Ultra-sharp Microneedle for Inner Ear Fluid Exchange
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Solution Overview
Problem
Current methods for accessing the inner ear for therapeutic delivery or fluid sampling are challenging due to the anatomical inaccessibility of the cochlea, often resulting in hearing impairment and difficulties with delivering large volumes of medication or sampling biological fluids without causing harm to the delicate structures.
Innovation Solution
An ultra-sharp microneedle with a multi-lumen design, capable of simultaneously injecting and aspirating fluids, is used to create controlled and precise perforations in the inner ear membrane, allowing for safe and reliable delivery of therapeutic agents and sampling of perilymph while maintaining fluid balance to prevent intracochlear pressure issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional methods are used to access the inner ear, then therapeutic delivery is achieved, but hearing impairment occurs due to traumatic disruption of the cochlea
Solution Approach 1:
The patent changes the physical parameters of the needle tip, reducing it to ultra-sharp dimensions (500-nm radius of curvature) to enable penetration of the round window membrane with minimal traumatic disruption, thereby achieving therapeutic delivery without hearing impairment
Solution Approach 2:
The patent segments the needle structure into distinct functional zones: an ultra-sharp tip for membrane penetration, a shaft for fluid delivery, and a base for mounting, allowing each segment to perform its specific function optimally without causing harm to surrounding structures
2Quantity of substance
If large volumes of medication are injected into the cochlea, then therapeutic dosage is achieved, but intracochlear pressure increases causing harm to delicate structures
Solution Approach 1:
The patent extracts fluid from the cochlea through aspiration simultaneously with injection, removing the harmful effect of pressure buildup while maintaining the beneficial effect of therapeutic delivery. This is achieved through the multi-lumen design that enables concurrent injection and aspiration
Solution Approach 2:
The patent discards excess fluid through aspiration while recovering the necessary therapeutic dosage through controlled injection, maintaining fluid balance and preventing pressure-related damage to cochlear structures
3Quantity of substance
If large volumes of biological fluids are sampled from the cochlea, then diagnostic quantity is achieved, but the cochlea suffers harm due to significant volume removal
Solution Approach 1:
The patent extracts perilymph samples through the multi-lumen microneedle apparatus, obtaining sufficient diagnostic volume (greater than 1 μL) while controlling the extraction process to prevent harm to cochlear structures through simultaneous fluid replacement
Solution Approach 2:
The patent changes the sampling parameters by using an ultra-sharp microneedle to create controlled perforations, enabling large-volume sampling without traumatic disruption to the cochlea, in contrast to conventional sampling methods
4Ease of operation
If conventional needles are used for inner ear access, then fluid delivery is possible, but precision and control of perforation are insufficient
Solution Approach 1:
The patent changes the geometric parameters of the needle tip to ultra-sharp dimensions (500-nm radius of curvature), enabling precise and controlled perforation of the round window membrane with minimal disruption to surrounding structures
Solution Approach 2:
The patent transitions from conventional blunt needle geometry to an ultra-sharp tip geometry, fundamentally changing the dimensional characteristics of the needle apex to achieve precise membrane penetration with controlled perforation size and shape
Data Source
AI summary
A microneedle having a body including a base, shaft and pointed tip, and at least one lumen disposed within the shaft. The lumen having an opening that is offset from the tip and open to the exterior of the microneedle.