Serrated Blade Inner Ear Perforation Device
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Solution Overview
Problem
Current treatments for inner ear disorders such as sudden sensorineural hearing loss (SSNHL) and Ménière's disease are non-specific and often ineffective, with intratympanic steroid injections and ototoxic antibiotics providing unproven efficacy and potential harm to cochlear functioning. Additionally, existing methods for diagnosing inner ear conditions are limited due to the anatomical inaccessibility of the cochlea, leading to idiopathic diagnoses and inadequate targeted therapies.
Innovation Solution
The development of an apparatus and method for precise, atraumatic perforation of the thin membrane in the inner ear, allowing for the aspiration of perilymph and the delivery of drugs. This apparatus features a hollow tubular member with serrated blades and an inside bevel, enabling controlled perforation and minimization of tissue damage. Additionally, the use of microperforations created by microneedles facilitates more precise drug delivery and diagnostics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional hypodermic needles or myringotomy knives are used to create an incision in the round window membrane, then access to the inner ear is achieved, but the membrane perforation is traumatic and uncontrollable in size and shape
Solution Approach 1:
The needle tip is segmented into multiple cutting edges arranged in a circular pattern, where each cutting edge is separated by gaps. This segmentation allows the needle to create a precise circular perforation through rotational cutting action rather than traumatic puncture, resolving the contradiction between ease of operation and precision control.
Solution Approach 2:
The needle tip features a circular arrangement of cutting edges forming a ring-like structure. This curved geometry enables the needle to create a round, controlled perforation in the membrane, transforming the linear cutting action of conventional needles into a rotational cutting mechanism that provides precise control over perforation size and shape.
2Ease of operation
If larger incisions are made to facilitate implant insertion, then implant access is improved, but perilymph leakage and tissue damage increase
Solution Approach 1:
The device creates a localized, precisely-controlled circular opening with smooth edges through rotational cutting, rather than a large irregular incision. This local quality approach ensures that only the minimal necessary tissue is removed, reducing perilymph leakage and tissue damage while still providing adequate access for implant insertion.
3Measurement precision
If repeated traumatic perforations are performed, then diagnostic sampling can be achieved, but membrane healing is inhibited and contamination risk increases
Solution Approach 1:
The traumatic mechanical puncture action is replaced with a controlled rotational cutting mechanism. The circular cutting edges rotate to gradually cut through the membrane, creating a clean perforation with smooth edges that minimizes tissue trauma and preserves membrane healing capability while still enabling diagnostic sampling.
Data Source
AI summary
An apparatus for controlled perforation and aspiration of the inner ear having a distal portion including a plurality of apices and a plurality of valleys therebetween defining a plurality of serrated blades.