Self-Expanding Scaffold Delivery for Sinus Drug Elution
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Solution Overview
Problem
Current treatments for chronic rhinosinusitis (CRS) lack effective, non-surgical options for local and sustained anti-inflammatory drug delivery to the sinuses, often requiring invasive surgeries like FESS, which come with complications and limited response rates.
Innovation Solution
Development of scaffold delivery systems comprising self-expanding scaffolds that can be loaded and delivered to the sinuses using various assemblies and devices, including crimping devices, flexible tapered loading members, and delivery sheaths, allowing for precise placement and expansion within sinus cavities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical interventions like FESS are performed to treat CRS, then sinus drainage pathways are improved and ventilation is restored, but patients experience post-operative pain, require burdensome cleaning, and face surgery-associated risks
Solution Approach 1:
A delivery system acts as an intermediary to transport a scaffold containing anti-inflammatory medication directly to the sinus cavity. The system includes a catheter with a distal end that can be positioned in the sinus, allowing localized drug delivery without surgical intervention. This mediator approach avoids the harmful effects of surgery while achieving the therapeutic goal of reducing sinus inflammation.
Solution Approach 2:
The scaffold provides self-service by continuously releasing anti-inflammatory medication directly at the site of inflammation over an extended period. The scaffold's structure allows for sustained elution of the drug, creating a self-contained therapeutic system that maintains treatment effectiveness without requiring repeated surgical procedures or extensive post-operative care.
2Quantity of substance
If topical corticosteroids are applied via nasal sprays as first-line therapy, then anti-inflammatory effects are achieved, but drug delivery is not sustained and localized concentration is insufficient
Solution Approach 1:
The scaffold is pre-loaded with anti-inflammatory medication before insertion into the sinus cavity. This preliminary preparation ensures that the drug is already positioned at the target site in high concentration, eliminating the need for repeated applications and providing immediate therapeutic effect. The scaffold's structure is designed to maintain this high local concentration over time.
Solution Approach 2:
The scaffold provides continuous drug delivery through its sustained-release mechanism. As the scaffold degrades or through controlled elution, the anti-inflammatory medication is released continuously over an extended period, maintaining therapeutic concentrations at the sinus site without interruption. This continuous action contrasts with the intermittent application of nasal sprays.
3Reliability
If oral corticosteroids are used for flare-ups, then anti-inflammatory effects are achieved, but systemic side effects occur including glaucoma, osteoporosis and avascular necrosis
Solution Approach 1:
The treatment achieves local quality by delivering anti-inflammatory medication directly to the sinus cavity where it is needed. The scaffold releases drug locally at the site of inflammation, creating high concentrations where required while maintaining low systemic levels. This localized approach preserves treatment effectiveness while eliminating the systemic side effects associated with oral corticosteroid therapy.
4Duration of action of moving object
If scaffolds are delivered to sinuses for sustained drug delivery, then local and sustained anti-inflammatory therapy is achieved, but delivery system complexity increases
Solution Approach 1:
The delivery system employs a nested structure where the scaffold containing the drug is positioned within a catheter. The catheter serves as an outer container that guides and protects the inner scaffold during insertion. This nested arrangement allows for sustained drug delivery capability while organizing the system components in a hierarchical manner that manages complexity through structured integration.
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
Enables localized, sustained drug delivery to inflamed sinus tissues, potentially reducing the need for surgery and minimizing post-operative complications by providing a safe and effective treatment for CRS.
Implementation Method 1
self-expanding scaffolds that comprise a scaffold wall and have a scaffold lumen
Implementation Method 2
They also have the capability of being integrated with therapeutic agent(s) that may be delivered topically over time
Data Source
AI summary
This disclosure describes, inter alia, materials, devices, kits and methods that may be used for loading scaffolds into delivery devices and delivery of scaffolds into the body of a patient, including delivery of scaffolds to the sinuses for the treatment of chronic sinusitis, among other purposes.