Devices, systems, and methods for treating ear disorders
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.
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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. The system of claim 7 , wherein the injection shaft of the gel injection device comprises a needle.
9. 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.
10. 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.
11. 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.
12. The system of claim 10 , wherein the endoscope shaft is positionable through the tympanic membrane via an opening having a diameter of 1 mm.
13. 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.
14. The system of claim 1 , wherein the gel formulation source comprises a syringe reservoir containing the therapeutic gel formulation comprising an anti-inflammatory agent.
15. 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.
16. 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.
17. 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.