drug bioavailability at the target site while minimizing exposure and side effects in other body systems.
Solution Approach 2:
The patent employs an endoscope as an intermediary device to deliver drugs directly to the gastrointestinal tract. The endoscope serves as a mediator between the drug source and the target tissue, enabling precise localization of drug delivery. This intermediary approach allows the system to bypass systemic circulation and deposit medication directly where needed in the submucosal layer.
2Reliability
If higher doses of systemic medications are used to address localized symptoms, then treatment efficacy may improve, but side effects increase due to drug concentration in other body parts
Solution Approach 1:
The system applies local quality by concentrating the full therapeutic dose directly at the localized disease site within the submucosal layer. Instead of distributing a high dose systemically and hoping for sufficient concentration at the target, the entire dose is delivered locally where it is needed, maximizing treatment efficacy while avoiding toxicity in other organs and tissues.
Solution Approach 2:
The patent changes the delivery parameter from systemic circulation to direct submucosal injection. This parameter change allows the full therapeutic dose to be administered locally without the dilution effect of systemic circulation, thereby maintaining high treatment efficacy at the target site while preventing harmful concentration in non-target areas.
3Adaptability or versatility
If a collapsible extension with conduits is used to advance past the endoscope, then drug delivery capability is improved, but device complexity increases
Solution Approach 1:
The patent applies the nested doll principle by placing the supply conduit and depot conduit within a collapsible extension that fits inside the housing. The conduits are nested within the extension, which itself is contained within the housing during storage and delivery. This nested structure allows the complex multi-component system to be compacted into a manageable size while maintaining full functionality when deployed.
Solution Approach 2:
The system employs dynamics through the collapsible extension that can transition between compressed and extended states. The extension dynamically changes its configuration - collapsing within the housing during insertion and advancing past the endoscope during drug delivery. This dynamic behavior allows the device to adapt its form factor to different operational phases, reducing complexity during storage while enabling extended functionality during use.
Data Source
AI summary
Provided herein is a delivery system and method for delivering a depot within a submucosal pocket comprising a housing including a central opening and a fluidic connector configured to secure to a fluidic supply, an extension configured to at least partially collapse within the central opening of the housing, a supply conduit configured to extend through the housing and the extension, the supply conduit configured to deliver a lift solution configured to form a submucosal pocket within a subject, and a depot conduit configured to extend through the housing and the extension and to deposit a depot within the submucosal pocket, where when the extension is configured to at least partially collapse within the housing, whereby at least one of the supply conduit or depot conduit, or both advance distally past a distal end of an endoscope.