Bent Needle Inner Ear Fluid Delivery Device
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Solution Overview
Problem
Delivering therapeutic agents to the inner ear is challenging due to its deep location within the skull and isolation from the blood circulatory system by a blood-cochlear barrier, resulting in low efficacy as only a small percentage of the administered fluid and therapeutic agent enters the inner ear fluid space, with distribution relying on simple diffusion and significant dilution.
Innovation Solution
A device and system for delivering fluids to the inner ear, featuring a bent needle with a sterile and biocompatible design, allowing precise administration of small volumes at controlled flow rates, visualization of the round window membrane, and minimization of damage, with a distal tip camera for monitoring and a pump for controlled fluid delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If fluid is delivered to the middle ear cavity with the hope that it diffuses across the round window membrane into the inner ear, then the delivery process is simple, but only a very small percentage of the administered fluid and therapeutic agent actually enters the inner ear
Solution Approach 1:
The delivery system is segmented into distinct components: an outer cannula for access, an inner needle for precise membrane penetration, and a fluid delivery mechanism. This segmentation allows the device to combine the simplicity of external access with the precision of targeted inner ear delivery, resolving the contradiction between easy administration and effective drug delivery.
Solution Approach 2:
The round window membrane serves as an intermediary structure that the device is specifically designed to penetrate. By creating a controlled pathway through this membrane using the needle component, the system enables direct access to the inner ear fluid space, significantly improving the quantity of therapeutic agent that reaches the target while maintaining a relatively simple overall delivery approach.
2Device complexity
If distribution throughout the inner ear relies on simple diffusion, then no additional delivery mechanism is needed, but the delivered fluid and therapeutic agent are highly diluted by the time it reaches the target site
Solution Approach 1:
The system replaces reliance on passive diffusion with an active mechanical fluid delivery mechanism. The pump-driven fluid delivery system provides controlled flow rates that ensure adequate therapeutic agent concentration reaches the target site, overcoming the dilution problem inherent in diffusion-based delivery while maintaining manageable device complexity.
Solution Approach 2:
The device utilizes hydraulic principles through the fluid delivery system and pump mechanism to achieve controlled fluid transport. This hydraulic approach enables precise delivery of small volumes at controlled flow rates, ensuring sufficient therapeutic agent concentration reaches the inner ear target site without relying on inefficient passive diffusion.
3Manufacturing precision
If a needle is used to deliver fluid directly to the inner ear, then delivery precision is improved, but risk of damage to the round window membrane and inner ear structures increases
Solution Approach 1:
The device incorporates protective features before the needle penetrates the membrane, including a beveled tip design that gradually separates membrane layers rather than abruptly piercing them, and a controlled insertion mechanism that allows the operator to regulate penetration depth. These beforehand cushioning measures reduce mechanical trauma to the round window membrane and surrounding structures while maintaining delivery precision.
Solution Approach 2:
The needle tip is designed with a curved or beveled geometry rather than a sharp angular point. This curvature allows the tip to gently separate and penetrate the round window membrane layers in a controlled manner, reducing the risk of tearing or damaging the delicate membrane and underlying inner ear structures while still achieving precise fluid delivery.
4Quantity of substance
If small volumes are delivered at controlled flow rates, then therapeutic agent concentration is maintained, but the device complexity increases
Solution Approach 1:
The device integrates multiple functions into a single unified system: the cannula provides both access and structural support, the needle serves as both a protective sheath and delivery conduit, and the pump system handles both fluid storage and controlled delivery. This multi-functionality allows precise control of small fluid volumes without proportionally increasing device complexity, as each component performs multiple roles.
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
Enhances the safety and efficacy of therapeutic agent delivery by ensuring precise and controlled administration, reducing dilution and leakage, and improving the distribution of therapeutic agents within the inner ear, potentially treating hearing and balance disorders.
Implementation Method 1
Distribution throughout the inner ear generally relies on simple diffusion, which causes the delivered fluid and therapeutic agent to be highly diluted
Data Source
AI summary
A device (10) to deliver fluid to an ear includes: a handle portion (12) including a proximal end and a distal end; a needle sub-assembly (26) coupled to the distal end of the handle portion (12) and including a bent needle (38); and tubing (36) coupled to the proximal end of the handle portion (12). The bent needle (38) extends through the handle portion (12) and fluidly connects directly to the tubing (36).