System and method for the simultaneous bilateral integrated tympanic drug delivery and guided treatment of target tissues within the ears

• US 8,849,394 B2
• Filed: 08/16/2012
• Issued: 09/30/2014
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Clifford, Anton G., Liu, Greg, Morriss, John H., Makower, Joshua, Facteau, William M., Goldfarb, Eric, Chang, John Y.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/587,806
• Publication Number:
  US 20120310145A1
• Time in Patent Office: 775 Days
• Field of Search: 604/20, 606/109
• US Class Current: 604/20
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/227 for ears, i.e. otoscopes
• CPC Class Codes: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61F 11/202 Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61M 2210/0662 Ears
• CPC Class Codes: 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
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Systems and methods for treating a patient having a head with a first ear and a second ear function by mounting a support system to the head of the patient so that the support system is aligned with a target tissue of the first ear; applying a therapeutic agent to the first car by energizing an iontophoresis electrode supported by the support system; and actuating a device while the device is supported by the support system so that the device therapeutically remodels the target tissue of the first ear.

Claims

1. A method for treating a patient using an iontophoresis electrode system, the patient having a head with a first ear and a second ear, the method comprising:

(a) mounting a first iontophoresis electrode of the iontophoresis electrode system to the head of the patient so that the first iontophoresis electrode is aligned with a target tissue of the first ear;

(b) applying a therapeutic or anesthetic agent to the first ear by energizing the first iontophoresis electrode prior to any remodeling of the patient'"'"'s tympanic membrane in the first ear; and

(c) applying a therapeutic agent to the second ear by energizing a second iontophoresis electrode of the iontophoresis electrode system prior to any remodeling of the patient'"'"'s tympanic membrane in the second ear, wherein the electrodes are operatively coupled to iontophoresis driving circuitry of the iontophoresis electrode system, wherein the iontophoresis circuitry is configured for simultaneous application of the agent using the iontophoresis electrodes.

2. The method of claim 1, wherein the patient is sitting upright.

3. The method of claim 1, wherein the target tissue comprises a tympanic membrane, the method further comprising forming a fluid barrier configured to retain a fluid in an ear canal of the first ear while applying the agent, the fluid comprising the agent, so that the fluid provides fluid communication between the first iontophoresis electrode and the tympanic membrane.

4. The method of claim 3, wherein the iontophoresis electrode system further comprises a first lumen extending through the fluid barrier for introducing the fluid to the ear canal, and a second lumen through the fluid barrier for venting the canal.

5. The method of claim 4, further comprising perforating the tympanic membrane of the first ear after applying the agent to the first ear.

6. The method of claim 5, further comprising deploying a tympanostomy tube in the perforated tympanic membrane.

7. The method of claim 1, the agent comprising at least one of lidocaine, epinephrine, or combinations thereof.

8. The method of claim 1, the agent comprising at least one of an anesthetic, an anti-inflammatory, a mucolytic, an antibiotic, a steroid, an anti-viral, a surfactant or combinations thereof.

9. The method of claim 1, wherein the iontophoresis electrode system further comprises a support structure and an iontophoresis module, wherein the iontophoresis module further includes the first iontophoresis electrode, the iontophoresis module releasably engaging an interface of the support structure.

10. The method of claim 1, wherein the iontophoresis electrode system further comprises hardenable material and an injection system for advancing the material into the ear canal of the first ear so as to stabilize the first iontophoresis electrode relative to the target tissue.

11. The method of claim 10 wherein the hardenable material is removable from the ear canal.

12. The method of claim 1, further comprising imaging the target tissue of the ear via an image capture device.

13. The method of claim 1, wherein the iontophoresis electrode system further comprises a support system associated with the first and second electrode modules.

14. The method of claim 13 wherein the support system comprises a headset.

15. The method of claim 13 wherein the support system comprises a pair of ear plugs.

16. A system for treating a patient, the patient having a head with a first ear and a second ear, the system comprising:

(a) a first electrode module;

(b) a second electrode module;

(c) a first iontophoresis electrode coupled with the first electrode module, wherein the first iontophoresis electrode is operable to couple with target tissue in the first ear via an agent, wherein the first iontophoresis electrode is operable to be activated to thereby apply the agent to the target tissue in the first ear prior to any remodeling of the target tissue in the first ear;

(d) a second iontophoresis electrode coupled with the second electrode module, wherein the second iontophoresis electrode is operable to couple with target tissue in the second ear via an agent, wherein the second iontophoresis electrode is operable to be activated to thereby apply the agent to the target tissue in the second ear prior to any remodeling of the target tissue in the second ear;

(e) iontophoresis driving circuitry operatively coupleable with the electrodes for simultaneous application of the agent to the first and second ears; and

(f) a return electrode operatively coupled with the iontophoresis driving circuitry, said return electrode being configured for location beyond the reach of the patient on the patient'"'"'s skin.

17. A method for treating a patient, the patient having a head with a first ear and a second ear, the method comprising:

(a) mounting a first iontophoresis electrode to the head of the patient so that the iontophoresis electrode is positioned within the first ear;

(b) communicating an anesthetic iontophoresis solution into the ear canal of the first ear; and

(c) activating the first iontophoresis electrode to cause the iontophoresis electrode to apply the anesthetic iontophoresis solution to the first ear through iontophoresis prior to any remodeling of tissue in the first ear.

18. The method of claim 17, further comprising:

(a) mounting a second iontophoresis electrode to the head of the patient so that the iontophoresis electrode is positioned within the second ear;

(b) communicating an anesthetic iontophoresis solution into the ear canal of the second ear; and

(c) activating the second iontophoresis electrode to cause the iontophoresis electrode to apply the anesthetic iontophoresis solution to the second ear through iontophoresis prior to any remodeling of tissue in the second ear.

19. The method of claim 18, wherein the act of activating the first iontophoresis electrode and the act of activating the second iontophoresis electrode are performed simultaneously.

20. The method of claim 18, wherein the first and second iontophoresis electrodes are mounted to a headset, wherein the acts of mounting the first and second iontophoresis electrodes to the head of the patient comprise mounting the headset to the head of the patient.