Devices, systems, and methods for otology

Inventors

de Juan, Eugene • Erickson, Signe • Limb, Charles • Levering, Vrad

Assignees

Spiral Therapeutics Inc

Abstract

Systems and methods can be employed for facilitating access and procedures in the outer, middle, and inner ear in order to diagnose or treat ear disorders including, but not limited to hearing loss and excessive ear wax. In some examples, the systems and methods include instruments and techniques that facilitate trans-tympanic membrane or trans-fibrous ring access to the middle ear. The systems and methods can also be used to improve accessibility for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

Core Innovation

The invention relates to an otology platform for minimally invasive access and treatment of a middle ear or inner ear disorder. The platform includes implanting a port device in an annulus tympanicus and accessing the middle ear by advancing a distal end portion of an otologic instrument through or adjacent to the annulus tympanicus such that the distal end portion passes through a passage defined by the port device. In other embodiments, access is performed by making a puncture or incision in or adjacent to the annulus tympanicus and passing the distal end portion of the otologic instrument through the puncture or incision.

Concurrent, dual-instrument access is provided by advancing a first and a second otologic instrument through or adjacent to the annulus tympanicus so that the distal end portions are positioned in the middle ear concurrently. The first otologic instrument is used for direct visualization, and an end effector of the second otologic instrument is used within the middle ear to perform tissue and fluid handling actions. The document describes instrument geometries including handle and instrument shaft axes with a non-zero angle and curved, deflectable, steerable shafts to enable access and operation under visualization.

The invention further provides delivery of therapeutic formulations to the round window niche under direct visualization, with optional middle-ear "underwater" flooding to maintain cochlear fluid equilibrium. The document also describes uses of aspiration, irrigation, and tamponade bleeding while improving visualization. Specialized modalities are described, including micro-diathermy, coaxial bipolar diathermy with built-in illumination and/or aspiration, pneumatic aspirating cutter/guillotine cutter with aspiration and optional infusion, high-speed rotary aspirating end cutter, and ultrasonic cutters/debriders with fragmentation/emulsification and cooling in air-filled spaces.

A console system integrating multiple modalities with synchronized multimodal control is also described, supporting precision suction and infusion. The platform is characterized by surgical visualization alongside tissue and fluid management, including concurrent endoscope visualization and end effector actions, coordinated through the console.

Claims Coverage

The partial content provides coverage for three independent methods that treat middle ear or inner ear disorders using (i) a port device implanted in the annulus tympanicus with passage-defined instrument advancement, (ii) a puncture or incision adjacent to the annulus tympanicus with concurrent endoscope visualization and injection delivery to a round window niche, and (iii) concurrent dual-instrument operation via puncture/incision with direct visualization plus tissue/fluid handling and therapeutic formulation delivery to the round window niche. Across these independent claims, there are 3 main inventive structures and multiple shared inventive features centered on access via the annulus tympanicus and concurrent endoscope-based visualization with an instrument action end effector or delivery instrument.

Across the independent claims, the inventive coverage centers on implanting a port device in an annulus tympanicus and advancing an otologic instrument through a passage defined by the port device, and on forming a puncture or incision adjacent to the annulus tympanicus to concurrently position an endoscope for direct visualization with an injection instrument, and in one claim an end effector, delivering a therapeutic formulation to the round window niche.

Stated Advantages

Documented Applications

No documented applications found