System and Method for the Simultaneous Bilateral Placement of Pressure Equalization Tubes

• US 20080262508A1
• 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: Makower, Joshua, Clifford, Anton, Facteau, William
• Granted Patent: US 9,216,112 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 bilateral treatment of a patient having a head with a first ear and a second ear function by aligning a first device with a target tissue of the first ear; aligning a second device with a target tissue of the second ear; and therapeutically remodeling, with synchronization, the target tissues of the first and second ear with the first and second aligned devices, respectively.

Claims

1. A method for bilateral treatment of a patient, the patient having a head with a first ear and a second ear, the method comprising:

aligning a first device with a target tissue of the first ear;

aligning a second device with a target tissue of the second ear; and

therapeutically remodeling, with synchronization, the target tissues of the first and second ear with the first and second aligned devices, respectively.

2. The method of claim 1, wherein the patient comprises a child, wherein the child is awake and perceives a sound or at least some sensation induced by the therapeutic remodeling.

3. The method of claim 2, wherein the therapeutic remodeling of the ears are sufficiently simultaneous to inhibit therapeutic remodeling induced movement or apprehension by the child after the treatment of the first ear and before the treatment of the second ear.

4. The method of claim 3, wherein the target tissue comprises the tympanic membranes, and wherein the therapeutic remodeling comprises a myringotomy.

5. The method of claim 4, wherein the therapeutic remodeling further comprises the bilateral implantation of tympanostomy tubes.

6. The method of claim 1, wherein the therapeutic remodeling comprises penetration of the target tissue, and further comprising applying a local pain inhibitor to both ears before initiation of the therapeutic remodeling.

7. The method of claim 6, wherein the therapeutic remodeling is effected while the patient is awake, wherein the local pain inhibitor comprises a local anesthetic or local anesthesia, and wherein the local pain inhibitor is applied using iontophoresis.

8. The method of claim 6, wherein the therapeutic remodeling of both ears is completed within an hour of the initiation of the application of the local pain inhibitor.

9. The method of claim 6, wherein the treatment is performed in a doctor office setting.

10. The method of claim 1, further comprising supporting each of the aligned devices relative to the head of the patient with a support system.

11. The method of claim 10, wherein the support system comprises an ear alignment structure with a first body engaging the first ear, a second body engaging the second ear, and a member extending around the head of the patient between the first and second body.

12. The method of claim 10, further comprising supporting, with the support system, at least one module selected from:

an iontophoresis module including an iontophoresis electrode in fluid communication with the tympanic membrane so as to apply a therapeutic agent;

or

a range module configured to indicate a distance between the support system and the tympanic membrane;

wherein the at least one module is interchangeable with a tympanastomy tube module configured for perforation of and deployment of a pressure equalization tube through the tympanic membrane, the tympanostomy tube module comprising the first device.

13. The method of claim 1, further comprising preoccupying the patient with one or more of:

an audio track;

or

a video.

14. The method of claim 1, further comprising preoccupying the patient with one or more of:

an audio track, wherein the therapeutic remodeling is synchronized with the audio track;

or

a video, wherein the therapeutic remodeling is synchronized with the video.

15. The method of claim 1, further comprising simultaneously displaying the target tissue of the first ear and the target tissue of the second ear to a medical professional, wherein the medical professional inputs a command to an input device, and wherein the therapeutic remodeling of the first ear and the second ear is performed in response to the input command.

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

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

a first device alignable with a target tissue of the first ear, the first device having at least one treatment delivery surface; and

a second device alignable with a target tissue of the second ear while the first device is in alignment with the target tissue of the first ear, the second device having at least one treatment delivery surface;

the first and second treatment delivery devices being actuatable to effect therapeutic remodeling of the target tissues.

18. The system of claim 17, further comprising a support system configured to concurrently support each of the aligned devices relative to the head of the patient.

19. The system of claim 18 wherein the support system comprises an ear alignment structure with a first body engaging the first ear, a second body engaging the second ear, and a member extending around the head of the patient between the first and second body.

20. The system of claim 17, wherein the first and second devices are configured for actuation when aligned so as to effect synchronized bilateral therapeutic remodeling of the target tissues of the first and second ear.

21. The system of claim 17, further comprising an input device coupled to the first and second input devices by a controller, the controller configured to effect the therapeutic remodeling of the first and second ears in response to a command to the input device, and one or more of:

a speaker coupled to the ear alignment structure, the controller configured to synchronize the therapeutic remodeling with an audio track played by the speaker;

or

a video display oriented toward the patient, the controller configured to synchronize the therapeutic remodeling with a video shown on the video display.

22. The system of claim 17, further comprising a first image capture device aligned with the treatment surface(s) of the first device and a second image capture device aligned with the treatment surface(s) of the second device, the image capture devices coupled to a display system by the processor so as to simultaneously display the target tissue of the first ear and the target tissue of the second ear to the user.

23. The system of claim 17, the patient being a child and a sound or at least some sensation being induced by the therapeutic remodeling, wherein the first and second delivery devices are sized for a pediatric treatment of the ears of the child, and wherein the first and second treatment devices are operatively coupled together so that therapeutic remodeling of the ears is effected sufficiently simultaneously to inhibit remodeling induced movement or apprehension by the child after the treatment of the first ear and before the treatment of the second ear.

24. The system of claim 23, the target tissue including the tympanic membranes, wherein the treatment delivery surfaces of the first device and the second device each comprise tympanic membrane penetrators configured for a myringotomy.

25. The system of claim 24, wherein the treatment devices comprise electromechanical actuators effecting movement of the penetrators in response to electrical signals, the electromechanical actuators comprising springs biased to extend and/or retract the penetrators along an axis oriented along the ear canal.

26. The system of claim 25, wherein the treatment devices further comprise tympanostomy tubes carried with the movement of the penetrators, the electromechanical actuators inhibiting retraction of the tubes when the penetrators are retracted so that the therapeutic remodeling comprises the implantation of the tympanastomy tubes in the tympanic membrane.

27. The system of claim 17, further comprising a local pain inhibitor for application to the ears to effect the therapeutic remodeling, the therapeutic remodeling including a myringotomy of each tympanic membrane, the local pain inhibitor comprising a local anesthetic or local anesthesia, and further comprising first and second iontophoresis electrodes supported in first and second ear canals of the first and second ears, respectively, by a support structure such that the therapeutic remodeling of both ears can be completed within an hour of the initiation of the application of the local pain inhibitor, and a return iontophoresis electrode configured to be operatively coupled with the first and second iontophoresis electrodes.