CN-115426989-B - Otology devices, systems, and methods

CN115426989BCN 115426989 BCN115426989 BCN 115426989BCN-115426989-B

Abstract

Devices, systems, and methods may be used to facilitate performing procedures in the outer ear, middle ear, and/or inner ear in order to diagnose and/or treat diseases, including but not limited to hearing loss and other ear diseases. For example, devices, systems, and methods are described herein, including instruments and techniques, to minimize invasiveness and/or enhance the efficacy of procedures performed in the outer ear, middle ear, and/or inner ear space, such as mastectomy, tympanometry, cholesteatoma treatment, otosclerosis treatment, and eustachian tube treatment.

Inventors

DE JUAN EUGENE
H. Peres
S. ERIKSSON
V. Liverin
N. Tarrega

Assignees

斯皮拉尔诊疗有限公司
斯皮拉尔诊疗有限公司

Dates

Publication Date: 20260421
Application Date: 20210122
Priority Date: 20200124

Claims (8)

1. A system for treating a cholesteatoma or soft tissue lesion (50) in the middle ear, the system comprising an instrument (300, 400) configured to: Advancing the shaft of the instrument through the external auditory canal (25) such that the distal tip of the instrument is in contact with a cholesteatoma or soft tissue lesion in the middle ear, and Delivering therapeutic treatment from the device to the cholesteatoma or soft tissue lesion to reduce the volume of the cholesteatoma or soft tissue lesion, Wherein the system further comprises a lens assembly (210) for viewing the middle ear (40) configured for temporary positioning in the tympanic membrane (30) between the external auditory canal (25) and the middle ear, the lens assembly comprising a frustoconical proximal portion extending into the external ear, the frustoconical proximal portion being gradually flared in a direction towards the external ear.
2. The system of claim 1, wherein the instrument is an injection instrument (300), and wherein the delivery therapy treatment comprises injection of a medicament from the injection instrument into a cholesteatoma or soft tissue lesion, and/or Wherein the instrument is an ultrasonic instrument (400), and wherein the delivering a therapeutic treatment comprises applying ultrasonic energy from the ultrasonic instrument to a cholesteatoma or soft tissue lesion to emulsify at least a portion of the cholesteatoma or soft tissue lesion, and/or Wherein the instrument is a laser instrument, and wherein the delivering therapeutic treatment comprises applying laser energy to a cholesteatoma or soft tissue lesion.
3. A system for removing ossified packing around the stapes footplate in the middle ear, the system comprising an instrument configured to: Advancing the shaft of the instrument through the external auditory canal such that the distal tip of the instrument approximates bony packing around the stapes footplate, and Delivering therapeutic treatment from the instrument to ossified packing around the stapes footplate to remove at least some of the packing, Wherein the system further comprises a lens assembly (210) for viewing the middle ear (40) configured for temporary positioning in the tympanic membrane (30) between the external auditory canal (25) and the middle ear, the lens assembly comprising a frustoconical proximal portion extending into the external ear, the frustoconical proximal portion being gradually flared in a direction towards the external ear.
4. The system of claim 3, wherein the instrument is a cutting and aspiration instrument, and wherein the delivering therapeutic treatment comprises cutting and aspirating portions of the stack using the cutting and aspiration instrument, and/or Wherein the instrument is an ultrasonic instrument, and wherein the delivering a therapeutic treatment comprises applying ultrasonic energy from the ultrasonic instrument to the stack to emulsify at least a portion of the stack, and/or Wherein the instrument is a laser instrument, and wherein the delivering a therapeutic treatment comprises applying laser energy from the laser instrument to the buildup to remove at least a portion of the buildup, and/or Wherein the instrument is a diathermy instrument, and wherein the delivering a therapeutic treatment comprises applying thermal energy from the diathermy instrument to a stack to remove at least a portion of the stack.
5. A system for treating otosclerosis in the middle ear, the system comprising an instrument configured to: advancing the shaft of the instrument through the external auditory canal such that the distal tip of the instrument is within the middle ear, and A therapeutic treatment is delivered from the device, Wherein the instrument is (i) a cutting and aspiration instrument, (ii) an ultrasonic instrument, (iii) a laser instrument, or (iv) a diathermic instrument, and Wherein the system further comprises a lens assembly (210) for viewing the middle ear (40) configured for temporary positioning in the tympanic membrane (30) between the external auditory canal (25) and the middle ear, the lens assembly comprising a frustoconical proximal portion extending into the external ear, the frustoconical proximal portion being gradually flared in a direction towards the external ear.
6. A system for treating eustachian tube dysfunction, the system comprising an instrument (500) configured to: Advancing a shaft of an instrument via an external auditory canal towards a eustachian tube (42), wherein the instrument comprises a balloon (520) on a distal end portion of the shaft, wherein the balloon is in a deflated state during advancement; Positioning the balloon in a eustachian tube, and The balloon is inflated while in the eustachian tube, Wherein the system further comprises a lens assembly (210) for viewing the middle ear (40) configured for temporary positioning in the tympanic membrane (30) between the external auditory canal (25) and the middle ear, the lens assembly comprising a frustoconical proximal portion extending into the external ear, the frustoconical proximal portion being gradually flared in a direction towards the external ear.
7. The system of claim 6, wherein advancing the shaft of the instrument toward the eustachian tube (42) via the external auditory canal includes passing the shaft of the instrument through an opening of a myringotomy tube (80) located in the tympanic membrane, and/or Wherein the stent device is positioned on the balloon during advancement of the shaft of the instrument via the external auditory canal towards the eustachian tube (42), and wherein inflation of the balloon while the balloon is in the eustachian tube inflates the stent device such that the eustachian tube is held open therein by the inflated stent device after removal of the balloon from the eustachian tube.
8. The system of claim 7, wherein the stent device is a drug eluting stent device.

Description

Otology devices, systems, and methods Cross Reference to Related Applications The present application claims U.S. provisional application No. 62/965,481 filed on month 1 and 24 in 2020, U.S. provisional application No. 63/024,183 filed on month 5 and 13 in 2020, which is incorporated herein by reference in its entirety, U.S. provisional application No. 63/040,495 filed on month 6 and 17 in 2020, which is incorporated herein by reference in its entirety, U.S. provisional application No. 63/051,568 filed on month 7 and 14 in 2020, U.S. provisional application No. 63/077,448 filed on month 9 and 11 in 2020, which is incorporated herein by reference in its entirety, U.S. provisional application No. 63/078,141 filed on month 9 and 14 in 2020, which is incorporated herein by reference in its entirety, U.S. provisional application No. 63/080,510 filed on month 9 and 18 in 2020, which is incorporated herein by reference in its entirety, and U.S. provisional application No. 63/081,015 filed on month 21 in 2020, which is incorporated herein by reference in its entirety, and U.S. provisional application No. 63/0826 in 2020, which is filed on month 24 in 2020, which is incorporated herein by reference in its entirety. Technical Field This document relates to devices, systems, and methods for facilitating surgery in the outer, middle, and inner ear to diagnose and/or treat diseases including, but not limited to, hearing loss and other ear diseases. In some examples, the systems and methods include instruments and techniques that can be used to minimize the invasiveness of procedures performed in the outer ear, middle ear, and/or inner ear space. Background Human ears are susceptible to a variety of diseases including, but not limited to, hearing loss, tinnitus, balance disorders including dizziness, meniere's disease, vestibular neuritis, vestibular schwannoma, labyrinthine, otosclerosis, ossicular dislocation, cholesteatoma, external ear infection, middle ear infection, and tympanic membrane perforation, to name a few examples. In one example, conductive Hearing Loss (CHL) includes loss of normal mechanical pathways for sound to hair cells in the cochlea, such as due to deformity, middle ear effusion, tympanic membrane rupture, presence of tumors, and/or lesions of the auditory ossicles. Sensorineural hearing loss (SNHL) is due to a loss or damage of hair cells in the cochlea, or an impaired downstream nerve signaling. SNHL is often associated with exposure to noisy noise, head trauma, aging, infection, meniere's disease, tumors, ototoxicity, genetic diseases such as Usher syndrome, and the like. Disclosure of Invention Described herein are devices, systems, and methods for performing surgery, for example, but not limited to, in the outer, middle, and/or inner ear to diagnose and/or treat diseases including, but not limited to, hearing loss and other ear diseases. For example, devices, systems, and methods including instruments and techniques are described herein to minimize invasiveness and/or enhance the efficacy of procedures performed in the outer ear, middle ear, and/or inner ear space. In some embodiments, the devices, systems, and methods for facilitating the procedures described herein may be used for middle and/or inner ear procedures involving surgical access via methods including, but not limited to, trans-mastoid, trans-aural canal, in-the-ear, behind-the-ear, pose, and the like. For example, techniques and instruments for performing transepidermal access to middle ear space at a reduced level of invasiveness are described herein. In another example, the present disclosure describes instruments and techniques for reducing a deposition of cholesteatoma in a minimally invasive manner. Further, enhanced instruments and techniques for procedures such as tympanostomy and myringotomy are described herein. Furthermore, in addition to middle and/or inner ear visualization, the devices, systems, and methods described herein are well suited for use with other cavities or spaces in the body, as well as other approaches. For example, the devices, systems, and methods are well suited for visualization and surgery in connection with eustachian tubes, mastoid sinus space, and outer drum, among others. The devices, systems, and methods described herein may be used in conjunction with other therapeutic techniques. For example, the devices, systems, and methods described herein may be used in conjunction with therapeutic techniques such as, but not limited to, therapeutic agent delivery (which may be in gel, liquid, or solid form), antibiotic delivery, gene delivery, device or implant delivery, diagnostic procedures, surgery, and the like. In one aspect, the present disclosure relates to a method for treating a cholesteatoma or soft tissue lesion in the middle ear. The method includes advancing a shaft of the instrument through an external auditory canal such that a distal tip of the instrument is in contact with a cholestea