APPARATUS AND METHOD FOR APPLICATION OF A PHARMACEUTICAL TO THE TYMPANIC MEMBRANE FOR PHOTODYNAMIC LASER MYRINGOTOMY

• US 20080108936A1
• Filed: 11/03/2006
• Published: 05/08/2008
• Est. Priority Date: 11/03/2006
• Status: Active Grant

• Current Assignee: Mobius Otologics, LLC
• Original Assignee: Mobius Therapeutics, Inc.
• Inventors: Timm, Edward J.
• Granted Patent: US 7,494,487 B2
• Time in Patent Office: Days
• US Class Current: 604/21
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61P 27/16 Otologicals

Abstract

A packaged kit for performing a photodynamic laser myringotomy includes a plurality of ear needles having different shaped absorbent applicators on distal ends of the needles, a vial of a single dose of an otologic formulation of mitomycin-C, a diluent carrier containing sterilized water, and a syringe. The component parts of the kit are used together to reconstitute the contents of the vial with the water in the diluent carrier, and then draw the reconstituted drug into the syringe. A selected one of the plurality of ear needles is then communicated with the syringe. The syringe and needle are then used to inject the reconstituted drug into the absorbent pad at the end of the needle, and the absorbent pad containing the drug is used to apply the drug to the tympanic membrane. The application of the drug to the tympanic membrane prepares the membrane for a myringotomy procedure, and in particular, a photodynamic laser myringotomy.

Claims

1. An apparatus for application of a pharmaceutical comprising:

the pharmaceutical being a single dose of an otologic formulation of mitomycin-C.

2. The apparatus of claim 1, further comprising:

the single dose of mitomycin-C being suspended in an agent that permeates living tissue with the mitomycin-C.

3. The apparatus of claim 1, further comprising:

the single dose of mitomycin-C being suspended in a viscous agent.

4. The apparatus of claim 1, further comprising:

the single dose of mitomycin-C being suspended in an adhesive agent.

5. The apparatus of claim 1, further comprising:

the single dose of mitomycin-C having a specific color.

6. The apparatus of claim 5, further comprising:

an ear needle that is adapted for receiving the single dose of mitomycin-C and delivering the mitomycin-C to a tympanic membrane to remain in situ on the tympanic membrane and cause anti-metabolic activity on the tympanic membrane that is localized and defined by the specific color.

7. The apparatus of claim 6, further comprising:

a laser that is specifically tuned to emit a laser beam that will ablate tympanic membrane tissue defined by the specific color.

8. The apparatus of claim 1, further comprising:

an ear needle that is adapted for receiving the single dose of mitomycin-C and delivering the mitomycin-C to a tympanic membrane to remain in situ on the tympanic membrane and cause anti-metabolic activity on the tympanic membrane.

9. The apparatus of claim 8, further comprising:

the ear needle having a tubular length with opposite proximal and distal ends, the needle proximal end being adapted for communicating the needle with a syringe, and the needle distal end having an absorbent pad fixed to the distal end.

10. The apparatus of claim 9, further comprising:

the pad having a cone shape projecting from the needle distal end to a tip of the cone shape.

11. The apparatus of claim 9, further comprising:

the pad having a cylindrical shape that projects from the needle distal end.

12. The apparatus of claim 9, further comprising:

the needle distal end having a center axis; and

, the pad being planar and being positioned transverse to the needle distal end center axis.

13. The apparatus of claim 1, further comprising:

a plurality of ear needles that are each adapted for receiving the single dose of mitomycin-C, each needle having a tubular length with opposite proximal and distal ends, each needle proximal end being adapted for communicating the needle with a syringe; and

,

a plurality of absorbent pads fixed to the distal end of the plurality of needles, at least some of the plurality of absorbent pads having different shapes.

14. The apparatus of claim 13, further comprising:

a tray;

a lid positionable over the tray;

the plurality of needles being positioned in the tray and covered by the lid;

a container of the single dose of mitomycin-C positioned in the tray and covered by the lid; and

,

a syringe positioned in the tray and covered by the lid.

15. The apparatus of claim 14, further comprising:

the tray having a plurality of separated compartments;

the plurality of ear needles being positioned in a compartment of the tray;

the container being positioned in a compartment of the tray; and

, the syringe being positioned in a compartment of the tray.

16. The apparatus of claim 14, further comprising:

a diluent carrier positioned in a compartment of the tray.

17. An apparatus for application of a pharmaceutical comprising:

a container containing a single dose of an otologic formulation of mitomycin-C;

a syringe;

at least one ear needle having a tubular length with opposite proximal and distal ends, the proximal end of the ear needle being adapted for communication with the syringe;

at least one absorbent pad adapted for communication with a distal end of an ear needle; and

,

a packaging containing the container, the syringe, the ear needle, and the pad as a packaged kit.

18. The apparatus of claim 17, further comprising:

the at least one ear needle being one of a plurality of ear needles with opposite proximal and distal ends, the proximal ends of the ear needles each being adapted for communication with the syringe;

the at least one absorbent pad being one of a plurality of absorbent pads having different shapes, each pad of the plurality of absorbent pads being adapted for communication with a distal end of an ear needle of the plurality of ear needles; and

, the packaging containing the plurality of ear needles and the plurality of pads.

19. The apparatus of claim 18, further comprising:

each pad of the plurality of pads being fixed to a distal end of an ear needle of the plurality of ear needles.

20. The apparatus of claim 19, further comprising:

a diluent carrier; and

,

the packaging containing the diluent carrier in the packaged kit.

21. The apparatus of claim 19, further comprising:

the mitomycin-C having a specific color.

22. The apparatus of claim 19, further comprising:

the mitomycin-C being suspended in an agent that can permeate living tissue.

23. A method for application of a pharmaceutical comprising:

providing a single dose of an otologic formulation of mitomycin-C; and

, applying the single dose of mitomycin-C to interior tissue of an ear canal.

24. The method of claim 23, further comprising:

applying the mitomycin-C to a tympanic membrane in the ear canal.

25. The method of claim 23, further comprising:

suspending the mitomycin-C in a viscous agent.

26. The method of claim 23, further comprising:

suspending the mitomycin-C in an adhesive agent that can permeate living tissue.

27. The method of claim 23, further comprising:

giving the mitomycin-C a specific color.

28. The method of claim 27, further comprising:

applying the mitomycin-C to a tympanic membrane in the ear canal.

29. The method of claim 28, further comprising:

causing anti-metabolic activity on the tympanic membrane by application of the mitomycin-C at a location on the tympanic membrane that is defined by the color of the mitomycin-C.

30. The method of claim 29, further comprising:

treating the location on the tympanic membrane by ablating the location with a laser specifically tuned to the color of the mitomycin-C.