System and Method for the Simultaneous Bilateral Integrated Tympanic Drug Delivery and Guided Treatment of Target Tissues Within the Ears

• US 20080262509A1
• Filed: 05/16/2007
• Published: 10/23/2008
• Est. Priority Date: 04/19/2007
• Status: Active Grant

• Current Assignee: Tusker Medical, Inc. (Smith & Nephew PLC)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Liu, Greg, Makower, Joshua, Goldfarb, Eric, Chang, John Y., Clifford, Anton, Facteau, William, Morris, John
• Granted Patent: US 8,249,700 B2
• Time in Patent Office: Days
• US Class Current: 606/109
• 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 ear 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, the patient having a head with a first ear and a second ear, the method comprising:

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 ear 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.

2. The method of claim 1, wherein the target tissue comprises a tympanic membrane, and further comprising retaining a fluid in an ear canal of the first ear with a fluid barrier while applying the agent, the fluid comprising the therapeutic agent and providing fluid communication between the electrode and the tympanic membrane.

3. The method of claim 2, wherein the support system comprises the fluid barrier, and further comprising introducing the fluid to the ear canal through a first lumen, the supply lumen extending through the fluid barrier, and venting the canal with a second lumen through the fluid barrier.

4. The method of claim 2, wherein the agent comprises a local anesthetic or local anesthesia, and wherein the therapeutic remodeling effected by the device is associated with at least some sensation or a noise.

5. The method of claim 4, wherein the therapeutic remodeling comprises perforating the tympanic membrane.

6. The method of claim 5, wherein the therapeutic remodeling further comprises deployment of a tympanostomy tube.

7. The method of claim 2, wherein the agent comprises at least one of lidocaine, epinephrine, or combinations thereof.

8. The method of claim 2, wherein the agent comprises at least one of an antibiotic, an anti-inflammatory, a mucolytic, an anesthetic, a steroid, an anti-viral, a surfactant or combinations thereof.

9. The method of claim 2, wherein the therapeutic remodeling is initiated within one hour of the initiation of the application of the agent.

10. The method of claim 1, further comprising replacing an iontophoresis module with a remodeling module between the applying of the agent and the remodeling, the modules sequentially engaging a module interface of the support structure.

11. The method of claim 1, further comprising applying a therapeutic agent to the second ear by energizing another iontophoresis electrode supported by the support system, the electrodes operatively coupled to iontophoresis driving circuitry, the iontophoresis circuitry configured for simultaneous application of the agent using the electrodes;

and

actuating another device while the other device is supported by the support system so that the other device therapeutically remodels the target tissue of the second ear.

12. The method of claim 1, further comprising stabilizing the support structure relative to the target tissue by injecting a material into the canal and hardening the material.

13. The method of claim 1, further comprising imaging the target tissue of the ear with an image capture device supported by the support structure.

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

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

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 ear by energizing an iontophoresis electrode supported by the support system; and

applying a therapeutic agent to the second ear by energizing another iontophoresis electrode supported by the support system, the electrodes operatively coupled to iontophoresis driving circuitry, the iontophoresis circuitry configured for simultaneous application of the agent using the electrodes.

16. The method of claim 15, wherein the patient is sitting upright.

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

a support system mountable to the head of the patient so that the support system is aligned with a target tissue of the first ear;

an iontophoresis electrode mountable to the support system for coupling with the target tissue by a therapeutic agent so as to apply the agent thereto; and

a device mountable to the support system, the device actuatable so that the device therapeutically remodels the target tissue of the first ear.

18. The system of claim 17, wherein the target tissue comprises a tympanic membrane, and further comprising a fluid barrier configured to retain a fluid in an ear canal of the first ear while applying the agent, the fluid comprising the therapeutic agent, so that the fluid provides fluid communication between the electrode and the tympanic membrane.

19. The system of claim 18, wherein the support system comprises the fluid barrier, and further comprising 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.

20. The system of claim 19, wherein the device comprises a mechanically articulating mechanism having a perforator, articulation of the mechanism effecting advancement of the perforator suitable for safely perforating the tympanic membrane.

21. The system of claim 20, wherein the device further comprises a tympanostomy tube releasably carried with the perforator for deployment in the tympanic membrane.

22. The system of claim 17, further comprising an agent for iontophoretic application using the iontophoresis electrode, the agent comprising a local anesthetic or local anesthesia.

23. The system of claim 17, further comprising an agent for iontophoretic application using the iontophoresis electrode, the agent comprising at least one of lidocaine, epinephrine, or combinations thereof.

24. The system of claim 17, further comprising an agent for iontophoretic application using the iontophoresis electrode, 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.

25. The system of claim 23, wherein the iontophoresis electrode is included in an iontophoresis module, the iontophoresis module releasably engaging an interface of the support structure, and wherein the device is included within a remodeling module releasably engageable by the interface of the support structure so that the modules are sequentially supportable by the interface of the support structure.

26. The system of claim 17, further comprising another iontophoresis electrode supportable by the support system for applying a therapeutic agent to the second ear;

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

another device actuatuatable while the other device is supported by the support system so that the other device therapeutically remodels the target tissue of the second ear.

27. The system of claim 17, further comprising hardenable material and an injection system for advancing the material into the canal so as to stabilize the support structure relative to the target tissue.

28. The system of claim 27 wherein the hardenable material and the support structure are removable from the canal.

29. The system of claim 17, further comprising an image capture device supportable by the support structure for imaging the target tissue of the ear.

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

a first and a second support system aligned with a target tissues of the first ear and the second ear;

an iontophoresis electrode mountable to the first support system for coupling with the target tissue by a therapeutic agent so as to apply the agent thereto;

another iontophoresis electrode supportable by the second support system for applying a therapeutic agent to the second ear;

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

a return electrode operatively coupled with the iontophoresis driving circuitry, said return electrode being located beyond the reach of the patient on the patient'"'"'s skin.