Apparatuses, systems and methods for perforating and aspirating inner ear
Inventors
Aksit, Aykut • Kysar, Jeffrey W. • Lalwani, Anil K. • Arteaga, Daniel N.
Assignees
Columbia University in the City of New York
Publication Number
US-12263066-B2
Publication Date
2025-04-01
Expiration Date
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Abstract
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.
Core Innovation
The present disclosure provides enabled teachings of an apparatus and method for the atraumatic, precise perforation of a thin membrane and sampling fluid in the inner ear. The apparatus comprises a hollow tubular member having a proximal portion and a distal portion and a length there between, the distal portion including a plurality of alternating apices and valleys forming serrated blades and an inside bevel around its circumference, the inside bevel providing for capture of the plug of tissue cut from the membrane; the tubular member may be configured to aspirate perilymph fluid from within the inner ear and introduce drugs to the inner ear.
The background identifies a clinical need arising from the anatomic inaccessibility of the cochlea, the current inability to perform specific diagnostics within the inner ear, and limitations of existing approaches including hypodermic needles, myringotomy knives and cochleostomy-based sampling which can cause traumatic perforation, contamination of perilymph samples, inconsistent intratympanic dosing, and variable molecular transport across the round window membrane; accordingly, there is a need for an apparatus that can create a precise, circular perforation in a thin membrane, aspirate perilymph without causing traumatic perforation, and improve delivery of drugs to the cochlea.
Claims Coverage
Independent claims identified: claim 1 and claim 15. Nine inventive features extracted from the independent claims.
Tubular member with proximal and distal portions
Claim 1: A tubular member including a proximal portion, a distal portion, and inner and outer surfaces defining a circumference around the tubular member.
Apices arranged around the circumference
Claim 1: A plurality of apices extending from a distal end of the tubular member and arranged around the circumference.
Valleys adjoining neighboring apices
Claim 1: A plurality of valleys arranged around the circumference, wherein each valley adjoins neighboring apices.
Serrated blades forming a circumferential crown shape
Claim 1: The plurality of apices and plurality of valleys define a plurality of serrated blades around the circumference and define a circumferential crown shape.
Inside bevel directed toward central axis
Claim 1: Each of the valleys are configured to include an inside bevel disposed on the inner surface of the tubular member in which the face of the inside bevel is directed toward a central axis of the tubular member.
Translation between positions upon membrane entry
Claim 1: The tubular member being configured to translate between a first position and a different second position upon entering a membrane.
Extraction of a membrane portion by engaging an apex
Claim 1: The tubular member being configured to extract a portion of the membrane by engaging at least one apex of the plurality of apices with the membrane.
Lumen-equipped tubular member with serrated distal portion
Claim 15: A tubular member having a proximal portion, a distal portion and a lumen there between, wherein the distal portion includes a plurality of alternating apices and valleys to define a plurality of serrated blades and comprises an inside bevel around a circumference of a distal end such that the face of the inside bevel is directed toward a central axis of the tubular member.
Aspirator operatively engaged to the tubular member
Claim 15: An aspirator operatively engaged to the tubular member as part of a system for penetrating an anatomic membrane.
The independent claims define a tubular, lumen-bearing distal apparatus with multiple apices and adjoining valleys forming serrated blades and a circumferential crown shape, valleys incorporating an inside bevel directed toward the tubular central axis, functionality for translating during membrane entry and extracting a membrane portion, and, in system form, operative engagement with an aspirator.
Stated Advantages
Atraumatic, precise perforation of a thin membrane with minimal damage.
Capture of the tissue plug severed from the membrane via the inside bevel.
Precise and efficient aspiration of perilymph fluid from the inner ear.
Ability to introduce drugs to the inner ear and to improve intratympanic dosing by reducing variability in drug delivery.
Enables effective fluid analysis of perilymph for personalized and accurate diagnostics.
Microneedle perforations heal within one week in vivo and have minimal lasting effect on hearing.
Documented Applications
Sampling perilymph fluid from the inner ear for diagnosis and proteomic analysis to individualize inner ear diagnosis and treatment.
Aspirating perilymph from the cochlea.
Introducing or delivering drugs to the inner ear, including intratympanic dosing adjacent to microperforations with drug formulations dissolved in a compound that undergoes gelification at human body temperature (for example, hydrogels such as poloxamer 407 and drugs such as gentamicin).
Creating precision perforations to accommodate a permanent or semi-permanent implant, such as cochlear implants, or for tympanostomy.
Use of microneedles to provide multiple microperforations to enhance diffusive transport of therapeutics into the cochlea.
Adaptation of the apparatus for use in other areas requiring precision holes, such as ophthalmology.
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