# US 11,906,719 B2 · Devices, systems, and methods for treating ear disorders

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- Number: US 11,906,719 B2
- Document ID: US11906719B2
- Status: Granted
- Kind: B2
- Application number: 17/155,589
- Filed: 2021-01-22
- Published: 2021-07-29
- Granted: 2024-02-20
- Earliest claimed: 2020-01-24
- Assignees: Spiral Therapeutics Inc.
- Applicants: Spiral Therapeutics Inc.
- Inventors: Eugene de Juan; Hugo Peris; Signe Erickson; Vrad Levering
- Web page: https://patentgrep.com/patent/US11906719B2

## CPC

- G02B 21/0012: {Surgical microscopes (counterbalanced structures for surgical microscopes G02B7/001)}
- A61B 1/018: for receiving instruments
- A61B 1/227: for ears, i.e. otoscopes
- A61B 17/205: {Vaccinating by means of needles or other puncturing devices}
- A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 17/29: Forceps for use in minimally invasive surgery
- A61B 17/32002: {with continuously rotating, oscillating or reciprocating cutting instruments}
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 17/3201: Scissors (for biopsy A61B10/02)
- A61B 17/3205: Excision instruments
- A61B 17/3423: {Access ports, e.g. toroid shape introducers for instruments or hands (access sites for liquids A61M39/0247)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/1485: {having a short rigid shaft for accessing the inner body through natural openings}
- A61B 18/20: using laser
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61F 11/00: Methods or devices for treatment of the ears or hearing sense (implantable prostheses that substitute or replace internal ear parts, e.g. ear-drums, A61F2/18; methods or devices to cause a change in the state of auditory consciousness A61M21/00; electrotherapy applying electrical stimulation of the auditory system, or circuits therefor A61N1/36; radiotherapy using optical stimulation of the auditory system A61N5/06; electro-acoustic hearing aids H04R25/00); Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand (headwear, e.g. caps or helmets, with means for protecting the ears A42B1/0188, A42B3/16)
- A61F 11/20: Ear surgery
- A61F 11/202: {Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor}
- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61M 37/0015: {by using microneedles}
- G02B 21/0032: {Optical details of illumination, e.g. light-sources, pinholes, beam splitters, slits, fibers (G02B21/0036 - G02B21/008; means for illumination of specimens in general G02B21/06)}
- G02B 21/22: Stereoscopic arrangements
- G02B 23/2476: {Non-optical details, e.g. housings, mountings, supports}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00323: {Cables or rods}
- A61B 2017/00331: {with preformed bends}
- A61B 2017/00544: {pneumatically}
- A61B 2017/00738: {part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon}
- A61B 2017/00787: {Surgery of the ear}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00907: {for light}
- A61B 2017/305: {Tweezer like handles with tubular extensions, inner slidable actuating members and distal tools, e.g. microsurgical instruments}
- A61B 2017/320028: {with reciprocating movements}
- A61B 2017/320069: {for ablating tissue}
- A61B 2017/32007: {with suction or vacuum means}
- A61B 2017/3445: {used as instrument channel for multiple instruments}
- A61B 2017/3447: {Linked multiple cannulas}
- A61B 2017/345: {for introduction into a natural body opening}
- A61B 2018/00327: {Ear, nose or throat}
- A61B 2217/005: with suction drainage system
- A61F 2002/183: {Ear parts}
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/0046: {Solid microneedles}
- A61M 2205/04: implanted
- A61M 2210/0662: Ears
- A61M 2210/0668: Middle ear
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a formulation or implant device to a target location under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

## Claims

### Claim 1

A system for delivering a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization, the system comprising:
an endoscope including an endoscope shaft with a distal tip portion sized to be positioned within a middle ear;
a sleeve device defining: (i) a first lumen through which the endoscope shaft extends such that the distal tip portion of the endoscope is positionable through a tympanic membrane and into a middle ear to visualize a round window niche of a cochlea while the sleeve device is entirely external from the tympanic membrane, and (ii) a second lumen adjacent to the first lumen;
a gel injection device including a proximal actuator and an injection shaft with an injector distal tip portion defining a side-cut delivery port positioned proximally of a distal-most end of the injection shaft to dispense a therapeutic gel formulation, the injection shaft sized to be slidably received in the second lumen of the sleeve device while the endoscope shaft is slidably received in the first lumen of the sleeve device, wherein the injector distal tip portion of the gel injection device is positionable through the tympanic membrane and movable distally of the distal tip portion of the endoscope such that the side-cut delivery port of the gel injection device is advanceable to the round window niche to dispense the therapeutic gel formulation to the round window niche while the distal tip portion of the endoscope is spaced proximally from the side-cut delivery port of the injection injector shaft to provide visualization of the injection; and
a gel formulation source in fluid communication with the gel injection device so that the side-cut delivery port is configured to deliver the therapeutic gel formulation at the round window niche in response to movement of the proximal actuator of the gel injection device.

### Claim 2 (depends on 1)

The system of claim 1, wherein the injector distal tip portion of the gel injection device is adjustable from a longitudinally straight shape to a curved shape to orient the side-cut delivery port toward the round window niche.

### Claim 3 (depends on 2)

The system of claim 2, wherein the injector distal tip portion of the gel injection device is selectively adjustable to the curved shape by manipulating one or more control members slidably coupled with the injector distal tip portion.

### Claim 4 (depends on 1)

The system of claim 1, further comprising a first tympanic membrane port device configured to be removably implanted in the tympanic membrane, wherein the first membrane port device defines a port lumen, and wherein at least one of the endoscope and the gel injection device is configured to pass through the port lumen.

### Claim 5 (depends on 1)

The system of claim 1, wherein the sleeve device is a two-channel alignment sleeve in which the first lumen is a primary channel having a first diameter and the second lumen is an auxiliary working channel having a second diameter smaller than the first diameter and being laterally separated from the primary channel by an intermediate wall portion of the two-channel alignment sleeve.

### Claim 6 (depends on 5)

The system of claim 5, wherein the injector distal tip portion of the gel injection device is movable relative to both the two-channel alignment sleeve and the distal tip portion of the endoscope.

### Claim 7 (depends on 6)

The system of claim 6, wherein a proximal portion of the gel injection device located proximally of the two-channel alignment sleeve has a curved shape.

### Claim 8 (depends on 7)

The system of claim 7, wherein the injection shaft of the gel injection device comprises a needle.

### Claim 9 (depends on 7)

The system of claim 7, wherein the endoscope shaft has an outer diameter larger than an outer diameter of the injection shaft and is sized to pass through a first incision through the tympanic membrane.

### Claim 10 (depends on 9)

The system of claim 9, wherein the outer diameter of the injection shaft is sized to pass through a second incision through the tympanic membrane while positioned adjacent to the endoscope shaft.

### Claim 11 (depends on 10)

The system of claim 10, further comprising at least one tympanic membrane port device configured to be removably implanted in the tympanic membrane, the tympanic membrane port device including a central port lumen having a diameter of 1 mm.

### Claim 12 (depends on 10)

The system of claim 10, wherein the endoscope shaft is positionable through the tympanic membrane via an opening having a diameter of 1 mm.

### Claim 13 (depends on 5)

The system of claim 5, wherein the two-channel alignment sleeve is configured to compress against an exterior of the endoscope to affix the two-channel alignment sleeve to the endoscope while the endoscope shaft is positioned with the primary channel so that the injector distal tip portion of the injection shaft is movable relative to both the two-channel alignment sleeve and the distal end portion of the endoscope.

### Claim 14 (depends on 1)

The system of claim 1, wherein the gel formulation source comprises a syringe reservoir containing the therapeutic gel formulation comprising an anti-inflammatory agent.

### Claim 15 (depends on 14)

The system of claim 14, wherein the therapeutic gel formulation comprising the anti-inflammatory agent comprises first and second functional components mixed to generate a crosslinking reaction of the therapeutic gel formulation.

### Claim 16 (depends on 14)

The system of claim 14, wherein the therapeutic gel formulation contained within the syringe reservoir comprises the anti-inflammatory agent selected from group consisting of: hydrocortisone, hydrocortisone acetate, dexamethasone, dexamethasone 21-phosphate, fluocinolone, medrysone, prednisolone, prednisolone 21-phosphate, prednisolone acetate, fluoromethalone, betamethasone, and triamcinolone.

### Claim 17 (depends on 14)

The system of claim 14, wherein the anti-inflammatory agent of the therapeutic gel formulation is provided in an amount sufficient to move passively by diffusion across a membrane of the round window and into the cochlea.